DIA 2019 Global Annual Meeting: Full Schedule

8:00am

Exhibitor Registration

Saturday June 22, 2019 8:00am - 5:00pm
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

Registration for Full Day and Morning Preconference Short Courses

Sunday June 23, 2019 8:00am - 9:00am
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

Exhibitor Registration

Sunday June 23, 2019 8:00am - 6:00pm
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC20: #20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

This course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December, 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning Objectives

At the conclusion of this course, participants should be able to:

Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies;
Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments;
Recognize when RWE based approaches are of sufficient quality to enable decision making.

Speakers

Brian Bradbury

Executive Director, Head, Data and Analytics, Center for Observational Research, Amgen, Inc.

Brian D. Bradbury is Executive Director in the Center for Observational Research (CfOR) at Amgen, Inc, and an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who use real-world data (RWD) to... Read More →

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA

Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health... Read More →

Jessica Franklin

Assistant Professor of Medicine, Div of Pharmacoepidemiology and Pharmacoeconomi, Brigham and Women's Hospital and Harvard Medical School

Jessica Franklin, PhD, is an Assistant Professor of Medicine at Harvard Medical School and biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on developing and applying statistical methods for the study... Read More →

Paul Muntner

Professor of Epidemiology and Associate Dean for Research, University of Alabama at Birmingham

Paul Muntner is Associate Dean for Research and Professor of Epidemiology at the University of Alabama at Birmingham. He earned a Master’s degree in biostatistics and a doctorate degree in epidemiology from the Johns Hopkins University. Since 2014, he has served as Co-Director of... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 01: ClinSafety-PV, Tutorial

Level Intermediate
Featured Topics Real World Evidence
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC27: #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-507-L04-P; CME 3.25; IACET 3.25; RN 3.25

Evidence suggests that capturing clinical outcome assessment data electronically (eCOA) has many benefits over paper. However, barriers to adoption still remain. Poor adoption is in part attributable to unfamiliarity with benefits, but also poor experiences during study start-up, absence of clear expectations among sponsors and vendors, and misalignment among all stakeholders. This is also an area where no formal training exists for sponsors or eCOA providers. This short course is designed to introduce participants to key eCOA topics including:

Benefits of and barriers to eCOA adoption
Regulatory guidance applicable to eCOA vendors
Key measurement science and design principles applicable when using eCOA
Considerations when choosing a solution for your study based on study design and patient population
Start-up processes and considerations for migrating from paper to electronic modes of data collection, developing specification documents, and conducting user acceptance testing
Role of sponsors and sites in the trial technology implementation process and in optimizing quality of data collected with eCOA
Best practice recommendations for training site staff and study subjects on eCOA data collection in clinical trials
Considerations for the use of bring your own device (BYOD) in clinical trials

The interactive short course, created in collaboration with the Critical Path Institute’s ePRO Consortium, will provide real world examples and case studies including challenges and proposed solutions for the audience to work through in small groups.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals in the clinical operations, digital technologies, procurement, clinical science or outcomes research areas at pharmaceutical companies who are considering collection of eCOA data or evaluating eCOA technology providers for their clinical studies. eCOA provider staff and developers new to the field would also benefit from this course.

Learning Objectives

At the conclusion of this course, participants should be able to:

Review benefits and challenges of capturing eCOA data in clinical trials;
Identify measurement science principles applicable to eCOA data capture and considerations for measurement comparability;
Discuss roles and responsibilities of eCOA providers, sponsors and sites in the implementation/deployment of clinical trials collecting electronic COA data.

Speakers

Paul O'Donohoe

Scientific Lead, eCOA and Mobile Health, Medidata Solutions

Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company's scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and supports... Read More →

Susan Vallow

Executive Director, Patient-Centered Outcomes Research, Worldwide Clinical Trials

Susan Vallow, VP, Patient Centered Outcomes Strategy, MedAvante-ProPhase, is an experienced outcomes researcher with a specialty in the strategy, development and implementation of PROs. Sue previously was Senior Director & Head, Patient Focused Outcomes at GSK, where she managed the... Read More →

Patricia DeLong

Manager, Patient-Reported Outcomes, Janssen Global Services, LLC

Patricia (Trish) Shepherd Delong has worked in the PRO and eCOA fields for more than ten years in both contract research and pharmaceutical organizations. She currently holds the role of PRO Process expert within the PRO team at Janssen. In this role Trish represents the PRO functional... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 02: ClinTrials -ClinOps, Tutorial

Level Intermediate
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC24: #24: Data Visualization in the Life Sciences

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response. For example, we may have a clear understanding for how a novel therapy induces an efficacious response, but there is typically limited knowledge into the downstream effects of the drug to other body systems. A second challenge to communication lies in the increased use of sensitivity analyses to assess the consistency and robustness of study results to varying assumptions. Given the volume of data to review and the variety of analyses to perform, it should come as no surprise that clear insight is often out of reach. In this environment, the traditional means of data summary – tables and listings – are ineffective for gaining insight; visualization is the key to effective communication for the modern clinical trialist. Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon. At least 2/3 of the course will focus on case studies specific to clinical trials, while the remainder will be spent on examples in genomics. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.

Learning Objectives

At the conclusion of this course, participants should be able to:

Describe the transition from traditional methods of data analysis to visual approaches;
Interpret life science data using one or more data visualizations;
Assess the strengths and limitations of various graphical techniques;
Explain the “data story” of numerous clinical research examples using data visualization techniques.

Speakers

Kelci Miclaus

Senior Manager, Advanced Analytics R&D, SAS Institute Inc., JMP Division

Dr. Kelci Miclaus is Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute where she manages the R&D team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics from North Carolina... Read More →

Richard Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc

Richard C. Zink is Senior Director of Data Management and Statistics at TARGET PharmaSolutions. He is the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, host of the Biopharmaceutical Section Statistics Podcast, and Associate Editor for the DIA... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 03: Data-Data Standards, Tutorial | 03: Data-Data Standards, Tutorial | 11: Statistics, Tutorial

Level Intermediate
Featured Topics Real World Evidence
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC22: #22: Protocol Co-Design with Patients and Advocates

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

This short course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates. Following a brief introduction outlining the benefits of interactive activities with multiple stakeholders, you will engage in several activities:

Protocol red lining (individual/partner activity)
Design your own protocol (small group activity)
Walk the protocol (large group activity)

The first activity asks you to react to a draft protocol individually. You will then share your reactions with a partner representing a different stakeholder group. The second activity encourages collaboration among multiple stakeholders as table teams work to design a protocol that meets the needs of all stakeholders. The third and final activity will have the entire group reacting individually to a sample protocol (represented by posters on the wall), then discuss their reactions and seek consensus. Each activity will be debriefed to not only assess the experience, but to discuss how a similar activity might be applied to your needs. We will conclude by presenting a case-study that outlines the successful application of these methods for trial design. These exercises were designed by clinicians, instructional designers, and experts in patient literacy. They have been used successfully in numerous workshop settings to obtain input on protocol design features and trial recruitment and retention methods. Feedback on the experience from past participants has been very positive. It is our hope that you will leave the workshop with an understanding of how these types of exercises can be designed and executed to encourage collaboration and to design clinical trials that meet the needs of all stakeholders. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals responsible for clinical trial design and protocol development; clinical trials operations professionals; advocacy leaders who wish to collaborate with trial sponsors; CRO professionals; patient engagement professionals; advocacy engagement professionals.

Learning Objectives

At the conclusion of this course, participants should be able to:

Evaluate valuable and detailed input from patients and advocates on clinical trial design;
Design patient interactions that encourage collaboration among patients, sponsors, and advocacy groups;
Critique clinical trials to ensure they meet the needs of all stakeholders.

Speakers

Kelly Franchetti

Vice President, Global Head Patient Insights and Engagement, ICON plc

Kelly Franchetti has a diverse background comprised of nursing, patient advocacy and clinical research. This broad range of experiences gives her a unique view of patients’ and caregiver’s perspectives in the realm of disease management and treatment. As a critical care nurse... Read More →

Maggie Adamski

Senior Director, Global Patient Insights, ICON plc.

Maggie brings over 25 years of marketing and clinical research experience within pharma, CROs and agencies. Her work spans patient recruitment, advocacy engagement, patient insights, site training and patient engagement technology. Currently, as Senior Director, Global Patient Insights... Read More →

Ariel Rosen

Director, Global Patient Insights, ICON plc.

Ariel has over 15 years of wide-ranging experience in clinical research including tenures as a study coordinator at large academic medical centers. She has an MS in Clinical Neuropsychology and spent a large portion of her career focusing on CNS indications. Ariel has extensive experience... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 05: Patient Engagement, Tutorial

Level Intermediate
Featured Topics Patient Focused
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management. Through hands-on experience with hypothetical case studies developed for this course, you will design a proactive approach for the identification and management of quality risks and issues; develop thresholds for triage thereby setting tolerance limits; and experience design trending leading to analytics to identify future signals and risks. You will leave with knowledge and access to materials that will enable you to design a framework for identification and mitigation of quality risks as well as management of issues with tolerance limits which could reside in your own organization’s risk management program.
The instructors will take you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections. The value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Learning Objectives

At the conclusion of this course, participants should be able to:

Describe the risk process;
Design a comprehensive quality strategy to manage risk throughout the drug lifecycle and establish Quality Tolerance Limits and Issue Management;
Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.

Speakers

Victoria Burk

Senior Director R&D Quality Assurance, AbbVie, Inc.

Vicki Burk is the Sr. Director R&D Quality Assurance Clinical QA Program Management, Combination Products and Medical Devices and the Comprehensive Quality Strategy at AbbVie. She leads teams responsible for Clinical QA across all stages of development and Combination Product/Medical... Read More →

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie, Inc.

Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has... Read More →

Tim Grey

Senior Director,R&D Quality Systems, AbbVie, Inc.

Tim Grey joined AbbVie in December 2013. He is currently Senior Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team which includes Quality Systems, Documentation Management, training, QKM, QRM, CAPA, Qualification and Validation... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 08: R-D Quality-Compliance, Tutorial | 10: RegCMC-Product Quality, Tutorial | 02: ClinTrials -ClinOps, Tutorial

Level Beginner
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC21: #21: Basics of European Medical Device Regulation

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

This short course will cover what a medical device is (and what it is not) and discuss the legislation surrounding the European medical device regulation and why in Europe there is no combination product legislation. Participants will have the opportunity to classify medical devices which is the first step in the conformity assessment pathway leading to the affixing of a CE Mark to a product. This pathway includes a risk assessment, the basics of which will be explained. Mitigation of risk can be achieved in a variety of ways and the course will address some of them, particularly clinical investigations and labelling. The objective of this short course is to provide a basic understanding of European medical device regulatory requirements and how to ensure compliance with those regulations. Throughout the course there will be short exercises to confirm understanding and opportunities to apply knowledge gained. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals with no experience of European medical device legislation who require an introduction to the topic and staff working in the pharmaceutical sector who require a basic understanding of medical devices legislation in Europe.

Learning Objectives

At the conclusion of this course, participants should be able to:

Define what a medical device is, and is not;
Describe the key elements of the European Medical Device Regulation (MDR);
Classify a medical device;
Recognize the different steps relating to conformity assessment, risk and data required to gain a CE Mark;
Interpret the legislation to conduct a clinical investigation and manage a clinical evaluation report.

Speakers

Neil Armstrong

CEO, MeddiQuest Reg Affairs Ltd

Angela Stokes

Vice President, Head Global Regulatory Consulting, Syneos Health

Angela has almost 30 years of experience in medicinal product and medical device development. Her strengths include regulatory and strategic advice, authorship of regulatory submissions, regulatory writing, regulatory research, and compliance with relevant guidelines and standards... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 09: Regulatory, Tutorial

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC23: #23: Preparing for a US FDA Advisory Committee Meeting

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:

What an advisory committee is
How an advisory committee is structured
Critical factors for advisory committee preparation
How to design the most applicable preparation program for your team
Top ten "best practices" and "must avoids"

An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

At the conclusion of this course, participants should be able to:

Identify the critical success factors in preparing for an advisory committee meeting;
Outline those factors that are most applicable to your team;
Design the most effective preparation strategy for your team(s).

Speakers

Kaia Agarwal

Strategic Lead, PharmApprove, A Member of the NDA Group

Kaia Agarwal is an independent regulatory consultant working with PharmApprove, with over 30 years of global leadership experience in the pharmaceutical and biotechnology industry, with strategic regulatory expertise across CMC and Clinical Development. Kaia has extensive experience... Read More →

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group

Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... Read More →

Sunday June 23, 2019 9:00am - 12:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 09: Regulatory, Tutorial

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC40: #40: Interdisciplinary Safety Evaluation During Product Development

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-19-517-L04-P; CME 6.50; IACET 6.50; RN 6.50

CIOMS VI (2005) states that “causality judgments based on analysis of multiple cases/aggregate data are almost always more meaningful and typically have a greater impact” (than the traditional case-based medical review). The FDA IND safety reporting final rule reflects that position by requiring an expedited IND safety report whenever aggregate analysis indicates that events occur more frequently in the drug treatment group than in a concurrent or historic control group. Further guidance has outlined how early planning for assessment of emerging safety signals and review of aggregated safety data throughout the development program should be driven by multi-disciplinary safety management teams (SMTs). Following product launch, connection of pre-launch investigations to data sources and analytics post-market enable ongoing surveillance, signal detection, and evaluation of benefit-risk. This short course will provide a systematic, coordinated approach to identify, assess and characterize safety topics of interest that enables investigators to develop clinical as well as quantitative understanding of the safety profile. Focus will target the application of appropriate statistical techniques with a safety mindset, as opposed to strict statistical inference, with the emphasis shifted from testing and confirming to exploration, learning, and medical decision-making within a quantitative framework. The goal is to empower the broader cross-disciplinary, cross-regional community to discover and promote practical quantitative solutions for safety evaluation during throughout the product life-cycle. Audience participation will be highly encouraged. This short course will present the work that has been done by the DIA-ASA Interdisciplinary Safety Evaluation scientific working group, TransCelerate, and ICH. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals from industry and regulatory agencies who practice in the areas of patient safety and pharmacovigilance. Specifically, individuals who routinely evaluate information and perform tasks such as signal detection, signal evaluation, benefit-risk assessment to determine the safety of products in development and on-market are the target for this proposed short course.

Learning Objectives

At the conclusion of this course, participants should be able to:

Examine the global regulatory landscape for interdisciplinary safety evaluation;
Develop an aggregate safety assessment planning (ASAP) process;
Execute ongoing aggregate safety evaluation (OASE), including: Blinded vs. unblinded analyses, static vs. dynamic assessments, and visual analytic methods, integration of data sources and analysis methods.

Speakers

Greg Ball

Clinical Safety Statistics, Merck & Co., Inc

After graduating from Northwestern University with a bachelor’s in economics, Greg served in the Navy for 4 years and taught high school math and physics for 5 years, before going back to school to get a master’s in applied statistics from Purdue University. Eventually, while... Read More →

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA

Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay... Read More →

Jeremy Jokinen

Senior Director, Decision Sciences, AbbVie, Inc.

Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, analysts, and data managers developing novel analytical approaches and methodologies to improve patient safety. Jeremy is also... Read More →

James Buchanan

Drug Safety Consultant, Covilance LLC

Dr. Buchanan has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical... Read More →

Sunday June 23, 2019 9:00am - 5:00pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 01: ClinSafety-PV, Tutorial

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC42: #42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-519-L04-P; CME 6.50; IACET 6.50; RN 6.50

The need to understand patient preferences for health and healthcare has become well established and demand for stated preference studies has grown exponentially in recent years. This short course is designed as an introduction to a range of stated-preference methods and the application of these methods in drug development, regulatory decision-making, and patient advocacy. The short course will also provide an overview of good research practices and principles that are broadly applicable to all stated-preference methods and describe how good research practices can be applied to discrete choice experiments and several other stated-preference methods. Topics to be covered will include designing a survey, developing an experimental design, analyzing data, and presenting results. This short course will include hands-on exercises and detailed case studies of recent empirical examples to illustrate concepts. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This introductory to mid-level course designed to acquaint attendees with the current state of the art in the use of methods for the development of evidentiary patient preference information. Expected attendees may include: industry, regulators, payers, patients and patient advocacy representatives.

Learning Objectives

At the conclusion of this course, participants should be able to:

Identify when & how to successfully develop and present patient preference information for use in a range of applications, including regulatory interactions such as new drug applications;
Discuss specific methodologies frequently used in the development of patient preference information.

Speakers

Rachael DiSantostefano

Senior Director, Benefit Risk / Epidemiology, Janssen Research & Development, LLC

Rachael L. DiSantostefano, MS PhD, is a Senior Director of Benefit-Risk in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has more than 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and... Read More →

Brett Hauber

Senior Economist, Vice President of Health Preference Assessment, RTI Health Solutions

Brett Hauber is Senior Economist and Vice President of Health Preference Assessment at RTI Health Solutions and Affiliate Associate Professor in the School of Pharmacy at the University of Washington. His is an expert in stated-preference methods. He was principal investigator for... Read More →

Carol Mansfield

Senior Economist and Head, Health Preference Assessment, RTI Health Solutions

Carol Mansfield, PhD, is a Senior Economist and Head in the Health Preference Assessment group at RTI-HS, where she conducts stated-preference studies for pharmaceutical applications. She has 25 years of experience conducting research related to health and the environment. She has... Read More →

Christine Poulos

Senior Research Economist and Head, Health Preference Assessment, RTI Health Solutions

Kristin Bullok

Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company

Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →

Sunday June 23, 2019 9:00am - 5:00pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 05: Patient Engagement, Tutorial | 01: ClinSafety-PV, Tutorial | 09: Regulatory, Tutorial

Level Beginner
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC43: #43: Back to the Future: Combination Products in the 21st Century

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-520-L04-P; CME 6.50; IACET 6.50; RN 6.50

As innovation abounds in science and medicine, there exist endless new opportunities for combining different technologies to solve some of the world’s most pressing medical issues. The lines between engineering, chemistry, and advanced biologic processes are becoming blurred – the age of combination products is here. There are significant differences between the development processes for drugs, devices, and biologics. Theoretically, if the product complies with the regulations specific for each component of the combination product, then your company should be covered, right? Not quite! The requirements and governing bodies for each part of the product are vastly different making it nearly impossible to reconcile all the rules. Factor in new laws and regulations, such as the 21st Century Cures Act (CCA), and the complexity of compliance increases further. This short course provides an overview and comparison of drug, device, and biologics regulation in the United States, and the complex place where combination products fit within these regulations. It follows the product lifecycle, from development through post-market activities, including classification, pre-clinical and clinical requirements, applicability of Good Manufacturing Practices (GMPs) and quality systems, and labeling requirements. It will also introduce the latest statutes, regulations and guidances that impact combination products and discuss how these changes are affecting the existing market. The short course will be interactive. It has been designed to integrate substantive regulatory knowledge and the real-world problems of combination products. You will dive into case studies of unique combination products and get a sense of the gray areas that make the current regulatory scheme so difficult to navigate. It’s an opportunity to ask questions, share your challenges, gain the insights of your instructors, and learn from the experiences of your colleagues. If you are new to the field of combination products, this course will give you the foundation to move forward in your career. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for regulatory, quality, and clinical professionals and project managers who are new to combination products.

Learning Objectives

At the conclusion of this course, participants should be able to:

Discuss how combination products fit into the development processes for drugs/biologics and medical devices;
Identify the unique challenges of pre-market and post-market requirements for combination products in the US;
Discuss how recent regulatory developments, including the 21st Century Cures Act enacted in 2016 and resulting FDA guidances, affect combination products.

Speakers

Caitlin Bancroft

Associate, Regulatory Affairs Consultant, Pharmatech Associates Inc.

Lynn Hansen

Director, Regulatory Affairs, Pharmatech Associates Inc.

Sunday June 23, 2019 9:00am - 5:00pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 06: PreClin Dev-EarlyPhaseCR, Tutorial | 09: Regulatory, Tutorial

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

9:00am

SC41: #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-518-L04-P; CME 6.50; IACET 6.50; RN 6.50

According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. This short course will demonstrate by using interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, challenges will be presented of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals and auditors involved in Good Clinical, Laboratory, or Manufacturing Practices.

Learning Objectives

At the conclusion of this course, participants should be able to:

Describe and train individuals on best industry practices in CAPA management;
Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and Effectiveness Checks to ensure compliance and remediation of observations;
Discuss case studies that will help solidify how to use the different tools and why to use each one.

Speakers

Christy Mazzarisi

Associate Director, Development Operations, Q&C/CTD, Kinapse

Accomplished Quality Systems Professional with a broad background in Pharmaceutical and Laboratory sciences with R&D and commercial manufacturing (sterile and non-sterile) experience with 15 years industry practice. Overall background and specialties include GMP and GLP; which has... Read More →

Danielle Metzger

Senior Consultant, CGI Technologies

Accomplished Quality Professional with a broad background in Pharmaceutical life sciences having R&D and commercial (sterile/non-sterile) experience with over 20 years practice. Specialize in Deviation/CAPA Management and TrackWise systems. Well versed in cGMP knowledge, FDA/EU regulations... Read More →

Sunday June 23, 2019 9:00am - 5:00pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 08: R-D Quality-Compliance, Tutorial

Level Intermediate
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

11:00am

Forum for Students and Emerging Professionals

Component Type: Forum
Level: Basic

This forum is a unique opportunity for students and young/emerging professionals to meet, network, share and learn about career opportunities and participate in small group discussions and activities.

Learning Objectives

Navigate the DIA Annual Meeting effectively;Identify emerging career trends;Develop awareness of tools and skills that may help in their career path.

Chair

Nancy Pire Smerkanich, DrSc

Speaker

Panelist
Amelia Rose Spinrad, MS

Panelist
Dan Tierno, MA, MBA

Panelist
Meredith Y. Smith, PhD, MPA

Panelist
Kayla Valdes, PhD

Speakers

Nancy Smerkanich

Assistant Professor, Department of Regulatory and Quality Sciences, University of Southern California

Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.

Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →

Amelia Spinrad

Regulatory Knowledge Support Administrator, USC International Center For Regulatory Science

Amelia Spinrad, MS is currently a Regulatory Knowledge Support Administrator working at the International Center for Regulatory Science on projects with the Southern California Clinical and Translational Science Institute (SC-CTSI). She manages a regulatory research and her main project... Read More →

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics, Bayer

Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry, specializing in drug development, data sciences and analytics for clinical trials, and commercialization of novel small molecule and cell based therapeutics. Mr. Tierno has spoken on training... Read More →

Kayla Valdes

Associate Director, Scientific Programs, DIA

Dr. Kayla Valdes is an Associate Director of Scientific Programs at DIA, based out of Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to... Read More →

Sunday June 23, 2019 11:00am - 12:30pm
Marriott Marquis Marina San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Forum

Level Intermediate
Featured Topics Student Programming
Tags Forum

12:30pm

Registration for Afternoon Preconference Short Courses, Conference Attendees, and Speakers

Sunday June 23, 2019 12:30pm - 6:00pm
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:45pm

Student Networking Luncheon

Component Type: Session

DIA is excited to welcome student and emerging professionals to the Global Annual Meeting. This luncheon is dedicated to helping our student to connect with one another and spend quality time with several members of the DIA 2019 Program Committee.

Sunday June 23, 2019 12:45pm - 2:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Session

Featured Topics Student Programming
Featured Topics Student Programming
Tags Session

1:30pm

SC30: #30: Machine Learning in Pharmacovigilance

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

Since machine learning (ML) requires resources from across the organization, this course is designed for anyone interested in sponsoring or joining a ML project within their organization which focuses on pharmacovigilance (PV). Therefore, we will specifically explore ML and its application within the PV regulatory landscape and provide a high-level introduction to ML, including tools and project tips. The core of the course will also dive deeper into applications within PV, including examples from our own experiences with ICSR identification, and discussion around what the future of ML in PV could look like. There will be time for Q&A but this years course will also be very interactive between the instructors and attendees, with both questions and some relevant tool demonstrations. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for members of Pharma, Academia, Regulators, and Medicine interested in Machine Learning in PV.

Learning Objectives

At the conclusion of this course, participants should be able to:

Identify advances that make ML practical;
Describe how ML can be applied to the regulatory and PV landscape;
Develop potential future use cases for ML in PV.

Speakers

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA

Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →

Shaun Comfort

Principal Medical Director, Genentech, A Member of the Roche Group

Dr. Comfort is Principal Medical Director for Roche in the Inflammatory, Infectious Disease, and Ophthalmology Safety Science group and leads innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 16 years combined industry/regulatory experience including... Read More →

Bruce Donzanti

Senior Group Director, Global Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group

Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while... Read More →

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)

Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →

Sunday June 23, 2019 1:30pm - 5:00pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 01: ClinSafety-PV, Tutorial | 09: Regulatory, Tutorial

Level Intermediate
Featured Topics Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

1:30pm

SC36: #36: A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-515-L04-P; CME 3.25; IACET 3.25; RN 3.25

The DIA-ASA Biopharm Safety Evaluation Working Group is developing a series of novel interactive safety graphic tools to enhance the ability of safety and clinical development professionals to identify and evaluate safety signals. Each will be made available as an open-source, non-proprietary application widely available to anyone interested in drug safety evaluation. An open source project like this will likely result in a longer-lasting software solution. The first tool to be released is designed to explore cases of potential drug-induced hepatotoxicity based on the eDISH plot developed by FDA. Building upon the existing static eDISH plot, the tool allows the user to dynamically adjust laboratory thresholds to account for disease states with elevated transaminase and bilirubin values, modify the time dimension for the occurrence of peak ALT/AST and bilirubin values, account for the extent of alkaline phosphatase elevation, with filters for treatment assignment, gender, race and age group. Cases that appear in the potential Hy’s Law, Temple’s corollary and hyperbilirubinemia quadrants can be individually explored to detail the time course of changes in various analytes, and assess the concurrence with adverse events and the exposure to concomitant medications. In order to assist the safety reviewer, a workflow is provided to guide the user through the recommended analyses, using the features of the tool, for each of the quadrants of interest. The workflow is based on evaluations supported by expert hepatologists and the medical literature. The short course will demonstrate the functions of the tool by way of case examples exploring various hepatotoxicity signals. Prior attendees of the DIA Advanced Signal Detection course will find this course builds upon the concepts presented in that course, but it is not a prerequisite for attending this class. In addition, information will be provided on how attendees can implement this RShiny/JavaScript tool in their organizations. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved in:

Clinical safety and pharmacovigilance
Pharmacoepidemiology
Biostatistics
Benefit-risk management
Clinical development
Data scientists
Information technology supporting pharmacovigilance activities

Learning Objectives

At the conclusion of this course, participants should be able to:

Evaluate the potential for drug-induced hepatotoxicity with a new open-source, interactive safety graphic based on the eDISH plot;
Assess cases of potential Hy’s Law, Temple’s corollary and hyperbilirubinemia with respect to lab changes, clinical symptoms and identify possible confounding elements;
Perform analyses with a work-flow procedure based on established medical precedent.

Speakers

James Buchanan

Drug Safety Consultant, Covilance LLC

Jeremy Wildfire

Senior Data Scientist, Rho, Inc.

I have worked as a biostatistician for the NIAID funded Inner City Asthma Consortium (ICAC) for nearly 10 years. My work with ICAC has included the development of the Composite Asthma Severity Index, the first quantitative measure of asthma severity, and the analysis of multiple late-stage... Read More →

Sunday June 23, 2019 1:30pm - 5:00pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 01: ClinSafety-PV, Tutorial | 11: Statistics, Tutorial

Credit Type ACPE, CME, IACET, RN
Tags Tutorial

1:30pm

SC37: #37: Patient Literacy 101: Practical Strategies for Improving Your Patient Materials

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-516-L04-P; CME 3.25; IACET 3.25; RN 3.25

This short course is designed to teach participants a step-by-step approach to designing patient materials and educational initiatives that effectively communicate concepts at a level appropriate for their audiences. Patient literacy (or health literacy) is certainly not a new topic, yet isn’t getting its much-deserved attention these days. Materials developed for patient communications or education often miss the mark. The application of literacy and numeracy principles is now more critical than ever, due to the increased tendency of patients to seek out disease state and treatment-related information on their own. In this interactive short course, participants will learn principles of patient literacy, receive a number of tools to assist them in developing their own patient-literate materials, and learn about excellent resources that can be used to help them continue to develop their skills in this area. Interactive exercises will provide opportunities to practice these skills. This will include evaluating existing materials, editing to improve literacy, and development of new materials. We will address both written and oral communication. Finally, an active discussion will provide strategies on how participants can work to encourage a culture of patient literacy within their own organizations, becoming champions of this approach and bringing about true cultural change. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals responsible for the design and development of patient-facing materials; clinical educators; developers of patient educational materials.

Learning Objectives

At the conclusion of this course, participants should be able to:

Define patient literacy, numeracy and health literacy, describe how each affects the quality of patient communications and educational efforts;
Identify common mistakes in patient-facing materials;
Develop a strategy for improving your organization’s patient-facing communications;
Develop a culture that embraces patient literacy principles.

Speakers

Kelly Franchetti

Vice President, Global Head Patient Insights and Engagement, ICON plc

Valerie Martin

Associate, Global Patient Insights and Engagement, ICON plc.

Valerie’s career has been centered around leading and managing large-scale, global patient recruitment and retention programs. She also has extensive experience crafting individualized site support initiatives to accelerate enrollment. She prioritizes the needs of each program’s... Read More →

Ariel Rosen

Director, Global Patient Insights, ICON plc.

Sunday June 23, 2019 1:30pm - 5:00pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 05: Patient Engagement, Tutorial | 04: MedAffairs-SciComm, Tutorial

Level Beginner
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

1:30pm

SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

At the conclusion of this short course, participants should be able to:

Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
Discuss the use of key tools in the RBM process;
Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.

Speakers

Barbara Suarez

Director, Clinical Study Support, GlaxoSmithKline

Barbara A. Suarez, M.S., Director of Clinical Study Support for the US Local Operating Company at GlaxoSmithKline Pharmaceuticals. Over the course of 20 years within the industry, Barbara has served in diverse roles of increased responsibilities within Clinical Operations. Since 2013... Read More →

Rodrigo Perez

CSU Risk-Based Monitoring (RBM) Business Lead, Sanofi

Rodrigo Perez, based in Mexico City, has more than 12 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →

Sunday June 23, 2019 1:30pm - 5:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 08: R-D Quality-Compliance, Tutorial | 02: ClinTrials -ClinOps, Tutorial

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

1:30pm

SC33: #33: European Regulatory Meetings: How Best to Prepare and Perform

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

High-stakes meetings such as CHMP/PRAC oral explanations are often the ultimate chance for a pharmaceutical sponsor to convince EU regulators that the benefit:risk balance of their product is positive. Being well-prepared and performing professional is key to success. This include demonstrating intimate knowledge of your data to meet regulator’s concern as well as being able to present this in a crisp and clear manner. To get to this stage takes meticulous preparation of key messages, slides and the actual speech and may additionally include training key opinion leaders and/or patient representatives to speak or respond to questions in your support. Finally, preparing a head of questions and being able to respond clear and unequivocally to these are equally important to increase chances of success. This short course focuses on how best to plan, manage, prepare and execute successfully at EU high-stakes meetings. Former CHMP members, pharma executives and communication specialists will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with EU regulators. Focus will be on CHMP oral explanations, but the learnings will be applicable to all other EU regulatory oral interactions. We will discuss how best to present your key massages and supporting slides and manuscript. How to develop a Q&A grid in collaboration with your team and how best to manage back-up slides when responding to questions will be part of the learnings. How best to deal with practicalities and logistics around a CHMP oral explanation in order to minimize the stress on your team will also be touch upon. This short course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals in Regulatory and Clinical teams.

Learning Objectives

At the conclusion of this course, participants should be able to:

Identify the key messages and supporting slides needed to conduct a successful EU regulators meeting;
Develop a comprehensive Q&A grid;
Develop a strategy and encourage the development of back – up slides when preparing questions.

Speakers

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group

Sunday June 23, 2019 1:30pm - 5:00pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 09: Regulatory, Tutorial

Level Beginner
Credit Type ACPE, CME, IACET, RN
Tags Tutorial

1:30pm

SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-514-L04-P; CME 3.25; IACET 3.25; RN 3.25

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

At the conclusion of this course, participants should be able to:

Explain the major elements of the Japanese regulatory system;
Describe the regulatory procedures during development, registration, and post-approval;
Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.

Speakers

Alberto Grignolo

Corporate Vice President, Parexel

Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)

Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →

Sunday June 23, 2019 1:30pm - 5:00pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Short Course, Tutorial | 09: Regulatory, Tutorial

Credit Type ACPE, CME, IACET, RN
Tags Tutorial

2:30pm

#001: Self-Branding for Social Media

Component Type: Workshop
Level: Basic

How you are seen by others is important. You are your own brand. if one doesn’t manage one’s brand, it will be created for them by others.

Through this workshop we intend to demonstrate to attendees what this means, how it manifests itself and how it can positively or adversely affect your career success. Conference attendance is its own unique social media. From the time you arrive at the airport through the end of the conference, your brand is being seen. The various social media outlets will be discussed and appropriate use of them from the business perspective will be presented.

Learning Objectives

Recognize the importance of self-branding; Differentiate social media tools for career support versus sharing life with friends; Discuss the role your brand plays in your everyday life.

Chair

Chris Matheus, MBA

Speaker

Facilitator
Michele Sacher

Speakers

Chris Matheus

President, Matheus BD Connections LLC

Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a... Read More →

Michele Sacher

Business Development Strategist, Unconventional Counseling

Michele Sacher, MS, MEC, most recently acted as a Business Development Consultant, working in Hollywood, CA, resulting in producing a professional Grammy Academy-member’s rock music video; “Gift of the Gab”. This was filmed on the Warner-Brothers Studios’ famous “backlot... Read More →

Sunday June 23, 2019 2:30pm - 3:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Level Beginner
Featured Topics Student Programming
Tags Workshop

3:45pm

#002: Student and Young Professional Resume Workshop

Component Type: Workshop
Level: Basic

This interactive session will introduce students and young/new/emerging professionals to the fundamentals of resume/CV writing skills. Participants will be able to understand the difference between a resume and a curriculum vitae.This workshop will consist of some introductory training but will rely primarily on active learning sessions:
• Participants will bring either a virtual or printed version of their resume/CV for a peer review after the presentation.
• Participants have the option to ask questions during and after the peer review session.

Learning Objectives

Describe for students and young/new/emerging professionals to the fundamentals of resume/CV writing skills; Identify difference between a resume and a curriculum vitae; Identify the components of an effective document as well as common mistakes and information that should not be included.

Chair

Kristen Felthousen, MS

Speaker

Facilitator
Kristen Felthousen, MS

Facilitator
Nancy Pire Smerkanich, DrSc

Speakers

Kristen Felthousen

Program Administrator, Department of Regulatory and Quality Sciences, University of Southern California School of Pharmacy

Kristen Felthousen has more than 15 years of experience in HR, higher education, teaching, training and development. She earned her MS in HR Development from Rochester Institute of Technology. For the past 12 years, she has focused on career, professional and leadership development... Read More →

Nancy Smerkanich

Assistant Professor, Department of Regulatory and Quality Sciences, University of Southern California

Sunday June 23, 2019 3:45pm - 5:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Level Intermediate
Tags Workshop

3:45pm

#003: Effective Networking: Know Yourself

Component Type: Workshop
Level: Basic

Being effective in a clinical research career requires working well (networking) with others. Learning about personality types and how that makes for effective teamwork (networking) is beneficial. The myths of how each personality type networks will be explored and the differences will be explained. There will also be a portion of the workshop dedicated to practicing networking.

Learning Objectives

Differentiate how introverts and extroverts network effectively; Recognize the importance of networking; Explore myths of networking.

Chair

Chris Matheus, MBA

Speaker

Facilitator
Michele Sacher

Facilitator
Christina Cantrell, MSc

Speakers

Chris Matheus

President, Matheus BD Connections LLC

Michele Sacher

Business Development Strategist, Unconventional Counseling

Christina Cantrell

Senior Patient Insights Leader, Genentech, A Member of the Roche Group

Christina has worked for over 15 years in clinical research, always with a focus on the patient’s experience and primarily in outcomes research and insights gathering. She has worked at both large and community hospitals, health technology vendors, and she currently works at Roche... Read More →

Sunday June 23, 2019 3:45pm - 5:00pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Level Beginner
Featured Topics Student Programming
Tags Workshop

7:00am

Annual Meeting Orientation

Component Type: Session
Level: Basic

Are you new to the DIA Global Annual Meeting? Then join us for breakfast and learn how to navigate this incredible learning and networking experience from members of the Annual Meeting Program Steering Committee and Program Development Team. There is so much to discover on-site, let us help you with maximizing the value of your time at DIA 2019.

Chair

Meredith Kaganovskiy

Speakers

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA

Monday June 24, 2019 7:00am - 7:45am
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Session

Tags Session

7:00am

Coffee and Light Refreshments

Component Type: Social Event

Monday June 24, 2019 7:00am - 8:00am
Ballroom 20 Lobby San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Social Event

Tags Social Event

7:00am

Attendee, Speaker, and Exhibitor Registration

Monday June 24, 2019 7:00am - 6:00pm
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#100: Opening Plenary, Keynote, and DIAmond Session

Component Type: Forum
Level: Basic
CE: ACPE 1.50 Knowledge UAN: 0286-0000-19-730-L04-P; CME 1.50; IACET 1.50; RN 1.50

Join us for the DIA 2019 Global Annual Meeting Keynote Address and Opening DIAmond Session!
Keynote speaker Dr. Gibbons oversees the third largest institute at the NIH, with an annual budget of approximately $3 billion and a staff of nearly 2,100 federal employees, contractors, and volunteers. NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so they can live longer and more fulfilling lives.

Advancing Discovery Science for Public Health Impact
Dr. Gibbons will address the value of implementation science that turns discovery science into improved population health, as well as the innovation of evidence-based initiatives in the treatment of chronic disease, to balance the scales of health equity in all populations.

DIAmond Session: Who Owns My Health Data: Patients, Data, and the Future of R&D
Data is the fuel for modern medical research. From enabling precision medicine to innovative uses of real world data, regulators, researchers, and the bio-pharmaceutical industry are increasingly dependent upon access to data sets of increasing size and scope. Consumers today are increasingly sensitive to how their data is used and monetized, largely in the wake of Facebook/Cambridge Analytica and other high profile scandals. Use of personal health data is not immune from these concerns, from GDPR and California Consumer Privacy Act to the rise of state bills challenging ownership over personal health data even if de-identified.

These consumer and policy trends are raising new questions and challenging norms -- Who should be the legal owner of personal health data? Should patients be notified when their data is monetized even if it lacks identifying information? If personal health data is being sold, should patients be able to participate in the monetization or would this practice exploit underserved populations? What are the potential implications of this shifting landscape on medical research and public health?

Learning Objectives

Review the evolving relationship of patients and health data, from access and sharing to privacy and ownership; Discuss the consumer and policy trends that may reshape expectations when personal health data is monetized; Discuss the data dependence of drug development today and the implications for medical research tomorrow.

Chair

Barbara Lopez Kunz, MSc

Speaker

Honorary Chair Welcome
Guido Rasi, MD

Honorary Chair Welcome
Joanne Waldstreicher, MD

Keynote Address
Gary Gibbons, MD

DIAmond Session: Who Owns My Health Data - Patients, Data, and the Future of R&D
Craig Lipset, MPH

Panelist
Harlan M. Krumholz, MD

Panelist
Doug Peddicord, PhD

Panelist
Deven McGraw, JD, LLM, MPH

Panelist
Donna R. Cryer, JD

Speakers

Gary Gibbons

Director, National Heart, Lung, and Blood Institute, NIH

Dr. Gibbons oversees the third largest institute at the NIH, with an annual budget of more than $3 billion and a staff of 917 federal employees.The NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung... Read More →

Barbara Lopez Kunz

Global Chief Executive, DIA

Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s... Read More →

Craig Lipset

Former Head of Clinical Innovation, Pfizer

Craig Lipset has led at the intersection of patient engagement, personal health data, and accelerating clinical research. He created and led Clinical Innovation at Pfizer, developing and scaling “first in industry” approaches to improving patient experience and innovative data... Read More →

Guido Rasi

Executive Director, European Medicines Agency

Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →

Joanne Waldstreicher

Chief Medical Officer, Johnson & Johnson

Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson. In this role, she has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations transformation, collaborations on ethical science, and technology... Read More →

Donna R. Cryer

Interim Executive Director, People-Centered Research Foundation

Donna R. Cryer, JD, has channeled her personal experience as an IBD and liver transplant patient into professional advocacy as president and chief executive officer of the Global Liver Institute, the innovation and collaboration platform for the liver community. For almost a decade... Read More →

Harlan Krumholz

Harold H. Hines, Jr. Professor of Medicine and Director CORE, Yale University

Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine, is a cardiologist and the Director of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital, where he leads initiatives to improve the quality and outcomes of clinical... Read More →

Deven McGraw

Chief Regulatory Officer, Ciitizen

Deven McGraw is the Chief Regulatory Officer for Ciitizen, a consumer health technology start-up. Prior to joining Ciitizen, she directed U.S. health privacy and security through her roles as Deputy Director, Health Information Privacy at the HHS Office for Civil Rights (the office... Read More →

Doug Peddicord

Executive Director, Association of Clinical Research Organizations (ACRO)

Following a career as a clinical psychologist, Doug Peddicord came to Capitol Hill as an American Association for the Advancement of Science (AAAS) Congressional Fellow in 1994. With policy expertise in the conduct and regulatory oversight of clinical trials, Dr. Peddicord serves... Read More →

Monday June 24, 2019 8:00am - 10:00am
Ballroom 20 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

00: Plenary, Forum | 14: DIAmond, Forum

Credit Type ACPE, CME, IACET, RN
Tags Forum

10:00am

Coffee Break

Component Type: Social Event

Monday June 24, 2019 10:00am - 11:00am
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Social Event

Tags Social Event

10:00am

Student Poster Session

Component Type: Poster Presentation

Speakers

Junior Sinclair Awounvo

Student, University of Bremen

Junior Sinclair Awounvo is a master student at the University of Bremen in Germany studying Medical Biometry / Biostatistics. He wrote his bachelor’s thesis on the Application of weighted risk scores to estimate the relative contribution of pollution, lifestyle and genetics to skin... Read More →

Elham Heidari

PhD Student, Health Outcomes Division, University of Texas

Elham Heidari PharmD MSc is a PhD student in Health Outcomes Division at University of Texas at Austin. Her research interests include role of social determinants of health in health plans and Patient-Reported Outcomes (PROs) for oncology patients. Having experienced pharmacy from... Read More →

Hikari Ishii

Student, Waseda University

Jackline Kemboi

Student, African Institute For Mathematical Science (aims)-Rwanda

Being in love with mathematics, Jackline Kemboi took a brave decision to join the field of Applied statistics with computing. Her passion for mathematics enabled her to apply for Cooperative Master’s in mathematical science. She did her final project on Impact of different randomization... Read More →

Cezar Manansala

Student, Centro Escolar University

I am a registered Pharmacist who is in his last term of his Master of Science in Pharmacy Degree. I am also a consultant to various pharmaceutical and medical device companies in the Philippines. I am very passionate about research and would be very happy to collaborate with different... Read More →

Achint Raince

Student, Ernest Mario School of Pharmacy

Christina Salama

Pharmacy Student, Saint John's University

Ruoying Sheng

Student, University of Southern California

Advaita Chandramohan

Undergraduate Research Associate, University of Southern California

Advaita Chandramohan is a first year student at the University of Southern California studying Biomedical Engineering with an Electrical emphasis. She is an Undergraduate Research Associate at USC's International Center for Regulatory Science, where she studies the dissemination and... Read More →

Zhi Cui

Student, University of Macau

Postgraduate student majoring in Medicinal Administration, University of Macau.

Sean Kerns

Graduate Researcher, University of Southern California

Sean Kerns is currently a second year graduate student at USC’s Marshall School of Business pursuing his Masters in Global Supply Chain Management. His research project examines FDA warning letters to elucidate supplier related quality issues which can adversely affect the pharmaceutical... Read More →

Inyoung Lee

PhD Candidate, University of Illinois at Chicago

Inyoung Lee is a registered pharmacist in South Korea since 2012. She has worked as a part-time hospital pharmacist and a consultant at IMS Health (now known as IQVIA) in Korea affiliate. Inyoung came to the U.S. to start her graduate studies in pharmacoepidemiology and outcomes research... Read More →

Abhishek Mane

Student, Seth G S Medical College & KEM Hospital

He is Dr. Abhishek Mane, post graduate student from KEM Hospital, Mumbai, India. He completed his graduation in 2016. He has over 2 years of experience in clinical research. His core areas of interest include pre-clinical research and development, Phase-III clinical trials and medical... Read More →

Panini Patankar

Junior Resident, Seth G S Medical College & KEM Hospital

He is post-graduate student of Pharmacology & Therapeutics at Seth GS Medical College & KEM Hospital, Mumbai, India. His areas of interest include preclinical research in fields of psychopharmacology & neuropharmacology. He is well acquainted with clinical research and protocol writing... Read More →

Junnan Shi

Student, University of Macau

Junnan Shi is a master student from the Institute of Chinese Medical Sciences (State Key Laboratory of Quality Research in Chinese Medicine) in the University of Macau. Her major is Medicinal Administration, and the objectives of her research are (i) to evaluate the efficacy and safety... Read More →

Jiaqi Xu

Student, University of Macau

Millicent Yeboah-Awudzi

Graduate Assistant and PhD Student, Louisiana State University

Millicent found fulfillment in a career in the Food Sciences as a way of contributing to national development and the global food supply. With new lifestyles, imported dietary practices, and globalization taking root in Africa, chronic diseases such as diabetes and its complications... Read More →

Tony Yuan

PhD Candidate, The University of Sydney

Senior Associate, Regulatory Affairs at Phebra Pty Ltd. Tony Yuan has submitted his PhD thesis in the area of optimizing written medicine information for prescription medicines (AUS, EU & USA perspective). His experience in the pharmaceutical industry is predominately within regulatory... Read More →

Ismaeel Yunusa

Graduate Student, Massachusetts College of Pharmacy and Health Sciences

Monday June 24, 2019 10:00am - 6:00pm
Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: Posters, Poster Presentation

Tags Poster Presentation

10:10am

#101 CH: Modernizing Data Review in Drug Development with R Shiny

Component Type: Workshop
Level: Intermediate

ASA Biopharm/DIA Safety Working Group, safety clinicians, statisticians and data scientists, developed an R Shiny tool available for all, initially for detection and review of hepatotoxicity. Discuss this new tool and seek input on next steps and support.

Learning Objectives

Describe an R Shiny safety tool developed by the Interactive Safety Graphics taskforce of the ASA Biopharm/DIA Safety Working Group, for review of liver function and Hy’s Law for use during drug development and submission review; Discuss audience feedback on path forward for this new model of agile software development and support, with consideration of compliance.

Chair

Susan Duke, MSc

Speakers

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA

Susanis is a Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. She became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG, which lead to subsequent interests... Read More →

Monday June 24, 2019 10:10am - 10:40am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop | 11: Statistics, Workshop

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10:10am

#102 EE: The Female Perspective on the Clinical Trial Patient Experience: A Live Focus Group

Component Type: Workshop
Level: Basic

This workshop will discuss the factors that create a positive patient experience for the female clinical trial participant with regard to protocol design and clinical trial participation.

Learning Objectives

Elucidate the factors that create a positive patient experience for the female clinical trial participant – a historically underserved stakeholder group with regard to protocol design and clinical trial participation.

Chair

Bonnie A. Brescia

Speakers

Bonnie Brescia

Founding Principal, Corporate Planning Officer, BBK Worldwide

Bonnie A. Brescia has been a leader in patient recruitment and engagement for more than 35 years. Widely recognized for helping to shape the patient recruitment discipline and a preeminent voice for patient centricity, her insights regarding the global clinical research community... Read More →

Monday June 24, 2019 10:10am - 10:55am
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Engage-Exchange, Workshop | 02: ClinTrials -ClinOps, Workshop

Tags Workshop

10:15am

#103 IT: Advanced Clinical Innovation Theater: Raising the Bar on Clinical Oversight to Reduce Risk and Ensure Inspection Readiness

Component Type: Session

As a result of increasing compliance requirements like ICH E6 R2, competition and more - many sponsor organizations do not have the resources to provide proper oversight on outsourced clinical trials. Advanced Clinical will present a case study that features a successful sponsor-FSP oversight program using a winning combination of resources, processes and a data-driven decision-making platform that helped a client demonstrate regulatory obligations and inspection readiness while minimizing risk.

Chair

Advanced Clinical

Speakers

Advanced Clinical

Graham Belgrave

Sr. Vice President, Head of European Operations, Advanced Clinical

Cheryle Evans

Senior Vice President, Clinical and Medical Operations, Advanced Clinical

Cheryle Evans is a senior-level executive with extensive, progressive experience in operational execution of clinical trials including a track record of accomplishments in healthcare/pharmaceutical research. She is the head of Operations in North America for Advanced Clinical. Cheryle... Read More →

Julie Ross

President, Advanced Clinical

Ms. Ross, President of Essential Patient Recruitment and CRO, has a BS in Nuclear Medicine and has served the research industry for 23 years. She has comprehensive knowledge in all facets of clinical research and is a leader in patient recruitment, research operations and business... Read More →

Monday June 24, 2019 10:15am - 10:45am
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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10:15am

#104 IT: ArisGlobal Innovation Theater: Can Blockchain Technology Change Life Sciences?

Component Type: Session

How can the life sciences industry take advantage of the Blockchain technology? We will have a conversation about how the inherent characteristics of BlockChain and a Blockchain network can change the traditional models of exchanging data? What are some of the potential impacts from these changes?

Chair

ArisGlobal, LLC

Speakers

ArisGlobal, LLC

Emmanuel Belabe

Associate Vice President, Safety Business Unit, ArisGlobal

Monday June 24, 2019 10:15am - 10:45am
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

11:00am

#105: Addressing Heterogeneity of Real World Evidence in Drug Safety

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the concern of inconsistent real world evidence in drug safety by presenting 1) epidemiological approaches for assessing inconsistent findings in observational studies, 2) lessons learned from observational studies in a distributed research network and 3) challenges using methods that synthesize findings from observational studies.

Learning Objectives

Identify possible study factors contributing to heterogeneity of real world evidence using claims databases; Discuss lessons learned from observational studies in a distributed research network regarding heterogeneity of RWE; Describe methods for synthesizing findings from observational studies and their limitations.

Chair

Michael Blum, MD, MPH

Speaker

Epidemiological Approaches for Assessing Inconsistent Findings in Observational Studies
Huei-Ting Tsai, PhD, MS

Minimizing Heterogeneity in Distributed Research Networks: Examples from the Canadian Network for Observational Drug Effect Studies
Adrian Levy, PhD, MSc

Challenges with Methods Used to Synthesize Findings from Observational Studies
Alicia Gilsenan

Speakers

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA

Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →

Alicia Gilsenan

Senior Director and Head, Epidemiology, RTI Health Solutions

Alicia Gilsenan, PhD, is Senior Director and Head, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI... Read More →

Huei-Ting Tsai

Epidemiologist, Office of Surveillance and Epidemiology, CDER, FDA

Huei-Ting Tsai, Ph.D., is an Epidemiologist in the Office of Surveillance and Epidemiology in FDA CDER. Prior to joining FDA, she was an Assistant Professor at the Georgetown University Medical Center and served as the principle investigator of multiple grants to assess effectiveness... Read More →

Adrian Levy

Professor, Department of Community Health and Epidemiology, Dalhousie University

Adrian R. Levy PhD is Professor in the Department of Epidemiology and Community Health at Dalhousie University. He is author of over 150 peer reviewed publications (https://bit.ly/2CBWeI5) and is the co-editor of two volumes in the Springer Handbook of Health Services Research entitled... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 03: Data-Data Standards, Session

Level Intermediate
Featured Topics Real World Evidence, Innovative Trial Design, What's Next
Featured Topics Real World Evidence,Innovative Trial Design,What's Next
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#106: Moving Forward in EU Pharmacovigilance

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-523-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will introduce delegates to new ways of evaluating evidence of our activities and apply new types of science for our sector based on systems theory. By thinking how patients can be part of the pharmacovigilance team we can out new ways of more effectively managing benefit-risk.

Learning Objectives

Discuss ideas for describing the role and training needed for involving patients; Identify how to constructively criticize pros and cons of involving patients; Describe opportunities to apply systems theory to manage risk; Identify how evaluation of PRAC may help us more effectively manage risk.

Chair

Brian Edwards, DrMed

Speaker

System Analysis of UK Pregnancies Reported During and After Isotretinoin Administration
Brian Edwards, DrMed

Patient Perspective
François Houyez

Removal of Safety Concerns from EU-RMP: Lessons Learned from a Review of PRAC Meeting Minutes
Robert Massouh, MPharm, RPh

Speakers

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group

After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURODIS)

François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, Policy Advisor. He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases... Read More →

Robert Massouh

Risk Management Product Lead, Pfizer Ltd

Robert is a Risk Management Product Lead at Pfizer, supporting the development and execution of Risk Management strategies for Pfizer products. He was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Robert is a registered Pharmacist... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum | 09: Regulatory, Forum

Level Intermediate
Featured Topics Regulator Thinking,What's Next
Credit Type ACPE, CME, IACET, RN
Tags Forum

11:00am

#107: Emerging Technologies in Clinical Research

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will present innovative uses of technology to collect data from and about patients in clinical research studies, including an update on Bring Your Own Device (BYOD) technology, the use of in-home monitoring for patients with neurological disorders, and the use of technology for expression detection. An EMA regulatory perspective will also be presented. Join the Study Endpoints Community for a follow up Round Table discussion on Monday, June 24, 1:15-2:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the current state of BYOD and how it may evolve in the future; Discuss new approaches to patient assessment in neurological disorders including passive data collection and use of the artificial intelligence; Describe the use of expression detection as a clinical outcome assessment tool. Discuss a regulatory perspective on emerging technologies.

Chair

Sonya L. Eremenco, MA

Speaker

BYOD: The Current State of Play and Future Potential for Electronic Clinical Outcome Assessments (eCOA)
Chris David Watson, PhD

Using Passive In-Home Monitoring and Artificial Intelligence to Quantify Patients with Neurological Disorders
Dina Katabi, PhD, MS

The Face is a Mirror of the Mind: The Potential of Expression Detection for New Clinical Outcome Measures
Bill Byrom, PhD

EMA Perspective
Anthony Humphreys, MPharm

Speakers

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health

Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →

Sonya Eremenco

Associate Director, PRO Consortium, and Acting Director, ePRO Consortium, Critical Path Institute

Sonya Eremenco is Associate Director of the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute. Sonya has over 20 years of experience in PRO (and other clinical outcome assessment) instrument development, with a focus on multicultural development, linguistic... Read More →

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)

He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →

Dina Katabi

Andrew and Erna Viterbi Professor of Electrical Engineering and Computer Science, Massachusetts Institute of Technology (MIT)

Dina Katabi is the Andrew & Erna Viterbi Professor of Electrical Engineering and Computer Science, and the director of the MIT center for wireless networks and mobile computing. Katabi is a MacArthur Fellow, a member of the National Academy of Engineering. She received the ACM Grace... Read More →

Chris Watson

Director of Product Strategy - Digital Patient, ERT

Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Student Programming, Regulator Thinking, Patient Focused
Featured Topics Real World Evidence,Artificial Intelligence,Innovative Trial Design,Student Programming
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#108: Innovation in Enrollment, Recruitment, and Retention

Component Type: Session
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-535-L04-P; CME 1.00; IACET 1.00; RN 1.00

Speaker

Patient Video: A Powerful Tool for Clinical Trial Recruitment
Paul Ivsin

Optimizing Social Media Ads for Enrollment and Using Social Analytics Insights to Inform Strategy
Neil Weisman

Myth, Urban Legend, and an Element of Truth: Unwrapping Innovation in Enrollment, Recruitment, and Retention
Matthew Kibby, MBA

Speakers

Paul Ivsin

Managing Director, Clinical Trial Strategy, The Patient Experience Project

Paul leads the Clinical Trial Strategy and Patient Enrollment practice at The Patient Experience Project (PEP). He provides strategic planning services to both large pharma companies and biotechs, with an emphasis on patient engagement, clinical trial awareness, and performance a... Read More →

Matthew Kibby

Principal, President, BBK Worldwide

Matt Kibby is principal and president of BBK Worldwide. He has held a range of senior level positions in his 20-year tenure with the patient recruitment agency. He has had a formative impact on the sophistication of many of BBK’s breakthrough offerings – from enrollment feasibility... Read More →

Neil Weisman

President, Continuum Clinical

Neil Weisman, President of Continuum Clinical, helps pharmaceutical and biotech companies bring new therapies to market faster and more efficiently by solving critical communication challenges that impact the clinical development process. With nearly 20 years of experience, Neil leads... Read More →

Jennifer Burgess

Vice President, Global Engagement and Communications, TransCelerate BioPharma Inc.

Monday June 24, 2019 11:00am - 12:00pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics What's Next
Featured Topics What's Next
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-536-L04-P; CME 1.00; IACET 1.00; RN 1.00

We are faced with many challenges in drug development and clinical trial continuity, one that we must all be prepared for is how to manage your trial and team in the face of a natural disaster. Often we do not think about this until disaster strikes.

Learning Objectives

Discuss the importance of having a natural disaster management plan; Describe factors to consider when developing a natural disaster management plan; Identify key aspects of staff, site and patient support and how to be proactive and reactive in face of a natural disaster.

Chair

Mark Summers

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Raymond Policare, MPH

Speakers

Jennifer Sheller

Regional Head, NA, Global Clinical Trial Operations, Merck & Co, Inc.

Jennifer Sheller joined Merck in 2017 as an Associate Vice President and the North America Regional Head of Global Clinical Trials Organization. In this role she is responsible for all aspects of Merck Research Laboratories clinical trial operations in the United States and Canada... Read More →

Mark Summers

President, Patient Engagement Division, WIRB-Copernicus Group (WCG)

Mark Summers currently serves as President of the Patient Engagement Division at WCG, a division which includes all business units within WCG that provide services that directly interface with patients. Prior to his role at WCG he founded ThreeWire, Inc., a patient recruitment, enrollment... Read More →

Raymond Policare

Senior Director, Clinical Operations, PRA

Monday June 24, 2019 11:00am - 12:00pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Real World Evidence, Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-524-L04-P; CME 1.00; IACET 1.00; RN 1.00

Learn 1) challenges in adapting AI in risk management; 2) approaches in proactively managing clinical operation risk and in streamlining the process for automation; 3) a automation model to transform resource based monitoring into risk based approach

Learning Objectives

Discuss challenges in adapting artificial intelligence in risk management; Discuss innovative approaches in leveraging real-time access to clinical data and analytics in proactively managing clinical operation risk and in streamlining the process for automation in risk assessment and mitigation; Discuss automation maturity model to transform resource based monitoring into risk based approach.

Chair

Hanming H Tu, MSc

Speaker

Using Artificial Intelligence to Centralize, Standardize, and Ensure Data Integrity in Clinical Trial Monitoring
Michelle Marlborough

Artificial Intelligence in Risk Management
Susan Olson, PhD, MS

Utilizing AI to Transform Drug Safety Case Processing
Christina J Wocosky

Speakers

Susan Olson

Chief Operating Officer, edj

Susan is Chief Operating Officer at EdjAnalytics and manages operations and innovates advanced analytics solutions in life sciences. Edj is a Louisville, Kentucky company that offers advanced analytics for healthcare providers, pharmaceutical companies, government organizations, payers... Read More →

Hanming Tu

Vice President, IT, Frontage Laboratories, Inc.

* MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 20 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from... Read More →

Christina Wocosky

Industry Principal, Innovation and Though Leadership, Accenture

Chris Wocosky is an Industry Principal in Accenture’s Life Sciences R&D practice, and is based in San Diego, CA. She served as the Product Manager for an AI Platform, PV First, for case intake and pre-case processing, and was instrumental in developing and bringing the platform... Read More →

Michelle Marlborough

Chief Product Officer, AiCure

As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 23 years of experience in life sciences and software development, Michelle has been... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Data Standards, Session

Level Intermediate
Featured Topics Real World Evidence, Innovative Trial Design, What's Next
Featured Topics Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-525-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the phactMI benchmarking survey that was conducted in an effort to assess twenty seven member companies in the US through nine overall topics, such as company background, inquiry management, content development, decision makers, technology and website.

Learning Objectives

Discuss how twenty seven member companies are executing on medical information activities; Identify which technologies are currently being used, how medical content is being created and how inquiries coming from health care providers, patients and caregivers across the nation are being managed; Describe medical information executes on managed care situations and how medical information websites are being created and maintained.

Chair

Rania Gaspo, PhD

Speaker

Structure and Organization of Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information Departments
Kirstie Marasigan, PharmD

How Do Twenty Seven Medical Information Departments Execute on Healthcare Decision Making Materials for Payer Inquiries: A PhactMI(TM) Benchmarking Survey
Andrew Gazo, PharmD, MS

What is Happening Through Product Support, Key Performance Indicators, and Other MI Services: Insights from a PhactMI(TM) Survey of Twenty Seven US Pharmaceutical MI Departments
Meera Patel, PharmD

How Do We Create Medical Content? Fulfilling Customers’ Medical Information Needs: Insights from a PhactMI(TM) Survey of Twenty Seven US Pharmaceutical Medical Information Departments.
Teresa Flowers, MBA, MS, RPh

Speakers

Teresa Flowers

Senior Director, Medical Communications, Medical Affairs, Astellas Pharma Inc.

Teresa Flowers is Senior Director, and Global Medical Information Lead at Astellas Pharma Inc. She leads a co-located team of subject matter experts responsible for creating medical Information global core content. She has over 20 years of experience across multiple therapeutic areas... Read More →

Rania Gaspo

Director, Global Therapy Area Team Lead, External Medical Communications, Pfizer Inc

Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist. Rania joined Pfizer in 2003 where she held positions in medical... Read More →

Andrew Gazo

Head of CHC Global Content, Medical Information, Sanofi

Andrew Gažo is currently Head of Global Content for Consumer Healthcare in the Sanofi Medical Information Department and is a Board member of phactMI. Andrew has been active in all aspects of Medical Information, including content globalization, compliance monitoring, business development... Read More →

Kirstie Marasigan

Post-Doctoral Fellow, US Medical Affairs and Medical Communications, Genentech, A Member of the Roche Companies

Kirstie Marasigan is a first year US Medical Affairs Post-Doctoral Fellow at Genentech within the Rutgers Pharmaceutical Industry Fellowship Program. In May 2018, she graduated with a PharmD from the University of the Sciences, Philadelphia College of Pharmacy. During her last year... Read More →

Meera Patel

Associate Dierctor, Medical Information and Knowledge Integration, Janssen Pharmaceuticals

Meera has 15+ years of experience in Medical Information in the pharmaceutical industry. She is an Associate Director in Medical Information at Janssen Pharmaceuticals where she has oversight of products in infectious diseases. Prior to joining Janssen, she was a Medical Information... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Forum

Level Intermediate
Featured Topics Real World Evidence, Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

11:00am

#112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-526-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will present methods and success stories from three rare disease patient organizations that have collected meaningful patient experience data. Panelists will share their insights and challenges for data collection including surveys and patient registries.

Learning Objectives

Describe the importance of participating in registries and the methods by which data is collected; Identify strategies for overcoming the challenges of patient engagement to help provide pathways towards accelerating rare disease research.

Chair

Laura Trutoiu, PhD

Speaker

Panelist
Monica Weldon

Panelist
Pamela Mace, RN

Speakers

Pamela Mace

Executive Director, Fibromuscular Dysplasia Society of America

At the age of 37, Pam Mace was diagnosed with a rare disease called Fibromuscular Dysplasia (FMD). She struggled with her health for the first few years after her diagnosis and realized that medical professionals had no real understanding of the disease. Pam became an advocate for... Read More →

Laura Trutoiu

Director of Research, The Association For Creatine Deficiencies

Laura is a computer scientist and the Director of Research for the Association for Creatine Deficiencies. She holds a PhD in Robotics from Carnegie Mellon University and she has conducted research in several top industry labs including Disney Research, Industrial Light and Magic... Read More →

Monica Weldon

President/Chief Executive Officer, Bridge the Gap - SYNGAP Foundation

In November of 2012, Monica's twin son, Beckett, was the first to be diagnosed at Texas Children's Genetics Clinic with the gene mutation SYNGAP1 (6p21.3). When Beckett was 4 months old, she noticed he was not meeting the same milestones as his twin sister. Monica then began a journey... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient Engagement, Forum | 03: Data-Data Standards, Forum

Level Intermediate
Featured Topics Regulator Thinking
Featured Topics Real World Evidence,Patient Focused,Rare Disease
Credit Type ACPE, CME, IACET, RN
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11:00am

#113: Artificial Intelligence in Drug Discovery and Development: Emerging Technologies and Applications

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

A discussion of advances in artificial intelligence and related technologies in computer, information and data science, specifically as they apply to challenges and emerging application areas within pre-clinical drug discovery and early drug development.

Learning Objectives

Describe translatable experiences and practices concerning impactful applications of artificial intelligence.

Chair

Scott Spangler, MA

Speaker

Panelist: Activity Metabolomics and ArtificiaI Predictions
Erica Majumder, PhD

Challenges and Opportunities in Near-Term Quantum Computation
Yudong Cao, PhD, MS

Panelist
Craig Lipset, MPH

Speakers

Craig Lipset

Former Head of Clinical Innovation, Pfizer

Erica Majumber

Associate Director and Senior Safety Science Leader IIDO, Scripps Research

Dr. Majumder is a researcher with Dr. Gary Siuzdak in the Scripps Center for Metabolomics and Mass Spectrometry. Erica specializes in anaerobic metabolism and the activity of sulfur-containing metabolites. Recently, she has been spearheading their lab's new efforts using AI-based... Read More →

Yudong Cao

Co-founder and CTO, Zapata Computing

Yudong Cao is co-founder and CTO of Zapata Computing, a quantum software startup based in Cambridge, MA. His PhD thesis in Computer Science received 2016 Chorafas Award in Computer Science and Informatics. From 2016 to 2018 he worked as a postdoctoral researcher at Harvard University... Read More →

Scott Spangler

Distinguished Engineer, Chief Data Scientist for Life Sciences, IBM Watson

Scott Spangler is Chief Data Scientist, Distinguished Engineer, and Master Inventor in the Watson Health Life Sciences Group at the IBM Almaden Research Center. He has been doing knowledge base and data mining research for the past 25 years. Since coming to IBM in 1996, Scott has... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: PreClin Dev-EarlyPhaseCR, Forum

Featured Topics Artificial Intelligence,Innovative Trial Design,What's Next,Student Programming
Credit Type ACPE, CME, IACET, RN
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11:00am

#114: Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Consideration in US, EU, and Japan

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-528-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166ASOAHB; RN 1.00

This session will discuss potential cultural impacts on various patient engagement processes, especially in US, UK and Japan. Presenters will briefly overview the contextual differences, such as medical system, provide actual cases, and facilitate the participants to identify tips to listen to patients globally, in order to incorporate those into global drug development.

Learning Objectives

Describe general patient practice and value differences (including in patient-doctor relationships) between Eastern culture and Western culture, and also understand the background to those differences; Identify potential opportunities and limitations to leverage patient voices in different cultures; Discuss further incorporating global diverse patient voices into drug development.

Chair

Atsushi Tsukamoto, PhD

Speaker

Nurse Point of View
Noriko Fujiwara, MS, RN

Intercultural Point of View (UK)
Gareth Julian Monteath, PhD, MBA, MS

USA Point of View
Robert Hilke, MA

Speakers

Noriko Fujiwara

Research Nurse, Project Researcher, Department of Palliative Medicine, IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

Ms. Noriko Fujiwara is a research nurse and a project researcher of the department of palliative medicine, the Institute of Medical Science, the University of Tokyo. She has over 10 years' experience in research field. She is a Certified Nurse Specialist in Cancer Nursing with the... Read More →

Atsushi Tsukamoto

Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.

Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →

Robert Hilke

Chief Executive Officer, Hilke Communications Corporation

Robert Hilke is the CEO of Hilke Communications Corporation, a firm specializing in providing intercultural communications and TOEIC training for global businesspeople, many of whom work in the pharmaceutical industry. Mr. Hilke's primary research interest is the management of diverse... Read More →

Gaz Monteath

Executive Director, Link Global Solution Inc.

Dr. Gareth ("Gaz") Monteath is Executive Director at Link Global Solution Inc., an HR and OD consulting firm based in Tokyo. In his position, Gaz is responsible for the overall content and quality of programmes. LGS has long experience of working with pharmaceutical and medical instruments... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjMgt-StrategicPlanning, Forum | 05: Patient Engagement, Forum

Level Beginner
Featured Topics Student Programming
Featured Topics Patient Focused
Credit Type ACPE, CME, IACET, PMI, RN
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11:00am

#115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

The key characteristics of a QMS with a focus on how the size of an organization impacts the QMS characteristics and their risk-based methodologies, including what key learnings organizations of varying sizes can learn from each other’s experiences.

Learning Objectives

Discuss the differing characteristics of a QMS based on the size of the organization; Compare how these characteristics changed in preparation for ICH E6 R2 implementation; Determine whether risk-based approaches vary based on organizational size and what organizations of different sizes can learn from each other.

Chair

Jay A Turpen

Speaker

Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool
Michael Husovich

Please enter Presentation Title
Lenna Kimball, MBA

Panelist
RJ Doornbos, RPh

Speakers

Michael Husovich

Director, Global R&D Quality, Amgen Inc.

Michael is currently Director of Global R&D Quality Operations at Amgen. Michael is responsible for advancing Amgen's R&D Quality Management System including Business Process Management, Document Management, Issue CAPA Management, Quality Risk Management and driving Operational Excellence... Read More →

Lenna Kimball

Vice President of of Clinical Operations, Lyell Biotech

Jay Turpen

Senior Consultant, The Avoca Group

Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 30 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new... Read More →

RJ Doornbos

Head of Global Quality Systems, Global Quality, Bristol-Myers Squibb Company

RJ Doornbos has over 25 years experience in Pharmaceutical Industry in Brand and Generic concentrated in the areas of GxP Quality, Regulatory Affairs and Pharmaceutical Sciences. She has held various roles in Schering-Plough, Merck, Allergan/Teva and more recently in BMS where she... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: R-D Quality-Compliance, Forum

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Forum

11:00am

#116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-530-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide the insight to future of regulatory affairs in the digital world and how companies need to embrace advanced technology to disrupt the traditional way of handling regulatory information and submission.

Learning Objectives

Describe Regulatory 2.0 and the future of regulatory affairs and impact of advanced technology such as artificial intelligence and machine learning; Discuss how to build a regulatory intelligence system using voice assistant and machine learning; Illustrate how real world evidence ( RWE) gives a new paradigm shift for more predictable, effective, and value-based patient care and the use of RWE in regulatory affairs.

Chair

Susant Mallick, MBA

Speaker

Regulatory 2.0 and Digital Tranformation in Regulatory Affairs Using Advanced Technology
Susant Mallick, MBA

Impact of Artificial Intelligence and Machine Learning in Regulatory Affairs
Hans van Bruggen, MSc

Automated Risk Detection using Machine Learning in Clinical Trials
Francois Torche, MBA

Speakers

Hans van Bruggen

Senior Regulatory Affairs Consultant, Qdossier B.V.

Hans van Bruggen is Director of and Senior Regulatory Affairs Scientist at Qdossier and eCTDconsultancy. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European... Read More →

Susant Mallick

Leader and Evangelist, Healthcare and Life Sciences, EMEA, Amazon

Susant Mallick is leading Amazon AWS HCLS professional services for EMEA region. He comes up with 20+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial... Read More →

Francois Torche

Chief Executive Officer, CluePoints

François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 20 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Intermediate
Featured Topics Real World Evidence,Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#117: International Regulatory Convergence

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

Discuss how regulators approach relative effectiveness in various jurisdictions. The opportunity arises at a time when the EU is discussing joint evaluations and legal framework. Canada is also working on interactions with the bodies responsible for this evaluation. Japan has initiated a pilot on relative effectiveness comparison.
We intend to show how international regulatory authorities could cooperate and share experience to ensure global coordination of data, studies, and evaluation in the context of global development.

Learning Objectives

Discuss how the main regulatory Agencies collaborate and work with those involved in relative effectiveness and added therapeutic value of medicines; Identify the common criteria used and determine when independence should be maintained; Examine specific issues with Advanced Therapies/regenerative medicines and added value; Describe the importance of collaboration at the international level

Chair

Agnès Saint-Raymond, DrMed, MD

Speaker

Panelist
Guido Rasi, MD

Panelist
Pierre Sabourin, MBA

Panelist
Brian O'Rourke, PharmD

Panelist
Giovanni Tafuri, PhD, MS

Panelist
Katsuaki Ura

Speakers

Brian O'Rourke

President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health

Dr. Brian O’Rourke is the President and Chief Executive Officer of CADTH. He joined CADTH in January of 2009 following a distinguished career as a Pharmacist and Health Service Executive with the Canadian military. With over 30 years of experience in health care, Brian actively... Read More →

Guido Rasi

Executive Director, European Medicines Agency

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada

Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... Read More →

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency

Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →

Giovanni Tafuri

Senior Scientific Officer, EUnetHTA

Giovanni Tafuri is the Senior Scientific Officer of the European Network for Health Technology Assessment (EUnetHTA) at the EUnetHTA Secretariat in the Netherlands. Prior to his appointment, he worked at both the HTA and the regulatory department of the Italian Medicines Agency (2006-2018... Read More →

Brian O'Rourke

President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health

Katsuaki Ura

Deputy Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)

Mr. Katsuaki Ura is currently Deputy Director, Office of International Regulatory Affairs, Pharmaceuticals Safety and Environmental Health Bureau, Ministry if Health, Labour and Welfare (MHLW), Japan since April 2018. He is engaged in international regulatory harmonisation through... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Patient Focused
Featured Topics Student Programming,Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

11:00am

#118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

For slowly progressed diseases, it may take years, if not decades, to observe clinical outcomes, such as mortality. Owing to the regulatory agencies’ accelerated approval pathway, drug developers can now consider applying for a drug approval based on surrogate endpoints. In this session, many surrogate endpoints adopted in various diseases and statistical methods for determining the validity of the surrogacy will be discussed, including their implementation in real case examples.

Learning Objectives

Describe cases that utilize the accelerated approval and what good surrogate endpoints are for common and rare diseases; Identify how to apply appropriate statistical methods for assessing the association between surrogate endpoints and clinical outcomes.

Chair

Yeh-Fong Chen, PhD

Speaker

FDA Update
Aloka Chakravarty, PhD

Statistical Assessment of Potential Surrogate Endpoints: Is the Bar too High?
Marc E. Buyse, DrSc

Using the Biomarker Endpoint for Accelerated Approval
Stephanie O. Omokaro, MD

Speakers

Marc Buyse

Chief Scientific Officer, International Drug Development Institute (IDDI)

Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute... Read More →

Aloka Chakravarty

Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA

Dr. Chakravarty joined CDER in 1992. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and... Read More →

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA

Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →

Stephanie Omokaro

Lead Medical Officer, Office of New Drugs, CDER, FDA

Dr. Omokaro is a Lead Medical Officer in the Division of Gastroenterology and Inborn Errors Products in the Center for Drug Evaluation and Research at FDA. She was educated in Biochemistry at Cornell University, and in medicine at Boston University. She completed a pediatric residency... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Session | 02: ClinTrials -ClinOps, Session | 03: Data-Data Standards, Session

Level Intermediate
Featured Topics Precision Medicine, Patient Focused, Rare Disease, Innovative Trial Design
Featured Topics Regulator Thinking,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#119: Making Value-Based Contracting Stick

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-532-L04-P; CME 1.00; IACET 1.00; RN 1.00

Value-based contracting between payers, providers and manufacturers is an evolving space. Finding approaches that will can both scale and succeed long term have been challenging. The first speaker will describe a set of examples that focus on the payer-pharma relationships. The second two speakers will describe a new approach to using provider clinical outcomes in specialty conditions as the level of measurement.

Learning Objectives

Describe the current state of value-based contracting; Discuss examples of success and failure in value-based contracting; Identify a new approach to using provider clinical outcomes.

Chair

Richard Gliklich, MD

Speaker

Trends and Practices of Applying Real World Evidence to Market Access and Value-Based Care
Robert A. DiCicco, PharmD

Medical Scores to Enable Value-Based Care
Richard Gliklich, MD

Industry Update
Thomas Michael Renshaw, MBA, RPh

Speakers

Richard Gliklich

Chief Executive Officer, OM1

Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →

Thomas Renshaw

Senior Director, Business Solutions, Acentrus Specialty (Vizient)

Tom currently functions as the Senior Director of Business Solutions for Apexus with responsibility for innovative business strategies and development. Tom has served as a subject matter expert in the areas of transitional care, population health management, bioinformatics, 340B... Read More →

Robert DiCicco

Deputy Chief Health Officer, IBM

Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Session

Level Intermediate
Featured Topics Regulator Thinking, Innovative Trial Design
Featured Topics What's Next
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

FDA Perspective
Sheila Ryan, MPH, RAC

Panelist
Chris Leo Pashos, PhD

Panelist
Mitchell Higashi, PhD

Panelist
Denise Sanchez, JD, MPH, MS

Speakers

Mitchell Higashi

Vice President, Health Economics and Outcomes Research, Bristol-Myers Squibb

Mitch is the Vice President of HEOR at Bristol-Myers Squibb. Prior to joining BMS, he was the Chief Economist for GE Healthcare, where he led global efforts in health economics, pricing, reimbursement, and health policy. Mitch is a published author, including JAMA, and his work in... Read More →

Chris Pashos

Vice President, Global Evidence Strategy, AbbVie Inc.

Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He... Read More →

Sissi Pham

Chief Executive Officer, AESARA

Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →

Sheila Ryan

Acting Director, Division of Supply Chain Integrity, Fda/cder/Office Of Compliance/Office of Drug Security, Integrity and Response

Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in... Read More →

Denise Sanchez

Executive Director, Commercial Regulatory Affairs, Allergan

Denise is a leader in the commercial regulatory space with 15 years of combined industry, government and law firm experience. Industry roles include Regulatory overview of commercial promotion and practices at Allergan Aesthetics, Ironwood, Celgene, & Cubist. At the law firm of Hughes... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Session | 05: Patient Engagement, Session | 04: MedAffairs-SciComm, Session

Level Intermediate
Featured Topics Artificial Intelligence, Regulator Thinking, What's Next
Featured Topics Regulator Thinking,Patient Focused
Credit Type ACPE, CME, IACET, RN
Tags Session

11:00am

#121: Emerging Professionals: Making the Most of Your Networking Experience at the DIA Global Annual Meeting

Component Type: Workshop
Level: Basic

This workshop will help Emerging Professionals prepare to connect and grow their networks during the DIA conference, as well as develop a networking strategy and learn tactics to build and maintain professional relationships. This workshop will assist in helping attendees become acquainted with the networking nature of the DIA conference. A networking/collaboration style assessment will be given during the session and we will provide attendees with an activity.

Learning Objectives

Discuss recommended ways to maximize their networking opportunities at the DIA conference; Describe and review the various networking behaviors - Examiner, Promoter, Nurturer or Go-getter; Evaluate and develop a personal, effective, and achievable networking approach and strategy.

Chair

Jateh Major, PharmD

Speaker

Facilitator
Obi Okafor, PharmD

Facilitator
Kenneth Hu, PharmD

Speakers

Jateh Major

Senior Scientist, Global Regulatory Affairs, Oncology, Merck & Co., Inc.

Jateh Major is a Senior Scientist in Global Regulatory Affairs at Merck. He currently works in early and late phase oncology supporting health authority interactions and strategizing drug development activity.

Obi Okafor

CERSI Postdoc, University of California San Francisco

Kenneth Hu

Postdoctoral Fellow, Rutgers University/Ernest Mario School of Pharmacy

Kenneth is a Global Regulatory Affairs Fellow with the Rutgers Pharmaceutical Industry Fellowship Program. As a Fellow he has worked in Regulatory Science and Policy, Strategy, and Advertising and Promotion across I&I, oncology, and primary care while also gaining insight into digital... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Level Intermediate
Featured Topics Student Programming
Tags Workshop

12:00pm

Luncheon Service

Component Type: Social Event

Monday June 24, 2019 12:00pm - 2:00pm
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Social Event

Tags Social Event

12:15pm

#122 CH: Leveraging Extra Value from an Intern Program: Non- Traditional Majors Add Unexpected Value

Component Type: Workshop
Level: Basic

This workshop will assist attendees in conducting a needs assessment for an effective intern program, identify potential areas of opportunity and discuss the process for implementing/improving an intern program.

Learning Objectives

Define and create an intern program. Design an infrastructure to leverage new skills and ways of working; Identify and create an opportunity map with cross mapping of potential majors.

Chair

Diane Schommer, MBA

Speakers

Diane Schommer

Associate Director, Project Management, Global PV Strategy Management Office, AbbVie

Diane Schommer is an Associate Director, Project Management, Global Pharmacovigilance Strategy Management Office at AbbVie. She has over 25 years of project management experience and has had her PMP since 2000. She has her BBA from Baylor University and her MBA from the University... Read More →

Monday June 24, 2019 12:15pm - 12:45pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop | 13: ProfDevelopment, Workshop

Tags Workshop

12:15pm

#123 IT: IQVIA Innovation Theater: When Context is Hard to Come By – The Emerging Value of External Comparators

Component Type: Session

Today more pharmaceutical products are being evaluated based on data from a single-arm trial design. However, single-arm trials do not have an internal comparator to enable understanding of study results and overall patient impact. External comparators derived from real-world data can help to address this evidence gap, augmenting submissions to regulators and payers, and enabling better value articulation for healthcare stakeholders.

Chair

IQVIA

Speakers

IQVIA

Christina Mack

VP, Epidemiology, IQVIA

Dr. Mack is Sr. Director of Epidemiology and Clinical Evidence and Head of the Surveillance and Analytics team at IQVIA, where she oversees development of large evidence platforms and novel studies that augment primary data collection with existing data. She also holds an academic... Read More →

Tawana Wester

Director, Clinical Development, Bioventus

Monday June 24, 2019 12:15pm - 12:45pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

12:15pm

#124 IT: Parexel Innovation Theater: Transforming the Drug Development Journey Through the Patient’s Eyes

Component Type: Session

Since the 2018 DIA where PAREXEL launched The Innovation Imperative: The Future of Drug Development, research conducted by the Economist Intelligence Unit and commissioned by PAREXEL, we have convened global roundtables with key industry influencers on how to enable innovation to transform the drug development journey. We now want to share the insights gleaned and explain how leveraging multi-stakeholder input – and multiple innovations working together – can ultimately benefit the patient.

Chair

Parexel

Speakers

Alberto Grignolo

Corporate Vice President, Parexel

Parexel

Sy Pretorius

Executive Vice President, Chief Medical and Scientific Officer, Parexel

y Pretorius is the CMO & CSO at PAREXEL. As a member of the executive team, he is responsible for the overall leadership of several service lines & business units. Sy is passionate about drug development and leads several company-wide initiatives focused on clinical trial and drug... Read More →

Monday June 24, 2019 12:15pm - 12:45pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

12:15pm

#125 EE: ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)

Component Type: Workshop
Level: Intermediate

FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this session the implementation plan for E2B(R2) IND safety reporting will be discussed in use case-based scenarios.

Learning Objectives

Recognize that FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Event Reporting System (FAERS); Describe several E2B R2 data elements, including regional elements that are key for premarket safety reporting.

Chair

Meredith K. Chuk, MD, MHS

Speaker

Facilitator
Suranjan De

Speakers

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA

Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →

Meredith Chuk

Acting Associate Director for Safety, OOD, OND, CDER, FDA

Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Oncologic Diseases in OND/CDER at the FDA.

Monday June 24, 2019 12:15pm - 1:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Engage-Exchange, Workshop | 01: ClinSafety-PV, Workshop

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12:30pm

Community Meet Up: Discussion on Data Quality, Real-Time Calculated Metrics, Compliance

Component Type: Forum
Level: Basic

For any conference attendees interested in the topic of data quality, real-time calculated metrics across systems and all while staying in line with the highest level of compliance. This discussion includes (but is not limited to): • Peer insights & challenges • Machine learning • Artificial intelligence • Disparate data • Workflow insights • Leveraging your current systems

Chair

Adam Federman

Speakers

Adam Federman

Director, Business Development, Remarque Systems

Monday June 24, 2019 12:30pm - 1:30pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Data Standards, Forum | Networking-CommunityEvents, Forum

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1:00pm

#126 CH: Separating the Hype from Reality in Pharmacovigilance Automation

Component Type: Workshop
Level: Intermediate

This interactive session will synthesize the PV automation journey and share lessons learned through case studies of solutions implemented at pharma companies. It will cover the technical, process, governance, and compliance challenges encountered.

Learning Objectives

Develop an end-to-end perspective on implementing pharmacovigilance (PV) process automation and the benefits being achieved in operation; Describe preparing the business case and roadmap and how to manage expectations; Identify technology choices, compliance issues, and change management considerations.

Chair

Jill Notte

Speaker

Facilitator
Harpreet Singh Kanwar

Speakers

Jill Notte

Associate Director - Marketing, Cognizant

Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →

Harpreet Kanwar

CTO Life Sciences, Cognizant

Harpreet Kanwar has more than 25 years’ experience in information technology and leads digital transformation programs for global pharma companies. As Chief Technology Officer, he is responsible for driving emerging technology adoption, delivery transformation, technology and architecture... Read More →

Monday June 24, 2019 1:00pm - 1:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop | 01: ClinSafety-PV, Workshop

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1:00pm

#127 IT: Veeva Systems Innovation Theater: Annual Industry Report: Trends, Insights, and Strategies to Improve Study Execution

Component Type: Session

Hear new results from the Veeva 2019 Unified Clinical Operations survey. By gathering the experiences and opinions of more than 350 clinical operations professionals from around the globe, the goal of the annual research is to understand the challenges and advances in today’s clinical operating model. Topics include the industry’s progress towards streamlining clinical systems and processes, improving collaboration, and reducing complexity to improve trial performance.

Chair

Veeva Systems, Inc.

Speakers

Veeva Systems, Inc.

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →

Jim Reilly

Vice President, Clinical Market Strategy, Veeva Systems

Jim Reilly is a Director of Product Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Regulatory suite of products. For the last 15 years, he has held a variety of senior positions in Regulatory publishing, software delivery, consulting... Read More →

Monday June 24, 2019 1:00pm - 1:30pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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1:00pm

#128 IT: WIRB-Copernicus Group Innovation Theater: Getting the Most Out of Your Site Selection Strategy

Component Type: Session

When it comes to site selection, the decisions made will have the largest impact on the study timelines. In fact, the combination of utilizing predictive data, performance analytics, and creating meaningful relationships with sites are the perfect ingredients for timely startup and ultimate success. In this 30min. presentation, we will discuss moving your site selection strategy from a transactional approach to a portfolio-level approach to help accelerate enrollment timelines by 30%.

Chair

WIRB-Copernicus Group

Speakers

Suzanne Caruso

Vice President of Clinical Solutions, WCG

Suzanne Caruso serves as the Vice President of Clinical Solutions for WCG. In this role, Suzanne oversees WCG's robust suite of transformational solutions and manages the growth, development, and operational strategy relating to these services. She uses her unique expertise to design... Read More →

WIRB-Copernicus Group

Monday June 24, 2019 1:00pm - 1:30pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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1:15pm

#129 EE: The Potential Value of Shared Decision Making (SDM) in Clinical Trial Consideration and Participation

Component Type: Workshop
Level: Intermediate

Shared decision making is a form of collaborative communication to help patients and their providers consider various care options and potential clinical trials. Through facilitated discussion and small group activity, participants will examine the value of SDM from the point of view of people living with different disease types, from common, chronic diseases, such as diabetes, to various stages of cancer and rare diseases. They will also consider a study design with patient-centered outcome measures related to decision-making and patient experience.

Learning Objectives

Explore the application of SDM in discussions including clinical trials as options; Examine examples from clinical development operations, assess them for their suitability for decision support; Discuss the challenges of implementation Explain a study design that could help demonstrate the potential of SDM to transform traditional clinical trial recruitment into patient-centered decision support.

Chair

Mary Stober Murray, MBA

Speaker

Facilitator
Diana Pankevich, PhD

Facilitator
T.J. Sharpe, PMP

Speakers

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company

As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the... Read More →

Diana Pankevich

Director,Innovation Policy, Pfizer Inc

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC

T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in his Patient #1 Blog. He was diagnosed in August 2012 with metastatic melanoma, weeks after his second child was born. He has undergone six surgeries and four immunotherapy treatments over two different... Read More →

Monday June 24, 2019 1:15pm - 2:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Engage-Exchange, Workshop | 05: Patient Engagement, Workshop

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1:15pm

#130 RT: Round Table Discussion: Emerging Technologies in Clinical Research

Component Type: Session
Level: Basic

Round table discussion tied to session #107: Emerging Technologies in Clinical Research (Monday, June 24, 11:00AM - 12:00PM). Seating is limited. To include special guests from the session: Anthony Humphreys, Sonya Eremenco.

Chair

Keith W. Wenzel

Speakers

Keith Wenzel

Senior Director, Scientific Data Organization, Parexel

Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working... Read More →

Monday June 24, 2019 1:15pm - 2:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Community Rounds, Session | 02: ClinTrials -ClinOps, Session

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1:30pm

#131 SB: On the Soapbox: Designing Babies - Medical, Ethical, and Social Questions

Component Type: Forum
Level: Intermediate
CE: ACPE 0.75 Knowledge UAN: 0286-0000-19-733-L04-P; CME 0.75; IACET 0.75; RN 0.75

New gene editing technology known as “clustered regularly interspaced short palindromic repeats” or CRISPR can alter the genes of cells, including embryos, changing the organism and its descendants, and raising critical ethical, legal, and social concerns. First discovered in 2014, scientists have rapidly used this technology in many species. This technique can also alter genes in microorganisms to create superbugs, and in 2016, the Pentagon listed it as a weapon of mass destruction. In 2018, a Chinese researcher stated that he had edited human embryos and transferred them into a womb, producing twin girls. Yet CRISPR can have ‘off-target’ effects, accidentally eliminating additional DNA, and genes may have multiple, unknown functions. In March 2019, scientists recommended a moratorium on transfer of altered embryos into wombs, and a registry of all CRISPR trials. Questions remain, however of how long such a moratorium should last, when it should end, who should decide, based on what criteria, whether all nations and researchers will agree, and what should be done if non-compliance occurs. Questions emerge of when CRISPR will be “safe enough” for initial research studies, and later for broader clinical use. The first human offspring may need to be followed through adulthood and the birth of their own children. This talk will explore these critical challenges, related to ethical principles of autonomy, risks, benefits and social justice, and how these questions might best be addressed.

Learning Objectives

Discuss the critical challenges related to ethical principles of autonomy, risks, benefits of gene editing technology.

Chair

Robert Klitzman, MD

Speakers

Robert Klitzman

Professor of Clinical Psychiatry; Director, Masters of Bioethics Program, Columbia University

Robert Klitzman, M.D., is a professor of psychiatry at the College of Physicians & Surgeons, & the Mailman School of Public Health, & the Director of the online and in-person Bioethics Masters & Certificate Programs at Columbia University. He has written over 130 scientific journal... Read More →

Monday June 24, 2019 1:30pm - 2:15pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: PreClin Dev-EarlyPhaseCR, Forum

Featured Topics Precision Medicine
Credit Type ACPE, CME, IACET, RN
Tags Forum

1:45pm

#132 CH: Advancing Trailblazing Research and Development: When to Speed Up, When to Slow Down

Component Type: Workshop
Level: Intermediate

Using a case study, participants will discuss a real-life example of a manufacturing roadblock and discuss problem-solving strategies, the importance of taking prudent risk, and building the right team for success.

Learning Objectives

Analyze risks and recognize trade-offs in preclinical development planning; Identify problem-solving strategies and formulate a plan to proceed accordingly in development planning; Apply case study-specific steps and learnings to any potential scenario; Apply best practices in participants’ own work.

Chair

Sandy Macrae, PhD

Speakers

Sandy Macrae

Chief Executive Officer, Sangamo Therapeutics

Sandy Macrae serves as a member of the Company’s Board of Directors. He has twenty years of experience in the pharmaceutical industry most recently serving as the Global Medical Officer of Takeda Pharmaceuticals, where he established and led the Global Medical Office, which encompasses... Read More →

Monday June 24, 2019 1:45pm - 2:15pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

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1:45pm

#133 IT: Cognizant Innovation Theater: Shared Investigator Platform: Innovating Clinical Trials Feasibility and Study Start Up

Component Type: Session

The Shared Investigator Platform (SIP), the industry's only open clinical ecosystem, is changing the way that sites and sponsors interact with each other across the clinical trials life cycle. Learn how clinical trials feasibility and study start up are being managed more efficiently, reducing administrative burden and accelerating cycle times.

Chair

Cognizant

Speakers

Cognizant

Cognizant Technology Solutions Corporation

Cognizant partners with companies to develop strategies and apply solutions to healthcare challenges. Products such as Cognizant Protocol Creator and Shared Investigator Platform are digitizing interactions between sponsors, investigators, CROs, patients, and regulators across every... Read More →

Larissa Comis

Shared Investigator Platform, Product Lead, Cognizant

Larissa Comis is Cognizant’s Product Leader for the Shared Investigator Platform. She works closely with sponsors, investigators, CROs, and technology partners to drive adoption across the clinical ecosystem. Larissa has extensive experience in clinical trial informatics and technology... Read More →

Monday June 24, 2019 1:45pm - 2:15pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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1:45pm

#134 IT: SAS Institute Inc Innovation Theater: Smarter Clinical Trial Enrollment with Real World Data and Simulation Analytics

Component Type: Session

Real world data is transforming the way therapies are discovered, developed and delivered to market. In this fast-paced symposium, learn about how real world data can help inform smarter clinical trial enrollment. Real world data gives you richer, more accurate data on the patients involved to make your enrollment simulations more accurate and therefore more valuable. From there, discrete event simulation can be used to identify the optimal enrollment plan.

Chair

SAS Institute Inc.

Speakers

Jim Box

Principal Data Scientist, SAS Institute Inc

Box provides strategic insights across the life sciences industry, with a focus on optimizing the execution of clinical trials. He spent 18 years in the CRO industry, holding leadership roles in statistics, statistical programming, data management and information technology. Throughout... Read More →

Sherrine Eid

Principal Industry Consultant, SAS Institute Inc

Sherrine Eid is an Industry Consultant with Health and Life Sciences at SAS. She has over 20 years of experience in Real-World Evidence, Epidemiology and Biostatistics. Previous positions include both private sector and public service roles, including work for USAID, CDC, the City... Read More →

SAS Institute Inc.

SAS Institute Inc

Monday June 24, 2019 1:45pm - 2:15pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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2:15pm

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.

Learning Objectives

Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH

Speakers

Kimberly Brodovicz

Executive Director of Global Epidemiology, Boehringer Ingelheim

Kim Brodovicz is Executive Director, Late Stage Cardiometabolism Team Lead in Global Epidemiology and Real World Evidence at Boehringer Ingelheim. Kim has supported drugs and vaccines from early development to post-approval in a variety of therapeutic areas and has conducted numerous... Read More →

Noelle Cocoros

Research Scientist, Department of Population Medicine, Harvard Medical School

Noelle Cocoros is an epidemiologist with a broad background in public health surveillance, pharmacoepidemiology, and infectious disease epidemiology and has expertise in the use of claims, electronic health records, and registry data for surveillance (FDA's Sentinel System; ESPhealth.org... Read More →

Jeremy Rassen

President and Chief Science Officer, Aetion

Jeremy A. Rassen, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 02: ClinTrials -ClinOps, Session | 06: PreClin Dev-EarlyPhaseCR, Session

Level Intermediate
Featured Topics Real World Evidence,Regulator Thinking,Innovative Trial Design,Generics,What's Next
Credit Type ACPE, CME, IACET, RN
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2:15pm

#136: Interpretation of New Pharmacovigilance Regulations: Key Insights

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

Building on the ongoing collaborative efforts of nineteen sponsor companies, a key workstream has been established on how each is addressing major new pharmacovigilance regulations and guidances. This session will provide feedback on key learnings and best practices. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 9:30-10:30AM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Explain some of the challenges associated with major new pharmacovigilance guidelines; Discuss how companies are interpreting and implementing the aforementioned guidelines; Share best practices across the industry and learnings from feedback from regulators.

Chair

Ajay B. Singh

Speaker

Reference Satety Information: Implementing the Recommendations Noted in the CTFG
Ajay B. Singh

Update From MHRA
Mick Foy

Combination Products: Focus on FDA Guidance on Postmarketing Safety Reporting
Jane M. Carroll, BSN, MS, RN

Speakers

Jane Carroll

Head of Global Patient Safety Region - Americas, EMD Serono

Jane Carroll is the interim Head of Global Patient Safety Regions since February 25, 2019 and Head of Global Patient Safety Region Americas for the Biopharma business of Merck KGaA Darmstadt, Germany since 2015. Jane is responsible to ensure a robust system to collect and report adverse... Read More →

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)

Ajay Singh

Team Leader, Safety Evaluation and Risk Management, GlaxoSmithKline

Ajay is a nephrologist by training and currently serves as a team leader in the Safety Evaluation and Risk Management group at GSK. The main focus of the group currently is development of oncology/immune-oncology products. Ajay represents GSK on the TransCelerate work stream focused... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum | 09: Regulatory, Forum

Level Intermediate
Featured Topics Precision Medicine, Advanced Therapies, Rare Disease
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#137: Emerging Technology to Improve Sponsor-Site Interactions

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-547-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will include updates on the growth of functionality, adoption, and engagement initiatives to further strengthen Sponsor-Site collaboration. This session will also describe the value and benefits of SIP being open for adoption across the industry, which means that realized benefits would be further multiplied across participating sponsors and sites.

Learning Objectives

Discuss how Sponsors, technical partners, and Investigators collaborated in an unprecedented way to create a first of its breed technology platform that will enable a seamless investigator experience; Describe the value, benefits, and latest system updates from the Shared Investigator Platform being available for adoption across all interested Sponsors and respective vendors.

Chair

Lisa Bartoli Moneymaker

Speaker

An Evolution of Sponsor-Site Collaboration in the Planning and Execution of Clinical Trials
Lisa Bartoli Moneymaker

Chatbot Implementation for Improving Site-Sponsor Relationship: A Lean Start-up Approach
Johan Chaparro

Speakers

Johan Chaparro

Lead Clinical Data Manager, Merck, Sharp and Dohme

Passionate for the use of new technologies Chemical Engineer and Data Manager with 2+ years of experience in oncologic clinical trials. Specialized in Innovation Management, the main motivation is to bring disruption considering to the highly regulated pharmaceutical industry. Strong... Read More →

Lisa Moneymaker

Principal Architect, Clinical Trial Management Systems, Amgen Inc.

Lisa is a Principal Architect within the Development Information Systems organization at Amgen, specializing in Clinical Trial Management ecosystems. She additionally supports TransCelerate in both the Investigator Registry and Shared Investigator Platform initiatives, and is the... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
Tags Session

2:15pm

#138: Blockchain in Clinical Trials Demo: Truth or Dare

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use blockchain to show the design and implementation of faster, less onerous user identification processes through permissioned access to a federated database pointing to a variety of traditionally siloed sources (inc. EMR, wearables, IoT etc).

Learning Objectives

Describe how a blockchain-powered health wallet could support greater efficiencies across the clinical trial process.

Chair

Adama Ibrahim, MBA

Speaker

Facilitator
Maria Palombini, MBA

Facilitator
Jim Nasr, MBA

Facilitator
Disa Lee Choun, MBA, RPh

Blockchain
Mathew Rose, MD, MS, MSc

Speakers

Disa Lee Choun

Head of Innovation, Global Clinical Services and Operations, UCB Celltech

Disa has years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation within the Global Clinical Sciences & Operations at UCB, she is responsible for evaluating and piloting innovative solutions... Read More →

Adama Ibrahim

Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen

An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion... Read More →

Jim Nasr

Founder, Acoer

Maria Palombini

Life Sciences Practice Lead, Global Business Strategy and Intelligence (GBSI), IEEE-Standards Association

Maria joined IEEE-SA with a directive to build communities and advance initiatives to develop standards for enterprise adoption of emerging technologies. Her area of focus includes research on challenges and opportunities in integrating cutting-edge technologies such as AI, IoT, ML... Read More →

Jim Nasr

Vice President, Technology and Innovation, Certara

Jim Nasr is the VP of Technology & Innovation at Certara. Jim leads the development of OpenPharma: modern, open technology healthcare platform—including: blockchain, open APIs, real-time data services and machine learning—to improve patient outcome and transform life sciences... Read More →

Mathew Rose

Founder and Chief Executive Officer, SAAVHA Inc.

Dr. Rose is a Physician, Entrepreneur, and Blockchain Specialist, who strives to use cutting-edge technology to simplify secure user experiences that increase patient engagement and drive better health outcomes. He has more than 9 years working on Translational Medicine and Phase... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Workshop

Level Intermediate
Featured Topics What's Next
Featured Topics Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
Tags Workshop

2:15pm

#139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an opportunity for stakeholders to hear about FDA’s effort to advance the development of a publicly available core set(s) of clinical outcomes assessment measures and endpoints.

Learning Objectives

Describe FDA efforts, including plans and progress on an anticipated new FDA extramural grants program, to advance the development of a publicly available core set(s) of clinical outcomes assessment (COA) measures and endpoints for specific disease indications; Discuss the opportunities for key stakeholders including, academia, Health Technology Assessors, payers, health care providers, and regulated industry.

Chair

Meghana Chalasani, MHA

Speaker

FDA Update
Theresa Mullin, PhD

FDA Update
Laura Lee Johnson, PhD

FDA Update
Elektra Johanna Papadopoulos, MD, MPH

Industry Update
Tara Symonds, PhD

Industry Update
Anton Hoos, MD, PhD, MBA

Speakers

Anton Hoos

Executive Team, Patient Focused Medicine Development

Tony is a founding member of the non-profit, multi-stakeholder alliance ‘Patient Focused Medicines Development’ (www.pfmd.org); members include many patient groups, industry and others; Tony currently serves on PFMD’s executive team. He has 30 years of professional experience... Read More →

Meghana Chalasani

Senior Research Analyst, Office of the Center Director, CDER, FDA

Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and... Read More →

Laura Lee Johnson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA

Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA

Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other... Read More →

Elektra Papadopoulos

Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA

Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome... Read More →

Tara Symonds

Chief Science Officer, Clinical Outcomes Solutions

Tara Symonds is Strategic Lead at Clinical Outcomes Solutions providing advice on COA strategy from development to dissemination. Tara has 25+ years of experience in the COA field both negotiating labelling and in disseminating results effectively with payers. She has worked in numerous... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Session

2:15pm

#140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

Standardizing real world data, consisting of EHR and claims encounters, into a clinical trial endpoint relies on a complex process of selecting the appropriate data-set and filtering, mapping and merging healthcare encounters from EHR to trial endpoints.This session will describe and appraise approaches and challenges in formulating the endpoints, in both prospective and retrospective research projects, with a focus on cardiovascular endpoints as well as demographic data.

Learning Objectives

Describe process to extract clinical trial endpoints from EHR and claims datasets; Identify how to apply a process to supplement objective EHR and claims dataset endpoints with correlated patient-reported outcomes.

Chair

Debra Fasteson Harris

Speaker

Phenotypic Diagnosis of Rare or Difficult to Diagnose Diseases
Richard Gliklich, MD

PRO Perspective not Typically Available in EHR or Other Large Existing Real World Datasets
Amanda Harrington

Speakers

Richard Gliklich

Chief Executive Officer, OM1

Debra Harris

Associate Director (Operations), Pragmatic Health Systems Research (PHSR), Duke Clinical Research Institute

Debra Harris is the Associate Director of the Center for Pragmatic Health Systems Research at the Duke Clinical Research Institute where she focuses on the use of real-world data for clinical research. She is clinical trial-ist with more than 20 years of data management, cardiovascular... Read More →

Amanda Harrington

Lead Clinical Trial Coordinator, Duke Clinical Reserach Institute

Monday June 24, 2019 2:15pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Data Standards, Session

Level Beginner
Featured Topics What's Next
Featured Topics Real World Evidence,Innovative Trial Design,What's Next
Credit Type ACPE, CME, IACET, RN
Tags Session

2:15pm

#141: Knowledge Management and Information Sharing to Support Business Continuity

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-541-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will demonstrate how knowledge management is key to support business continuity during times of change. A panel of representatives will present examples of how their companies enable knowledge preservation and information sharing.

Learning Objectives

Discuss different models for knowledge management and information sharing within medical affairs organizations to support continuity and increase organizational efficiency; Identify the key drivers for preserving knowledge and identify ways in which a medical affairs organization can leverage tools and processes to bolster a culture of collaboration.

Chair

Divya Raman, JD, MS

Speaker

Panelist
Anne Arvizu, PharmD

Panelist
Chris Clevenger, PhD

Speakers

Anne Arvizu

Chief Executive Officer and Medical Affairs Advisor, RxER Communications Corp

Dr. Anne Arvizu is founder and CEO of RxER Communications Corp (www.rxercommunications.com). With 22 years of executive leadership experience in the pharma/biotech industry, she has served in key roles such as Head of Global Med Info, Knowledge Mgmt. and Literature Surveillance for... Read More →

Chris Clevenger

Managing Director, Rype Health

Chris Clevenger is a Managing Director at Rype Health, a boutique consulting firm focused on helping start-up, small and mid-size biopharmaceutical companies design fit-for-purpose Medical Affairs teams. Prior to joining Rype Health, Chris led Medical Affairs teams at Ultragenyx... Read More →

Divya Raman

Program Manager, Medtronic

Divya Raman works at Medtronic, where she is a program manager, leading initiatives related to compliance to the European Union Medical Device Regulation. Divya has been with Medtronic since 2012 in roles within technical communication, regulatory affairs, and medical affairs. Prior... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Forum

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#142: Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-542-L04-P; CME 1.00; IACET 1.00; RN 1.00

With advancements in stakeholder engagement prompted most recently by the 21st Century Cures Act, PCORI, and FDA’s Patient-Focused Drug Development initiatives, patients and caregivers have increasingly shifted from being passive subjects to more active partners in research and healthcare innovation. Groups like the Clinical Trials Transformation Initiative have established best practices for how and when to engage patients in research and development, NIH’s NCATS has created toolkits to support patient engagement in therapy development, and PCORI has put forth recommendations that patients be included as valued research team members who are appropriately compensated for their time. However, no framework to date has put a spotlight on patient and caregiver motivations and expectations around involvement and compensation nor mapped competencies and support needs from their standpoint. As we work towards embracing patients and caregivers as valued partners, it is important to understand challenges as well as best practices to ensure we can pave a path forward.Through our research we will illustrate the motivations, needs and expectations of patient and caregiver involvement in research and healthcare innovation.

Learning Objectives

Discuss the types of roles patient/caregivers serve in research, development, and healthcare innovation; Describe the various mechanisms for patients and caregivers to get engaged and their respective barriers/facilitators to involvement from the patient/caregiver perspective; Discuss patient/caregiver views on ethics, competency, and support required for each role; Illustrate patient/caregiver motivations and expectations around involvement and compensation.

Chair

Sarah Krug, MS

Speaker

Panelist
Bray Patrick-Lake, MS

Panelist
Veronica Todaro, MPH

Panelist
Jaye Bea Smalley, MPA

Speakers

Sarah Krug

Chief Executive Officer, CANCER101

Sarah Krüg is the CEO of CANCER101, a patient advocacy organization whose mission is to help patients and caregivers navigate the cancer journey and partner with their healthcare team to make informed decisions. Sarah is also Founder of the Health Collaboratory, a global innovation... Read More →

Bray Patrick-Lake

Director of Stakeholder Engagement, Duke Clinical Research Institute

Bray Patrick-Lake supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in Duke Clinical Research Institute’s local and national research programs. She has led extensive efforts through the CTTI to incorporate patient voice into clinical... Read More →

Jaye Bea Smalley

Director, Global I and I Patient Advocacy and Life Cycle Management, Celgene Corporation

Jaye Bea joined Celgene as Global Director, Patient Advocacy and Life Cycle Management, Inflammation & Immunology in March 2018. Her twenty-five-year career in health care includes extensive experience in the public and private sector focused on advancing the needs and interests of... Read More →

Veronica Todaro

Chief Operating Officer, Parkinson's Foundation

Veronica (Ronnie) Todaro, M.P.H., has led the national programs of the Parkinson’s Disease Foundation (PDF) since joining the organization in 2004. In this role, she has pioneered national programs focused on patient engagement both at PDF and in the broader community. She has advocated... Read More →

Veronica Todaro

Chief Operating Officer, Parkinson's Foundation

Monday June 24, 2019 2:15pm - 3:15pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient Engagement, Forum

Level Intermediate
Featured Topics Regulator Thinking, Patient Focused
Featured Topics Patient Focused
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use of the multiple expansion cohort design in oncology trials offers advantages and challenges. This session presents views on the success and hurdles of this design by regulators and industry. Implications for global development are also raised.

Learning Objectives

Discuss the important differences between phase 1 FIH studies and the FIH multiple expansion cohort design; Identify key safety challenges and risk mitigation steps; Discuss ethical consideration with oncology studies involving expansion cohorts; Identify examples of implementation challenges and opportunities of this design; Describe lessons learned from industry and regulators.

Chair

Sherry Leonard, RAC

Speaker

The Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Oncology Drug Development
Pamela Balcazar, MS

Implementation Challenges and Opportunities with FIH Multiple Expansion Cohorts
Sherry Leonard, RAC

Ethical Considerations in Oncology Studies Involving Expansion Cohorts
Lindsay McNair, MD, MPH, MSc

Speakers

Pamela Balcazar

Regulatory Health Project Manager, OHOP, CDER, FDA

Pamela Balcazar is Regulatory Project Manager in the Office of Oncology and Hematology Products (OHOP) at the FDA. In OHOP, her responsibilities include developing policies and overseeing regulatory initiatives related to the review of oncology products including guidances and process... Read More →

Sherry Leonard

Director, Regulatory Affairs, Celgene Corporation

Sherry A. Leonard, RAC, Director, Regulatory Affairs, Celgene Corporation Sherry joined Celgene Corporation in 2014 where she is a Director Regulatory Affairs within the Hematology/Oncology Franchise. She is the global regulatory lead for new chemical entities and biologic products... Read More →

Lindsay McNair

Chief Medical Officer, WIRB-Copernicus Group (WCG)

Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: PreClin Dev-EarlyPhaseCR, Session | 02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Regulator Thinking, Advanced Therapies
Featured Topics Regulator Thinking,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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2:15pm

#144: Ready or Not: Business Continuity Planning

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-544-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166VN1HY6; RN 1.00

This panel discussion will discuss business continuity planning as a key operational tool across the healthcare ecosystem, with a focus on biopharmaceutical companies. Representatives with experience across a variety of companies will share their insights and experiences with business continuity planning.

Learning Objectives

Assess which business processes are most critical to maintain in the event of a business disruption, key steps in developing business continuity plans, and linkages to risk management and crisis management.

Chair

Leigh Shultz, PhD, PMP

Speaker

Panelist
Jinus Moghbeli Pashai

Panelist
Mobeen Faqih, PhD, MBA

Panelist
Colleen Merritt Severyn, PhD

Speakers

Mobeen Faqih

Lead - Business Continuity (Supply Chain), Bristol-Myers Squibb

Highly accomplished leader with over 14 years of professional experience in the pharmaceutical industry across multiple functional groups. As a Strategic Product Leader, developed and led global teams for product launch and life cycle management, supplier performance and relationship... Read More →

Jinus Moghbeli Pashai

Director of Risk Managament, Amgen

Colleen Severyn

Director, Business Development, Supplier and Alliance Management, GRA, Merck & Co., Inc.

Colleen Merritt Severyn is director of Merck Global Regulatory Affairs and Clinical Safety (GRACS). Colleen currently leads the Business Continuity Program and GRACS Innovation Council. She has 17 years of project, portfolio and change management leadership experience. Previously... Read More →

Leigh Shultz

Associate Vice President, Global Project and Alliance Management, Merck & Co., Inc.

Global R&D Project & Alliance Management at Merck, leading the R&D Project Management (non-oncology) and Alliance Management (all therapeutic areas). PhD in chemistry; started at Merck in 2001 as a chemist in Pharm R&D. Joined Project Management in 2004; PMP-certified in 2007.

Monday June 24, 2019 2:15pm - 3:15pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjMgt-StrategicPlanning, Forum

Level Beginner
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, PMI, RN
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2:15pm

#145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present pillars of effective vendor oversight and governance. A panel of experts will provide perspectives on benefits, lessons learned and challenges of various models.

Learning Objectives

Discuss the importance of comprehensive and transparent vendor oversight in light of increasing partnerships and outsourcing; Identify and review real life examples of issues and how to effectively address in both new and ongoing vendor relationships; Discuss ways to improve and accelerate trust in relationships.

Chair

Leo Dodds, MBA

Speaker

Panelist
Judith Sernatinger, MA

Panelist
Albert Cosenza, MS

Speakers

Albert Cosenza

Head, Vendor and Capacity Management, Johnson & Johnson

A Pharmaceutical executive with a passion for building successful partnerships between vendors and corporations. As the cross-sector head of vendor and capacity management, he is responsible for providing strategic leadership for vendor management and oversight, as well as capacity... Read More →

Leo Dodds

Partner, Triradial Solutions

A biopharma executive and management consultant with a background in statistics and business operations. Leo helps clients accelerate their success strategies through leading practice and experience-based methods. His experience spans both commercial and R&D operations and his focus... Read More →

Judith Sernatinger

Vice President, Global Head of Quality, Prothena Biosciences Inc

Judith is a Quality Management Executive recognized for her ability to collaborate to build quality organizations and processes that drive patient safety and product quality. As VP, Global Head of Quality at Prothena Biosciences, she is responsible for Quality strategic planning and... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: R-D Quality-Compliance, Forum

Level Intermediate
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#146: Communications with Regulators Beyond Formal Meetings

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-546-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA and industry experts share best practices when seeking advice via Critical Path Innovation Meetings (CPIM), parallel scientific advice, and the Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT).

Learning Objectives

Identify when you should seek advice beyond formal meetings with FDA; Discuss best practices in obtaining parallel scientific advice from FDA and EMA; Discuss best practices in obtaining advice via a Critical Path Innovation Meeting (CPIM); and, discuss the impact to regulatory strategies and timelines.

Chair

Khyati Roberts, PharmD, RPh

Speaker

Overview of FDA-EMA Parallel Scientific Advice
Sandra L. Kweder

Seeking Advice from EMA
Tânia Teixeira, PharmD

Overview of Critical Path Innovation Meetings
Chekesha Clingman, PhD, MBA

Industry Perspective on Communications Beyond Formal Meetings
Nicole Mahoney, PhD

Overview of INTERACT Meetings
Christopher Joneckis, PhD

Speakers

Chekesha Clingman

Associate Director for Strategic Partnerships, OTS, CDER, FDA

Dr. Chekesha Clingman is a Commander in the US Public Health Service and the Associate Director for Strategic Partnerships in the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). Dr. Clingman manages the... Read More →

Christopher Joneckis

Associate Director for Review Management, CBER, FDA

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA

Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →

Nicole Mahoney

Senior Director, Regulatory Policy, Flatiron Health

Nicole Mahoney is the Senior Director of Regulatory Policy at Flatiron Health, helping advance the use of real world evidence for regulatory decision making. Prior to her current role, she was a Director of Global Regulatory Policy at Merck, advocating for incentives to spur antibiotic... Read More →

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.

Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →

Tânia Teixeira

EMA Official at the FDA, European Medicines Agency

Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Intermediate
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
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2:15pm

#147: Update from Health Canada: The Health Protection Branch

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-552-L04-P; CME 1.00; IACET 1.00; RN 1.00

While we generally speak of Health Canada abroad, there is a need to understand that responsibilities for health-related matters are split between the Federal and Provincial and Territorial Governments. This sessions aims to provide a broad and comprehensive picture in order to draw a comprehensive picture of the activities within our mandates.

Learning Objectives

Describe the health system in Canada and the place of the regulator within that system; Discuss the most current regulatory innovations.

Chair

Agnes Victoria Klein, MD

Speaker

Regulatory Reform
Celia Lourenco, PhD

Naming of Biologics and Real World Evidence: Status in Canada
Agnes Victoria Klein, MD

Speakers

Agnes Klein

Senior Medical Advisor, Health Canada

Agnes V. Klein MD is currently the Senior Medical Advisor in the Director General's Office, in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in multiple aspects of drug development and medical bioethics. Dr. Klein is... Read More →

Celia Lourenco

Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada

Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Patient Focused, What's Next
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#148: Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-553-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA’s approach to digital health is evolving. The agency has issued a series of guidances and other policies in recent years on digital health technologies <b><b This panel will explore how these policies may impact patients and innovators. As part of this discussion, panelists will also consider how digital health policies are shifting and where additional work could be done to facilitate innovation. We’ll explore FDA’s thoughts on how DH could help to incorporate the patient voice, generate real world evidence, and improve postmarket surveillance. Join us for an interactive discussion among a diverse set of stakeholders.

Learning Objectives

Describe FDA’s current thinking on digital health; Assess the potential impact of digital technologies on FDA priorities such as patient voice, real world evidence generation, post-market safety; Assess future opportunities for digital health to impact medical product development.

Speakers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc

Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA

Catherine Kopil

Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson's Research

As Director of Research Partnerships at The Michael J. Fox Foundation (MJFF), Katie focuses on building the Foundation’s capacity as an unprecedented stakeholder in Parkinson’s drug development — a nimble, patient-focused problem-solver whose efforts are demonstrably accelerating... Read More →

Yarmela Pavlovic

Partner, Global Regulatory, Hogan Lovells

Monday June 24, 2019 2:15pm - 3:15pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#149: Hype Versus Reality: Artificial Intelligence and Drug Development

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-554-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss maturation of the development of artificial intelligence (AI) over time and how AI has matured more for R&D and signal detection and less so for regulatory support.

Learning Objectives

Discuss how artificial intelligence has matured over time.

Chair

Ranjini Prithviraj

Speaker

Results of DIA (Tufts) Survey of 1000+ Members About Their Ideas About Digital Health
Mary Jo Lamberti, PhD, MA

Artificial Intelligence in Regulatory Affairs
Patrick Brady, PharmD

What is Believed Can Be Done Versus What is Now Being Done
David Meyers

Speakers

Patrick Brady

Vice President, Regulatory Affairs Head, Regulatory Policy and Intelligence, Bayer AG

Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory... Read More →

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development

Mary Jo Lamberti leads multi-company sponsored research studies at the Tufts Center for the Study of Drug Development (CSDD). She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative... Read More →

David Meyers

National Director, US Life Sciences, Microsoft

Dave Meyers is National Director - US Life Sciences at Microsoft; focused on strategy, business development, and the solutions portfolio in pharma, genomics and precision medicine. He joined Microsoft in 1997 - held various technical, program management, and product development positions... Read More →

Ranjini Prithviraj

Global Associate Director, Content Collaboration, DIA

Dr. Ranjini Prithviraj is Global Associate Director, Content Collaboration, at DIA. She provides strategic thought leadership and delivers content that advances DIA’s mission through various media, including traditional journal publications. Prior to DIA, she was a Managing Editor... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Beginner
Credit Type ACPE, CME, IACET, RN
Tags Session

2:15pm

#150: TFDA Town Hall: Focus on Regenerative Medicine

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-734-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regenerative medicine is a potential treatment that can help repair or replace damaged or diseased human cells or tissues to restore normal function. This forum will discuss the regulatory aspects and experience with regenerative medicine.

Learning Objectives

Discuss regulations governing implementation or use of specific medical technology, examination, laboratory testing and medical devices; Describe the management of regenerative pharmaceutical products; Describe the experience of reviewing regenerative medicine affairs.

Chair

Shou-Mei Wu, PhD

Speaker

New Regulation on Cell Therapy: Challenge and Prospect
Chung-Liang Shih, PhD

Regulation of Cell and Gene Therapy Products
Lien-Cheng Chang, PhD

Regulatory Considerations and Experiences for the Evaluation of Regenerative Medicinal Products
I-Ning Tang, MD, MSc

Speakers

Chung-Liang Shih

Director-General, Department of Medical Affairs, Ministry of Health & Welfare

Dr. Shih, Chung-Liang serves as the Director-General of Department of Medical Affairs, MOHW of Taiwan since 2016. From 2008 to 2012, he was the head of Bureau of Medical Affaires that oversees the health care system and leads the health care reform including the programs addressing... Read More →

I-Ning Tang

Section Chief, Regulatory Science, Center for Drug Evaluation (CDE)

Dr. Tang is currently the Section chief of Regulatory science, Center of consultation at Taiwan Center for Drug Evaluation. Since joining in the regulatory science field in 2010, Dr. Tang has been involved in various projects. She is an experienced medical reviewer in evaluating market... Read More →

Shou-Mei Wu

Director General, TFDA

Dr. Wu has been the Director-General of the Food and Drug Administration, Taiwan (TFDA) since February 2017. Now she is in charge of the overall policies. Under Dr. Wu’s leadership, TFDA have actively safeguarded food, drug, medical devices and cosmetics, and made best effort overcoming... Read More →

Lien-Cheng Chang

Section Chief, Division of Medicinal Products, TFDA

Lien-Cheng (Eric) Chang received his PhD degree from the Institute of Biopharmaceutical Sciences at Yang Ming University. Previously, he worked in Taichung Hospital and NTU Hospital in Clinical Pharmacy Services and also served in the former Bureau of Pharmaceutical Affairs for six... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Featured Topics Precision Medicine
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#151: Update on ICH Quality Topics

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide updates on ICH’s efforts to develop new and revised globally harmonized guidelines related to product quality and regulatory CMC topics. Topics include Lifecycle Management, Continuous Manufacturing, and Analytical Methods.

Learning Objectives

Identify the technical and regulatory issues under discussion in ICH as they related to regulatory CMC and product quality topics; Discuss various perspectives from the expanded ICH membership on the impact, opportunities and challenges for the new and ongoing ICH Quality Topics.

Chair

Olivia Shopshear, MS

Speaker

ICH Quality Vision and Context Setting
Camille Jackson

M9 and IQDG
Roger Nosal, PhD

Q2(R2) - Analytical Procedure Validation / Q14 - Analytical Procedure Development
Nasir Egal, PhD

Q12
Sarah Pope Miksinski, PhD

Q13
Ganapathy Mohan, PhD

Speakers

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)

Camille Jackson is currently Associate Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she manages PhRMA’s international regulatory policy initiatives including engagement in the International Council for Harmonization (ICH) and the APEC Regulatory Harmonization... Read More →

Nasir Egal

Head of Global Quality External Affairs, Sanofi

Nasir EGAL currently leads the Sanofi Global Quality External Affairs strategy. Prior to this role, he held various positions of increasing responsibilities in Sanofi, Novartis & Merck. He has a broad international experience working across various cultures and geographies leading... Read More →

Sarah Pope Miksinski

Senior Director, AstraZeneca

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc.

Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →

Roger Nosal

Vice President, Global CMC, Pfizer Inc

Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →

Olivia Shopshear

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)

Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and regulatory policy experience in the biopharmaceutical and biodefense industries, ranging... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Session

2:15pm

#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data visualization can transform and advance clinical trial safety analysis. Discover the latest data visualization use cases for safety and how dynamic data exploration yields meaningful data review, better patient outcomes and trial efficiency.

Learning Objectives

Discuss various data visualization examples that can be applied to the area of clinical trial safety analysis; Outline key benefits and efficiencies statisticians, medical monitors, and others in charge of safety can achieve through data visualizations that are being used in this area of clinical trials today.

Chair

Demi Niforos, MS

Speaker

Summary of Safety Visualization Efforts
William Wang, PhD

Panelist
Nathan Bennett, PhD, MA

Speakers

Demi Niforos

Vice President, Biostatistics and Statistical Programming, eClinical Solutions

Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics... Read More →

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories

Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Forum | 01: ClinSafety-PV, Forum | 02: ClinTrials -ClinOps, Forum | 03: Data-Data Standards, Forum

Level Intermediate
Featured Topics Artificial Intelligence, What's Next
Featured Topics Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
Tags Forum

2:15pm

#153: How Storytelling, Images, and Engagement Can Wow Your Audience: Presentations with Punch!

Component Type: Workshop
Level: Basic

This session will focus on strategies to create a more memorable presentation, one that draws in the audience and holds its attention. We will explore the use of steamlined slides, images, and storytelling as well as specific presenting techniques to grab and hold the attention of an audience. Attendees will leave with plans for how to approach their next presentation.

Learning Objectives

Discuss how to create more impactful presentations; Explain how to present with confidence and flair; Identify how to engage and inform audiences.

Chair

Robin Whitsell

Speakers

Robin Whitsell

President, Whitsell Innovations, Inc.

Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 20 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Monday June 24, 2019 2:15pm - 3:15pm
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Featured Topics Student Programming
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3:30pm

#154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-555-L04-P; CME 1.00; IACET 1.00; RN 1.00

The forum will cover latest developments on CIOMS XI from the perspective of patients, regulators, and industry. Current thinking in more closely involving patients throughout the medicines lifecycle will be presented and audience feedback sought. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss the latest developments in patient involvement and engagement in the medicinal product lifecycle from development to post-marketing, pharmacovigilance and risk management; Describe current progress of the CIOMS XI WG in terms of involving patients and patient groups or associations more closely with medicines addressing medical needs.

Chair

Judith Zander, MD

Speaker

An Introduction to CIOMS and the CIOMS XI Initiative on Patient Involvement in the Medicinal Product Lifecycle
Herve Le Louet, DrMed, DrSc, MD, PhD, MS

FDA Perspective
Theresa Mullin, PhD

The Role of Patients in Drug Development and Lifecycle Use
Marc M. Boutin, JD

An Overview of the CIOMS XI Initiative
Kerry Leeson-Beevers

Using Patient Data to Evaluate the Benefits and Risks of Medicines
Meredith Y. Smith, PhD, MPA

Speakers

Marc Boutin

Chief Executive Officer, National Health Council (NHC)

Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →

Kerry Leeson-Beevers

National Development Manager, Alström Syndrome UK

I joined Alström Syndrome UK (ASUK) in 2003 when my son was diagnosed with the condition. I am now the National Development Manager responsible for overseeing the Family Support Service and I work closely with our medical teams in Birmingham, UK to support the highly specialised... Read More →

Herve Le Louet

Head of PV Coordination; President, CIOMS

Herve is Professor of Pharmacology. He is the head of PV Dept of Paris University Hospitals. He is an hepatologist by training and has a PhD in Pharmacogenetics. He was a co-opted member by the European Commission of the PRAC. He is the President of the CIOMS and Past President of... Read More →

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA

Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA).She oversees the Divisions of Pharmacovigilance 1 and... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Level Intermediate
Featured Topics Regulator Thinking, Patient Focused, Rare Disease, Innovative Trial Design
Featured Topics Regulator Thinking,Patient Focused,Rare Disease,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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3:30pm

#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Chair

Brian Edwards, DrMed

Speaker

Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc

Speakers

Nichola Crust

National Investigator, Healthcare Safety Investigation Branch

Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training... Read More →

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC

Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 02: ClinTrials -ClinOps, Session | 06: PreClin Dev-EarlyPhaseCR, Session | 07: ProjMgt-StrategicPlanning, Session

Level Intermediate
Featured Topics What's Next,Patient Focused
Credit Type ACPE, CME, IACET, RN
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3:30pm

#156: Clinical Research in Emerging Regions

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-566-L04-P; CME 1.00; IACET 1.00; RN 1.00

Changing times, technology and a surge in activities in the emerging regions have prompted the global clinical research industry to further enhance capabilities by building capacity and developing talent. Outsourcing services to emerging regions continue to grow especially in the realm of risk based monitoring, data management, clinical trial management and site management. On the scientific arena, innovative research activities in countries like Korea, China, and Singapore to name a few have developed biomedical, biotech and clinical research infra structures with the ultimate goal of attracting big pharma to partner with them to co-develop their discoveries. However, capability, capacity, credibility and overall quality remain to be sticking points.

In this session, current trends, issues, challenges and opportunities will be discussed by experts who work in these emerging regions. Their hope is that by sharing experiences and information the global pharma and biotech industry would have better understanding of the huge opportunities and untapped potential these emerging regions can provide. Join the Good Clinical Practices & Quality Assurance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss the current environment of clinical research in emerging regions; Identify strategic advantages in conducting clinical trials in emerging regions; Identify solutions to challenges in conducting clinical research activities and trial management in these emerging regions.

Chair

Nadina Jose, MD

Speaker

What is the Best Collaborative Model to Deliver Pivotal Clinical Trials in Developing Countries
Asita De Silva, MD, PhD, FRCP

Strategic Inclusion of Regions in Multi-Regional Clinical Trials
Eunyoung Kim, PharmD, PhD

An Integrated Mobile eSource-EDC Solution to Streamline Clinical Trial Data Management for Large Global Trials
Avik Kumar Pal, MBA

Speakers

Nadina Jose

Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative, Rutgers, The State University of New Jersey

Rejoined academia on Oct 2016 and is currently Assistant Professor at Rutgers University, Department of Health Informatics, Biopharma Education Initiative, School of Health Professions MS in Clinical Research Management. Dr. Jose is the Founder and President of Anidan Group Pte. Ltd... Read More →

Eunyoung Kim

Professor, College of Pharmacy, Chungang University

Avik Pal

Chief Executive Officer, CliniOps

Avik is the CEO of CliniOps, a mobile, cloud-based, digital solutions company, for the clinical trial industry & global health research. Prior to that, he worked with two successful startups and is a Founding Board member at iKure, a healthcare startup. He is passionate about Global... Read More →

Asita De Silva

Professor of Pharmacology, University of Kelaniya

Professor Asita de Silva has held many positions in academic medicine over the last 25 years. He is a Clinical Pharmacologist, and is currently Senior Professor of Pharmacology at the Faculty of Medicine, University of Kelaniya, Sri Lanka. He is also Director of the Clinical Trials... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Innovative Trial Design
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, RN
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3:30pm

#157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-567-L04-P; CME 1.00; IACET 1.00; RN 1.00

Hear how scientists and physicians at Johns Hopkins Medicine in Baltimore and Microsoft collect and tap vast amounts of data from clinical care, genomics, and wearable devices, to better predict disease progression and pinpoint individual treatments.

Learning Objectives

Describe using data analytics, machine learning, and precision medicine, how to distinguish, analyze, and reclassify disease based on subgroups; Identify the best prognosis for patients using these tools; Describe how to better predict disease progression and pinpoint individual treatments.

Chair

David Meyers

Speaker

Academic Perspective
Dwight Raum

Speakers

David Meyers

National Director, US Life Sciences, Microsoft

Dwight Raum

Vice President and Chief Technical Officer, Johns Hopkins

Dwight Raum is Vice President and Chief Technology Officer of Johns Hopkins Health System and Johns Hopkins University. His passion lies in challenging the status quo, mobilizing teams to harness technology and championing change. Since 2016, Dwight has helped lead a precision medicine... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Regulator Thinking
Featured Topics Real World Evidence,Artificial Intelligence,Precision Medicine,Student Programming
Credit Type ACPE, CME, IACET, RN
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3:30pm

#158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-568-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the evolution of patient-focused outcome assessment and how current FDA efforts and resources support measuring what matters most to patients in medical product development. Join the Study Endpoints Community for a follow up Round Table discussion on Tuesday, June 25, 9:30-10:30AM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe FDA's activities to promote patient voice in outcome measurement; Describe FDA resources to support the science of patient input in medical product development.

Chair

Elektra Johanna Papadopoulos, MD, MPH

Speaker

Update from CDRH
Michelle Tarver, MD, PhD

Panelist
Telba Irony, PhD

Industry Perspective
Robyn T. Carson, MPH

Patient Perspective
Bray Patrick-Lake, MS

Speakers

Elektra Papadopoulos

Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA

Michelle Tarver

Director of Patient Science and Engagement, PSE, CDRH, FDA

The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Her program interacts with digital health... Read More →

Robyn Carson

Head, Patient-Centered Outcomes Research, Global Evidence and Value Development, Allergan

Robyn T. Carson has worked in the pharmaceutical industry for 12 years and leads the Patient-Centered Outcomes Research (PCOR) function at Allergan. In this role, Robyn is responsible for the development of innovative strategies to evaluate meaningful outcomes to patients and consumers... Read More →

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA

Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →

Bray Patrick-Lake

Director of Stakeholder Engagement, Duke Clinical Research Institute

Monday June 24, 2019 3:30pm - 4:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum | 05: Patient Engagement, Forum

Level Intermediate
Featured Topics Patient Focused
Featured Topics Regulator Thinking,Patient Focused
Credit Type ACPE, CME, IACET, RN
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3:30pm

#159: Understanding the Data Journey In Virtual Trials

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

Virtual trials promise to improve clinical research. New methods of data collection and usage also bring new challenges. This forum will model the journey of data in a virtual trial, identify key challenges, and offer solutions for sponsors and CROs.

Learning Objectives

Recognize data collection and usage challenges at all stages of virtual trials; Design successful data practices in a virtual trial.

Chair

Jon Roth, MBA

Speaker

Panelist
Oladele Babalola

Panelist
Robert A. DiCicco, PharmD

FDA Update
Vaishali Popat, MD, MPH

FDA Update
Isaac R. Rodriguez-Chavez, MHS, PhD, MS

Speakers

Oladele Babalola

Associate Director, Data Management, Apellis Pharmaceuticals

Robert DiCicco

Deputy Chief Health Officer, IBM

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA

Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

Isaac Rodriguez-Chavez

Officer, Clinical Research Methodology, Reg Compliance & Medical Policy, CDER, FDA

Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →

Jon Roth

VP, Data Sciences and Biometrics, Biorasi

With over 25 years of clinical trial experience, including a decade as CEO/CTO of a clinical data driven CRO, and a penchant for innovative approaches to clinical study management featuring big data analysis and on-study analytics of live and historical clinical study data, Jon has... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Data Standards, Forum

Level Intermediate
Featured Topics Artificial Intelligence
Featured Topics Innovative Trial Design,What's Next
Credit Type ACPE, CME, IACET, RN
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3:30pm

#160: New Communication Channels for Medical Information

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-557-L04-P; CME 1.00; IACET 1.00; RN 1.00

Technology and social media are redefining the ways that healthcare professionals research, receive, and even share medical information. In this new environment, pharmaceutical companies are evaluating different channels for communicating information to their customers. This session will explore delivery different channels pharmaceutical companies are using and present case studies on new methods that companies are using to share information with healthcare professionals..

Learning Objectives

Identify and evaluate the different channels of medical information delivery currently used in the pharmaceutical industry, including cost effectiveness, usage, healthcare professional preference, and future delivery channels; Discuss specific case studies of pharmaceutical companies successfully implementing new communication channels with healthcare professionals.

Chair

David Bowers, PharmD

Speaker

Evolution of Medical Information Response Delivery Channels in the Pharmaceutical Industry
Walter Frank Eng, PharmD, MBA, RPh

Industry Perspective
Jenny Ko, PharmD

Speakers

David Bowers

Director, Medical Communications, PPD

David Bowers has 15+ years of experience managing pharmaceutical contact center programs at PPD. As Director of Operations, David supports global medical information for pharmaceutical, biotechnology and medical device clients. He has a background in pharmacy, with a Doctorate of... Read More →

Walter Frank Eng

Multidisciplinary Fellow, Novo Nordisk

Walter Frank attended Creighton University where he received his Bachelors of Science in Healthcare Studies, Doctorate of Pharmacy, and Masters of Business Administration. During his studies, Walter Frank worked as a consultant in the specialty pharmacy industry, helped to establish... Read More →

Jenny Ko

Vice President, Specialty and Primary Care Markets, Haymarket Media, Inc.

Jenny is the Vice President, Specialty & Primary Care Markets at Haymarket Media and oversees a growing roster of brands within the Haymarket Medical Network, which serves to provide healthcare professionals with specialty-focused clinical support tools and informational resources... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

Level Intermediate
Featured Topics What's Next
Credit Type ACPE, CME, IACET, RN
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3:30pm

#161: Making Trials Work for Special Populations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session discusses a variety of ways to address patient needs that help recruit and retain special populations in clinical trials.

Learning Objectives

Identify useful guidelines and regulations regarding special populations in various countries; Discuss useful models of patient engagement that focus on special populations; Discuss case studies that show how some clinical trials have attracted special groups of patients.

Chair

Deborah E. Collyar

Speaker

Therapeutic Needs of Older Patients in the Era of Mobile Health
Dinah Duarte, MSc

Implementation of a Peer Advocate Model to Optimize Trial Enrollment, Diversity, and Retention
Caroline Donovan, MPH

Site Awareness and Best Practices for Inclusion of Diverse Populations in Research
Diana Foster, BSN, PhD, MSN

Speakers

Deborah Collyar

President, Patient Advocates In Research (PAIR)

Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →

Caroline Donovan

Manager of Patient Engagement, LuCIN, Lupus Therapeutics, LLC

Caroline Donovan, MPH is the Manager, Patient Engagement for Lupus Therapeutics, an affiliate of Lupus Research Alliance. She is responsible for the development and implementation of a peer education program in which prospective lupus clinical trial patients are matched with a trained... Read More →

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED

Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →

Diana Foster

CEO, Society For Clinical Research Sites

Dr. Foster serves as a consultant to the Society for Clinical Research Sites as the Vice President of Strategy and Development. In her role she is responsible for building relationships with industry that help amplify the voice of the clinical research site. She has been integrally... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient Engagement, Session

Level Beginner
Featured Topics Real World Evidence, Patient Focused, Rare Disease
Featured Topics Precision Medicine,Patient Focused,Rare Disease
Credit Type ACPE, CME, IACET, RN
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3:30pm

#162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-559-L04-P; CME 1.00; IACET 1.00; RN 1.00

Precision Medicines in Clinical Trials (PMCT) are demonstrably impactful in drug development yet are not widely adopted by industry. This forum explores reasons for low adoption from the viewpoints of scientists, drug developers and regulators and explores solutions.

Learning Objectives

Describe the value of precision medicine trials (PMCT) as an innovative approach to drug development; Identify the regulatory, scientific, operational and technical challenges and barriers to the execution of these trials.; Explain key considerations for precision medicine trial design and execution.

Chair

Anita Nelsen

Speaker

Academic Perspective from Korea
Yeul Hong Kim, MD, PhD

Panelist
Edward Abrahams, PhD

Panelist
Rebecca Blanchard, PhD

Speakers

Edward Abrahams

President, Personalized Medicine Coalition

Edward Abrahams, Ph.D., is the President of the Personalized Medicine Coalition. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and... Read More →

Rebecca Blanchard

Vice President, CRISPR Therapeutics

Dr. Blanchard’s career in academia and industry has spanned basic, translational, and clinical research. She is currently responsible for Clinical Biomarkers and Exploratory Research, Assay Development and Pharmacology/Toxicology at CRISPR Therapeutics. After receiving her Ph.D... Read More →

Yeul Hong Kim

Professor, Section of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital

Yeul Hong Kim, MD, PhD, is a Professor in the Department of Internal Medicine at the Korea University College of Medicine in Seoul. He is actively involved in cancer genomic research, using circulating tumor DNA, for lung and gastrointestinal cancers. His primary area of interest... Read More →

Anita Nelsen

Senior Vice President, Translational Medicine, Parexel

Anita is a pharmaceutical industry leader who has applied pharmacogenetic, human and molecular genetics research in drug discovery and development. As Head of Translational Medicine, Anita leads a global team of scientists who are recognized thought leaders and influencers in quantitative... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: PreClin Dev-EarlyPhaseCR, Forum | 02: ClinTrials -ClinOps, Forum

Level Intermediate
Featured Topics Artificial Intelligence,Regulator Thinking,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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3:30pm

#163: Strategic Integration: Is Anyone Getting it Right?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-560-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166060YI7; RN 1.00

Despite the regularity of asset or company acquisitions, integration into an existing portfolio is rarely straightforward. This forum will discuss successful (and less successful) strategies for integration across various healthcare organizations.

Learning Objectives

Describe the different components that lead to the successful integration of acquired assets or companies; Compare and contrast different strategies for strategic integration and discuss best practices from a business development, project and portfolio management perspective to promote streamlined integration of an asset or company.

Chair

Erin Mulrooney, MSc

Speaker

Industry Perspective
Vijayalakshmi Agnani, MBA, MS

Industry Perspective
Erin Mulrooney, MSc

Integration of Cultures and Teams in a Hospital Setting
Elizabeth Somers, MS

Speakers

Vijayalakshmi Agnani

Associate Director, Transactions, Global Business Development and Licensing, Sanofi

Vijayalaksmi (Viju) Agnani is currently Associate Director, Transactions in the Global Business Development and Licensing team at Sanofi. In this role, she engages throughout all phases of business development and licensing activities to lead and manage the execution of strategic... Read More →

Erin Mulrooney

Associate Director, Project Management, Merck & Co., Inc.

Erin Mulrooney joined the Global Project and Alliance Management group at Merck in 2016 as an Associate Director. She specializes in the management of large-scale, complex collaborative projects in Discovery and Early Development. Prior to her transition to Project Management, she... Read More →

Erin Mulrooney

Director, Portfolio Management and Operations, Biocelerate

Elizabeth Somers

Executive Director of Infectious Disease, Global Project and Alliance Management, Merck & Co., Inc.

Liz is an Executive Director of Infectious Diseases in Global Project and Alliance Management at Merck. In addition to accountability for the ID TA, she manages a team focused on Discovery collaborations which leverages her experience managing complex cross functional drug development... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjMgt-StrategicPlanning, Forum

Level Advanced
Featured Topics Regulator Thinking, Rare Disease
Credit Type ACPE, CME, IACET, PMI, RN
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3:30pm

#164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-561-L04-P; CME 1.00; IACET 1.00; RN 1.00

The importance of periodic screenings (e.g. assessments, mock inspections) to ensure good inspection health. An interactive and colorful discussion of how being prepared by getting a thorough ‘check-up’ is the best way to be ready for an inspection.

Learning Objectives

Demonstrate how periodic screenings are an important part of inspection readiness; Discuss where hidden challenges lurk and how mock inspections can bring these items to light; Identify appropriate remediation plans that are organizationally focused and not study specific.

Chair

Grace M Crawford, MS

Speaker

Panelist
Barbara Maley

Panelist
Lauren Blomberg

Panelist
Gina C Lucas

Panelist
Matthew Krumrai

Speakers

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca

Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →

Barbara Maley

Sr. Consultant, The Avoca Group

Barb Maley is a Quality Assurance professional with 29 years of research experience including 26 years within the pharmaceutical industry (GLP and GCP) and 17 years hands-on experience within Quality Assurance and Continuous Improvement. Barb has extensive experience providing quality... Read More →

Lauren Blomberg

GCP Inspection Lead, Quality and Continuous Improvement, GCTO, Merck & Co., Inc.

Lauren Blomberg is an Associate Director, GCP Inspection Lead within the Global Clinical Trial Operations department at Merck & Co., Inc. Lauren has over 10 years of GCP and PV experience in the pharmaceutical industry, with expertise in Inspection Preparation and Inspection Management... Read More →

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie

Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →

Gina Lucas

Director, Strategic Advice, AstraZeneca Pharmaceuticals LP

Gina Lucas is a professional with over 25 years of GXP QA pharmaceutical industry experience. Her current role includes providing GCP strategic direction for Immuno-oncology programs at AstraZeneca including providing quality and compliance advice during study conduct, submission... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: R-D Quality-Compliance, Forum

Level Intermediate
Credit Type ACPE, CME, IACET, RN
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3:30pm

#165: Drug Development Tools in a Digital Era

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-562-L04-P; CME 1.00; IACET 1.00; RN 1.00

Explore opportunities and challenges ahead for digital drug development tools (DDTs) from an EMA, consortium, and industry perspective. Analyze how existing regulatory frameworks apply to the emerging field of digital health technologies including case examples, and discuss issues to be addressed to promote advancement of digital DDTs.

Learning Objectives

Describe the EMA, industry, and consortium views on digital drug development tools (DDTs); Discuss the growing value of digital health tools as part of the drug development process including key learnings from sponsor experience; Evaluate case example(s) in the development of digital DDTs.

Chair

Lauren Oliva, PharmD, RPh

Speaker

Critical Path Update
Stephen Joel Coons, PhD

EMA Update
Zahra Hanaizi, PharmD, MPharm

Industry Update
Josh Cosman, PhD

Speakers

Josh Cosman

Associate Director, Digital and Quantitative Medicine, Biogen

Dr. Cosman has 15 years’ experience exploring novel markers of cognition, motor function, and quality of life in healthy aging and neurological disorders. His work has focused on the development of functional measures using scalable research-grade tools and consumer devices in a... Read More →

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)

Zahra Hanaizi joined EMA in 2007 as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology. Since 2015, she has been working on the creation, implementation... Read More →

Lauren Oliva

New Technologies Global Regulatory Policy Lead, Biogen

Lauren Oliva is Global Regulatory Policy Lead for New Technologies at Biogen. She oversees the development and execution of R&D’s policy roadmap for digital health tools and gene therapy to enable Biogen’s neuroscience portfolio. In her time at Biogen she launched a widely used... Read More →

Stephen Joel Coons

Executive Director, PRO Consortium, Critical Path Institute

Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Intermediate
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
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3:30pm

#166: Updates on China Regulatory Reform

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-563-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, experts from government, academia and industry will present and discuss updates in NMAP's regulatory reform and progress in drug review and approval, and development of Chinese pharmacopeia 2020.

Learning Objectives

Discuss and understand the latest progress in NMPA’s regulatory reform and the impacts on Chinese pharmaceutical regulation and drug development; Recognize China’s evolving regulatory environment and future development.

Chair

Ling Su, PhD

Speaker

Regulatory Reform Enhancing Drug Review and Approval
Xiao Yuan Chen, PhD

Regulatory Reform: Industry EWxoerience and Perspective
Wendy Yan, MD, MBA

Brief Introduction on Chinese Pharmacopoeia 2020
Xiaoxu Hong

Speakers

Ling Su

Professor, Shenyang Pharmaceutical University

Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management... Read More →

Xiao Yuan Chen

Office Director, Tsinghua University

Xiaoxu Hong

Deputy Division Director, Chinese Pharmacopoeia Commission

Wendy Yan

Senior Vice President, Head of Regulatory Affairs, BeiGene (Beijing) Co., Ltd.

Wendy Yan is Senior Vice President, Global Head of Regulatory Affairs, for BeiGene, a commercial-stage biotechnology company focused innovative molecularly-targeted and immuno-oncology drugs for treatment of cancer. She has more than two decades of regulatory affairs experience, having... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Student Programming, Regulator Thinking
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

3:30pm

#167: Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

The International Coalition of Medicines Regulatory Authorities (ICMRA) will explore its strategic priorities in the context of a globalized world. To overcome these challenges ICMRA can champion greater harmonisation and convergence. The session will be delivered by members of ICMRA and conclude with a panel discussion of questions raised by the audience.

Learning Objectives

Describe strategic priorities of ICMRA in the context of the globalized world.

Chair

Ian Hudson

Speaker

Overview of ICMRA and Strategic Priorities: Including Vigilance, Track, and Trace
Guido Rasi, MD

The 'Innovation' Priority Project
Lorraine Nolan, PhD

Current Topics of Interest to ICMRA Members Including Biosimilars and AMR
John Skerritt, PhD

Panelist
Yasuhiro Fujiwara, MD, PhD

IFPMA View
David B. Jefferys, MD

Speakers

Yasuhiro Fujiwara

Chief Exective, Pharmaceuticals and Medical Devices Agency (PMDA)

Dr. FUJIWARA Yasuhiro has been Chief Executive, PMDA since April 2019. He is a medical oncologist, specializing in breast cancer. He was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National... Read More →

Guido Rasi

Executive Director, European Medicines Agency

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA)

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)

Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →

John Skerritt

Deputy Secretary for Health Products Regulation, Department of Health

Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and... Read More →

David Jefferys

Chair of the IFPMA Regulatory Science Committee; Senior Vice President, Eisai

Monday June 24, 2019 3:30pm - 4:30pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

3:30pm

#168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-569-L04-P; CME 1.00; IACET 1.00; RN 1.00

The pace of innovation in the pharmaceutical industry has accelerated tremendously. Future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization and industry efforts. This session will present an overview of the landscape for innovative modalities and emerging technologies in the field of human therapeutics, and the regulatory CMC challenges associated with their product development and approval.

Learning Objectives

Discuss the landscape for innovative modalities and emerging technologies in the field of human therapeutics; Describe the regulatory CMC challenges associated with their product development and approval.

Chair

Nina S. Cauchon, PhD, RAC

Speaker

Regulating Innovation in CMC – A Perspective from Industry
Nina S. Cauchon, PhD, RAC

Integrated Manufacturing and its Opportunities to Low Cost Vaccine Manufacture
J. Christopher Love, PhD, MA

Regulating Advanced Therapy: Gene and Cell Therapy Products
Raj K. Puri, MD, PhD

Speakers

Nina Cauchon

Director Regulatory Affairs CMC, Amgen

Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. She is chair of the AAPS CMC Community, and is also active in ISPE, CASSS/WCBP, and PQRI. Her areas... Read More →

J. Christopher Love

Professor; Member, Koch Institute for Integrative Cancer Research, Koch Institute At MIT

J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering and member of the Koch Institute for Integrative Cancer Research at MIT. Dr. Love received his Ph.D. in 2004 in physical chemistry at Harvard University. His research centers on... Read More →

Raj Puri

Director, Division of Cellular and Gene Therapies, OTAT, CBER, FDA

Raj K. Puri, M.D., Ph.D. is a director of the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) at FDA’s Center for Biologics Evaluation and Research (CBER). He has been directing this division for more than16 years. He is also... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Featured Topics Advanced Therapies
Credit Type ACPE, CME, IACET, RN
Tags Session

3:30pm

#169: How Statistics Can Help Improve Data Quality: ICH E6 R2

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-564-L04-P; CME 1.00; IACET 1.00; RN 1.00

ICH E6 (R2) guidance stresses the importance of centralized monitoring, especially by leveraging statistical analyses in order to assess data quality. This session will discuss how statistical methodology fits in the overall quality risk management strategy for the trial portfolio.

Learning Objectives

Discuss centralized statistical monitoring approaches and their impacts to data quality and integrity.

Chair

Cheng Su, PhD

Speaker

Using Appropriate Count-Based Statistical Models for KPIs, Risk Metrics, QTLs, etc.
Michael Farnum, PhD, MS

ICH E6 R2: How Statistics Can Help Improve Data Quality
Stephen Young, MSc

Centralized Statistical Monitoring: A Large Pharma's Approach
Taras Carpiac, MBA

Speakers

Taras Carpiac

Director, Head of Innovation and Process Improvement, Amgen, Inc.

Michael Farnum

Senior Director, Covance

Michael Farnum is a Senior Director for Covance Informatics. In 5+ years working at Covance, he has helped to create the Xcellerate platform, consisting of data integration, analytics, and decision support tools that enable Risk-Based Monitoring, Medical Review, Statistical Review... Read More →

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical

Cheng got his Ph.D. in statistics from NCSU and has 22 years of experiences in both nonclinical and clinical areas. Cheng has a broad interpest in applying statistical thinking and analytics to support drug research and development. His specific areas of expertise include high throughput... Read More →

Stephen Young

Chief Scientific Officer, CluePoints

As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Session | 03: Data-Data Standards, Session

Level Advanced
Featured Topics Regulator Thinking, Patient Focused, Advanced Therapies, Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
Tags Session

3:30pm

#170: Making Early Access for Patients Happen

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-565-L04-P; CME 1.00; IACET 1.00; RN 1.00

Research costs are increasing exponentially and patient populations are becoming more targeted. Healthcare systems throughout the world are struggling to cope with the costs of ever more specialized medicines. While these drug candidates hold the promise of slowing, or even curing disease progression, these innovations also often have limited evidence on long-term impacts. Regulators might wrestle with decisions on early access, but payers may also be reluctant to grant coverage for eligible patient populations. Early access may mean continued evidence generation once the drug is on the market, but traditional payment methods may not be well suited to address these issues, and their use may result in reduced coverage and patient access. This forum will identify challenges associated with early access, as well as coverage and reimbursement decisions associated with novel drug types, where there may be incomplete evidence or uncertainty of long-term value. Participants will focus on whether the current system is equipped to handle upcoming, novel therapies, and if not, what approaches would be best to pursue.

Learning Objectives

Recognize the difficulties in balancing patient access with incomplete understanding of a drug's benefits and long-term impacts; Analyze factors that contribute to coverage and reimbursement decisions; Discuss how to consider novel payment approaches to support appropriate patient access.

Chair

Monika Schneider, PhD

Speaker

Early Access: Life Saver for Patients or Unacceptable Weakening of Evidential Requirements?
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

Optimizing Coverage, Access, and Reimbursement for Drugs that Target Early-Stage Alzheimer’s Disease
Monika Schneider, PhD

Cell and Gene Therapy Development and the Impact on the Payer System
Dan Tierno, MA, MBA

Patient Perspective
François Houyez

Speakers

Stella Blackburn

Vice President, Global Head of Early Access and Risk Management, IQVIA

Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTP, Dip Pharm Med.VP, Global Head of Early Access & Risk Management, Real World Insights at IQVIA. Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry... Read More →

Monika Schneider

Managing Associate, Duke-Margolis Center For Health Policy

Monika Schneider is a Managing Associate within the biomedical innovation team at the Duke-Margolis Center for Health Policy. Her work focuses incentive mechanisms and payment reform models that could encourage development in areas of medical unmet need. Monika's portfolio includes... Read More →

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics, Bayer

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURODIS)

Monday June 24, 2019 3:30pm - 4:30pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Forum | 05: Patient Engagement, Forum

Level Intermediate
Featured Topics What's Next
Featured Topics Patient Focused
Credit Type ACPE, CME, IACET, RN
Tags Forum

3:30pm

#171: The Courage of Career Transitions

Component Type: Session
Level: Intermediate

This session will present examples of career transition considerations to advance growth and development. Speakers who have transitioned from within industry functional areas, from industry to consulting or regulatory agencies; and from health care

Learning Objectives

Discuss critical career decision-making criteria; Describe challenges and opportunities to career transitions; Outline benefits and risks of career transition; Describe best practices in cultivating new skills and experience to inform transitions; Identify strategies to help ensure transitions are successful.

Chair

Matthew Wong, PharmD, MBA

Speaker

Industry Perspective
Dan Fredeman

Industry Perspective
Jasminder Kumar, PharmD, RPh

Speakers

Dan Fredeman

Associate Director, US Oncology Markegting, AML Franchise, Daiichi Sankyo

My educational background is in materials engineering, biomaterials, and engineering management. After several years of interning at multiple research labs, I transitioned to an office-based commercial position within healthcare. I have been with Daiichi Sankyo (DSI) for almost 6... Read More →

Jasminder Kumar

Manager, Global Regulatory Affairs, Oncology, Janssen Research & Development, LLC

Jasminder Kumar, PharmD, is a North America Regulatory Affairs Manager within the Global Regulatory Affairs Oncology group at Janssen Research & Development, LLC. At Janssen, she has contributed to the operational and strategic aspects of regional oncology drug development for early... Read More →

Matthew Wong

Chief of Staff, Global Regulatory Affairs, Celgene Corporation

Matt graduated in 2008 with his Pharm.D. from Rutgers University and subsequently completed a post-doctoral fellowship in Medical Affairs. From 2008 to 2015, he held various responsibilities and roles within the Medical Affairs umbrella at Daiichi Sankyo. In 2016, Matt made a transition... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Session

Level Intermediate
Featured Topics Innovative Trial Design
Tags Session

3:30pm

#172 CH: Paving the Path for Family-Centered Design: Caregiver Roles in Medical Product Development

Component Type: Workshop
Level: Basic

Family caregivers are increasingly important to health care systems. Findings from a national multi-stakeholder summit on the caregiver’s role in medical product development offers new insight for engaging caregivers.

Learning Objectives

Discuss how informal caregivers, such as friends and relatives, support patients with activities of daily living and medical/nursing tasks; Describe existing regulatory pathways for family engagement in clinical trials; Discuss potential frameworks to engage caregivers in medical product development.

Chair

Grace Whiting, JD

Speakers

Grace Whiting

President and Chief Executive Officer, National Alliance for Caregiving

C. Grace Whiting, J.D., is the President and CEO of the National Alliance for Caregiving, a non-profit committed to advancing family caregiving through research, innovation, and advocacy. Ms. Whiting has led national and global research including Caregiving in the U.S. 2015 with AARP... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop

Tags Workshop

3:30pm

Community Meet Up: Forum of Pharmacovigilance Quality Heads

Component Type: Forum
Level: Basic

Open to anybody interested in safety and pharmacovigilance! Come join PV quality heads for a lively discussion on current challenges and goals in the field and to identify topics for collaboration.

Chair

Bruno Mendez

Speakers

Bruno Mendez

Vice President Global Quality Pharmacovigilance, Sanofi Corporation

Bruno has started his life in the pharmaceutical industry more than 25 years ago first in clinical monitoring and then has been in charge of clinical operations for Sanofi Pasteur. After 17 years in clinical development, he has been attaché of the Chief Medical officer of Sanofi... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Forum | 01: ClinSafety-PV, Forum

Tags Forum

4:30pm

DIA Welcome Reception

Network with thousands of attendees and more than 400 exhibiting companies at the DIA Opening Reception, held in the Exhibit Hall.

Monday June 24, 2019 4:30pm - 6:00pm
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Social Event

4:45pm

#173 IT: Appian Innovation Theater: Accelerating the Regulatory Information Management Journey with Intelligent Automation

Component Type: Session

In this session we will cover: -Overview of key Life Sciences trends and the drivers for innovation. -How to realize a new innovative approach to Regulatory Information Management. -Leveraging intelligent automation, with Business Process Management (BPM), to accelerate product development and commercialization life cycle. -The vision for world-class regulatory information further leveraging approaches such as BPM.

Chair

Appian

Speakers

Appian

Evi Cohen

Vice President, Global Life Sciences and Healthcare, Appian

Evi is an experienced pharmaceutical executive with extensive background in developing global business portfolios with emphasis on new products, technologies, and IP. He is a skilled innovation management professional with experience managing global business process transformations... Read More →

Rohit Malhotra

GSRS Quality & Operations - Head of Submission Sciences, Biogen

Monday June 24, 2019 4:45pm - 5:15pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

4:45pm

#174 IT: Deloitte Consulting Innovation Theater: Reimagining Patient Safety

Component Type: Session

Innovation is a term that has been thrown around in Pharmacovigilance for years associated with a promise to change the entire PV paradigm, reduce costs, and optimize patient safety outcomes. No longer a distant concept, cognitive automation and a consolidated data repository are now strategic initiatives leveraged by firms globally. These advanced strategies could allow regulators and sponsors to leverage new tools to improve identification of important safety signals and generate more meaningful health care insights. So, what does this actually mean? What are the benefits? What are the risks? And where do we start? Hear from Deloitte as we provide a perspective on how patient safety is being reimagined through the cooperation and lessons learned of industry, regulators, investigators, HCPs, and patients.

Chair

Deloitte Consulting

Speakers

Deloitte Consulting

Amanda Bowles

Life Sciences Specialist Leader, Deloitte

Amanda has over 14 years of life sciences experience including over 11 years specializing as a pharmacovigilance and drug safety subject matter advisor. Her experience spans drug safety and regulatory affairs, including extensive experience in PV operations strategy consulting, global... Read More →

Glenn Carroll

Principal, Life Sciences Strategy, Deloitte

Glenn is a Principal in Deloitte’s Life Science practice with over 15 years of Pharmaceutical and Biotechnology consulting experience delivery strategic and operating model engagements. He has significant consulting experience in Compliance, R&D, Medical Affairs and Pharmacovigilance... Read More →

Monday June 24, 2019 4:45pm - 5:15pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

5:15pm

#175 EE: Data Analytics Use in Quality Processes

Component Type: Workshop
Level: Advanced

Roche is using data analytics as a key component for planning and conducting audits and providing ongoing support to our study teams. A brief overview will be given, and participants will be invited to share their experiences.

Learning Objectives

Discuss how Roche is integrating data analytics into issue/audit management; Describe how other companies are/will be using data analytics in support of their quality processes.

Chair

Eileen Magruder, DrMed, MD

Speaker

Facilitator
Alaina Barros

Speakers

Alaina Barros

Principal Auditor/Quality Program Lead, Genentech, A Member of the Roche Group

Alaina Barros has worked within the pharmaceutical industry for 17+ years in the areas of manufacturing, clinical operations and quality. She is currently employed with Genentech, a member of the Roche Group, as a Quality Program Lead/Principal Auditor.

Eileen Magruder

Senior Auditor, Product Development Quality- PDQ-AFM, Genentech, A Member of the Roche Group

Eileen E. Magruder, MD has over 20 years of experience as a GCP and PV auditor. She is currently a senior auditor for the Product Development Quality - Audit and Finding Management team at Genentech, Inc., a member of the Roche Group.

Monday June 24, 2019 5:15pm - 6:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Engage-Exchange, Workshop | 08: R-D Quality-Compliance, Workshop

Tags Workshop

5:15pm

Community Meet Up: Patient Engagement

Component Type: Forum

Chair

Mary Stober Murray, MBA

Speakers

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company

Monday June 24, 2019 5:15pm - 6:15pm
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Forum | 05: Patient Engagement, Forum

Tags Forum

5:30pm

#176 IT: Statistics & Data Corporation Innovation Theater: Artificial Intelligence and Machine Learning: Innovations in Clinical Trial Data Automation

Component Type: Session

With a focus toward achieving faster time to market, reducing R&D costs, and increasing clinical trial success rates, Artificial Intelligence (AI) and Machine Learning (ML) capabilities are quickly becoming the next frontier in clinical research. In this presentation, SDC will share an overview of AI/ML applications in clinical trials, a case study featuring AI/ML deployment in clinical data services, and several lessons learned to help you integrate AI/ML capabilities in your clinical trials.

Chair

Statistics & Data Corporation

Speakers

Richard Abelson

President and CEO, SDC

Dale Usner

CSO & Sr. VP, Strategic Scientific Consulting, SDC

Dale Usner is the VP of Biostatistics & Data Management at SDC, joining in September 2011. Prior to his position with SDC, he worked at AVI and ZymoGenetics as the head of statistics and data management, at Bausch & Lomb as the global head of statistics and data management, and at... Read More →

Statistics & Data Corporation

Monday June 24, 2019 5:30pm - 6:00pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

5:30pm

#177 IT: Syneos Health Innovation Theater: Dialing In the Optimal FSP Solution

Component Type: Session

The functional service provider (FSP) model has evolved beyond traditional approaches to accommodate a wide spectrum of needs within the pharma, biotech and medical device sectors. The FSP approach, in any iteration, delivers cost savings and time efficiencies while freeing sponsor resources to advance other product development goals. This presentation will describe the latest FSP models and their benefits in more detail.

Chair

Syneos Health

Speakers

Syneos Health

Eleanore Doyle

Executive Vice President, FSP Strategic Solutions, Syneos Health

Eleanore Doyle, Executive Vice President, FSP Strategic Solutions at Syneos Health, is responsible for building and maintaining long-term relationships with sponsors, ensuring exceptional customer service, and increasing market reputation. With more than two decades of functional... Read More →

Syneos Health

Shaun Williams

Vice President, Investigator Management Solutions, Syneos Health

Monday June 24, 2019 5:30pm - 6:00pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

Tags Session

6:00pm

Community Meet Up: Statistics Community Meet and Greet

Component Type: Forum

Please join the Statistics Community for a meet and greet. This is an opportunity for members and non-members to learn more about our Community and activities, to share ideas and discuss future direction, and most importantly to volunteer and be part of a dynamic group!

Chair

Joan Buenconsejo, PhD, MPH

Speakers

Joan Buenconsejo

Senior Director, Biostatistics, AstraZeneca

Joan Buenconsejo is Senior Director, Biostatistics supporting late stage cardiovascular, renal and metabolic therapeutic areas within biopharmaceutical R&D at AstraZeneca. Prior to AZ, she was a statistics team lead at CDER, FDA. Dr. Buenconsejo is chair of the DIA Statistics Community... Read More →

Monday June 24, 2019 6:00pm - 7:00pm
Community Area 2 Sails San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Forum | Networking-CommunityEvents, Forum

Tags Forum

7:00am

Coffee and Light Refreshments

Component Type: Social Event

Tuesday June 25, 2019 7:00am - 8:00am
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Social Event

Tags Social Event

7:00am

Attendee, Speaker, and Exhibitor Registration

Tuesday June 25, 2019 7:00am - 5:15pm
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

7:30am

DIAlogue Session 1: Welcome to Day 2 of DIA 2019

Component Type: Session

Check in with our Student Advisor, Nancy Smerkanich, from the Global Annual Meeting Program Committee. Let us know how your experience is going so far and map out a game plan for Day 2 of DIA 2019!

Chair

Nancy Pire Smerkanich, DrSc

Tuesday June 25, 2019 7:30am - 8:00am
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Session

Featured Topics Student Programming
Featured Topics Student Programming
Tags Session

7:30am

Talent Show

Component Type: Forum

Join us before the first session of the day on Tuesday for special musical performances from some of our talented exhibitors!
Dan Weddle | WCCT Global | Singer, Songwriter, Guitar
Michael Frantz | Pharmaceutical eConsulting | Trombone

Tuesday June 25, 2019 7:30am - 8:00am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Forum

Tags Forum

8:00am

#202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Following the initial success of an unprecedented collaboration between nineteen sponsors to address major pharmacovigilance challenges with regulators, this session will provide lessons learned and an update on an increasing scope of collaborative work. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Identify expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges in the long-term.

Chair

Jose Vega, MD

Speaker

The European IV Iron PASS Consortium: Experiences from Coordinating a Multi-Company, Multi-Registry PASS
Michael Forstner, PhD

Regulator Observations and Feedback
Gerald J. Dal Pan

Advancing Safety Analytics
Paul Chang, MD

Intelligent Automation in Pharmacovigilance
Songlin Xue, MD, PhD

Speakers

Paul Chang

Chief Safety Officer, Janssen Pharmaceuticals

Dr. Paul Chang is the Chief Safety Officer at Janssen, the Pharmaceutical Companies of Johnson & Johnson, where he is responsible for all aspects of patient safety and pharmacovigilance. Paul joined J&J in 2006, and has held various leadership positions including the Head of Cardiovascular... Read More →

Michael Forstner

Senior Vice President, Head of Risk Management and Pharmacoepidemiology, PrimeVigilance

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA

Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →

Jose Vega

Vice President, Chief Safety Officer, Merck & Co., Inc.

José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Chair of the TransCelerate Pharmacovigilance Steering Committee and as Merck's representative on the Clinical Trials... Read More →

Songlin Xue

Executive Vice President and Global Head of Pharmacovigilance, Astellas

Songlin Xue, M.D., Ph.D., is Executive Vice President and Head of the global Pharmacovigilance in Astellas. In this position, he leads a global pharmacovigilance organization that includes pharmacovigilance operation and processes, medical safety, risk management, and epidemiology... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Level Intermediate
Featured Topics Regulator Thinking, What's Next
Featured Topics Regulator Thinking,Innovative Trial Design,What's Next
Credit Type ACPE, CME, IACET, RN
Tags Session

8:00am

#201: To Err is Human: Progress and Challenges in the Prevention of Medication Errors

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-572-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will look at progress in the reduction of medication errors due to name confusion. A panel of experts, representing major health authorities and WHO will provide a concise summary of guidelines these bodies have developed to minimize these errors, discuss differences in their approaches and what they see are the challenges that remain.

Learning Objectives

Discuss progress in the reduction of medication errors due to the development of regulations surrounding the development of drug names; Evaluate progress and identify challenges in the development of guidance by FDA, Health Canada, and EMA for proprietary names development and challenges with name confusion in the development of INNs; Describe best practices in the development of acceptable proprietary and non-proprietary names.

Chair

Tony E. Catka, PhD

Speaker

ISMP Perspective
Michael R. Cohen, DrSc, MS, RPh

FDA Perspective
Lubna Merchant, PharmD, MS

WHO Perspective
Raffaella Giovanna Balocco Mattavelli, PharmD, PhD

Speakers

Tony Catka

Senior Director, Regulatory Affairs, Addison Whitney, A Syneos Health Company

As the Lead of Addison Whitney's Center for Regulatory Guidance, Tony ensures that Addison Whitney stays abreast of changes that affect drug naming worldwide. He provides analysis of regulatory guidance, precedents, and the emerging environment and collaborates with team members in... Read More →

Michael Cohen

President, Institute for Safe Medication Practices

Michael Cohen, RPh, MS, ScD, is president of The Institute for Safe Medication Practices, a non-profit healthcare organization that specializes in understanding the causes of medication errors and providing error-reduction strategies to the healthcare community, policy makers, and... Read More →

Raffaella Balocco Mattavelli

Group Lead, International Nonproprietary Name Programme, World Health Organization (WHO)

Dr. Raffaella Balocco is a pharmacist Doctor and has a PhD in Pharmacology. She worked at the "Mario Negri Institute for Pharmacological Researches" in Milan before joining the World Health Organization in 1993. From 1993 until 2001 she worked in the regulatory support Unit within... Read More →

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER, FDA

Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum | 04: MedAffairs-SciComm, Forum

Level Intermediate
Featured Topics Artificial Intelligence, Regulator Thinking, Patient Focused
Featured Topics Artificial Intelligence,Regulator Thinking,Patient Focused
Credit Type ACPE, CME, IACET, RN
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8:00am

#203: eConsent Done Right

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-585-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will present real world case studies from sponsor companies that have already begun piloting eConsent.

Learning Objectives

Explain how eConsent can improve patient understanding of clinical trials, enable better informed decision-making and increase patient participation; Describe eConsent implementation best practices from real world case studies; Discuss where and how eConsent is utilized around the globe.

Chair

Carrie Guglielmo

Speaker

Enabling the Future of eConsent: An Overview of the TransCelerate Initiative and Real-World Implementation
Carrie Guglielmo

How eConsent will Support Increased Insights and Future Enhancement of Informed Consent Content and Processes
Bill Byrom, PhD

Utilizing Mobile Apps and eConsent in Global Research Registries: Ethical and Legal Considerations
Robyn Shapiro, JD

Moving the Needle: Improving the Clinical Trial Informed Consent Process with Tools to Increase Understanding
Lauren McCormack, PhD, MPH

Speakers

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health

Lauren McCormack

Vice President, Public Health Research Division, RTI International

Lauren McCormack, PhD, MSPH is Vice President of RTI’s Public Health Research Division and Adjunct Associate Professor in the UNC Gillings School of Global Public Health. Her research bridges the fields of health communication and health policy, and involves developing, testing... Read More →

Robyn Shapiro

Founder and Partner, Health Sciences Law Group LLC

Robyn Shapiro is Founder and Attorney at Health Sciences Law Group LLC. She represents clients in research and healthcare compliance issues, bioethics issues, health information privacy issues, and corporate and commercial issues faced by pharma and device manufacturers. Her past... Read More →

Carrie Guglielmo

eConsent Initiative Lead, Novartis Pharmaceuticals Corporation

Carrie Guglielmo Novartis eConsent Initiative Lead Carrie has been in the pharmaceutical industry for over 20 years. She has held various roles in clinical operations including Trial Management, Resource and Performance Management, and Process and Training. Carrie has been leading... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Real World Evidence, Regulator Thinking, What's Next
Featured Topics Real World Evidence,Patient Focused,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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8:00am

#204: Protocol Developments of the Future

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-586-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss specific areas in the protocol development process and the use of emerging technologies.

Learning Objectives

Identify where and how technology can be applied to improve or transform traditional protocol development processes: Describe best practices for creating, managing and implementing templates, and standard re-usable content; Discuss how consistently drafted protocols can lead to better success in a regulatory submission and aligned global transparency: Explain how to succeed developing protocols and managing amendments for complex study designs including master protocols.

Chair

Bob Brindle, MA

Speaker

Enforcing Better Standards in Protocol Development
Bob Brindle, MA

Objectives, Endpoints, and Outcome Measures: Developing Protocols to Achieve Consistency Between Documents and Registrations
Nate Root, MSc

Using Technology Innovations to Navigate Substantial Protocol Amendments for Studies with Complex Innovative Design
Rachael Cui Song, MBA

Protocol Development of the Future
Robert A. DiCicco, PharmD

Speakers

Bob Brindle

Venture Leader and Associate Director, Life Sciences R&D Practice, Cognizant

After graduating in Biochemistry from Cambridge University, Bob spent more than 20 years working at a major pharmaceutical company. Starting his career in Data Management, he progressed to become Head of Technology for Clinical Operations, and has extensive expertise in clinical trials... Read More →

Robert DiCicco

Deputy Chief Health Officer, IBM

Nate Root

Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals

Nate is a disclosure and transparency professional, with over 6 years of experience in the environment, working for and with CROs, Big Pharma, Non-Profit, and Small Biotech. He is a member of the DIA Disclosure Community Core Team, PhUSE CTD initiatives, and creator of the West Coast... Read More →

Rachael Song

Associate Director - Global Project Management, PPD

Rachael is currently global Project Leader for Oncology clinical trials with focus on Immuno-Oncology and master protocol studies. She has experiences in compound-level clinical planning and design, study-level operational planning and strategy development, and program implementation... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

Level Intermediate
Featured Topics Real World Evidence, Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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8:00am

#205: Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial intelligence, blockchain, natural language processing and real world evidence have been all the rage lately in industry news. Hear perspectives on these new technologies from a panel of experts from sponsor, technology vendor, patient advocacy group, and patients on what's working and what's not.

Learning Objectives

Describe how to drive patient enrollment in clinical studies with a patient-centric approach, allowing patients to pre-screen themselves and retargeting them if excluded; Identify how to address patient recruitment issues associated with pre-screening, screening and dropout to reduce the current average conversion ratio from 10:1; Discuss how to reduce pre-screening burden via mining of EMR records.

Chair

Rob Wynden, PhD

Speaker

Introduction to Patient-Facing Trial Technology
Rob Wynden, PhD

A Bulls-Eye Clinical Trial via Patient's Point- of-View
Abhit Singh, MD, MHA

User-Driven Markets Data that Help Clinicians Assess Treatments and Cure Diseases
Collin Powell, MBA

Turning Clinical Trial Recruitment on its Head Using EHR-Connected Applicants
Scott Cressman

Pragmatism and AI in Research
Mike Nolte, MBA

Speakers

Scott Cressman

Business Development and Strategic Partnerships, Human API

Scott Cressman leads business development & strategic partnerships in clinical research and digital health for Human API. He spends much of his time working at the intersection of life sciences + digital technologies with startups and Fortune 500s alike. His focus is on improving... Read More →

Mike Nolte

Chief Executive Officer, Signant Health

Mike Nolte is the CEO of CRF Bracket. Mike is a seasoned operational leader in healthcare and technology who is passionate about the patient experience. Before CRF Bracket, Mike was CEO at Influence Health, President and COO at MedAssets, and he held several leadership roles in healthcare... Read More →

Collin Powell

Founder, Chief Executive Officer, The Health Exchange Market (THEM)

The Health Exchange Market (T.H.E.M.) is an online marketplace for de-identified healthcare data that allows organizations to realize new revenue streams through data commercialization, while also being able to obtain access to prospective and retrospective data from a variety of... Read More →

Abhit Singh

Chief Medical Advisor, Medical Advisory Board, WeHeal Foundation

Dynamic (Global) Physician Leader, Speaker and Visionary- specializing in the Medical Advisory, Transactional and Transformational management of Healthcare Advisory, Biotech & Biopharma organizations. Among many, a Medical Advisor for WeHeal Inc, a 'CrowdHealing' Therapeutic Options... Read More →

Rob Wynden

Chief Executive Officer, Aloha Health Network

Rob has been a computer scientist and programmer for over 30 years in the scientific programming, e-commerce, biotech, and health care industries. He implemented study startup and CTMS functionality at 9 bay area biotech companies, and invented a method that allows medical and biotech... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum | 05: Patient Engagement, Forum

Level Intermediate
Featured Topics Patient Focused, Innovative Trial Design
Featured Topics Real World Evidence,Artificial Intelligence,Patient Focused
Credit Type ACPE, CME, IACET, RN
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8:00am

#206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel discussion will explore ways to improve connectedness of clinical data in today's CDM world and talk about if Single Source of Truth, Integrations or IoT (Internet of Things) are the best ways to move forward.

Learning Objectives

Describe why, what, where, when and how of data integrations between clinical systems; Describe recent technologies in CDM world and how these technologies are increasing the need for efficient integrations; Identify current challenges in data integrations between clinical systems; Discuss ways to improve efficiency of integrations and use cases where technology has improved integration.

Chair

Joby John, DDS

Speaker

Panelist
Nick Neri, MS

Panelist
Kelly Ritch, MBA, MS

Panelist
Jennifer Price

Speakers

Joby John

Senior Director, Technology Operations, Bioclinica

Dr Joby John is a versatile Clinical Research executive with over 16 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing... Read More →

Nick Neri

Director of Data Services & Integration, ERT

Mr. Neri has over 20 years of industry experience, and has established himself as a thought leader in the industry for applying next generation concepts and technologies to the clinical research space. He currently serves as Director, Data Integration and Services, CoE at ERT. Previously... Read More →

Jennifer Price

Senior Director, Clinical Data Management, Paidion Research

Jennifer has 25+ years of pharmaceutical industry experience with Biometrics, Data Management and related technologies. Jennifer currently is the head of Data Management for Paidion Research, a Pediatric CRO. In this role, Jennifer is responsible for the collection and management... Read More →

Kelly Ritch

VP, Clinical Trial Solutions, ArcheMedX

Dynamic and innovative executive with 20 years experience creating, managing, and driving high-performance, outcomes, and long-term value. Strategic thinker with strong analytical skills as well as a proven ability to affect positive change and significantly improve business processes... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Data Standards, Forum

Level Beginner
Featured Topics Regulator Thinking, Student Programming
Credit Type ACPE, CME, IACET, RN
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8:00am

#207: Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-575-L04-P; CME 1.25; IACET 1.25; RN 1.25

From Watson to self-driving cars to Netflix, the phrase “artificial intelligence” feels like a buzzword. What is reality versus hype and how can this emerging technology impact medical, regulatory, and commercial writing? This session will define the language of artificial intelligence(AI), discuss the potential impact for AI in creation and re-use of medical content, detail the emerging technologies of artificial intelligence in the writing space, and describe the challenges of developing a medical writing tool that uses AI. Participants will leave with an understanding of the practical applications of AI and how those uses could translate into disruption of medical writing, regulatory submissions, and more.

Learning Objectives

Define artificial intelligence (AI) and natural language processing (NLP) in the context of medical writing; Describe the potential for re-use of content across functional areas using AI; Discuss the challenges of developing and socializing an AI tool.

Chair

Robin Whitsell

Speaker

AI in Medical Writing Intelligent Creation and Reuse of Medical Content
Anand Kiran, MBA, MPharm

AI in the Medical Writing Landscape
Julia Forjanic-Klapproth, PhD

Speakers

Julia Forjanic-Klapproth

President/Senior Partner, Trilogy Writing & Consulting

After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice and is an active... Read More →

Anand Kiran

Executive Vice President, Global Operations, Medical Solutions, Indegene

Anand Kiran is Executive Vice President of R&D Solutions and Global Delivery, Indegene. He is one of the co-founders of the company. Anand is responsible for business solutions and execution of R&D Solutions (Clinical, Safety, Regulatory and Medical) for Pharmaceuticals/Lifesciences... Read More →

Robin Whitsell

President, Whitsell Innovations, Inc.

Tuesday June 25, 2019 8:00am - 9:15am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

Level Beginner
Featured Topics Student Programming
Featured Topics Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
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8:00am

#208: Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-576-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are at the heart of everything we do. Integrating patient focus into the regulatory mindset can be a challenge. Panelists will discuss their experiences, share best practices, and describe challenges in achieving this goal.

Learning Objectives

Identify best practices for integrating a patient focus mindset into the regulatory affairs organization; Recognize challenges faced by leaders in achieving this goal; Describe experiences with implementing patient focused practices as part of regulatory strategies.

Chair

Max Wegner, PharmD, RPh

Speaker

FDA Perspective
Theresa Mullin, PhD

Patient Representative
Marc M. Boutin, JD

Industry Perspective
Miu Chau, PhD

Patient Representative
Jill Bonjean, MSc

Speakers

Jill Bonjean

Corporate Relations Advisor, Rare Diseases International

Jill Bonjean is Corporate Relations Advisor for Rare Diseases International - the global alliance of rare disease patient organizations. Jill works with RDI and other patient organizations to build effective relationships with companies and other partners. Previously, she's managed... Read More →

Marc Boutin

Chief Executive Officer, National Health Council (NHC)

Miu Chau

Senior Regulatory Program Director, Genentech, A Member of the Roche Group

Miu joined Genentech in 2008 and held different roles. Currently she is a Senior Regulatory Program Director responsible for the global regulatory strategy and execution of projects and leading a matrix team of regulatory professionals in oncology. Miu had been the Global Head of... Read More →

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA

Max Wegner

Head Regulatory Affairs, Bayer AG

After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient Engagement, Forum | 09: Regulatory, Forum

Level Intermediate
Featured Topics Patient Focused
Credit Type ACPE, CME, IACET, RN
Tags Forum

8:00am

#209: Emerging Issues in CRISPR and Gene Editing Symposium

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss emerging issues related to gene editing, including standards for off-target effects, immunogenicity issues , and DNA base editors.

Learning Objectives

Describe potential concerns related to immune responses in gene editing; Discuss the concept of on-target and off-target genome editing, and collaborative approaches to address this issue; Identify the difference between gene editing that involves making a double-stranded break in DNA versus DNA base editors that do not.

Chair

Philip (P.J.) Brooks, PhD

Speaker

Immunogenicity Issues Related to Gene Editing
Zuben Erach Sauna, PhD

Update on the Genome Editing Consortium
Samantha Maragh, PhD, MS

Base Editing: Performing Chemsitry on the Genome
Alexis C Komor, PhD

Speakers

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH

Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →

Zuben Sauna

Principal Investigator, OTAT, CBER, FDA

Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety... Read More →

Alexis Komor

Assistant Professor, University of California San Diego

Alexis Komor received her B. S. degree in chemistry from UC Berkeley in December 2008. She then joined the lab of Jacqueline K. Barton at Caltech where she worked on the design, synthesis, and study of DNA mismatch-binding metal complexes and received her Ph.D. in 2014. She pursued... Read More →

Samantha Maragh

Leader, Genome Editing Program, NIST

Dr. Samantha Maragh Leads the Genome Editing Program at the National Institute of Standards and Technology (NIST). Included in this program is the newly launched NIST Genome Editing Consortium, a public-private partnership to bring together government, industry and academia to address... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: PreClin Dev-EarlyPhaseCR, Session

Level Intermediate
Featured Topics Rare Disease
Featured Topics Precision Medicine,What's Next
Credit Type ACPE, CME, IACET, RN
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8:00am

#210: Increasing Personal Resilience To Manage Change

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-578-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166FSI3MB; RN 1.25

This interactive workshop will help you to identify how your behaviors influence how ready you are to deal with and manage change. You will learn to recognize key factors of resilience and implement approaches to increase your personal resilience.

Learning Objectives

Discuss why change is difficult and how your change type impacts how you adapt; Recognize what resilience is, why it is so important and what are the key factors to increasing your personal resilience; Develop an action plan on managing your personal resilience.

Chair

Kim Przenioslo, PMP

Speaker

Increasing Personal Resilience To Manage Change
Ryan Bailey, MA

Speakers

Ryan Bailey

Senior Clinical Researcher, Rho, Inc.

Ryan Bailey, Senior Clinical Researcher, has over 13 years experience coordinating multi-disciplinary clinical research teams. He is a corporate leader for communication, innovation, and project management. His current interests within clinical research include: change management... Read More →

Kim Przenioslo

Director, Global Regulatory Affairs & Clinical Safety, Strategy Realization Off, Merck & Co., Inc.

Kim Przenioslo, is a Director, Global Regulatory Affairs & Clinical Safety (GRACS) Strategy Realization Office at Merck & Co. Inc, based out of Rahway, New Jersey. Kim leads the GRACS Change Management Center of Excellence, focused on building organizational capability, while driving... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjMgt-StrategicPlanning, Workshop | 13: ProfDevelopment, Workshop

Level Beginner
Featured Topics Student Programming
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, PMI, RN
Tags Workshop

8:00am

#212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

This is the kickoff to a GxP series on the importance of implementing quality standards in early drug development conducted in academia and start-ups that govern how a compound is to be manufactured, tested in animals and studied in clinical trials.

Learning Objectives

Define GxP, G(R)P, GMP, GTP, GLP, and GCP; Discuss the importance of GxPs in manufacturing and translational research; Identify the challenges of implementing GxPs in an academic research and development environment.

Chair

Nancy Pire Smerkanich, DrSc

Speaker

Panelist
Eunjoo Pacifici, PharmD, PhD

Panelist
Paul W. Price, PhD, MS

Panelist
Andrew Norris, PhD

Panelist
Gary Gilleskie, PhD

Panelist
Susan E Vogel, BSN, RN

Speakers

Gary Gilleskie

Acting Director, Biomanufacturing Training and Education Center, North Carolina State University

Dr. Gary Gilleskie has been with NC State’s Biomanufacturing Training and Education Center (BTEC) since 2007 and is currently BTEC’s Acting Director. Gary’s work at BTEC focuses on downstream processing of biopharmaceuticals, including protein therapeutics, vaccines, and gene... Read More →

Andrew Norris

Director of Research, BCN Biosciences

Dr. Andrew Norris has a varied background in both business and the technology sector. He is co-founder of The Midvale Group LLC in 2002, consulting in both the technology and biotechnology sector. Dr. Norris has also co founded BCN Biosciences, a company with principal focus in the... Read More →

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California

Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →

Paul Price

Regulatory Officer, Office of Regulatory Affairs, DAIT, National Institute of Allergy and Infectious Diseases, NIH

Dr. Price is a Regulatory Officer with NIH, NIAID, DAIT, ORA . Paul received his Ph.D. in Biology (Immunology) from Georgetown University, and completed post doctorate training at the Department of Microbiology and Immunology, University of MD School of Medicine. Paul has over 35... Read More →

Nancy Smerkanich

Assistant Professor, Department of Regulatory and Quality Sciences, University of Southern California

Susan Vogel

Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH

Susan Vogel is a Clinical Research Oversight Manager within the Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Division of Clinical Research (DCR)/ NIAID/ NIH. Ms. Vogel has 18 years of experience in the clinical trials management environment and has been providing... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: R-D Quality-Compliance, Forum

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Forum

8:00am

#211: Pharmacovigilance Reporting and Quality

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

Expectations for quality and compliance in pharmacovigilance process and systems continues to rise Having a comprehensive quality system, including a robust CAPA process, is now essential for both good quality management and to drive continuous improvement. CAPA is also a focus of inspection by many key regulatory authorities. Meanwhile, the global expansion pharmacovigilance and evolving safety requirements continue to add complexity, increasing the challenge of executing consistently in a compliant manner. This is exemplified in the challenges presented by assuring proper distribution of safety report to the right person at the right time as well as in the management of Reference Safety Information (RSI) and Investigator's Brochures (IBs) according to the EU requirements.

This session will explore these hot topics in pharmacovigilance quality and compliance and provide insight on current expectations.

Learning Objectives

Describe the trending of PV audit findings and how to detect systemic issues before the proliferation of conflicting or redundant CAPA and constructing CAPA hygiene; Discuss how to develop a CAPA at the right level of detail, with reasonable timelines and root cause classifications; Identify the changing landscape related to Reference Safety Information (RSI) and perspectives on navigating RSI complexities in light of new EU requirements; Discuss approaches for consideration in context of global

Chair

Matthew Krumrai

Speaker

CAPAs, CAPAs Everywhere: How Effective are They and How Can they be Improved?
Kelly Traverso

Optimizing Global Safety Reporting in Clinical Trials Using Local Laws
Steven Beales

Global Clinical Trials and the Complexities of Reference Safety Information (RSI)
Andrea Best, DO, MPH

Speakers

Steven Beales

Senior Vice President, Scientific and Regulatory, WCG Clinical

Steven Beales is the SVP of Scientific and Regulatory at WCG and co-chair of the Safety Reporting Reference Model working group. Steven has led the implementation of Clinical Trial Safety Portals for over 100 countries, working with 1 each of the top 3 Pharmaceutical, Biotech and... Read More →

Andrea Best

Executive Medical Director, AbbVie, Inc.

Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical... Read More →

Kelly Traverso

Consulting Specialist Leader, Deloitte

Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process... Read More →

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie

Tuesday June 25, 2019 8:00am - 9:15am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: R-D Quality-Compliance, Session | 01: ClinSafety-PV, Session

Level Intermediate
Credit Type ACPE, CME, IACET, RN
Tags Session

8:00am

#213: Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-581-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will introduce a streamlined approach to the development of therapies to address severely-debilitating or life threatening diseases and consider the potential value of global regulatory guidance.

Learning Objectives

Discuss the use of streamlined development programs to expeditiously deliver promising new treatments to patients with severely debilitating or life-threatening diseases from the patient perspective.

Chair

Judith Prescott, DVM, PhD

Speaker

Proposal for Development of Pharmaceuticals for Severly-Debilitating or Life Threatening Indications
Judith Prescott, DVM, PhD

Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Considerations
Haleh Saber, PhD

Perspective from The Patients' Academy For Research Advocacy
Susan Schaeffer

Panelist
Catherine Kopil, PhD

Panelist
Isabelle Lousada, MA

Speakers

Catherine Kopil

Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson's Research

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium

As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015 to address the critical needs in clinical trials and related research... Read More →

Judith Prescott

Executive Director, Safety Assessment, Merck & Co., Inc.

Judith Prescott, DVM, PhD, DACVP is an Executive Director in Safety Assessment, Merck & Co, Inc. She has responsibility for all nonclinical drug development programs supporting FIH through post marketing across the Merck portfolio including small molecules, biologics, and vaccines... Read More →

Haleh Saber

Deputy Director, DHOT/ OHOP/ CDER, FDA

Dr. Saber is the Deputy Director in the Division of Hematology Oncology Toxicology (DHOT). In this role, she provides leadership for day-to-day activities, leads and coordinates scientific research, and participates in guidance development. Dr. Saber has extensive industry and regulatory... Read More →

Susan Schaeffer

President and Chief Executive Officer, The Patients' Academy For Research Advocacy

Susan founded The Patients’ Academy for Research Advocacy in 2018 to equip patients and care partners to apply their unique expertise to inform the development of new and better medicines. She spent 15 years at biopharmaceutical industry journal BioCentury informing and educating... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Patient Focused,Advanced Therapies,Rare Disease
Credit Type ACPE, CME, IACET, RN
Tags Forum

8:00am

#214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-582-L04-P; CME 1.25; IACET 1.25; RN 1.25

The new requirements in FDARA Section 504 represent a significant paradigm shift in pediatric oncology development. This session will review these requirements and their likely global impacts, as well as possible mitigation strategies.

Learning Objectives

Describe and explain the new provisions in FDARA Section 504 that will impact pediatric oncology development in the US within the context of the EU requirements; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development; Describe the use of Master Protocols as a possible mitigation strategy.

Chair

Melodi J McNeil, MS, RPh

Speaker

Industry Perspective: Industry Perspective: Master Protocols as an Option to Design and Conduct Pediatric Oncology Studies under FDARA, Sec 504
Pamela Simpkins, MBA

FDARA 504 Overview/Implementation Planning
Gregory Reaman, DrMed, MD

Lessons Learned from Two Public-Private Partnership Master Protocols
Stacey J. Adam, PhD

Speakers

Stacey Adam

Director, Cancer Reserach Partnerships, Foundation for the National Institutes of Health (FNIH)

Dr. Stacey Adam is the Director of Cancer Research Partnerships at the Foundation for the National Institute of Health (FNIH). She oversees major partnerships, including the Partnership for Accelerating Cancer Therapies (PACT), the Lung Master Protocol (Lung-MAP) clinical trial, and... Read More →

Melodi McNeil

Director, AbbVie, Inc.

Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Gregory Reaman

Associate Director for Pediatric Oncology , OCE, OC, FDA

Dr. Gregory Reaman is a pediatric oncologist with a long career in clinical investigation and translational research. Prior to joining the FDA in 2011, he was the inaugural Chair of the Children's Oncology Group and was previously the Associate Chair for Scientific Affairs and the... Read More →

Pamela Simpkins

Senior Director & Strategy Lead, Child Health Innovation Leadership Dept. (CHILD, Johnson & Johnson

Pamela L. Simpkins, MBA is a biopharmaceutical business leader with 20+ years of experience in leading strategic initiatives and departments across R&D, corporate strategy, regulatory, marketing, business development and finance. She leads internal and external innovation programs... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Intermediate
Featured Topics Precision Medicine,Advanced Therapies,Rare Disease,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
Tags Session

8:00am

#216: Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-590-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA’s Orange Book and other information resources are essential to potential applicants in developing their generic submissions. This session will provide an overview of these resources and the different information that each contains.

Learning Objectives

Describe the content of FDA’s Orange Book; Identify and understand drug product, patent, exclusivity, and therapeutic equivalence information in the Orange Book; Explain FDA’s process for making exclusivity determinations. Describe the process to qualify for Paragraph IV and Competitive Generic Therapy 180-day exclusivities as well as events which may result in exclusivity forfeiture. Understand which applicants are blocked by these exclusivities and triggering events.

Chair

Kendra Stewart, PharmD, RPh

Speaker

Orange Book Overview
Kendra Stewart, PharmD, RPh

Identifying the Reference Listed Drug for ANDA Submissions
Martha Nguyen, JD

Understanding Exclusivities for ANDAs: 180-Day Exclusivity and Competitive Generic Therapy Exclusivity
Martin Shimer

Speakers

Martha Nguyen

Director, Division of Policy Development, OGD, CDER, FDA

Martha Nguyen is the Director of the Division of Policy Development in FDA CDER's Office of Generic Drugs, where she provides strategic leadership and direction on broad policy issues affecting generic drugs and oversees the development and clearance of regulations, guidance documents... Read More →

Martin Shimer

Deputy Director, Division of Legal and Regulatory Support, FDA

Captain Martin Shimer is the Deputy Director of the Division of Legal and Regulatory Support within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). He was commissioned as an officer in the US Public Health Service in July 2000 and joined the Office... Read More →

Kendra Stewart

Supervisor, Orange Book Staff, Office of Generic Drug Policy, CDER, FDA

Captain Kendra Stewart is the Supervisor of the Orange Book Staff within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). She began her career in 2001 as a pharmacist for the Veterans Affairs Hospital. In 2003, she was commissioned as a Lieutenant... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Featured Topics Generics,Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Session

8:00am

#215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

Global clinical trials conducted with GMOs pose unique regulatory, logistical and strategic challenges. This session will presents case studies addressing lessons learned and perspectives from regulatory authorities, investigators and patients.

Learning Objectives

Describe strategies to optimize the conduct of clinical trials with GMOs, in order to facilitate approval across multiple layers and regulatory bodies; Discuss efforts among different stakeholders (Sponsor, CRO, vendors) to enable adequate IP management; Identify how to implement educational plans to overcome cultural barriers (patients, families and site staff) and facilitate enrolment completion.

Chair

Esther Mahillo, PhD

Speaker

Clinical Research with GMOs: Regulatory, Ethical, and Biosafety Challenges
Daniel Kavanagh, PhD

Operational and Logistical Aspects of Working with GMOs
Esther Mahillo, PhD

Patient Perspective
Kathleen Higgins

Speakers

Daniel Kavanagh

Senior Scientific Advisor, Gene Therapy, WIRB-Copernicus Group (WCG)

Dr. Kavanagh is Senior Scientific Advisor, Gene Therapy at WIRB-Copernicus Group (WCG). Prior to joining WCG, he was Assistant Professor of Medicine and Institutional Biosafety Committee Vice Chair at Harvard Medical School, Assistant Immunologist at the Massachusetts General Hospital... Read More →

Esther Mahillo

Customer Relationship Executive, Oncology and Hematology, Syneos Health

I have been working for 24 years in the clinical research arena. Over the past 20 years, I have conducted 47 phase I-III clinical trials enrolling more than 13,000 patients at over 1,000 sites in 50 countries.I obtained my PhD with a research on the role of multicatalytic proteinase... Read More →

Kathleen Higgins

Director of Community Outreach, Li Fraumeni Syndrome Association

Tuesday June 25, 2019 8:00am - 9:15am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum

Level Intermediate
Featured Topics What's Next,Patient Focused,Advanced Therapies
Credit Type ACPE, CME, IACET, RN
Tags Forum

8:00am

#217: Quality Considerations for Complex Generics

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

Increasing the availability of complex generics is a major component of FDA’s recent efforts to enhance the affordability of medicines. The complexity of these products, which includes complex active ingredients, formulations, and drug-device combinations, make both their development and the associated regulatory review challenging. In this session, FDA and industry speakers will provide an introduction to the science and risk-based considerations for developing and reviewing these important products.

Learning Objectives

Discuss the definition and examples of complex generics; Describe considerations for the development of complex generics; Identify the challenges in regulatory review of complex generics.

Chair

Katherine Tyner, PhD

Speaker

Considerations for Manufacturing Assessment for Drug-Device Combination Products: Transdermal Systems and Intravaginal Rings
James Jefferis Norman, PhD

Strategies for Preparing High-Quality Submission of Generic Orally Inhaled Drug Products: Drug Product Quality Perspective
Fang Yuan, PhD

Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study
Mike Darj, PhD

Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study Part 2
Xiaohua Huang, PhD

Quality ANDA Considerations for Complex Generics: Industry Perspective
Scott Tomsky, MS

Speakers

Mike Darj

Quality Assessment Lead (Acting), OLDP, OPQ, CDER, FDA

Mike has been with the Agency in various roles since 2003. He currently serves as Quality Assessment Lead (acting) in the Office of Lifecycle Drug Products of the FDA. Mike is also actively involved in working groups and expert committees as pertain to guidance and USP monograph developments... Read More →

Scott Tomsky

Vice President, Regulatory Affairs, Generics, North America, Teva Pharmaceuticals

Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy... Read More →

Katherine Tyner

Associate Director for Science, Office of Pharmaceutical Quality, CDER, FDA

Dr. Katherine Tyner is the Associate Director of Science (acting) in the Immediate Office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ... Read More →

Fang Yuan

Chemistry Reviewer, OLDP, OPQ, CDER, FDA

Fang Yuan is a Drug Product Quality Reviewer in Office of Life Cycle Drug Product (OLDP), specialized in pre-market submissions of complex generics including oral inhalation and nasal, and long-acting injectable drug products. She is involved in reviewing pre-ANDA meeting packages... Read More →

Xiaohua Huang

Chemist, Office of Lifecycle Drug Products, OPQ, CDER, FDA

Xiaohua serves as a review chemist in the Office of Lifecycle Drug Products of the FDA. His work at FDA involves the quality assessment of abbreviated new drug applications. Prior to joining FDA, he worked in the pharmaceutical industry including Schering-Plough and then Merck on... Read More →

James Norman

Senior Chemist, OPF, OPQ, CDER, FDA

James Norman is a senior chemist in FDA’s Office of Process and Facilities. He joined FDA in 2015, where he primarily reviews complex combination products such as transdermal systems, intravaginal rings, and microneeedles. He completed his PhD in Chemical Engineering at Georgia... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Featured Topics Generics
Credit Type ACPE, CME, IACET, RN
Tags Session

8:00am

#218: Real World Data to Real World Evidence

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

We discuss the advantages and disadvantages of real world data and real world evidence compared to other sources. Join the Clinical Research Community for a follow up Round Table discussion on Wednesday, June 26, 9:30-10:30AM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the importance of real world data for answering regulatory questions; Discuss the benefits and challenges of evidence derived from real world sources compared to clinical trials.

Chair

Richard Zink, PhD

Speaker

Real World Data to Real World Evidence: A Case Study of Direct-Acting Antivirals for the Treatment of Hepatitis C Infection
Richard Zink, PhD

Machine Learning 2.0: Causal Models and Big Data in the Era of Real World Evidence
Andrew Wilson, PhD, MS

Matching with Replacement: The COLLECTION of ‘Personal’ EFFECTs Should be Handled with Care
Sarah Anselm Short, MPH

Speakers

Sarah Short

Sr. Statistical Mgr, RWE - Biostats & Medical Writing, ICON plc.

Sarah has over ten years’ experience in health related statistical analysis, primarily in disease or product registries and other prospective observational studies. Her experience encompasses a wide array of therapeutic areas and study designs. As a Senior Statistical Manager, she... Read More →

Andrew Wilson

Scientific lead, Parexel

I lead the pharmacoepidemiology & statistics initiatives within Real World Data Services at PAREXEL. To be part of the real world evidence movement, it is essential we embrace the data generation process, and keep data context as all-important. Real world data typically comes from... Read More →

Richard Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc

Tuesday June 25, 2019 8:00am - 9:15am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Session | 09: Regulatory, Session

Level Advanced
Featured Topics Patient Focused, Innovative Trial Design
Featured Topics Real World Evidence,Regulator Thinking,Generics
Credit Type ACPE, CME, IACET, RN
Tags Session

8:00am

#219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-584-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will present examples evaluating real world endpoints using electronic health records, current application, and challenges. A panel of experts will provide interpretation, discuss approaches to increase its reliability and acceptability. Join the Study Endpoints Community for a follow up Round Table discussion on Wednesday, June 26, 9:30-10:30AM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe opportunities and challenges utilizing real world endpoints in health care; Discuss examples and approaches to increase objectivity and reliability of real world endpoints; Explain implications for regulatory and payer decision-making.

Chair

Natalia Sadetsky, MD, PhD

Speaker

Panelist
Natalia Sadetsky, MD, PhD

Real World Data in 2019: What's New
Michelle Hoiseth

Real World Data Model with Visualization for Value and Access
Sharon Hensley Alford, PhD, MPH

Panelist
Ronald Cantrell, PhD, MPH

Panelist
Gillis Carrigan, PhD, MS

Speakers

Michelle Hoiseth

Chief Data Officer, Scientific Data Organization, Parexel International

Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently leads PAREXEL’s... Read More →

Natalia Sadetsky

Senior Scientist, Genentech, A Member of the Roche Group

Natalia Sadetsky, is an medical doctor and epidemiologist by training. She has over 18 years of academic and industry experience in oncology. She joined Genentech, a member of a Roche group in 2013 and currently a Senior Data Scientist in Personalized Health Care Data Science, RWD... Read More →

Sharon Hensley Alford

Offering Management, IBM Watson Health

Sharon Hensley Alford, PhD is Associated Chief Health Officer for Data & Evidence within the Life Science (LS) pillar of IBM Watson Health. Dr. Alford has been working on data and analytic strategy for life science clients since she joined IBM 2+ years ago. Prior to IBM, she worked... Read More →

Ronald Cantrell

Senior Director and Principal Data Scientist, Verana Health

Ronald Cantrell leads clinical data science at Verana as Senior Director and Principal Data Scientist. He has over a decade of experience working with and analyzing real world data in the life science industry. He previously served as Principal Data Scientist at Genentech, where he... Read More →

Gillis Carrigan

Director, Epidemiology, Covance Market Access

Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Forum | 09: Regulatory, Forum

Level Intermediate
Featured Topics Real World Evidence, Patient Focused
Featured Topics Real World Evidence,Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Forum

8:00am

#220: DISC and RISK: How DISC Profile in Clinical Trial Teams Impact Implementation of Risk-Based Approaches

Component Type: Workshop
Level: Basic
CE: IACET 1.25

An interactive workshop that instructs attendees on how to best implement and operationalize risk-based approaches to clinical operations and quality management by recognizing what their DISC ( D- Dominance, I – Influence, S – Steadiness and C – Compliant) profile makes them most apt to do and how each of these personality types plays a key role in the design, development, and implementation of a new idea and how each personality type has a varied risk tolerance.

Learning Objectives

Identify your DISC personality type; Identify strategies for analyzing the situation from an alternative viewpoint/DISC type to facilitate change management and adoption; Discuss how personality type variations in clinical trial execution impact risk-based approach implementation and may be leveraged for success.

Chair

Dawn Auerbach, MPA

Speaker

Facilitator
William E Bennett, III, MS

Facilitator
Jay A Turpen

Speakers

Dawn Auerbach

Executive Director, Client Development, The Avoca Group

Dawn Auerbach is the Executive Director of Avoca’s Client Development team. She is responsible for The Avoca Group’s sales processes and for driving new business within the organization. Dawn leads activities to develop proposals and deliver presentations. She is also actively... Read More →

William Bennett

Principal, CEO Empowerment LLC

After an extensive career in Marketing and Sales at a Fortune 50 corporation, Bill established himself as an Executive Coach in 1997. His coaching clients have included ADP, AT&T, Cisco Systems, The Federal Reserve Bank, Informatica, The New York Times Company, Salesforce, Thomson... Read More →

Jay Turpen

Senior Consultant, The Avoca Group

Tuesday June 25, 2019 8:00am - 9:15am
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Level Beginner
Featured Topics Student Programming
Featured Topics Student Programming
Credit Type IACET
Tags Workshop

9:00am

Professional Poster Session 1

Component Type: Poster Presentation

Speakers

Lien-Cheng Chang

Section Chief, Division of Medicinal Products, TFDA

Elisa Conrad

Clinical Science Advisor, ERT

Ms. Conrad is a licensed clinician with more than 12 years of experience with patients across many CNS (Neurology and Psychiatry/Psychology) indications. In addition to being an experienced sub-investigator and site rater, she has extensive expertise in the development and delivery... Read More →

Christina Cantrell

Senior Patient Insights Leader, Genentech, A Member of the Roche Group

Teresa Curto

Associate Director, Biostatistics, Cytel

Anthony Davidson

Associate Consultant Scientific Writing, Eli Lilly and Company

Anthony is a medical writer within the Design Hub which is part of the Clinical Design, Delivery, and Analytics organization at Lilly. He is responsible for the writing of oncology clinical trials. Anthony has been at Lilly for 6 years and has worked in clinical research for 14 y... Read More →

Hunter Davis

Medical Affairs / Medical Science Liaison Fellow, Genentech, Rutgers University, Ernest Mario School of Pharmacy

Hunter Davis is a recent graduate from the University of California, San Francisco School of Pharmacy. He is currently a Medical Affairs and Medical Science Liaison Post Doctoral fellow at Genentech with an adjunct faculty appointment at Rutgers University, Ernest Mario School of... Read More →

Ye Jin Eun

Senior Data Scientist, Janssen

Andre Ghetti

Chief Executive Officer, AnaBios

Andre Ghetti, PhD, is our Chief Executive Officer. During the last several years, Dr. Ghetti focused on the creation of new tools and strategies to advance biomedical sciences, with special emphasis on enabling the direct study of human biology and pharmacology to accelerate the rate... Read More →

Daphne Guinn

ORISE Post-Doctoral Fellow, FDA

Daphne Guinn is currently a Post-Doctoral Policy Fellow in the Office of Clinical Pharmacology. Prior to joining FDA, Daphne completed a post-doctoral fellowship in regulatory science at Georgetown University. She used the training opportunity to pursue her interest in innovative... Read More →

Adam Hamm

Director, Biostatistics, Cytel

Joanne Hathaway

Manager, Global Regulatory Affairs, Promotion Compliance, Otsuka Pharmaceutical Commercialization & Development

Joanne Hathaway joined Otsuka Development & Commercialization (OPDC) as Senior Analyst, Document Management in 2016. In this role, she was responsible for managing promotional materials for all marketed products that required submission to the Office of Prescription Drug Promotion... Read More →

Lauren Holmes

Global Trial Manager, Rutgers University/Ernest Mario School of Pharmacy

Lauren is currently a post-doctoral fellow with the Rutgers Pharmaceutical Industry Fellowship Program. Her fellowship is in global development and trial management at Novartis Pharmaceuticals where she is about to begin her second year in the program.

Chin-Fu Hsiao

Investigator, National Health Research Institutes

Chin-Fu Hsiao received his Ph.D. degree from Department of Statistics at University of Wisconsin-Madison. His research interests include Bayes decision theory, sequential analysis, clinical trials and genetic study. His current research focuses on the design and evaluation of multi-regional... Read More →

Shu-Mei Hsu

HTA Researcher, TFDA/Center for Drug Evaluation

MPH. in Global Health Systems, Tulane University, USA. MSc. in Preventive Medicine, National Taiwan University, Taiwan. BSM. in Veterinary Medicine, National Chung-Hsing University, Taiwan

Dalong Huang

Mathematical Statisitician, CDER, FDA

Dr. Huang has served as a statistical reviewer to provide statistical expertise regarding QT issues since he jointed FDA in 2015. He is active in regulatory science research, and has several publications and presentations in ICH E14 related research area in particular. Prior to joining... Read More →

Toshiko Ishibashi

Clinical Operation I, Clinical Operation Management, Ono Pharmaceutical Co., Ltd.

Toshiko Ishibashi, PhD, serves in Clinical Operations at Ono Pharmaceutical Co. Ltd. She has more than 16 years of clinical research experience as a Clinical Research Coordinator at Kumamoto University Hospital and St Luke’s International Hospital. Dr. Ishibashi previously served... Read More →

Mohit Juneja

Co-Founder, Lyfescience

Miah Jung

Pharmacologist, FDA

Miah Jung is a Pharmacologist in the Compliance Enforcement Branch, Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), FDA. She has been with FDA for six years, and serves as a subject matter expert in Good Clinical Practice (GCP) inspections to evaluate... Read More →

Oksana Karavaeva

ClinOps Director, IPHARMA LLC

Andrea Keyter

Deputy Director, Medical Devices, South African Health Products Regulatory Authority

Andrea is a pharmacist and has 10 years of experience within the field of regulatory affairs, quality assurance, quality risk management, pharmaceutical production, complementary medicines manufacture and risk-based inspection planning. In her current role, Andrea is responsible for... Read More →

Namita Kothary

Consumer Safety Officer, FDA

Namita Kothary is a Consumer Safety Officer on the Postmarketing Adverse Drug Experience Compliance Team in CDER’s Office of Compliance. As a Consumer Safety Officer, Dr. Kothary monitors and assesses industry compliance with postmarketing adverse drug experience statutory requirements... Read More →

Tetsuya Kusakabe

Professor, Osaka City University, Graduate School of Medicine

Tetsuya KUSAKABE is a Professor at the Osaka City University, Graduate School of Medicine, since July 2017. Prior to this, he was a Director at the Ministry of Health, Labour and Welfare (MHLW) from November 1996 to July 2017. He was involved in pharmaceutical regulations, research... Read More →

Samir Lababidi

Statistician, FDA

Connie Langer

Regulatory Scientist, Pfizer Inc

Connie Langer is an Associate Director at Pfizer in Groton, CT, where she is accountable to manage and provide global strategy and submissions for investigational studies, new commercial registrations and maintenance of product licenses. She had the unique opportunity to work closely... Read More →

Xin (Joy) Li

Mathematic Statistician, Office of Translational Science, CDER, FDA

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS)

Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →

Masaki Mihaila

Programming Lead, Manager, Pfizer

Ms. Mihaila is a SAS programmer who analyzes data from clinical trials mostly for Regulatory Agencies and publications. She has been working in the Pharmaceutical industry for 13 years and for most of her career, she has been working on Oncology data. With her current position at... Read More →

Juliane Mills

Director Scientific Affairs, Real World Solutions, PRA Health Sciences

Juliane Mills, Director of Scientific Affairs, has a comprehensive understanding of drug development from the laboratory to the patient’s bedside from over 20 years of experience in various scientific roles in academic institutions and industry. She has extensive experience in the... Read More →

Tomoko Minamiguchi

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)

Tomoko Minamiguchi is a reviewer at Pharmaceuticals and Medical Devices Agency (PMDA) since 2012. She is involved in the review of blood products. She is a member of Orphan Drug Working Group in PMDA.

Nipa Parikh

Senior Director, PV Operations, Global Head Aggregate Reports/RMPs, Otsuka Pharmaceutical Development and Commercialization Inc.

Nipa Parikh is a Senior Director in Global Pharmacovigilance at Otsuka Development & Commercialization (OPDC). She has experience in pharmacovigilance for the past 16 years, but has specialized in aggregate reporting and risk management plans for the past 10 years. Nipa received her... Read More →

Yannick Pouliot

Sr. Computational Biologist, Unlearn.AI

Computational biologist and software developer with deep expertise in data mining and modeling, including meta-analysis, data cleansing, metadata encoding, and visualization.

Susan Pusek

Director, Education Programs (Clinical/Translational Research), University of North Carolina Chapel Hill

Susan Pusek is the Director of Education Program at the North Carolina Translational and Clinical Sciences Institute. She is also a doctoral student in Regulatory Science at the University of Southern California. Ms. Pusek has over 25 years of experience within the clinical research... Read More →

George Quartey

Scientific Enablement Leader, Genentech, A Member of the Roche Group

"George joined Roche/Genentech in January 2009 as an Expert Statistician, responsible for developing, Driving and Embedding Innovative Statistical Methods for the Analysis and Reporting of Safety, and Epidemiological Data. George previously worked for GSK and Cambridge University... Read More →

Caroline Seo

Senior Analyst, Patient-Centered Outcomes, Pharmerit International

Caroline Seo is a senior research analyst within the patient-centered outcomes group at Pharmerit International. With a background in mixed-method research, Caroline conducts patient journey studies and develops/validates patient-reported outcome measures in various therapeutic areas... Read More →

Jit Sheth

Postdoctoral Medical Affairs Fellow, Alnylam Pharmaceuticals and Northeastern University

Landon Shupe

Pst-Doctoral Fellow, Rutgers University/Ernest Mario School of Pharmacy

Manfred Stapff

CMO, Trinetx

Meng Ting Tsai

Project Manager, Center For Drug Evaluation (CDE)

Meng Ting Tsai is a Project Manager in Division of Regulatory Affairs and Compliance of CDE Taiwan for more than 3 years. Meng Ting Tsai holds a Master of Life Science from National Taiwan University and is Project Management Professional (PMP) certification holder.

Hanming Tu

Vice President, IT, Frontage Laboratories, Inc.

Brian Ung

Manager, U.S. Health Economics & Outcomes Research (HEOR), Celgene Corporate

Christopher Varghese

Post Doctoral Fellow, Global Scientific Engagement, Johnson & Johnson, Rutgers University

Post-doctoral fellow at Johnson & Johnson through Rutgers University. Have experience in community, hospital and industry settings. Interests lie in developing novel drug therapies, consumer behaviors, and creating a healthier world for future generations.

Renee Willmon

Manager, Behaviour Science, Self Care Catalysts

Denise Meade

Director, Product Management, IBM Watson Health

Denise Meade, Director of Product Management at IBM Watson Health, oversees the development of new offerings using real-world evidence for access, value, and commercial needs. In addition, she chairs the Innovation Council on Value-Based Purchasing and manages strategic collaborations... Read More →

Danielle Abatemarco

World Wide Patient Safety, BMS, Business Capabilities and Innovation, Bristol Myers Squibb

Danielle leads the Publications strategy and execution for World Wide Patient Safety at BMS, where she joined via the acquisition of Celgene. With background in neuroscience and nursing, Danielle is passionate about the value of AI/ML in pharmacovigilance. She recently graduated with... Read More →

Bruno Assuncao

Associate Director Pharmacovigilance Innovation, Celgene

Tuesday June 25, 2019 9:00am - 4:00pm
Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: Posters, Poster Presentation

Tags Poster Presentation

9:15am

#221 CH: Getting the Question Right (GTQR) with Interdisciplinary Collaboration

Component Type: Workshop
Level: Intermediate

Inspired by the E9 R1 estimand framework, the DIA Getting the Question Right (GTQR) webinar series was organized in 2018 via intercommunity collaboration. This hub will provide a synthetic overview of the 6 popular webinars, followed by open Q&As.

Learning Objectives

Discuss the estimand framework described in the draft ICH E9 addendum; Recognize how the estimand framework may help get the question right and can be applied in various therapeutic and safety/benefit-risk contexts; Define how the estimand framework may advance the interpretation of study results.

Chair

William Wang, PhD

Speakers

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories

Tuesday June 25, 2019 9:15am - 9:45am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop | 11: Statistics, Workshop

Tags Workshop

9:15am

Coffee Break

Component Type: Social Event

Tuesday June 25, 2019 9:15am - 10:30am
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Social Event

Tags Social Event

9:30am

#222 EE: The Negotiation Game: Learn What you Never Knew About Negotiation in a Fun, Interactive, Collaborative Game

Component Type: Workshop
Level: Basic

This is an interactive game for people who want to build negotiating skills, and we ALL negotiate, for everything, all day long regardless of your role or title. Guaranteed to be thought provoking, fun, and talked about!

Learning Objectives

Describe team collaboration- how do we negotiate with other teams to our greatest benefit; Discuss collaboration in the context of competition.

Chair

Sheila Mahoney Jewels, MBA

Speakers

Sheila Mahoney Jewels

Independent Workforce Advocate, LifeSciHub

Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last... Read More →

Tuesday June 25, 2019 9:30am - 10:15am
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Engage-Exchange, Workshop | 13: ProfDevelopment, Workshop

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9:30am

#223 RT: Round Table Discussion: Interpretation of New Pharmacovigilance Regulations: Key Insights

Component Type: Session
Level: Basic

Round table discussion tied to session #136: Interpretation of New Pharmacovigilance Regulations: Key Insights (Monday, June 24, 2:15-3:15PM). Seating is limited. To include special guests from the session: Ajay Singh, Jane Carroll.

Chair

Jeremy Jokinen, PhD, MS

Speakers

Jeremy Jokinen

Senior Director, Decision Sciences, AbbVie, Inc.

Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Community Rounds, Session | 01: ClinSafety-PV, Session

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9:30am

#224 RT: Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development

Component Type: Session
Level: Basic

Round table discussion tied to session #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Elektra Papadopoulos, Telba Irony, Michelle Tarver.

Chair

Emuella Flood

Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Community Rounds, Session | 02: ClinTrials -ClinOps, Session | 05: Patient Engagement, Session

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9:45am

#225 IT: DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation: ‘Wide-Angle-Data’ – Fully Integrated Platform with Advanced Analytics and Customized Algorithms for Real Time Safety and Risk Management

Component Type: Session

Conventional approach to risk management and patient safety is often fraught with review delays which can lead to reduced regulatory compliance. Fully integrated data sciences platform (W-A-D) with intuitive customized algorithms, smart data reduction, advanced analytics & visualization facilitates real-time ‘signal detection & adjudication’ and comprehensive risk management while ensuring review efficiency. 'Operational & predictive analytics' and machine learning give full control over data.

Chair

DiagnoSearch Life Sciences

Speakers

Opus Analytics

Vasudeo Ginde

President, Opus Analytics

A physician by training, Dr. Vasudeo Ginde is an eminent clinical research thought leader in India. After playing a pivotal role in setting up Eli Lilly’s Indian clinical research infrastructure in early 1990s, he co-founded the full-service CRO DiagnoSearch in 1995 & currently... Read More →

Tuesday June 25, 2019 9:45am - 10:15am
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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9:45am

#226 IT: Covance Innovation Theater: Fixing the Patient Recruitment "Leaky Funnel"

Component Type: Session

Patient recruitment has long been considered the primary pain point in clinical trials. We lose potential patients in 4 key stages: pre-screen failures, consent declines, screen failures and post randomization drop-outs. To increase efficiencies and stop the "leaky" patient recruitment funnel, we need to address these challenges with a new approach. In this presentation, we will share how Covance leverages its proprietary data sources and assets to "seal" the leaks to produce better outcomes.

Chair

Covance Inc.

Speakers

Covance Inc.

Michelle Jones

Senior Director, Data and Technology Organization, Covance

Michelle has more than 30 years of experience in pharmaceutical research and development. She currently leads Covance’s global Clinical Informatics group, which uses the latest methods and creates new ones to statistically and computationally analyze and model Real World Data and... Read More →

Kate Reese

Executive Director, Site and Patient Centricity, Covance

Kate has spent more than 20 years in the Pharmaceutical Industry and has broad experience in Project management and Clinical Operations, including several years in project feasibility strategy, within the CRO, Pharmaceutical, and Device company arenas. Throughout her career she has... Read More →

Kate Reese

Clinical Research Pharmacist in Charge, Celerion

Tuesday June 25, 2019 9:45am - 10:15am
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: InnovTheater, Session

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10:00am

#227 CH: GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions

Component Type: Workshop
Level: Intermediate

Emerging regions are participating in clinical trials, but that only provides drug benefits to a small number of patients. Shifting to Investigator-initiated trials maximizes patient access, but requires more activities to be GCP compliant.

Learning Objectives

Define GCP for Investigator-Initiated trials; Discuss strategies for GCP compliance in emerging regions.

Chair

Terry Katz, MS

Speakers

Terry Katz

Director, Head of Global Data Management and Statistics, Merck Animal Health

Terry Katz is Head of Global Data Management and Statistics at Merck Animal Health. Previously he was Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician... Read More →

Tuesday June 25, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

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10:30am

#228: Emerging Safety Challenges in New Oncology Treatments

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS

Speakers

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc

He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme

Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →

Meredith Chuk

Acting Associate Director for Safety, OOD, OND, CDER, FDA

Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Oncologic Diseases in OND/CDER at the FDA.

Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 02: ClinTrials -ClinOps, Session | 06: PreClin Dev-EarlyPhaseCR, Session | 08: R-D Quality-Compliance, Session

Level Beginner
Featured Topics Real World Evidence, Regulator Thinking, Innovative Trial Design, Generics, What's Next
Featured Topics Precision Medicine,Advanced Therapies,Rare Disease
Credit Type ACPE, CME, IACET, RN
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10:30am

#229: An Industry Collaboration on Pharmacovigilance Analytics

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss an initiative and how it is facilitating biopharmaceutical companies to enable earlier and systematic identification of potential safety issues to help minimize harm to patients, improve quality of analytic methods to improve product development, and deliver accelerated method development through collaboration and piloting. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 12:45-1:45PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss methods for collaborating and innovating in analytics to improve patient safety; Identify how to build awareness of opportunities for greater alignment across the industry in signal detection and management; Describe industry best practices of current and future signal detection and management.

Chair

Andres Gomez, PhD, MPH

Speaker

Panelist
John Van Stekelenborg, PhD, MBA, MSc

Panelist
Neal Grabowski, MS

Speakers

Andres Gomez

Vice President, Head of Epidemiology, Safety Science, and Analytics, Bristol-Myers Squibb

Dr. Gomez joined at Bristol Myers Squibb Company as an Associate Director of Pharmacoepidemiology in the Global Pharmacovigilance and Epidemiology department in 2003. He currently heads the epidemiology, safety science and analytics groups which is accountable for the real world research... Read More →

Neal Grabowski

Director, Pharmacovigilance & Patient Safety, AbbVie

Prior to joining AbbVie, Neal held multiple roles in Patient Safety and Clinical Operations at Amgen, Genzyme and Sanofi. He holds a MS in biomedical engineering and MBA from Pepperdine University.

John Van Stekelenborg

Director, Group Lead, Methods and Analysis, Johnson & Johnson

John van Stekelenborg is the Head of the Methods & Analysis group in the Global Medical Safety department of Janssen, the Pharmaceutical Companies of Johnson & Johnson. John has been with J&J since 2002 and assumed leadership of the M&A group in 2011 where he leads a group of data... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum | 09: Regulatory, Forum | 03: Data-Data Standards, Forum

Level Intermediate
Featured Topics Real World Evidence, Regulator Thinking, Innovative Trial Design, What's Next
Featured Topics Regulator Thinking,What's Next
Credit Type ACPE, CME, IACET, RN
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10:30am

#230: Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-604-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session reviews original benchmark research and experiences with outsourcing practices to identify opportunities to optimize the management, execution and performance of CRO relationships.

Learning Objectives

Identify benchmarks characterizing outsourcing practices and identifying opportunities to improve outsourcing effectiveness and efficiency; Describe risk-based quality management and monitoring practices to improve effectiveness; Discuss data-driven insights to inform improvement in the vendor qualification assessment process.

Chair

Kenneth A. Getz, MBA

Speaker

Risk-Based Quality Management and Monitoring; How to Perform Oversight
Liz Wool, BSN

Benchmarking the Oversight and Vendor Qualification Assessment Process
Kenneth A. Getz, MBA

Speakers

Kenneth Getz

Deputy Director, Research Professor, Tufts Center For the Study of Drug Development

Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →

Liz Wool

President, Wool Consulting Group Inc.

Liz Wool CCRA, CID, CMT, is President, Wool Consulting Group. Inc. Liz possesses 28 years in the product development with expertise in CRO-Vendor Oversight, GCP compliance, SOP gap analyses and development, development and delivery of training programs (live, webinar, virtual classroom... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Credit Type ACPE, CME, IACET, RN
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10:30am

#231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-605-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of past challenges and future opportunities for outcomes research in the Oncology and Alzheimer therapy areas. This will include an update on the state of eCOA and the use of connected devices inside oncology clinical trials as well as a review of existing and future endpoints that could be relevant for immunotherapies. The session will also discuss the eCOA led methodological improvements that are positively supporting Alzheimer clinical trials.

Learning Objectives

Describe the use of eCOA and connected health devices inside oncology clinical trials, areas of controversy and opportunity; Discuss current challenges in Alzheimer clinical trials - traditional approaches to eCOA implementation with central oversight; Identify Current challenges associated with measuring c the effects of immunotherapies with existing metrics and proposed metrics to measure outcomes into the future.

Chair

Brad Sanderson, MHS

Speaker

eCOA and Connected Devices for Supporting Oncology Patients in Clinical Trials
Brad Sanderson, MHS

Measuring and Understanding the Outcomes of Immunotherapies in Oncology
Imad Al-Dakkak, DMD, MPA, MPH

Speakers

Imad Al-Dakkak

Director, Huron Consulting Group

Imad is a clinical epidemiologist with over 14 years of experience from government, industry, and academia across multiple disease areas. His areas of expertise include research methodology, epidemiology, study designs, database analytics, and evidence-based medicine. Imad is based... Read More →

Brad Sanderson

Senior Scientific Advisor, Signant Health

Brad is a physiologist and researcher with over 15 years of industry experience. Brad is currently Senior Scientific Advisor - Head of Health Outcomes at CRF Bracket where he leads the Health Outcomes discipline and seeks to advance the company’s scientific and technical expertise... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Student Programming
Featured Topics What's Next
Credit Type ACPE, CME, IACET, RN
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10:30am

#232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-606-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.

Learning Objectives

Discuss and compare your organization’s approach with leading practices shared in the session; Describe some of the gaps in standard approaches to risk assessment and ways to overcome them; Explain the importance of metrics in risk assessment and risk control.

Chair

Linda B. Sullivan, MBA

Speaker

Panelist
Sherry Merrifield

Panelist
Ann McCabe

Panelist
Suzanne Lukac

Speakers

Suzanne Lukac

Senior Account Director, CluePoints

Suzanne has nearly 20 years experience in the pharmaceutical industry including hands-on experience with RBM implementation. She is currently Senior Account Director at CluePoints where she is responsible for managing enterprise-level accounts and working with customers to lay the... Read More →

Ann McCabe

Director, Process Excellence and Risk Management, Daiichi Sankyo Inc

Ann E. McCabe Director, Process Excellence & Risk Management Ann McCabe is Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked... Read More →

Sherry Merrifield

Senior Director, Global Operations Management, Syneos Health

Sherry Merrifield has over 20 years of clinical operations experience. In her current role she is Senior Director of the Global Operations Management group focused on the optimization of Syneos Health’s data-driven RBM solution and application of ICH E6 R2. Her experience in this... Read More →

Linda Sullivan

Executive Director, Metrics Champion Consortium

Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session

Level Intermediate
Featured Topics Artificial Intelligence
Credit Type ACPE, CME, IACET, RN
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10:30am

#233: Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-593-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the recommendations of the Blue-Ribbon Commission, an overview of CDISC 2.0, the innovation initiative CDISC is currently undertaking to and what benefits these efforts will bring for all stakeholders.

Learning Objectives

Describe CDISC 2.0 and how this initiative and what benefits these efforts will bring for all CDISC stakeholders; Describe how beginning to end connected standards can streamline clinical data management make and data sharing easier.

Chair

Kit Howard, MS

Speaker

CDISC 360 and CDISC Library: Continuing the Journey Toward Beginning-to-End Automation
Bess LeRoy, MPH

SEND: What's New Today and on the Horizon for CDISC's Standard for Nonclinical Research
Lou Ann Kramer

CDISC Primer: Making CDISC Easier: A Collaboration Between CDISC and PhUSE
Kit Howard, MS

Speakers

Kit Howard

Senior Director, Standards Development & Education, CDISC

Kit Howard has over 30 years’ experience in many areas of research and development, including developing data and process standards for exploratory through post-marketing human clinical research, pharmacogenomics and non-clinical research. She is CDISC's Senior Education Expert... Read More →

Lou Kramer

Senior Director, Standards Development, CDISC

Lou Ann Kramer is a Senior Director of Standards Development at CDISC. Prior to joining CDISC, she had over 30 years experience at a major pharmaceutical sponsor company where she held roles in IT, early phase Clinical and non-clinical regulatory. She managed non-clinical submissions... Read More →

Bess LeRoy

Head of Standards Development, CDISC

Bess LeRoy has over 15 years of experience working in public health research. She is currently the Head of Standards Development at CDISC. She has been a CDISC team member since 2011 and has been involved in the development of over 16 CDISC Therapeutic Area User Guides. Bess has a... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Data Standards, Session

Level Intermediate
Featured Topics Regulator Thinking
Featured Topics What's Next
Credit Type ACPE, CME, IACET, RN
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10:30am

#234: Quality and Compliance Management in Medical Information/Medical Affairs

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-594-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how meeting both quality and compliance high standards can ensure effective success in supporting any pharmaceutical brand which is primarily defined by its image.

Learning Objectives

Discuss the factors that effectively influence and measure quality and compliance; Describe the risk and impact of the performance in quality and compliance; Identify reliable approaches to monitor and measure the performance at local versus global level.

Chair

Philippe Sorel Takam, PharmD, MSc, RPh

Speaker

Industry Perspective
Joseph Mack, JD

Techniques for Successful System Validation
Joseph Pierce

Speakers

Philippe Sorel Takam

Global Director, Head of Medical Information, PrimeVigilance Ltd

Phil is a time-honoured healthcare professional and holds a Doctorate in Pharmacy (Pharm.D.), a Master Degree in Pharmaceutical Science and three Post-Graduate Diplomas in Medicines Information, Patient’s Clinical Management and Business Administration. Throughout his professional... Read More →

Joseph Mack

Senior Compliance Counsel, US Office of Compliance, Bayer U.S.

At Bayer, Joe Mack is responsible for both advising various businesses on compliance issues and conducting internal investigations. Prior to joining Bayer, Joe served for over nine years as an Assistant U.S. Attorney in the U.S. Attorney's Office for the District of New Jersey. During... Read More →

Joseph Pierce

President, EndPoint Technologies

Joe Pierce has worked with pharmaceutical and biotech companies since 1995, specifically in the area of medical information and medical affairs. He was VP of Sales and Marketing for Online Business Applications, leading that company’s core product IRMS, to become the most widely... Read More →

Philippe Sorel Takam

Former Global Director, Head of Medical Information and Medical Review, Global CRO

Tuesday June 25, 2019 10:30am - 11:30am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

Level Intermediate
Featured Topics What's Next
Credit Type ACPE, CME, IACET, RN
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10:30am

#236: Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-608-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore and discuss agency-wide patient engagement programs and initiatives that provide patient stakeholders (patients, caregivers and advocates) opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review.

Learning Objectives

Describe how FDA has established organizational components to ensure patients are a priority; Describe avenues for patient stakeholders to engage with the agency; Explain key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss the value of patient stakeholder participation.

Chair

Samir Shaikh, MBA

Speaker

FDA Perspective
Patroula Smpokou, MD

Patient Perspective
Debbie Drell

Patient Perspective
Sabina A. Kineen

Speakers

Debbie Drell

Director of Membership, National Organization for Rare Disorders (NORD)

Debbie joined the National Organization for Rare Disorders (NORD) in 2017 with more than 18 years of nonprofit experience in public health education, awareness and advocacy. Most recently, she worked for the Pulmonary Hypertension Association, a NORD member organization. Debbie says... Read More →

Sabina Kineen

Fabry Disease, Patient Advocate

Diagnosed with Fabry Disease in her early teens, Sabina provides a unique perspective as both a patient and caregiver. Over the years, she has shared her experiences living with a rare genetic condition, as well as helping manage the complicated and multi-faceted healthcare needs... Read More →

Patroula Smpokou

Clinical Team Leader, Office of New Drugs, CDER, FDA

Patroula Smpokou, MD, currently serves as an acting deputy director in the Division of Rare Diseases and Medical Genetics at FDA’s Center for Drug Evaluation and Research where she is involved in the scientific review and regulation of products intended for rare genetic diseases... Read More →

Samir Shaikh

Deputy Director, Patient Affairs Staff, Office of the Commissioner, FDA

Samir Shaikh works at the U.S. Food and Drug Administration (FDA) and serves as the Deputy Director for the Patient Affairs Staff (PAS) in the Office of the Commissioner. PAS leads and enhances patient engagement activities across the medical product Centers—facilitating dialogue... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient Engagement, Session

Level Beginner
Featured Topics Patient Focused,Regulator Thinking
Credit Type ACPE, CME, IACET, RN
Tags Session

10:30am

#235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session examines the use of home trial support services from the perspectives of the study sponsor, CRO partner and the potential patient participant. During this session we will discuss the logistics of home trial support, its benefits and pitfalls, when it is most appropriate to use and the patient perception of the service and how it may affect their willingness to participate.

Learning Objectives

Describe the benefits of use of home nursing (specifically, home trial support) in clinical trials from the sponsor, CRO and patient perspectives; Identify barriers to implementation of home trial support; Discuss scenarios where the greatest return on investment for home trial support is realized.

Chair

Ellyn Getz

Speaker

Academic Perspective
Ellyn Getz

Industry Perspective
Todd McGrath

Study Sponsor Perspective
Nour Ziyadeh, MS

Patient Perspective
Mary Koestler

CRO Perspective
Kelly Franchetti, RN

Speakers

Mary Koestler

Assistant Professor, Clinical Trials Adminstrator, Memory and Aging Center, University of California San Francisco

Nour Ziyadeh

Clinical Trial Oversight Lead, Alnylam Pharmaceuticals

Nour Ziyadeh is a Clinical Trial Oversight Lead ensuring compliance for Alnylam’s outsourced clinical trials. She has 15 + years of industry experience including third party auditing for the FDA, CRO , SMO and Pharma. She has held roles including Clinical Research Coordinator, Clinical... Read More →

Kelly Franchetti

Vice President, Global Head Patient Insights and Engagement, ICON plc

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP

Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →

Todd McGrath

Vice President Operations A/O, Medical Research Network

Todd has over 15 years' experience in the clinical trial and life science industry; beginning his career in pharmaceutical and biotech consulting and then holding operational positions at a clinical research organization. As Vice President Operations Americas Oceania at MRN, Todd... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient Engagement, Session | 02: ClinTrials -ClinOps, Session

Level Beginner
Featured Topics Patient Focused
Featured Topics Patient Focused
Credit Type ACPE, CME, IACET, RN
Tags Session

10:30am

#237: The Rare Disease Experience in Clinical Trials

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-596-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide a look at the rare disease patient’s experience, and provide professionals with insight on how to craft accessible trials that meet this patient population’s needs. The session will also focus on the importance of increasing the number of rare disease trials throughout the industry.

Learning Objectives

Discuss how the rare disease patient’s experience differs from those suffering from more common indications, and ways in which it is the same.

Chair

Steven L. Roberds, PhD

Speaker

No Two Patients Are the Same: The Rare Disease Experience in Clinical Trials
Christian Burns

Panelist
Isabelle Lousada, MA

Speakers

Steven Roberds

Chief Scientific Officer, Tuberous Sclerosis Alliance

Steve leads the development and execution of the TS Alliance's scientific strategy through partnerships and conversations with stakeholders including individuals and families affected by TSC, basic and clinical researchers, healthcare providers, government agencies, and other non-profit... Read More →

Christian Burns

President, ClinEdge

Christian, an avid entrepreneur and research advocate, is the President & co-founder of ClinEdge & BTC. He is passionate about serving patients and sites by identifying innovative solutions that will transform the traditional clinical trial model. ClinEdge & BTC work directly with... Read More →

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium

Tuesday June 25, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: PreClin Dev-EarlyPhaseCR, Session

Level Advanced
Credit Type ACPE, CME, IACET, RN
Tags Session

10:30am

#238: Build and Leverage Your Networks to Influence Stakeholders

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-19-597-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166OO2I8F; RN 1.00

Most project managers have to lead the project teams without positional authority. Learn how to cultivate a network of relationships whose influence can used to achieve personal and project success.

Learning Objectives

Describe your projects and explain how to expand your networks to include key influencers; Discuss how to leverage your networks to achieve personal and project priorities.

Chair

Jayanthi Reddy

Speaker

Industry Perspective
Maureen McNamara, MBA

Academic Perspective
Nancy Slater, MBA, PMP

Speakers

Maureen McNamara

Executive Director, Global Project Management and Leadership, Daiicho Sankyo

Maureen has over 30 years industry experience primarily in drug development project management. She is currently Executive Director of Global Project Management & Leadership at Daiichi Sankyo Inc where she is responsible for leading project and portfolio management. Prior to this... Read More →

Jayanthi Reddy

Director, Global Project Management, Merck & Co., Inc.

Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.

Nancy Slater

Senior Director, Portfolio Program Management Therapeutic Area Head, AbbVie, Inc.

Nancy Slater, MBA, PMP is Senior Director, Portfolio Program Management Therapeutic Area Head for Virology and General Medicines at AbbVie. Nancy has over 24 years of Project Management experience in drug development, strategic process improvement initiatives and global lifecycle... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjMgt-StrategicPlanning, Forum | 13: ProfDevelopment, Forum

Level Intermediate
Featured Topics Student Programming
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, PMI, RN
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10:30am

#239: Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose

Component Type: Session
CE: ACPE 1.00 Application UAN: 0286-0000-19-598-L04-P; CME 1.00; IACET 1.00; RN 1.00

Speaker

Approach to Advancing Proactive Quality Through the Implementation of an Integrated Quality Risk Management Framework
Fidelle Jarmon, MS

CRO Perspective
Ben Quartley, PhD

Speakers

Fidelle Jarmon

Director, Risk Management, Bioresearch Quality and Compliance, Janssen

Fidelle has been with Johnson & Johnson for 10 years. She is currently the Director of Risk Management in the Bioresearch Quality & Compliance organization at Janssen. She is responsible for the further development, implementation, and continuous improvement of the Integrated Risk... Read More →

Ben Quartley

Head of Feasibility, Patient Recruitment and Engagement, Covance

Ben has spent more than 20 years in the Pharmaceutical Industry and has broad experience in Project management and Clinical Operations, having worked at a Site Management Organization, large Pharma and CROs. Early in his career he saw the challenges of accurately planning and delivering... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: R-D Quality-Compliance, Session

Level Intermediate
Credit Type ACPE, CME, IACET, RN
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10:30am

#240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-599-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of the ICH Association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH.

Learning Objectives

Identify the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH; Describe the current harmonization initiatives that are currently underway and the impact on global drug development.

Chair

Camille Jackson

Speaker

FDA Update
Theresa Mullin, PhD

EMA Update
Agnès Saint-Raymond, DrMed, MD

MHLW Update
Naoyuki Yasuda, MS

Speakers

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency

Naoyuki Yasuda

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)

Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Intermediate
Featured Topics Real World Evidence, Artificial Intelligence
Featured Topics Student Programming,Regulator Thinking
Credit Type ACPE, CME, IACET, RN
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10:30am

#241: PMDA Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-600-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, PMDA will share the latest details regarding its policies and initiatives and other related strategic directives.Three senior level representatives from PMDA and MHLW will introduce the latest situations regarding scientific review systems, regulatory capacity building activities, and the current international collaboration.

Learning Objectives

Discuss the latest information regarding PMDA and Japanese regulations; Describe how to foster dialogue between participants and senior PMDA officials concerning drug/device regulatory concerns.

Chair

Nobumasa Nakashima, PhD

Speaker

Regulatory Updates: Facilitating Early Patient Access
Kazuhiko Mori, MSc

The Future of PMDA
Yasuhiro Fujiwara, MD, PhD

Current Initiatives of PMDA Regulatory Science Center
Hiroyuki Arai, PhD

Speakers

Yasuhiro Fujiwara

Chief Exective, Pharmaceuticals and Medical Devices Agency (PMDA)

Hiroyuki Arai

Director of Center for Product Evaluation and Center of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA)

Dr. ARAI Hiroyuki is currently Executive Director and Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA). He oversees all aspects of medical product evaluation including review, scientific advice and standard compliance of pharmaceuticals... Read More →

Kazuhiko Mori

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)

Kazuhiko Mori, MSc., is currently Councilor for Pharmaceutical Affairs, Minister’s Secretariat of the Ministry Health, Lobour and Welfare (MHLW). Mr. Mori has led many of MHLW/PMDA’s drug initiatives. He contributed to introduce new approaches to drug safety regulation including... Read More →

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA)

Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Regulator Thinking
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
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10:30am

#242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-601-L04-P; CME 1.00; IACET 1.00; RN 1.00

The Cures Act and the PDUFA IV mandated that the US FDA develop rules to guide industry on the use of real world evidence (RWE) for drug approvals. The session will bring together researchers and regulators to discuss the role of real world evidence.

Learning Objectives

Describe the DUPLICATE project replicating RCTs with real world data (RWD) analyses and provide an interim update on the findings from the first year; Discuss key considerations in implementing non-randomized studies using real world data to ensure valid and unbiased findings; Facilitate discussion how real world evidence may be used in regulatory decision-making.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Initial Learnings From the RCT DUPLICATE Project
Jessica Franklin, PhD

Industry Perspective
Brande Yaist, MHS

Overview of the DUPLICATE Real World Evidence Demonstration Project
David Martin, MD, MPH

Speakers

Jessica Franklin

Biostatistician, Div of Pharmacoepidemiology & Pharmacoeconomics;Asst Professor, Brigham and Women's Hospital and Harvard Medical School

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA

David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →

Jeremy Rassen

President and Chief Science Officer, Aetion

Jessica Franklin

Assistant Professor of Medicine, Div of Pharmacoepidemiology and Pharmacoeconomi, Brigham and Women's Hospital and Harvard Medical School

Brande Yaist

Senior Director, Global Patient Outcomes & Real World Evidence, Eli Lilly and Company

Mrs. Yaist is the Senior Director of the Center of Expertise in Global Patient Outcomes and Real World Evidence at Eli Lilly and Company. She leads and develops the research talent and capabilities needed to provide scientific services/expertise and support across an array of core... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Level Intermediate
Featured Topics Regulator Thinking, Innovative Trial Design
Featured Topics Real World Evidence
Credit Type ACPE, CME, IACET, RN
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10:30am

#243: The Future of Combination Products in the EU

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-609-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will focus on the applicability of the new European Medical Device Regulation (EU-MDR) on 26 March 2020. Implications and challenges of the new legal requirements and technical provisions for drug-device combination products will be discussed from the perspective of regulators, industry and patients.

Learning Objectives

Describe the complexity and consequences of the new EU Medical Device Regulation for drug-device combination products; Identify the challenges of the new requirements for industry, regulators, and Notified Bodies (NB) e.g. new designation process of Notified Bodies and competent staff, accountability, new technical requirements etc; Describe the challenges against patients' expectations and join the discussion.

Chair

Maren von Fritschen, PharmD

Speaker

EMA Perspective
Zahra Hanaizi, PharmD, MPharm

Industry Perspective
Trine B. Moulvad, MSc

Patient Perspective
Nicholas Brooke, MBA

Speakers

Maren von Fritschen

Managing Director, Addon Pharma

Maren von Fritschen, PhD has been working for a variety of pharmaceutical/MedTech companies SMEs /Start-ups and global entities for 20+ years. She is Managing Director at AddOn Pharma (Regulatory Affairs, Intelligence, Policy), Professor at the University of Applied Sciences, Berlin... Read More →

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)

Trine Moulvad

Vice President, Regulatory, Medical Writing and Pharmacovigilance, Zealand Pharma

Trine Moulvad has an MSc from University of Copenhagen, Denmark. She is an all-round experienced drug developer and leader with more than 25 years of experience within the pharmaceutical industry. She previously worked at Eli Lilly, Ferring and Novo Nordisk in global Regulatory leadership... Read More →

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), The Synergist.org

Nicholas Brooke is Founder of The Synergist, a collaboration platform incubator that brings key players together with the express aim of solving significant societal problems through collective action. Under Nicholas’ leadership, The Synergist acts as a backbone, providing vision... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Credit Type ACPE, CME, IACET, RN
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10:30am

#244: Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-607-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, panelists will discuss how to define quality on patient relevance rather than on ever-tightening process and analytical capabilities that can reduce efficiency and limit patient access to drugs.

Learning Objectives

Identify purpose-driven as opposed to process-driven approaches to establishing specifications; Define how to apply toxicological concepts to manufacturing process parameters; Describe how to justify more robust design spaces.

Chair

Bowman Cox

Speaker

Panelist
Nina S. Cauchon, PhD, RAC

Panelist
Sarah Pope Miksinski, PhD

Panelist
Eric Jayjock, PhD

Panelist
Geoffrey Wu, PhD

Panelist
Paul Seo, PhD

Panelist
Christine M. V. Moore, PhD

Speakers

Nina Cauchon

Director Regulatory Affairs CMC, Amgen

Bowman Cox

Executive Editor, Manufacturing, Informa Pharma Intelligence

Bowman Cox leads Informa's coverage of pharmaceutical manufacturing. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to manufacturers and their quality organizations. Bowman has followed various energy... Read More →

Eric Jayjock

Director, Continuous Manufacturing, Patheon, A Part of Thermo Fisher Scientific

Eric Jayjock performed his graduate studies at Rutgers University where he was a part of the NSF Center for Structured Organic Particulate (C-SOPS) systems. During his time at Rutgers, one of his main areas of research was the development of scalable manufacturing processes for oral... Read More →

Paul Seo

Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

Paul has worked for the FDA 15 years, and has gained experience in the Office of Generic Drugs, Office of Pharmaceutical Science, and Office of New Drug Quality Assessment. He currently oversees review processes in the Division of Biopharmaceutics, Office of New Drug Products, as... Read More →

Geoffrey Wu

Associate Director for Science and Communication, OLDP, O