DIA 2019 Global Annual Meeting: Full Schedule

9:00am PDT

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

Vice President, Center for Observational Research, Amgen, United States

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →

Nancy Dreyer

Chief Scientific Officer & SVP, IQVIA, United States

Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA Real World Solutions and Adjunct Professor of Epidemiology at Univ of N Carolina at Chapel Hill. She leads the IQVIA Center for Advanced Evidence Generation and is a fellow of both the International Society for Pharmacoepidemiology... 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 PDT
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 PDT

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

Head of Safety Statistics, Global Vaccine Safety, Novavax, Inc., United States

Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists... Read More →

Jacqueline Corrigan-Curay

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States

Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications... Read More →

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →

James Buchanan

President, Covilance LLC, United States

Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →

Sunday June 23, 2019 9:00am - 5:00pm PDT
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 PDT

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, Epidemiology, Janssen Research & Development, LLC, United States

Rachael L. DiSantostefano, MS PhD, is a Senior Director 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 health outcomes... 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, United States

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

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 PDT
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

1:30pm PDT

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, United States

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 and biologic product safety and effectiveness using Real World... Read More →

Shaun Comfort

Principal Science Enablement Director, Genentech, A Member of the Roche Group, United States

Dr. Comfort is a Principle Scientific Enablement Director for Roche in Science Enablement and Processes, leading innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 20 years combined biopharma industry/regulatory experience. Dr. Comfort’s current... 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

Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom

Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries... Read More →

Sunday June 23, 2019 1:30pm - 5:00pm PDT
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 PDT

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

President, Covilance LLC, United States

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 PDT
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

11:00am PDT

#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, United States

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

Vice President, Epidemiology, RTI Health Solutions, United States

Alicia Gilsenan, PhD, is Vice President, 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 in 1997, she... 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 PDT
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 PDT

#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, United Kingdom

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 (EURORDIS), France

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also... 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 PDT
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

12:15pm PDT

#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, United States

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 PDT
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

Tags Workshop

1:00pm PDT

#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 PDT
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

Tags Workshop

2:15pm PDT

#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 PDT
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 PDT

#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

Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom

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 PDT
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 PDT

#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 PDT
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
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3:30pm PDT

#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

President, Head of PV Coordination, CIOMS and APHP

Herve Le Louet is Professor of Clinical Pharmacology. He is currently head of Pharmacovigilance department of Paris University Hospitals (AP-HP). He is an hepatologist by training and has a PhD in Pharmacogenetic from the Paris University. He is the President of CIOMS and immediate... Read More →

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... 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 →

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA , United States

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 PDT
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 PDT

#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, United Kingdom

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 PDT
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 PDT

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 PDT
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

Networking-CommunityEvents, Forum | 01: ClinSafety-PV, Forum

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8:00am PDT

#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, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... 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 PDT
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
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8:00am PDT

#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 PDT
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 PDT

#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 & Regulatory Review, WCG

Steven Beales is the SVP of Safety Reporting 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 CRO companies... 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

Vice President - R&D Business Development and Sales, Deloitte, United States

Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design... 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 →

Tuesday June 25, 2019 8:00am - 9:15am PDT
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
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9:30am PDT

#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

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

Tuesday June 25, 2019 9:30am - 10:30am PDT
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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10:30am PDT

#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 PDT
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 PDT

#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, United States

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 PDT
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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2:00pm PDT

#254.1 RT: Round Table Discussion: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI

Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to the session #154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Meredith Smith, Marc Boutin, Herve Le Louet, Theresa Mullin, Kerry-Leeson-Beevers.

Chair

Judith Zander, MD

Speakers

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA , United States

Tuesday June 25, 2019 2:00pm - 3:00pm PDT
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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2:00pm PDT

#255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-610-L04-P; CME 1.25; IACET 1.25; RN 1.25

Machine Learning is one approach in the fast-paced field of artificial intelligence that is positioned to address many key issues in pharmacovigilance. However, it presents several challenges which must be addressed by both industry and regulators. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 3:15-4:15PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Review updated developments in machine learning in PV; Discuss risks and challenges; Describe updates on regulatory landscape and areas of future development and collaboration.

Chair

Bruce Donzanti, PhD

Speaker

Chapter Two: Implementing Automation, Machine Learning, and Analytics in Pharmacovigilance - Case Study
Lisa George, RPh

FDA Perspective
Robert Ball, MD, MPH, MSc

MHRA Perspective
Mick Foy

Speakers

Robert Ball

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

Bruce Donzanti

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

Mick Foy

Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom

Lisa George

Advisor, Global Patient Safety, Case Management, Eli Lilly and Company

Lisa George has a B.S. in Pharmacy from Butler University, Indianapolis IN. Lisa started in the pharmaceutical industry in 1998 with Eli Lilly and Company's Global Patient Safety (GPS) department. During her time in GPS, she has worked with case management in various capacities. Lisa... Read More →

Tuesday June 25, 2019 2:00pm - 3:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Level Intermediate
Featured Topics Artificial Intelligence, Regulator Thinking, Patient Focused, Innovative Trial Design
Featured Topics Artificial Intelligence,Regulator Thinking,Patient Focused,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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2:00pm PDT

#264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

The development of immuno-oncology products has spanned decades, culminating in approvals for the use of immune modulating cytokines, monoclonal antibodies, fusion proteins, genetically modified T cells, cancer vaccines and oncolytic vectors, for the treatment of cancer. Currently there are hundreds of immuno-oncology products in clinical trials.

This session will provide an overview of immuno-oncology products, highlighting the relevant preclinical safety regulations and potential safety concerns ascribed to different categories of products. Preclinical development challenges, such as, selecting the relevant pharmacology and toxicology models, distinguishing pharmacologic from toxicologic responses, and justifying first in human dose, will be discussed. Case examples highlighting the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology drugs will also be presented.

Learning Objectives

Describe immuno-oncology products, including the potential safety concerns ascribed to different immunotherapeutic modalities; Identify the regulatory requirements (and/or challenges) associated with preclinical safety evaluation for different modalities of immuno-oncology drugs; Discuss the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology products through case study presentations.

Chair

Laurie Iciek, PhD

Speaker

New Challenges for Developing HER2-Targeted Cancer Immunotherapeutics
Karin Staflin, PhD

Strategies for Preclinical Safety Assessment of Immune-Oncology Biologics
Simone Nicholson, PhD

Challenges in Predicting Animal-to-Human Safety for Immune-Stimulatory Agents from Toxicology Studies
Theresa Sweeney, PhD

Speakers

Laurie Iciek

Senior Consultant, Nonclinical, Biologics Consulting

Laurie is currently a Sr. Nonclinical Consultant for Biologics Consulting. Previously she spent 17 years in industry as a lead Toxicologist for MedImmune/AstraZeneca, Abbott Laboratories, and Bristol-Myers Squibb. Her academic training is in cellular and molecular immunology and her... Read More →

Simone Nicholson

Toxicologist, AstraZeneca

Simone is a Toxicologist at MedImmune/AstraZeneca, she supports the safety assessment of multiple biologics modalities at all stages of development. Prior to her time at MedImmune, Simone performed in vivo pharmacology and safety studies at Dyax, the antibody library company. She... Read More →

Karin Staflin

Senior Scientist, Genentech, A Member of the Roche Group

Dr. Karin Staflin, PhD., DABT., is a Development Toxicologist within the Safety Assessment Group at Genentech. She is responsible for the safety assessment of early- to late-stage large and small molecule therapeutics, within a range of disease areas. Before joining the Development... Read More →

Theresa Sweeney

Vice President, Safety Assessment, Nektar Therapeutics

Dr. Sweeney is currently the Vice President of Safety Assessment at Nektar Therapeutics where she leads a team responsible for evaluating the safety of both large and small molecule drugs. She has more than 25 years of drug development experience at Nektar and Genentech. Her professional... Read More →

Tuesday June 25, 2019 2:00pm - 3:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

Level Intermediate
Featured Topics Regulator Thinking, Patient Focused, Advanced Therapies
Featured Topics Regulator Thinking,Rare Disease
Credit Type ACPE, CME, IACET, RN
Tags Session

3:15pm PDT

#276 RT: Round Table Discussion: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration

Component Type: Session
Level: Basic

Round table discussion tied to session #202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration (Tuesday, June 25, 8:00-9:15AM). Seating is limited. To include special guests from the session: Songlin Xue, Michael Forstner, Jose Vega, Paul Chang.

Chair

Jill Notte

Speakers

Jill Notte

Associate Director - Marketing, Cognizant

Tuesday June 25, 2019 3:15pm - 4:15pm PDT
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

Tags Session

4:15pm PDT

#281: Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-627-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will convene experts from the regulatory authority, payer, industry, and patient communities to discuss how a new type of strategic “quality by design” framework for drug development.

Learning Objectives

Describe a comprehensive framework for evidence generation to support optimal drug development and more efficient pathways to product approval; Identify pragmatic approaches for integrating this framework into regulatory authority and pharmaceutical company organizational structures.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

SEPPE Framework and Implications for Regulators
Robyn R. Lim, PhD

Implications for Patients
Marc M. Boutin, JD

Pragmatic Lessons Learned from Implenting Within a Pharmaceutical Company
Meredith Y. Smith, PhD, MPA

EMA Perspective
Anthony Humphreys, MPharm

Speakers

Marc Boutin

Chief Executive Officer, National Health Council (NHC)

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 →

Robyn Lim

Senior Science Advisor, Health Products and Food Branch, Health Canada

Dr Lim’s focus is modernizing Canada’s federal drug regulatory system, developing the benefit-harm-uncertainty evidence standard for Canada’s amended Food and Drugs Act. Her interests are scientifically and socially-responsible patient-focussed and life-cycle approaches for... Read More →

Meredith Smith

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

Tuesday June 25, 2019 4:15pm - 5:30pm PDT
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, Innovative Trial Design, What's Next
Featured Topics Regulator Thinking,Patient Focused,Innovative Trial Design,What's Next
Credit Type ACPE, CME, IACET, RN
Tags Forum

4:15pm PDT

#282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-628-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum-style enquiry session is designed as a panel discussion driven by audience participation. Speakers will present prepared summary comments on effective communication of safety and risk concepts in reference safety information (RSI). These short, introductory statements will prepare the audience for discussion of the evolving product labeling landscape, using Japan and Asia as examples. Additional comments will describe the existing regulatory guidance from Canada, the EU, and the US that supports simplification of suspected adverse reactions in RSI. To facilitate convergence of several independent efforts aimed at grouping near-synonymous medical concepts, CIOMS has formed an exploratory working group to assess the feasibility of developing internationally harmonized consensus principles for “MedDRA® Labeling Groupings” (MLGs). If developed, these principles could be available for consideration when the existing MedDRA hierarchy does not support the desired groupings. Practical examples of current challenges will be discussed in the context of enhancing understandability of medical concepts by the health care community. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe regional safety labeling requirements in Japan and Asia and their international implications (for the benefit of patients); Identify existing regulatory guidance that supports simplification of RSI; Define practical examples of medical concepts that are nearly synonymous from a clinical perspective and which might be appropriate candidates for application of MLGs; Explain the new CIOMS initiative that is exploring feasibility of developing principles for MLGs.

Chair

Judith Jones

Speaker

Dynamic Trends for Value and Meaningful Product Safety Labeling in Asia, Including Japan
Rie Matsui, RPh

A Perspicacious CIOMS View of a Sometimes Tangled Mass of Adverse Reaction Communication Challenges
William Gregory, PhD

MedDRA Labeling Groupings (MLGs): A New CIOMS Initiative
Sonja Brajovic, MD

MedDRA Labeling Groupings (MLGs): Practical Examples Underscore Feasibility
Ilona Grosse-Michaelis, MD, PharmD

Speakers

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc

Judith Jones

Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management, PharmaLex

Dr. Jones is a clinical pharmacologist/pharmacoepidemiologist trained in geriatrics and internal medicine with a longstanding interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College... Read More →

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer Inc, Japan

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates... Read More →

Sonja Brajovic

Medical Officer, OSE, CDER, FDA

Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities... Read More →

Ilona Grosse-Michaelis

Senior Medical Dictionary Expert, Bayer AG

Dr. Große-Michaelis is a clinical pharmacologist trained in internal medicine and pharmacology/ toxicology with a longstanding interest in the risk-benefit profile of drugs, and drug development. She obtained her medical degree from the Humboldt University of Berlin, Germany. The... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

4:15pm PDT

#298: Clinical Safety Assessment: What’s a Statistician Got to Do with It?

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-637-L04-P; CME 1.25; IACET 1.25; RN 1.25

Statistical attention to safety data is often times left to routine, basic calculations and tabulations. Absent statistical input, the data run the risk of being presented in ways that are unintuitive, uninformative, or in the worst case, deceptive. Speakers in this session will present examples where statisticians are collaborating with clinical colleagues and data scientists to more effectively analyze and clinically interpret safety data.

Learning Objectives

Recognize the importance of statistical engagement in the assessment of clinical trial safety data; Apply appropriate statistical methods in the analysis of safety data; Identify the need to work collaboratively with clinicians and data scientists.

Chair

Mat Soukup, PhD

Speaker

Improving Analyses and Displays for Clinical Trial Safety Data
Mary Nilsson, MS

ASA/DIA Safety WG Presents: Finding Safety Signals During Clinical Development with R Shiny
Susan Duke, MSc

FDA Perspective
Matthew Guerra, PhD

Speakers

Susan Mayo

Senior Mathematical Statistician, CDER Office of Biostatistics, FDA, United States

After many years as an industry statistician, Susan joined FDA in 2018 and is now a Senior Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. Susan’s interests in estimands, safety and benefit-risk assessment, and graphics have... Read More →

Matthew Guerra

Mathematical Statistician, OB, OTS, CDER, FDA

Matthew is a senior statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Matthew joined the FDA in 2011 immediately after receiving his Ph.D. in Biostatistics from the University of... Read More →

Mary Nilsson

Researcher, Safety Analytics Group, Eli Lilly and Company, United States

Mary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function. She consults with compound teams on safety analysis planning... Read More →

Mat Soukup

Deputy Director, Division of Biometrics VII, OB, OTS CDER, FDA, United States

Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm PDT
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Session | 01: ClinSafety-PV, Session | 02: ClinTrials -ClinOps, Session

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

8:00am PDT

#302: Triple-s (3S) Smart Safety Surveillance

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-682-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will inform attendees about the 3S project. Funded by the Bill and Melinda Gates the WHO are working with low and middle income countries with a high disease burden in specific areas that are subject to new treatments to increase their pharmacovigilance capabilities. MHRA are collaborating in the project to ensure regulatory pharmacovigilance capacity is increased to collect, analyse and act on safety data.

Learning Objectives

Describe the rationale for 3S; Discuss how industry is key to the success of PV in low and middle income countries; Identify the need for robust regulatory frameworks for PV.

Chair

Mick Foy

Speaker

Smart Safety Surveillance (TripleS)- Pharmacovigilance Strengthening in Low- to Middle-Income Countries (LMIC)
Raj Long, MEd, MSc

Panelist
Andrea Best, DO, MPH

Speakers

Andrea Best

Executive Medical Director, AbbVie, Inc.

Mick Foy

Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom

Raj Long

Deputy Director, Safety and Pharmacovigilance, Bill and Melinda Gates Foundation, United Kingdom

Raj is currently a Senior Regulatory Officer at the Bill & Melinda Gates Foundation (BMGF) responsible for Malaria and Neglected Diseases medicines portfolio. In 2014 Raj was invited by the UK Secretary of State to be a member to the World Dementia Council (WDC) she is also appointed... Read More →

Wednesday June 26, 2019 8:00am - 9:15am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

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

8:00am PDT

#301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-646-L04-P; CME 1.25; IACET 1.25; RN 1.25

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?

Learning Objectives

Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson

Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE

EMA Perspective
Douwe Postmus, PhD, MSc

Speakers

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands

Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →

Meredith Smith

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

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States

Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Staff (DSAS) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and... Read More →

Wednesday June 26, 2019 8:00am - 9:15am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

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

10:30am PDT

#327: Digital Risk Minimization: The “Next Generation” Risk Management Tools

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-664-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe the process of conceptualizing, implementing, and evaluating digital risk minimization tools, using several real world examples. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 4:15-5:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the process of developing a digital risk minimization tool; Outline considerations for the effective implementation and evaluation of a digital risk minimization tool.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Leveraging Digital for Effective Risk Minimization Tools: Operational and Policy Considerations
Simon Ingate, PhD, MBA

One Company's Perspective on Implementing Digital Risk Minimization Tools Globally
Sarah A. Frise, PhD, MS

Applying the Diffusion of Innovaton Theory Framework to the Implementation of Innovative Digital Risk Minimization Measures
Carmit Strauss, PharmD

Speakers

Simon Ingate

Director, Huron Consulting Group

Simon Ingate is a Principal Consultant at Huron Consulting Group (Formerly Pope Woodhead) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures... Read More →

Meredith Smith

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

Carmit Strauss

Global Benefit Risk Management Scientist, Safety Management, Amgen Inc.

Carmit Strauss, PharmD, is currently a Benefit Risk Management Scientist at Amgen. Dr. Strauss obtained her PharmD at the University of Southern California and completed her industry Post-Doctoral fellowship in medical affairs at Baxter Bioscience. Dr. Strauss has a global medical... Read More →

Sarah Frise

Global Director Risk Management, AstraZeneca

Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Director, Risk Management at AstraZeneca and a faculty position in Epidemiology at the University of Toronto. She is an active member of many Pharmacovigilance working groups... Read More →

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

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

10:30am PDT

#336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-678-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug scheduling is implemented by regulatory agencies to mitigate the risk of drug abuse. Learn about the pivotal clinical studies required to evaluate the abuse and dependence potential of CNS-active drugs and the evolving regulatory requirements.

Learning Objectives

Describe the most recent FDA recommendations for the clinical evaluation of abuse and physical dependence of CNS-active drugs; Discuss how this data is used to determine drug scheduling and the implications of controlled substances;Evaluate the best strategies to design robust abuse/dependence potential clinical trials.

Chair

Beatrice Setnik, PhD

Speaker

Panelist
Jack Henningfield, PhD

Panelist
Beatrice Setnik, PhD

Speakers

Jack Henningfield

Vice President, Research, Health Policy, and Abuse Liabiliy, Pinney Associates

Professor Adjunct, Johns Hopkins School of Medicine, past chief Abuse Potential and Clinical Pharmacology, NIDA. 400+ articles and books related to drug abuse & regulation, public health, and neuropharmacology. My PinneyAssociates focus is on drug development, risk management, and... Read More →

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health

Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

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

12:45pm PDT

#351 RT: Round Table Discussion: An Industry Collaboration on Pharmacovigilance Analytics

Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #229: An Industry Collaboration on Pharmacovigilance Analytics (Tuesday, June 25, 10:30-11:30AM). Seating is limited.

Chair

Jill Notte

Speakers

Jill Notte

Associate Director - Marketing, Cognizant

Wednesday June 26, 2019 12:45pm - 1:45pm PDT
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

Tags Session

2:00pm PDT

#375.1 RT: Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions

Component Type: Session
Level: Basic

Join DIA Clinical Safety and Pharmacovigilance Community for a round table discussion tied to the session #282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions (Tuesday, June 25, 4:15-5:30PM). Seating is limited.

Chair

Judith Jones

Speakers

Judith Jones

Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management, PharmaLex

Wednesday June 26, 2019 2:00pm - 3:00pm PDT
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Community Rounds, Session | 01: ClinSafety-PV, Session

Tags Session

2:00pm PDT

#355: History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-683-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks when used in real-world settings. Today, there are approximately 75 active REMS programs. This forum will discuss the evolution of risk management in the U.S. culminating with the inception and implementation of REMS. Presentations by speakers from FDA, industry, and academia will discuss FDA Guidance to Industry; how REMS are being operationalized and integrated into the healthcare system; FDA’s framework for benefit-risk counseling to patients about drug’s with a REMS; and pragmatic approaches from implementation science for informing REMS design and assessment. Interactive audience engagement will occur throughout the forum to stimulate dialogue on implications for advancing risk management science and practice. Discussion questions will include: What areas for further risk management guidance development are you most interested in? and why? What opportunities do you see for further integrating REMS into the healthcare system? What challenges, or barriers, have you experienced when implementing patient-counseling frameworks? How have you overcome them? What ideas do you have for further advancing the science of REMS?

Learning Objectives

Describe the evolution of FDA risk management guidance and implementation of REMS over the past decade; Discuss challenges and solutions for operationalizing risk management frameworks and guidance and integrating REMS into the healthcare system; Identify pragmatic scientific approaches for ensuring pre- and post-market continuity in safety management planning and execution.

Chair

Elaine Morrato, DrPH, MPH

Speaker

Evolution of Risk Management and FDA’s Regulatory Guidance
Cynthia LaCivita, PharmD

Opportunities for Integrating REMS into the Healthcare System
Gita Toyserkani, PharmD, MBA

The FDA’s New Benefit-Risk Counseling Framework: How Do Manufacturers Operationalize It?
Hilda Wiryawan Chan, MD, PhD, MPH

Application of Implementation Science for REMS Design and Assessment
Elaine Morrato, DrPH, MPH

Speakers

Hilda Chan

Benefit Risk Management Scientist, Amgen

Hilda Chan, MD, MPH, PhD is a Benefit-Risk Management Scientist in the Global Patient Safety, Labeling, and Pediatrics department at Amgen Inc. Her primary responsibilities include leading teams in conducting structured benefit-risk assessments for products in the therapeutic areas... Read More →

Cynthia LaCivita

Director, Division of Risk Management, OMEPRM, OSE, CDER, FDA, United States

Cynthia LaCivita earned her undergraduate degree in microbiology and Doctor of Pharmacy from the University of Maryland (U of MD) and completed an oncology residency at the University of Maryland Cancer Center (UMCC). She was an assistant professor in the Department of Pharmacy Practice... Read More →

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health

Elaine Morrato, DrPH MPH is a Professor in Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into practice, and she has contributed her... Read More →

Gita Toyserkani

Associate Director, Research & Strategic Initiatives, FDA

Gita A. Toyserkani, PharmD, MBA, is the Associate Director for Research and Strategic Initiatives in the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology. She has over 15 years of experience in drug safety and advises on pre and post-marketing activities... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

2:00pm PDT

#356: Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing?

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-732-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore the state-of-the-science in regard to patient involvement in benefit-risk communication for medicinal products. Interactive audience engagement will occur throughout the session to stimulate dialogue on implications for advancing the science and practice in this area. Questions will include: • What steps are regulators taking to involve patients in benefit-risk communication? • What new tools are being developed to educate patients about the benefits and risks of drugs, and how effective are they? • What are the current challenges and barriers that impede greater patient involvement in benefit-risk communication of medicinal products? How can they be addressed? • What are promising avenues for further advancing the science of patient involvement in benefit-risk communication?

Learning Objectives

Describe the state-of-the-science in terms of patient involvement in benefit-risk communication of pharmaceutical products; Discuss challenges and solutions for enhancing patient involvement in benefit-risk communication and for improving how such information is provided to them; Identify pragmatic scientific approaches for enhancing patient involvement in benefit-risk communication and the role of new types of interactive digital educational tools for patients.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Trends in the Use of Interactive Digital Tools to Educate Patients Regarding Safe and Appropriate Use of Drugs: What Has Been Learned to Date?
Meredith Y. Smith, PhD, MPA

Patient Engagement in Pharmacovigilance and Benefit-Risk Communication: Update from EMA
Tânia Teixeira, PharmD

Involving Patients in Benefit-Risk Communication: What are the Opportunities? What are the Challenges?
Marc M. Boutin, JD

Speakers

Marc Boutin

Chief Executive Officer, National Health Council (NHC)

Meredith Smith

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

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 →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

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

3:15pm PDT

#377 RT: Round Table Discussion: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance

Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bruce Donzanti.

Chair

Jill Notte

Speakers

Jill Notte

Associate Director - Marketing, Cognizant

Wednesday June 26, 2019 3:15pm - 4:15pm PDT
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

Tags Session

4:15pm PDT

#379: From Trials to Real World: How Safety Protocols Impact REMS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-700-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will present the approach for evaluation of interventions and/or protocol amendments in trials, and how these interventions impact the determination of the need for a REMS, and its design. Presentation will use an approved REMS.

Learning Objectives

Describe how safety interventions/trial protocol modifications are evaluated to ensure pre- and post-market continuity in safety management planning and the need for a REMS; Discuss evaluation of safety interventions in trials and their impact on REMS design; Discuss an example of the evaluation of trial protocol modifications and safety intervention considerations effecting an approved REMS.

Chair

Jamie Wilkins, PharmD

Speaker

Panelist
James Nickas, PharmD

Panelist
Christine Brown, MS

Moderator
Elaine Morrato, DrPH, MPH

Speakers

Christine Brown

Executive Director, National PKU Alliance

Christine Brown is the first Executive Director of the National PKU Alliance, a non-profit organization working to improve the lives of individuals with PKU and pursue a cure. Christine has more than 30 years of experience in building and leading non-profit organizations at the local... Read More →

James Nickas

Vice President, Pharmacovigilance and Clinical Medical Writing, Biomarin

James (Jim) Nickas is currently Vice President of Pharmacovigilance & Clinical Medical Writing at BioMarin in San Rafael, California. He joined the company in October 2010 bringing with him 12 years of academic experience at UCLA Medical Center and 18 years of drug development and... Read More →

Jamie Wilkins

Deputy Director, Division of Risk Management, OSE, CDER, FDA

Jamie Wilkins, Pharm.D. is the Deputy Director for the Division of Risk Management (DRISK) in the Office of Surveillance and Epidemiology (OSE) in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA). DRISK provides risk management expertise on development... Read More →

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health

Wednesday June 26, 2019 4:15pm - 5:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum | 02: ClinTrials -ClinOps, Forum

Level Intermediate
Featured Topics Regulator Thinking, Patient Focused, Innovative Trial Design
Featured Topics Regulator Thinking,Patient Focused,Innovative Trial Design
Credit Type ACPE, CME, IACET, RN
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4:15pm PDT

#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.

Chair

Matt Baldwin, MS

Speaker

Facilitator
Stephen Corson, PhD

Facilitator
Munish Mehra

Speakers

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA), United States

Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →

Stephen Corson

Associate Director, Statistics and Technical Solutions, Phastar

I am a Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of Mathematics... Read More →

Munish Mehra

Senior Principal Biostatistician and Executive Director Biometrics, Tigermed, United States

Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm PDT
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics, Workshop | 01: ClinSafety-PV, Workshop | 02: ClinTrials -ClinOps, Workshop | 03: Data-Data Standards, Workshop

Level Beginner
Featured Topics Student Programming
Credit Type ACPE, CME, IACET, RN
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4:30pm PDT

#398 RT: Round Table Discussion: Digital Risk Minimization: The “Next Generation” Risk Management Tools

Component Type: Session
Level: Basic

Round table discussion tied to session #327: Digital Risk Minimization: The “Next Generation” Risk Management Tools (Wednesday, June 26, 10:30-11:45AM). Seating is limited. To include special guest from the session: Carmit Strauss, Simon Ingate, Meredith Smith.

Chair

Karen Ward, MS

Wednesday June 26, 2019 4:30pm - 5:30pm PDT
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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8:30am PDT

#402 CH: Manage Risks and Enhance Engagement Through Digital Approaches

Component Type: Workshop
Level: Intermediate

Even now, most risk minimization programs are paper based, though digital communication is used in all aspects of our lives. Digital channels provide a more engaging and effective educational experience through dynamic presentation and interactivity

Learning Objectives

Describe where digital approaches can be used to achieve better engagement in risk management outreach; Discuss what lessons can be learned from current projects through case studies; Determine top priority changes in people, process or tech to enable a move to digital in their own organizations.

Chair

Mark Perrott, PhD

Speakers

Mark Perrott

Head of Development Consulting, Huron Life Sciences

Mark is Head of Development Consulting at Huron Consulting Group where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined Huron in November 2016 and his >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and... Read More →

Thursday June 27, 2019 8:30am - 9:00am PDT
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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9:00am PDT

#403: Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-718-L04-P; CME 1.25; IACET 1.25; RN 1.25

With the advent of biosimilars on a global scale and thus the introduction of multi-source biological products, the importance of accurate pharmacovigilance and unique product traceability cannot be understated. Not only do these efforts support detection of adverse drug reactions, they give confidence to providers and patients in the safe and appropriate use of these medicines. Various approaches have been taken in attempts to facilitate unique product traceability and improve risk minimization.

This session will focus on some of these approaches and their effectiveness and will highlight the role of National Regulatory Authorities and evolving technology infrastructure to improve traceability and enable global harmonization in these approaches.

Learning Objectives

Describe the current state of pharmacovigilance efforts for biological products in various regions; Identify different approaches to unique product traceability and determine their effectiveness; Discuss how to help to identify opportunities for global harmonization to facilitate unique product identification.

Chair

Brad Jordan, PhD

Speaker

Analysis of Biosimilars Approved in EU and US: Insights into Risk Minimization Strategies
Kalindi Hapani, MPharm

Biosimilars: Should They Have a ‘Similar’ System to the Originator?
Brian Edwards, DrMed

FDA Perspective
Lubna Merchant, PharmD, MS

Biologic and Biosimilar Nomenclature: How Important is Distinguishability and International Harmonization?
Philip J Schneider, MS, RPh

Speakers

Brian Edwards

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

Kalindi Hapani

Assistant Manager, Pharmacovigilance, APCER Life Sciences

Kalindi is a Registered Pharmacist, having done Masters in Pharmacy. With stint as Lecturer for initial years (4 years in academics), she pursued Post Graduate Diploma in Clinical Research and Pharmacovigilance. She has 10 years of global experience with 6 years concentrated in pharmacovigilance... Read More →

Brad Jordan

Director, Global Regulatory and R&D Policy, Amgen

Dr. Brad Jordan is a Director of Global Regulatory and R&D Policy at Amgen where his role focuses on global technical regulatory policy relating to biologics and biosimilars. Dr. Jordan joined Amgen in 2006, and prior to his role in Policy, spent 10 years in the Discovery Research... Read More →

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER, FDA

Philip Schneider

Chair, Advisory Board, Alliance for Safe Biologic Medicines, United States

Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →

Thursday June 27, 2019 9:00am - 10:15am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Level Intermediate
Featured Topics Generics
Featured Topics Generics
Credit Type ACPE, CME, IACET, RN
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9:00am PDT

#410: Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-724-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA currently uses a structured, qualitative framework for benefit-risk assessment of human drugs and biologics. This session will cover FDA’s efforts to enhance this qualitative framework and explore more advanced benefit-risk assessment methods.

Learning Objectives

Describe FDA’s approach to benefit-risk assessment under PDUFA V and VI; Discuss efforts to continue enhancing FDA’s methodological approach to benefit-risk assessment; Summarize findings from analysis of BRFs in 2017 novel drug approvals.

Chair

Graham Thompson

Speaker

Implementation of a Structured Benefit-Risk Framework into FDA's Human Drug Review
Leila Grace Lackey, MHS, PhD

CBER’s Experience with Benefit-Risk
Hong Yang, PhD

Planning and Assessing Benefit-Risk Quantitatively in the Next Decade
Susan Duke, MSc

Best Practices for Quantitative Benefit-Risk Assessments
Tommi Tervonen

Speakers

Susan Mayo

Senior Mathematical Statistician, CDER Office of Biostatistics, FDA, United States

Leila Lackey

Program Lead, Decision Support Service, OPSA, OSP, CDER, FDA, United States

Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Professionally, she has worked for the Environmental Protection Agency and for the Food and Drug Administration leading... Read More →

Tommi Tervonen

Research Scientist, Evidera, PPD

Tommi Tervonen, PhD, is an Associate Director of Patient Preferences and Research Scientist at the Patient-Centered Research team of Evidera in London, UK. Dr. Tervonen joined Evidera in September 2015 after leaving his position of Assistant Professor at the Erasmus School of Economics... Read More →

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States

Hong Yang

Biologist, OBPV, CBER, FDA, United States

Dr. Hong Yang is a senior advisor for benefit-risk assessment in OBPV/CBER/FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products and Modeling and Simulation to inform drug development. She has been devoted in... Read More →

Thursday June 27, 2019 9:00am - 10:15am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

Level Intermediate
Featured Topics Precision Medicine, Advanced Therapies, Rare Disease, Innovative Trial Design
Featured Topics Regulator Thinking
Credit Type ACPE, CME, IACET, RN
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