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02: ClinTrials -ClinOps [clear filter]
Sunday, June 23
 

9:00am

SC27: #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-507-L04-P; CME 3.25; IACET 3.25; RN 3.25

Evidence suggests that capturing clinical outcome assessment data electronically (eCOA) has many benefits over paper. However, barriers to adoption still remain. Poor adoption is in part attributable to unfamiliarity with benefits, but also poor experiences during study start-up, absence of clear expectations among sponsors and vendors, and misalignment among all stakeholders. This is also an area where no formal training exists for sponsors or eCOA providers. This short course is designed to introduce participants to key eCOA topics including:
  • Benefits of and barriers to eCOA adoption
  • Regulatory guidance applicable to eCOA vendors
  • Key measurement science and design principles applicable when using eCOA
  • Considerations when choosing a solution for your study based on study design and patient population
  • Start-up processes and considerations for migrating from paper to electronic modes of data collection, developing specification documents, and conducting user acceptance testing
  • Role of sponsors and sites in the trial technology implementation process and in optimizing quality of data collected with eCOA
  • Best practice recommendations for training site staff and study subjects on eCOA data collection in clinical trials
  • Considerations for the use of bring your own device (BYOD) in clinical trials
The interactive short course, created in collaboration with the Critical Path Institute’s ePRO Consortium, will provide real world examples and case studies including challenges and proposed solutions for the audience to work through in small groups.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

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

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Review benefits and challenges of capturing eCOA data in clinical trials;
  • Identify measurement science principles applicable to eCOA data capture and considerations for measurement comparability;
  • Discuss roles and responsibilities of eCOA providers, sponsors and sites in the implementation/deployment of clinical trials collecting electronic COA data.



Speakers
avatar for Paul O'Donohoe

Paul O'Donohoe

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

Susan Vallow

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

Patricia DeLong

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


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

9:00am

SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

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

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the risk process;
  • Design a comprehensive quality strategy to manage risk throughout the drug lifecycle and establish Quality Tolerance Limits and Issue Management;
  • Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.



Speakers
avatar for Victoria Burk

Victoria Burk

Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the R&D Quality Assurance director of Combination Products and Medical Devices at AbbVie. She leads a team responsible for Design Quality Assurance and the R&D Combination Product and Device Quality System. Vicki is also the business process owner for the R&D Comprehensive... Read More →
avatar for Kevin Grebner

Kevin Grebner

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

Tim Grey

Director,R&D Quality Systems, AbbVie, Inc.
Tim Grey joined AbbVie in December 2013. He is currently Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product... Read More →


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

1:30pm

SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

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

Who should attend?

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

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
  • Discuss the use of key tools in the RBM process;
  • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.



Speakers
avatar for Barbara Suarez

Barbara Suarez

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

Rodrigo Perez

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


Sunday June 23, 2019 1:30pm - 5:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Monday, June 24
 

10:10am

#102 EE: The Female Perspective on the Clinical Trial Patient Experience: A Live Focus Group
Component Type: Workshop
Level: Basic

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

Learning Objectives

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

Chair

Bonnie A. Brescia


Speakers
avatar for Bonnie Brescia

Bonnie Brescia

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


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

11:00am

#107: Emerging Technologies in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Sonya L. Eremenco, MA

Speaker

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

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

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

EMA Perspective
Anthony Humphreys, MPharm



Speakers
avatar for Bill Byrom

Bill Byrom

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

Sonya Eremenco

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

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 →
avatar for Dina Katabi

Dina Katabi

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

Chris Watson

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


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

11:00am

#108: Innovation in Enrollment, Recruitment, and Retention
Component Type: Session
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-535-L04-P; CME 1.00; IACET 1.00; RN 1.00



Speaker

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

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

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



Speakers
avatar for Paul Ivsin

Paul Ivsin

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

Matthew Kibby

Principal, President, BBK Worldwide
Matt is president and principal of BBK Worldwide, the industry leader in patient recruitment and engagement. Matt leads the company in its commitment to the industry’s adoption of patient-centric recruitment best practices and is a vocal advocate for efforts to enhance the patient... Read More →
avatar for Neil Weisman

Neil Weisman

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

Jennifer Burgess

Executive Director of Engagement, TransCelerate BioPharma Inc.


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

11:00am

#109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-536-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Mark Summers

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Raymond Policare, MPH



Speakers
JS

Jennifer Sheller

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

Mark Summers

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

Raymond Policare

Senior Director, Clinical Operations, PRA


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

11:00am

#118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Yeh-Fong Chen, PhD

Speaker

FDA Update
Aloka Chakravarty, PhD

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

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



Speakers
avatar for Marc Buyse

Marc Buyse

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

Aloka Chakravarty

Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development... Read More →
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Chen is the Acting Associate Director of the Division of Biometrics II within CDER of FDA, supervising reviewers for the Division of Metabolism and Endocrinology Products and Division of Anesthesia, Analgesia, and Addiction Products. She joined FDA in 2000 after receiving her... Read More →
avatar for Stephanie Omokaro

Stephanie Omokaro

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


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

1:15pm

#130 RT: Round Table Discussion: Emerging Technologies in Clinical Research
Component Type: Session
Level: Basic

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

Chair

Keith W. Wenzel


Speakers
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Business Opeartions, Scientific Data Organization, Parexel
Mr. Wenzel holds the position of Senior Director within PAREXEL Informatics’ Solution Incubator, a team that brings innovation to clinical trials. He is responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance... Read More →


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

1:45pm

#132 CH: Advancing Trailblazing Research and Development: When to Speed Up, When to Slow Down
Component Type: Workshop
Level: Intermediate

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

Learning Objectives

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

Chair

Sandy Macrae, PhD


Speakers
avatar for Sandy Macrae

Sandy Macrae

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


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

2:15pm

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Jeremy Rassen, DrSc, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH



Speakers
KB

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 →
NC

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 →
avatar for Jeremy Rassen

Jeremy Rassen

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


Monday June 24, 2019 2:15pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Regulator Thinking,Innovative Trial Design,Generics,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:15pm

#137: Emerging Technology to Improve Sponsor-Site Interactions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-547-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Lisa Bartoli Moneymaker

Speaker

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

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



Speakers
avatar for Johan Chaparro

Johan Chaparro

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

Lisa Moneymaker

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


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

2:15pm

#138: Blockchain in Clinical Trials Demo: Truth or Dare
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Adama Ibrahim, MBA

Speaker

Facilitator
Maria Palombini, MBA

Facilitator
Jim Nasr, MBA

Facilitator
Disa Lee Choun, MBA, RPh

Blockchain
Mathew Rose, MD, MS, MSc



Speakers
avatar for Disa Lee Choun

Disa Lee Choun

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

Adama Ibrahim

Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen
An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion... Read More →
avatar for Jim Nasr

Jim Nasr

Founder, Acoer
avatar for Maria Palombini

Maria Palombini

Life Sciences Practice Lead, Global Business Strategy and Intelligence (GBSI), IEEE-Standards Association
Maria joined IEEE-SA with a directive to build communities and advance initiatives to develop standards for enterprise adoption of emerging technologies. Her area of focus includes research on challenges and opportunities in integrating cutting-edge technologies such as AI, IoT, ML... Read More →
avatar for Jim Nasr

Jim Nasr

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

Mathew Rose

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


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

2:15pm

#139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Meghana Chalasani, MHA

Speaker

FDA Update
Theresa Mullin, PhD

FDA Update
Laura Lee Johnson, PhD

FDA Update
Elektra Johanna Papadopoulos, MD, MPH

Industry Update
Tara Symonds, PhD

Industry Update
Anton Hoos, MD, PhD, MBA



Speakers
avatar for Anton Hoos

Anton Hoos

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

Meghana Chalasani

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

Laura Lee Johnson

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

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
EP

Elektra Papadopoulos

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

Tara Symonds

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


Monday June 24, 2019 2:15pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:15pm

#143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Sherry Leonard, RAC

Speaker

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

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

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



Speakers
PB

Pamela Balcazar

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

Sherry Leonard

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

Lindsay McNair

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


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

2:15pm

#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

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

Learning Objectives

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

Chair

Demi Niforos, MS

Speaker

Summary of Safety Visualization Efforts
William Wang, PhD

Panelist
Nathan Bennett, PhD, MA



Speakers
DN

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 →
avatar for William Wang

William Wang

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


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

3:30pm

#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Chair

Brian Edwards, DrMed

Speaker

Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc



Speakers
NC

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 →
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:30pm

#156: Clinical Research in Emerging Regions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-566-L04-P; CME 1.00; IACET 1.00; RN 1.00

Changing times, technology and a surge in activities in the emerging regions have prompted the global clinical research industry to further enhance capabilities by building capacity and developing talent. Outsourcing services to emerging regions continue to grow especially in the realm of risk based monitoring, data management, clinical trial management and site management. On the scientific arena, innovative research activities in countries like Korea, China, and Singapore to name a few have developed biomedical, biotech and clinical research infra structures with the ultimate goal of attracting big pharma to partner with them to co-develop their discoveries. However, capability, capacity, credibility and overall quality remain to be sticking points.

In this session, current trends, issues, challenges and opportunities will be discussed by experts who work in these emerging regions. Their hope is that by sharing experiences and information the global pharma and biotech industry would have better understanding of the huge opportunities and untapped potential these emerging regions can provide. Join the Good Clinical Practices & Quality Assurance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss the current environment of clinical research in emerging regions; Identify strategic advantages in conducting clinical trials in emerging regions; Identify solutions to challenges in conducting clinical research activities and trial management in these emerging regions.

Chair

Nadina Jose, MD

Speaker

What is the Best Collaborative Model to Deliver Pivotal Clinical Trials in Developing Countries
Asita De Silva, MD, PhD, FRCP

Strategic Inclusion of Regions in Multi-Regional Clinical Trials
Eunyoung Kim, PharmD, PhD

An Integrated Mobile eSource-EDC Solution to Streamline Clinical Trial Data Management for Large Global Trials
Avik Kumar Pal, MBA



Speakers
avatar for Nadina Jose

Nadina Jose

Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative, Rutgers, The State University of New Jersey
Rejoined academia on Oct 2016 and is currently Assistant Professor at Rutgers University, Department of Health Informatics, Biopharma Education Initiative, School of Health Professions MS in Clinical Research Management. Dr. Jose is the Founder and President of Anidan Group Pte. Ltd... Read More →
EK

Eunyoung Kim

Professor, College of Pharmacy, Chungang University
avatar for Avik Pal

Avik Pal

Chief Executive Officer, CliniOps
Avik is the CEO of CliniOps, a mobile, cloud-based, digital solutions company, for the clinical trial industry & global health research. Prior to that, he worked with two successful startups and is a Founding Board member at iKure, a healthcare startup. He is passionate about Global... Read More →
AD

Asita De Silva

Professor of Pharmacology, University of Kelaniya
Professor Asita de Silva has held many positions in academic medicine over the last 25 years. He is a Clinical Pharmacologist, and is currently Senior Professor of Pharmacology at the Faculty of Medicine, University of Kelaniya, Sri Lanka. He is also Director of the Clinical Trials... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-567-L04-P; CME 1.00; IACET 1.00; RN 1.00

Hear how scientists and physicians at Johns Hopkins Medicine in Baltimore and Microsoft collect and tap vast amounts of data from clinical care, genomics, and wearable devices, to better predict disease progression and pinpoint individual treatments.

Learning Objectives

Describe using data analytics, machine learning, and precision medicine, how to distinguish, analyze, and reclassify disease based on subgroups; Identify the best prognosis for patients using these tools; Describe how to better predict disease progression and pinpoint individual treatments.

Chair

David Meyers

Speaker

Academic Perspective
Dwight Raum



Speakers
avatar for David Meyers

David Meyers

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

Dwight Raum

Vice President and Chief Technical Officer, Johns Hopkins
Dwight Raum is Vice President and Chief Technology Officer of Johns Hopkins Health System and Johns Hopkins University. His passion lies in challenging the status quo, mobilizing teams to harness technology and championing change. Since 2016, Dwight has helped lead a precision medicine... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Featured Topics Real World Evidence,Artificial Intelligence,Precision Medicine,Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:30pm

#158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-568-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the evolution of patient-focused outcome assessment and how current FDA efforts and resources support measuring what matters most to patients in medical product development. Join the Study Endpoints Community for a follow up Round Table discussion on Tuesday, June 25, 9:30-10:30AM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe FDA's activities to promote patient voice in outcome measurement; Describe FDA resources to support the science of patient input in medical product development.

Chair

Elektra Johanna Papadopoulos, MD, MPH

Speaker

Update from CDRH
Michelle Tarver, MD, PhD

Panelist
Telba Irony, PhD

Industry Perspective
Robyn T. Carson, MPH

Patient Perspective
Bray Patrick-Lake, MS



Speakers
EP

Elektra Papadopoulos

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

Michelle Tarver

Director of Patient Science and Engagement, OST, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Under her leadership, CDRH is making... Read More →
avatar for Robyn Carson

Robyn Carson

Head, Patient-Centered Outcomes Research, Global Evidence and Value Development, Allergan
Robyn T. Carson has worked in the pharmaceutical industry for 12 years and leads the Patient-Centered Outcomes Research (PCOR) function at Allergan. In this role, Robyn is responsible for the development of innovative strategies to evaluate meaningful outcomes to patients and consumers... Read More →
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →
avatar for Bray Patrick-Lake

Bray Patrick-Lake

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


Monday June 24, 2019 3:30pm - 4:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-559-L04-P; CME 1.00; IACET 1.00; RN 1.00

Precision Medicines in Clinical Trials (PMCT) are demonstrably impactful in drug development yet are not widely adopted by industry. This forum explores reasons for low adoption from the viewpoints of scientists, drug developers and regulators and explores solutions.

Learning Objectives

Describe the value of precision medicine trials (PMCT) as an innovative approach to drug development; Identify the regulatory, scientific, operational and technical challenges and barriers to the execution of these trials.; Explain key considerations for precision medicine trial design and execution.

Chair

Anita Nelsen

Speaker

Academic Perspective from Korea
Yeul Hong Kim, MD, PhD

Panelist
Edward Abrahams, PhD

Panelist
Rebecca Blanchard, PhD



Speakers
avatar for Edward Abrahams

Edward Abrahams

President, Personalized Medicine Coalition
Edward Abrahams, Ph.D., is the President of the Personalized Medicine Coalition. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and... Read More →
avatar for Rebecca Blanchard

Rebecca Blanchard

Vice President, CRISPR Therapeutics
Dr. Blanchard’s career in academia and industry has spanned basic, translational, and clinical research. She is currently responsible for Clinical Biomarkers and Exploratory Research, Assay Development and Pharmacology/Toxicology at CRISPR Therapeutics. After receiving her Ph.D... Read More →
avatar for Yeul Hong Kim

Yeul Hong Kim

Professor, Section of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital
Yeul Hong Kim, MD, PhD, is a Professor in the Department of Internal Medicine at the Korea University College of Medicine in Seoul. He is actively involved in cancer genomic research, using circulating tumor DNA, for lung and gastrointestinal cancers. His primary area of interest... Read More →
avatar for Anita Nelsen

Anita Nelsen

Vice President, Translational Medicine, Parexel
Anita has more than 20 years of experience in the pharmaceutical industry and 29 years of experience in pharmacogenetic, human and molecular genetics research in roles including bench scientist, manager, and business leader. As Head of Translational Medicine Services, Anita leads... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence,Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum
 
Tuesday, June 25
 

8:00am

#203: eConsent Done Right
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-585-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will present real world case studies from sponsor companies that have already begun piloting eConsent.

Learning Objectives

Explain how eConsent can improve patient understanding of clinical trials, enable better informed decision-making and increase patient participation; Describe eConsent implementation best practices from real world case studies; Discuss where and how eConsent is utilized around the globe.

Chair

Carrie Guglielmo

Speaker

Enabling the Future of eConsent: An Overview of the TransCelerate Initiative and Real-World Implementation
Carrie Guglielmo

How eConsent will Support Increased Insights and Future Enhancement of Informed Consent Content and Processes
Bill Byrom, PhD

Utilizing Mobile Apps and eConsent in Global Research Registries: Ethical and Legal Considerations
Robyn Shapiro, JD

Moving the Needle: Improving the Clinical Trial Informed Consent Process with Tools to Increase Understanding
Lauren McCormack, PhD, MPH



Speakers
avatar for Bill Byrom

Bill Byrom

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

Lauren McCormack

Vice President, Public Health Research Division, RTI International
Lauren McCormack, PhD, MSPH is Vice President of RTI’s Public Health Research Division and Adjunct Associate Professor in the UNC Gillings School of Global Public Health. Her research bridges the fields of health communication and health policy, and involves developing, testing... Read More →
avatar for Robyn Shapiro

Robyn Shapiro

Founder and Partner, Health Sciences Law Group LLC
Robyn Shapiro is Founder and Attorney at Health Sciences Law Group LLC. She represents clients in research and healthcare compliance issues, bioethics issues, health information privacy issues, and corporate and commercial issues faced by pharma and device manufacturers. Her past... Read More →
avatar for Carrie Guglielmo

Carrie Guglielmo

eConsent Initiative Lead, Novartis Pharmaceuticals Corporation
Carrie Guglielmo Novartis eConsent Initiative Lead Carrie has been in the pharmaceutical industry for over 20 years. She has held various roles in clinical operations including Trial Management, Resource and Performance Management, and Process and Training. Carrie has been leading... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#204: Protocol Developments of the Future
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-586-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss specific areas in the protocol development process and the use of emerging technologies.

Learning Objectives

Identify where and how technology can be applied to improve or transform traditional protocol development processes: Describe best practices for creating, managing and implementing templates, and standard re-usable content; Discuss how consistently drafted protocols can lead to better success in a regulatory submission and aligned global transparency: Explain how to succeed developing protocols and managing amendments for complex study designs including master protocols.

Chair

Bob Brindle, MA

Speaker

Enforcing Better Standards in Protocol Development
Bob Brindle, MA

Objectives, Endpoints, and Outcome Measures: Developing Protocols to Achieve Consistency Between Documents and Registrations
Nate Root, MSc

Using Technology Innovations to Navigate Substantial Protocol Amendments for Studies with Complex Innovative Design
Rachael Cui Song, MBA

Protocol Development of the Future
Robert A. DiCicco, PharmD



Speakers
avatar for Bob Brindle

Bob Brindle

Venture Leader and Associate Director, Life Sciences R&D Practice, Cognizant
After graduating in Biochemistry from Cambridge University, Bob spent more than 20 years working at a major pharmaceutical company. Starting his career in Data Management, he progressed to become Head of Technology for Clinical Operations, and has extensive expertise in clinical trials... Read More →
avatar for Robert DiCicco

Robert DiCicco

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

Nate Root

Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals
Nate is a disclosure and transparency professional, with over 6 years of experience in the environment, working for and with CROs, Big Pharma, Non-Profit, and Small Biotech. He is a member of the DIA Disclosure Community Core Team, PhUSE CTD initiatives, and creator of the West Coast... Read More →
avatar for Rachael Song

Rachael Song

Associate Director - Global Project Management, PPD
Rachael is currently global Project Leader for Oncology clinical trials with focus on Immuno-Oncology and master protocol studies. She has experiences in compound-level clinical planning and design, study-level operational planning and strategy development, and program implementation... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#205: Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial intelligence, blockchain, natural language processing and real world evidence have been all the rage lately in industry news. Hear perspectives on these new technologies from a panel of experts from sponsor, technology vendor, patient advocacy group, and patients on what's working and what's not.

Learning Objectives

Describe how to drive patient enrollment in clinical studies with a patient-centric approach, allowing patients to pre-screen themselves and retargeting them if excluded; Identify how to address patient recruitment issues associated with pre-screening, screening and dropout to reduce the current average conversion ratio from 10:1; Discuss how to reduce pre-screening burden via mining of EMR records.

Chair

Rob Wynden, PhD

Speaker

Introduction to Patient-Facing Trial Technology
Rob Wynden, PhD

A Bulls-Eye Clinical Trial via Patient's Point- of-View
Abhit Singh, MD, MHA

User-Driven Markets Data that Help Clinicians Assess Treatments and Cure Diseases
Collin Powell, MBA

Turning Clinical Trial Recruitment on its Head Using EHR-Connected Applicants
Scott Cressman

Pragmatism and AI in Research
Mike Nolte, MBA



Speakers
avatar for Scott Cressman

Scott Cressman

Business Development and Strategic Partnerships, Human API
Scott Cressman leads business development & strategic partnerships in clinical research and digital health for Human API. He spends much of his time working at the intersection of life sciences + digital technologies with startups and Fortune 500s alike. His focus is on improving... Read More →
avatar for Mike Nolte

Mike Nolte

Chief Executive Officer, Signant Health
Mike Nolte is the CEO of CRF Bracket. Mike is a seasoned operational leader in healthcare and technology who is passionate about the patient experience. Before CRF Bracket, Mike was CEO at Influence Health, President and COO at MedAssets, and he held several leadership roles in healthcare... Read More →
CP

Collin Powell

Founder, Chief Executive Officer, The Health Exchange Market (THEM)
The Health Exchange Market (T.H.E.M.) is an online marketplace for de-identified healthcare data that allows organizations to realize new revenue streams through data commercialization, while also being able to obtain access to prospective and retrospective data from a variety of... Read More →
avatar for Abhit Singh

Abhit Singh

Chief Medical Advisor, Medical Advisory Board, WeHeal Foundation
Dynamic (Global) Physician Leader, Speaker and Visionary- specializing in the Medical Advisory, Transactional and Transformational management of Healthcare Advisory, Biotech & Biopharma organizations. Among many, a Medical Advisor for WeHeal Inc, a 'CrowdHealing' Therapeutic Options... Read More →
avatar for Rob Wynden

Rob Wynden

Chief Executive Officer, Aloha Health Network
Rob has been a computer scientist and programmer for over 30 years in the scientific programming, e-commerce, biotech, and health care industries. He implemented study startup and CTMS functionality at 9 bay area biotech companies, and invented a method that allows medical and biotech... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

Global clinical trials conducted with GMOs pose unique regulatory, logistical and strategic challenges. This session will presents case studies addressing lessons learned and perspectives from regulatory authorities, investigators and patients.

Learning Objectives

Describe strategies to optimize the conduct of clinical trials with GMOs, in order to facilitate approval across multiple layers and regulatory bodies; Discuss efforts among different stakeholders (Sponsor, CRO, vendors) to enable adequate IP management; Identify how to implement educational plans to overcome cultural barriers (patients, families and site staff) and facilitate enrolment completion.

Chair

Esther Mahillo, PhD

Speaker

Clinical Research with GMOs: Regulatory, Ethical, and Biosafety Challenges
Daniel Kavanagh, PhD

Operational and Logistical Aspects of Working with GMOs
Esther Mahillo, PhD

Patient Perspective
Kathleen Higgins



Speakers
avatar for Daniel Kavanagh

Daniel Kavanagh

Senior Scientific Advisor, Gene Therapy, WIRB-Copernicus Group (WCG)
Dr. Kavanagh is Senior Scientific Advisor, Gene Therapy at WIRB-Copernicus Group (WCG). Prior to joining WCG, he was Assistant Professor of Medicine and Institutional Biosafety Committee Vice Chair at Harvard Medical School, Assistant Immunologist at the Massachusetts General Hospital... Read More →
avatar for Esther Mahillo

Esther Mahillo

Customer Relationship Executive, Oncology and Hematology, Syneos Health
I have been working for 24 years in the clinical research arena. Over the past 20 years, I have conducted 47 phase I-III clinical trials enrolling more than 13,000 patients at over 1,000 sites in 50 countries.I obtained my PhD with a research on the role of multicatalytic proteinase... Read More →
avatar for Kathleen Higgins

Kathleen Higgins

Director of Community Outreach, Li Fraumeni Syndrome Association


Tuesday June 25, 2019 8:00am - 9:15am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

9:30am

#224 RT: Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Component Type: Session
Level: Basic

Round table discussion tied to session #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Elektra Papadopoulos, Telba Irony, Michelle Tarver.

Chair

Emuella Flood


Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:00am

#227 CH: GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions
Component Type: Workshop
Level: Intermediate

Emerging regions are participating in clinical trials, but that only provides drug benefits to a small number of patients. Shifting to Investigator-initiated trials maximizes patient access, but requires more activities to be GCP compliant.

Learning Objectives

Define GCP for Investigator-Initiated trials; Discuss strategies for GCP compliance in emerging regions.

Chair

Terry Katz, MS


Speakers
avatar for Terry Katz

Terry Katz

Director, Head of Global Data Management and Statistics, Merck Animal Health
Terry Katz is Head of Data Management and Statistics at Merck Animal Health. Previously he was Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications... Read More →


Tuesday June 25, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#228: Emerging Safety Challenges in New Oncology Treatments
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for William Gregory

William Gregory

Worldwide Medical and Safety, 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 →
avatar for Tarek Hammad

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 →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#230: Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-604-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session reviews original benchmark research and experiences with outsourcing practices to identify opportunities to optimize the management, execution and performance of CRO relationships.

Learning Objectives

Identify benchmarks characterizing outsourcing practices and identifying opportunities to improve outsourcing effectiveness and efficiency; Describe risk-based quality management and monitoring practices to improve effectiveness; Discuss data-driven insights to inform improvement in the vendor qualification assessment process.

Chair

Kenneth A. Getz, MBA

Speaker

Risk-Based Quality Management and Monitoring; How to Perform Oversight
Liz Wool, BSN

Benchmarking the Oversight and Vendor Qualification Assessment Process
Kenneth A. Getz, MBA



Speakers
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor (PHCM); Founder and Chairmen, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT; CISCRP
Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategies and tactics, outsourcing, and global... Read More →
avatar for Liz Wool

Liz Wool

President, Wool Consulting Group Inc.
Liz Wool CCRA, CID, CMT, is President, Wool Consulting Group. Inc. Liz possesses 28 years in the product development with expertise in CRO-Vendor Oversight, GCP compliance, SOP gap analyses and development, development and delivery of training programs (live, webinar, virtual classroom... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-605-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of past challenges and future opportunities for outcomes research in the Oncology and Alzheimer therapy areas. This will include an update on the state of eCOA and the use of connected devices inside oncology clinical trials as well as a review of existing and future endpoints that could be relevant for immunotherapies. The session will also discuss the eCOA led methodological improvements that are positively supporting Alzheimer clinical trials.

Learning Objectives

Describe the use of eCOA and connected health devices inside oncology clinical trials, areas of controversy and opportunity; Discuss current challenges in Alzheimer clinical trials - traditional approaches to eCOA implementation with central oversight; Identify Current challenges associated with measuring c the effects of immunotherapies with existing metrics and proposed metrics to measure outcomes into the future.

Chair

Brad Sanderson, MHS

Speaker

eCOA and Connected Devices for Supporting Oncology Patients in Clinical Trials
Brad Sanderson, MHS

Measuring and Understanding the Outcomes of Immunotherapies in Oncology
Imad Al-Dakkak, DMD, MPA, MPH



Speakers
IA

Imad Al-Dakkak

Director, Huron Consulting Group
Imad is a clinical epidemiologist with over 14 years of experience from government, industry, and academia across multiple disease areas. His areas of expertise include research methodology, epidemiology, study designs, database analytics, and evidence-based medicine. Imad is based... Read More →
BS

Brad Sanderson

Senior Scientific Advisor, Signant Health
Brad is a physiologist and researcher with over 15 years of industry experience. Brad is currently Senior Scientific Advisor - Head of Health Outcomes at CRF Bracket where he leads the Health Outcomes discipline and seeks to advance the company’s scientific and technical expertise... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-606-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.

Learning Objectives

Discuss and compare your organization’s approach with leading practices shared in the session; Describe some of the gaps in standard approaches to risk assessment and ways to overcome them; Explain the importance of metrics in risk assessment and risk control.

Chair

Linda B. Sullivan, MBA

Speaker

Panelist
Sherry Merrifield

Panelist
Ann McCabe

Panelist
Suzanne Lukac



Speakers
avatar for Suzanne Lukac

Suzanne Lukac

Senior Account Director, CluePoints
Suzanne has nearly 20 years experience in the pharmaceutical industry including hands-on experience with RBM implementation. She is currently Senior Account Director at CluePoints where she is responsible for managing enterprise-level accounts and working with customers to lay the... Read More →
avatar for Ann McCabe

Ann McCabe

Director, Process Excellence and Risk Management, Daiichi Sankyo Inc
Ann E. McCabe Director, Process Excellence & Risk Management Ann McCabe is Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked... Read More →
avatar for Sherry Merrifield

Sherry Merrifield

Senior Director, Global Operations Management, Syneos Health
Sherry Merrifield has over 20 years of clinical operations experience. In her current role she is Senior Director of the Global Operations Management group focused on the optimization of Syneos Health’s data-driven RBM solution and application of ICH E6 R2. Her experience in this... Read More →
avatar for Linda Sullivan

Linda Sullivan

Executive Director, Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session examines the use of home trial support services from the perspectives of the study sponsor, CRO partner and the potential patient participant. During this session we will discuss the logistics of home trial support, its benefits and pitfalls, when it is most appropriate to use and the patient perception of the service and how it may affect their willingness to participate.

Learning Objectives

Describe the benefits of use of home nursing (specifically, home trial support) in clinical trials from the sponsor, CRO and patient perspectives; Identify barriers to implementation of home trial support; Discuss scenarios where the greatest return on investment for home trial support is realized.

Chair

Ellyn Getz

Speaker

Academic Perspective
Ellyn Getz

Industry Perspective
Todd McGrath

Study Sponsor Perspective
Nour Ziyadeh, MS

Patient Perspective
Mary Koestler

CRO Perspective
Kelly Franchetti, RN



Speakers
MK

Mary Koestler

Assistant Professor, Clinical Trials Adminstrator, Memory and Aging Center, University of California San Francisco
avatar for Nour Ziyadeh

Nour Ziyadeh

Clinical Trial Oversight Lead, Alnylam Pharmaceuticals
Nour Ziyadeh is a Clinical Trial Oversight Lead ensuring compliance for Alnylam’s outsourced clinical trials. She has 15 + years of industry experience including third party auditing for the FDA, CRO , SMO and Pharma. She has held roles including Clinical Research Coordinator, Clinical... Read More →
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Ellyn Getz

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP
Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →
TM

Todd McGrath

Vice President Operations A/O, Medical Research Network
Todd has over 15 years' experience in the clinical trial and life science industry; beginning his career in pharmaceutical and biotech consulting and then holding operational positions at a clinical research organization. As Vice President Operations Americas Oceania at MRN, Todd... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#245: Artificial Intelligence Enhanced Data Analytics for Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-602-L04-P; CME 1.00; IACET 1.00; RN 1.00

Artificial Intelligence (AI) enhanced drug development is becoming increasingly important in the era of precision medicine.This session illustrates with examples how AI can impact and facilitate modern drug development.

Learning Objectives

Recognize the benefit of using artificial intelligence (AI) approaches in modern drug development; Identify the regulatory paths using biomarker-based, AI-enhanced strategies in clinical trials; Outline how to incorporate advanced analytics into trial analyses and future trial designs.

Chair

Felix Frueh, PhD

Speaker

Panelist
Mohammad Afshar, MD, PhD

Panelist
Federico Manuel Goodsaid, PhD



Speakers
avatar for Mohammad Afshar

Mohammad Afshar

Chief Executive Officer, Ariana Pharma
Mohammad founded Ariana® to accelerate the development of novel drugs with the help of computational decision support technologies. It has developed KEM®, for rapid & exhaustive analysis of multi-parametric/multi-objective data for biomarkers, drug discovery, clinical and early... Read More →
FF

Felix Frueh

Executive Partner, Opus Three LLC
avatar for Federico Goodsaid

Federico Goodsaid

Associate Partner, Biomarkers and Regulatory Affairs, Opus Three LLC
B.A. was in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D from Yale University, New Haven, in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University in Ithaca, New York and at Washington University in St... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#256: Wearables and Patient Technologies Utilized in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-623-L04-P; CME 1.25; IACET 1.25; RN 1.25

Explore an initiative which seeks to facilitate and accelerate progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce their burden in clinical trials. Describe lessons learned from 3 "smart" trials executed for top 5 pharma companies. Explore the use of technology, devices, and virtual visits in a pediatric clinical trial setting and help to alleviate some of the questions and concerns sponsors and regulators have when endpoints or key outcome measures come from personal devices, wearables, or other patient controlled technology.

Learning Objectives

Define opportunities and challenges with use of patient-facing technology in clinical trials; Discuss how to complement eClinical platform with new technologies; Demonstrate how technology and virtual visits are being utilized to ease burden of participation and increase compliance.

Chair

Margareth Dimitrov-Kuhl, MA

Speaker

Patient-Driven Digital Platform: The Need to Integrate eClinical Technologies, Wearables, RPA, and AI/Machine Learning
Isabelle M de Zegher, DrMed, MD, MS, MSc

Making Pediatric Clinical Trials Fun (and Easy?): Virtualization, Wearables, and Other Technologies Utilized in Clinical Trials
Gina Calarco, BSN, MPH

Implementing Patient-Facing Technology in Clinical Trials: How to Overcome the Industry’s Greatest Challenges
Margareth Dimitrov-Kuhl, MA



Speakers
avatar for Gina Calarco

Gina Calarco

Director of Pediatric Strategy & Planning, Covance
Gina Calarco is Director of Operational Strategy and Planning for the Rare Disease and Pediatric Team at Covance. She is a nurse and received her MPH from the University of Kansas. She is an affiliate member of the American Academy of Pediatrics Section on Advances in Therapeutics... Read More →
MD

Margareth Dimitrov-Kuhl

Clinical Development Function Head, Novartis Pharmaceutical
Margareth Dimitrov-Kuhl is a Clinical Director Function Head at Novartis Pharmaceuticals. She is also a Sponsor-company representative serving on TransCelerate BioPharma’s Patient Technology Initiative focused on developing tools for study teams utilizing patient-facing technologies... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#257: Clinical Trial Diversity: Moving from Admiring the Problem to Solving it
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-624-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will take discussions about clinical trial diversity to the next level, focusing on practical solutions and strategies for strengthening diversity in clinical trials. A panel of multi-stakeholder experts will provide their perspectives.

Learning Objectives

Describe strategies for increasing diversity in clinical trial research; Discuss examples of innovations in enrollment and recruitment of diverse patients as well as challenges overcome.

Chair

Jane E. Myles, MS

Speaker

Inclusive Trial Participation: Imperative or Nice to Have?
Jane E. Myles, MS

FDA Perspective
Richardae Araojo, PharmD, MS

Panelist
Fabian Sandoval, MD

Panelist
Madeline Geday

Patient Perspective
Mindy Leffler



Speakers
RA

Richardae Araojo

Associate Commissioner and Director, Office of Minority Health and Health Equity, FDA
CAPT Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration. In this role, she provides leadership, oversight, and direction on minority health and health disparity... Read More →
avatar for Madeline Geday

Madeline Geday

Director, Patient Innovation and Engagment, Global Clinical Trial Operations, Merck & Co., Inc.
avatar for Jane Myles

Jane Myles

Head, Operational Intelligence and Innovation, Genentech, A Member of the Roche Group
Jane is the Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation into the way we design and execute trials to get medicines to patients faster. She's worked at Genentech for 17 years in many roles, including line manager... Read More →
FS

Fabian Sandoval

Chief Executive Officer and Research Director, Emerson Clinical Research Institute
Dr. Sandoval has over 20 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount Unv. and his Doctorate of Medicine... Read More →
ML

Mindy Leffler

Rare Disease Parent; Partner, Casimir


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

2:00pm

#258: Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-625-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop gives participants a hands-on experience with designing and building chat bots as service automation agents for their functional area. Participants will identify opportunities for Conversational AI and leave with a working prototype.

Learning Objectives

Identify specific opportunities to leverage automation to engage with internal and external customers; Discuss fundamentals of how bots are designed and how to think through the logic and use cases; Describe how to get hands-on experience designing and making a working prototype; Discuss how to put automation and chat bots into a real world practical context.

Chair

Bryan Hill


Speakers
avatar for Bryan Hill

Bryan Hill

Chief Technology Officer, Life Sciences, Cognizant
Bryan Hill serves as Chief Technology Officer responsible for Cognizant’s range of digital solutions and innovation within the Life Sciences industry. His focus is on identifying how emerging digital technologies can help life sciences companies increase innovation in clinical development... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next
  • Featured Topics Artificial Intelligence,Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Workshop

2:00pm

#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
avatar for Laurie Iciek

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 →
SN

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 →
KS

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 →
avatar for Theresa Sweeney

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
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#271: Master Protocols: Applications in Oncology
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-621-L04-P; CME 1.25; IACET 1.25; RN 1.25

Future advances in medicine depend on our ability to leverage complex innovative designs of clinical trials. Master protocols, including basket, umbrella, and platform trials, as one type of complex innovative designs, provide a method to answer multiple questions in one overall trial structure. In this session, the concept of master protocols, some case studies using real world examples in oncology, and the advantages and challenges of designing and implementing master protocols will be discussed. Join the Statistics Community for a follow up Round Table discussion on Wednesday, June 26, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Explain the concept of master protocols; Discuss case studies in master protocols with applications in oncology; Describe opportunities and challenges in applying master protocols as an innovative approach in oncology drug development.

Chair

Amy Xia, PhD

Speaker

FDA Update
Yuan-Li Shen, DrPH

Industry Update
Scott M Berry, PhD, MS

Industry Perrspective About Platform Trials
Karen Lynn Price, PhD, MA



Speakers
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
avatar for Karen Price

Karen Price

Senior Research Advisor, Statistical Innovation Center, Eli Lilly and Company
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Senior Research Advisor at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis... Read More →
avatar for Amy Xia

Amy Xia

Vice President, Biostatistics, Design & Innovation, Amgen Inc.
Amy Xia is Vice President, Biostatistics, Design & Innovation at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 22+ years. Currently, she heads up the Biostatistics and Design & Innovation organizations... Read More →
YS

Yuan-Li Shen

Acting Associate Director, Office of Biostatistics, OTS, CDER, FDA
Yuan-Li is the acting Associate Director in Division of Biometrics V, Office of Biostatistics, Office of Translational Science, CDER, FDA. The teams that she is associated with support all statistical aspects of regulatory submissions in Gastrointestinal, Lung/Head and Neck, Neuro-oncology/Rare... Read More →


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

2:00pm

#272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is for agencies, industry, and other organizations to present their observations around the types of facilitated pathways that are available in North America to speed access to medicines that address an unmet medical need.

Learning Objectives

Describe initiatives that the US and Canada has implemented to streamline the process for approval of and access to therapies that address unmet medical need (UMN); Illustrate opportunities and challenges with aligning regulatory and access pathways; Discuss if these pathways may have a broader remit than just for therapies for UMN.

Chair

Lawrence Eugene Liberti, PhD, RPh, RAC

Speaker

Market Access on the Two Sides of the Atlantic: Barriers and Opportunities
Maria Isabel Manley, LLM

Aligning Approval and Access: The US Experience
Sean Tunis, MD, MSc

Patient Perspective
Julie Eller



Speakers
avatar for Lawrence Liberti

Lawrence Liberti

Executive Director, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for Julie Eller

Julie Eller

Manager, Grassroots Advocacy, Arthritis Foundation
Julie leads a patient network of more than 100,000 patient Advocates as they share their story to effect change. Julie has had arthritis since she was seven years old and the Arthritis Foundation has helped her foster a passion for translating the patient experience into advocacy... Read More →
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#283: Let's Talk Risk-Based Monitoring
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: Let's Talk Risk-Based Monitoring; CME 1.25; IACET 1.25; RN 1.25

Let’s face it, Risk Based Monitoring (RBM) has been in the forefront of our industry for more than 10 years. From the beginning, RBM challenged the belief that 100% source document verification (SDV) would yield quality data in clinical trials. Regulators responsible for making decisions based on reliable data were also challenging industry as to the utility of this monitoring methodology as a way to identify and manage issues in clinical trials. It took some time for the focus of RBM to shift risks in a clinical trial that would include identification and assessment, ongoing monitoring, mitigation as well as even prevention. We are now in an epoch of understanding that it’s about the management of risks in clinical trials that could impact the reliability of patient data, patient safety and patient rights and welfare. In March of 2019, FDA has provided a draft guidance to augment the 2013 guidance relating to risk based-monitoring whereby FDA is making recommendations for planning a monitoring approach, developing content for monitoring plans, and the monitoring of results. Since regulations establish the expectations, it remains up to the sponsor to determine the how in order to achieve the expectation.

RBM has come a long way however sponsors may still struggle with certain aspects in the multi-prong processes needed to be successful with RBM. This forum will present various approaches to RBM, and give the opportunity to learn from experts, so Let’s Talk Risk-Based Monitoring!

Learning Objectives

Describe what is comprehensive RBM , with an understanding of key components to achieve goals of Risk-Based Monitoring in Clinical Trials; Develop a risk-based approach to monitoring of clinical trials that will achieve the expectations for quality clinical data; Identify how to determine best approach based on risks within the clinical trial and consider how to best monitor ongoing risks.

Chair

Susan Callery-D'Amico, BSN

Speaker

A Comparison of SDV to MANA Method: A Risk-Based Monitoring Approach
Penelope K. Manasco, MD, MS

Holistic Approach to Risk-Based Management of Studies and Monitoring of Investigators
Gregg Larson, PhD



Speakers
avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

Vice President, R&D Quality Assurance, AbbVie, Inc.
Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of... Read More →
avatar for Penelope Manasco

Penelope Manasco

Chief Executive Officer, MANA RBM
Dr. Manasco has conducted clinical research for over 30 years at the NIH and as an executive at GSK. She has spent 10 years in the area of clinical trial technology. Since starting MANA RBM, her focus has been on enhancing the processes of clinical research to rapidly identify and... Read More →
avatar for Gregg Larson

Gregg Larson

Vice President, Development Operations, AbbVie
Gregg’s career over 25+ years has spanned medical affairs, clinical research, and clinical operations. Gregg assumed his current role as VP, Development Operations in October 2017, which includes Site Management and Monitoring, Clinical Program Development, Strategic Clinical Operations... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#284: Virtual Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-640-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how virtual clinical trials represent a relatively new method of collecting safety and efficacy data from clinical trial participants, from study start-up through execution to follow-up.

Learning Objectives

Discuss the concept of assessing a protocol visit by visit to identify opportunities to minimize patient burden of participation; Discuss how to appraise and choose the right visit location, data collection method, patient support service or technology for each visit; Design and plan trials that consider patient burden enabled by utilizing relevant technology or patient support services.

Chair

Lucas Garmon

Speaker

A Patient-Centric Approach to Study Visits and Data Collection: What if I'm not Ready for 100% Virtual Trial?
Lucas Garmon

Research Passport: Ethics Review and Regulatory Implications for Participants in Virtual Trials
David Babaian, JD, LLM

Back to the Future with Virtual Clinical Trials
Juliana Nino Ortegón



Speakers
avatar for Juliana Nino Ortegón

Juliana Nino Ortegón

Senior Clinical Data Manager, Merck, Sharp and Dohme
Senior Clinical data management at Merck Sharp and Dohme. Microbiologist and Biomedical Engineer interested in research and development in pharmaceutical industry. I've got three years of experience in Data management of different Oncology trials working in data cleaning to achieve... Read More →
DB

David Babaian

Senior Consulant and Senior Regulatory Attorney, Advarra
David Babaian leverages his expertise in regulatory affairs, healthcare law, and project management to provide consultation on U.S. and international research compliance and data privacy law. David graduated cum laude from The John Marshall Law School in Chicago and earned an LL.M... Read More →
LG

Lucas Garmon

Recruitment Manager, Patient Recruitment Solutions, ICON plc.
Lucas has over 10 years of experience supporting recruitment and retention of clinical trials with techniques in the digital space. He has a creative agency background and works at the forefront of integrating patient-centric research insights into the campaigns he implements. His... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#285: Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-641-L04-P; CME 1.25; IACET 1.25; RN 1.25

We will review the current work of the Study Endpoint Community wearables group. Specifically three areas: how to select a clinical endpoint derived from mobile sensor data; how to select a fit for purpose device and how to provide evidence to support its use; considerations regarding the positioning of endpoints derived from mobile sensor data alongside other clinical endpoints in the endpoint hierarchy.

Learning Objectives

Identify the format and content of an evidence dossier to support clinical endpoints derived from wearable devices in regulatory drug submissions; Outline key considerations in the practical implementation of wearables to measure intervention effects in clinical trials; Discuss endpoint hierarchy considerations when including new objective sensor-based clinical endpoints.

Chair

Bill Byrom, PhD

Speaker

Practical Considerations for the Implementation of Mobile Sensors for Measurement in Clinical Trials
Jennifer Goldsack, MA, MBA, MS

Developing an Evidence Dossier to Support the Use of Mobile Sensors to Collect Clinical Endpoints in Regulatory Submissions
Bill Byrom, PhD

Endpoint Hierarchy Considerations When Including New Objective Sensor-Based Clinical Endpoints
Emuella Flood



Speakers
avatar for Jennifer Goldsack

Jennifer Goldsack

Interim Executive Director, Digital Medicine Society (DiMe)
Jen Goldsack is the Interim Executive Director of the Digital Medicine (DiMe) Society and is Vice President of Digital Measurement at monARC Bionetworks.
avatar for Bill Byrom

Bill Byrom

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

Emuella Flood

Director, Patient-Reported Outcomes, AstraZeneca
Emuella Flood is co-chair of the DIA Study Endpoints Community and has been working in the field of patient-centered outcomes for over 20 years. She recently joined AstraZeneca as PRO Director, with a focus on PRO strategy and implementation in women's cancer. Prior to joining AstraZeneca... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-632-L04-P; CME 1.25; IACET 1.25; RN 1.25

In today’s pharmaceutical and biotech industry we are at an inflection point with regard to the future of therapeutic development. In this forum the focus will be to explore how industry, agencies, and academic institutions collaborate to drive innovative technologies to speed therapeutic development. Specifically, the forum will explore how we are leveraging STEM (Science, Technology, Engineering, Mathematics) programs both independently and interactively to enable current and future entrepreneurial opportunities. The goal is to foster an environment where we best take advantage of the opportunities presented by advances in life sciences and technology.

Learning Objectives

Evaluate the quality of interaction among various stakeholders in cure-based drug development; Assess the quality of those interactions in their own environments; Recognize the importance of fostering an environment where creativity and an entrepreneurial spirit is nurtured. Determine how STEM (Science, Technology, Engineering, Mathematics) programs are put to use to address the aforementioned objectives.

Chair

Dan Tierno, MA, MBA

Speaker

Industry Perspective
Yaron Drucker, MBA

Student Perspective
Advaita Chandramohan

Panelist
Melanie Matheu, PhD



Speakers
avatar for Advaita Chandramohan

Advaita Chandramohan

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

Yaron Drucker

Staffing Lead, Cloud Partners, Google
Yaron has a Bachelor's Degree in Electrical Engineering, and an MBA from Baruch College. In his early career, Yaron worked in aerospace and defense as an EMC/EMI Engineer, and at SAP for a year. He then worked at Microsoft for 7 years in various roles in digital media on the advertising... Read More →
avatar for Dan Tierno

Dan Tierno

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

Melanie Matheu

Founder and Chief Executive Officer, Prellis Biologics, Inc.


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#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
avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →
MG

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 →
avatar for Mary Nilsson

Mary Nilsson

Statistician, Eli Lilly and Company
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 →
MS

Mat Soukup

Deputy Div. Director, Div. of Biometrics VII, Office of Biostatistics, OTS CDER, FDA
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
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Wednesday, June 26
 

8:00am

#303: Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-659-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial Intelligence, machine learning, blockchain, and mobile devices are all disruptive technologies that promise to transform research. Expert panelists will discuss each technology and its current and future relevance to research.

Learning Objectives

Describe the way disruptive technologies including artificial intelligence and machine learning, bockchain and mobile/wearables can be applied to clinical research; Discuss examples and case studies of how these technologies are currently being used in clinical research; Analyze which of these technologies offer the most potential benefit to clinical research.

Chair

Sam Anwar

Speaker

Industry Perspective on Artificial Intelligence and Machine Learning
Jeffrey Blaine Smith, MS, PMP

Understanding the Promise, Risk, and Requirements for Using Blockchain Technology in Clinical Trials
Karin Beckstrom

Mobile Tech and Wearables
Joseph Dustin



Speakers
avatar for Karin Beckstrom

Karin Beckstrom

Innovation Lab, ERT
Karin Beckstrom is responsible for discovering common ground among technologists, scientists and clinical trial leaders, transforming ideas into solutions that enhance the patient and investigator experience during clinical trials. She has over 20 years’ experience driving software... Read More →
avatar for Sam Anwar

Sam Anwar

Chief Technology Officer, eClinical Solutions
I have spent that past 20 years of my career in leveraging cutting edge technologies to revolutionize clinical trials. In my current role as CTO at eClinical Solutions, I harness the power of software development, big data, AI and machine learning to help advance the technology innovations... Read More →
JD

Joseph Dustin

Solutions Director, Mobile Health / eCOA, Medidata Solutions
Since 2002, I have been immersed in the world of eClinical. I came in as the new guy, with new ideas, and new perspectives in an industry that still needs help when using technology to facilitate clinical research. Past companies include Medidata, CRF Health, and etrials. www.joedustin.com... Read More →
JS

Jeffrey Smith

Senior Director, Analyst, GARTNER
Jeffrey Smith is a Senior Director Analyst on Gartner's Healthcare and Life Sciences Industry Research team. Mr. Smith's research is focused on clinical development activities within pharmaceutical and medical device companies, helping CIOs and R&D IT leaders to better navigate strategic... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

8:00am

#304: Operationalizing Master Protocols
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-660-L04-P; CME 1.25; IACET 1.25; RN 1.25

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (including basket, umbrella, and platform trials) provide a method to answer multiple questions in one overarching trial structure. Although these trials require more intentional planning, coordination and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial.

In this session, we consider this emerging family of clinical trial designs within the context of broader efforts to increase efficiency, effectiveness, and quality in the development paradigm.

Learning Objectives

Analyze different trial designs that can be described and executed under a master protocol (including umbrella, basket and platform); Describe considerations and challenges for master protocol development; Discuss a case example for using the common protocol template basket studies; Identify critical elements around data collection, analysis, and interpretation;

Chair

MaryAnn Morgan-Cox, PhD

Speaker

Master Protocols; Design and Execution Considerations
Meredith Buxton, PhD, MPH

Utilizing the TransCelerate Common Protocol Template for Novel Clinical Trial Designs, Such as Platform Trials
Mitzi Allred, PhD

Statistical Analysis Opportunities and Challenges with Master Protocols
Karen Lynn Price, PhD, MA



Speakers
avatar for Mitzi Allred

Mitzi Allred

Director Clinical Operations; Head, Clinical Content Standards, Merck & Co., Inc.
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse... Read More →
avatar for Meredith Buxton

Meredith Buxton

Chief Operating Officer, Global Coalition For Adaptive Research
Meredith provides operational leadership for the Global Coalition for Adaptive Research (GCAR), a nonprofit research organization founded to expedite the discovery and development of cures for patients with rare and deadly diseases, and home of GBM AGILE, an international, seamless... Read More →
avatar for MaryAnn Morgan-Cox

MaryAnn Morgan-Cox

Senior Director, Immunology Design Hub, Eli Lilly and Company
MaryAnn Morgan-Cox is a Sr Director and Leader of the Immunology Design Hub at Eli Lilly and Company, where she focuses on innovative approaches to drug development, clinical research, commercialization, and portfolio management.
avatar for Karen Price

Karen Price

Senior Research Advisor, Statistical Innovation Center, Eli Lilly and Company
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Senior Research Advisor at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#305: Demystifying Technology Selection in Mobile Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-661-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will describe CTTI resources that support the adoption of mobile technologies into clinical research by 1) eliminating redundant feasibility testing, and 2) promoting streamlined, informative studies where there are knowledge gaps.

Learning Objectives

Describe how feasibility testing can reduce the risk of conducting mobile clinical trials; Identify how to initiate their own feasibility studies, where appropriate; Describe how to access and utilize the consortium's database of feasibility studies available as a resource summarizing current knowledge.

Chair

Thomas Switzer, MEd

Speaker

FDA Perspective
Isaac R. Rodriguez-Chavez, MHS, PhD, MS

Industry Update
Barry Peterson, PhD

Panelist
Aaron Coleman



Speakers
AC

Aaron Coleman

Founder and Chief Executive Officer, Fitabase
In 2012 Aaron Coleman founded Fitabase, forming an early partnership with Fitbit and creating a software platform to connect consumer devices to the needs of researchers and data scientists. Fitabase has been used by over 500 research studies, clinical care pilots, and pharma trials... Read More →
avatar for Barry Peterson

Barry Peterson

Wearable Devices, Independent Consultant
Dr. Peterson has extensive experience with the application of actigraphy and physiological measurements in pharmaceutical clinical trials. After 20 years of academic research on acute lung injury and respiratory measurement techniques, he joined Pfizer's Clinical Technology group... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Clinical Research Methodology, Reg Compliance and Policy Development, OMP, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →
avatar for Thomas Switzer

Thomas Switzer

Business Ops Leader, Digital Health Platforms, Genentech, A Member of the Roche Group
Tom is a Business Operations Lead in the Roche PHC Center of Excellence supporting Digital Health Platforms.  His current focus is on developing technology platforms supporting molecule teams across the Roche late-stage organization.  Tom has over 18 years of clinical development... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-650-L04-P; CME 1.25; IACET 1.25; RN 1.25

Neoantigen-based cancer therapy is an approach based on the specific genetic information unique to individual tumor(s) of an individual patient. Such information can be utilized in many ways for cancer treatment, e.g., to generate antigens for vaccination or specific T-cells. Results from earlier clinical trials have shown that this approach is feasible, able to elicit the intended immune response, and in some cases generating anti-tumor activities that may mediate the tumor regression. However, this approach has many scientific and regulatory challenges, for example, optimal ways / algorithms in identifying and selecting neoantigens, and regulatory framework for regulating such products given that drug product and indications are not explicitly defined. This session is intended to address these challenges and discuss the opportunities for the neoantigen-based cancer therapies.

Learning Objectives

Describe the concepts of cancer immunoediting and neoantigen;Discuss the recent advances in neoantigen-based novel cancer therapy, e.g., vaccine and cell-based therapies;Discuss scientific and regulatory challenges, focusing on pre-clinical studies and early clinical trials; Identify opportunities in facilitating and accelerating the development.

Chair

Peter F. Bross, MD

Speaker

CMC Considerations: Regulatory Perspective
Elena Gubina, PhD

CMC Considerations: Industry Perspective
Karin Jooss, DrSc

Clinical Consideration for Early-Phase Trials: Academic Perspective
Aaron M. Miller, MD, PhD

Clinical Consideration for Early-Phase Trials: Regulatory Perspective
Peter F. Bross, MD

Panelist
Alyssa K. Galaro, PhD



Speakers
avatar for Alyssa Galaro

Alyssa Galaro

Biomedical Engineer, DCEPT, OTAT, CBER, FDA
Dr. Galaro joined the Office of Tissues and Advanced Therapies in 2018 as a Pharmacology and Toxicology Reviewer. Prior to joining CBER, she completed her PhD in biomedical engineering at the Johns Hopkins School of Medicine where her research focused on engineering nanoparticle-based... Read More →
PB

Peter Bross

Medical Team Leader, OTAT, CBER, FDA
Peter Bross is a clinical oncology team leader in the FDA Center for Biological Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) and previously worked as a clinical reviewer in the Division of Oncology Drug Products in the Center for Drug Evaluation and... Read More →
avatar for Elena Gubina

Elena Gubina

Expert Biologist, OTAT, CDER, FDA
KJ

Karin Jooss

Executive Vice President of Oncology and Chief Scientific Officer, Gritstone Oncology
Dr. Karin Jooss serves as executive vice president of research, chief scientific officer at Gritstone and interim head of manufacturing. She joined Gritstone from Pfizer, where she was head of cancer immuno-therapeutics, was a member of the vaccine immuno-therapeutics leadership team... Read More →
AM

Aaron Miller

Medical Oncologist, Assistant Professor of Medicine, University of California San Diego
Dr. Miller is a board-certified medical oncologist who specializes in diagnosing and treating gastrointestinal cancers. He is an assistant professor in the Department of Medicine, where he instructs medical students, residents and fellows at UC San Diego School of Medicine. He holds... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#316: Implementation of Innovative and Adaptive Designs in Clinical Trials
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-656-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of innovative designs and possible adaptations can help reduce the number of patients required for trial recruitment, thereby shortening drug development time. Experts from FDA and the industry will provide feedback on the complex innovative designs and how they inform regulatory decision making.

Learning Objectives

Outline the advances in adaptive designs; Utilize newly developed innovative designs in clinical trials.

Chair

Aloka Chakravarty, PhD

Speaker

Recent Advances in Group Sequential and Adaptive Designs for Unblinded Sample Size Re-estimation and Seamless Phase 2/3 Pivotal Trials
Sandra Bihary-Waltz, BSN, MSN

EMA Update
Andrew Thomson, PhD, MA, MS

FDA Update
Meiyu Shen, PhD



Speakers
MS

Meiyu Shen

Expert Mathematical Statistician, Office of Translational Sciences, CDER, FDA
A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D... Read More →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
Andrew Thomson is a statistician in the Office of Biostatistics & Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH... Read More →
SB

Sandra Bihary-Waltz

Senior Director, Global Regulatory Affairs, PRA Health Sciences
Sandra joined Idis as the Global Head of REgulatory Affairs in 2012, after spending over 24 years in the pharmaceutical industry, predominantly in regulatory affairs. She has extensive experience in all phases of drug development, through post-approval activities, including EAP p... Read More →
SB

Sandra Bihary-Waltz

Senior Director, Global Regulatory Affairs, PRA Health Sciences
Sandra joined Idis as the Global Head of REgulatory Affairs in 2012, after spending over 24 years in the pharmaceutical industry, predominantly in regulatory affairs. She has extensive experience in all phases of drug development, through post-approval activities, including EAP p... Read More →
avatar for Aloka Chakravarty

Aloka Chakravarty

Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-657-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.

Learning Objectives

Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.

Chair

Munish Mehra

Speaker

Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD

Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc

Estimands for Efficacy Analyses
Thomas J. Permutt, PhD



Speakers
MC

Martin Clancy

Senior Statistician, PHASTAR
I'm a Senior Statistician at PHASTAR, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services by providing expert consultants and delivering in-house projects. Working in a Contract Research Organisation (CRO) for the past 4 years... Read More →
avatar for Yi Liu

Yi Liu

Director Biostatistics, Nektar Therapeutics
Yi Liu got her Ph.D. degree in Statistics from the department of Statistics at The Ohio State University. She is currently a director at Nektar Therapeutics responsible for clinical trials in collaborations with external partners and CMC and biomarker related statistical analyses... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →
avatar for Thomas Permutt

Thomas Permutt

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA
Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

9:30am

#323 RT: Round Table Discussion: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
Component Type: Session
Level: Basic

Round table discussion tied to session #219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine? (Tuesday, June 25, 8:00-9:15AM). Seating is limited.

Chair

Emuella Flood


Wednesday June 26, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#328: Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-673-L04-P; CME 1.00; IACET 1.00; RN 1.00

Organizations have faced challenges when implementing risk-based monitoring (RBM) and there is no one size fits all approach to overcome these challenges. Sharing best practices and implementing new facets of technology are opportunities to take RBM from the present to the future.

Learning Objectives

Discuss experiences and best practices on risk-based monitoring implementation including central monitoring; Demonstrate how technology enablement such as process automation and artificial intelligence can enhance the risk-based monitoring experience.

Chair

Suzanne Lukac

Speaker

The Keys to Successful Risk-Based Monitoring Implementation
Suzanne Lukac

Ahead of Curve in Risk-Based Monitoring Through Process Automation and Artificial Intelligence
Zabir Macci, MBA

Central Monitoring: Best Practices
Hadley Stinson



Speakers
avatar for Suzanne Lukac

Suzanne Lukac

Senior Account Director, CluePoints
Suzanne has nearly 20 years experience in the pharmaceutical industry including hands-on experience with RBM implementation. She is currently Senior Account Director at CluePoints where she is responsible for managing enterprise-level accounts and working with customers to lay the... Read More →
avatar for Hadley Stinson

Hadley Stinson

Associate Director, Clinical Monitoring Services, Premier Research
I am currently the Associate Director of Clinical Monitoring Services at Premier and oversee the NA CRA division. Prior to that I have worked in CRA Line Management and CRA positions and have global experience in multiple therapeutic areas including Oncology, Cardiovascular and R... Read More →
ZM

Zabir Macci

Centralized Monitoring Manager, IQVIA
Zabir is a Process Design & Analytics Manager for IQVIA focused on their approach to risk-based monitoring (RBM), Data-driven Trial Execution. He brings expertise spanning risk-based monitoring, business analysis, continuous process improvement, and analytics for clinical trials... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#329: Global Clinical Trials: Make Them Really Global and Involve Africa
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-674-L04-P; CME 1.00; IACET 1.00; RN 1.00

Changing how we do global clinical trials, with the inclusion of emerging markets in this development process, is imperative. A panel of experts will discuss how to plan and involve pharma/biotech and technology providers.

Learning Objectives

Describe ways in which to integrate emerging markets in global clinical trials using innovative technologies;Discuss approaches to process optimization, mobile health digitalization, blockchain, and change management on how to undertake clinical trials within Africa as the process model: Identify challenges and solutions from actual cases and experience.

Chair

Adama Ibrahim, MBA

Speaker

Next Generation Real World Evidence with Blockchain
Alexis Normand, MPA, MSc

Panelist
Tina Barton, PhD, MBA



Speakers
TB

Tina Barton

Chief Operating Officer, Emerging Markets Quality Trials (EMQT)
Tina Barton is an experienced Board member and Chair, with a BSc, PhD in cancer research and MBA, and has held Senior Management roles in large global through mid-size to small emerging organisations, working in partnership to lead for success, as a customer-focused clinical research... Read More →
avatar for Adama Ibrahim

Adama Ibrahim

Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen
An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion... Read More →
avatar for Alexis Normand

Alexis Normand

Head of Blockchain for Health Consortium, Embleema
Alexis Normand is head of the Embleema Blockchain Consortium bringing together patients, their advocacy groups, life sciences companies (and regulators, ie FDA to set a new digital standard for sharing Real World Evidence (RWE), to have new treatments approved faster, while ensuring... Read More →


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

10:30am

#330: The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-675-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss advanced analytics techniques such as machine learning and AI and how they bring enormous opportunity for improving clinical development operations, but also significant process and cultural challenges that must be addressed head on.

Learning Objectives

Discuss some immediate term and future possibilities for transforming clinical development operations through application of advanced analytics; Share key process and cultural considerations that may threaten the success of this transformation – and how to address head on.

Chair

Jacqueline Gough, MS

Speaker

Industry Perspective
Gary Thompson, MS

Industry Perspective
Jacqueline Gough, MS



Speakers
JG

Jacqueline Gough

Director, Central Monitoring and Data Surveillance, Astellas
Jackie Gough is the Director for Central Monitoring and Data Surveillance at Astellas. Previously she led the RBM team at Lilly. Jackie began her career as a statistician – first in the academic world, then at a CRO and for the last 15 years on the sponsor side. She has been a member... Read More →
GT

Gary Thompson

Vice President, Strategic Consulting, Medidata Solutions
Gary Thompson, MS, is the VP of Strategic Consulting at Medidata Solutions, focused on helping clients maximize value from the Medidata platform and achieve transformative business goals. Gary has over 24 years of experience in clinical research in a variety of CRO, pharma, and technology... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#331: A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-680-L04-P; CME 1.00; IACET 1.00; RN 1.00

The paperless clinical trial is a paradigm shift that must occur to enable the clinical trial enterprise to embrace the modern era. We will share our experience partnering, planning, and implementing these trials to assure that there is no compromise on patient safety, data integrity, trial efficiencies and regulatory review.

Learning Objectives

Describe the elements of the paperless clinical trial and how it differs from paper-based studies; Discuss the paradigm shift and its impact on the clinical trial stakeholders; Identify how to plan and implement the paperless clinical trial.

Chair

Jules T Mitchel, PhD, MBA

Speaker

Paperless Clinical Trial
Michelle Eli

Paperless Clinical Trial
Thomas Haag



Speakers
avatar for Michelle Eli

Michelle Eli

Clinical Project Management Advisor, Chorus, Eli Lilly and Company
Michelle Eli has worked in the pharmaceutical industry for 28 years with positions primarily in Clinical Project Management and Pharmacokinetics. She started her career at the former Upjohn Company (now Pfizer) and is currently a Clinical Project Management Advisor within the Chorus... Read More →
avatar for Thomas Haag

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC
Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →
avatar for Jules Mitchel

Jules Mitchel

President, Target Health, Inc.
Dr. Mitchel is President and co-founder of Target Health Inc., a New York City-based full service eCRO dedicated to all aspects of Drug and Device Development. He also leads the team at Target Health developing software tools to enable the “Paperless Clinical Trial.” Dr. Mitchel... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#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
avatar for Jack Henningfield

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 →
avatar for Beatrice Setnik

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 →
avatar for Beatrice Setnik

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 →


Wednesday June 26, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Regulator Thinking,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-672-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide a platform to discuss measurement challenges and practical considerations for selection of fit-for-purpose clinical outcome assessments (COAs) to support endpoints in rare disease drug development programs.

Learning Objectives

Discuss practical considerations for utilizing clinical outcome assessments (COAs) to support clinical trial endpoint(s) in drug development; Identify the measurement challenges and recommendations for the selection of COAs for rare disease drug development.

Chair

Michelle Campbell, PhD

Speaker

Generalized Pairwise Comparisons for Benefit/Risk Assessment in Personalized Medicine
Marc E. Buyse, DrSc

Endpoint Selection and Use of Clinical Outcome Assessments (COAs) in Rare Disease Drug Development: A Regulatory Perspective
Lili Garrard, PhD

Selection of Fit-for-Purpose COAs to Support Endpoints in Rare Disease
Jean Paty, PhD



Speakers
avatar for Marc Buyse

Marc Buyse

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

Michelle Campbell

Division of Neurology Products, Office of New Drugs, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →
LG

Lili Garrard

Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA
Lili Garrard is a statistical reviewer on the Clinical Outcome Assessment (COA) Statistical Support Team at the Division of Biometrics III, Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration... Read More →
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Endpoints, IQVIA
Dr. Paty is an acknowledged leader in the effective strategies and practices of capturing patient perspective data for use in the clinical development of new medical products. He has published extensively in the areas of Patient Reported Outcomes (PRO) and electronic PRO (ePRO), as... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#357: Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-696-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include presentations to introduce the new Common SAP and CSR templates, describing how these were designed and the key guiding principles in their structure, content, and format. Attendees will hear learnings from early case studies.

Learning Objectives

Describe the Clinical Template Suite (CPT-SAP-CSR) developed by an industry member consortium; Analyze the new Common Statistical Analysis Plan and Clinical Study Report templates; Explain how this technology enabled edition allows for content use across the protocol, statistical analysis plan and clinical study report.

Chair

Stacy Tegan

Speaker

Panelist
Vivian Combs, MS

Panelist
Kelly Lengyel, MS

Panelist
Yihua Gu, MS



Speakers
VC

Vivian Combs

Advisor/Process Owner, Clinical Information and Process Automation, Eli Lilly and Company
Vivian Combs currently leads the TransCelerate workstream responsible for the development of the TransCelerate Clinical Template eSuite. She is the acting rapporteur for the ICH M11 CESHarP (Clinical Electronic Structured Harmonized Protocol) Expert Working Group, and is a full-time... Read More →
avatar for Yihua Gu

Yihua Gu

Director of Statistics, Abbvie
Yihua has dedicated 22 years of career in Abbott/Abbvie. Her experience spans across immunology, neurology, infectious diseases, and analgesia. Her combined statistical knowledge, scientific insights, the ability to look beyond statistics and the operation excellence have made her... Read More →
avatar for Kelly Lengyel

Kelly Lengyel

Director of Medical Writing, Allergan
Kelly Lengyel is a Director of Medical Writing at Allergan and oversees the medical writing team for multiple therapeutic areas. Kelly has nearly 15 years of regulatory affairs and medical writing experience across multiple pharmaceutical companies. Over the course of her career in... Read More →
avatar for Stacy Tegan

Stacy Tegan

Senior Program Manager, Transcelerate Biopharma Inc.
Stacy Tegan is a Sr. Program Manager at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:00pm

#358: Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-697-L04-P; CME 1.25; IACET 1.25; RN 1.25

Participants will engage in an “overcoming obstacles” activity designed to encourage collaboration among rare disease patients, trial sponsors, and advocates. You will identify obstacles to trial participation and work to develop creative solutions.

Learning Objectives

Describe valuable and detailed input from patients on clinical trial design; Design patient interactions that encourage collaboration among patients, sponsors, and advocacy group; Explain how to optimize clinical trials to ensure they meet the needs of rare disease patients.

Chair

Kelly Franchetti, RN

Speaker

Patient Perspective
Kim Stephens, PhD, MA

Industry Perspective
Kelly Franchetti, RN

Academic Perspective
Ellyn Getz



Speakers
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Ellyn Getz

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP
Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →
avatar for Kim Stephens

Kim Stephens

President, Project Alive - Hunter Syndrome
Dr. Kim Stephens is the President of Project Alive, a nonprofit organization whose mission is to cure Hunter Syndrome/Mucopolysaccharidosis II through research and advocacy. Having a son with Hunter Syndrome herself, this is also a personal mission for Dr. Stephens. Dr. Kim Stephens... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#359: Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-698-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum presents the ePRO Consortium’s best practices recommendations for training subjects and sites on technology use in clinical trials. Sponsor, ePRO vendor, site, and patient perspectives will be shared on training challenges and solutions.

Learning Objectives

Discuss best practice recommendations from the Consortium for training on the use of technology to collect PRO data in clinical trials; Identify challenges associated with training subjects and study sites from a vendor, sponsor, site, and patient perspective.

Chair

Serge Bodart, MS

Speaker

Panelist
Jenny Ly, PhD

Panelist
Patricia DeLong, MS

Panelist
T.J. Sharpe, PMP

Panelist
Jessica Branning



Speakers
avatar for Serge Bodart

Serge Bodart

Senior Advisor, Outcomes Science, CRF Bracket
Serge has extensive experience working in patient outcomes and new technologies. With Dr Bruno Pornel, he founded SYMFO, a European based ePRO provider in 2000. After he sold his company, he acted as the eCOA Subject Matter Expert at Biomedical Systems. Serge is currently Senior Advisor... Read More →
avatar for Patricia DeLong

Patricia DeLong

Manager, Patient-Reported Outcomes, Janssen Global Services, LLC
Patricia (Trish) Shepherd Delong has worked in the PRO and eCOA fields for more than ten years in both contract research and pharmaceutical organizations. She currently holds the role of PRO Process expert within the PRO team at Janssen. In this role Trish represents the PRO functional... Read More →
avatar for Jenny Ly

Jenny Ly

Clinical Science Advisor, ERT
Jenny Ly is currently a Clinical Science Advisor at ERT. She is a neuropsychologist with over 10 years of experience in the management and design of clinical trials. She has extensive experience developing training content for site staff, study participants, and caregivers that align... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog.  He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four... Read More →
avatar for Jessica Branning

Jessica Branning

Owner and Co-Founder, ClinCloud
Jessica Branning is the Co-Founder and Owner of ClinCloud, LLC, a Florida based clinical research site. She has nearly 5 years of clinical research experience in multiple therapeutic areas including Alzheimer's disease, Parkinson's disease, migraine, osteoarthritis, diabetes, and... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-687-L04-P; CME 1.25; IACET 1.25; RN 1.25

Intense research on the multiple fronts advanced our understanding of neurodegenerative diseases. Many disease-specific animal models have been used to test emergent medicines in neurology. Genetics and mechanism of neuronal pathogenesis contributed greatly and has created a wealth of knowledge and became the bases for novel technologies and multiple therapeutic targets for these neurodegenerative diseases. There is however substantial difficulty in choosing/accessing an optimal model or choosing measurements which would be truly informative of the product’s efficacy in neurodegenerative rare diseases or more prevalent diseases like pediatric neurodegenerative diseases and Alzheimer’s. This session will discuss nonclinical models supporting efficacy in rare neurodegenerative conditions, looking also at the challenges in early development in pediatric neurodegenerative diseases and highlight successes and failures in the development of treatments for dyslipidemia that may be applicable to the treatment of neurodegenerative diseases like Alzheimer’s disease.

Learning Objectives

Describe the importance and value of nonclinical in vivo models in rare neurodegenerative conditions and share highlights on the challenges in early development in pediatric neurodegenerative diseases; Identify optimal strategies for testing putative Alzheimer therapies; Recognize how to select and qualify biomarkers to identify patient and measure relevant drug activity; Define how to apply lessons from development of drugs to prevent Alzheimer Dementia.

Chair

Dinah Duarte, MSc

Speaker

Rare Neurodegenerative Diseases: Early-Stage Challenges and Optimal Animal Models in Orphan Drug Development
Dinah Duarte, MSc

Alzheimers Disease Prophylaxis: Lessons from Lipid Therapeutics
Richard Scheyer, MD

The Challenges in Early Development in pediatric Neurodegenerative Diseases
Scott Demarest, MD



Speakers
SD

Scott Demarest

Assistant Professor, Departments of Pediatrics and Neurology, University of Colorado School of Medicine; Children's Hospital Colorado
Scott Demarest received a Bachelor of Science in biology from the University of Texas at Austin before going on to medical school at the University of Texas Health Science Center in San Antonio. He completed his residency in Pediatrics and child neurology at Children's National Health... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY... Read More →


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

2:00pm

#371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-694-L04-P; CME 1.25; IACET 1.25; RN 1.25

Pediatric drug development for adult indications is mandated. Yet children should be protected from unnecessary risks. This session discusses innovative techniques using extrapolation from adult data as an efficient way to study drugs in children.

Learning Objectives

Explain the regulatory and ethical context of pediatric drug development; Discuss the role, assumptions, and data needed for using extrapolation from adult data; Identify innovative approaches using Bayesian methodologies to demonstrate the efficacy of drugs in pediatrics; Discuss ways to integrate pediatric into adult drug development.

Chair

Robert Meland Nelson, MD, PhD

Speaker

The Use of Extrapolation in Pediatric Drug Development
Robert Meland Nelson, MD, PhD

Using Historical Data to Establish More Efficient Clinical Trials
Jeen Liu, PhD

Design and Analytic Strategies for Incorporating External Data in a Global Pediatric Trial
Margaret Gamalo-Stiebers, PhD



Speakers
MG

Margaret Gamalo-Stiebers

Principal Research Scientist, Eli Lilly and Company
JL

Jeen Liu

Associate VP, Biostatistics, Allergan Inc.
I have worked in the Pharma industry for 20+ years as a statistician, currently responsible for biostatistics support of all the ophthalmology products for the company. Prior to joining Allergan, I have worked for Novartis, Astellas and Eisai. My experience in clinical trials covers... Read More →
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development, Johnson & Johnson
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:15pm

#376 EE: Assessing Medical Adherence in a Clinical Trial Setting: Challenges and Solutions
Component Type: Workshop
Level: Intermediate

This workshop will provide a dynamic environment for participants to share experiences related to medication adherence in drug development, and to learn new approaches for collecting, analyzing, and reporting adherence data.

Learning Objectives

Describe the extent of challenges with medication adherence across all phases of drug development; Identify where risk of medication non-adherence with a drug may arise: initiation, implementation and discontinuation; Evaluate strategies to collect, analyze, and report medication adherence across phase 2-3 clinical trial settings.

Chair

Sarah Clifford, PhD, MSc

Speaker

Facilitator
Lina Eliasson, PhD



Speakers
avatar for Sarah Clifford

Sarah Clifford

Senior Principal, Patient-Centered Outcomes, ICON Clinical Research, Inc
Sarah Clifford is Senior Principal and Division Leader for ICON’s Patient Centered Outcomes’ West Coast Division, where she oversees the development and execution of the PCO scientific strategy. She has 20 years of experience in patient-reported outcomes and health-services research... Read More →
avatar for Lina Eliasson

Lina Eliasson

Founding Director, Sprout Behaviour Change Ltd
As a Behavioral Psychologist, I specialize in understanding, measuring and improving treatment adherence, in clinical trials and in the real world. My experience spans the worlds of academic research, and the commercial sector. I worked as a post-doc researcher at Imperial College... Read More →


Wednesday June 26, 2019 3:15pm - 4:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#378.1 SB: On the Soapbox: Good for People and Good for Research - Individuals as Research Partners
Component Type: Forum
Level: Basic
CE: ACPE 0.50 Knowledge UAN: 0286-0000-19-737-L04-P; CME 0.50; IACET 0.50; RN 0.50

The intersection of data privacy and an acknowledgement that research data lacks depth, diversity, and real-world information are driving new health database models. The benefits of promoting people from subjects to research partners will be covered.

Learning Objectives

Identify new models in patient engagement and data stewardship towards richer research; Analyze how patient privacy and data connectivity can co-exist; Explore the benefits of patients as partners in research versus research subjects.

Chair

Dawn Barry, MBA


Speakers
avatar for Dawn Barry

Dawn Barry

President and Co-Founder, LunaPBC
Dawn Barry is President and Co-founder of Public Benefit Corporation, LunaPBC. LunaPBC launched LunaDNA, the first people-powered health data sharing platform owned by its community of data donors. LunaDNA members share in the value created by the platform through the offering of... Read More →


Wednesday June 26, 2019 3:30pm - 4:00pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

4:15pm

#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
avatar for Christine Brown

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 →
JN

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 →
avatar for Jamie Wilkins

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 →
avatar for Elaine Morrato

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 →


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

4:15pm

#381: A New Path Forward for Using Decentralized Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-713-L04-P; CME 1.25; IACET 1.25; RN 1.25

Barriers are hindering the widespread use of decentralized clinical trials. However, new recommendations developed by CTTI offer new approaches to improve recruitment and retention, participant diversity, and the research experience for patients.

Learning Objectives

Describe proven methods for executing decentralized clinical trials through telemedicine and mobile healthcare providers; Discuss actionable recommendations for navigating state medical licensing laws and issues with drug supply chain of custody; Identify the broad continuum of hybrid protocol designs possibilities for implementing decentralized clinical trials.

Chair

Penny Randall, MD

Speaker

Panelist
Laura Byrnes Podolsky, JD, MPH

Panelist
Gail Adinamis

Panelist
Michael O'Brien, CPA



Speakers
avatar for Gail Adinamis

Gail Adinamis

CEO, GlobalCare Clinical Trials, LLC
Ms Adinamis has >35 yrs of global clinical trials experience including tenures at Abbott and Astellas. She established & headed clinical trials divisions for 3 national home infusion companies then started an independent ambulant care service company for clinical trials in 2004 where... Read More →
avatar for Michael O'Brien

Michael O'Brien

Chief Strategy Officer, The Avoca Group
Michael brings more than 30 years of executive management experience in the life sciences and information technology industries. Michael is currently the Chief Strategy Officer for The Avoca Group. For the prior 5 years, Michael has been an early pioneer in the development and support... Read More →
LP

Laura Podolsky

General Counsel, Science 37, Inc.
Laura is a health care lawyer focusing on novel healthcare technologies. She has served as Science 37's General Counsel since its founding, assisting the company in navigating legal and regulatory issues surrounding decentralized clinical trials. She earned her JD from the UCLA School... Read More →
avatar for Penny Randall

Penny Randall

Vice President and Head, CNS Center of Excellence, IQVIA
Dr. Randall is Vice President and Head of the CNS Center of Excellence at IQVIA. Her scientific focus is on optimizing trial design and implementation to minimize the risk of inconclusive trials. She is also interested in leveraging disruptive technologies to modernize and accelerate... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#380: Incorporating Patient Input into the Design and Conduct of Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-712-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will outline efforts, best practices, and key considerations to enhance the incorporation of patient input into the design and conduct of clinical trials.

Learning Objectives

Outline current efforts and opportunities to incorporate patient input into the design and conduct of clinical trials (CT); Discuss approaches, best practices, and key considerations to facilitate patient recruitment, enrollment and retention, and minimize the burden of patient participation in CTs; Identify opportunities to enhance patient engagement and ensure patient input informs CTs.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Alexis Reisin Miller, JD

Panelist
Michelle Tarver, MD, PhD

Panelist
Marilena Flouri, PhD

Panelist
Mary Elmer, BSN, MSN, RN

Panelist
T.J. Sharpe, PMP



Speakers
avatar for Meghana Chalasani

Meghana Chalasani

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

Alexis Miller

Senior Director, Regulatory Science and Policy, Sanofi
Alexis is a Senior Director for Sanofi Global Regulatory Science & Policy, helping to shape the regulatory and policy environment on topics like patient-focused drug development, digital health technology regulation, and various PDUFA initiatives and FDA program implementation. Prior... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, OST, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Under her leadership, CDRH is making... Read More →
avatar for Mary Elmer

Mary Elmer

Executive Director, Patient, Caregiver and Consumer Experience, Patient Engagement Operations, Merck
Mary Elmer is the Executive Director, Patient, Caregiver, and Consumer Experience, Patient Engagement Operations at Merck. This group seeks to create an experience that engages consumers and patients in optimizing their health, wellbeing, and healthcare outcomes.She also leads a team... Read More →
MF

Marilena Flouri

Mathematical Statistician, OTS, CDER, FDA
Marilena is a statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Marilena joined the FDA in 2016 immediately after receiving her Ph.D. in Statistics from the University of Maryland... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog.  He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#385: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-704-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how human-focused translational technologies help ensure the safety and efficacy of novel therapies, reduce product development costs, shorten time to market and provide an unprecedented opportunity to unlock new possibilities for preclinical drug discovery.

Learning Objectives

Discuss the importance of human cells and/or tissue in early drug discovery for success in clinical trials; Identify strategies for using human cells and/or tissue in every stage of preclinical research (i.e., from target identification to lead optimization and into phase 1; Identify from case studies that describe how data from human cells/tissues can be more predictive than in vivo animal studies.

Chair

Christopher Mathes, PhD, MBA

Speaker

Industry Perspective
Andre Ghetti, PhD

PMDA Update
Satoshi Tsunoda

Translation of Safety Pharmacology Testing to Human Trials: What Do We Know?
Hugo M Vargas, PhD



Speakers
avatar for Andre Ghetti

Andre Ghetti

Chief Executive Officer, AnaBios
Andre Ghetti, PhD, is our Chief Executive Officer. During the last several years, Dr. Ghetti focused on the creation of new tools and strategies to advance biomedical sciences, with special emphasis on enabling the direct study of human biology and pharmacology to accelerate the rate... Read More →
avatar for Christopher Mathes

Christopher Mathes

Chief Commercial Officer, AnaBios
As Chief Commercial Officer (CCO) of AnaBios, Dr. Chris Mathes provides leadership in business development & contributes to strategic direction. Previously, Mathes acted as CCO of Icagen. led the North American business development team for Discovery Services at Charles River & was... Read More →
avatar for Satoshi Tsunoda

Satoshi Tsunoda

Deputy Specialist, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Hugo Vargas

Hugo Vargas

Executive Director, Amgen Inc.
I am an Executive Director at Amgen, and lead the Safety Pharmacology & Animal Research Center (SPARC) department. My team includes 60+ staff (Thousand Oaks, San Francisco, Burnaby BC) and we contribute actively and extensively to the entire drug discovery and development pipeline... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-709-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will cover regulatory and research perspectives on challenges and opportunities for selecting, developing and implementing fit-for-purpose digital technology tools for to derive study endpoints to support drug development.

Learning Objectives

Describe the regulatory and practical consideration for successfully selecting, developing, and implementing patient-focused digital technology tools for use to derive study endpoints (e.g., accelerometer or mobile technology derived endpoints) that are fit for purpose for use in clinical trials to support drug development.

Chair

Ebony Dashiell-Aje, PhD

Speaker

What Can Technology-Derived Endpoint Tell us About the Patient’s Experience?
Jean Paty, PhD

Fit-for-Purpose in the Digital Era: Digital Measurement Tools in Clinical Trials
Jennifer Goldsack, MA, MBA, MS

Fit-for-Purpose Digital Health Technology Driven Study Endpoints: Regulatory Considerations for Implementation
Ebony Dashiell-Aje, PhD



Speakers
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Clinical Outcome Assessments Reviewer, COA Staff, OND, CDER, FDA
Dr. Dashiell-Aje is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Center for Drug Evaluation and Research (CDER) at the FDA. She serves as an expert consultant to CDER and other FDA Centers (e.g., CDRH, CBER), advising on COAs, study endpoint issues and regulatory... Read More →
avatar for Jennifer Goldsack

Jennifer Goldsack

Interim Executive Director, Digital Medicine Society (DiMe)
Jen Goldsack is the Interim Executive Director of the Digital Medicine (DiMe) Society and is Vice President of Digital Measurement at monARC Bionetworks.
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Endpoints, IQVIA
Dr. Paty is an acknowledged leader in the effective strategies and practices of capturing patient perspective data for use in the clinical development of new medical products. He has published extensively in the areas of Patient Reported Outcomes (PRO) and electronic PRO (ePRO), as... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#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
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA)
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 →
avatar for Stephen Corson

Stephen Corson

Senior Statistician, Phastar
I am a Senior 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... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →


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

4:15pm

#395: Utilization and Evaluation of Innovative Approaches for Efficient Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-716-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to promote utilization of innovative methodologies such as M&S and Bayesian approach for efficient drug development. Regulators will present their recent activities for reviewing/qualifying innovative methodologies and share their experiences.

Learning Objectives

Identify how to recognize innovative methodologies recently applied for efficient new drug development and related activities in regulatory agencies aiming at accelerating drug development; Discuss how to consider the use of such methodologies in drug development through better communication between industry and regulatory agencies.

Chair

Yuki Ando, PhD

Speaker

Utilization and Evaluation of Innovative Methodologies: PMDA Perspective
Yuki Ando, PhD

Extrapolation: Recent European Regulatory Considerations
Andrew Thomson, PhD, MA, MS

Model-Based Bayesian Methods in Pharmaceutical Clinical Trials
Neal Thomas, PhD



Speakers
YA

Yuki Ando

Senior Scientist for Biostatistics, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She received a master’s degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University. Currently she is responsible for the... Read More →
avatar for Neal Thomas

Neal Thomas

Executive Director, Biostatistics, Pfizer Inc
Neal Thomas joined Pfizer in 2002, and has been a member of the Statistics Research and Innovation center since 2004 where he has worked on clinical and non-clinical applications in many therapeutic areas. He received a PhD in Statistics from the University of Chicago, and he was... Read More →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
Andrew Thomson is a statistician in the Office of Biostatistics & Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Thursday, June 27
 

9:00am

#404: Investigational Medicinal Products: eLabeling Initiative, Supply Forecasting Strategies, and Patient-Centric Technology for Medicine Adherence
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-725-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss three key aspects in digitally supporting Investigational Medicinal Product (IMP) management and adherence. The topics include a cross-industry patient-centric eLabeling initiative, next generation clinical supply forecasting, and a case study of patient centric technology supporting medication adherence.

Learning Objectives

Discuss concepts of eLabeling and digitally supported, patient-centric clinical supply chains; Describe the clinical forecasting landscape and evaluate the role of technology to support supply strategies; Describe a case study of patient-centric technology supporting medical adherence.

Chair

Mark Paul, MBA

Speaker

Leveraging Real World Evidence and Patient-Centric Technology to Drive a Virtual Study of Treatment Adherence: A Case Study
Mark Paul, MBA

Evolving Clinical Supply Forecasting Strategies to Drive Supply Chain Efficiency
Jan Pieter Kappelle, MS

eLabels: A Cross-Industry Perspective on Managing IMP with Patient-Centric Technology
Jennie Deem, BSN, RN



Speakers
JD

Jennie Deem

Regulatory Consultant, Clinical Trial Labeling and Supplies, Eli Lilly and Company
Jennie Deem is a Regulatory Consultant, Clinical Trial Labeling and Supplies, at Eli Lilly and Company.  She has over 15 years of experience in international regulatory affairs, global clinical supplies and pharmacovigilance spanning multiple therapeutic areas.  In her current role... Read More →
JP

Jan Pieter Kappelle

Vice President, Strategy, 4G Clinical
Jan Pieter (JP) Kappelle, 4G Clinical Vice President of Strategy, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies. JP has a strong financial background... Read More →
MP

Mark Paul

Customer Success Manager, Medable Inc.
Mark Paul has served in progressive management positions in the clinical trials industry for over 25 years. Mr. Paul began his career in clinical research at Quintiles as a clinical programmer and project manager. Mr. Paul was Project Director for several global clinical programs... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

9:00am

#405: eSource and the Sites: Have They Bonded?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-726-L04-P; CME 1.25; IACET 1.25; RN 1.25

In an era where technology has taken over almost every form of information dissemination and data collection; at the clinical investigative site level, there still remains a divided and skeptical attitude towards the most efficient way to collect data. While most pharmaceutical and biotech companies have adopted the use of EDC, eCRFs and almost every type of electronic capture of clinical trial data, clinical trial sites are still struggling between using the standard patient chart in a manila folder or three ring binder as the repository of their source documents versus the use of electronic source documents or EMR.

In this session, pros and cons, issues and challenges, opportunities and solutions will be discussed and debated. Current trends and status of adoption of technology by different site models, as an ideal way of improving efficiency of collecting data will likewise be reviewed.

Learning Objectives

Identify advantages and disadvantages of using eSource; Discuss the ways of transitioning use of paper source to eSource.

Chair

Nadina Jose, MD

Speaker

Panelist
Avik Kumar Pal, MBA



Speakers
avatar for Nadina Jose

Nadina Jose

Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative, Rutgers, The State University of New Jersey
Rejoined academia on Oct 2016 and is currently Assistant Professor at Rutgers University, Department of Health Informatics, Biopharma Education Initiative, School of Health Professions MS in Clinical Research Management. Dr. Jose is the Founder and President of Anidan Group Pte. Ltd... Read More →
avatar for Avik Pal

Avik Pal

Chief Executive Officer, CliniOps
Avik is the CEO of CliniOps, a mobile, cloud-based, digital solutions company, for the clinical trial industry & global health research. Prior to that, he worked with two successful startups and is a Founding Board member at iKure, a healthcare startup. He is passionate about Global... Read More →


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