Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series | Workshop 1: Incentives

When: September 19, 2017 - September 20, 2017 (8:30 AM Eastern)

Topic Biomedical and Health Research
Activity: Forum on Drug Discovery, Development, and Translation
Board: Board on Health Sciences Policy

Workshop Series Background, Sequence, and Focus

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) will plan and conduct a three-part workshop series to be held over the course of a two-year period. As part of FDA's continued focus on building a national governance system for evidence generation, the proposed focus of these workshops will be on the generation and utilization of real-world evidence to evaluate efficacy, effectiveness, tolerability, and safety for both review of new indications and postapproval studies. These workshops would include presentations and perspectives from thought and knowledge leaders representing a range of disciplines, including but not limited to federal regulatory and funding agencies, clinical and academic medicine and research, medical professional organizations, the regulated biopharmaceutical industry, patients and patient-focused and disease-advocacy organizations, payers, consumer organizations, health systems, and other interested stakeholders that represent the myriad views of those involved in drug, biologic, and device discovery, development, translation, and regulation. The workshop audiences are expected to be similarly diverse, and they will have opportunities to engage in discussion during the workshops.
  • The objectives of the workshops are:
    • To advance discussions and common knowledge among key stakeholders (including FDA and the public) about complex issues relating to the generation and utilization of real-world evidence.
    • To foster development and implementation of the science and technology of real-world evidence generation and utilization.

 Workshop One (September 19-20, 2017)

  • This workshop will focus on how to align incentives to support collection and use of real-world evidence in health product review, payment, and delivery. Incentives need to address barriers impeding the uptake of real-world evidence, including barriers to transparency.
  • Staff or invited experts will prepare background papers describing the characteristics of, and gaps in, current data generation efforts. Thought leaders will be invited to react to and build on the papers.

Workshops Two and Three (2018)
  • Workshop Two will explore what types of data are appropriate for what specific purposes and suggest approaches for data collection that match the “right data to the right questions”.
  • Workshop Three will foster discussions that will examine and suggest approaches for operationalizing the collection and use of real-world evidence.
  • The workshop series will employ case studies to illustrate the current state and illuminate potential ways forward.



Workshop 1: Incentives

Tuesday, September 19, 2017 | 8:00 a.m. – 5:30 p.m.
Wednesday, September 20, 2017 | 8:00 a.m. – 12:30 p.m.

National Academy of Sciences
Lecture Room

2101 Constitution Avenue, NW
Washington, DC 20418


Workshop 1: Incentives Planning Committee Roster

Mark McClellan (Series Co-Chair)Director, Duke-Robert J. Margolis, MD Center for Health Policy 
Gregory Simon (Series Co-Chair)Investigator, Kaiser Permanente Washington Health Research Institute 

Jeff Allen, President and CEO, Friends of Cancer Research
Andrew Bindman, Professor of Medicine and Epidemiology & Biostatistics, University of California, San Francisco
Adam Haim, Chief, Treatment and Preventive Intervention Research Branch, Division of Services and Intervention Research, National Institute of Mental Health, NIH
Petra Kaufmann, Director, Office of Rare Diseases Research Director, Division of Clinical Innovation, National Center for Advancing Translational Sciences, NIH
Richard Kuntz, Senior Vice President Chief Scientific, Clinical & Regulatory Officer, Medtronic, Inc.
Elliott Levy, Senior Vice President, Global Development, Amgen
David Madigan, Professor of Statistics, EVP and Dean, Faculty of Arts and Sciences, Columbia University
Deven McGraw, Deputy Director, Health Information Privacy, Office for Civil Rights, US Department of Health and Human Services
John David Nolen, Physician Executive, Clinical Strategy, Cerner Corporation
Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Medical School
Patrick Vallance, President, Research and Development, GlaxoSmithKline
Joanne Waldstreicher, Chief Medical Officer, Johnson&Johnson
Marcus Wilson, President, HealthCore, Inc.

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