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

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

Workshop 1: Incentives

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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 Series Background, Sequence, and Focus

The National Academies of Sciences, Engineering, and Medicine (National Academies) is convening a three-part workshop series, sponsored by the U.S. Food and Drug Administration, examining how real-world evidence development and uptake can enhance medical product development and evaluation. The workshops will advance discussions and common knowledge about complex issues relating to the generation and utilization of real-world evidence, including fostering development and implementation of the science and technology of real-world evidence generation and utilization.

  • Workshop One (September 19–20, 2017) focused 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. 
  • Workshop Two (March 67, 2018) will illuminate what types of data are appropriate for what specific purposes and suggest practical approaches for data collection and evidence use by developing and working through example use cases. 
  • Workshop Three (July 1718, 2018) will examine and suggest approaches for operationalizing the collection and use of real-world evidence. 


Workshop Series 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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