Examining the Impact of Real-World Evidence on Medical Product Development: Application
Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series
Workshop 3: Application
Tuesday, July 17, 2018 | 8:30 a.m. – 5:30 p.m.
Wednesday, March 18, 2018 | 8:00 a.m. – 12:00 p.m.
National Academy of Sciences
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 FDA, 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 6–7, 2018) was a “town-hall” style meeting with active audience participation to illuminate what types of data are appropriate for what specific purposes and to suggest approaches for data collection and evidence use by developing and working through example use cases.
- Workshop Three (July 17–18, 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–Margolis 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
- John Graham, GlaxoSmithKline
- Adam Haim, Chief, Treatment and Preventive Intervention Research Branch, Division of Services and Intervention Research, National Institute of Mental Health, NIH
- Michael Horberg, Kaiser Permanente Mid-Atlantic Medical Group
- Richard Kuntz, Senior Vice President Chief Scientific, Clinical & Regulatory Officer, Medtronic, Inc.
- Elliott Levy, Senior Vice President, Global Development, Amgen Inc.
- David Madigan, Professor of Statistics, Executive Vice President and Dean, Faculty of Arts and Sciences, Columbia University
- Deven McGraw, Ciitizen
- Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Medical School
- Joanne Waldstreicher, Chief Medical Officer, Johnson & Johnson
- Marcus Wilson, President, HealthCore, Inc.
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