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The Role of Real-World Evidence in Regulatory and Value-Based Payment Decision-making

Bipartisan Policy Center
1225 Eye St NW, Suite 1000
Washington, DC 20005
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The number of new therapies available to patients is growing at a considerable pace, showing promise for those with cancer, neurodegenerative conditions, and other diseases. At the same time, the amount of clinical and patient-generated data is increasing exponentially, with a majority of the nation’s providers now using electronic health records and individuals increasingly using digital tools to manage their health and health care.

New and more timely sources of data derived from patients and the clinical care process after the opportunity to speed the discovery, development, and delivery of safe and effective drugs and biologics and inform decision-making on payment.

Join the current and former FDA commissioners to explore the ways in which new data sources can serve as evidence for both regulatory evaluation and value-based payment programs.

The event will be webcast. 

Keynote remarks by:

Scott Gottlieb, MD
Commissioner, FDA

Panel discussion with:

Robert Califf, MD, PhD
Professor of Medicine, Donald F. Fortin, MD Professor of Cardiology, Duke School of Medicine
Former Commissioner, FDA

Mark McClellan, MD, PhD
Founding Director, Duke-Margolis Center for Health Policy
Former Administrator, CMS
Former Commissioner, FDA

Andrew von Eschenbach, MD
President, Samaritan Health Initiatives
Former Commissioner, FDA
Former Director, National Cancer Institute

Moderated by:

Janet Marchibroda
Fellow, Health Innovation, BPC

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