Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics August 2019 LEADERSHIP William H
Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics August 2019 LEADERSHIP William H. Frist, M.D. Mark McClellan, M.D., Ph.D. Former U.S. Senate Majority Leader Robert J. Margolis Professor of Business, Medicine, Senior Fellow, Bipartisan Policy Center and Policy, Duke University Founding Director, Duke-Margolis Center for Robert Califf, M.D., Ph.D. Health Policy Professor of Medicine, Donald F. Fortin, M.D., Former Administrator, Centers for Medicare and Professor of Cardiology, Duke School of Medicine Medicaid Services Member, Duke Clinical Research Institute Former Commissioner, Food and Drug Administration Former Commissioner, Food and Drug Administration Andrew von Eschenbach, M.D. President, Samaritan Health Initiatives Former Commissioner, Food and Drug Administration Former Director, National Cancer Institute Senior Fellow, Bipartisan Policy Center STAFF G. William Hoagland Janet M. Marchibroda Senior Vice President Fellow, Bipartisan Policy Center CONSULTANTS Gregory Daniel, Ph.D., R.Ph. Morgan Romine Deputy Director, Duke Margolis Center for Research Director, Duke Margolis Center for Health Policy Health Policy Clinical Professor, Fuqua School of Business, Mark Segal, Ph.D., FHIMSS Duke University Principal, Digital Health Policy Advisors ACKNOWLEDGMENTS The Bipartisan Policy Center would like to thank the Jayne Koskinas Ted Giovanis Foundation for Health and Policy for their generous support for this project. BPC would like to thank the leadership of this effort, including Senator Bill Frist, Dr. Rob Califf, Dr. Mark McClellan, and Dr. Andrew von Eschenbach, for their guidance, as well as Morgan Romine, Gregory Daniel, Mark Segal, and Ann Gordon who contributed to the development of this report.
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