Vice President and Senior Scientist

Marc L. Berger, MD, retired in July 2017 after serving five years as Vice President, Real World Data and Analytics (RWDnA) at Pfizer, Inc. During his career, Marc has held senior-level positions in the industry including Executive Vice President and Senior Scientist at OptumInsight; Vice President, Global Health Outcomes at Eli Lilly and Company; and Vice President, Outcomes Research and Management at Merck & Co., Inc. He currently serves as Chair of the Real World Evidence Advisory Board for SHYFT Analytics. During his career in the industry, he was involved with all aspects of drug development and commercialization including the design and execution of Phase 2/3/4 clinical trials, real world data studies, and market access strategies.

Marc earned his M.D. from Johns Hopkins University School of Medicine in Baltimore, Maryland. He has held adjunct appointments as Senior Fellow at the Leonard Davis Institute at the Wharton School of the University of Pennsylvania and Professor in the Department of Health Policy and Administration at the University of North Carolina at Chapel Hill School of Public Health.

During his career, Marc has served on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) for CMS, the steering committee for the AHRQ Centers for Research and Education on Therapeutics (CERTs), the board of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Advisory Council for North America (ACNA) of the DIA, the editorial advisory board of Value in Health and has chaired the Innovative Technology Advocacy Committee of PhRMA.

Marc is also actively involved in promoting best practices for the leveraging of real world data to inform healthcare decision making.  He co-chaired the recent joint ISPOR-ISPE Task Force on enhancing the credibility of real-world evidence for decision making.  He also is a member of the Advisory Group for the Real-World Evidence Collaborative at the Duke-Margolis Center for Health Policy that will be holding workshops in 2018 on what constitutes quality in real world data and in what circumstances could real world evidence be considered substantial and therefore suitable for regulatory bodies to consider in making label changes.