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Marc L. Berger, MD

Marc L. Berger, MD

Advisory Board Member

Marc is a retired, part-time consultant.  Until July 2017, he was Vice President, Real World Data and Analytics (RWDnA) at Pfizer, Inc. Marc has held senior-level positions in 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 and as an advisor to EvidScience, Inc. During his career in industry, he has been 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 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 Healthand has chaired the Innovative Technology Advocacy Committee of PhRMA.

Marc has written or co-written more than 100 peer-reviewed articles, book chapters, and other publications on a range of topics including health services research, outcomes research, health economics, and health policy. He co-edited “Health Care, Cost, Quality, and Outcomes – ISPOR Book of Terms” which was published in 2003 and was subsequently translated into nine languages.  His current research focuses on rapid cycle analytics of real world data including electronic health records to provide timely insights into the outcomes associated with alternative therapeutic strategies and the use of big data and advanced analytics (including machine learning) to develop predictive models in support of precision medicine drug development and to support a learning healthcare system.

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.