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CHIP Frontline Dispatch Seminar - Dr. Aaron Kesselheim
Dr. Aaron Kesselheim, former member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee who resigned over the agency’s approval of Aducanumab, will speak about the FDA’s accelerated approval pathway, how it is implemented, and how it was applied in the controversial Aducanumab case – which he dubbed the “worst drug approval decision in recent U.S. history.” Dr. Kesselheim will also give suggestions for the future. This should be a fascinating talk with wide implications for all future accelerated drug approval pathways.

Sep 23, 2021 04:00 PM in Eastern Time (US and Canada)

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Speakers

Aaron Kesselheim, MD, JD, MPH
Professor of Medicine @Harvard Medical School
Aaron S. Kesselheim MD JD MPH is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (PORTAL, www.PORTALresearch.org), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. PORTAL is now among the largest, independent academic centers focusing on these issues in the country (Twitter: @PORTAL_research, @akesselheim). Dr. Kesselheim received his medical and legal training at the University of Pennsylvania and his M.P.H. at the Harvard School of Public Health. Author of over 450 publications in the peer-reviewed medical and health policy literatures, Aaron has testified before Congress on pharmaceutical policy and medical device regulation.