Frontline Dispatch Series: Accelerated Drug Approval and Aducanumab

Speaker: Aaron Kesselheim, MD, JD, MPH, at Harvard Medical School

Date: September 23, 2021 at 4:00PM - 5:30PM

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.

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, medical device regulation, generic drugs, and modernizing clinical trials, was a member of the FDA Peripheral and Central Nervous System Advisory Committee, and served on a National Academies of Science, Engineering and Medicine consensus committees on addressing the opioid epidemic and bioidentical hormone replacement. At the HMS Center for Bioethics, he co-teaches a course on health policy, law, and bioethics and organizes the monthly policy and ethics consortium.


Publications

Nelson LF, Weitzman ER, Levy S. Prevention of Substance Use Disorders. The Medical clinics of North America 2022.

Kristensen NP, Heeke C, Tvingsholm SA, Borch A, Draghi A, Crowther MD, Carri I, Munk KK, Holm JS, Bjerregaard AM, Bentzen AK, Marquard AM, Szallasi Z, McGranahan N, Andersen R, Nielsen M, Jönsson GB, Donia M, Svane IM, Hadrup SR. Neoantigen-reactive CD8+ T cells affect clinical outcome of adoptive transfer with tumor-infiltrating lymphocytes in melanoma. The Journal of clinical investigation 2021.

Perlis RH, Green J, Simonson M, Ognyanova K, Santillana M, Lin J, Quintana A, Chwe H, Druckman J, Lazer D, Baum MA, Della Volpe J. Association Between Social Media Use and Self-reported Symptoms of Depression in US Adults. JAMA network open 2021.

Kossowsky J, Weitzman ER. Instrumental Substance Use Among Youth with Rheumatic Disease-A Biopsychosocial Model. Rheumatic diseases clinics of North America 2022.

Taxter AJ, Natter MD. Using the Electronic Health Record to Enhance Care in Pediatric Rheumatology. Rheumatic diseases clinics of North America 2022.