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

Hopper RK, Abman SH, Elia EG, Avitabile CM, Yung D, Mullen MP, Austin ED, Bates A, Handler SS, Feinstein JA, Ivy DD, Kinsella JP, Mandl KD, Raj JU, Sleeper LA, . Pulmonary Hypertension in Children with Down Syndrome: Results from the Pediatric Pulmonary Hypertension Network Registry. The Journal of pediatrics 2022.

Wang X, Zhang HG, Xiong X, Hong C, Weber GM, Brat GA, Bonzel CL, Luo Y, Duan R, Palmer NP, Hutch MR, Gutiérrez-Sacristán A, Bellazzi R, Chiovato L, Cho K, Dagliati A, Estiri H, García-Barrio N, Griffier R, Hanauer DA, Ho YL, Holmes JH, Keller MS, Klann MEng JG, L'Yi S, Lozano-Zahonero S, Maidlow SE, Makoudjou A, Malovini A, Moal B, Moore JH, Morris M, Mowery DL, Murphy SN, Neuraz A, Yuan Ngiam K, Omenn GS, Patel LP, Pedrera-Jiménez M, Prunotto A, Jebathilagam Samayamuthu M, Sanz Vidorreta FJ, Schriver ER, Schubert P, Serrano-Balazote P, South AM, Tan ALM, Tan BWL, Tibollo V, Tippmann P, Visweswaran S, Xia Z, Yuan W, Zöller D, Kohane IS, Avillach P, Guo Z, Cai T, . SurvMaximin: Robust federated approach to transporting survival risk prediction models. Journal of biomedical informatics 2022.

Torous J, Stern AD, Bourgeois FT. Regulatory considerations to keep pace with innovation in digital health products. NPJ digital medicine 2022.

Levy S, Wisk LE, Minegishi M, Ertman B, Lunstead J, Brogna M, Weitzman ER. Association of Screening and Brief Intervention With Substance Use in Massachusetts Middle and High Schools. JAMA network open 2022.

Nielsen M, Presti M, Sztupinszki Z, Jensen AWP, Draghi A, Chamberlain CA, Schina A, Yde CW, Wojcik J, Szallasi Z, Crowther MD, Svane IM, Donia M. Co-existing alterations of MHC class I antigen presentation and IFNγ signaling mediate acquired resistance of melanoma to post-PD-1 immunotherapy. Cancer immunology research 2022.