Aaron Seth Kesselheim

Aaron Seth Kesselheim, MD, JD, MPH

Professor of Medicine
Member, HMS Center for Bioethics

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, is 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 View
An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19.
Authors: Authors: Kesselheim AS, Darrow JJ, Kulldorff M, Brown BL, Mitra-Majumdar M, Lee CC, Moneer O, Avorn J.
Health Aff (Millwood)
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Characteristics of Clinical Trials Launched Early in the COVID-19 Pandemic in the US and in France.
Authors: Authors: Raimond V, Mousquès J, Avorn J, Kesselheim AS.
J Law Med Ethics
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INTRODUCTION: Public Sector and Non-Profit Contributions to Drug Development - Historical Scope, Opportunities, and Challenges.
Authors: Authors: Sarpatwari A, Kesselheim AS.
J Law Med Ethics
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Public funding for transformative drugs: the case of sofosbuvir.
Authors: Authors: Barenie RE, Avorn J, Tessema FA, Kesselheim AS.
Drug Discov Today
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Promoting Competition in Drug Pricing: A Review of Recent Congressional Legislation.
Authors: Authors: Nagar S, Kesselheim AS.
J Law Med Ethics
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Social, cultural and economic aspects of antimicrobial resistance.
Authors: Authors: Minssen T, Outterson K, Rogers Van Katwyk S, Batista PHD, Chandler CIR, Ciabuschi F, Harbarth S, Kesselheim AS, Laxminarayan R, Liddell K, Osterholm MT, Price L, Hoffman SJ.
Bull World Health Organ
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Comparing Onset of Biosimilar Versus Generic Competition in the United States.
Authors: Authors: Beall RF, Ronksley PE, Wick J, Darrow JJ, Sarpatwari A, Kesselheim AS.
Clin Pharmacol Ther
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Generic Competition for Drugs Treating Rare Diseases.
Authors: Authors: Beall RF, Quinn AE, Kesselheim AS, Tessema FA, Sarpatwari A.
J Law Med Ethics
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Up Is Down - Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval.
Authors: Authors: Avorn J, Kesselheim AS.
N Engl J Med
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Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.
Authors: Authors: Rome BN, Kesselheim AS.
Clin Infect Dis
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Address: 
Brigham and Women's Hospital
Boston, MA 02120