About
Aaron Seth Kesselheim is a Professor of Medicine at Harvard Medical School and Visiting Professor of Law at Yale Law School. He holds dual appointments in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and as a faculty member at the Harvard Medical School Center for Bioethics. He leads the Program On Regulation, Therapeutics, And Law (PORTAL) research group and maintains clinical practice as a primary care physician at the Phyllis Jen Center.
His educational background includes:
- A.B. from Harvard University (1996)
- M.D. and J.D. from University of Pennsylvania (2002)
- M.P.H. from Harvard School of Public Health (2007)
Dr. Kesselheim's research examines intersections between pharmaceutical regulation, intellectual property law, and patient health outcomes. His work spans pharmacoepidemiology, pharmacoeconomics, and health policy with focus on drug pricing, regulatory pathways, and global access to medicines. He has pioneered research on biologics substitution, generic drug competition, and FDA approval processes through PORTAL's interdisciplinary framework.
His contributions have been recognized through:
- Greenwall Faculty Scholar in Bioethics (2013)
- Robert Wood Johnson Investigator Award in Health Policy Research
Current research funding comes from Arnold Ventures, Harvard-MIT Center for Regulatory Science, and Engelberg Foundation. Past support includes Agency for Healthcare Research and Quality, FDA, Robert Wood Johnson Foundation, Edmond J. Safra Center for Ethics, and Pew Charitable Trusts. He has testified before Congress six times, serves on the FDA Peripheral and Central Nervous System Advisory Committee, and chairs National Academies committees on opioid policy. As editor-in-chief of the Journal of Law, Medicine, and Ethics, he bridges legal and medical scholarship while directing PORTAL's research on pharmaceutical regulation.
PORTAL operates as one of the nation's largest independent academic centers studying therapeutics regulation, with over 450 publications and global impact through initiatives like the edX course 'FDA and Prescription Drugs' reaching 10,000+ participants worldwide.
