Aaron Seth Kesselheim, M.D.
|Title||Associate Professor of Medicine|
|Institution||Brigham and Women's Hospital|
|Address||Brigham and Women's Hospital|
Pharmacoepidemiology, Suite 3030
1620 Tremont St
Boston MA 02120
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|2010||Alice Hersh New Investigator Award|
|2014||Chair's Research Award|
|2015 - 2016||Young Mentor Award|
|2016||Research Leadership Award|
Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate 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. He graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. He has also investigated how other issues at the intersection of law and public health can affect the health care system, including health care fraud, expert testimony in malpractice cases, and insurance reimbursement practices. He is a member of the New York State Bar and is a Patent Attorney.
Within the Division, Dr. Kesselheim leads the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. In 2013, Dr. Kesselheim was named a Greenwall Faculty Scholar in Bioethics by the Greenwall Foundation, which supports innovative empirical research in bioethics. Dr. Kesselheim’s work is also currently funded by the FDA, Laura and John Arnold Foundation, and by a Robert Wood Johnson Investigator Award in Health Policy Research. In the past, he has received research support from the Edmond J. Safra Center for Ethics at Harvard University, AHRQ, Pew Charitable Trusts, and the Harvard Clinical and Translational Science Center.
Dr. Kesselheim has received wide recognition for his work. In 2012, he was named to the Perspectives Advisory Board of the New England Journal of Medicine. He has testified before Congress on pharmaceutical policy, medical device regulation, and modernizing clinical trials, and served as a consultant for the NIH, FDA, Institute of Medicine, USPTO, and numerous state government offices. He has been a visiting scholar at the Yale School of Medicine and School of Management, Johns Hopkins Medical School, and Memorial Sloan Kettering Cancer Center.
Dr. Kesselheim also serves as a core faculty member in the Harvard Medical School Center for Bioethics, a supervisor for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and is a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health. In the Center for Bioethics, he co-teaches a course titled "Health Law, Policy, and Bioethics" for masters-level students each spring.
In 2014-2015 and again in 2016-2017, he has been a Visiting Associate Professor of Law at Yale Law School, where he teaches Food and Drug Administration Law.
FDA Premarket Approval Supplements and Medical Device Safety and Effectiveness
Summer, 03/01/13 - 12/21/13
Clinical and Regulatory Features of Drugs Not Initially Approved by the US Food and Drug Administration
Full Time/Year Long, 05/01/13 - 04/30/14
Technological innovations in medication packaging to improve patient adherence: a systematic review
Summer, 06/11/12 - 08/10/12
Clinical Equivalence of Generic and Brand-Name Drugs in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Summer, 12/10/07 - 10/19/08
Promoting Medical Innovation: The Case of Coronary Artery Stents
Summer, 06/13/11 - 08/31/11
The research activities and funding listed below are automatically derived from
NIH ExPORTER and other sources, which might result in incorrect or missing items.
to make corrections and additions.
U01FD004856 (KESSELHEIM, AARON SETH)Sep 15, 2013 - Sep 14, 2014FDA
Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods
Role: Principal Investigator
K08HS018465 (KESSELHEIM, AARON SETH)Sep 30, 2009 - Jul 31, 2014AHRQ
Off-label prescribing: Comparative evidence, regulation, and utilization
Role: Principal Investigator
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