Faculty of Law Health Law, Ethics & Policy Seminar Series
and
WHO Collaborating Centre for Governance, Transparency
& Accountability in the Pharmaceutical Sector
present
Aaron Kesselheim MD JD MPH
Associate Professor
Harvard University Medical School
Expedited Regulatory Review of Prescription Drugs:
The Impact of the FDA’s New Breakthrough Therapy Designation
Commentator: Megan Bettle
Director, Regulatory Review of Drugs and Devices, Biologics and
Genetic Therapies Directorate, Health Canada
Thursday, January 18, 2018
12:30 – 2:00
Solarium (Room FA2), Falconer Hall - 84 Queen’s Park
In 2012, Congress created the Breakthrough Therapy designation to expedite the testing and approval by the FDA of important new drugs. It was the fifth expedited review program for new drugs in the last 30 years. We will review the performance of all of these programs with a focus on the outcomes from the Breakthrough Therapy designation in the past 5 years.
Aaron Kesselheim MD JD MPH 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. 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. Author of over 300 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 committee on addressing the opioid epidemic. His work has been funded by the Greenwall Faculty Scholar in Bioethics Program, the Commonwealth Fund, the Robert Wood Johnson Foundation, the Laura and John Arnold Foundation, the Engelberg Foundation, the FDA, and AHRQ. Aaron is a core faculty member at the HMS Center for Bioethics, where he co-teaches a course on health policy, law, and bioethics and organizes a monthly policy and ethics seminar series. Aaron also serves as a Visiting Associate Professor of Law at Yale Law School, where he teaches a yearly course on Food and Drug Administration Law. He is the editor-in-chief of the Journal of Law, Medicine, and Ethics.
A light lunch will be served.
We will start promptly at 12.30 so in order to take your lunch, please come on time.
