Tuesday Luncheon Keynote
April 11, 12:15-1:45, Memorial Hall, McNamara Alumni Center
“Medical Device Regulations in the New Age”
Michelle McMurry-Heath, MD, PhD, Vice President & Global Head of Regulatory Affairs, Medical Devices, Johnson & Johnson
Michelle is a physician and scientist with more than two decades of experience working to bring cutting-edge medical technologies to patients. Prior to joining Johnson & Johnson, Michelle was responsible for providing advisory and advocacy services to clients across the health and life sciences sector at FaegreBD Consulting. As the lead for the firm’s regulatory team, she delivered insights on the current regulatory landscape for medical devices and pharmaceuticals, while also working to shape the future regulatory environment.
Previously, she served as Associate Center Director for Science at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the branch of the agency responsible for regulating medical devices. In her role at the FDA, Michelle led the creation of the Medical Device Innovation Consortium (MDIC), a novel public-private partnership between the agency and almost 50 members of the medical technology industry and patient advocacy community. She also led efforts at the agency to stimulate innovation for pediatric and special patient populations, to develop standards, and to measure the impact of FDA-sponsored research.
Prior to the FDA, Michelle was founding director of the Health, Biomedical Science and Society Initiative at the Aspen Institute. She has been a MacArthur Fellow at the Council on Foreign Relations and a Robert Wood Johnson Foundation Health and Society Scholar focused on biomedical innovation. Michelle previously served as Senator Joseph Lieberman’s senior health policy legislative assistant from 2001-04 and served on President Obama’s transition team for the National Science Foundation.
Michelle holds a joint MD/PhD degree from Duke University School of Medicine and completed her undergraduate training at Harvard University in biochemistry.
Plenary Welcome: Samuel Mukasa, University of Minnesota
Plenary Presentation: Angela Sykes, United States Patent and Trademark Office
Wednesday Lunch: Stephen Oesterle, M.D.
Thursday Lunch: Jeffrey Shuren, FDA CDRH