Michelle McMurry-Heath, MD, PhD is president and CEO of the Biotechnology Innovation Organization, which represents the biotechnology industry. She also serves as the Chair of the National Evaluation System for Health Technology (NEST) Governing Committee, a public-private partnership between the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services, patients, private payers, leading epidemiologists, and device companies. NEST seeks to strengthen the real world evidence infrastructure for medical device studies.

Dr. McMurry-Heath previously served as Worldwide Vice President for Global Regulatory Affairs, International Clinical Evidence, and Strategic Operations for the Medical Device Companies of Johnson & Johnson, where she led a team that generates clinical and preclinical studies and executed approval strategies for a wide range of medical devices in countries around the world. She also served as Associate Center Director for Science in the Center for Devices and Radiological Health at the FDA, where her team drove regulatory science innovation. This included the refinement and use of formal patient preference studies in regulatory decisions and the founding of the Medical Device Innovation Consortium, a partnership between FDA, medical technology companies, and the patient advocacy community to address common challenges in regulatory science.

After completing her undergraduate studies at Harvard University, she received an MD and PhD in immunology from Duke University.

Conflicts of Interest

As of September 2, 2020

Financial Associations

  • Biotechnology Innovation Organization (BIO), Employed as President and CEO
  • Johnson & Johnson, Stock

Personal Associations

  • Duke University, Board member and Committee member

Tags

Person Type
Panel / Committee