Michelle McMurry-Heath MD, PhD,
WW Vice President Global Regulatory Affairs and International Clinical Evidence (GRACE),
Johnson & Johnson Medical Device Companies
Michelle McMurry-Heath leads the clinical, preclinical, and regulatory teams for the medical device companies of Johnson & Johnson. She is also the Global lead for Evidence Generation. In her roles, she leads the evidence and approval strategy development for companies that range from Electrophysiology (Biosense Webster) to orthopedics (DePuy Synthes) to general surgery (Ethicon) in 150 markets around the globe. She is physician and scientist with more than two decades of experience. After studying biochemistry at Harvard University, Dr. McMurry-Heath became the first African-American to receive both M.D. and Ph.D. degrees from Duke University. Trained in pediatrics and immunology, Dr. McMurry-Heath has committed her life's work to providing patients with better health information and greater clinical options through science and innovation policy. She oversaw health for Senator Joseph Lieberman and was the senior health policy advisor for the Lieberman for President Campaign. She was the founding director of the Aspen Institute's Health, Biomedical Science and Society Initiative which brought pharmaceutical and diagnostic leaders together with leaders in the patient advocacy and health care to focused projects on issues ranging from regulation to tackling chronic diseases in the context of health insurance reform. Her health diplomacy work included projects in 11 countries, including Cambodia and Rwanda. From 2010-14, Dr. McMurry-Heath was the Associate Center Director for Science in CDRH science at the FDA's Center for Devices and Radiological Health (CDRH). Dr. McMurry-Heath led the FDA team tasked with defining a new role for patients in the regulation of medical devices and diagnostics. She drew on this experience as the primary architect of the Medical Device Innovation Consortium (MDIC), a novel public-private partnership between the FDA and almost 50 members of the medical technology industry and patient advocacy community. MDIC members have pooled resources and talent to take on some of the most intractable topics in medical device innovation: optimizing clinical trials, applying computer modeling to device design and regulation, compliance science, pathways for insuring the clinical validity of new diagnostics, and the science behind measuring patient preferences. She joined Johnson & Johnson in 2014, as Worldwide Vice President of Regulatory Affairs Dr. McMurry-Heath unified all the business and regional regulatory teams into one global organization and implemented a new global approach to regulatory policy and service to 100 smallest markets. She assumed responsibility for the clinical and preclinical device teams in July, 2017 to drive synergies and improve quality across the functions and develop a comprehensive evidence generation strategy to promote market introduction and acceptance of device innovation.