Alexander “Zan” Fleming, M.D.

Alexander “Zan” Fleming, M.D.

Senior Consultant
Drug, Biologics, and Device Development

Dr. Fleming is the founder and Executive Chairman of Kinexum, a company of professionals from across the world with diverse expertise in developing drugs, biotech products, medical devices, and digital health technologies. He received his M.D. and internal medicine training from Emory, Fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow.

At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. He led reviews of landmark approvals including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications.

Dr. Fleming oversaw clinical review of the earliest biotech products including human insulin and growth hormone. He helped to shape FDA policies and practices related to therapeutic review and regulatory communication. He represented the FDA at multiple international programs, including the World Health Organization, and led the reviewer education program at FDA’s Center for Drug Evaluation and Review.