Alexander Fleming

Founder and Executive Chairman at Kinexum

Founder of Kinexum, a multi-faceted, strategic advisory firm, who led landmark FDA approvals of the first statin, insulin analog, metformin and other novel therapies. Represented FDA at ICH, WHO, and other initiatives. Brings broad experience and well recognized expertise beyond his endocrinology and research background. Works across drugs, biotech, cell therapies, medical devices and digital health modalities to provide clinical, regulatory, scientific, and commercial advice in metabolic, cardiovascular, GI, neurology, immunology, oncology and wound care. Well connected and involved internationally; skilled in helping programs in Asia Pacific, Europe, and Israel. Education and training at Emory, Vanderbilt and National Institutes of Health.

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 also helped to shape FDA policies and practices related to therapeutic review and regulatory communication. He was a major contributor to FDA's Good Review Practice (GRP) initiative and led the committee responsible for education and training at CDER. He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication.

He is also President and Co-Founder of Kitalys Institute.

Visit website: https://kinexum.com/team-member/zan-fleming/

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See also: Company Kinexum - Translational Research and Strategic Services company.