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G. Alexander Fleming, MD
G. Alexander Fleming, MD

    Dr. Alexander "Zan" Fleming is co-founder, president, and CEO of Kinexum, LLC, a cardiometabolic strategic consulting organization. He also sits on over a dozen clinical advisory boards for major pharma and biotech companies. 

    Previously, he served as chief medical officer of Boston Medical Technologies and chief scientific officer of Ingenix Pharmaceutical Services — A UnitedHealth Group Company. For 12 years, he served as reviewer and supervisory medical officer at the FDA, as head of the metabolic group. He has extensive clinical experience and regulatory responsibility in 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 those of the first statin, insulin analogs, metformin, PPAR-agonist, and growth hormone for non-GH deficiency indications. He was responsible for the regulation of the earliest biotech products including human insulin and growth hormone. He also helped to shape a number of FDA policies and practices related to therapeutic review and regulatory communication.

    His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned during 1991-92. Dr. Fleming was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH) and participated on other ICH committees.

    He was also the founder and editor in chief of the Virtual Journal of Drug Evaluation, of FDA's Center for Drug Evaluation and Research (CDER), a major contributor to FDA's Good Review Practice (GRP) initiative, and chair of the committee responsible for education and training at CDER. Dr. Fleming is lead author of the book, “Optimizing Development of Therapies for Diabetes.” He serves on numerous scientific advisory boards and expert committees and has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.

    Schedule1 Oct 2023