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Dr. Alexander Fleming is 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 is also President and co-founder of Kitalys Institute. Dr. Fleming 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 was a major contributor to FDA’s Good Review Practice (GRP) initiative and led the committee responsible for education and training at FDA’s Center for Drug Evaluation and Research (CDER). He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication.
His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was stationed by FDA 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 including the Common Technical Document working group.
Dr. Fleming has frequently authored scientific articles, books, and book chapters. He has been a member of many corporate and advisory boards to academic and commercial institutions and professional societies. He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association.
Dr. Fleming coined the term, Metabesity, which refers to the constellation of cancer, heart and neurologic diseases, diabetes, and the aging process itself, all which share common metabolic root causes and potential preventive therapies. He organized the first Congress on Metabesity in London in October 2017, which has since been followed by annual conferences in October. Dr. Fleming founded in 2020 the not-for-profit Kitalys Institute as a means of producing Metabesity conferences [now, The Targeting Healthy Longevity Conference] and advancing all measures that can improve health and healthspan.
Dr. Fleming is involved in service to his community and educational institutions, serving on two boards of governors.