Dr. Fleming received his MD and internal medicine training from Emory University, US. He is Founder and Executive Chairman of Kinexum. He is also Chief Medical Officer of Tolerion, a biotechnology company developing disease-modifying treatments for type 1 diabetes and other autoimmune diseases. At the US Food and Drug Administration from 1986 to 1998, he 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. He oversaw clinical review of the earliest biotech products, including human insulin and growth hormone. He was assigned from FDA to the World Health Organization from 1991-92. He 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). He also participated on other ICH committees, including the Common Technical Document working group. Dr. Fleming coined the term “Metabesity,” which refers to the constellation of cancer, cardiovascular and neurological diseases, diabetes, and the aging process itself, all of which share common metabolic root causes and potential preventive therapies.
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