Alexander Fleming, MD
Founder and Executive Chairman, Kinexum; CMO, Tolerion, USA
Dr. Alexander Fleming 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, 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.
Dr. Fleming’s regulatory and technical expertise has been requested in numerous international settings. He was assigned from FDA to the World Health Organization from 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). He also participated on other ICH committees, including the Common Technical Document working group.
Dr. Fleming frequently publishes scientific articles and book chapters, the most recent of which is “Regulatory Considerations for Early Clinical Development” in Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development, published by Springer in April 2019. Dr. Fleming is also lead author of the book, Optimizing Development of Therapies for Diabetes. 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 and several editorial boards.
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. He organized the first Congress on Metabesity in London in October 2017, which will be followed by the second Congress in Washington, DC, in 2019.
Dr. Fleming received his MD and internal medicine training from Emory. He completed fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow.