Alexander Fleming, MD
Kinexum Services LLC, Harpers Ferry, West Virginia, USA

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 Executive Vice-President 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 1986-98, 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 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 on assigned from 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 is lead author of the book, Optimizing Development of Therapies for Diabetes. He has frequently published scientific articles and book chapters, the most recent chapter, Regulatory Considerations for Early Clinical Development, is in Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development, published by Springer in April 2019. 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, followed by the second conference in Washington, D.C. in October 2019. The third conference will be held in Washington in October 2020.