Dr. Alexander “Zan” Fleming

Alexander “Zan” Fleming, M.D. is a well-recognized authority in the metabolic and endocrine fields with extensive U.S. Food and Drug Administration (FDA) experience. He is Cofounder, President, and CEO of Kinexium, President and Cofounder of Kitalys Institute, and Partner at the Regulatory Harmonization Institute.

Zan is the Founder and has been the CEO at Kinexium since 2004. Kinexium is a cardiometabolic strategic consulting organization for therapeutic product development covering the relevant wide range of scientific, clinical, and business disciplines by professionals with extensive industry and FDA experience.

In 2011, Zan, with his Kinexum, joined Regulatory Harmonization Institute Inc. (RHI), as a Founding Organization. RHI is an international, not-for-profit association dedicated to global harmonization of drug and medical device regulatory requirements.

In 2013, Zan coined the term, Metabesity, which refers to the constellation of chronic diseases of aging, including diabetes, obesity, cardiovascular and neurodegenerative diseases, cancer, and the aging process itself, that have common metabolic roots, and thus may be susceptible to common solutions. Today Metabesity is a recognized geroscience term, cited in dozens of articles.

In 2017, Zan and Professor Lawrence Steinman, the former long-time head of the immunology department at Stanford University and co-discoverer of the M.S. drug Tysabri, organized the inaugural Targeting Metabsity conference in London 2017, which has since been followed by annual conferences in October.

The second Metabesity conference was held in Washington, DC in 2019. In early 2020, Zan founded The Kitalys Institute, a non-profit entity as a means of producing Metabesity conferences (now, The Targeting Healthy Longevity Conference) and advancing all measures that can improve health and healthspan.

Previously, he served as chief medical officer of Boston Medical Technologies and chief scientific officer of Ingenix Pharmaceutical Services – A UnitedHealth Group Company.

Zan was also President, Chief Medical Officer, and Chief Executive Officer of Tolerion between 2018 and 2020. Tolerion is a biotechnology company developing “disease-modifying” treatments for type 1 diabetes and other autoimmune diseases.

In 2005 and until 2011, Zan was the Chief Medical Officer and Chairman of the Board at Exsulin, where he was leading clinical development and regulatory strategy for INGAP Peptide and other islet regeneration therapies.

Zan earned his M.D. in 1977 and received his internal medicine training from the Emory University School of Medicine. He earned his Bachelor’s Degree of Science from the University of West Florida. Zan received his fellowship training in endocrinology at the Vanderbilt University School of Medicine and in metabolism at National Institutes of Health, where he was a senior fellow.

After his Fellowship at NIH in 1985, Zan joined the FDA in 1986 as a Supervisory Physician. At the US Food and Drug Administration from 1986 to 1998, Zan 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, P PAR-agonist, and growth hormone for non-GH deficiency indications. Zan 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 the FDA’s Good Review Practice (GRP) initiative and led the committee responsible for education and training at the 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 the FDA between 1991 and 1992. Zan 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.

Zan has frequently authored scientific articles, books, and book chapters. He has been a member of many corporate and advisory boards for 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.

Zan is involved in service to his community and educational institutions, serving on two boards of governors. Read Know Labs Announces Formation of Advisory Board.

He is the cofounder and editor-in-chief of the Virtual Journal of Drug Evaluation and of FDA’s Center for Drug Evaluation and Research (CDER). He is lead author of the book, Optimizing Therapeutic Development in 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.

Watch Dr. Alexander (Zan) Fleming – Targeting Healthy Longevity.

Listen to Dr. Zan Fleming, M.D. and Thomas Seoh, Kinexum.

Read Kitalys Institute: breaking down the barriers to longevity clinical trials, Healthy longevity, and Kinexum at JP Morgan Week 2023.

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