Dr. Alexander Fleming, founder of Kinexum, a strategic advisory firm that provides regulatory and clinical development guidance for life science product development, observed many barriers to translating breakthroughs into public health protocols, including: (i) lack of a clear regulatory pathway for approval of therapeutic interventions; (ii) the need for clinical trials that are too large and last too long to attract funding to demonstrate prevention or delay of chronic diseases; and (iii) misalignment of incentives for a payer to reimburse an intervention today that might only benefit another reimburse years later.

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At the FDA 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. Given this background, Dr. Fleming re-imagined the regulatory system and our national health focus around aging to increase the speed (with safety) of scientific advances and make geroscience an integral part of public health. He believed that a not-for-profit organization could play a leading role in catalyzing stakeholders to take the moonshot to increased healthspan for all.

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Therefore, in the spring of 2020, Kinexum decided to form the not-for-profit, The Kitalys Institute, to organize the Metabesity conferences, Project Healthspan, Project Endpoints, and other initiatives to translate emerging science into the material, accessible gains in public health.