The Kitalys Institute is a not-for-profit created by Dr. Alexander Fleming. Dr. Fleming is founder and Executive Chair of Kinexum, a strategic advisory firm that provides regulatory and clinical development guidance for life science product development.

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Dr. Fleming worked at the FDA from 1986 to 1998, where he oversaw therapies related to nutrition; disorders of growth, development, and reproduction; diabetes and its complications; and other metabolic and endocrine diseases. He led reviews of landmark approvals including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. 

 

During his career, Dr. Fleming observed many barriers to translating breakthroughs into public health protocols, including: (i) the 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) insufficient incentives for a payer to cover preventative interventions today that rather than paying for treatment years later.

 

He re-imagined the regulatory system and scientific culture to safely increase the speed 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 inspiring stakeholders to take the moonshot to increase healthspan for all. Therefore, in the spring of 2020, Kinexum formed the Kitalys Institute to organize conferences and other initiatives to turn emerging science into practical, equitable policy.