Hideo Makimura

As Chief Medical Officer, Makimura leads clinical development strategy and execution as insitro advances its AI-derived metabolic disease and neuroscience pipeline.

Makimura brings a two-decade record of academic work and clinical execution across modalities and stages. He has personally led programs from early-stage human testing through Phase 4 clinical trials, spanning small molecules, large molecules (antibodies), therapeutic peptides, small interfering RNA (siRNA), and adeno-associated virus (AAV) gene therapy, with more than a dozen successful investigational new drug (IND) and clinical trial application (CTA) filings.

Most recently, as Chief Medical Officer of Affinia Therapeutics, he led clinical development, clinical operations, regulatory, and quality functions. He, along with his team, advanced AFTX-201, an AAV gene therapy for BAG3-associated dilated cardiomyopathy, to the U.S. Food and Drug Administration (FDA) acceptance of its IND, Health Canada authorization of its CTA, and FDA Fast Track designation, and received the FDA’s Orphan Drug designation.  His efforts supported Affinia’s successful Series C financing.

Before Affinia, he spent six years at Johnson & Johnson (J&J), rapidly rising to Global Vice President and Head of Global Translational and Experimental Medicine, responsible for early clinical development from late discovery through Phase 2a across cardiometabolic, kidney, retinal, and pulmonary disease. In 2024, he was appointed Global Head of Research & Development for Specialty Ophthalmology within J&J’s neuroscience therapeutic area.

His work has consistently used human genetics to de-risk development. At J&J, he led early clinical development of a GalNAc-siRNA targeting PNPLA3 in metabolic dysfunction-associated steatohepatitis (MASH) through Phase 1, with results published in the New England Journal of Medicine. Earlier, at Merck, he served on the global new drug application (NDA) filing team for ertugliflozin, the SGLT2 inhibitor approved by the FDA in 2017, gaining experience that spanned the full arc of development through approval.

Makimura began his career in academic medicine as an NIH-funded faculty member at Harvard Medical School, where his research and clinical practice focused on metabolic and endocrine disease. He earned his M.D. and a Ph.D. in neuroscience from the Icahn School of Medicine at Mount Sinai and is board certified in endocrinology, diabetes, and metabolism, a foundation at the intersection of the two therapeutic areas insitro is advancing.