Affinia Therapeutics, a gene therapy company with a pipeline of adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, has appointed Hideo Makimura, M.D., Ph.D., as its Chief Medical Officer.

Makimura brings leadership experience in both early- and late-stage clinical research and development (R&D) in the biopharmaceutical industry and academic research, as well as complementary clinical practice expertise as an endocrinologist to Affinia. He has taken many novel molecules into humans for the first time and has contributed to more than 12 successful Investigational New Drug (IND), Clinical Trial Authorization (CTA) and regulatory approval submissions.

“Hideo brings decades of experience in early- and late-stage drug development across multiple therapeutic areas and modalities including cardiovascular disease, neuroscience, and gene therapies,” said Rick Modi, Affinia’s CEO. “He is a respected thought leader in our industry whose experience will enable designing and executing development pathways which can evaluate meaningful efficacy in first-in-human trials adaptable to pivotal trials to potentially support new drug applications. The addition of Hideo to our leadership team is a key step in progressing our lead investigational drug program, AFTX-201 in BAG3 dilated cardiomyopathy, toward an IND application later this year and building our pipeline of cardiovascular and neurologic programs.”

Experience

Makimura is a drug developer with more than 20 years’ experience as a physician-scientist at biopharmaceutical companies and academia. He has broad R&D, clinical, translational, business, regulatory, and executive management experience across multiple phases, modalities, geographies, and therapeutic areas.

Makimura has particular expertise in early- and late-phase drug development in cardiovascular, metabolic, ophthalmology, neuroscience, oncology, and rare diseases while holding roles of increasing seniority at Johnson & Johnson (J&J) and Merck. He joins Affinia from J&J where he was most recently Global Vice President (VP) and Head of R&D for Ophthalmology, and before that, Global VP and Head of Translational & Experimental Medicine for Cardiometabolic Disease. Before J&J, Makimura had successful careers at Merck and Harvard Medical School.

Prior to joining industry, Makimura was an Assistant Professor of Medicine at Harvard Medical School and Massachusetts General Hospital. A patent holder and recipient of numerous academic and professional honors, research awards, and grants, he is an author on more than 60 manuscripts, reviews, and abstracts.

He earned his medical degree and a Ph.D. in neuroscience from the Mt. Sinai Icahn School of Medicine and a bachelor of science degree from Yale University. Makimura trained as a clinical endocrinologist and is board certified in endocrinology, diabetes, and metabolism.

Makimura remarked, “I am excited to join this outstanding team and apply my knowledge and experience to advance our investigational programs to the clinic to achieve our mission of delivering potentially curative therapies to patients in desperate need of better treatments.”