Kurt Gunter, MD, Fascp
About Kurt Gunter, MD, Fascp
Kurt Gunter, MD, FACSP, serves as the Senior Vice President and Chief Medical Officer at Inozyme Pharma, where he has worked since 2022. He has over 30 years of experience in regulatory affairs and clinical development, having held leadership roles at various organizations, including the FDA and multiple biotech companies.
Work at Inozyme
Kurt Gunter has been serving as the Senior Vice President and Chief Medical Officer at Inozyme Pharma since June 2022. In this role, he is responsible for overseeing the company's medical strategy and clinical development initiatives. His extensive background in regulatory affairs and clinical development supports Inozyme's mission to advance innovative therapies.
Education and Expertise
Kurt Gunter holds a Doctor of Medicine (MD) degree from the University of Kansas School of Medicine. He also earned a Bachelor of Science (BS) in Biological Sciences with distinction from Stanford University. His postdoctoral training includes significant experiences at Johns Hopkins University and the U.S. National Institutes of Health. Gunter has over 30 years of expertise in regulatory affairs, clinical development, and government relations.
Background
Kurt Gunter has held various leadership positions in the biotechnology and pharmaceutical industries. He worked at ViaCell as Senior Vice President of Clinical and Regulatory Affairs from 2001 to 2005 and served as Chief Medical Officer at Kuur Therapeutics from 2020 to 2021. His career also includes roles at Hospira, Inc. and Transkaryotic Therapies, Inc., where he contributed to significant regulatory strategies and clinical developments.
Achievements
Kurt Gunter has served on the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee for five years and has been involved in various scientific advisory boards. He played a key role in the global regulatory strategy for Replagal at Transkaryotic Therapies, Inc. Additionally, he has acted as a grant reviewer for the California Institute of Regenerative Medicine (CIRM) and has held the position of President and Advisory Board Chair of the International Society for Cell and Gene Therapy (ISCT).