Kurt Gunter, M.D. has served as a key member of Inozyme’s leadership team since joining the company in June 2022. He now contributes as a senior advisor, following his tenure as Chief Medical Officer. Dr. Gunter brings over 30 years of experience in regulatory affairs, clinical development, and government relations, with deep expertise in cell and gene therapy.
Prior to joining Inozyme, he served as Chief Medical Officer, Cell Therapy, and Head of Regulatory Affairs at Athenex. He previously held the role of Chief Medical Officer at Kuur Therapeutics (formerly Cell Medica), where he oversaw medical affairs, clinical operations, and regulatory affairs.
Earlier in his career, Dr. Gunter held senior positions at Hospira, Inc., including Vice President of Clinical Development and Global Medical Director for Hematology-Oncology. He also played a key role in the development of enzyme replacement therapies during his time at Transkaryotic Therapies, Inc., where he helped lead the global regulatory strategy for Replagal, approved for Fabry disease. Additional biotech experience includes roles at Zymequest and ViaCell.
Dr. Gunter has contributed meaningfully to the broader field of cellular therapy, serving as President of the International Society for Cellular Therapy (ISCT), where he helped advance global understanding of clinical, regulatory, and commercial pathways for innovative therapies.
Earlier in his career, Dr. Gunter worked at the U.S. Food and Drug Administration (FDA) as a Medical Officer in the Center for Biologics and was appointed Acting Deputy Director of the Division of Cell and Gene Therapy. He also served for five years on the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee.
Dr. Gunter earned his M.D. from the University of Kansas School of Medicine and holds a B.S. in Biological Sciences with Distinction from Stanford University. His postdoctoral training was completed at Johns Hopkins University and the U.S. National Institutes of Health.