Axel Bolte, MBA
Kurt Gunter, M.D.
Kurt Gunter, M.D., is Chief Medical Officer at Inozyme. He brings to Inozyme over 30 years of expertise in regulatory affairs, clinical development, and government relations. Prior to joining Inozyme, he most recently served as Chief Medical Officer, Cell Therapy, and Head of Regulatory Affairs at Athenex, Inc. Prior to Athenex, Dr. Gunter served as Chief Medical Officer at Kuur Therapeutics, Inc. (formerly Cell Medica), where he headed the medical affairs, clinical operations, and regulatory affairs departments. He also previously held positions of increasing responsibility at Hospira, Inc., including Vice President, Clinical Development, and Global Medical Director for Hematology-Oncology. Before Hospira, Dr. Gunter held positions at Zymequest Inc., ViaCell, Inc., and Transkaryotic Therapies, Inc. While at Transkaryotic Therapies, he played an integral role in the global regulatory strategy for Replagal, an enzyme replacement therapy approved for Fabry disease. He also previously served as President of the International Society for Cellular Therapy, where he played a worldwide leadership role in promoting understanding of the clinical, regulatory, manufacturing, and marketing requirements for the successful development of cell and gene therapies. Prior to his biotech 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 within the Center for Biologics Evaluation and Research. 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 his B.S. in Biological Sciences, with Distinction, from Stanford University. His postdoctoral training included Johns Hopkins University and the U.S. National Institutes of Health.