Kevin B. Johnson, Ph.D., MBA
Senior Vice President, Regulatory Affairs, Quality, and Product Development
Kevin B. Johnson, Ph.D., MBA, is our senior vice president, regulatory affairs, quality, and product development, joining Inozyme in November 2020. Dr. Johnson brings to Inozyme more than 25 years of experience in developing and implementing global regulatory, quality assurance, and clinical development strategies for rare diseases across entire product development lifecycles from preclinical through clinical development and ultimately to product approval for a variety of drugs, biologics, combination products and cell/gene therapies.
Dr. Johnson joins Inozyme from IMARA Inc. where he served as senior vice president, head of regulatory affairs, quality and pharmacovigilance during which time the company received several regulatory designations for orphan diseases such as sickle cell disease and beta-thalassemia. Before IMARA, Dr. Johnson led global regulatory strategies at Vtesse (later acquired by Sucampo), addressing ultra-rare diseases such as Niemann-Pick disease type C under Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine designation from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). Dr. Johnson also served as the director, global regulatory affairs for rare diseases and gene therapies at GlaxoSmithKline, working on the international regulatory team for the European approval of the gene therapy Strimvelis® for ADA-SCID, and later received Regenerative Medicine Advanced Therapy (RMAT) designation for a retinal gene therapy product.
Dr. Johnson holds a Ph.D. in Neurobiology from the University of North Carolina School of Medicine, an MBA from the Kenan-Flagler School of Business at the University of North Carolina, and a B.S. in Chemistry from the University of South Florida. Dr. Johnson also holds a Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professional Society.