Contract Pharma Staff11.09.20
Inozyme Pharma Inc. has appointed Kevin B. Johnson, Ph.D., MBA, as senior vice president, regulatory affairs, effective immediately.
Johnson brings more than 25 years of experience in developing and implementing global regulatory 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. He will be responsible for leading Inozyme’s global regulatory strategy.
“We are thrilled to have Kevin join the Inozyme leadership team during this period of steady execution and as we prepare to enter clinical development,” said Axel Bolte, MSc, MBA, co-founder, president and CEO of Inozyme Pharma. “Kevin is a talented regulatory affairs executive with deep experience in rare diseases and I look forward to Kevin’s contributions in helping Inozyme meet the needs of underserved patient communities.”
Experience
Johnson joins Inozyme from Magenta Therapeutics Inc., where he served as the senior vice president, head of regulatory and quality, and led global strategy for a portfolio of biologics. Prior to that, he served as senior vice president, head of regulatory affairs, quality and pharmacovigilance at IMARA Inc., during which time the company received several regulatory designations for orphan diseases such as sickle cell disease and beta-thalassemia.
Before IMARA, 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). 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 which team subsequently received Regenerative Medicine Advanced Therapy (RMAT) designation for a retinal gene therapy product.
“Based on the compelling science and preclinical research conducted with INZ-701, Inozyme has the potential to help patients with devastating and debilitating rare metabolic diseases who currently lack effective treatment options,” Johnson commented. “I am excited to join Inozyme at such an important time in the company’s growth trajectory, and I look forward to contributing to Inozyme’s success.”
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. He also holds a Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professional Society.
Johnson brings more than 25 years of experience in developing and implementing global regulatory 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. He will be responsible for leading Inozyme’s global regulatory strategy.
“We are thrilled to have Kevin join the Inozyme leadership team during this period of steady execution and as we prepare to enter clinical development,” said Axel Bolte, MSc, MBA, co-founder, president and CEO of Inozyme Pharma. “Kevin is a talented regulatory affairs executive with deep experience in rare diseases and I look forward to Kevin’s contributions in helping Inozyme meet the needs of underserved patient communities.”
Experience
Johnson joins Inozyme from Magenta Therapeutics Inc., where he served as the senior vice president, head of regulatory and quality, and led global strategy for a portfolio of biologics. Prior to that, he served as senior vice president, head of regulatory affairs, quality and pharmacovigilance at IMARA Inc., during which time the company received several regulatory designations for orphan diseases such as sickle cell disease and beta-thalassemia.
Before IMARA, 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). 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 which team subsequently received Regenerative Medicine Advanced Therapy (RMAT) designation for a retinal gene therapy product.
“Based on the compelling science and preclinical research conducted with INZ-701, Inozyme has the potential to help patients with devastating and debilitating rare metabolic diseases who currently lack effective treatment options,” Johnson commented. “I am excited to join Inozyme at such an important time in the company’s growth trajectory, and I look forward to contributing to Inozyme’s success.”
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. He also holds a Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professional Society.
