Darin J. Weber, PhD

Dr. Weber joined ProKidney as Senior Vice President of Regulatory Development in September 2020, and was promoted to Chief Regulatory Officer, SVP and Head of Global Regulatory Affairs, Quality Management, Biometrics and Market Access. He is responsible for leading the development and implementation of ProKidney’s regulatory strategy in all markets, worldwide, interfacing with regulatory authorities and oversight of quality management, market access, pricing and reimbursement. Dr. Weber has over 25 years of experience in cellular and tissue-based regenerative medicine products, with previous roles as Senior Vice President of Regulatory and Quality at Medeor Therapeutics, from February 2016 to December 2019; Executive Vice President of Global Regulatory Affairs and Quality Management at Mesoblast, from June 2011 to February 2016; Senior Consultant for Cell and Gene Therapies at Biologics Consulting Group from February 2004 to May 2011, and positions of increasing responsibility at the FDA’s Center for Biologics Evaluation and Research, including as Chief of Cellular Therapies Branch in the Office of Cellular, Tissues and Gene Therapies, (now known as the Office of Tissues and Advanced Therapies) from September 1996 to January 2004. He is a long-serving member of United States Pharmacopeia (USP) expert committees for human tissues and advanced therapies. Dr. Weber received his B.S. in Molecular Biology from The Evergreen State College and a Ph.D. in Biochemistry and Biophysics from Oregon State University.