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Darin J. Weber
Chief Regulatory Officer
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Prokidney
4454t.2.q9l20@417fxq127.l5g
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Known information
- Joined ProKidney as Senior Vice President of Regulatory Development in September 2020
- Promoted to Chief Regulatory Officer, SVP and Head of Global Regulatory Affairs, Quality Management, Biometrics and Market Access
- Responsible for leading the development and implementation of ProKidney's regulatory strategy in all markets, worldwide
- Interfaces with regulatory authorities and oversees quality management, market access, pricing and reimbursement
- Has over 25 years of experience in cellular and tissue-based regenerative medicine products
- Previously served as Senior Vice President of Regulatory and Quality at Medeor Therapeutics from February 2016 to December 2019
- Served as Executive Vice President of Global Regulatory Affairs and Quality Management at Mesoblast from June 2011 to February 2016
- Worked as Senior Consultant for Cell and Gene Therapies at Biologics Consulting Group from February 2004 to May 2011
- Held 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, from September 1996 to January 2004
- Long-serving member of United States Pharmacopeia (USP) expert committees for human tissues and advanced therapies
- Received a B.S. in Molecular Biology from The Evergreen State College
- Earned a Ph.D. in Biochemistry and Biophysics from Oregon State University
About Prokidney
ProKidney is a biotechnology company developing cell therapy products like REACT to transform the treatment of Chronic Kidney Disease (CKD), focusing on delaying kidney failure and reducing the need for dialysis.
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