Darin Weber, PhD is the Principal Consultant at Advanced Therapies Regulatory Advisors, LLC. With more than 20 years of experience in the area of regenerative medicine and advanced therapies product development, Darin provides regulatory expertise to facilitate the commercial development of these novel therapies. Darin’s regulatory career began at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Cell and Gene Therapy where over a seven year period he held roles of increasing responsibility, including the founding Chief of the Cellular Therapies Branch in the Office of Cellular, Tissues and Gene Therapies (OCTGT), which is now known as the Office of Therapeutic Products (OTP). Following his tenure at FDA, Darin was a Senior Consultant at the Biologics Consulting Group and worked on a broad portfolio of regenerative medicine products and advanced therapies, encompassing, human tissues, immunotherapies, tumor vaccines, stem cells, gene therapy, xenotransplantation, and biologic-device combination products. More recently, Darin has held senior leadership positions in Regulatory Affairs & Quality Management at Mesoblast LTD and Medeor Therapeutics, Inc.
Advanced Therapies Regulatory Advisors LLC