Bio

Scott R. Burger, MD is the Founder and Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell therapy and gene therapy product development, GMP manufacturing, and regulatory affairs. Dr. Burger has over 30 years of experience developing cell and gene therapy products and has consulted for over 180 companies in North America, Europe, Asia, and Australia. He has deep knowledge of key issues such as closed-system processing, scale out/scale up, automation, potency testing, and comparability. His experience covers a wide range of cell and gene therapy products including CAR-T, NK, and dendritic cell immunotherapy, in vivo and ex vivo gene therapy, CRISPR gene editing, and stem cell regenerative medicine products. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous IND submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT, formerly the Office of Cellular, Tissue and Gene Therapies, OCTGT). Dr. Burger has served as an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance, and as a subject matter expert for NIH and CIRM. He has performed due diligence for numerous investment firms and Big Pharma. Dr. Burger has served on the USP Cell, Gene and Tissue Therapies Expert Committee, ISCT advisory board and committees. He often speaks on regulatory and manufacturing topics at cell and gene therapy conferences and webinars. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.