About Us

SCOTT R. BURGER, MD

• Principal and Founder of Advanced Cell & Gene Therapy, a consulting firm specializing in manufacturing, regulatory, and strategic aspects of cell and gene therapy products.  Over 30 years of experience developing advanced therapies.  Have served over 180 companies, from biotech startups to Big Pharma, in North America, Europe, Australia, and parts of Asia, working on products from preclinical development through Phase I/II/III, and commercialization.

• Directed or consulted on process development, GMP manufacturing, and CMC regulatory aspects of CAR T-cell, TCR-T cell, TIL, NK, and DC immunotherapies; gene-edited cell therapy products, in vivo gene therapy products; stem cell- and somatic cell-based regenerative medicine products.

• Deep knowledge and extensive experience addressing key issues such as closed-system processing, scale out/scale up, automation, potency testing, and comparability.

• Established regulatory expert in cell and gene therapy, has consulted on preparation of over 100 regulatory submissions for cell therapy or gene therapy products at all stages of development. Numerous productive interactions with FDA-CBER Office of Therapeutic Products and its predecessors, Office of Tissues and Advanced Therapies (OTAT) and Office of Cellular, Tissue and Gene Therapies (OCTGT).

• Extensive experience performing technical and regulatory due diligence for investment firms and Big Pharma. and providing guidance on investor expectations to cell and gene therapy startups seeking funding.

• Experienced expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance.