Tissue Engineering Expert Witnesses
Tissue engineering expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on tissue engineering. The tissue engineering expert witness listings on this page are typically from fields/areas of expertise such as: Regenerative Medicine.
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Scott R. Burger, MD
Cell therapy and gene therapy expert
Advanced Cell & Gene Therapy
Chapel Hill, North Carolina
Regenerative Medicine
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Cell therapy, Gene therapy, Tissue engineering, Immunotherapy, Regulatory (FDA and non-US agencies), HCT/Ps, Stem cells, MSCs iPSCs HSCs, T cells CAR-T cells, Viral vectors (AAV lenti adeno), Apheresis, Umbilical cord blood/tissue, Bone marrow, Cell banking, GMPs, GTPs, Autologous, Allogeneic, Due diligence, Donor eligibility
Dr. Burger has over 30 years of experience developing cell therapy, gene therapy, and tissue-engineered products for regenerative medicine and immunotherapy. Since 2002 he has been a full-time consultant on development, manufacturing, regulatory, and strategic aspects of cell therapy, gene therapy, and tissue-based products. He has served over 200 companies, from biotech startups to Big Pharma, in North America, Europe, Asia, and Australia, consulting on advanced therapies from preclinical development through Phase I/II/III, and commercialization.
Dr. Burger has been an expert witness in cases involving intellectual property, commercialization, FDA regulatory affairs, Good Manufacturing Practices (GMPs), and Good Tissue Practices (GTPs) including donor eligibility. He is frequently an invited speaker at international conferences and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the International Society for Cell and Gene Therapy (ISCT) advisory board an...
