Contact this Expert Witness
- Company: Advanced Cell & Gene Therapy
- Phone: 919-414-6947
- Website: www.ac-gt.com
Specialties & Experience of this Expert Witness
General Specialties:
Regenerative MedicineKeywords/Search Terms:
cell therapy, gene therapy, stem cell therapy, immunotherapy, regulatory, FDA, due diligence, HCT/P, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), viral vectors, T cells, CAR-T cells, NK cells, stem cells, autologous cell therapy, allogeneic cell therapyEducation:
B.S., Tulane University; M.D., University of PennsylvaniaYears in Practice:
30Number of Times Deposed/Testified in Last 4 Yrs:
6Additional Information
Dr. Burger has 30 years of experience developing cell therapy and gene therapy products for immunotherapy and regenerative medicine. Since 2002 he has been a full-time consultant on development, GMP manufacturing, regulatory, and strategic aspects of cell and gene therapy. He has served over 180 companies, from biotech startups to Big Pharma, in North America, Europe, Asia, and Australia, consulting on cell and gene therapies from preclinical development through Phase I/II/III, and commercialization. Dr. Burger has been an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance. He is frequently an invited speaker at international conferences and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. 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.