Cell therapy and gene therapy expert
Contact this Expert Witness
- Company: Advanced Cell & Gene Therapy
- Phone: 919-414-6947
- Cell: 919-414-6947
- Website: www.ac-gt.com
Specialties & Experience of this Expert Witness
General Specialties:
Regenerative MedicineKeywords/Search Terms:
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 eligibilityEducation:
B.S., Tulane University; M.D., University of PennsylvaniaYears in Practice:
30Number of Times Deposed/Testified in Last 4 Yrs:
7Additional Information
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 and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. Dr. Burger is an established regulatory expert in cell and gene therapy and has been an invited speaker at in-house workshops by regulatory agencies including US FDA, Taiwan FDA, South Korea's Ministry of Food and Drug Safety, and the Saudi FDA, as well as many international conferences. He has served on the organizing committee of the ISCT Global Regulatory Perspectives workshop since 2008, and co-chaired the committee for five years. 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.