Scott R. Burger, MD

(Available Nationwide)

General Specialty

Cell Therapy
Gene Therapy
Regenerative Medicine

Specialty Focus

Allogeneic Cell Therapy
Apheresis Collection
Autologous Cell Therapy
CAR-T Cells
Cell Therapy
Donor Screening and Eligibility
Due Diligence
FDA
Gene Therapy
Good Manufacturing Practices (GMPs)
Good Tissue Practices (GTPs)
HCT/Ps
Immunotherapy
INDs
MSCs
NK Cells
Regulatory
Stem Cell Therapy
Stem Cells
T Cells
Viral Vectors

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 200 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.

 

Education: 

  •  B.S., Tulane University
  • M.D., University of Pennsylvania School of Medicine

Medical Licensure and Board Certification:

  • 1990 Diplomate, National Board of Medical Examiners, #341174
  • 11/19/97 Diplomate in Clinical Pathology, American Board of Pathology, #97-650
  • 9/94-02 State of Minnesota Medical License #37314

Additional Information: 

Scott Burger speaker bio – 2025-03-07

Scott Burger – expert witness history – 2019-2024

celltherapy@ac-gt.com

http://www.ac-gt.com/

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