Immunotherapy Expert Witnesses

Oncology, Hematology - cutaneous malignancies, gastrointestinal malignancies, melanoma, skin cancers, merkel cell, gastric, esophageal, liver, pancreas, colon, rectal, small bowel, neuroendocrine tumors, adenocarcinoma, soft tissue sarcoma, bone sarcoma, anal, abdominal, immunotherapy, chemotherapy, pd1, ctla4, pdl1

Sajeve S. Thomas, MD, is a board-certified medical oncologist and hematologist at Orlando Health UF Health Cancer Center. He specializes in the treatment of melanoma, sarcoma and gastrointestinal malignancies. See www.MEDONCMD.com where he educates patients, families, and healthcare providers oncologic issues that most oncologist do not say to their patients or do not have the time to say. Dr. Thomas earned his medical degree at University of Florida College of Medicine. He completed his residency in internal medicine at University of South Florida College of Medicine, where he received the Outstanding Resident award. He completed his hematology and oncology fellowship at University of Florida, where he became chief fellow and board review coordinator teaching 4-6 lectures a month to the fellows, residents and medical students. Dr. Thomas serves as an assistant professor at both Florida State University College of Medicine and University of Central Florida College of Medicine. H...

Regenerative Medicine - 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 therapy

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 Sc...