Bone Marrow Expert Witnesses

Miami, Florida

Hematology, Oncology - Multiple Myeloma, Immunotherapy, Malignant hematology, Plasma cell dyscrasias, Causation, CAR-T cell therapy, Leukemia, Smoldering, Lymphoma, Stem cell transplant, Amyloidosis, POEMS, Chemotherapy, Blood cancer, Waldenstrom’s macroglobulinemia, MGUS, Bone marrow , Bispecific antibodies, Refractory, Cytogenetics

Dr. Ariel F. Grajales-Cruz, MD is a triple board-certified physician in Internal Medicine, Hematology, and Medical Oncology, internationally recognized for his expertise in multiple myeloma, hematologic malignancies, CAR-T cell therapies, and bispecific antibody treatments. With a strong record in clinical practice, research, and consulting, he is widely sought as a medical expert witness, advisor, and opinion leader. Dr. Grajales-Cruz is an Assistant Member in Malignant Hematology & Cellular Therapy at Moffitt Cancer Center in Tampa, Florida, a leading cancer research institution. His practice focuses on plasma cell disorders, leukemia, lymphoma, and complex blood cancers, with special emphasis on novel immunotherapies. He plays an active role in clinical trial development and real-world evidence studies, bridging patient care and pharmaceutical innovation. In 2022, he founded Grajales Medical Solutions Corp, a consulting practice providing expert medical opinions, litigation suppo...

Chapel Hill, North Carolina

Regenerative Medicine - 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...