Gene Therapy Expert Witnesses

Toxicology, Pharmaceutical Research - Pharmacology, Neuroscience, Toxicology, Industrial Chemicals, Contract Research Organizations, Academic Research, Drug Development, Human Health Risk Assessment, Diplomate of the American Board of Toxicology, DABT, US FDA, US EPA, Gene Therapy, Biologics, Toxicologist, Pharmacologist

I am toxicologist and pharmacologist with a board certification in toxicology. I have 20 years of experience working with in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology, regulatory affairs issues and human health risk assessment. I have more than 30 years of research, consulting and regulatory experience. I have worked with law firms for the last 15 years in various capacities to support litigation. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.

Ophthalmology - Retina, retinopathy of prematurity, retinal detachment, ocular trauma, ruptured globe, macular hole, vitreoretinal surgery, intravitreal injection, retinopathy, epiretinal membrane, vitrectomy, scleral buckle, endophthalmitis, uveitis, pediatric retina, gene therapy, shaken baby

Dr. Aaron Nagiel is Director of the Retina Service at Children's Hospital Los Angeles/ University of Southern California specializing in retinal disease with a special emphasis on disorders affecting children. He earned his bachelor’s degree from Harvard University summa cum laude, and then underwent combined MD and PhD training at Cornell University and The Rockefeller University in New York City. After an internship at Memorial Sloan-Kettering Cancer Center, Dr. Nagiel completed both ophthalmology residency and vitreoretinal fellowship at the renowned Stein Eye Institute at UCLA. He treats a broad array of surgical and medical vitreoretinal diseases, including ocular trauma and retinopathy of prematurity. He has authored four book chapters and published over 50 peer-reviewed journal articles.

Toxicology, Pharmaceutical Research - Pharmacology, Neuroscience, Toxicology, Industrial Chemicals, Contract Research Organizations, Academic Research, Drug Development, Human Health Risk Assessment, Diplomate of the American Board of Toxicology, DABT, US FDA, US EPA, Gene Therapy, Biologics, Toxicologist, Pharmacologist

I am toxicologist and pharmacologist with a board certification in toxicology. I have 20 years of experience working with in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology, regulatory affairs issues and human health risk assessment. I have more than 30 years of research, consulting and regulatory experience. I have worked with law firms for the last 15 years in various capacities to support litigation. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.

Toxicology, Pharmaceutical Research - Pharmacology, Neuroscience, Toxicology, Industrial Chemicals, Contract Research Organizations, Academic Research, Drug Development, Human Health Risk Assessment, Diplomate of the American Board of Toxicology, DABT, US FDA, US EPA, Gene Therapy, Biologics, Toxicologist, Pharmacologist

I am toxicologist and pharmacologist with a board certification in toxicology. I have 20 years of experience working with in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology, regulatory affairs issues and human health risk assessment. I have more than 30 years of research, consulting and regulatory experience. I have worked with law firms for the last 15 years in various capacities to support litigation. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.

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...