Gene Therapy Expert Witnesses

Los Angeles, California

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.

Bethesda, Maryland

Pharmaceutical Research, DNA - Drug development, Gene therapy, Oligonucleotide, Drug manufacturing, Bioprocessing, Biologics, Biopharmaceuticals, Monoclonal antibodies, Peptides, Drug discovery, Biotechnology, Business valuation, Due diligence, Drug regulation, Therapeutics, Cell therapy, Drug research, Research and development, RNA therapeutics, Drug research

Management consultant and fractional management services to biopharma companies providing a broad set of services. Hands on management experience from Big Pharma, biotech companies, and as consultant COO for biotech companies. Consulting experience from Boston Consulting Group. Large industry network. Over 25 years broad experience in US, EU, Japan and Australia. Doctor of Science from MIT in Biochemical Engineering with minor in Management. Master of Science in Chemical Engineering from Royal Institute of Technology, Sweden. Consulting Experience from Boston Consulting Group, Arthur D. Little and IBM. Biopharma experience from Pharmacia, BASF Pharma and several biotech companies. Fulbright scholar. Member of the Umbrex, BiotechExcec and Alacrita consultant networks. Uniquely broad and deep experience both as a hands-on manager and consultant, in drug discovery, preclinical and clinical development (including IND filings and clinical trial management), biologics and gene thera...

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...