Stem Cells Expert Witnesses

Westminster, Colorado

Products Liability, Biomedical Engineering - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science, Accident Recon

Qualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles 10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patents

Brookline, Massachusetts

Biomedical Engineering, Gastroenterology - Diabetes, Obesity, Inflammatory bowel disease, IBD, Stem cells, Bariatric surgery, Microfluidics, Drug screening, Biotechnology, Organoids

I am an Associate Professor at Harvard Medical School, Massachusetts General Hospital, and Shriners Hospital. I received my Ph.D. in Biomedical Engineering and have a well-established record of research in several research areas, including stem cells, gastroenterology, and metabolism (diabetes and obesity). My laboratory's research has been published in leading scientific journals such as Science, Nature Medicine, and Gastroenterology. I also have a successful track record of funding from both federal agencies (such as NIH) and private organizations (including small and large biotech and biopharma companies). I have also frequently served as a consultant for various companies.

Cambridge, Massachusetts

Regenerative Medicine, Biomedical Engineering - Regenerative Medicine, Cellular Therapies, Stem Cells, Extracellular Matrix, Perinatal Tissues (Placenta, Amnion, Chorion, Umbilical Cord Blood/Tissue), Transplantation, Cellular & Tissue Engineering, Biotechnology, Bioengineering, Medical Devices, Tissue Processing/Banking, HSCs, MSCs

Rouzbeh R. Taghizadeh, PhD, is a Cellular Therapy, Regenerative Medicine and Biomedical Engineering Expert offering more than 20 years of expertise as a Scientist, Innovator, and Entrepreneur in the development, processing, manufacturing of tissues, including bone marrow, umbilical cord (blood & tissue), amnion, chorion, placenta, adipose (fat), and other organs for clinical and non-clinical use, while considering the complex regulatory, trade secret, patent claims that arises from these areas. Litigation Support - Dr. Taghizadeh provides subject matter expertise and expert witness testimony for scientific, technical, regulatory, trade secret and patent claims in the areas of: Regenerative Medicine Blood / Tissue Banking Cellular and Tissue Based Therapeutics Stem Cell Bioengineering Extracellular Matrix HSCs / MSCs Processing Cryopreservation Longevity Cellular and Tissue Engineering Biotechnology Medical Devices Perinatal Tissues Transplantation Quality Control Regulatory and Po...

Chapel Hill, North Carolina

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...