Cell Therapy Expert Witnesses

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...

Media, Pennsylvania

Medical Devices, Biomedical Engineering - Mechanical Engineering, R&D, Product Development, Clinical diagnostics, Blood collection, Biospecimens, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics, Imaging, Mathematics, Laboratories & Testing, Lasers

Dr. Fletcher is Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm focused on industrial biomedical and mechanical engineering, and research and product development, in medical devices, diagnostics, optical devices, point-of-care blood sample testing, and on expert witness patent litigation, including subject matter expertise in medical device mechanical engineering, and subject matter expertise in medical devices for blood collection and blood sample processing for diagnostics and therapeutics. He has particular expertise in mechanical engineering design and development of non-invasive and minimally invasive biomedical diagnostics systems, blood collection and stabilization, blood separation, and blood and cell preparation for both diagnostic and therapeutic applications, including the development of sample collection devices, needles, and lancets. He is co-inventor on 23 patents for devices and methods in blood collection and processing. Yale educated Ph...