Apheresis Expert Witnesses

Clearwater, Florida

Legal Nurse Consulting, Phlebotomy - IV, Intravenous, IV Medication, Peripheral Venipuncture, Phenergan, Extravasation, Infiltration, CRBSI, CRPS, Compartment Syndrome, PICC Midline Injury, Iron Infusion, IV Injury, Blood Draw, Apheresis, Blood Collection, Phlebotomy, IV Nerve Damage, Chemotherapy Infusion, Sepsis

Kay Coulter, CRNI, VA-BC provides legal case review and expert opinion for IV therapy / infusion-related malpractice issues; and has been doing so for over 25 years during which time she has consulted on over 150 cases. Her company, Infusion Knowledge, Inc., also represents several other highly qualified, IV certified, legal nurse consultants. Please go to our website www.infusionknowledge.com for more information. We will provide a thorough, honest opinion using current IV therapy references and INS Standards of Practice for any case (plaintiff or defense). Our experts are proficient IV therapy clinicians who have experience in the outpatient, home care, and acute care settings; accessing implanted venous ports, placing PICC lines, midlines and peripheral IV catheters. Additional clinical activities include phlebotomy / venipuncture for blood collection / lab draws, blood donation, blood transfusions, apheresis / plasma donation, IV medication administration, iron infusion, on...

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...