Gene Therapy Expert Witnesses
Biotechnology and pharmaceutical companies face litigation whenever a gene therapy product’s safety, efficacy, or underlying technology is challenged in a patent, regulatory, or product liability dispute. These matters commonly involve patent infringement and licensing disputes over gene delivery vectors and therapeutic constructs, product liability claims following an adverse clinical outcome, and disputes over whether a company’s development or manufacturing process complied with FDA regulatory requirements. Because gene therapy sits at the intersection of molecular biology, virology, and clinical medicine, the central issue in these disputes is typically whether the scientific and technical record supports the safety, efficacy, or infringement claims at the center of the case. Evaluating that record requires expertise across several overlapping scientific disciplines.
A gene therapy expert reviews the underlying molecular biology, preclinical data, and clinical trial results to determine whether a therapy’s design, delivery mechanism, or manufacturing process met accepted scientific and regulatory standards. That analysis often informs causation in product liability matters by clarifying whether an adverse outcome is attributable to the therapy itself, the underlying disease, or an unrelated factor. In patent disputes, the expert’s technical comparison of gene therapy vectors, constructs, and delivery methods supports infringement and validity analysis. This scientific grounding also shapes regulatory and litigation strategy by clarifying whether development and manufacturing decisions were consistent with FDA guidance at the relevant time.
Because gene therapy litigation depends on a precise understanding of fast-moving science, selecting an expert with direct research or clinical development experience in the specific therapeutic approach at issue is essential. The experts we can provide include molecular biologists, virologists, and pharmaceutical scientists who have led gene therapy research programs, published extensively on vectors and delivery mechanisms, and in some cases founded biotechnology companies built on the technology at issue. Round Table Group has completed more than 75,000 expert searches for litigators, and we draw on that depth to match counsel with gene therapy experts whose specific scientific background fits the case. Let us help you find the right gene therapy expert for your case by calling us at (202) 908-4500.
