Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, considers the key remaining barriers facing the approval and ultimate clinical adoption of cell & gene therapies. Dr Levine states that the predominant challenge being faced is obtaining clinical trial data, although recent advancements in tools and technologies are rapidly aiding translation to clinical trials. As research moves towards multicenter clinical trials, clinical onboarding and training around cell and gene therapies for the wider healthcare team poses an additional challenge. Finally, novel pricing and reimbursement models are required to ensure patient access to approved therapies in the future. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.
Declaration of financial interest due to intellectual property and patents in the field of cell and gene therapy: University of Pennsylvania Alliance with Novartis and resulting milestones and royalties.
Consultant for: Terumo
Scientific Advisory Board for: Akron, Avectas, Immuneel, Immusoft, In8bio, Ori Biotech, Vycellix Co-Founder and equity holder Tmunity Therapeutics.
Conflict of interest is managed in accordance with University of Pennsylvania policy and oversight.