By Larry Blandford and Aaron Burke

Gene therapy has sparked significant interest among researchers, health care providers, and patients because it offers the tantalizing possibility of a cure, particularly for rare diseases with a genetic basis. While gene therapy holds great promise, this field of research is still in its nascent stages, and the optimal methods and solutions for unlocking its full clinical potential are still being defined. Commercialization of gene therapies is complex with challenges ranging from vector development and trial design to regulatory hurdles, patient selection, and reimbursement.

In this article, we explore critical factors in the development of gene therapies, including trial management, accelerated approval pathways, and companion diagnostic development and its coordination with therapeutic development. We also discuss the implications of these factors on decisions made by clinicians, health systems, and payers regarding the place of gene therapies in the treatment pathway.

Read the full article at the Journal of Clinical Pathways

Disclosures
Precision Value & Health and Precision for Medicine are part of Precision Medicine Group, which supports the development and commercialization of gene therapies as well as companion diagnostics. Dr. Blandford is executive vice president, customer solutions with Precision Value & Health. Mr. Burke is strategic product marketing director with Precision for Medicine.

Citation
J Clin Pathways. 2019;5(9):34-35. doi:10.25270/jcp.2019.11.00104