By Naomi Kautz
Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine.
In our previous blog post, we discussed site selection, manufacturing, long-term follow-up, and other critical considerations for gene therapy trials at the study design phase. In this follow-up, we’ll continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.