Horses for courses: an approach to the qualification of clinical trial sites and investigators in ATMPs

The advanced therapy medicinal products (ATMPs) landscape is entirely different from classical drug development. Academia has been the major source of ATMP development, and academic hospitals act as trial sites for the clinical testing of ATMPs, including early academic-led trials as well as industry-sponsored trials that pursue the full developmental pathway to market authorization. The recent breakthrough developments in some ATMPs, such as genetically engineered immune cells, have confronted academic hospitals with a substantial amount of public demand, competitive pressure, and costs. At the same time, risks, toxicities, and necessary countermeasures demand an infrastructure, and expertise and training have not yet been fully standardized. How can Ethics Committees consider trial sites and investigators in clinical trials with ATMPs as appropriately qualified?