Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight new advanced therapy products in 2021.
As advanced therapy research develops across modalities and therapeutic areas, developers are tasked with designing and executing trials in a competitive landscape where regulations are evolving rapidly. In this article, we explore critical factors for the successful execution of advanced therapy studies.