In this episode, Fortrea experts discuss how external control arms can enable efficient and ethical cell and gene therapy trials, particularly in rare diseases where traditional control arms are challenging. The conversation highlights study design strategies, regulatory considerations, and how sponsors can use high‑quality external data to accelerate development, reduce patient burden, and support regulatory decision‑making.
Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea
Participant: Christina Wassel, Director of Epidemiology at Fortrea