Hope in a Dose | Ep 10 | Regulatory landscape for ATMPs in EU

Hope in a Dose | Ep 10 | Regulatory landscape for ATMPs in EU

In this episode, we talk through what sponsors really need to think about when navigating regulatory pathways for cell and gene therapies. We cover everything from early conversations with regulators and managing CMC risk, to using accelerated approval pathways and building a joined up regulatory and operational strategy to help get innovative therapies to patients faster.

Hope in a Dose | Ep 9 | CGT Development: External Control Arms

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.

Hope in a Dose | Ep 8 | Inside China’s Cell & Gene Therapy Boom

In this episode we focus on one of the most dynamic regions in the CGT space: China. Why is this important? China has roughly become a major hub for cell and gene therapy research, driven by regulatory innovation, technological progress, and significant investment with a large patient population and high unmet medical need.

Hope in a Dose | Ep 7 | Long-term Follow Up in Cell and Gene Therapy Trials

In this episode we tackle one of the most critical aspects of these programs: long-term follow-up. Why is it so important? With CAR-T therapies, lentiviral vector-based treatments, and gene editing approaches requiring up to 15 years of follow-up, we’re looking at a rapidly growing population of patients who will need monitoring for years—sometimes decades. Featuring insights from Gordon Cummings, Global Growth Lead, this episode highlights why long-term follow-up is essential, how sponsors can reduce burden on patients and sites, and the exciting role of data technologies in making these studies more efficient.

Hope in a Dose | Ep 6 | Tumor-Free Territory: Navigating CAR-T in Non-Oncology Landscapes

Expanding cell therapy beyond oncology opens new doors for patients—but it also introduces unique challenges in site identification and startup. From competing studies and resource limitations to regulatory nuances and cross-department collaboration, these hurdles can delay timelines if not addressed early. In this episode of Hope in a Dose, host Louise Kearney is joined by Erin Jackson and Rielle Giannino to discuss why site selection for CAR-T and other cell therapies is so complex—and how strategic planning and relationship-building can make all the difference.