The Fortrea Podcast

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

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.

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea

Participant: Yang Dong, Head of Regulatory Affairs for China at Fortrea

In this episode of Accelerating Oncology – Inside the EPON Network, host Maria Garcia discusses why partnerships matter in early phase oncology. We’ll also find out what makes an EPON site different and talk about partnership design principles. 

Host: Maria Garcia, Fortrea Medical Director

Participants: Dr. William McKean, Medical Oncologist and Principal Investigator at The START Center for Cancer Research and Anne Himmel, Senior Manager, Site Engagement and Partnership Delivery at Fortrea

Early Phase Oncology trials have evolved from simple safety checks to the most scientifically demanding stage of cancer drug development. In this episode of Accelerating Oncology – Inside the EPON Network, host Ken Morrison and guest Maria Garcia unpack why Phase 1 trials are no longer “entry-level” and why they require a specialized model for success.

Host: Ken Morrison, Fortrea Global Leader of Strategic Delivery and Growth in Oncology

Participant: Maria Garcia, Fortrea Medical Director

Today we explore the unique challenges and opportunities in Phase 1 ophthalmology clinical trials, focusing on gene therapy and inherited retinal diseases. 

Host: Amber Burg

Participants: David Hoelscher, Senior Medical Director, Ophthalmology 

Tanya Richardson, Therapeutic Strategy Head, Ophthalmology and Neuroscience 

In today’s episode, we delve into the fascinating world of Phase 1 clinical research at Fortrea’s Leeds Clinical Pharmacology Unit in the UK. We explore the operational challenges and innovative solutions behind a recent, complex ophthalmology clinical trial. 

Host: Amber Burg

Participants: Warren Edwicker, Director of Clinic Operations at Fortrea’s Leeds CPU

Natalie Wood, Clinical Research Associate, Leeds UK

In this conversation today, we're going to dive into the evolving landscape of patient recruitment in ophthalmology and explore how Belite Bio and Fortrea are collaborating to overcome protocol complexities, and discuss the unique opportunities Asia PAC represents for ocular development. We'll also look ahead to the most promising trends shaping the future of ophthalmology trials. 

Host: Amber Burg

Participants: Tanya Richardson Fortrea’s Therapeutic Strategy Head for Neuroscience and Ophthalmology

Lisa Liang, Senior Director of Clinical Operations at Belite Bio. 

Join Leone Atkinson, Fortrea’s Executive Medical Director of Neuroscience and Ophthalmology, and Dr. John Huffaker from the Neuropsychiatric Research Center as they discuss the evolving landscape of Alzheimer’s clinical trials. Explore challenges in patient recruitment and retention, the role of caregivers, and how digital tools and AI are transforming at-home data collection. Learn why collaboration between CROs, sponsors, and research sites is key to advancing patient-centric trial design and improving outcomes.

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.

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.