The Fortrea Podcast

Radiopharmaceuticals are generating significant excitement across oncology, offering a highly targeted approach that combines precision medicine with the power of radiation. In this opening episode of Radiopharmaceutical Trials: An Operational Playbook , the discussion explores why these therapies are attracting growing attention from sponsors, researchers, clinicians, and investors alike, and wha...

This episode of Radiopharmaceutical Trials: An Operational Playbook explores why logistics isn’t just a support function in radiopharmaceutical trials—it’s often the deciding factor in whether treatment can happen at all. From managing ultra-short half-lives to understanding the real impact of even small delays, it unpacks five critical questions shaping this high-stakes field. Featuring expert pe...

This episode of Radiopharmaceutical Trials: An Operational Playbook takes a closer look at the critical role of manufacturing, quality release, and cross-border distribution in radiopharmaceutical trials—where every minute counts. It explores the operational complexity of producing and delivering treatments under extreme time constraints and strict regulatory controls. The conversation highlights...

In this episode, we focus on building the right CMC foundation for cell and gene therapy success. From manufacturing variability and potency assays to comparability and cold chain logistics, the CMC story is often the story regulators focus on. Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participant: Sanjay Jain, Executive Director of Global Regulatory Aff...

Rare neurological diseases present unique challenges for clinical development, where progress is often limited not only by scientific complexity, but by gaps in meaningful, high-quality data. In this episode of Cortex Conversations , experts explore how aligning regulatory expectations with real-world patient and caregiver needs can help overcome these barriers. The discussion examines the critica...

In this episode, Why Location Matters: Country and Site Placement Strategy , we explore why geography is more than a backdrop—it is a strategic lever in early phase oncology trials. From patient access and regulatory timelines to investigator expertise and data governance, every decision about trial placement can accelerate or stall innovation. Join host Maria Garcia and Ken Morrison, as they unpa...

Rare diseases are often misunderstood—and Primary Sclerosing Cholangitis (PSC) is no exception. This Rare Disease Day, join Fortrea and patient advocate leaders to explore why early patient engagement, smarter trial design, and global collaboration are essential to improving outcomes for people living with PSC. Hear the patient perspective on diagnostic challenges, access to clinical trials, and h...

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. 

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 suppor...

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...

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...

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 Cance...

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 Associ...

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:...

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 collaborat...

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,...

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 Riell...

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participant: Frederick Derosier Description : Cell and gene therapy (CGT) trials are rewriting the rules of early-phase research. Unlike traditional first-in-human studies, these programs involve patients—not healthy volunteers—and often target rare or ultra-rare genetic diseases. That means smaller populations,...

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participants:   Andrea Seres, Senior Director of Strategic, Delivery and Growth in Oncology and Gene Therapy, Fortrea Martin Collins, Director of Global Site Identification, Fortrea Description : In this episode of podcast series “Hope in a Dose” we discuss the essential elements for successful cell and gene ther...

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participants:   Jan Skoumal, Head of Delivery for Oncology, Fortrea  Ludek Sojka, CEO, SCT Bio Description: In this episode we will discuss topics that are critical to the success of CGT programs: seamless collaboration between CDMOs and CROs. In cell and gene therapy, complexity isn't just in science, it&ap...

In this episode, host Laura Vidal, VP of Oncology at Fortrea, sits down with Dr. Ron Korn, Founder and Chief Medical Officer of Imaging Endpoints, to explore the evolving role of imaging in precision oncology. The conversation covers the latest advancements in molecular imaging, including PSMA PET for prostate cancer and the integration of AI-driven radiomics in clinical trials. The episode highli...

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participant: Isabella Presch, Pediatric Clinical Research and Advanced Therapies Description: Today we're diving into one of the most exciting frontiers in medicine: cell and gene therapy for pediatric diseases. Why is it so important? Part of the answer lies in the fact that cell and gene therapy offers som...

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participant: Darby Thomas, Senior Scientific Director for Cell and Gene Therapies, Fortrea  Description: In this first episode, we're discussing why we should think differently about cell and gene therapy, clinical trials, and the kinds of challenges to conventional trial design, and which means that we have...

Host: Dr. Mala Puri, Senior Medical Director at Fortrea  Participant: Dr. Sanjoy Dutta PhD, Chief Scientific Officer at Breakthrough T1D Description: This episode brings together Mala Puri, Senior Medical Director at Fortrea and Dr. Sanjoy Dutta PhD, Chief Scientific Officer to discuss the unique challenges faced by pediatric populations in Type 1 diabetes clinical trials.   In our previous episod...