Welcome to Hope in a Dose—the podcast where we explore the science, strategy, and stories behind the therapies redefining what’s possible.
Designed for CGT innovators, this series helps you move smarter, faster, and with greater operational confidence.
Across each episode, we unpack the real-world challenges sponsors face today: selecting truly CGT-capable sites, navigating early-phase risk, activating global trials in rare populations, and demonstrating meaningful clinical impact.
Hosted by Lousie Kearney Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea, a seasoned leader with decades of experience guiding emerging biotechs, Hope in a Dose equips CGT innovators, clinical sites, and Principal Investigators with practical tools to navigate the unique complexities of advanced therapy development.
Hope in a Dose | Ep 11 | CMC Foundations for FIH Success: Getting CGT-Ready from Day Zero
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.
6 Apr 2026
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.
6 Apr 2026
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.
6 Apr 2026
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.
6 Apr 2026
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.
6 Apr 2026
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.
6 Apr 2026
Hope in a Dose | Ep 5 | Early Phase Challenges in Advanced Therapies
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, complex logistics, and long-term follow-up requirements that can span decades.
In this episode of Early Phase Challenges in Advanced Therapies, we explore the unique challenges of designing and delivering early-phase CGT trials—from patient recruitment and dosing to regulatory oversight and global coordination.
6 Apr 2026
Hope in a Dose | Ep 4 | Patients, Sites, and Speed: Building a Realistic CGT Trial Strategy and Finding the Right Sites
In this episode of podcast series “Hope in a Dose” we discuss the essential elements for successful cell and gene therapy trials: understanding patient eligibility and journey, selecting the right sites, and acting with strategic urgency to accelerate outcomes. Learn how data-driven site selection, operational planning, and collaboration help overcome the unique challenges of CGT studies.
Featuring insights from Andrea Seres and Martin Collins, this episode highlights Fortrea’s proactive approach to supporting sites, optimizing trial placement, and fostering innovation in advanced therapies. Whether you’re a sponsor, investigator, or interested in the future of CGT, you’ll gain practical strategies and real-world perspectives to guide your next steps.
Tune in to discover how thoughtful planning and expertise drive success in cell and gene therapy.
6 Apr 2026
Hope in a Dose | Ep 3 | Partners in Scale: CDMOs and CROs Working as One
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's in the execution. And that's where integrative thinking comes in, where manufacturing and clinical operations work as one, we can accelerate timelines, reduce risk, and optimize costs. In this episode, we'll explore how early alignment between CDMOs and CROs can transform technologies into opportunities, from protocol design to study chain logistics and overall project success.
Learn how proactive coordination—from tech transfer and manufacturing to clinical operations and regulatory submissions—creates a unified strategy that drives success. Hear real-world insights on overcoming challenges, synchronizing supply chains, and delivering hope to patients faster through true partnership.
Listen now to explore the power of working as one in advanced therapy trials.
6 Apr 2026
Hope in a Dose | Ep 2 | CGT in Pediatric Patient Population
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 something extraordinary: a cure, not just symptom management. In this episode hear from leading experts about the science, challenges, and human impact of pediatric CGT clinical trials.
Join us as we discuss the evolving landscape, regulatory considerations, and the importance of community support in transforming lives.
Listen now to “Hope in a Dose” and learn how science is turning hope into reality for children and families worldwide.
6 Apr 2026
Hope in a Dose | Ep 1 | Breaking Ground: What Makes CGT Phase Trials Different
Discover what sets cell and gene therapy (CGT) clinical trials apart. From “one-and-done” treatments to complex logistics and evolving regulations, our first episode of this podcast series explores the unique challenges and transformative potential of CGT studies. Join us as we dive into science, strategy, and stories behind Hope in a Dose.
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