The Fortrea Podcast

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, 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.

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 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

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 highlights how imaging is transforming patient selection, early response identification, and the design of clinical studies.

Listeners will gain an understanding of the challenges and opportunities in aligning imaging with liquid biopsy data, the rise of theranostics, and the regulatory landscape shaping the future of drug development. With practical examples and visionary perspectives, this attachment offers a comprehensive look at how imaging endpoints are driving innovation in oncology and beyond.

If you’re involved in clinical research or interested in the future of medical imaging, this episode—is a must-listen.

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'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.

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 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.

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 to think about different operation models. 

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 episode, we explored the scientific foundation behind treating T1D as an autoimmune disease and the critical importance of those first 100 days after diagnosis. In this episode, we shift our focus to the human side of the equation. We'll tackle the real-world hurdles families face when navigating a new T1D diagnosis - from emotional overwhelm to information overload. More importantly, we'll discuss how we can design clinical trials that work for families, not against them, and explore the transformative power of true partnerships between sponsors, CROs, and patient advocacy groups.

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.  

We explore the specific needs and barriers for children and their families, and the role of advocacy and research groups in supporting them. The conversation highlights practical examples of support programs and tools that can help pediatric patients participate in clinical trials, ensuring their voices are heard and their needs are met. 

Obesity is a serious, chronic disease with multiple health consequences. Effective treatment should go beyond simply reducing body weight. It must focus on decreasing fat mass, improving body composition including preserving muscle mass and enhancing muscle quality addressing associated metabolic comorbidities, and ultimately improving overall quality of life.

Today, scientific advances highlighted by Claudia Filozof and Arya Sharma are reshaping obesity treatment. In this episode, their discussion on body composition explores why both the quantity and quality of muscle mass matter in managing obesity as a chronic disease.

Participants:

Host: Claudia Filozof, Vice President and Therapeutic Head Obesity, MASH, and Hepatology at Fortrea

Dr. Arya Sharma, MD, DSc (hon), FRAHS – Emeritus Professor, Thought Leader in Obesity

Host: Dr. Friedrich Mittermayer, Sr. Medical Director for Endocrinology, Fortrea

Participant: Dr. Esther Latres PhD, VP of Research at Breakthrough T1D

Description: This episode brings together Dr. Friedrich Mittermayer and Dr. Esther Latres PhD, VP of Research, to discuss the exciting cures for T1D, and the challenges those clinical trials face.

This podcast episode explores the urgent realities and untapped opportunities in adult T1D diagnosis and treatment. From the heartbreak of misdiagnosis to the promise of cell and gene therapies, we spotlight the real-world journeys that shape clinical trial access and outcomes. You’ll hear how delayed diagnoses push young adults beyond critical trial windows, why older patients are often overlooked, and how new tools—from EMR pilots to genetic rescores—are helping us find the right patients, faster.

With insights from Breakthrough T1D, we rally around a shared vision: a world without T1D. Because the future of diabetes care isn’t just about innovation—it’s about inclusion.