Operationally, radiopharmaceutical studies behave differently than more traditional oncology studies. We are talking not only about site capability to handle radiopharmaceuticals or having a license for the specific radioisotope, but also having been trained on the study specifics, or calibrating the instruments. To explore this from the clinical perspective, we are joined by Dr. Cristina Matsushita and Dr. Paolo Nunes, oncologist and senior medical director at Fortrea, with extensive hands-on experience conducting pharmaceutical clinical trials.

Host: Hector Herrero, Senior Director on Global Project Management at Fortrea

Participants: Dr. Cristina Matsushita, R2 Pharma

Dr. Paolo Nunes, Oncologist and Senior Medical Director at Fortrea

Site selection is one of the most underestimated and most critical success factors in radiopharmaceutical studies. Operationally, they behave differently than more traditional oncology studies. Infrastructure workflows, regulatory readiness, and timing all play a much bigger role. The ability of the investigational site as a whole is very important to the patient and drug journeys. To explore this from the clinical perspective, we are joined by Dr. Cristina Matsushita and Dr. Paolo Nunes, oncologist and senior medical director at Fortrea, with extensive hands-on experience conducting pharmaceutical clinical trials.

Host: Hector Herrero, Senior Director on Global Project Management at Fortrea

Participants: Dr. Cristina Matsushita, R2 Pharma

Dr. Paolo Nunes, Oncologist and Senior Medical Director at Fortrea

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 how precision at every step directly impacts whether patients can receive their dose on time.

Host: Hector Herrero, Senior Director on Global Project Management at Fortrea

Participant: Graham McCarthy, MIAS Pharma

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 perspectives, the conversation highlights the precision, pressure, and patient impact behind radiopharma logistics.

Host: Hector Herrero, Senior Director on Global Project Management at Fortrea

Participant: Graham McCarthy, MIAS Pharma

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 what is driving their rapid momentum across the drug development landscape. 

Host Hector Herrero is joined by Dr. Kavi Karra and Dr. Paulo Nunes to examine both the scientific promise and the operational realities of radiopharmaceutical development. Together, they discuss how radiopharmaceutical trials differ from traditional oncology studies, from specialized site requirements and radiation safety considerations to the complex coordination needed across clinical, manufacturing, and logistics teams.

Host: Hector Herrero, Senior Director on Global Project Management at Fortrea

Participants: Dr. Kavi Karra, Senior Medical Director GE HealthCare and Dr. Paulo Nunes, Medical Director at Fortrea

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 Affairs Strategy at Fortrea

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 critical role of natural history data in supporting external control arms and alternative trial designs, while also addressing the burden traditional site-based trials can place on patients—particularly in pediatric and neurodegenerative conditions. Participants share perspectives on emerging hybrid and decentralized approaches, the growing value of patient-driven data, and the collaborative efforts required to build natural history datasets that are both scientifically robust and practical for rare disease communities.

Together, the conversation highlights a path forward for advancing research in rare neurological diseases through innovation, partnership, and patient-centered trial design.

Host: 
Amber Burg, Therapeutic Delivery Head of Neuroscience and Ophthalmology at Fortrea 

Participants 
Louise Kearney, Executive Director of Cell and Gene Therapy at Fortrea

Hannah Simonds, Director of Patient Recruitment and Engagement at Fortrea

Karmen Trzupek, Senior Director of Scientific Programs, Global Genes

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 unpack how Fortrea’s EPON Network optimizes site selection to deliver speed, precision, and confidence in early phase studies.

Host: María García Requesens, Medical Director Fortrea

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

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 how patient‑centered research is reshaping the rare disease treatment landscape.

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.