Radiopharmaceutical Trials: An Operational Playbook
A four-part podcast series exploring the scientific promise, operational realities, and executional demands of radiopharmaceutical clinical trials.
Description: Radiopharmaceuticals are reshaping the oncology landscape, combining targeted therapy with precision radiation in ways that are generating growing interest across sponsors, researchers, and clinical teams. But behind the promise lies a uniquely complex trial environment — one that demands specialized infrastructure, tightly coordinated logistics, and deep operational expertise.
In Radiopharmaceutical Trials: The Operational Playbook, Fortrea along with industry specialists unpack the critical factors that can influence study success, from site selection and feasibility to supply chain timing, manufacturing, and distribution. Designed for biotech and biopharma teams navigating this evolving space, the series offers practical insight into what it takes to execute radiopharmaceutical trials with confidence.
Episode 1: Why Radiopharmaceuticals? Scientific Promise + Market Momentum
Description: 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
References:
- Global Radiopharmaceuticals Market. MarKNtel Advisors. https://www.marknteladvisors.com/research-library/radiopharmaceuticals-market.html
- Biological targets. Nucleus RadioPharma. 2024 milestones and 2025 trends for radiopharma
- Industrial scale production. Radiopharmaceutical Manufacturing in 2026: Industrial Scale
- Chelator conjugate. Matching chelators to radiometals for radiopharmaceuticals - Chemical Society Reviews (RSC Publishing) DOI:10.1039/C3CS60304K
- Transport across countries. Transport of Radiopharmaceuticals: Safety and Compliance - PHSE
- Expanded Indications and combinations: Nucleus RadioPharma. 2024 milestones and 2025 trends for radiopharma
- PSMA Theranostics in Prostate Cancer and Beyond: Current and Future Perspectives
- Frontiers. An overview of current phase 3 radiopharmaceutical therapy clinical trials
- FDA. Radioactive Drug Research Committee (RDRC) Program
- Imaging Standardization Across Multicenter Trials. Standardization of Preclinical PET/CT Imaging to Improve Quantitative Accuracy, Precision, and Reproducibility: A Multicenter Study - PMC
- Companion Diagnostics & IVD Regulation. Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
- European Medicines Agency (EMA). Companion diagnostics ('in vitro diagnostics')
- Journal of Nuclear Medicine. Theranostics Explained: A Personalized Approach to Cancer Care
- Nuclear Medicine Seminars. Quality Assurance and Quality Control Methods in Radiopharmacy
Episode 2: Timing Is Everything: The Importance of Logistics in Radiopharmaceutical Trials
Description: 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
Participants: Graham McCarthy, MIAS Pharma
References:
- European Commission. (2022, February 16). EudraLex Volume 4: Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use – Annex 21: Importation of Medicinal Products. Retrieved from https://health.ec.europa.eu/system/files/2022-03/vol4_annex21_en.pdf vol4_annex21_en.pdf
- Mastascusa, N. (2026, April 9). Just in Time Oncology: The Logistics Behind Radiopharmaceutical Delivery. Blood Cancers Today. Retrieved from https://www.bloodcancerstoday.com/videos/just-in-time-oncology-the-logistics-behind-radiopharmaceutical-delivery
Episode 3: Manufacturing & Distribution Constraints: When Precision Meets Pressure
Description: 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
Participants: Graham McCarthy, MIAS Pharma