Cencora Experts Discuss Regulatory and Supply Chain Challenges in Radiopharmaceutical Distribution

In the second of a three-part interview with BioPharm International®, Andrea Zobel, senior manager of dangerous goods at Cencora World Courier, and Marco Hogenboom, senior director of specialty logistics , discussed the challenges of ensuring radiopharmaceutical therapies reach patients safely and efficiently.

How can the industry overcome regulatory barriers to global radiopharmaceutical distribution?

As radiopharmaceuticals continue to gain momentum in oncology and other therapeutic areas, developers must navigate a complex regulatory environment that combines pharmaceutical and radioactive material requirements.

According to Zobel, radiopharmaceutical developers operate within two distinct regulatory frameworks. In addition to pharmaceutical regulations such as Good Manufacturing Practice and Good Clinical Practice standards, companies must also comply with international requirements governing the transport of radioactive materials.

"We have the pharmaceutical world, they know very well about pharmaceutical development and all applicable regulations, but now they have to add a new area, which is unknown for them," Zobel said.

She noted that while international guidance exists for both pharmaceutical products and radioactive materials, implementation often varies by country, creating additional complexity for global distribution. The lack of harmonized approaches in some regions can present obstacles for companies seeking to move products across borders within narrow delivery windows.

Hogenboom emphasized that radiopharmaceutical logistics must be considered early in development because the products have limited shelf lives and require specialized packaging, transportation, and handling procedures.

"It is an integral part of the supply chain, so you need to really consider the shipping part as a serious part, basically of delivering your therapy to the patient," he said.

The discussion also addressed public perceptions of radioactivity. Zobel explained that while some stakeholders may initially have concerns about radioactive therapies, patients are often focused on treatment effectiveness and quality of life. She noted that many patients appreciate having an alternative to conventional therapies when radiopharmaceuticals can provide clinical benefit with manageable side effects.

As the radiopharmaceutical sector continues to expand, both experts emphasized the importance of regulatory planning, stakeholder education, and supply chain readiness to support broader patient access.

About the speakers

Maco Hogenboom, senior director of specialty logistics, Cencora World Courier

With over eight months as the Global Head of Personalized Supply Chain at Cencora's World Courier, contributions focus on leveraging profit and loss accountability, strategic planning, and negotiation to enhance supply chain operations. Efforts are concentrated on advancing solution development for ATMP and optimizing the pharmaceutical supply chain to drive impactful results in the clinical and pharmaceutical sectors.

Andrea Zobel, senior manager of dangerous goods, Cencora World Courier

Andrea leads the Cell and Gene Therapy and Direct-to-Patient service lines at Cencora, where she focuses on strategy, growth, and addressing the operational complexities associated with advanced therapy logistics. Drawing on experience across academia, pharmaceutical services, and clinical trial supply chains, she has held senior leadership roles in research and development, clinical trial supply management, and product and project management.