Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents With Zero Sample Loss

By Alexis Hobbins-White

Autologous cell therapy trials require precision at every stage—and this biomarker-specific solid tumor study exemplified the challenge. The sponsor needed to scale quickly across Europe and North America while navigating fragmented GMO/IVD frameworks, coordinating high-stakes apheresis and cell workflows, and ensuring sites were fully equipped for specialized procedures. Precision addressed these hurdles with a layered strategy.

Country-specific regulatory mapping and playbooks, feasibility processes that identified sites with JACIE/FACT accreditation, and a dedicated Logistics Coordinator safeguarded sample/IP integrity were just some of the factors Precision focused on. The result: efficient cross-border activation, uninterrupted logistics, resilience in patient screening, and data integrity to support dose-escalation. For cell therapy sponsors, this case shows that success comes from weaving regulatory foresight, site readiness, and operational intelligence into the trial’s foundation.