Advancing radiopharmaceuticals from early development into pivotal trials brings unique challenges that extend beyond traditional drug modalities. Compressed timelines, complex supply chains, and evolving regulatory expectations demand that critical technical and strategic choices are made earlier than ever before. Success depends on anticipating late-stage requirements while balancing the realities of early-phase development.

This workshop will bring together industry leaders to share insights, highlight lessons learned, and discuss strategies to de-risk the path to commercialization through:

• Comparing early- vs. late-phase drug product lifecycles and their clinical implications

• Applying Quality by Design principles to pivotal and commercial assets

• Navigating regulatory interactions and integrating CMC to ensure scalability