Breaking the Preclinical-to-Clinical Bottleneck: Advancing Novel Theranostic Radiopharmaceuticals into First-in-Human Trials

• Navigating the transition from a completed preclinical package into first-in-human development, identifying the critical hurdles that emerge as novel theranostic programmes approach the clinic
• Coordinating clinical, CMC and regulatory requirements to build a cohesive translational strategy and avoid delays between preclinical completion and patient dosing
• Applying lessons learned from preparing an early-stage radiopharmaceutical programme for Phase I to anticipate translational challenges earlier and accelerate novel theranostics towards patients

Speakers:

Friedmund Bachmann

Vice President CMC & Project Lead

OncoOne