Scaling What’s Never Been Scaled: Lessons Learned From Building Late- Stage Manufacturing Readiness for Global PCV Trials

• How to design a scalable, modular manufacturing model to enable Phase II/III execution without overcommitting pre-commercial – including lessons from scaledown modeling to simulate future bottlenecks

• Strategic considerations in platform selection and core workflow standardization to support repeatability, reduce cost, and accelerate late-stage development

• Lessons from early investments in future-proofing critical processes – minimizing tech transfer complexity and enabling global trial expansion and real-world access

Speakers: