Spotlight session: Avoiding common pitfalls in the clinical-to-commercial transition

Transitioning from clinical programs to commercial supply presents complex operational, regulatory, and strategic challenges. This session explores lessons learned from developers, highlighting approaches to mitigate risks, ensure manufacturing readiness, and streamline commercialization. 

Key Takeaways: 

• Identify common pitfalls in the clinical-to-commercial transition 

• Align manufacturing, regulatory, and commercial strategies for launch readiness 

• Implement risk mitigation strategies across supply chain and operations 

• Evaluate workforce, infrastructure, and technology requirements for commercial scale 

• Learn from case studies of successful transitions from clinical to commercial programs