Avoiding common pitfalls in the clinical-to-commercial transition

The clinical-to-commercial transition in advanced therapies involves complex operational, regulatory, and translational considerations. This spotlight session outlines frameworks to mitigate risks, align clinical outcomes with manufacturing and delivery, and preserve predictive validity throughout program scale-up.

Key takeaways

• Identify common operational and translational pitfalls during commercialization
• Align clinical data with manufacturing, regulatory, and delivery requirements
• Maintain predictive validity and translational fidelity through scale-up
• Define frameworks for dose selection, biomarker strategy, and safety margin management
• Implement processes that support smooth program handoff from trial to market