The Cost Of Working In Silos

Clinical, CMC, regulatory and logistics may each have distinct priorities, timelines and partners. But the decisions made within those workstreams rarely stay contained.

A clinical decision can change CMC demand and supply requirements. A manufacturing decision can limit future clinical options. A logistics delay can become a supply issue with potential consequences for patients. And when development spans multiple partners, sponsors are responsible for maintaining visibility and alignment across them all.

In this on-demand panel, experts across clinical, CMC, regulatory and logistics examine what happens between workstreams, where cross-functional risks and opportunities can be missed and what sponsors can do earlier to make more informed decisions across the broader development program.

What you will learn

• Why timing matters: Cross-functional visibility needs to happen early enough to influence decisions, not simply communicate them after the fact.
• Where dependencies emerge: How clinical, CMC, nonclinical, regulatory and logistics decisions can change the assumptions another function is working against.
• How to plan for change: Why anticipating likely scenarios and building appropriate flexibility earlier can help programs respond without unnecessary delays or rework.
• What effective collaboration looks like: How shared visibility, governance and cross-functional risk planning can help sponsors manage the spaces between specialized workstreams and partners.
• What to pressure-test: The warning signs that strong coordination within individual functions may not be translating into better decision-making across the program.

Meet our experts: