The Rationalization of EAPs for Small Biotech
- Profit, survival or compassionate use • Navigating the evolving Expanded Access Programs globally
- Discussing the “all-in-one” role by managing regulatory, supply, clinical, and commercial responsibilities simultaneously
- Establishing priorities and workflows when multiple functions rely on one or two team members
- Building internal awareness and educating cross-functional teams to secure cooperation and reduce bottlenecks
- Leveraging vendor partnerships strategically to supplement expertise while maintaining oversight