Running Expanded Access Alongside Clinical Development: Adapting the Approach Across Disease Areas
4:00 pm - Thursday 25th March 2027
- Balancing Expanded Access alongside active clinical development without disrupting the clinical trial pathway
- Comparing approaches across different disease areas, including when and how to introduce a formal EAP
- Deciding when real-world data collection adds value versus when rapid access and safety monitoring need to take priority
- Navigating different levels of physician and internal team familiarity with EAPs and avoiding programs being approached operationally like clinical trials
