Mallory Fredericks
Seminars
Monday 19th October 2026
The EAP Flywheel: Sequencing Expanded Access from Trial Design to Commercial Launch
3:00 pm
- Learning how to position Expanded Access as a cross-functional capability across Medical, Clinical, and Commercial teams, supported by governance models that enable launch readiness while remaining compliant and patient-centric
- Exploring how patient experience and outcomes from Expanded Access can generate longitudinal insights that inform regulatory, medical, and market-access decisions across jurisdictions
- Learning a framework for determining where and when to establish Expanded Access, balancing country prioritization, patient continuity, launch sequencing, and regulatory considerations
- Discovering how EAP insights, including patient outcomes, site experience, and operational learnings, can support Medical Affairs, Market Access, HEOR, and launch planning objectives
Monday 19th October 2026
Workshop G: The EAP Flywheel: Sequencing Expanded Access from Trial Design to Commercial Launch
3:00 pm
- Learning how to position Expanded Access as a cross-functional capability across Medical, Clinical, and Commercial teams, supported by governance models that enable launch readiness while remaining compliant and patient-centric
- Exploring how patient experience and outcomes from Expanded Access can generate longitudinal insights that inform regulatory, medical, and market-access decisions across jurisdictions
- Learning a framework for determining where and when to establish Expanded Access, balancing country prioritization, patient continuity, launch sequencing, and regulatory considerations
- Discovering how EAP insights, including patient outcomes, site experience, and operational learnings, can support Medical Affairs, Market Access, HEOR, and launch planning objectives
Tuesday 20th October 2026
Market Access & EAPs: A closer look at the France AAP model
2:30 pm
- Practical considerations for internal ownership of AAP
- For-charge AAP: setting the price and implications
- Cross-functional coordination between Market Access, Medical Affairs, and Commercial teams in AAP execution
- Navigating surprises during HAS review: lessons learned from unexpected evidence requests, comparator challenges, and assessment outcomes
