Explore the Agenda
Workshop A
9:00 am Expanded Access Foundations & Ecosystem Masterclass
Expanded Access no longer sits at the margins of development. As companies launch EAPs earlier – often in parallel with trials, named patient sales, and post-trial access – misalignment is creating regulatory risk, internal friction, and patient confusion. This masterclass establishes a shared foundation for positioning Expanded Access correctly
within the broader access ecosystem and designing first programs that are credible, compliant, and future-proof.
This workshop will gather experts to discuss:
- Clarify where Expanded Access sits within the broader access ecosystem – and where it does explain not fit
- Differentiate Expanded Access, compassionate use, right-to-try, named patient sales, and post-trial access to avoid regulatory and operational missteps
- Design a first EAP with clear intent, governance, and guardrails that withstand internal and external scrutiny
- Align medical, regulatory, clinical, supply, and patient-facing teams from day one
- Build a scalable foundation that prevents rework as programs expand
11:00 am Morning Break & Networking
12:00 pm Session Reserved for myTomorrows
Session details to be confirmed
2:00 pm Lunch Break & Networking
3:00 pm Governing Expanded Access at Scale – Building Sustainable, Defensible Programs
As Expanded Access moves from ad-hoc requests to standing global programs, governance, sustainability, and scalability are becoming the defining challenges. This workshop is designed for leaders responsible for ensuring EAPs remain ethically sound, operationally viable, and defensible as volume, geography, and scrutiny increase.
This workshop will gather experts to discuss:
- Design governance models that support consistent decision-making across regions, therapies, and program types
- Establish clear ownership, escalation pathways, and cross-functional accountability as programs scale
- Building consistency and scalability through automated tracking and response systems
- Build assurance that Expanded Access remains ethical, compliant, and viable over the long term