Danielle Rafferty
Director - Research Grants & Expanded Access Alkermes plc
Seminars
Tuesday 14th July 2026
Expanded Access Foundations & Ecosystem Masterclass
9:00 am
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
Wednesday 15th July 2026
Designing Post-Trial Access Strategies Before the First Patient Enrolls
11:30 am
- Embedding post-trial access planning into clinical trial design to avoid last-minute ethical and operational dilemmas
- Evaluating when post-trial access, long-term extensions, or hybrid approaches make the most sense by disease, geography, and duration
- Anticipating regulatory constraints that may prevent post-trial access in certain countries and adjusting trial footprints accordingly
- Aligning clinical development, medical affairs, and access teams early to support continuity of care
