Dawn Sullivan

Global Medical Affairs, UltraPrograms, EAPs & ISTs Department Manager Ultragenyx Pharmaceutical Inc.

Seminars

Wednesday 15th July 2026
Transitioning Patients Without Breaking Programs, Budgets, or Trust
12:00 pm
  • Managing patient transitions as programs move from trial to post-trial access and into commercialization
  • Navigating internal handoffs as responsibility shifts from clinical operations to medical affairs or access teams
  • Balancing ethical obligations to patients with resource constraints and long-term sustainability
Wednesday 15th July 2026
Roundtable – Middle East: Expanding Access in High-Demand, Rapidly Evolving Regulatory Environments
9:30 am
  • Supporting access where regulatory frameworks are still evolving
  • Operating without local affiliates or established infrastructure
  • Managing political sensitivity, sanctions, and cross-border care realities
Tuesday 14th July 2026
Expanded Access Foundations & Ecosystem Masterclass
8:30 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
Dawn Sullivan, Global Medical Affairs, Ultragenyx