Setting the Stage – Expanded Access in 2026: From Ethical Imperative to Strategic Necessity

  •  Discussing how EAPs have evolved since their inception, from ad hoc programs to strategic global tools
  • Highlighting the key forces shaping the landscape today: regulatory variability operational challenges, supply pressures, and the not-so-subtle shift toward data collection for regulatory purposes
  • How EAPs are redefining their role and impact as vehicles for generating Real World Data/Evidence in clinical development and commercialization