Achieving Stakeholder Alignment in Early Access Programmes: Strategies for Clarity, Consent & Collaboration

  • Mapping key stakeholder roles and identifying potential conflicts of interest or misalignment early in programme development
  • Practical steps to ensure clear, transparent communication with patients, HCPs, and advocacy groups to manage expectations and ethical concerns
  • Case examples of how stakeholder alignment improved operational efficiency, patient enrolment, and long-term treatment outcomes in rare and non-rare diseases