Real-World Data in Expanded Access: An Integral Part of Evidence Generation

  • Gaining new insights into the practical application of RWD from EAPs through continuation of PhD research in collaboration with University Medical Center Utrecht (2021–2025)
  • Learning how to embed EAP-derived RWD into integrated evidence generation that supports both clinical development and post-approval commitments
  • Discovering how proactive workflows and high-quality standards maximize data utility for regulatory and payor submissions