Implementing MIDD Frameworks for Emerging Modalities & Modern Evidence Generation

3:30 pm - Wednesday 18th November 2026

  • Exploring how organisations are applying the M15 framework to support strategic decision-making and regulatory interactions
  • Examining the role of MIDD in cell & gene therapies, novel modalities, and other emerging therapeutic platforms
  • Leveraging MIDD alongside New Approach Methodologies (NAMs) to generate evidence and reduce development uncertainty
  • Sharing practical lessons learned for embedding MIDD frameworks across multidisciplinary teams and global development programmes

Speakers:

Associate Director of Pharmacometrics
Astellas Pharma