Building Managed Access Programs That Align with Development, Launch & Evidence Strategy – where to start? (US & Europe)
- Deciding when and where to initiate managed access across the US and Europe as assets approach planning for submission
- Structuring early access, individual patient, protocol-based, and post-trial access pathways within a single coherent strategy
- Aligning managed access programs with clinical development plans to avoid trial interference while meeting unmet needs
- Navigating labeling, launch sequencing, and regional differences when operationalizing programs pre-approval
- Embedding managed access into broader investigator-driven research and evidencegeneration capabilities