Workshop G: Designing Expanded Access That Works With – Not Against – Your Clinical Development & Commercial Readiness
- Enable teams to treat Expanded Access as a deliberate strategic choice—rather than a reactive obligation, while keeping patients, data integrity, and launch success in balance
- Explain how Expanded Access fits into the full product lifecycle from early-stage development through launch and post-commercialization
- Anticipate and manage cross-functional tensions, balancing perspectives from clinical, regulatory, medical, commercial, manufacturing, and ethics