Global Launch Readiness for a Novel Intravitreal Biologic

Challenge

The sponsor had strong clinical data but limited internal ophthalmic launch experience. Medical, market access, and commercial teams were planning in parallel without a shared evidence narrative or sequenced access milestones. Payer policy for the mechanism was still forming in major EU markets, and the US medical affairs organization needed a unified core story before approval — with only nine months between expected FDA action and first EU launches.

Approach

BEEÑA-E led a structured readiness assessment across six workstreams: medical narrative, publications, MSL readiness, access evidence gaps, supply and administration training, and regional launch sequencing. We facilitated governance forums with decision rights and weekly escalation paths, aligned publication and congress plans to label claims under development, and defined US vs EU access scenarios with explicit evidence dependencies. Medical affairs and access leads reviewed a single source-of-truth narrative before field deployment.

Results

• Established a single launch governance model with documented owners across US and EU regions
• Delivered a core medical narrative, objection handling, and publication plan accepted by medical and regulatory leadership
• Completed first-wave launches in the US and five major EU markets within the planned window after approval
• Reduced post-approval access rework by resolving HTA evidence gaps identified during readiness (Germany, France)
• Coordinated MSL and medical training materials with label-aligned claims prior to field deployment