Challenge
With a competitive haemophilia pipeline (including gene therapies and other novel agents), a key priority for our client was to drive alignment across functions and regions to generate an impactful evidence-generation strategy and expand LCM opportunities. The goal was to maximise launch readiness for their asset, with a core focus on understanding stakeholder market-value drivers, differentiation opportunities versus competitors and priority evidence gaps.
Solution
Integrated process to drive internal alignment and external validation of asset's integrated evidence-generation plan:
- Internal gap assessment across regions (Global, US, EU, UK, Japan), and functions (Medical Affairs, Marketing, HEVA, Market Access and Clinical Development)
- Global cross-functional data gap analysis workshop
- HCP and payor data gap validation advisory board
- Structured field-based medical listening priorities exercise to gain community insights on data gaps
- Ongoing IEGP updates
Outcome
This process resulted in the redesign of four planned studies and the development of five new studies, based on comprehensive stakeholder and competitor insight.