SSI Strategy

Case Study

Accelerating Global HEOR & RWE Function Buildout & Support

How we helped accelerate global HEOR & RWE output to achieve optimal
value demonstration


  • Innovative gene therapy company obtained extraordinary clinical results, as such the pathway to launch of the product was accelerated.
  • Accelerated HEOR and RWE output required to ensure product could successfully achieve reimbursement
  • Company faced shifting market landscape and step-change in treatment with novel competition to its upcoming product launch
  • Value demonstration required to ensure a viable price and market opportunity – “likely to be most expensive drug in the world”
  • Data required to support market access was 2-3 years behind


  • Supported the existing principal investigator to improve the relationship
  • Prepared and guided the clinical site through FDA inspections
  • Revised the protocol to reduce adverse events and improve patient safety
  • Engaged additional clinical sites and investigators to diversify patient dosing
  • Supported the value generation framework, focusing on creative ways to remediate gaps.
  • Built out and operated the HEOR and RWE function, in partnership with sole functional lead.
  • Created and operationalized an internal stakeholder management forum, which was required due to lack of understanding from internal team members.
  • Leveraged key trusted vendors to help perform the detailed analysis and modeling
  • Transitioned the strategy and supplemented internal hires to continue the rapid growth


  • In partnership with functional lead, SSI enabled the client to catch up to market access evidence generation needs
  • SSI supported the development of an international disease registry.
  • Avoided expensive head-to-head comparison with standard of care yet sufficient product differentiation
  • Developed staffing plans and assisted with onboarding.
  • Defined requirements and geographical needs
  • Resulted in favorable pricing in the marketplace – demonstrating cost-effectiveness and justifying pricing

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