Strategic advisory: Pre-launch

Situation

  • Small biotech company in autoimmune/endocrinology space looking to bring their first product to market

  • PDUFA date fast approaching (~2 months) for a first-in-class disease modifying therapeutic

  • Validation and refinement of scientific messaging (eg, disease awareness, MOA, safety, efficacy)

Task

  • Deploy a launch readiness advisory series – engaging national and regional HCP opinion leaders to workshop and align on final scientific messaging

Action

  • Created an advisory engagement plan which consisted of 2 series with 3 advisory boards each (6 total)

  • First series of advisory boards was set to inform the second series of advisory boards

  • Developed pre-advisory message ranking polling, moderation guides that were tailored to message finalization, and all relevant advisory board content

Result

  • Consensus on novel messaging that transformed the understanding of the disease state

  • Finalized efficacy and MOA statements which were then used in their Day 1 materials

  • Relationships created through these engagements led to further partnership in scientific exchange and publications

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Strategic advisory: Label expansion