Intro

(Edward G. Spack, Fast Forward, LLC)

In addition to proof of concept (POC), there should also be consideration for “proof of relevance”.

  • Early establishment of clinically and commercially relevant value proposition, which includes:
    • Migration from a “me-too” strategy
    • Awareness of current drugs, pipelines, generics
    • Active comparator studies against established drugs
    • Clinical differentiation (build into early development)
    • Application of biomarkers to de-risk clinical outcomes (ID patient subpopulations)
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