STRATEGIC PLANNING CASE STUDIES

CASE STUDY: Indication prioritization

CASE STUDY: 

For this midsize biopharma company, we identified and prioritized additional clinical indications for a near-to-market product.

CLIENT SITUATION:

  • Client is a mid-sized biopharma company looking to prioritize further clinical development for their near-to-market product
  • Client asked Trinity to identify and prioritize potential indications for their product beyond its additional indication that would present the best commercial options for the company

TRINITY'S APPROACH:

Key criteria

  • Exhaustive review of potential indications from secondary literature, clinical trials, case reports, and internal resources to identify all applicable indications for product’s MOA
  • Clinical rationale for mechanism in disorders
  • Potential for differentiation from similar marketed product
  • Clinical risk
  • Market size and growth
  • Current/future competition
  • Regulatory risk
  • Detailed assessment of commercial opportunity
  • Path to proof-of-concept and clinical evidence
  • Potential competition with similar marketed product
  • Prioritized list of indications for development

ILLUSTRATIVE EXAMPLES:

Example output summary

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Example clinical development strategy

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One strategy would be to run 3 simultaneous PoC trials for signal generation

  • Design: ~20 patient placebo-controlled crossover design or failure then add-on therapy
  • Effect visible in 1-3 months in all conditions
  • Registration trial could then be run on strongest signal

PROJECT OUTCOMES:

Prioritized list of 6 potential indications for clinical investment

  • Trinity recommended six indications for further investigation in clinical trials for the product candidate
  • Trinity provided a strategic development plan highlighting the next steps necessary for bringing the product candidate into clinical trials