Commercialization Approach

We've adopted a three-pronged model for a successful project

1. Context

Targeted review of online evidence

  • Payers / budget holders
  • Regulatory approval
  • Treatment guidelines
  • Health policy, e.g., Affordable Care Act (ACA)
  • Competitors

2. Strategy

Payer Value Proposition

  • Disease review
  • Unmet need
  • Clinical and economic profile
  • Place in therapy
  • Value

3. Tactics

Communication Plan

  • Promotional channel, e.g., FDAMA 114
  • Non-promotional channel, e.g., response to unsolicited request

Evidence Plan

  • Efficacy – Randomized Clinical Trials (RCT)
  • Effectiveness – Real World Evidence (RWE)
    • Modeling
    • Prospective, naturalistic research
    • Retrospective research
  • Key research decisions
    • Comparators?
    • Endpoints?
    • Patient populations?

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