2. Key Steps in Early Clinical Development

These are the non-clinical studies that support the start of clinical studies.

  • Establish programme objectives, Proof of Concept (PoC) requirements, and development plan.
  • Design and conduct clinical studies: Phase I, PoC, (Phase II) (establish PK and PD assays).
  • Data driven development decisions.
    • Positive results: PoC achieved and dose/schedule selected for further evaluations
    • Negative results: PoC not achieved or unacceptable safety issues
      • => Stop development
    • Unclear results: Needs to be assessed again.