PREVENT Cancer Preclinical Drug Development Program (PREVENT) supports the best ideas in cancer prevention using NCI contract resources

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PREVENT Cancer Preclinical Drug Development Program (PREVENT) supports the best ideas in cancer prevention using NCI contract resources.

PREVENT Cancer Preclinical Drug Development Program (PREVENT)  supports the best ideas in cancer prevention using NCI contract resources

The 132 projects in PREVENT involve:

  • 79 Chemoprevention
  • 44 Immunoprevention
  • 9 Biomarkers

Preclinical Drug Development Pipelines involves:

  • Proof of Concept
    • 34 Chemoprevention
    • 31 Immunoprevention
    • 9 Biomarkers
  • Secondary Testing
    • 34 Chemoprevention
    • 4 Immunoprevention
  • Advances Preclinical Development
    • 11 Chemoprevention
    • 9 Immunoprevention

PREVENT Pipeline Points of Considerations for Go/No-Go Steps

Approved Concepts

Minimal Entry Criteria for Agents entering the pipeline

  1. Mechanism of Action defined
  2. Target population identified
  3. Preliminary efficacy in relevant animal models
  4. Agent availability
  5. No known toxicity or other potential for harmful effects particularly for repurposed agents for long-term use

PREVENT has flexible entry points. Approved concepts can enter the pipeline at any one of the following stages. Points of consideration for Go/No-go steps are provided under each stage.

NOTE: Provided points of consideration are some generalized examples. Additional details may be needed depending on the property of agents for deciding Go/No-Go between these phases.
 

  1. Confirmation (Confirm Activity)

    • Preventive/interceptive efficacy confirmed in animal models at clinically achievable doses?
    • No signs of toxicity at efficacious dose levels?
    • MOA/on-target effects confirmed?
    • Preliminary PK/PD elucidated?
    • Biomarkers correlate with intended activity?
    • Non-inferior to other relevant agents in the organ and cancer type?

  2. Optimization (Optimize Agents & Regimens)

    • Formulation and intervention regimen(s) optimized?
    • Detailed PK/PD data elucidated?
    • No signs of toxicity?
    • Scale-up feasible?
    • Analytical/bioanalytical assays validated?
    • Pre-IND meeting initiated?

  3. Advanced Preclinical Development (CGMP, GLP & IND)

    • Manufacturing : DS/API CGMP and CMC prep
    • Safety: IND-directed GLP tox done?
    • Clinical development plans
    • IND-documentation: IB, CMC, PK, Tox, and other information