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PREVENT Cancer Preclinical Drug Development Program

Preclinical Development Decision Gates

Screening/ Designed Synthesis Lead Development Candidate Seeking Clinical Candidate
  • Prepare a product profile
  • Conduct a technology overview
  • Develop a screening strategy
  • Identify potential biomarkers (efficacy/ surrogate)
  • Develop a strategy for "clinical readiness"*
  • Prepare medical needs assessment*
  • Prepare project operational plan
  • Run screen(s)
  • Assess mechanism of action for link to disease
  • Determine desirable potency
  • Determine evidence of structure–activity relationship
  • Evaluate functional activity in vitro*
  • Determine selectivity for target
  • Assess amenability to synthesis*
  • Evaluate stability
  • Establish laboratory objectives for clinical efficacy
  • Resolve IP issues
  • Evaluate activity in validated animal models*
  • Differentiate Leads from current therapies
  • Evaluate preliminary safety issues*
  • Develop PD and toxicology biomarker assays(s)
  • Assess achievability of human PK/PD profile*
  • Assess feasibility of scale-up and bulk synthesis*
  • Evaluate synthesis and proposed clinical formulation
  • Evaluate biopharma-ceutical properties
  • Assess potency against clinical efficacy*
  • Evaluate biodistribution
  • Evaluate clinical readiness of PK/PD assay(s)
  • Evaluate safety issues (most sensitive species) in range finding toxicology studies*
  • Manufacture GMP-grade bulk drug
  • Conduct IND-directed toxicology studies*
  • Define/ toxicokinetics*
  • Determine preclinical NOAEL and dose limited toxicities*
  • Validate PK/PD assay(s) and specimen handling SOPs*
  • Develop and validate product characterization and release assays
  • Characterize clinical product
  • Prepare CMC package and toxicology summary report*
  • Prepare and review clinical development plan

* Denotes the critical preclinical information needed to make go/no-go decisions. At the end, a decision to proceed with a clinical trial is the goal for the preclinical developmental process. The Management and Administration Committee (MAC) will make the go/no-go decisions and the Evaluation Oversight Committee (EOC) will oversee this process.

Preclinical data required for "go/no go" decision-making gates throughout drug development and for Investigational New Drug (IND) filing for clinical trials.

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