PREVENT Cancer Preclinical Drug Development Program
Preclinical Development Decision Gates
Exploratory
Screen/
Development |
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
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* 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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