Table 3.

Biomarkers can and should be applied throughout the drug development process for novel chemopreventive agents

• Identify and validate therapeutic targets
• Screen and optimize candidate targeted agents
• Provide proof-of-concept for agents and models
• Enhance mechanistic understanding of drug or drug combination effects (e.g., as clear indicators of target engagement, cell death, and changes in tumor biology)
• Identify optimal target populations
• Predict response, resistance, and toxicity
• Rapidly distinguish responders from nonresponders
• Once validated, serve as surrogate end points for clinical benefit to support drug approvals