Nonimaging detectors in drug development and approval

Area of Science:

• Biomedical Imaging
• Drug Development
• Regulatory Science

Background:

• Regulatory applications for imaging biomarkers are increasing with parameter validation.
• Validation is often specific to drug classes or mechanisms of action.
• Regulatory authorities have high awareness but also high costs associated with these technologies.

Purpose of the Study:

• To discuss the expansion of regulatory applications for imaging biomarkers.
• To highlight the need for careful evaluation of imaging biomarker technologies by the pharmaceutical industry.
• To emphasize the importance of method validation for regulatory approval.

Main Methods:

• Review of current trends in regulatory applications for imaging biomarkers.
• Analysis of the cost-benefit considerations for pharmaceutical sponsors.
• Discussion of validation requirements for regulatory authorities.

Main Results:

• The expansion of imaging biomarker applications is directly tied to validated parameters for specific disease management questions.
• Validation is typically limited to a particular drug class or single mechanism of action.
• High awareness of emerging imaging technologies by regulatory bodies is coupled with significant costs for sponsors.

Conclusions:

• Pharmaceutical companies must carefully assess the potential benefits of each imaging technology for their drug development programs.
• Regulatory authorities must meticulously evaluate the validity of methods for their intended use.
• For well-characterized tracer systems, cost-effective cameras for rapid assessments may be feasible.