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A prototypical process for creating evidentiary standards for biomarkers and diagnostics.

C A Altar¹, D Amakye, D Bounos

¹Foundation for National Institutes of Health, Washington, DC, USA.

Clinical Pharmacology and Therapeutics

|December 20, 2007

Summary

Developing biomarker evidentiary standards is crucial for drug development. A systematic framework, refined through collaboration, can create individualized standards for biomarker qualification.

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Area of Science:

Biomarker Development
Regulatory Science
Drug Discovery

Background:

The Food and Drug Administration's Critical Path Initiative highlighted the need for robust biomarker qualification standards.
Existing methods for establishing biomarker evidentiary standards lack a systematic, adaptable framework.

Purpose of the Study:

To describe a systematic framework for developing evidentiary standards for biomarker qualification.
To test and refine this framework through a collaborative workshop.

Main Methods:

Development of a systematic framework by Pharmaceutical Research and Manufacturers of America (PhRMA) committees.
Testing the framework in a workshop involving the Food and Drug Administration (FDA) and academic experts.
Incorporating necessary refinements based on workshop feedback.

Main Results:

The developed framework provides a structured approach to biomarker qualification.
The workshop demonstrated the framework's applicability and identified areas for refinement.
The framework is adaptable for various biomarker purposes.

Conclusions:

The systematic framework offers a viable pathway for establishing biomarker evidentiary standards.
Collaborative refinement is key to creating individualized and appropriate standards.
This framework can support the advancement of the FDA's Critical Path Initiative for biomarker use.