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Questions and answers about the Pilot Process for Biomarker Qualification at the FDA.
Federico M Goodsaid1, Felix W Frueh1
1Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
Drug Discovery Today. Technologies
|July 2, 2014
Summary
The U.S. Food and Drug Administration (FDA) outlines its Pilot Process for Biomarker Qualification. Careful planning and expert review are crucial for long-term success in biomarker qualification efforts.
Area of Science:
- Biomedical science
- Regulatory science
- Drug development
Background:
- The U.S. Food and Drug Administration (FDA) established a Pilot Process for Biomarker Qualification.
- Experience highlights the need for a long-term strategy in biomarker qualification, separate from specific drug development.
- Assembling internal regulatory teams and external industry consortia requires careful consideration.
Purpose of the Study:
- To describe the FDA's Pilot Process for Biomarker Qualification.
- To share initial experiences and lessons learned from the pilot process.
- To address frequently asked questions regarding biomarker qualification.
Main Methods:
- Development of a structured pilot process for biomarker qualification.
- Formation of internal regulatory expertise and external industry consortia.
- Identification of complex scientific and clinical issues relevant to biomarker review.
Main Results:
- Initial experiences underscore the importance of a long-term, independent approach to biomarker qualification.
- The need for comprehensive expertise in reviewing biomarkers has been identified.
- A consensus-building approach is paramount for successful qualification.
Conclusions:
- The FDA's Pilot Process for Biomarker Qualification requires careful assembly of regulatory and industry expertise.
- Addressing complex scientific and clinical issues is key to reaching consensus.
- The paper provides answers to frequently asked questions, reflecting the FDA's current perspective.
