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Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
Frank Dieterle1, Frank Sistare, Federico Goodsaid
1Novartis Pharma AG, Basel, Switzerland. frank.dieterle@novartis.com
Nature Biotechnology
|May 12, 2010
Summary
Seven renal safety biomarkers are now qualified for drug development, marking a milestone in regulatory decision-making. This advancement aids safety assessments in preclinical and clinical studies, guiding future biomarker evaluations.
Area of Science:
- Biomarker development
- Regulatory science
- Drug safety evaluation
Background:
- Biomarkers are crucial for drug development and safety assessment.
- Formal qualification of biomarkers by regulatory agencies is a significant step.
- The Predictive Safety Testing Consortium (PSTC) has focused on nephrotoxicity biomarkers.
Purpose of the Study:
- To report the formal qualification of seven renal safety biomarkers.
- To outline the process and requirements for biomarker qualification.
- To inform the evolution of biomarker qualification for regulatory use.
Main Methods:
- Submission of drug toxicity studies and biomarker performance analyses to regulatory agencies (FDA and EMEA).
- Evaluation by the PSTC Nephrotoxicity Working Group.
- Pilot qualification process to establish requirements and refine the process.
Main Results:
- Seven renal safety biomarkers have been formally qualified for limited use.
- The qualification enables guidance for safety assessments in drug development.
- This pilot process provides valuable experience for future qualifications.
Conclusions:
- The qualification of these biomarkers is a milestone for regulatory decision-making.
- The experience gained will clarify requirements for evaluating organ injury biomarkers.
- This process will inform the future evolution of biomarker qualification pathways.
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