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C-Path's Biomarker Data Repository (BmDR), launched in 2019, aims to advance the qualification of novel safety biomarkers as drug development tools, starting with kidney safety biomarkers that can detect kidney injury more sensitively and specifically. The BmDR collects and stores large, masked, de-identified datasets from multiple sponsors across nonclinical and clinical studies in a secure repository to support translational biomarker research. The data are intended to be accessible to C-Path, FDA staff, and other stakeholders to support research leading to regulatory qualification of novel safety biomarkers, with plans to expand to biomarkers for liver, skeletal muscle, vascular, and pancreatic injury.
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