Qualification of Safety Biomarkers

Several consortia, primarily driven by pharmaceutical industry members and encouraged by health authorities, have been formed to evaluate and qualify safety biomarkers for use in early clinical drug development trials. In the remainder of this manuscript, we will focus on the safety biomarker qualification efforts of the Critical Path Institute s (C-Path) Predictive Safety Testing Consortium (PSTC), as well as the PSTC collaborations with the Foundation for the National Institutes of Health s Biomarkers Consortium s (FNIH BC) Kidney Safety Project (KSP) and the Innovative Medicines Initiative s (IMI) Safer and Faster Evidence-based Translation Consortium (SAFE-T). Both of these collaborations are driven by the common goal of modernizing safety science through the qualification of clinical safety biomarkers for use in drug development. 

Hypothetical COU for novel safety biomarkers for pancreatic injury The qualified biomarker(s) may be used to monitor for pancreatic safety in early clinical studies with 

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Several key aspects should be considered in (seating scientific expectations specific to qualification of safety biomarkers. A brief list of considerations is presented in the following for safety biomarkers that are supported by both translational nonclinical data and clinical trial data ... 

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