Safety biomarkers PSTC

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. 

In order to help drug development sponsors understand the value of including exploratory biomarkers in nonclinical studies and clinical trials, the PSTC has posted summary data packages on each of the biomarkers that have received a Letter of Support on the C-Path website (Critical Path Institute s Predictive Safety Testing Consortium, 2015a). 

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