Predictive Safety Testing Consortium

Extrapolations of therapeutic index and toxicity data from animals to humans are reasonably predictive for many but not for all toxicities. Seeking an improved process, a Predictive Safety Testing Consortium of five of America s largest pharmaceutical companies with an advisory role by the Food and Drug Administration (FDA) has been formed to share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans. In 2007, this group presented to the FDA a set of biomarkers for early kidney damage. 

Mattes WB, Walker EG. Translational toxicology and the work of the predictive safety testing consortium. Clin Pharmacol Ther. 2009 85 327-330. 

Critical Path Institute. Predictive Safety Testing Consortium. 2008. Retrieved from http //www.c-path.org/pstc.cfm. Accessed March 18, 2009... 

Dieterle F et al. Renal biomarker qualification submission a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol. 2010 5 455-462. 

Goodsaid, F. M., F. W. Frueh, and W. Mattes (2007). The Predictive Safety Testing Consortium a synthesis of the goals, challenges and accomphshments of the critical path. Drug Discov Today Technol 4(2) 47-50. 

Predictive Safety Testing Consortium (PSTC), Critical Path Institute (C-Path), Tucson, AZ, USA... 

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). 

CRITICAL PATH INSTITUTE S PREDICTIVE SAFETY TESTING CONSORTIUM... 

Critical Path Institute s Predictive Safety Testing Consortium. Regulatory successes. 2015a. Available at http //c-path.org/ programs/pstc/regulatory-successes/ Accessed May 20, 2015. 

Dennis EH, Walker EG, Baker AF, Miller RT. Opportunities and challenges of safety biomarker qualification Perspectives from the Predictive Safety Testing Consortium. Drug Dev Res. 2013. 74(2) 112-26. 

Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, CoUins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W. Renal biomarker qualification submission A dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol. 2010a. 28(5) 455-62. 

Stephenson D, Sauer J-M. The Predictive Safety Testing Consortium and the coalition against major diseases. Nat Rev Drug Discov. 2014. 13(ll) 793-4. 

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