Biomarker consortium

Altar, C. A. (2008). The Biomarkers Consortium on the critical path of drug discovery. Clin. Pharmacol. Ther. 83 361-364. 

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. 

Pancost RD, Damste JSS, de Lint S, van der Maarel MJEC, Gottschal JC, The Medinaut Shipboard Scientific Party (2000) Biomarker evidence for widespread anaerobic methane oxidation in mediterranean sediments by a consortium of methanogenic archaea and bacteria. Appl Environ Microbiol... 

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. 

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. 

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). 

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. 

Testing Consortium and the Innovative Medicine Initiative, which have fueled the pace of research progress in predictive toxicology. These precompetitive collaborations represent ideal forums to share ideas and experience but also to test in an efficient and systematic way new methods for toxicity prediction. These collaborative efforts will undeniably accelerate the development of novel models or biomarkers that will ultimately benefit patients and support animal welfare efforts. Companies and scientists should be encouraged to be actively involved in those forums. 

---