News & Events
News & Events
March 14, 2019
C-Path, FNIH Announce Clinical Development User’s Guide for Kidney Safety BiomarkersTUCSON, Ariz., March 14, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) today announced availability of the User’s Guide: Kidney Safety Composite Measure Biomarker for Use in Clinical Development. Authored by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Kidney Safety Biomarker Project Team and PSTC’s...
October 25, 2018
FNIH Biomarkers Consortium and Critical Path Institute Achieve the First Ever Qualification of a Clinical Safety Biomarker by the U.S. Food and Drug AdministrationMajor Milestone will Improve Detection of Drug-Induced Acute Kidney Injury in Clinical Trials. October 25, 2018 — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC) have received the first ever qualification of a clinical safety biomarker awarded by...
September 17, 2018
Critical Path Institute and SIGNATOPE GmbH Team Up to Advance Research on Biomarkers for Drug-induced Organ InjuriesTUCSON, Ariz. and REUTLINGEN, September 17, 2018 — Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) and SIGNATOPE GmbH are excited to announce a new project, joining efforts on analyzing and qualifying promising protein safety biomarkers in mouse, rat, dog, monkey, and human. The work is expected to increase understanding of drug-induced toxicities...
January 22, 2018
Critical Path Institute Receives Regulatory Support for Liver Injury BiomarkerTucson, AZ — January 22, 2018 — Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) has issued a Letter of Support for measurement of glutamate dehydrogenase (GLDH) as a biomarker of hepatocellular liver injury. The letter was awarded to C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC)...
May 22, 2017
miR-122 An Exploratory Biomarker of Liver Injury: An Industry Perspective on the State of the Science and Experiences Pre-Clinically and ClinicallyThe Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) hosted a webinar focused on providing an industry perspective on the state of the science and preclinical and clinical experiences with mi-R122. This webinar was hosted by PSTC’s Hepatoxicity Working Group. The first presentation discussed the current state of miR-122 as a safety biomarker of liver...