News & Events
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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 Administration
Major 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 Injuries
TUCSON, 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 Biomarker
Tucson, 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 Clinically
The 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... -
October 17, 2016
IMI SAFE-T and C-Path PSTC Obtain Regulatory Support for New Liver Safety Biomarkers
Oct 17, 2016 IMI SAFE-T and C-Path PSTC Obtain Regulatory Support for New Liver Safety Biomarkers US FDA and EMA Letters of Support Pave the Way for Clinical Qualification The Innovative Medicines Initiative (IMI) SAFE-T (Safer and Faster Evidence Based Translation) Consortium and Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC)...