News & Events

• March 26, 2019
  

  Critical Path Institute and Japan’s Pharmaceuticals and Medical Devices Agency Collaborate on First-of-its-Kind Biomarker Project

  Aim is to generate critical data to support safety decisions made in early-stage clinical trials   TUCSON, Ariz., March 26, 2019 — Critical Path Institute (C-Path) announced today that a formal consultation between its Predictive Safety Testing Consortium (PSTC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has resulted in an agreement on a first-of-its-kind...
• March 14, 2019
  

  C-Path, FNIH Announce Clinical Development User’s Guide for Kidney Safety Biomarkers

      TUCSON, 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 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)...