News & Events

First-ever biomarker qualified for Parkinson’s is a vital step toward improved clinical trials

FOR IMMEDIATE RELEASE Contact: Kissy Black 615.298.1144 [email protected]   Tucson, AZ — July 26, 2018 – The Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), in partnership with Parkinson’s UK, announces that the European Medicines Agency (EMA) has issued a positive qualification opinion on an imaging test (biomarker) as a tool to enrich […]

“Improving Clinical Trials to Deliver Better Treatments,” as featured in the Spring 2018 edition of “Progress, the research magazine of Parkinson’s UK”

Right treatment, right patient, right time To give new treatments for Parkinson’s the best chance of success, we need to test them in the right group of people at the right time. This is the mission of the Critical Path for Parkinson’s consortium – an international collaboration, led by Parkinson’s UK, bringing together pharmaceutical companies, regulatory agencies, universities, charities and people with Parkinson’s to share data from major studies and trials.

CPTR Newsletter – April 2018

ReSeqTB to be Adopted for WHO Surveillance of Drug-Resistant TB New Collaborations Expand TB-PACTS Database and Leverage Data for Analyses CPTR Workgroup Works to Advance Regulatory Qualification of LAM, a Promising New Biomarker TB-PBPK Model Progresses Toward EMA and FDA Qualification TB-ReFLECT Update: A Collaborative Effort to Enhance TB Clinical Research New Project Launched to Evaluate Adaptive TB Clinical Trial Designs C-Path Partners with Catalysis Foundation for Health to Establish Database with Visualization and Analytic capabilities

Critical Path Institute Receives Regulatory Support for Liver Injury Biomarker

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) to encourage the further study of serum GLDH for monitoring hepatocellular liver injury.