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First-ever biomarker qualified for Parkinson’s is a vital step toward improved clinical trials
FOR IMMEDIATE RELEASE Contact: Kissy Black 615.298.1144 kissyblack@lotosnile.com 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.
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C-Path Successes
- >>First preclinical safety biomarkers (7) qualified by the FDA, EMA and PMDA
- >>First imaging biomarker for trial enrichment qualified by the EMA
- >>FDA and EMA reach landmark decisions on C-Path’s Simulation Tool for Alzheimer’s disease
- >>C-Path’s Alzheimer’s Disease Simulator Featured in the Wall Street Journal
- >>C-Path and CDISC partnership delivers therapeutic area standards
- >>FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
- >>EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- >>Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- >>C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- >>C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD