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IMI SAFE-T and C-Path PSTC Obtain Regulatory Support for New Liver Safety Biomarkers
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) announced today that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) each issued a Biomarker Letter of Support for new liver safety biomarkers investigated by the SAFE-T Drug-Induced Liver Injury Work Package and the PSTC Hepatotoxicity Working Group. The Drug-Induced Liver Injury Network (DILIN) in the US, an expert network established by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), contributed their expertise to the research, as well as rare samples from individuals with severe liver injury.
Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials
Oct 10, 2016 Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials London and Tucson, Ariz., October 10, 2016 — The Critical Path Institute (C-Path), in partnership with Parkinson’s UK, announced today that the European Medicines Agency (EMA) has issued a […]
Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials
Oct 10, 2016 Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials London and Tucson, Ariz., October 10, 2016 — The Critical Path Institute (C-Path), in partnership with Parkinson’s UK, announced today that the European Medicines Agency (EMA) has issued a […]
The Michael J. Fox Foundation for Parkinson’s Research Joins Multinational Critical Path for Parkinson’s Consortium
May 19, 2016 The Michael J. Fox Foundation for Parkinson’s Research Joins Multinational Critical Path for Parkinson’s Consortium Consortium, led by Parkinson’s UK and the Critical Path Institute, aggregates and analyzes study data to develop a model for quantitative characterization of Parkinson’s progression This asset would enrich the design of trials for novel […]
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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