News & Events

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 […]