Critical Path Institute, or C-Path, is an organization that brings together biopharmaceutical firms, universities, patient groups, and regulatory agencies from around the world to improve public health. Together, these stakeholders work to identify or create tools that can accelerate the drug development and regulatory review process.
Critical Path Institute, Ltd, is a wholly owned subsidiary based in Ireland to facilitate the work of C-Path in the European Community.
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- >>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
Shortly after its founding in 2005, Critical Path Institute began forging relationships with European entities. In 2007, C-Path’s Predictive Safety Testing Consortium (PSTC), which counted among its members European pharmaceutical company Novartis AG, was the first collaboration to use the Voluntary Exploratory Data Submission review process, which allowed them to submit qualification plans for seven kidney safety biomarkers to FDA and EMA simultaneously. In 2011, C-Path signed a Memorandum of Understanding (MoU) with the European Union’s Innovative Medicines Initiative (IMI) to further the missions of both organizations. Marking C-Path’s 10th anniversary in 2015, founder and former CEO Raymond Woosley, MD, PhD, reflected, “C-Path, because of its founding principles of trust, collaboration, and outstanding science, has become an internationally respected leader in advancing the innovative methods that are fundamentally changing the way new medicines are being developed.”