European HeadquartersNews & Events
C-Path Receives Qualification Opinion from EMA on Type 1 Diabetes Biomarker Initiative
TUCSON, Ariz., April 5, 2022 — Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC) today announced that the European Medicines Agency (EMA) has issued a positive qualification opinion for pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) prevention trials. The purpose of this model-based qualification is to make publicly available […]
C-Path European Nonprofit Established in Amsterdam
C-Path in Europe works seamlessly with its U.S. counterpart to advance the development of novel regulatory-endorsed methodologies to accelerate medical product development AMSTERDAM and TUCSON, Ariz., March 23, 2022 — In support of Critical Path Institute’s (C-Path) mission to catalyze innovation that accelerates the path to a healthier world, C-Path is excited to announce the […]
C-Path and the European Joint Programme on Rare Diseases to Expand Global Impact and Partnership
PARIS, France and TUCSON, Ariz., U.S., February 1, 2022 — Critical Path Institute (C-Path), an independent global nonprofit organization, and the European Joint Programme on Rare Diseases (EJP RD), an initiative that has received funding from the European Union’s Horizon 2020 research and innovation programme, have announced a collaboration to advance technologies and methodologies that […]
C-Path Appoints Health Outcomes Expert as Executive Director of the Rare Disease COA Consortium
Dr. Lindsey Murray will lead C-Path’s New Rare Disease COA Consortium TUCSON, Ariz., January 13, 2022 — Critical Path Institute (C-Path) today announced it has named Lindsey Murray, Ph.D., MPH, as Executive Director of its Rare Disease Clinical Outcome Assessment (COA) Consortium, effective immediately. Murray joined C-Path in 2019 as Associate Director for rare diseases […]
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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