European HeadquartersNews & Events
C-Path Appoints Two New Members to Board of Directors
Tucson-based Critical Path Institute (C-Path) today announced the appointment of two new members to its Board of Directors: James W. Newman, CPA, former Executive Chairman of Victory Pharma, Inc. and Tomas Salmonson, Ph.D., M.Sc., former Chair of the Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA).
C-Path ePRO Consortium and PRO Consortium Announce COVID-19 Risk Assessment and Mitigation Strategies
Recommendations provided for sponsors and eCOA providers to facilitate the continued collection of PRO data in clinical trials. TUCSON, Ariz., April 29, 2020 — In collaboration with Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium, the Electronic Patient-Reported Outcome (ePRO) Consortium announces “Coronavirus Disease 2019 (COVID-19): Risk Assessment and Mitigation Strategies for the Collection […]
C-Path Receives Letter of Support from EMA on Type 1 Diabetes Biomarker Initiative
TUCSON, Ariz., April 28, 2020 — The Critical Path Institute (C-Path) today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to […]
C-Path Awarded FDA Contract to Enhance the Assessment of Clinical Outcomes in Pediatric Asthma Treatment Trials
The Critical Path Institute (C-Path) announced today it has been awarded a U.S. Food and Drug Administration (FDA) contract in support of ongoing development of novel clinical outcome assessments for pediatric asthma. C-Path’s Patient-Reported Outcome (PRO) Consortium will carry out this work through its Pediatric Asthma Working Group. Specifically, these assessments are intended to facilitate innovative patient-focused drug development and aid regulatory decision making by filling an unmet measurement gap.
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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