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Funded by FDA, C-Path and NORD to Launch Rare Disease Data and Analytics Platform
C-Path and NORD Rare Disease Cures Accelerator Data Analytics Platform Launch, Tuesday, Sept. 17, Bethesda, MD C-Path and the National Organization for Rare Disorders® will host a meeting to formally launch development of a new rare disease data and analytics platform. Funded by a cooperative agreement through the U.S. Food and Drug Administration, the goal of the platform is to accelerate the movement of therapies from bench to bedside for rare diseases.
C-Path Taps Medical Science Operations Executive Kristen Swingle as Chief Operating Officer
TUCSON, Ariz., July 2, 2019 — The Critical Path Institute (C-Path) is pleased to announce that after an extensive search, it has appointed Kristen Swingle as its new Chief Operating Officer, effective July 1, 2019. Swingle, who previously served as Vice President of Stem Cell Operations for Cord Blood Registry (CBR), a part […]
C-Path’s PSTC Releases Points to Consider Outlining Recommendations for Analytical Validation of Assays Used in Qualifying Biomarkers
The document serves as a guide to the analysis of biomarkers in drug development TUCSON, Ariz., June 11, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) has released a new consensus paper titled, “Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the […]
C-Path, CDISC Develop Therapeutic Area Standard to Foster More Efficient and Meaningful Research for HIV
TUCSON, Ariz. and AUSTIN, April 16, 2019 — The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Therapeutic Area Standard that specifies how to structure commonly collected data and outcome measurements in clinical trials for HIV. The standard, released in the form of User Guide for data […]
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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