C-Path was launched
with visionary funding from Science Foundation Arizona, FDA, and generous community philanthropy.
We make cures happen.
Set standards that make cures happen
C-Path improves efficiency of the development of drugs, diagnostics, and medical devices by creating new data standards, measurement standards, and methods standards. Establishing these standards streamlines the regulatory submission process. As a trusted and neutral third party, C-Path then works closely with FDA, EMA, and other regulatory agencies to accelerate the final review process to bring new, safer products to market faster.
To improve global health
The failure rate of testing new drug therapies is an astounding (and unacceptable) 95%. Making this situation even worse is that many of the failures occur during late-phase testing – after the bulk of research dollars have already been committed to the project. Developing just ONE safe and effective medical product can take more than 12 years and $1 billion in research and testing.
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Create consensus science
Working in the pre-competitive research space,
C-Path orchestrates the sharing of data and knowledge among industry, government, patient advocacy groups, and academia. C-Path then engages the active participation of regulatory authorities (FDA, EMA, and others) with the goal of creating efficiencies and speeding products to market.
In just 7 years we have made great progress as this list of our "Firsts" illustrates
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First preclinical safety biomarkers (7) qualified by the FDA, EMA, and PMDA (the Japanese counterpart) |
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First CDISC (Clinical Data Interchange Standards Consortium) therapeutic area data standard |
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First and largest open database of CDISC aggregated clinical trial data for Alzheimer's disease (6,100 patients and 22 clinical trials) Read more |
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First drug-disease trial model & clinical trial simulation tool submitted and under review by the FDA |
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First imaging biomarker for trial enrichment qualified by the EMA |
Collaborating for Cures-Leveraging Global Public-Private Partnerships (PPPs) to Accelerate Medical Product Development: This first ever public conference co-sponsored by IMI and C-Path will feature cross-sector participants discussing challenges and opportunities in the rapidly-evolving PPP space. |
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Hepatotoxicity Special Interest Group: Detecting and Evaluating Drug-Induced Liver Injury:
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The National Multiple Sclerosis Society and Critical Path Institute (C-Path) joined forces to launch the Multiple Sclerosis Outcome Assessments Consortium (MSOAC).
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