Critical Path Institute (C-Path)
Description
The Critical Path Institute (C-Path) was created to support the U.S. Food and Drug
Administration (FDA) in its effort to implement the Critical Path Initiative. It is an
independent non-profit institute, unaffiliated with any single entity or interest group.
They develop innovative collaborative projects in research and education to enable the
safe acceleration of medical product development.
The Institute relies on three basic tenets in its approach to drug development:
"faster, safer and smarter." C-Path's programs address scientific, safety and educational
aspects of drug development to support the FDA's Critical Path Initiative.
Below is a summary list of current research and education projects.
Cancer Biomarkers: C-Path has developed a collaboration focusing on biomarkers
in lung cancer.
Collaborative Cardiovascular Drug Safety and Biomarker Research: This research
program is reviewing biomarkers in heart failure and assessing genetic polymorphisms in
relation to dosing of warfarin.
Rare/Orphan Diseases: C-Path is helping to create an infrastructure to encourage
the development of new therapies for rare diseases.
Predictive Safety Testing Consortium: This consortium is developing data and a
process to support the regulatory use of new safety biomarkers.
Education Partnership with The University of Arizona: C-Path has worked with The
University of Arizona to establish a curriculum on drug development.
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