The U.S. Food and Drug Administration launched the Critical Path Initiative in 2004 to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. C-Path was created as an independent organization to respond to the needs outlined in the FDA's initiative and with support and funding from the FDA, , and the Tucson, Arizona community. It operates as a neutral third party to enable scientists from the regulated industry and international regulatory agencies to work together with scientists from academia and patient groups to improve the drug development process.
Approach
In the interest of national and global public health, C-Path develops large databases of aggregated clinical trial data that can be used to study disease progression. These data are also used to develop and qualify biomarkers and clinical outcome assessment instruments that are shared with the greater community for use in drug development. C-Path also develops quantitative models to facilitate the design of efficient clinical trials.
C-Path Programs
C-Path programs are focused on reducing the time, cost, and risk of drug development and regulatory review. Where appropriate, C-Path forms consortia that are public/private partnerships that aim to improve the drug development process.
The Predictive Safety Testing Consortium works to find improved safety biomarkers to detect drug induced toxicity.
The Patient-Reported Outcome Consortium develops, evaluates, and qualifies PRO instruments for use in clinical trials designed to assess the safety and effectiveness of medical products.
The Critical Path to TB Drug Regimens aims to accelerate the development of new, safe, and highly effective tuberculosis treatment regimens with shortened durations of therapy.
The International Neonatal Consortium seeks to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates.
The TB-Platform for Aggregation of Clinical TB Studies curates and standardizes Phase IIItuberculosis clinical trial data.
The successfully completed Pediatric Trials Consortium worked toward the efficient evaluation of innovative drugs, biologics, and devices for children.
Location
C-Path is headquartered in Tucson, Arizona. Raymond L. Woosley, M.D., Ph.D. founded C-Path in 2005 and is President Emeritus. Joseph Scheeren, PharmD, is currently C-Path's President and Chief Executive Officer. The Board of Directors includes former Pfizer CFO Alan Levin and biochemist Paula J. Olsiewski.
