Critical Path Institute (C-Path) is a non-profit organization created to improve the drug development process; its consortia include more than 1,600 scientists from government regulatory and research agencies, academia, patient organizations, and bio-pharmaceutical companies.

Background

The U.S. Food and Drug Administration (FDA) 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, Science Foundation Arizona, 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 to improve the drug development process.

Location

C-Path is headquartered in Tucson, Arizona. Raymond L. Woosley, M.D., Ph.D. founded C-Path in 2005 and is President Emeritus. Kristen Swingle is currently C-Path's Interim President and Chief Operating Officer. The Board of Directors includes Robert M. Califf, Wainwright Fishburn, Timothy R Franson, Kay Holcombe, Jeffrey E Jacob, former Pfizer CFO Alan Levin and biochemist Paula J. Olsiewski.