Critical Path Institute (C-Path) is an independent, non-profit organization committed to transformational improvement of the drug development process. C-Path has established first-of-its-kind, global consortia that currently include over 1,000 scientists from government regulatory and research agencies, academia, patient advocacy organizations, and forty one major biopharmaceutical companies.
New drug development can cost nearly $1 billion and take, on average, 15 years to get from laboratory testing to regulatory approval; only five- to 15-percent of new medicines that enter human testing reach the market. In 2010, only 21 new drugs were approved for marketing.
To address the declining productivity of the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) launched the Critical Path Initiative (CPI) in 2004, its national strategy for forming collaborations to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. C-Path was created with support and funding from the FDA, Science Foundation Arizona, and the Tucson community. C-Path's creation was designed to fill an essential role as a neutral third party that enables scientists from the regulated industry and international regulatory agencies to work together to establish a faster, safer, and more efficient path through the drug development process.
Since its launch in 2005, six C-Path consortia—made up of participants from industry, academia, regulatory agencies, and patient advocacy groups—have focused on identifying the best methods for testing drug safety and efficacy, and have shared their data and knowledge about major diseases (clinical trial data, quantitative disease progression models, and biomarkers).
C-Path works with over 1,000 scientists from 41 major biopharmaceutical companies around the world under a common legal agreement; this agreement allows the sharing of data to generate new scientific knowledge and tools that will enable the design of more efficient clinical trials leading to rapid approval of therapies. They also work with scientists from academia, the National Institutes of Health, the Centers for Disease Control, the World Health Organization, the Bill & Melinda Gates Foundation, and others. C-Path focuses on work that has been identified as high priority by the FDA and is in the interest of national and global public health.
C-Path and FDA scientists have worked together to identify the guiding principles for how biomarkers can be scientifically reviewed in order to bring greater efficiency to the drug development process. Instead of describing biomarkers with general terms such as “validated” or “surrogate endpoints” as is generally done, C-Path prefers the designation qualified for a specific use or fit for use. By specifying the intended “use,” much greater clarity is provided on the context and intent for using a biomarker. Once a scientific consensus on how a biomarker can be used to support specific decisions to be made by the industry and/or the FDA, it can be designated as qualified for that use. Based on the work with C-Path consortia, the FDA recently released a Draft Guidance for Qualification of Drug Development Tools. This is the process being used by C-Path consortia and others to obtain regulatory decisions on the acceptability of new testing methods in drug development.
C-Path consortia are public/private partnerships that are revolutionizing the drug development process. Readers Digest selected C-Path as one of 18 Ideas to Reform Health Care, citing its ability to “bring together the FDA and drug, biotech, and diagnostic companies (many of them fierce competitors) to talk more openly so patients can get safer drugs more quickly and inexpensively.”
C-Path is headquartered in Tucson, Arizona with offices in Rockville, Maryland. Raymond L. Woosley, M.D., Ph.D. founded C-Path in 2005 and is President Emeritus. Carolyn Compton, M.D., Ph.D. is currently C-Path's President and Chief Executive Officer. The Board of Directors includes former Congressman James C. Greenwood, former Pfizer CFO Alan Levin and biochemist Paula J. Olsiewski.