Critical Path Institute, founded in 2005 in Tucson, Arizona, is an independent, non-profit organization dedicated to bringing scientists from the FDA, industry, and academia together to improve the path for innovative new drugs, diagnostic tests and devices to reach patients in need.
Who we are
Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the Food and Drug Administration (FDA) created under the auspices of the FDA's Critical Path Initiative program in 2005.
C-Path's aim is to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies.
These pre-competitive standards and approaches have been termed "drug development tools" (DDTs) by the FDA, which established a process for official review and confirmation of their validity for a given context of use.
C-Path orchestrates the development of DDTs through an innovative, collaborative approach to the sharing of data and expertise. We build consensus among participating scientists from industry and academia with FDA participation and iterative feedback. The process culminates in a formal application to FDA for official "qualification" of the DDT for a given use in product development. Qualified DDTs then become open standards for the scientific community which, in turn, may be assured both of the scientific rigor under which they were developed and of the FDA's understanding and acceptance of their validity.
Why we were formed
In their white paper now known as the Critical Path Initiative the FDA called attention to an alarming decline in the number of innovative medical products being submitted for FDA approval and cited the need for applied research to bridge the gap between basic scientific research and medical product development. Click here for more information.
Developing one efficacious medical therapy can take more than 12 years and $1 billion in laboratory research and human testing, and 95% of new compounds still fail during development. Out of this urgent call to action, C-Path was launched in 2005 as an independent, neutral, nonprofit organization dedicated to implementing the Critical Path Initiative by creating collaborations among government regulators (the FDA and its European and Japanese counterparts, the EMA and PMDA) and the medical product industry.
C-Path has clearly demonstrated that public/private partnerships focused on non-competitive consensus science can provide new tools that drug developers can use to move important new medicines from discovery to patients more quickly.
Who supports us
We have many supporters to thank for our formation — most notably the visionaries at the University of Arizona and the FDA. Another key funder early in our development was the state of Arizona through its Science Foundation Arizona. SFAz provided significant funding support to assure that we could build a firm foundation for our unique organization. Many businesses and individuals in Tucson, AZ also contributed to our early funding and continue to support us.
Our continuing success is due to a combination of public and private support for our global efforts.
To improve human health and well-being by developing new technologies and methods to accelerate the development and review of medical products
To be recognized internationally as the leading center of excellence for collaborative innovation for medical product development tools and regulatory science