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 all together to collaborate and improve the drug development and regulatory process for medical products.
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.
We have many supporters responsible 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 Science Foundation Arizona. SFAz provided significant funding support to ensure we could build a firm foundation for our unique organization. Many local businesses and private individuals in Tucson, AZ also contributed to our establishment and continue to support us.
Our continuing success is due to a combination of public and private support for our vision.
Dedicated to advancing regulatory science opportunities outlined in the FDA’s Critical Path Initiative, C-Path has forged key partnerships and created collaborations that include FDA, European and Japanese regulatory agencies and private industry.