Transforming the medical product development process by generating actionable regulatory science solutions, through cross-disciplinary collaboration with academia, industry, regulators and other partners to ultimately accelerate the approval of treatments and cures for patients and families.
Critical Path Institute is a catalyst for innovation that accelerates the path to a healthier world.
Who We Are
Critical Path Institute (C-Path) is an independent nonprofit, public-private partnership with the U.S. Food and Drug Administration (FDA) created under the auspices of the FDA’s Critical Path Initiative program in 2005.
C-Path provides the legal and scientific infrastructure to create a uniquely neutral environment for industry, academia, regulators and other government agencies, to work together to accelerate and de-risk the medical product development process. Such acceleration is achieved through the collaborative generation of actionable solutions for specific unmet needs in the process (optimized translation, improved patient selection for clinical trials, optimized clinical trial design, improved patient-centric outcome measures, etc.). Such solutions can be indication specific, i.e., Alzheimer’s Disease Clinical Trial Simulation Tool or indication agnostic, i.e., Qualified Biomarkers.
C-Path orchestrates the development of these actionable solutions through an innovative, collaborative approach to the sharing of data and expertise. C-Path builds consensus among participating scientists from industry and academia with regulatory participation and iterative feedback. Such consensus provides the mechanism to generate the necessary confidence to assure the adoption of the medical product development solutions by sponsors and regulators. Examples of pathways through which this confidence is achieved include informal and formal regulatory pathways. Through these various mechanisms, sponsors can confidently adopt the solutions generated through C-Path’s collaborative approach, thus ensuring the continuous optimization of the medical product development process.
* Note that despite the equivalent terms, LOS is a formal mechanism with EMA
Dedicated to advancing regulatory science opportunities outlined in the FDA’s Critical Path Initiative, C-Path has forged global partnerships and created collaborations that include the FDA, European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and private industry.
Our ongoing success is due to a combination of public and private support for our vision and there are many supporters responsible for C-Path’s 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. Local businesses and private individuals in Tucson, Arizona, where C-Path is headquartered, also contributed to our establishment and continue to support us.