Welcome to C-Path.

The Critical Path Institute (C-Path) was created to support the U.S. Food and Drug Administration (FDA) in its effort to implement the Critical Path Initiative.  We develop innovative collaborative projects in research and education to enable the safe acceleration of medical product development.

THE CHALLENGE

In the past decade, U.S. pharmaceutical research and development expenditures rose 250% and the National Institutes of Health (NIH) budget for biomedical research doubled.  Yet, during the same time, the number of innovative new therapies submitted for FDA approval declined by approximately 50%.

C-PATH, A PART OF THE SOLUTION

The FDA released the Critical Path Initiative and the Critical Path Opportunities List in 2004 and 2006 respectively, calling attention to the declining number of new medical products and the need for innovations in the drug development process. This report and other studies concluded that a major factor contributing to the bottleneck in drug development is the time-consuming and inefficient process for preclinical and clinical testing of drugs.  The Pharmaceutical Research and Manufacturers of America (PhRMA) and others estimate that, on average, the industry spends from $0.8 to $1.7 billion and devotes 12-15 years of research and development to bring a product to market. This lengthy process results in delayed access to important new therapies and market prices so high that many cannot benefit from new products.

C-Path facilitates groundbreaking collaborations among government regulators, the academic community and regulated businesses to improve the process of developing new medical products, making it faster, safer, smarter.

Founding Partners