Programs

Sharing Knowledge that Leads to Innovation

C-Path relies on three basic tenets in its approach to improving medical product development: "faster, safer, and smarter." Our programs support the FDA's Critical Path Initiative and were developed with detailed input from scientists from the FDA, industry, and academia.

Although C-Path's work can be looked at as a series of projects funded by grants and performed by collaborations and consortia, the work generally falls under the goal of creating tools to enable personalized medicine that improves health and saves lives.

 

Establishing Consortia

From its beginning, the creation of consortia has been fundamental to the work of C-Path. The FDA, after consulting with experts in industry, government, academia, and patient advocacy groups, in 2006 identified the critical work that was needed to ensure that novel therapies could move through development and to patients as quickly as possible, i.e., the 76 projects on the Critical Path Opportunity List.¹ Many of these projects required collaboration, and C-Path has since become the international leader in forming successful collaborations that advance scientific innovation to improve human health.²

One of C-Path's first steps was to reach agreement with the FDA and leading industry scientists on what processes they would use to advance the Critical Path Initiative.

The resulting process is transparent and entrepreneurial, driven by swift, thoughtful decisions, and accountable to timely, predetermined milestones.

The challenge was to create a productive environment among private sector competitors, while balancing their needs with those of the FDA, academic scientists, and public health. Please click here for more information.

1. Food and Drug Administration. Critical Path Opportunities Report and List; http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf. 3-16-2006. Internet Communication

2. Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu Rev Med 2008; 59:1-12.

 

Resulting Tools

Biomarkers, disease models, patient-reported outcomes, processes, diagnostic tests, and other tools qualified by the FDA for use in medical product development.