What We Do and Why We Do It

A wake-up call: In a 2004 white paper now known as the Critical Path Initiative, the U.S. Food and Drug Administration (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.

C-Path's Role as a Neutral Third Party

Out of this call to action, Critical Path Institute (C-Path) was launched in 2005 as an independent, non-profit organization dedicated to implementing the Critical Path Initiative by creating collaborations among regulators (scientists from the FDA, European Medicines Agency (EMA), and Japanese Pharmaceutical and Medical Devices Agency (PMDA)) and the regulated (medical product industry) that result in improved testing methods and processes to evaluate the safety and effectiveness of new medical products. These collaborations also include academic institutions and patient advocacy organizations.

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. C-Path has demonstrated that public/private partnerships focused on non-competitive consensus science have the capacity to provide new tools so that drug developers can speed important new medicines from discovery to patients more quickly.