Critical Path Institute

C-Path is a nonprofit organization that is dedicated to improving and streamlining the process of drug development. As a staple in community of our Tucson, Az. headquarters for the past two decades, we’ve achieved tangible, actionable results by fostering collaboration between industry executives and scientists, academic researchers, regulators, and patient groups that affect global development.

Created under the auspices of the FDA’s Critical Path Initiative in 2005, C-Path operates as an independent, public-private partnership with Since its founding, C-Path has been unique in its ability to develop actionable solutions through open, precompetitive collaboration. Innovations for which we have helped pave the way include:

• Process improvements that contributed to the first new treatment and regimen for tuberculosis in more than 50 years.
• C-Path’s Friedreich’s Ataxia Integrated Clinical Database (FA-ICD) is used to develop nonlinear mixed effects-based models of disease progression in Friedreich’s Ataxia to investigate and compare available outcome measures collected interventional and non-interventional studies in FA, the most common form of hereditary ataxia.
• The first-of-its kind imaging biomarker for polycystic kidney disease, which contributed to the first-ever drug to be approved to slow the progression of this disease.
• The first-ever computerized tool to transform clinical trial design in Alzheimer’s disease to be endorsed by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Clinical outcome assessments that have optimized incorporation of the patient’s voice in the evaluation of treatment efficacy for asthma, depression, irritable bowel syndrome, myelofibrosis, and non-small cell lung cancer.
• New approaches to research that have led to the regulatory endorsement of viable biomarkers in Alzheimer’s disease, Parkinson’s disease, type 1 diabetes, kidney disease, and tuberculosis.

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. 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.