Mission

C-Path leads collaborations that accelerate drug development, advancing better treatments for people worldwide.

The Problem

It takes too long and costs too much to take a new compound discovered in the laboratory through the drug development process and achieve a regulatory-approved safe and effective therapy.

A new product development toolkit — containing powerful new scientific and technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques — is urgently needed to improve predictability and efficiency along the critical path from laboratory concept to commercial product. We need superior product development science to address these challenges — to ensure that basic discoveries turn into new and better medical treatments. We need to make the effort required to create better tools for developing medical technologies. And we need a knowledge base built not just on ideas from biomedical research, but on reliable insights into the pathway to patients.

— Challenge and Opportunity on the Critical Path to New Medical Products

The Solution

C-Path forms collaborative work groups comprised of diverse stakeholders to identify specific barriers to developing a safe and effective therapy for a given disease, and then creates tools and solutions that help drug developers overcome those barriers.

The Impact

C-Path is responsible for:

• Process improvements that contributed to the first new treatment and regimen for tuberculosis in more than 50 years
• 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 original 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