What We Do
C-Path leads collaborations that accelerate drug development, advancing better treatments for people worldwide.
The Problem
It takes too much time and costs too much money to take a potential new medicine discovered in the laboratory through the drug development process and achieve a regulatory-approved safe and effective product.
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 safe and effective therapies for a given disease, and then creates tools and solutions that help drug developers overcome those barriers.
How We Do It
Core Competencies and Key Concentration Areas of Critical Path Institute
C-Path provides a unique, neutral environment for relevant stakeholders in the drug development ecosystem to collaborate. As partners, our stakeholders align on the challenges they face when developing therapies and work together to determine solutions to these challenges. C-Path creates tools that solve unmet needs and makes these tools available to researchers and drug developers.
How do we create these drug development tools? We leverage our Core Competencies in Data Management and Standards, Biomarkers, Modeling and Analytics, Regulatory Science and Clinical Outcome Assessments to generate the appropriate tool for the specific challenge identified by our stakeholders. Currently, we are focused on addressing unmet needs for therapies in Neuroscience, Rare and Orphan Diseases, Pediatrics, and Safety Sciences.
Tools and Platforms
For nearly two decades, C-Path has been providing the legal, scientific, and regulatory infrastructure to generate a unique neutral environment for stakeholders in the drug development ecosystem to collaborate. This collaboration has resulted in solutions that include clinical outcome assessment tools, clinical trial simulators and other quantitative tools, plus data resources and analytic platforms. These tools and platforms help de-risk decision making in the development and regulatory review process of novel medical products. Click below to utilize C-Path’s current and accessible tools and platforms.
Training and Education
We are proud to have partnered with premier institutions to develop training and educational programs that support the advancement of drug development scientists, through C-Path’s Model-Informed Drug Development curriculum, developed with support provided by FDA, and C-Path’s Regulatory Science Training Certificate Program, developed in partnership with The University of Arizona College of Law.
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 as a drug development tool, 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).
The largest integrated data and analytics platform for rare and orphan diseases, which contributed to augment the totality of evidence that resulted in the approval of the first-ever treatment for Friedreich’s ataxia.
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.