Dedicated to advancing regulatory science opportunities outlined in the FDA’s Critical Path Initiative, C-Path has forged global partnerships and created collaborations that include the FDA, European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and private industry.
Industry and Academic Scientists
- C-Path facilitates cooperation between scientists and academic researchers, with industry executives, patient groups, and regulators to deliver novel, life-changing medical products to the public.
- By addressing broad process inefficiencies, C-Path enables industry and academic scientists to focus on their true goal: developing therapies and medical products that will improve human health and well-being.
- The data sharing, the development of open-source solutions based on such data, and the regulatory partnership that C-Path facilitates has a profound influence on the treatment of rare and orphan diseases, to truly accelerate the development of breakthrough therapies for these conditions.
- C-Path has developed the infrastructure to integrate and store dynamic patient data across disease states; our consortia rely on our collective repositories to inform product development and trial design, as well as optimize outcome measurement.
Regulatory Agencies
- C-Path recognizes the critical role regulatory agencies play in medical product development, and we invite regulators to share insights at every stage of the process.
- C-Path acts as a “neutral convener”, providing a collaborative and pre-competitive space for regulators to meet with commercial and scientific stakeholders.
- By incorporating our fluency in regulatory frameworks and guidelines from the very outset of the development process, C-Path helps to bridge gaps and advance transformative medical products and therapies.
- C-Path has developed the infrastructure to integrate and store dynamic patient data across disease states; our consortia rely on our collective repositories to inform product development and trial design, as well as optimize outcome measurement.
Patients and Patient Advocacy Groups
- Medical product development is a complex process in which companies, scientific organizations, and regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) each play crucial and distinct roles. C-Path fosters collaboration between these groups to help simplify the process and advance the delivery of life-changing products.
- C-Path provides a space for experts from the worlds of science and industry to work together towards a common goal: improving the quality of life of people with disease by accelerating the development of transformative medical products and therapies.
- C-Path relies on insights from patients fighting diseases, and the caregivers and advocacy groups that support them around the world, to help make the process of developing cures, therapies, and medical products more efficient.
- C-Path is a nonprofit organization dedicated to accelerating the development of products and therapies that stand to benefit those with the greatest need.
Medical Product Development Executives
- C-Path fosters precompetitive collaboration and data sharing to increase competitive benefits, bringing together industry executives and scientists, academic researchers, patient groups, and regulators in a neutral setting to help make the product development process more efficient.
- C-Path works to de-risk the development of new therapies and medical products by guiding and streamlining the clinical development process.
- By increasing process efficiencies, C-Path helps industry stakeholders focus on their organizations’ goals and meet their investor milestones.
- C-Path has developed the infrastructure to integrate and store dynamic patient data across disease states; our consortia rely on our collective repositories to inform product development and trial design, as well as optimize outcome measurement.
Donors and the Philanthropic Community
- C-Path fosters collaboration in an industry typically driven by competition, providing an open, unbiased space for experts from every corner of the medical development landscape to work together to provide safe and effective treatments to the patients who need them most.
- C-Path is a nonprofit organization dedicated to accelerating the development of products and therapies that can benefit patients whose conditions lack a safe and effective treatment.
- Since its founding in 2005, C-Path has been unique in its ability to produce actionable solutions from open collaboration, helping to optimize clinical trial design, identify key biomarkers, and assess meaningful patient outcomes.
- C-Path’s work has had a profound influence in the world of rare and orphan diseases, where open-source data sharing and regulatory insights remove roadblocks that so often slow—or prevent—the development of breakthrough therapies.
Our ongoing success is due to a combination of public and private belief in our vision — there are many patrons responsible for C-Path’s formation. Most notably, the visionaries at the FDA and the University of Arizona. Founded in Tucson, Arizona, C-Path’s success is rooted in the support provided by Science Foundation Arizona, Flinn Foundation and local businesses and private individuals in “The Old Pueblo.”