Advancing Drug Development.
Improving Lives. Together.

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Critical Path Institute leads collaborations that accelerate drug development, advancing better treatments for people worldwide.

Who We Are


Critical Path Institute (C-Path) is a nonprofit organization dedicated to improving and streamlining the process of drug development. We achieve tangible, actionable results by fostering collaboration between industry executives and scientists, academic researchers, regulators, and patient groups. 

To meet this mission, C-Path  operates as an independent, public-private partnership with the U.S. Food and Drug Administration (FDA), created under the auspices of the FDA’s Critical Path Initiative program in 2005. 


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. 

Who We Serve

Industry and Academic Scientists FAQ Icon
  • 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 FAQ Icon
  • 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 FAQ Icon
  • 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 Executives FAQ Icon
  • 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 FAQ Icon
  • 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.

Timeline

Support Our Mission

Imagine a world where our loved ones are no longer affected by diseases like Parkinson’s, Alzheimer’s, diabetes or rare diseases like ALS and Duchenne. Today’s drug development process can take up to 10 or 15 years. For the past 20 years, Critical Path Institute (C-Path) has brought together experts in patient advocacy groups, those with firsthand experience with these conditions, and leaders from global regulatory agencies, medical research, and the pharmaceutical and biotech industry to identify and overcome the challenges with getting safe and effective therapies to patients in need. Together, we accelerate the drug development and approval process, advancing therapies and cures that improve lives.

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Join Us!

Interested in joining one of our programs or exploring a new opportunity?

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Our Team

With headquarters in Tucson, Arizona, but powered by a team that works remotely around the globe, C-Path values a healthy work-life balance. We enjoy organizational gatherings, while generous PTO policies give us the time needed to refresh.

Careers

Founded as part of the FDA’s Critical Path Initiative in an ongoing effort to remove obstacles in the medical research industry, our team knows it’s doing great work every day toward its most vital mission: Accelerating drug development and advancing better treatments for people worldwide. 

Frequently Asked Questions

What is C-Path? How is C-Path funded? How was it formed? You’ve got questions, we’ve got answers.

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.”

Memorandum of Understanding with the FDA. View Official Record