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What is C-Path?
Critical Path Institute, or C-Path, is a global, independent, nonprofit organization dedicated to the generation of actionable solutions to transform the medical product development process. C-Path brings together regulatory agencies, biopharmaceutical firms, universities, other non-profits, and patient groups from around the world to improve public health. Together, these stakeholders work to develop new tools and processes that can accelerate decision-making and medical product development and approval.
What is C-Path’s Mission?
C-Path leads collaborations that accelerate drug development, advancing better treatments for people worldwide.
How does C-Path achieve its mission?
C-Path achieves its mission by acting as an independent, neutral third party to form and lead public-private partnerships of regulatory agencies, biopharmaceutical firms, universities, and patient groups in a pre‐competitive collaboration and sharing of scientific data.
How is C-Path funded?

C-Path is a public/private partnership funded by government agencies such as the *FDA, grants from foundations such as the Bill & Melinda Gates Foundation, Michael J. Fox Foundation and the Polycystic Kidney Disease Foundation, as well as fees from industry participants.

*Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

How was C-Path formed?
In 2004, in response to the FDA’s Critical Path Initiative (CPI) program — a national effort to modernize the process through which FDA‐regulated products are developed, evaluated, and manufactured–an independent 501(c)(3) was founded with the mission to “foster development of new evaluation tools to inform medical product development.” In 2005, a Memorandum of Understanding was created between FDA and Critical Path Institute.
What is the structure of C-Path?

Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. Each perform program work through consortia and separate initiatives. These are:

What therapeutic areas do C-Path’s collaborations cover?

C-Path’s collaborations advance the generation of actionable solutions that help transform the drug development process for the following indications:

  • Alzheimer’s disease
  • Asthma
  • Ataxias, including Friedreich’s Ataxia
  • Depression
  • Duchenne Muscular Dystrophy
  • Functional Dyspepsia
  • Huntington’s Disease
  • Irritable Bowel Syndrome
  • Multiple Sclerosis
  • Non-Small Cell Lung Cancer
  • Organ Transplant
  • Parkinson’s Disease
  • Polycystic Kidney Disease
  • Rare Diseases
  • Rheumatoid Arthritis
  • Tuberculosis
  • Type 1 Diabetes

They also have expertise in the following:

  • Biomarker qualification
  • Clinical outcome assessment qualification
  • Clinical trial simulation tools
  • Data collaboration
  • Data standards development
  • Database and data repository management
  • Drug repurposing
  • Drug safety and drug testing
  • Evidentiary considerations for biomarker qualification
  • Patient-reported outcomes and electronic patient-reported outcomes
  • Quantitative medicine – modeling and simulation
  • Regulatory science

Please visit our Core Competencies page for more information.

What are C-Path’s achievements?
Can you send me your annual report or financial statements?

Our IRS Form 990 can be found at GuideStar.org.

To obtain printed copies of our audited financial statements or if you have any questions, please contact us at info@c-path.org.

Click here to view our list of annual reports.

Is Critical Path Institute rated by any outside charity groups?
Yes, we currently have the highest possible ratings on GuideStar.org (Platinum) and charitynavigator.org (100/100).
What is your Federal Tax ID Number?
Our Federal Tax ID number is 20-1991334.

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