FAQ

What is C-Path?
What is C-Path’s Mission?
How does C-Path achieve its mission?
How is C-Path funded?
How was C-Path formed?
What is the structure of C-Path?
What areas do C-Path’s consortia cover?
What are C-Path’s achievements?
Can you send me your annual report or financial statements?
Is Critical Path Institute rated by any outside charity groups?
What is your Federal Tax ID Number?

What is C-Path?

Critical Path Institute, or C-Path, is a global, independent, nonprofit organization created to foster development of new evaluation tools and standards for drug therapy trials. 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?

Mission Statement:

Critical Path Institute is a catalyst in the development of new approaches to advance medical innovation and regulatory science. We achieve this by leading teams that share data, knowledge, and expertise, resulting in sound, consensus-based science.

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 consortia 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, and fees from industry participants.

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?

C-Path is an independent 501(c)(3) nonprofit based in Tucson, Arizona. C-Path has a wholly owned subsidiary based in Dublin, Ireland, named the Critical Path Institute, Limited. Each perform program work through consortia and separate initiatives. These are:

Establishing Consortia

From the beginning, the creation of consortia has been fundamental to C-Path’s work. In 2006, FDA—after consulting with experts in industry, government, academia, and patient advocacy groups—identified the 76 projects that make up the Critical Path Opportunities List. The list outlines the critical work that is needed to ensure that novel therapies can move through development and to patients as quickly as possible. Many of these projects require collaboration, and C-Path has become the international leader in forming successful collaborations that advance scientific innovation to improve human health.

What areas do C-Path’s consortia cover?

C-Path’s consortia advance the qualification of drug development tools in the following areas of focus:

Alzheimer’s disease
Asthma
Depression
Duchenne Muscular Dystrophy
Friedreich’s Ataxia
Functional Dyspepsia
Huntington’s disease
Irritable Bowel Syndrome

Multiple Sclerosis
Non-Small Cell Lung Cancer
Organ transplant
Parkinson’s disease
Polycystic Kidney disease
Rheumatoid Arthritis
Tuberculosis
Type 1 diabetes

They also have expertise in the following:

Biomarker qualification
Clinical outcome assessment qualification
Data collaboration
Data standards development
Database and data repository management
Drug safety and drug testing
Evidentiary considerations for biomarker qualification
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?

Not long ago, a public-private partnership in the field of drug development was a novel concept. The success of C-Path’s collaborative model of bringing together experts from academia, government and industry to share previously proprietary data and information has now spawned numerous global consortia that include over 1500 scientists who have achieved:

published data standards that facilitate regulatory review
qualified biomarkers that can be used to make more rapid decisions on the safety and efficiency of compounds
qualified clinical outcome assessments to accelerate the drug development process
modeling and simulation tools that can be applied at an early phase to make the best predictions around whether a study design is going to be successful

C-Path emphasizes sharing knowledge and expertise wherever possible but particularly in the fields of quantitative medicine and data collaboration to educate and to facilitate the use of better tools and methodologies. C-Path will continue to focus on bridging the gaps between emerging science and technology and their practical application in drug development and regulatory review, and remain at the forefront of broad-based initiatives that further define and advance regulatory science.

Please visit our Successes page for more information.

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.