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20 Years of
Improving Lives. Together.

C-Path

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For the past 20 years, Critical Path Institute® has led collaborations that accelerate drug development and advance better treatments for people worldwide.

C-Path is a nonprofit organization that is dedicated to improving and streamlining the process of drug development. As a staple in community of our Tucson, Az. headquarters for the past two decades, we’ve achieved tangible, actionable results by fostering collaboration between industry executives and scientists, academic researchers, regulators, and patient groups that affect global development.

Created under the auspices of the FDA’s Critical Path Initiative in 2005, C-Path operates as an independent, public-private partnership with 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.

20 Milestones for 20 Years

2005: C-Path is Founded

C-Path begins its fiscal year with six employees establishing itself as a key player in accelerating drug development. December ribbon-cutting launches the Critical Path Institute (C-Path). FDA partners with C-Path to materialize the FDA’s Critical Path Initiative mission.

2006: C-Path Founds PSTC

C-Path spearheads the formation of the Predictive Safety Testing Consortium (PSTC), an unprecedented collaboration with pharma companies and FDA. C-Path receives monetary award recognizing collaborative efforts with FDA.

2007: Dr. Woosley Testifies Before Congress

Founder and CEO Dr. Ray Woosley testifies before Congress. C-Path receives grant for personalized medicine, President Bush signs bill authorizing FDA partnership, C-Path wins Arizona Innovation Award.

2008: C-Path Receives FDA/EMA Endorsement of Kidney Biomarker

C-Path global efforts leads to FDA/EMA endorsement of kidney safety biomarkers. C-Path ranked No.7 on Reader’s Digest’s “Fix Healthcare Now!” List.

2009: C-Path Launches PRO Consortium & CAMD

C-Path launches the Patient-Reported Outcomes Consortium and Coalition Against Major Diseases, now Critical Path for Alzheimer’s disease and Critical Path for Parkinson’s disease consortia, partnering with industry, patients, FDA, and NIH to elevate the voice of living experiences in drug development, and accelerate drug development for neurodegenerative diseases, respectively.

2010: PMDA Accept Kidney Biomarkers

Japanese Regulatory Agency, PMDA, accepts kidney biomarkers—marking Japan’s first-ever biomarker qualification decision. Nature Biotechnology features PSTC’s evaluation of seven kidney biomarkers for use in drug safety assessment. Two new consortia in tuberculosis and polycystic kidney disease are formed.

2011: C-Path Hosts Drug Development Conference

C-Path hosts global drug development conference, launches the electronic Patient-Reported Outcomes Consortium, collaborates with Europe’s Innovative Medicines Initiative (IMI), releases Alzheimer’s standards, and is named in NIMH’s “Top 10 Research Advances of 2011.

2012: C-Path Receives EMA Endorsement for Imaging Biomarker

C-Path receives EMA endorsement for imaging biomarker aiding early Alzheimer’s trials. CDISC and C-Path launch CFAST. C-Path and National MS Society collaborate to start MSOAC.

2013: C-Path & IMI Hold First Joint Meeting, "Collaborating for Cures"

C-Path and IMI hold first joint meeting in Brussels titled “Collaborating for Cures.” FDA and EMA make landmark decisions to endorse the first-ever computational trial simulator for Alzheimer’s disease.

2014: FDA Issues First-ever Biomarker LOS For C-Path's Kidney Biomarkers

FDA issues first-ever biomarker Letter of Support for C-Path’s kidney biomarkers and receives $1 million Flinn Foundation grant.

2015: C-Path Celebrates 10th Anniversary with Launch of 3 New Consortia, Secures EMA & FDA Support, Selection by WHO

Happy 10 years, C-Path! new consortia launched for neonatal drug development, Duchenne muscular dystrophy, and Parkinson’s disease. C-Path secures EMA and FDA support for multiple kidney biomarkers. WHO selects C-Path to host TB clinical trials data.

2016: C-Path Co-develops Biomarker Qualification Framework

C-Path co-develops biomarker qualification framework, launches further efforts in tuberculosis, releases multiple sclerosis trial database, gains EMA support for novel Parkinson’s biomarker, and receives three new FDA grants.

2017: C-Path Makes Tuberculosis Pathogen Genomics Sequencing Database Publicly Available

C-Path makes a tuberculosis pathogen genomics sequencing database publicly available, launches consortia in type 1 diabetes and solid organ transplantation, receives a $1.1 million grant for activities in tuberculosis, gains EMA support for liver biomarker and PRO Consortium achieves FDA endorsement of patient-reported outcome instrument for major depression.

2018: C-Path, WHO, and FIND Announce Integrated TB Data Platform

C-Path, WHO, and FIND announce integrated TB data platform. Huntington’s disease consortium launches. C-Path gets first-ever clinical safety biomarker qualification. University of Arizona and C-Path launch graduate certificate program in regulatory science.

2019: C-Path Launches European Headquarters in Dublin, launches FA Database, Gains FDA Qualification

C-Path opens European headquarters in Dublin, launches the Friedreich’s Ataxia database with the Friedreich’s Ataxia Research Alliance and begins a biomarker project with Japan’s PMDA. PRO Consortium gains FDA qualification and the largest data and analytics platform launches at C-Path, together with the Trial Outcome Markers Initiative in T1D.

2020: C-Path Joins ERA4TB Pediatric Device Effort

C-Path joins ERA4TB and leads pediatric device effort. Receives FDA contracts for asthma and neuroscience. Launches collaborations on COVID-19 through the Cure Drug Repurposing Collaboratory.

2021: C-Path's Symptom Diary for IBS Supports First FDA Label Claim

C-Path’s symptom diary for IBS supports first FDA label claim, Ataxia Consortium and Acute Kidney Injury Project launch, Duchenne database opens, and C-Path joins the UNITE4TB Partnership.

2022: C-Path Launches Rare Disease COA, Rare Neurodegenerative Disease Consortia

Rare Disease COA Consortium and Critical Path for Rare Neurodegenerative Diseases launch. C-Path consolidates European headquarters to Amsterdam. EMA supports T1D Biomarker Initiative and TTC Receives EMA endorsement for novel biomarker panel for kidney transplant trials.

2023: C-Path Receives EMA Support for DMD Clinical Trial Simulation Platform, FDA Support for Four Pancreatic Biomarkers

C-Path receives EMA support for its Duchenne muscular dystrophy clinical trial simulation platform. FDA backs PSTC’s four pancreatic biomarkers. Two new consortia in lysosomal diseases and alpha-1 anti-trypsin deficiency launch with FDA grants.

2024: C-Path Hosts Inaugural Global Impact Conference

C-Path hosts inaugural Global Impact Conference, leads Limb-Girdle Muscular Dystrophies task force, receives $1.5M Niemann-Pick grant, unveils Alzheimer’s imaging method, launches Duchenne trial simulator, and receives landmark funding to convene Gender Equitable Medicines in Parkinson’s disease initiative.

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