Programs
- Biomarker Data Repository (BmDR)
- CURE Drug Repurposing Collaboratory (CDRC)
- Critical Path for Rare Neurodegenerative Diseases (CP-RND)
- Critical Path for Sickle Cell Disease (CP-SCD)
- Critical Path For Alzheimer's Disease (CPAD)
- Critical Path for Parkinson's (CPP)
- Critical Path to Therapeutics for the Ataxias (CPTA)
- Critical Path to TB Drug Regimens (CPTR)
- Duchenne Regulatory Science Consortium (D-RSC)
- Data Collaboration Center (DCC)
- Electronic Clinical Outcome Assessment Consortium (eCOA Consortium)
- Huntington’s Disease Regulatory Science Consortium (HD-RSC)
- International Neonatal Consortium (INC)
- Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
- Polycystic Kidney Disease Outcomes Consortium (PKD)
- PredicTox Knowledge Environment (PredicTox KE)
- Patient-Reported Outcome Consortium (PRO Consortium)
- Predictive Safety Testing Consortium (PSTC)
- Quantitative Medicine Program (QuantMed)
- Rare Disease Clinical Outcome Assessment Consortium (RD-COA Consortium)
- Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP)
- System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD)
- Type 1 Diabetes Consortium (T1D)
- TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS)
- Trial Outcome Markers Initiative in T1D (TOMI-T1D)
- Translational Therapeutics Accelerator (TRxA)
- Transplant Therapeutics Consortium (TTC)

Biomarker Data Repository
C-Path is developing a repository for data on novel translational safety biomarkers from drug development programs, with the goal of accelerating qualification of novel biomarkers as new tools for drug developers. This initial pilot focuses on kidney safety biomarkers.

CURE Drug Repurposing Collaboratory
CDRC is designed to capture real-world clinical outcome data to advance drug repurposing and inform future clinical trials for diseases of high unmet medical need.

Critical Path for Rare Neurodegenerative Diseases
CP-RND will bring together multiple experts in rare neurodegenerative diseases, including ALS, as well as private entities, patient communities and advocacy organizations to accelerate and advance our understanding of disease pathology, treatment options, diagnostics, and drug development.
Critical Path for Sickle Cell Disease
CP-SCD aims to accelerate drug development for sickle cell disease through collaborative development and regulatory endorsement of new medical product development tools. CP-SCD will work with the sickle cell community to identify and prioritize tools needed to optimize drug development, such as outcome assessments and disease progression models.

Critical Path For Alzheimer's Disease
The Critical Path For Alzheimer’s Disease (CPAD) is a public-private partnership aimed at creating new tools and methods that can be applied to increase the efficiency of the development process of new treatments for Alzheimer disease (AD) and related neurodegenerative disorders with impaired cognition and function.

Critical Path for Parkinson's
Created in partnership with Parkinson’s UK, one of the world’s largest charity funders of Parkinson’s research, the Critical Path for Parkinson’s Consortium (CPP) was launched on October 14, 2015.
Critical Path to Therapeutics for the Ataxias
CPTA is a public-private partnership with the mission to optimize clinical trials for inherited ataxias.

Critical Path to TB Drug Regimens
The CPTR initiative is dedicated to delivering a safer, more efficacious, and faster-acting tuberculosis (TB) regimen by developing and promoting innovative regulatory science essential for supporting new combination drug development in collaboration with its partners across industry, academia, and government.

Duchenne Regulatory Science Consortium
D-RSC supports collaborative research through shared data access and development of drug development tools.

Data Collaboration Center
Developing data solutions for scientific research.

Electronic Clinical Outcome Assessment Consortium
The Electronic Clinical Outcome Assessment (eCOA) Consortium provides scientific leadership and best practice recommendations surrounding electronic data capture technologies and services that support the collection of patient-focused outcomes data in clinical trials.

Huntington’s Disease Regulatory Science Consortium
Created in partnership with CHDI Foundation and the Critical Path Institute, HD-RSC was launched on March 28, 2018, with the aim of accelerating the regulatory approval of Huntington’s disease therapies.

International Neonatal Consortium
Launched on May 19, 2015, INC is C-Path’s ninth consortium – a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates.

Multiple Sclerosis Outcome Assessments Consortium
Launched in December, 2012, MSOAC is another dynamic partnership formed to promote consensus science. Created jointly with the National Multiple Sclerosis Society, MSOAC will collect, standardize, and analyze data about MS with the goal of qualifying a new measure of disability as a primary or secondary endpoint for future trials of MS therapies.

Polycystic Kidney Disease Outcomes Consortium
C-Path's Polycystic Kidney Disease (PKD) Outcomes Consortium is a collaborative partnership whose research leads to discovery of treatments for PKD.

PredicTox Knowledge Environment
The aim of the PredicTox Knowledge Environment (KE) project is to advance the science of adverse event prediction by creating an integrated web-based knowledge environment consisting of multiple interconnected databases that capture quantitative multiscale biology of drug action.

Patient-Reported Outcome Consortium
The Patient-Reported Outcome Consortium supports patient-focused drug development by obtaining qualification of clinical outcome assessment tools that measure how patients feel and function in their everyday lives as a result of treatment.

Predictive Safety Testing Consortium
C-Path's Predictive Safety Testing Consortium (PSTC) serves as a neutral third party in the independent assessment and validation of drug safety tests.

Quantitative Medicine Program
C-Path’s Quantitative Medicine program aims to improve population and individual health by transforming drug development through methodological innovation.
Rare Disease Clinical Outcome Assessment Consortium
The Rare Disease Clinical Outcome Assessment Consortium enables precompetitive, multi-stakeholder collaboration aimed at identifying scientifically sound tools and methodologies for collecting clinically meaningful outcomes data in treatment trials for rare diseases.
Rare Disease Cures Accelerator-Data and Analytics Platform
RDCA-DAP is an FDA-funded initiative that will provide a centralized and standardized infrastructure to support and accelerate rare disease characterization with the goal of accelerating therapy development.
System of Hospitals for Innovation in Pediatrics – Medical Devices
The National Innovation Ecosystem for Pediatric Medical Devices
SHIP-MD aims to improve public health for children by transforming the pediatric medical device ecosystem by de-risking and accelerating developmental processes to stimulate investment and innovation in pediatric devices.
Type 1 Diabetes Consortium
The T1D Consortium is working to qualify islet autoimmunity antibodies as prognostic biomarkers to be used in the development of therapies for the treatment, and ultimately the prevention, of type 1 diabetes.

TB-Platform for Aggregation of Clinical TB Studies
The TB-PACTS data platform is designed to catalyze and accelerate TB research by curating and standardizing Phase III tuberculosis (TB) clinical trial data and making this data publicly available to qualified researchers.

Trial Outcome Markers Initiative in T1D
TOMI-T1D’s mission is to accelerate drug development in T1D with the goal of slowing or preventing disease progression. By aggregating patient-level data from previously conducted clinical trials, TOMI-T1D will develop and seek the regulatory endorsement of a clinical trial simulation tool capable of de-risking decision making and optimizing the design of clinical trials.
Translational Therapeutics Accelerator
The Critical Path Institute’s (C-Path) Translational Therapeutics Accelerator (TRxA) is a global drug discovery and development program focused on supporting academic scientists in defining optimal strategies for advancing new, cutting-edge therapeutics from the lab to patients.

Transplant Therapeutics Consortium
Co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS), the Transplant Therapeutics Consortium (TTC) is a collaboration between the transplant community, industry, and regulatory agencies, and is managed and supported by Critical Path Institute (C-Path).

Creating and testing Alzheimer’s disease tools to facilitate drug development

Collaborating to develop instruments that measure the patient’s perspective

Developing and qualifying PRO instruments with the FDA for use in clinical trials

Qualifying biomarkers to identify patients for type 1 diabetes prevention clinical trials

Supporting collaborative research through shared data access and development of drug development tools

Friedreich’s Ataxia Integrated Clinical Database (FA-ICD)

Bringing together experts with a range of skills to explore how patients view their therapy

Accelerating approval of Huntington’s therapeutics

Working with the FDA and medical product firms to assess patient outcomes

Collaborating to develop tools to accelerate drug development in transplantation

Developing standards for assessing outcomes in clinical trials of MS therapies

Qualifying instruments for use in clinical trials to evaluate treatment benefit


Centralized and standardized infrastructure with the goal of accelerating therapy development

Enriching our understanding of the effect of interventions on how patients feel and function

Accelerate drug development for sickle cell disease through collaborative development and regulatory endorsement of new medical product development tools
Areas of Focus
Critical Path Institute, founded in 2005 in Tucson, Arizona, is an independent, nonprofit organization dedicated to bringing together experts from regulatory agencies, industry, and academia to collaborate and improve the medical product development process. More…
Successes
- COA Qualification from FDA for Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
- Qualification of drug-induced kidney injury (DIKI) clinical safety biomarker, composite measure
- COA Qualification from FDA for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
- C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)
- C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD
- C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- C-Path Opportunities Table
- EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers