Programs
- Biomarker Data Repository (BmDR)
- Critical Path for Alzheimer's Disease (CPAD)
- Critical Path for Parkinson's (CPP)
- Critical Path for Sickle Cell Disease (CP-SCD)
- Critical Path to TB Drug Regimens (CPTR)
- CURE Drug Repurposing Collaboratory (CDRC)
- Data Collaboration Center (DCC)
- Duchenne Regulatory Science Consortium (D-RSC)
- Electronic Patient-Reported Outcome Consortium (ePRO Consortium)
- Huntington’s Disease Regulatory Science Consortium (HD-RSC)
- International Neonatal Consortium (INC)
- Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
- Patient-Reported Outcome Consortium (PRO Consortium)
- Polycystic Kidney Disease Outcomes Consortium (PKD)
- Predictive Safety Testing Consortium (PSTC)
- PredicTox Knowledge Environment (PredicTox KE)
- Quantitative Medicine Program (QuantMed)
- Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP)
- TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS)
- Transplant Therapeutics Consortium (TTC)
- Trial Outcome Markers Initiative in T1D (TOMI-T1D)
- Type 1 Diabetes Consortium (T1D)
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.
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 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 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.
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.
Data Collaboration Center
Developing data solutions for scientific research.
Duchenne Regulatory Science Consortium
D-RSC supports collaborative research through shared data access and development of drug development tools.
Electronic Patient-Reported Outcome Consortium
The Electronic Patient-Reported Outcome (ePRO) 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.
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.
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.
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.
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.
Quantitative Medicine Program
C-Path’s Quantitative Medicine program aims to improve population and individual health by transforming drug development through methodological innovation.
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.
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).
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.
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.
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
Enriching our understanding of the effect of interventions on how patients feel and function
Areas of Focus
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Accelerating the path
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Alzheimer’s Disease
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Asthma
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Data Collaboration
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Depression
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Diabetes
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Drug Safety
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Duchenne Muscular Dystrophy
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Friedreich’s Ataxia
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Functional Dyspepsia
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Huntington’s Disease
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Irritable Bowel Syndrome
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Kidney Transplant
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Multiple Sclerosis
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Non-Small Cell Lung Cancer
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Parkinson’s Disease
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Polycystic Kidney Disease
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Rheumatoid Arthritis
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Tuberculosis
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…
Upcoming Events
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Oct 19, 2020 - Oct 19, 2020 Workshop: RDCA-DAP 2020 Virtual Workshop -
Oct 28, 2020 - Oct 29, 2020 October 28-29 | International Neonatal Consortium 2020 Virtual Workshop -
Oct 29, 2020 WEBINAR – COVID-19: Risk Assessment and Mitigation Strategies for the Collection of PRO Data through Clinical Sites – Lessons Learned
Past Events
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Sep 18, 2020 Accelerating Drug Development for Rare Diseases through Data Sharing and Analysis -
Sep 17, 2020 How Math, Statistics, and Artificial Intelligence Can be Used to Develop Treatments for Major Diseases: Quantitative Medicine at the Critical Path Institute -
Sep 16, 2020 New Uses for Existing Drugs: Applications for COVID-19 and Valley Fever
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
News
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Sep 21, 2020 C-Path Awarded FDA Drug Development Tool Research Grant to Develop a Qualification Plan for the Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA) -
Sep 17, 2020 C-Path Launches Consortium to Accelerate Medical Product Development in Sickle Cell Disease -
Sep 3, 2020 C-Path Awarded FDA Drug Development Tool Research Grant to Develop a Qualification Plan for the PROMIS® Short Form v2.1—Physical Function-Multiple Sclerosis 15a (PROMIS PFMS—15a)
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Aug 25, 2020 Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions
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Aug 21, 2020 C-Path’s PKDOC and The PKD Foundation Set to Collaborate Once Again -
Aug 14, 2020 ePRO Consortium Announces Publication of Open Access Article