Advancing Drug Development.
Improving Lives. Together.

At Critical Path Institute’s Scientific Breakthrough Summit, the organization announced the progression from pre-consortia to consortia for Critical Path to Lysosomal Diseases (CPLD), established with grant funding provided by CDER, and Critical Path for Alpha-1 Antitrypsin Deficiency (CPA-1), established with grant funding provided by CBER.

C-Path’s Predictive Safety Testing Consortium (PSTC) achieved a major milestone with the FDA’s support for four new pancreatic injury biomarkers. These biomarkers, identified by PSTC’s Pancreatic Injury Working Group, are crucial for detecting drug-induced pancreatic injury in phase 1 clinical trials. The FDA’s endorsement reflects a significant advancement in enhancing drug safety and efficacy during the early stages of clinical development, reinforcing C-Path’s dedication to improving clinical care and drug development processes.

C-Path Receives Letter of Support from EMA on Duchenne Muscular Dystrophy Clinical Trial Simulation Platform: C-Path announced that the European Medicines Agency (EMA) has issued a letter of support for the Duchenne Regulatory Science Consortium’s (D-RSC) Model-based Clinical Trial Simulation Platform for Duchenne Muscular Dystrophy (DMD).

C-Path’s Transplant Therapeutics Consortium Receives EMA Qualification Opinion for iBox Scoring System: C-Path announced that its Transplant Therapeutics Consortium (TTC) received a qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients.

C-Path Receives Letter of Support from EMA for Parkinson’s Disease Clinical Trial Simulation Platform: C-Path announced that the European Medicines Agency (EMA) has issued a letter of support for the Critical Path for Parkinson’s (CPP) Consortium’s Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studies in Parkinson’s Disease (PD).

‘Rare Disease Moonshot’ – Scaling-up public-private partnerships to accelerate research into world’s rarest diseases: A new initiative to boost research and development into rare and paediatric diseases will launch today [Thursday 8 December] at the European Health Summit.

C-Path Receives Data Transfer from Network of Hospitals in Japan: C-Path received properly anonymized electronic patient record (EPR) data from three hospitals in the Neonatal Research Network of Japan — Nagano Children’s Hospital, Kyorin University and Osaka General Hospital.

FDA Expands Support of C-Path CDRC to Automate EHR Data Extraction: C-Path’s CURE Drug Repurposing Collaboratory (CDRC) has received additional funds as part of a new U.S. Food and Drug Administration (FDA) Health and Human Services (HHS) grant.

C-Path launched a pre-consortium collaboration with the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research, focusing on accelerating medical product development for alpha-1 antitrypsin deficiency (AATD). Named Critical Path for alpha-1 antitrypsin deficiency (CPA-1), this initiative collaborates with stakeholders to identify and address unmet needs in AATD drug development. Leveraging C-Path’s expertise in regulatory science, data management, and individual-focused solutions, CPA-1 aims to foster advancements in treatment options for AATD, a condition linked to liver disease and COPD.

C-Path Awarded FDA Grant to Establish Public-Private Partnership to Advance Treatments for Rare Neurodegenerative Diseases: C-Path announced that it has recently launched a pre-consortium collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), focused on accelerating medical product development in alpha-1 antitrypsin deficiency (AATD). The FDA announced the pre-consortium today in a statement on its website.

C-Path Awarded FDA Grant to Establish Public-Private Partnership to Advance Treatments for Rare Neurodegenerative Diseases: C-Path announced it will serve as the convener of the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a new public-private partnership (PPP) to benefit people across multiple rare neurodegenerative diseases, supported by a grant from the U.S. Food and Drug Administration (FDA). The Agency announced the PPP today in a press release.

C-Path to Lead Pre-Consortium Aimed at Transforming, Accelerating Medical Product Development in Lysosomal Diseases: C-Path announced the launch of a pre-consortium collaboration focused on accelerating medical product development in lysosomal diseases, supported by a grant from the U.S. Food and Drug Administration (FDA).

C-Path Launches Unique Translational Therapeutics Accelerator with Support from Cottrell Foundation: C-path announced it has been awarded a grant from the Frederick Gardner Cottrell Foundation, a non-profit organization established by Research Corporation Technologies, Inc. (RCT) that provides financial support for scientific research and educational programs, to create the C-Path Translational Therapeutics Accelerator (TRxA).

C-Path Receives Largest Data Transfer to Date from UK’s National Neonatal Research Database: C-Path received fully anonymized electronic patient record (EPR) data from the National Neonatal Research Database (NNRD).

C-Path Receives Qualification Opinion from EMA on Type 1 Diabetes Biomarker Initiative: C-Path’s Type 1 Diabetes Consortium (T1DC) announced that the European Medicines Agency (EMA) has issued a positive qualification opinion for pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) prevention trials.

C-Path European Nonprofit Established in Amsterdam: C-Path is excited to announce the opening of its EU nonprofit headquarters in the Netherlands, which will focus on the development of existing and future activities in Europe.

C-Path and the European Joint Programme on Rare Diseases to Expand Global Impact and Partnership

C-Path Launches Rare Disease Clinical Outcome Assessment Consortium

C-Path’s ePRO Consortium Announces Rebranding, Changes Name to eCOA Consortium

C-Path Joins New Coalition to Improve Patient Care and Address Unmet Medical Needs through Community-Level Clinical Trials

Rare Disease Innovation and Data Sharing Accelerated by New RDCA-DAP Program

Launch of UNITE4TB Partnership Marks a New Era in Tuberculosis Treatment Development

C-Path Opens Access to Duchenne Regulatory Science Consortium Database

C-Path Launches Acute Kidney Injury Project with Support from FDA

C-Path Receives FDA Qualification for the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C)

C-Path and Global Partners Launch Ataxia Consortium

Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim

C-Path Quantitative Medicine Program Awarded FDA Contract to Develop Tools for Neuroscience Diseases

Pediatric IBD Foundation, ImproveCareNow, C-Path to Establish the Children’s Registry for the Advancement of Therapeutics

FDA Awards C-Path Grant to Use Real-World Data to Generate Real-World Evidence in Neonates

C-Path Launches Consortium to Accelerate Medical Product Development in Sickle Cell Disease

C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate Identification of New Uses of Existing Drugs to Treat Infectious Diseases, Including COVID-19

C-Path’s Transplant Therapeutics Consortium Receives Acceptance of Letter of Intent for iBox Scoring System (Composite Biomarker Panel) as a Reasonably Likely Surrogate Endpoint

T1D Consortium receives Letter of Support for Type 1 diabetes biomarker initiative

C-Path Awarded FDA Contract to Enhance the Assessment of Clinical Outcomes in Pediatric Asthma Treatment Trials

C-Path to lead multi-stakeholder engagement to enhance the pediatric medical device ecosystem

C-Path, Ltd. and 30+ partners participate in international ERA4TB project

Trial Outcome Markers Initiative in T1D launches

Rare Disease Cures Accelerator-Data and Analytics Platform launches

PRO Consortium receives FDA grant to establish rare disease COA consortium

PRO Consortium awarded contract to advance COAs for pediatric asthma

PRO Consortium receives COA qualification from FDA for the Asthma Daytime Symptom Diary and Asthma Nighttime Symptom Diary

PSTC and Japan’s PMDA collaborate on first-of-its-kind biomarker project

C-Path and FARA Launch Friedreich’s Ataxia Integrated Clinical Database to advance the development of treatments for FA

C-Path, Ltd. European headquarters opens

FDA awards contract to TTC for kidney transplant database

PSTC and FNIH Biomarkers Consortium achieve the first ever qualification of a clinical safety biomarker

University of Arizona and C-Path launch graduate certificate program in regulatory science

CPP receives Qualification Opinion from EMA on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials

PRO Consortium receives COA qualification for Non-Small Cell Lung Cancer Symptom Assessment Questionnaire

C-Path receives Leona M. and Harry B. Helmsley Charitable Trust grant for Crohn’s Disease Biomarker Pre-consortium

Huntington’s Disease-Regulatory Science Consortium launches

WHO, FIND and C-Path announced relational sequencing TB data platform

PRO Consortium receives COA qualification for Symptoms of Major Depressive Disorder Scale

D-RSC, in collaboration with PSTC, receives EMA Letter of Support for liver safety biomarker

CPTR receives $1.1 million grant, partners with TGen to advance TB research

C-Path launches Transplant Therapeutics Consortium (TTC)

C-Path launches Type 1 Diabetes (T1D) Consortium

Relational Sequencing TB Data Platform (ReSeqTB) becomes available to the public

FDA awards C-Path three grants, one contract

CPTR launches TB-ReFLECT collaboration to enhance TB clinical research

C-Path’s PSTC and IMI SAFE-T obtain regulatory support for new liver safety biomarkers

CPP obtains EMA regulatory support for use of imaging biomarker in PD clinical trials

CAMD becomes partner in Global Alzheimer’s Association Interactive Network (GAAIN) data portal

MSOAC makes available new database for sharing MS clinical trial data

TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS) launched

C-Path collaborates with FDA’s CDER and FNIH’s Biomarker Consortium in drafting a “Framework for Defining Evidentiary Criteria for Biomarker Qualification”

C-Path’s Polycystic Kidney Disease Outcomes Consortium Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD

Parkinson’s UK and C-Path launch Critical Path for Parkinson’s (CPP)

FDA qualifies PKDOC’s Total Kidney Volume Biomarker as an enrichment biomarker in PKD clinical trials

C-Path’s 10-year anniversary celebration in Tucson

C-Path launches Duchenne Regulatory Sciences Consortium (D-RSC)

C-Path establishes Pediatric Trials Consortium (PTC)

C-Path launches International Neonatal Consortium (INC)

WHO selects C-Path to host TB clinical trials data

FDA issues Letters of Support to CAMD for Alzheimer’s and Parkinson’s disease biomarkers

EMA qualifies “Hollow Fiber System” for anti-tuberculosis drug development

EMA issues first-of-its-kind Biomarker Letter of Support for two kidney safety biomarkers identified and evaluated by PSTC’s nephrotoxicity working group

Second Annual Meeting with Innovative Medicines Initiative

Flinn Foundation Awards C-Path $1 Million Grant

FDA issues first-of-its-kind Biomarker Letter of Support for two kidney safety biomarkers identified and evaluated by PSTC’s nephrotoxicity working group

FDA and EMA Reach Landmark Decisions on Critical Path Institute’s Clinical Trial Simulation Tool for Alzheimer’s Disease

C-Path and IMI hold first joint meeting in Brussels: “Collaborating for Cures: Leveraging Global Public-Private Partnerships to Accelerate Medical Product Development”

National Multiple Sclerosis Society and C-Path launch Multiple Sclerosis Outcome Assessments Consortium (MSOAC)

CDISC and C-Path launch Coalition For Accelerating Standards and Therapies (CFAST)

C‐Path receives approval from the European Medicines Agency (EMA) for imaging biomarker as a qualified measure to select patients with early stage cognitive impairment for Alzheimer’s disease clinical trials.

The National Institutes of Mental Health selects C‐Path as “One of the Top 10 Research Advances of 2011.”

C-Path and The Hamner Institutes for Health Sciences (The Hamner) announce formal collaboration.

C-Path, CDISC, and FDA host global 2-day conference on drug development, “Creating Consensus Science: Tools and Tactics for Next-Gen Drug Development.”

C‐Path and CDISC announce release of data standards for Alzheimer’s disease research, the first in a series of therapeutic area common data standards.

C‐Path and Innovative Medicines Initiative (IMI) announce formal collaboration to further the mission of both organizations and to prevent duplication of efforts.

C‐Path announces formation of the Electronic Patient‐Reported Outcome (ePRO) Consortium.

C‐Path and CDISC announce partnership.

C-Path testifies before Congress on Alzheimer’s disease progress

C‐Path and industry‐partner Ventana Medical Systems receive award from Science Foundation Arizona to develop national resource for clinical research standardization.

With support and funding from the Polycystic Kidney Disease Foundation, C‐Path launches Polycystic Kidney Disease Outcome Consortium (PKDOC).

First‐ever biomarker qualification decision announced by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to accept PSTC’s new kidney biomarkers.

C‐Path announces the availability of its database of 11 industry‐sponsored clinical trials that included more than 4,000 Alzheimer’s disease patients. This database is the first effort of its kind to aggregate clinical trial data from multiple companies in a common CDISC data standard.

Nature Biotechnology features the PSTC’s evaluation of 7 kidney biomarkers for use in drug safety assessment.

C‐Path launches Critical Path to TB Drug Regimens (CPTR).

C‐Path launches Coalition Against Major Diseases (CAMD) as a consortium with pharmaceutical companies, patient groups, FDA and NIH to address clinical trial needs in neurological diseases.

C‐Path launches the Patient‐Reported Outcome (PRO) Consortium.

Reader’s Digest lists C‐Path as No. 7 on its list of “18 Big Ideas to Fix Healthcare Now!”

Science Foundation Arizona (SFAz) awards C-Path a grant to assist in developing better testing methods to accelerate drug development for major diseases including lung cancer, stroke, Alzheimer’s disease, and Parkinson’s disease.

C‐Path leads novel transatlantic drug safety effort which yields FDA/EMEA qualification of new drug tests for kidney safety. C‐Path qualifies first set of preclinical safety biomarkers.

Arizona’s Governor Janet Napolitano honors C‐Path with an “Arizona Innovation Award” to recognize its groundbreaking approach to speeding the development of safe, innovative medicines and medical devices.

President George W. Bush signs bill that authorizes FDA to create “Critical Path Public/Private Partnerships.” The first (and most successful) of these is the collaboration between the FDA and C‐Path.

Science Foundation Arizona (SFAz) awards grant to C‐Path and industry‐partner Ventana Medical Systems to collaborate on personalized medicine initiative.

C‐Path hosts ribbon‐cutting ceremony at the Library of Congress to officially announce opening of its Rockville, Maryland office.

Dr Raymond Woosley, C-Path’s founder, provides expert testimony in Congressional hearings.

C-Path receives monetary award for FDA collaboration.

C‐Path creates unprecedented collaboration between pharmaceutical companies and the FDA to form the Predictive Safety Testing Consortium (PSTC).

FDA announces first‐of‐its‐kind partnership with C‐Path to fulfill mission of Government’s “Critical Path Initiative.”

C‐Path hosts Tucson ribbon‐cutting ceremony to officially launch institute.

C‐Path begins first fiscal year with six full‐time employees.

State of Arizona awards C-Path a planning grant. C-Path files articles of non-profit incorporation.

The U.S. Food & Drug Administration releases the Critical Path Initiative report. C-Path enters into verbal agreement with FDA.