C-Path Europe

For more than a decade, C-Path has worked with the European Medicines Agencies (EMA) to seek the endorsement of drug development tools and additional medical product solutions developed by its consortia.

Additionally, it pursues a number of projects, initiatives and ventures each year in the EU as independent endeavors. C-Path’s strategic plan and priorities include expansion of its global strategy to best leverage its core competencies in regulatory and data science worldwide and facilitate global collaboration in areas of unmet need.

C-Path’s European nonprofit headquarters in the Netherlands officially launched in March 2022. Based in Amsterdam, the foundation pursues complementary opportunities to bolster existing and new partnerships with EU stakeholders. Like its U.S. counterpart, C-Path in EU also provides the legal and scientific infrastructure to create a uniquely neutral environment for industry, academia, patients, regulators and other government agencies.

C-path’s European Impact.

Alzheimer´s Solid Badge

Alzheimers

EMA qualification opinion on model-based AD imaging biomarker
EMA letter of support for pre-dementia clinical trial enrichment tool
EMA qualification for clinical trial simulation tool

Neuromuscular disease

Duchenne Muscular Dystrophy

EMA letter of support for pre-dementia clinical trial enrichment tool

multiplesclerosis_solid_badge

Multiple Sclerosis

EMA qualification opinion for test battery for four Perf0 measures

PKD

Polycystic Kidney Disease

EMA qualified Total Kidney Volume (TKV) imaging biomarker

Kidneys

Predictive Safety Testing

EMA qualified non-clinical kidney safety biomarkers
Five EMA letters of support

Parkinson´s Solid Badge

Parkinson’s Disease

EMA qualification opinion for model-based PD imaging Biomarker
EMA letter of support for PD imaging biomarker
EMA letter of support for clinical trial simulation platform

Tuberculosis Solid Badge

Tuberculosis

EMA qualification opinion for translational drug development platform

Transplant Therapeutics

Transplant Therapeutics

EMA qualification opinion for iBox Scoring System

Biomarker

Type 1 Diabetes

EMA letter of support and subsequent qualification opinion for model-based islet autoantibodies biomarker for trial enrichment

C-Path Global Timeline