C-Path Europe



For more than a decade, C-Path has worked with the European Medicines Agency (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.

European activities articulated around
C-Path programs

To connect with someone regarding collaborations in Europe, email info@c-path.org.

C-Path’s Impact in Europe

Alzheimer´s Solid Badge


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


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

Neuromuscular disease

Duchenne Muscular Dystrophy

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


Multiple Sclerosis

EMA qualification opinion for test battery for four Perf0 measures


biomarket yellow badge

Type 1 Diabetes

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



Predictive Safety Testing

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

Tuberculosis Solid Badge


EMA qualification opinion for translational drug development platform


Transplant Therapeutics

Transplant Therapeutics

EMA qualification opinion for iBox Scoring System


Polycystic Kidney Disease

EMA qualified Total Kidney Volume (TKV) imaging biomarker

European Nonprofit Timeline



The Academia and Industry United Innovation and Treatment for Tuberculosis (UNITE4TB) project is a research collaboration funded under the Innovative Medicines Initiative Joint Undertaking 2 (IMI JU2) within the framework of the wider Antimicrobial Resistance Accelerator programme.

The aim of the Antimicrobial Resistance (AMR) accelerator programme is to progress a pipeline of potential medicines, including but not limited to new antibiotics, to treat patients with resistant bacterial infections in Europe and across the globe, or to aid in the prevention of tuberculosis (TB).

The AMR Accelerator programme consists of three pillars under which multiple actions are expected:

  • Pillar A: Capability Building Network (CBN)
  • Pillar B: Tuberculosis Drug Development Network (TBDDN)
  • Pillar C: Company-specific Portfolio Building Networks (PBNs)

The UNITE4TB project resides in Pillar B of the AMR Accelerator programme, the main objective is to create a framework to accelerate the development of new regimens for the treatment of TB.

During its seven-year duration, the project partners will gain access to anti-TB compounds resulting from different EFPIA/AP drug development activities which are currently in late Preclinical, Clinical Phase I, or Early Phase II stages of development. The primary aims of this project are to:

  • Deliver an efficient, global clinical trials network equipped to conduct Phase II trials, with a view to gathering data on the drugs’ safety and efficacy as well as the best dosage and delivery method (e.g., oral or injection)
  • Apply simulation tools to identify optimal doses in Phase IIA trials, and apply a multi-arm, multi-stage adaptive randomised controlled 2B/C trial design which is capable of rapid and simultaneous evaluation of best candidate regimens
  • Utilise Artificial Intelligence/Machine Learning (AI/ML) technologies to validate state-of-the-art molecular and imaging tools as treatment decision biomarkers with the aim of establishing new real-time outcome measures
  • Ultimately enable the selection and testing of novel combination regimens with a high probability of success in subsequent Phase III clinical

Within the context of this project, C-Path is responsible for establishing the processes and infrastructure to enable the secure sharing of standardised data to support the primary aims of the project as described above.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians- Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.


The ERA4TB (European Regimen Accelerator for Tuberculosis) project is a public-private initiative dedicated to the development of drugs against tuberculosis. With a team of more than thirty organizations and a budget of over 200 million euros ERA4TB focuses on developing a new, improved tuberculosis treatment. The partners share their expertise, knowledge and resources to rapidly progress new candidate drugs into clinical trials.

Tuberculosis is the leading cause of death by an infectious disease worldwide. According to the World Health Organization (WHO), an estimated 10 million people became ill with tuberculosis in 2018, and 1.6 million died. Even though the incidence of tuberculosis is declining, the drug-resistant form constitutes a growing threat to the safety of the world population. It is in this spirit that the UN has pledged to end the tuberculosis epidemic by 2030 through joint action of its member states.

Standard tuberculosis treatment is based on a combination regimen of four drugs that were all developed more than 60 years ago.

  • Treatment lasts for at least six months and, in the case of resistance to the standard drugs, can be as long as two years.
  • The current drugs are inefficient by today’s standards and a new, faster-acting and safer treatment is required to reduce the length of therapy and to overcome the menace of drug-resistant strains.
  • Until now, the development of new drugs has been slow and their incorporation into tuberculosis treatment regimens conducted in a sequential manner.

ERA4TB is set to change the paradigm of tuberculosis treatment development by abandoning the sequential approach in favor of a parallel pathway, which will allow the simultaneous investigation of more than a dozen drug candidates. By implementing a standardized approach to tuberculosis drug development, that is well coordinated with the collaborations outside Europe, ERA4TB has the potential to optimize, and, more importantly, greatly reduce the development times of the new regimens needed to eliminate this epidemic.


C-Path Europe Team

Cécile Ollivier, MS
Vice President of Global Affairs

Graham Higson, MSc
Senior Regulatory Advisor

Patrick O’Meara
Data Team Manager, Work Project Lead

Ahmad Faizan
Data Manager III

Alysha Taylor
Data Engineer

Fionnuala Murphy
Data Manager II

Pavan Kumar Sudhakar
Data Engineer

Kimberly Ward Barowicz
Senior Project Manager for Strategic Initiatives

Board of Directors

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