C-Path Europe

Overview

C-Path’s global efforts are focused on identifying, leveraging, and developing complementary C-Path U.S. and EU activities and partnerships based on its core competencies to facilitate global collaboration ​in areas of unmet medical need.

Introduction

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

• EMA Regulatory Science Strategy priorities and Regulatory Science Research Needs
• IHI and Horizon Europe​
• EJPRD and EU Rare Disease community activities
• C-Path and the European Joint Programme on Rare Diseases to Expand Global Impact and Partnership

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

C-Path’s Impact in Europe

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

 

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

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

 

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

EMA qualification opinion for translational drug development platform

 

Transplant Therapeutics

EMA qualification opinion for iBox Scoring System

Polycystic Kidney Disease

EMA qualified Total Kidney Volume (TKV) imaging biomarker

European Nonprofit Timeline

C-Path Integrates European Offices to Optimize Global Operations and Collaborative Partnerships

July 18, 2023

Completion of the integration of C-Path Ltd. in Dublin, Ireland, into the C-Path nonprofit in Amsterdam, Netherlands. This integration enables C-Path to increase its activity in Europe and broaden its global operations.

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C-Path Becomes Official Partner of WHO to Shape Global Innovation and Access Landscape for Better Paediatric Medicines

June 6, 2023

C-Path’s participation in the GAP-f project is multi-faceted, including representation in the Clinical Research Working Group, along with contributions to the GAP-f Paediatric Data Hub designed to improve the availability, quality and use of real-world data to monitor and optimize treatments.

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C-Path celebrates 1 year since establishing Amsterdam office

April 25, 2023

C-Path’s year-in-review highlights its continued commitment to advancing regulatory science and its efforts to optimize the drug development process through actionable tools and solutions.

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C-Path in Europe: Moving Global Regulatory Science Forward Webinar

April 20, 2022

Speakers include C-Path scientific leadership who will present on-going activities on key topics, including:

• Digital Technologies
• Real-World Evidence
• Model Informed Drug Development
• Complex Clinical Trials

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C-Path in Europe Launches Nonprofit Office in Amsterdam to Facilitate Global Collaboration and Global Regulatory Successes in Identified Unmet Needs Areas

March 23, 2022

The nonprofit’s headquarters in Amsterdam extend and complement C-Path’s activities to improve public health, as well as share expertise, data, risks and costs to expedite advancements in global regulatory science by facilitating public-private partnerships with members from the biopharmaceutical industry, government regulatory agencies, academic institutions and patient groups in Europe.

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Projects

Unite4TB

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.

ERA4TB

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.