Critical Path Institute Announces New Board Members Bonnie A. Allin and Louis Breton
Critical Path Institute (C-Path) today announced the appointments of Bonnie A. Allin and Louis Breton to its Board of Directors.
C-Path Europe
Overview
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 European stakeholders. Globally, C-Path provides the legal and scientific infrastructure to create a uniquely neutral environment for industry, academia, patients, regulators, and other government agencies.
The Problem
Developing safe, cost-effective, and efficacious drugs is hindered by significant barriers, including the complexity and variability across different countries, patient populations, therapeutic areas, and global clinical trials. The lack of standardized protocols and insufficient data sharing further obstructs progress and innovation, which are crucial for improving patient outcomes.
The Solution
C-Path’s international efforts date back to 2008, only five years after the launch of the organization. Over the last two decades, C-Path has built a reputation of regulatory excellence and neutrality, achieving more global regulatory endorsements for drug development tools than any other organization in the world. Today, C-Path’s global efforts are focused on identifying, leveraging, and developing complementary U.S. and European partnerships to facilitate global collaboration in areas of unmet medical need. Key partnerships and synergies are centred around:
- EMA Regulatory Science Strategy priorities and Regulatory Science Research Needs
- Innovative Health Initiative (IHI) and Horizon Europe
- European Joint Programme on Rare Diseases (EJPRD)
- World Health Organization (WHO)
The Impact
Alzheimer's
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
EMA letter of support and subsequent qualification opinion for model-based PD imaging Biomarker
EMA letter of support for clinical trial simulation platform
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 for injury biomarkers in kidney, skeletal muscle, renal tubular, vascular, and liver
Projects
Paediatrics
WHO GAP-f: 2022-2030
C-Path’s participation in the World Health Organization’s Global Accelerator for Paediatric Formulations Network (WHO GAP-f) project is multi-faceted, providing insights and expertise in regulatory science and data management in order to improve the availability, quality, and use of real-world data to monitor and optimize treatments.
Rare Disease
Our proven track record in establishing global partnerships to build solutions, advance technologies, and develop novel methodologies for regulatory purposes aims to further global rare disease research and drug development. Building on this foundation, our current initiatives and partnerships seek to address challenges and unmet needs in this space.
Rare Disease Moonshot: 2022-ongoing
C-Path’s activity in the coalition promotes the integration of regulatory science in rare disease public-private partnerships. Together, this partnership pools expertise, reduces fragmentation in research and fosters greater collaboration that explores opportunities to:
- Enhance translational research ecosystem to fill the research pipelines with new therapeutic options
- Optimise clinical trials and regulatory pathways for very small patient populations to de-risk and optimise development
- Develop infrastructure to accelerate the journey to diagnosis and treatment
ERDERA (pre-launch): 2024-2031
C-Path has been selected as a partner in the European Rare Disease Research Alliance (ERDERA), funded through Horizon Europe.
Real-World Data
More-EUROPA: 2023-2028
C-Path supports communication and training for the efficient use of real-world data in the development, registration and assessment of medicinal products in Europe as a partner in the More-EUROPA project funded by Horizon Europe.
Tuberculosis
C-Path’s global projects focus on Tuberculosis (TB) and Antimicrobial Resistance (AMR), building on our long-standing work in TB. TB is the leading infectious disease killer, with 10 million cases and 1.6 million deaths in 2018 (WHO). Despite declining TB incidence, drug-resistant TB is a growing threat. The UN aims to end the TB epidemic by 2030 through joint action. C-Path addresses these needs by leveraging our core competencies in strategic IMI/IHI projects.
Unite4TB: 2021-2028
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 to progress a pipeline of potential medicines to treat patients with resistant bacterial infections in Europe and across the globe, or to aid in the prevention of tuberculosis (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.
Within the context of this project, C-Path is the work package lead in supporting and 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: 2020-2025
The European Regimen Accelerator for Tuberculosis (ERA4TB) project, a public-private initiative with over 30 organizations, aims to develop drugs against tuberculosis and create improved outcomes. Unlike the traditional sequential approach, ERA4TB adopts a parallel pathway, enabling simultaneous investigation of over a dozen drug candidates. By implementing standardized drug development methods coordinated with global collaborations, ERA4TB has the potential to significantly reduce the development time for new regimens, crucial for eliminating the tuberculosis epidemic.
As work package leads for data and pipeline management, C-Path and associated work package partners are tasked in supporting and establishing the processes and infrastructure to enable the secure sharing of standardised data and images to support the primary aims of the project.
PAN-TB: 2023-ongoing
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration leverages members’ collective resources and expertise to identify and evaluate new drug regimens for both drug-sensitive and drug-resistant TB. These regimens aim to be safer, better tolerated, shorter in duration, and simpler to use than existing options. The focuses is on phase 2 clinical efficacy studies to identify promising regimens for further development.
The project plans to cooperate transparently with the ERA4TB, potentially incorporating their new molecular entities into later-stage clinical research. Closely synergized with the work of UNITE4TB and ERA4TB, data from the PAN-TB 2020-2023 pharmacokinetic and relapsing mouse model (RMM) studies are now available through Critical Path Institute’s Data Archive platform. These preclinical studies evaluated the combination pharmacokinetics and the combination efficacy of novel four-drug combinations of seven priority anti-TB drugs and drug candidates.
Team
C-Path Europe Team
Cécile Ollivier, MS
Vice President of Global Affairs
Based in Netherlands
Graham Higson, MSc
Senior Regulatory Advisor
Based in UK
Patrick O’Meara
Data Team Manager, Work Project Lead (ERA4TB & UNITE4TB)
Based in Ireland
Ahmad Faizan
Data Manager III
Based in Ireland
Alysha Taylor
Data Engineer
Based in Ireland
Fionnuala Murphy
Data Manager II
Based in Ireland
Pavan Kumar Sudhakar
Data Engineer
Based in Ireland
Kimberly Ward Barowicz
Senior Project Manager for Strategic Initiatives
Based in U.S.
Eva Fernandez-Gonzalez
Project Manager
Based in UK
Abinandhan Sundar
Data Manager
Based in Ireland