Connect on LinkedIn The AMR Accelerator Calls to Action: European Capacity for Antibiotic R&D Requires Long-term Funding
Note: You are reading this information because Critical Path Institute is a partner of both ERA4TB and Unite4TB.
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 crucial for improving patient outcomes but is hindered by siloed efforts at the national scale and is compounded by significant barriers, including the complexity and variability across different countries, patient populations, therapeutic areas, and global clinical trials. The drug development process occurs on a worldwide scale and C-Path’s work to de-risk and accelerate the process must translate globally.
The Solution
Since 2008, C-Path has achieved more global regulatory endorsements for drug development tools than any other organization in the world, building a reputation of regulatory excellence and neutrality. 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, in addition to continued development of regulatory-endorsed tools.
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 biomarkers in kidney, skeletal muscle, renal tubular, vascular, and liver injury
The Impact:
20 Years of Accelerating Regulatory Innovation
Extensive experience and scientific evidence:
5 unique core competencies
26 active drug development areas
40 formal, unprecedented regulatory endorsements
700k+ standardized and integrated individual patient records
Enabling high impact regulatory firsts in rare and non-rare diseases:
New drug regimen & new label expansion in global public health
First disease modifying drugs approved
First new treatment option in rare disease with limited option
First prevention drug in high burden disease
28 new regulatory endorsed tools for faster clinical development and treatment strategies
Projects & Partnerships
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. Along with an extensive list of ongoing initiatives, key partnerships include:
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
Associate Director, Work Package Lead (ERA4TB & UNITE4TB)
Based in Ireland
Ahmad Faizan, MS
Data Manager III
Based in Ireland
Alysha Taylor, PhD
Data Engineer
Based in Ireland
Fionnuala Murphy, PhD
Data Manager II
Based in Ireland
Pavan Kumar Sudhakar, MSc
Data Engineer
Based in Ireland
Kimberly Ward Barowicz
Senior Project Manager for Strategic Initiatives
Based in U.S.
Eva Fernandez-Gonzalez, MS
Project Manager
Based in UK
Abinandhan Sundar, MS
Data Manager
Based in Ireland
Scottie Kern
Executive Director, Electronic Clinical Outcome Assessment Consortium
Based in UK
Ruby Abrams, PhD
Quantitative Medicine Scientist, Digital and Precision Medicine
Based in Netherlands
Board of Directors
Robert Hemmings, MS
Robert Hemmings, MS is currently partner at Consilium Salmonson & Hemmings and has deep expertise in global clinical trial design, critical appraisal of clinical trial data and regulatory affairs. He was head of the group of statisticians and pharmacokineticists at the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for nearly 20 years. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) at the EMA for 11 years, has chaired EMA’s Scientific Advice Working Party for eight years, and chaired and served on EMA’s groups for biostatistics, modelling and simulation and extrapolation. Hemmings also represented the EU and was the Rapporteur for the revision of the ICH guideline E9 (R)1 addendum on estimands and sensitivity analysis in clinical trials, to the guideline on statistical principles for clinical trials. Additionally, he has involvement in multiple initiatives related to innovation in clinical trial design and regulatory strategy including, EMA’s Priority Medicines (PRIME) scheme for unmet medical needs, adaptable pathways, and accelerated access pathways in the UK.
Tomas Salmonson, PhD, MSc
Dr. Tomas Salmonson has deep expertise in pharmacokinetics, bioequivalence, clinical trial methodology, clinical drug development and regulatory affairs and is currently partner at Consilium Salmonson & Hemmings. He left the Medical Products Agency in February 2019 after more than 30 years at the Swedish agency and the European regulatory network. He chaired the CHMP at the EMA between 2012 and 2018. Before that he was a member of CHMP representing Sweden between 1999 and 2012. During his last 10 years there, he also represented the EU at the ICH Steering /Management Committee and the ICH Assembly. Salmonson obtained his Ph.D. from Faculty of Medicine Uppsala University, Uppsala, Sweden and an M.Sc. from Uppsala University. He did postgraduate research at the University of California in San Francisco in the mid-80s.
Salmonson has published over 60 publications in different areas including pharmacokinetics and regulatory affairs. In 2016, he received the DIA Outstanding Contribution to Health Award, the Pharmacist of the Year in Sweden in 2017 and the TOPRA Lifetime Achievement Award in 2018.
Cécile Ollivier, MS
Cécile Olivier as the Vice President of Global Affairs at C-Path. She is a senior health engineer with over 15 years of experience in global drug development, particularly for paediatric and rare diseases. Prior to joining Critical Path Institute, Cécile was with a medical technology company developing digital endpoints and for 11 years a scientific officer at the European Medicines Agency (EMA). At EMA, she provided technical and regulatory expert guidance on the design, conduct, and interpretation of paediatric developments across multiple therapeutic areas. Cécile has been recognized for her work leading the EMA extrapolation global strategy and activities including the EMA/FDA harmonization for Gaucher disease and global harmonization of criteria for development in paediatric Pulmonary Arterial Hypertension (PAH) with patients, healthcare professionals, FDA, and Health Canada.
She was also an expert in the E11 R(1) working group and the paediatric standing group for the International Conference of Harmonization (ICH).
Klaus Romero, MD, MS
Dr. Klaus Romero is a prominent clinician scientist and scholar, who serves as both the Chief Executive Officer and Chief Science Officer at Critical Path Institute. As a recognized thought-leader, Dr. Romero established C-Path’s Quantitative Medicine Program and has been an instrumental leader in the growth of the organization’s portfolio of transformative consortia and public-private-partnerships across more than 16 therapeutic development areas. As both a scientist and an executive, Dr. Romero led the generation of actionable drug development tools in Alzheimer’s disease, which introduced a transformation in the drug development process for this indication. In tuberculosis, Romero’s leadership was instrumental in generating a drug development infrastructure that allowed the approval of the first new individual drug and the first new regimen for this disease, in more than 50 years. Dr. Romero’s leadership has also resulted in the transformation of therapeutic development paradigms for many other diverse areas, like polycystic kidney, Parkinson’s and Huntington’s diseases, as well as type 1 diabetes prevention, kidney transplantation, Duchenne muscular dystrophy, and several other rare and orphan indications. As a trained clinical pharmacologist and epidemiologist, Dr. Romero is a fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics, and the International Society of Pharmacoepidemiology. He is also an Associate Research Professor at the University of Arizona, as well as an Adjunct Professor at the University of Southern California and Arizona State University.
