Work Package Description
Our work is divided into 7 work packages (WP), each led by a consortium member. Please use the filters below to learn more about our work and objectives.
Coordination and Project Management
The general objective of WP1 is to provide efficient management and coordination of the project and the consortium and to ensure the progress of the project towards its planned objectives. This work package encompasses strategic steering, project monitoring, risk and quality management, as well as administrative and financial support.
LEADER: University of Namur
PARTICIPANTS: All
Integrated Model
WP2 aims to develop a new model for integrated regulatory decision-making centred on drug development questions, alongside the development of reproducible standards applicable across diverse data sources, dedicated to data searching, structuring, analysis, and credibility assessment.
This work package will focus on the development of the repository, risk-informed credibility assessment, establishment of standards for data quality and an attributes framework, and the integration and application of these components to relevant use cases.
LEADER: University of Namur
PARTICIPANTS: UNamur, SRL, FAMHP, UV, UMCG, ANSM, CBG, AEMPS
Technical Development and AI-based Tools
The general objective of WP3 is to design and implement AI-driven solutions, including natural language processing (NLP), to identify relevant data sources, structure and analyse data, develop tools for credibility assessment, and automate the application of data standards and credibility evaluation within regulatory decision-making processes.
This work package covers the development of AI-based tools for data searching, structuring, and formatting to extract relevant summary and individual-level data; tools for credibility analysis; the creation of a Data Runtime Environment (DRE) to automate the ERAMET platform and support its application in use cases; and considerations for the platform’s sustainability, data management, and ethical compliance.
LEADER: Systems Resource Lab AS (SRL)
PARTICIPANTS: SRL, UoW, ARIDHIA
Clinical Trial Optimisation
WP4’s key objectives include applying the automated, question-centric approach to optimise orphan and paediatric clinical trials in conditions such as Ataxia, bronchopulmonary dysplasia (BPD), and transfusion-related haemoglobinopathies.
This work package encompasses the full development plan, from data sourcing and formatting to the creation of treatment layers, in silico models, and virtual cohorts. It includes the calibration and optimization of BPD drug development platform models, alongside the enhancement of experimental protocol design through Bayesian dynamic borrowing of historical priors. Additionally, it involves refining the AI-driven model integrated within Aparito’s Atom5™ clinical trial optimisation platform, conducting a credibility assessment, and preparing a comprehensive, high-level documentation package for regulatory submission and review.
LEADER: University of Catania
PARTICIPANTS: FAMHP, UV, UCL, CVBF, FGB, UMCG, UNICT, ARIDHIA, Athena, ANSM, CBG, AEMPS
Paediatric Extrapolation
WP5 aims to apply the automated, question-centric approach to paediatric drug development, with a specific focus on the extrapolation of efficacy and safety data.
This work package covers the full development plan, including data search, formatting, and analysis, as well as in-depth interrogation of the repository to extract insights on model-informed paediatric drug development. It also involves benchmarking the impact of alternative data sources and innovative methodologies on benefit-risk assessment, reviewing the quality of confirmatory data supporting model-informed strategies, conducting a credibility assessment, and preparing the high-level documentation package required for regulatory submission and review.
LEADER: CERTARA
PARTICIPANTS: CERTARA, FAMHP, UV, UCL, CVBF, FGB, UMCG, ARIDHIA, ANSM, CBG, AEMPS
Extrapolation in Groups of Rare Diseases
The objective of WP6 is to apply the automated, question-centric approach to predict dose and therapeutic effects (extrapolation) across groups of rare diseases, including Ataxia, BPD, transfusion-dependent inherited haemoglobinopathies, and neurodegenerative muscular diseases.
This work package includes the development plan, data searching, formatting, and analysis, along with credibility assessment. It also involves the preparation of a high-level documentation package intended for regulatory submission and review.
LEADER: University College London
PARTICIPANTS: FAMHP, UV, UCL, CVBF, FGB, UMCG, UNICT, ARIDHIA, Athena, ANSM, CBG, AEMPS
Dissemination, Exploitation and Communication
The objectives of WP7 are to inform all stakeholder groups about the project results and their potential implications for research, clinical practice, industry, regulation, and societal users, while maximising the exploitation potential of these outcomes and raising awareness of the opportunities offered by the integrated model. Additionally, well-targeted dissemination activities will be organised to ensure the project’s impact on society and patient communities is maximised.
This work package includes the development of a communication, dissemination, and exploitation plan and tools, multistakeholder engagement, networking, and organisation of events, creation of content and dissemination activities, organisation of two workshops, and exploitation activities along with intellectual property (IP) management.
LEADER: FAMHP
PARTICIPANTS: All
Meet the ERAMET Consortium Members
The ERAMET Consortium comprises 17 partners located in Belgium, Norway, the United Kingdom, Italy, Spain, France, Greece and the Netherlands. The Consortium’s expertise spans various fields, including regulatory science, computer modeling and simulation, data science, bioinformatics, artificial intelligence (AI) and machine learning (ML), digital twins, clinical trials, drug development, and evaluation. The Consortium brings together renowned researchers from across Europe, each possessing a strong technical, clinical and/or scientific background and the highest level of expertise in their respective fields.
The scientific excellence of the consortium is underscored by the remarkable track records of all partners in publishing research articles in peer-reviewed, prestigious scientific journals with extensive visibility and significant impact. Over the past five years, consortium members have consistently authored multiple articles as lead authors in the top 5% journals within the field of Modeling and Simulation (M&S), including Clinical Pharmacology and Therapeutics.
University of Namur, Belgium
Located in the heart of the Walloon capital, the University of Namur combines tradition and innovation to offer quality teaching and cutting-edge research. With a wide range of academic programs and a strong human dimension, the University of Namur prepares its students for a promising future.
The University of Namur is home to numerous research organisations, which bring together academics, scientists, administrative and technical staff, Belgians and foreigners, who all share the same passion for research.
Discover more about it here!
Systems Resource Lab (SRL), Norway
Systems Resource Lab AS (SRLAB for short, although using the abbreviation SRL in the ERAMET project) is a startup that focuses on developing and implementing tools and practices that foster learning across systems. But what do we mean when we talk about systems? Systems are just a condensed way of saying that a whole consists of parts and that these parts are related. And that one whole can be a part of another whole. Oh my, how fantastic – this goes on forever! As for learning, it is all about discovering. You learn by discovering, and when you share what you discover with another person – in your team, in your organisation, in another team in another organisation and so on, you are fostering learning across systems yourself.
SRL is all about developing, testing and sharing ways of working, talking and nice tools to help you in your daily work.
Federal Agency for Medicines and Health Products, Belgium
The Federal Agency for Medicines and Health Products (FAMHP) was established on 20 July 2006. The FAMHP is a public interest organisation with legal personality, classified under category A, as referred to in the law of 16 March 1954, on the control of certain public interest organisations.
The FAMHP plays an essential role in the protection of public health with the following mission: “Ensuring, from development to use, the quality, safety and efficacy:
- of medicines for human and veterinary use, including homoeopathic medicines and herbal medicines, pharmacy-made and officinal preparations;
- of health products, including medical devices and accessories, and raw materials for the preparation and production of medicines;
- of all operations involving blood, cells and tissues, which are also defined as health products”.
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University of Valencia, Spain
The old “Estudi General de València”, founded in 1499 and initially dedicated to the study of medicine, humanities, theology, and law, has evolved into a modern European university encompassing virtually every field of study.
The University of Valencia (UV) is one of the oldest universities in Spain, and, according to University Ranking by Academic Performance, UV is the third best university in Spain in scientific production. The outstanding research quality is exemplified by the Nobel Prize in Physiology or Medicine awarded to UV faculty member Santiago Ramón y Cajal in 1906.
The University of Valencia currently consists of 18 faculties and has more than 50.000 students.
UV is involved in the development of the ERAMET repository, regulatory science, Modelling and Simulation tools development and validation and in the use-cases (WP 2, 4, 5, 6 ).
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Consorzio per Valutazioni Biologiche e Farmacologiche, Italy
A non-profit research organisation that actively participates in European projects. Its primary goal is to accelerate the development of medical products, with a particular focus on paediatric and rare diseases. As the coordinator of various international projects and a partner in research initiatives funded by the European Commission, it strives to enhance the efficiency and effectiveness of research activities and services.
Through collaboration with scientific, clinical stakeholders, and policymakers, their goal it to transfer their expertise and contribute to the advancement of scientific excellence. In the ERAMET project, they’re actively but not exclusively involved in clinical trial optimisation (WP4), paediatric extrapolations (WP5), and the prediction of dose and treatment effects in small populations (WP6).
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Fondazione per la ricerca Farmacologica Gianni Benzi Onlus, Italy
University Medical Center Groningen, the Netherlands
The University Medical Center Groningen (UMCG) was established in 2005 as a joint activity of the University of Groningen and the Academic Hospital Groningen (AZG). At present, the UMCG is one of the largest hospitals in the Netherlands and the largest employer in the Northern Netherlands. More than 10,000 employees provide patient care, are involved in medical education and perform cutting-edge scientific research, focused on ‘healthy and active ageing’.
Research and education at the UMCG are funded through the University of Groningen, and the Faculty of Medical Sciences functions as an integral part of the University. The Dean of the Faculty of Medicine is appointed by the Board of the University and is a member of the Board of Directors of the UMCG. More than 3,400 students of the University of Groningen study Medicine, Dentistry or Human Movement Sciences, while more than 340 physicians are doing their speciality training at the state-of-the-art facilities of the UMCG.
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University of Catania, Italy
The University of Catania, situated in Sicily, Italy, stands as a beacon of academic excellence rooted in centuries of tradition. Founded in 1434, it boasts a rich history of scholarship and innovation. With its main campus nestled against the backdrop of Mount Etna, Europe’s tallest active volcano, the university offers a captivating blend of natural beauty and intellectual pursuit.
Renowned for its broad range of disciplines, including the humanities, sciences, engineering, and medicine, the University of Catania fosters a dynamic learning environment. Its distinguished faculty, state-of-the-art facilities, and vibrant student community contribute to its reputation as a leading institution in Italy and internationally.
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National Agency for the Safety of Medicines and Health Products, France
The French National Agency for the Safety of Medicines and Health Products (ANSM) is a public establishment under the authority of the French Ministry of Health. On behalf of the French State, it is responsible for the safety of health products and promotes access to therapeutic innovation. It acts on behalf of patients, alongside health professionals and in consultation with their respective representatives in all the Agency’s bodies. Through its evaluation, expertise and monitoring policy, ANSM ensures that the health products available in France are safe, effective, accessible and properly used.
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Agentschap College Ter Beoordeling Van Geneesmiddelen, the Netherlands
The MEB is an independent authority that regulates the quality, effects and safety of medicines and promotes the proper use of medicines for the right patient. Whether you are using a painkiller from your local chemist, or a treatment that is only available with a prescription from a medical specialist. From traditional to entirely new medicines. The MEB’s work involves medicines available in the Netherlands and, together with our European colleagues, medicines available across Europe.
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European Business Summit Network, Belgium
Building on over 20 years of experience in EU affairs, event planning and facilitation, EBSN Research Hub develops and implements communication, dissemination and advocacy strategies for EU-funded and consortium-managed projects.
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Spanish Agency of Medicines and Pharmaceutical Products, Spain
The Spanish Agency for Medicines and Health Products (AEMPS), a state agency attached to the Ministry of Health, is responsible for ensuring the quality, safety, efficacy, and proper use of medicines and health products throughout their lifecycle, from research and development to their use. Acting in the public interest, the Agency seeks to protect and promote human and animal health, as well as the environment.
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Certara UK Limited, United Kingdom
Certara is a consultancy company that provides Model-Informed Drug Development (MIDD) software, solutions, and insights to support decision-making across all therapeutic areas and innovative therapies, helping to accelerate the development of medicines and transform traditional drug research and development.
The results help anticipate and predict risks and benefits, support decision-making, and transform data into the knowledge and insights needed to deliver safe and effective new medicines to patients.
With more than 2,400 clients across 66 countries, including biopharmaceutical companies, academic institutions, and regulatory agencies. Certara leverages an integrated, proprietary end-to-end platform that combines AI technologies and biosimulation with the expertise of more than 1,400 scientists and specialists worldwide. This enables informed decision-making, increased R&D productivity, and improved patient outcomes.
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The University of Warwick, United Kingdom
The University of Warwick (UoW) is a renowned research institution, with 92% of its research rated as “world-leading” or “internationally excellent” in the UK’s Research Excellence Framework 2021. Its School of Engineering (SoE) specialises in healthcare technologies, modelling, and data analytics, and is home to more than 60 early-career researchers. Professors Mike Chappell and James Kermode, together with Dr Linda Wanika, contribute expertise in modelling, artificial intelligence (AI), and uncertainty quantification.
In the ERAMET project, UoW will help design robust models for paediatric and orphan medicines, develop AI/ML tools to format data, and create credibility tools for regulatory frameworks.
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University College London, United Kingdom
Founded in 1826 in the heart of London, UCL is London’s leading multidisciplinary university, with more than 16,000 staff and 50,000 students from over 150 different countries.
Through a progressive approach to teaching and research, its world-leading academics, curious students and outstanding staff continually pursue excellence, break boundaries and make an impact on real-world problems.
UCL is London’s research powerhouse, with a commitment to transforming lives in the capital, across the UK and around the world.
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Aridhia Informatics Limited, United Kingdom
Aridhia is a UK-based private limited company that helps clinical and life sciences pioneers in research hospitals, universities, pharmaceutical companies, and global medical networks advance medical research and improve outcomes more quickly. It does this by providing a safe and secure Digital Research Environment (DRE), also known as a Trusted Research Environment (TRE), for projects of any size or scale, whether local or global. Built to ensure compliance with industry standards and assessed against open specifications for TREs such as SATRE, it enables greater collaboration, knowledge sharing, and access to the potential of machine learning.
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Athena Research Center, Greece
Athena is a public Research Center in Greece focusing on Information technology and applications, with more than 800 researchers, hosting several Institutes and Units with themes ranging from data science to robotics. The Pharma-Informatics Unit of Athena offers a wide range of computational expertises and services from drug discovery to clinical drug development, while one of its strong points is pharmacometrics.
The role of Athena in ERAMET is to develop a predictive in silico platform of tuberculosis therapy for adults and children and demonstrate its potential regulatory impact, participating in WPs 4 and 6.
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