Step up the use for new approach methodologies to replace animal testing
Programme 2021 - 2027 Interreg VI-B North West EuropeDescription
O1.2 Two sector specific action plans helping to overcome particular challenges(EN)
Best practices in NAM uptake(EN)
NAM Validation Manual(EN)
O3.1 Participants in Stakeholder training & support programme(EN)
Website: http://step4nams.nweurope.eu
Thematic information
Priority:
(VI-B_NWE_4) Improving territorial resilience in NWE through innovative and smart transformationPriority specific objective:
RSO1.1. Developing and enhancing research and innovation capacities and the uptake of advanced technologiesPriority policy objective (Interreg specific objective):
PO1 A more competitive and smarter Europe by promoting innovative and smart economic transformation and regional ICT connectivityType of intervention:
027 Innovation processes in SMEs (process, organisational, marketing, co-creation, user and demand driven innovation)Partners (11)
Lead Partner: BioRegio STERN Management GmbH
PIC (Participant Identification Code): 912868650
Partner’s ID if not PIC: DE 218941367
Address: Friedrichstrasse , 70174 Stuttgart, Germany
Legal status: public
Organisation type: Business support organisation
Website: https://www.bioregio-stern.de/de
Total budget: EUR 877 645.00
Partner’s programme co-financing: EUR 526 587.00
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 351 058.00
GBER schemes / de minimis: GBER Article 20a
- Université du Luxembourg
-
Name: Université du Luxembourg
Department: Luxembourg Centre for Systems Biomedicine
PIC (Participant Identification Code): 999878620
Partner’s ID if not PIC: LU19805732
Address: Place de l’université, L-4365 Esch sur Alzette, Luxembourg
Department address: Avenue du swing, L-4367 Belvaux, Luxembourg
Legal status: public
Organisation type: Higher education and research organisations
Website: https://www.uni.lu/en/
Total budget: EUR 736 939.02
Partner’s programme co-financing: EUR 442 163.41
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 294 775.61
GBER schemes / de minimis: GBER Article 20a
- University of Galway
-
Name: University of Galway
Department: Anaesthesia and Intensive Care Mathematics Computer Science
PIC (Participant Identification Code): 999978045
Partner’s ID if not PIC: IE0022578J
Address: University Road, H91 TK33 Galway, Ireland
Department address: University Road, H91 TK33 Galway, Ireland
Legal status: public
Organisation type: Higher education and research organisations
Website: http://www.universityofgalway.ie
Total budget: EUR 958 356.52
Partner’s programme co-financing: EUR 575 013.91
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 383 342.61
GBER schemes / de minimis: GBER Article 20a
- Ollscoil Teicneolaiochta an Atlantaigh
-
Name: Ollscoil Teicneolaiochta an Atlantaigh
Department: Medical & Engineering Technologies Centre
PIC (Participant Identification Code): 887857685
Partner’s ID if not PIC: IE3926731JH
Address: Port Road , F92 FC93 Letterkenny, Ireland
Department address: Dublin RD, H91 T8NW Galway, Ireland
Legal status: public
Organisation type: Higher education and research organisations
Website: https://www.atu.ie/
Total budget: EUR 771 945.59
Partner’s programme co-financing: EUR 463 167.35
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 308 778.24
GBER schemes / de minimis: GBER Article 20a
- Biovia
-
Name: Biovia
PIC (Participant Identification Code): 872865850
Partner’s ID if not PIC: BE 1016 786 167
Address: Sint- Michielsstraat , 9000 Gent, Belgium
Legal status: public
Organisation type: Business support organisation
Website: http://www.biovia.be
Total budget: EUR 318 220.00
Partner’s programme co-financing: EUR 190 932.00
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 127 288.00
GBER schemes / de minimis: GBER Article 20a
- Groupement d'intérêt économique Eurasanté
-
Name: Groupement d'intérêt économique Eurasanté
Department: European and Structural projects
PIC (Participant Identification Code): 939183489
Partner’s ID if not PIC: FR74409044203 | SIRET n°40904420300035 | SIRETcodes is a INSEE code allows geographic identification of any French establishment or business (EN)
Address: Rue du Docteur Yersin, 59120 Loos, France
Department address: Rue du Docteur Yersin, 59120 Loos, France
Legal status: private
Organisation type: Business support organisation
Website: https://www.eurasante.com/
Total budget: EUR 305 200.00
Partner’s programme co-financing: EUR 183 120.00
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 122 080.00
GBER schemes / de minimis: GBER Article 20a
- Medicen Paris Region
-
Name: Medicen Paris Region
PIC (Participant Identification Code): 992944090
Partner’s ID if not PIC: FR85489590711 | FR85489590711 | SIRET number: 48959071100045 (EN)
Address: Rue de Lourmel, 75015 Paris, France
Legal status: public
Organisation type: Business support organisation
Website: https://medicen.org/
Total budget: EUR 401 632.00
Partner’s programme co-financing: EUR 240 979.20
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 160 652.80
GBER schemes / de minimis: GBER Article 20a
- InnovationQuarter
-
Name: InnovationQuarter
Department: innoveren
PIC (Participant Identification Code): 889728136
Partner’s ID if not PIC: NL 8531.98.688.B01 | 58827307 | KVK number (EN)
Address: Prinses Margrietplantsoen, 2595 AM Den Haag, Netherlands
Department address: Prinses Margrietplantsoen, 2595 AM Den Haag, Netherlands
Legal status: public
Organisation type: Regional public authority
Website: http://www.innovationquarter.nl
Total budget: EUR 324 455.90
Partner’s programme co-financing: EUR 194 673.54
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 129 782.36
GBER schemes / de minimis: GBER Article 20a
- Brabantse Ontwikkelings Maatschappij
-
Name: Brabantse Ontwikkelings Maatschappij
Department: BOM BD & FI BV
PIC (Participant Identification Code): 997331303
Partner’s ID if not PIC: 8523.18.315.B01
Address: Goirleseweg , 5026PB Tilburg , Netherlands
Department address: Goirlese Weg , 5026PB Tilburg, Netherlands
Legal status: public
Organisation type: Regional public authority
Website: http://www.BOM.nl
Total budget: EUR 308 000.00
Partner’s programme co-financing: EUR 184 800.00
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 123 200.00
GBER schemes / de minimis: GBER Article 20a
- Eberhard Karls Universitaet
-
Name: Eberhard Karls Universitaet
Department: Eberhard Karls University of Tübingen 3R-Center for in vitro models and animal testing alternatives Medical Faculty Institute of Biomedical Engineering Department for Microphysiological System
PIC (Participant Identification Code): 999991916
Partner’s ID if not PIC: DE812383453
Address: Geschwister-Scholl-Platz, 72074 Tübingen, Germany
Department address: Österbergstrasse , 72074 Tuebingen, Germany
Legal status: public
Organisation type: Higher education and research organisations
Website: https://www.the3rs.uni-tuebingen.de/en/
Total budget: EUR 1 329 971.44
Partner’s programme co-financing: EUR 797 982.86
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 531 988.58
GBER schemes / de minimis: GBER Article 20a
- flanders.bio
-
Name: flanders.bio
PIC (Participant Identification Code): 997629481
Partner’s ID if not PIC: BE 0863 763 620
Address: Technologiepark-Zwijnaarde, 9052 Zwijnaarde, Belgium
Legal status: public
Organisation type: Business support organisation
Website: https://flanders.bio/en
Total budget: EUR 318 220.00
Partner’s programme co-financing: EUR 190 932.00
Partner’s programme co-financing rate: 60.00%
Partner contribution: EUR 127 288.00
GBER schemes / de minimis: GBER Article 20a
Partners map
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Step up the use for new approach methodologies to replace animal testing
Lead partner
Project partner
Summary
Operation of strategic importance (OSI) or above EUR 5 million
Project acronym: STEP4NAMs
Project ID: NWE0400563
Project start date: 2025-01-01
Project end date: 2028-12-31
Project status:
ongoingRelevant linked projects:
- 3R-Network Baden-Württemberg (EN) | The 3R-Network Baden-Württemberg (BW), funded by the Ministry of Science, Research, and the Arts (MWK) Baden-Württemberg, Germany, brings together all major biomedical research centers in the region to equally advance scientific research and animal welfare. The network is dedicated to actively and sustainably reducing the number of animal experiments in research and academia. The network is anchored by five 3R-Centers, each serving as a central hub for the further expansion and integration of 3R principles across the state. These centers are supported by researchers from Baden-Württemberg who are engaged in three dedicated research projects and two educational initiatives aimed at structurally embedding replacement and supplementary methods, as well as the 3R-Principle, into scientific practice. To ensure that animal welfare remains a priority in research, education, and public discourse, the network consolidates the biomedical expertise of researchers across the state. It enhances the visibility of its activities through public relations efforts and offers specialized courses for education and training. This comprehensive approach ensures that the 3R principles are continuously promoted and integrated across various sectors.
- STEP4NAMs can leverage the 3R-Network Baden-Württemberg's expertise in embedding replacement methods, along with its educational and public outreach strategies, to gain valuable insights for designing sophisticated training programs for various stakeholders and raising awareness about the importance of adopting NAMs in industry. Additionally, the network and its experts can offer valuable guidance and advice, further strengthening STEP4NAMs' efforts to promote the integration of NAMs across Europe. (EN), Federal Network 3Rs Germany (EN) | The Federal Network 3Rs, launched by the Federal Ministry of Education and Research (BMBF) in 2022, is a national initiative to advance collaboration in 3R (Replace, Reduce, Refine) research across Germany. This network addresses the ethical challenge of balancing the need for animal testing in research with the commitment to animal welfare. The 3Rs framework aims to replace animal testing with alternative methods where possible, reduce the number of animals used, and refine experiments to minimize distress and enhance data quality.
- The Federal Network 3Rs fosters interdisciplinary collaboration among researchers, industry, policymakers, and other stakeholders to build a strong community dedicated to advancing 3R research in Germany. By joining the network, members can connect with experts, access resources, and stay informed about key events and training opportunities.
- STEP4NAMs will benefit from the Federal Network 3Rs Germany’s extensive network and expertise in 3R research to inform its own strategies for promoting NAMs. Additionally, the collaborative environment fostered by the Federal Network 3Rs offers a valuable platform for STEP4NAMs to connect with experts and regulatory agencies to share resources and align efforts in reducing animal testing across both research and industry sectors. This collaboration could lead to stronger, more unified approaches to ethical research practices in Germany and beyond. (EN), NAMWISE (HORIZON-HLTH-2024-IND-06-09) (EN) | The overarching aim of NAMWISE (NAMs Within Integrated Safety & Efficacy evaluation of chemicals and pharmaceuticals) project is to encourage and facilitate the uptake of NAMs (New Approach Methodologies) by providing a defined set of recommendations with concrete guidance and associated training resources on how effectively validate, integrate, and use NAMs for the assessment of the safety and efficacy of chemicals and pharmaceuticals. NAMWISE will implement a multi-actor approach bringing together NAM developers, users, regulators and stakeholders from both the chemical and pharmaceutical sectors: project activities will be largely based on an iterative dialogue among the stakeholders belonging to the project, and beyond the consortium, to reach a consensus on the most critical aspects regarding NAMs. In contrast to the focus of STEP4NAMs, which aims to support SMEs in the uptake of NAMs validating their confidence, predictability and robustness within pilot actions, NAMWISE clearly concentrates on the regulatory aspect of NAMs. This offers numerous synergistic overlaps from which the participating European partners and countries can mutually benefit. (EN), Codex4SMEs (EN) | The Interreg NWE project Codex4SMEs (Companion diagnostics expedited for small and medium-sized businesses) aimed to improve healthcare by increasing the uptake of personalised medicine in Northwest Europe. The project partners established a network to support SMEs along the value chain of companion diagnostics (Cdx) development. The project offered biobank-specific services such as sample access, knowledge transfer on biobank-related topics and biomarker validation as well as business development services such as pitch training with subsequent pitch events, market analyses and matchmaking activities. In the capitalisation phase, the partners offered additional services tailored to the specific needs of Dx SMEs, including a regulatory and translational assessment, a challenge-based matchmaking programme between SMEs and large pharma and medtech companies or a biomarker consultancy service. Analysing the impact of the support measures and the needs of the SMEs, it was found that support in the preclinical phase in particular would bring the greatest added value with more effective results. This led to the conclusion to create new innovation capacities by building a network to support the development and commercialisation of NAMs that could drive the development of new drugs and medical devices in terms of safety and efficacy. (EN), European Organ-on-Chip Society (EUROoCS) (EN) | The European Organ-on-Chip Society (EUROoCS) was established on November 5th, 2018, as an international independent not-for-profit organization aimed at encouraging Organ-on-Chip research and development and providing opportunities to share and advance knowledge and expertise in the field towards better health for all. EUROoCS provides a platform for dialogue and interaction between all stakeholders involved in the Organ-on-Chip field, to stimulate collaboration and dissemination of the latest developments. EUROoCS aims to facilitate OoC scientists, industry, government regulators and the general public in realizing sustainable progress in biological and medical research through education, communication, funding and matchmaking. Beneficiaries include the pharmaceutical-, cosmetics-, chemical- and agri-food industries with impact on consumer products. EUROoCS is thus a major catalyst for change around the experimental use of animals. Through EUROoCS, OoC technology becomes standardized and reproducible, promoting adoption by regulators, academia, industry and the general public, towards improving human health and safety.
- The STEP4NAMs project will significantly benefit from the involvement of its project partners who are an active EUROoCS members. This connection provides the project with direct access to the latest advancements and expert insights in OoC models, which are an important class of NAMs. The EUROoCS network facilitates collaborations with leading researchers, regulatory agencies, and institutions globally, enhancing the project's ability to incorporate cutting-edge OoC technologies. Additionally, this partnership strengthens the project's credibility and outreach efforts within the scientific community, driving broader industry acceptance of NAMs. (EN), RE-Place (EN) | RE-Place – Alternative methods to animal testing.
- The aim of Re-place, a joint initiative of the Vrije Universiteit Brussel (VUB) and Sciensano, is to collect and centralize existing expertise on animal-free new approach methods ( NAMs) in Belgium in one central database. All NAMs such as in vitro, ex vivo, in silico, in chemico assays are collected in this database.
- Re-place can be an essential partner in a this STEP4NAM project by providing expertise, facilitating for knowledge exchange, building networks, and providing a comprehensive database of alternatives. It offers expertise in scientific validation, supports the integration of NAMs into policies, and promotes harmonized guidelines across the EU.
- Additionally, Re-Place will serve as a catalyst to amplify the dissemination of the project's objectives, results, and success stories, including opportunities for participation in pilot studies and a comprehensive training and support program. Re-place can, through its network, as well offer complementary trainings to enhance the overall training program. (EN), International Microphysiological Systems Society (IMPSS) (EN) | The mission of the International Microphysiological Systems Society (IMPSS) is to foster global collaboration and communication among a diverse audience, including policymakers, funders, researchers, industries, medical practitioners, patient associations, and service centers. By connecting these stakeholders, the society aims to promote international standardization and harmonization of microphysiological systems (MPS) and create a global training environment. IMPSS seeks to facilitate a collaborative environment where challenges and opportunities in MPS development can be addressed collectively, advancing the technology and accelerating its acceptance by regulators and end users. Additionally, the society is committed to educating both new and established scientists, as well as regulators, to ensure the rapid, safe, and responsible adoption of MPS technology in advancing life sciences.
- The STEP4NAMs project will significantly benefit from the involvement of its project partners who are an active members of the International Microphysiological Systems Society (IMPSS). This connection provides the project with direct access to the latest advancements and expert insights in microphysiological systems (MPS), which are a key component of NAMs. The IMPSS network facilitates collaborations with leading researchers, regulatory agencies, and institutions globally, enhancing the project's ability to incorporate cutting-edge MPS technologies. Additionally, this partnership strengthens the project's credibility and outreach efforts within the scientific community, driving broader industry acceptance of NAMs. (EN), ORCHID (Organ-on-Chip development) (EN) | The ORCHID project (Organ-on-Chip development) was an EU initiative coordinated by Leiden University Medical Center and the Dutch Organ-on-Chip consortium hDMT in The Netherlands. The main goal of ORCHID was to create a roadmap for organ-on-chip technology and to build a network of all relevant stakeholders in this promising innovative field. In the ORCHID project that started on 1 October 2017 in total seven leading European research institutions were involved. The project is closed since 1 October 2019. The ORCHID project aligns synergistically with the STEP4NAMs proposal, as both initiatives emphasize innovation in biomedical research and safety testing through the application of novel new approach methodologies (NAMs). While ORCHID focused on developing cutting-edge Organ-on-Chip (OoC) systems as more accurate and ethical alternatives to animal testing, the STEP4NAM project aims to accelerate the adoption of commercially available models in industry by creating best-practice guidelines, training programs, and pilot studies. Insights gained from the ORCHID project, such as strategies for conducting detailed online surveys and developing roadmaps as guidance documents, will be invaluable in facilitating the practical integration of these advanced technologies into industrial processes.
- (EN), Interdisciplinary training network for advancing Organ-on-a-Chip Technology in Europe (EUROoC) (EN) | The Marie Skłodowska-Curie Innovative Training Network for advancing Organ-on-a-Chip Technology in Europe EUROoC created a trans-European network of application-oriented researchers fully trained in development and application of the emerging Organ-on-a-chip (OoC) technology.
- The STEP4NAMs and EUROoC projects both advance Organ-on-Chip (OoC) technology, but with different focuses. EUROoC established a trans-European network to train early-career researchers in the multidisciplinary field of OoC, integrating biology, engineering, and medicine, while also addressing commercialization and regulatory pathways. In contrast, STEP4NAMs aims to accelerate the industrial adoption of NAMs by creating best-practice guidelines, training programs, and pilot studies. We will leverage EUROoC's experience in designing high-quality training and the foundation it provided for the European Organ-on-Chip Society (EUROoCS) to assemble a strategic advisory board for STEP4NAMs, further enhancing its impact. (EN), MICROPLAITE (EN) | MICROPLAITE is a Cross-border Interreg project that aims to design a microfluidic platform for the development and evaluation of tissue reconstruction medical devices, as well as some of their properties such as antimicrobial effect and biosafety. This organ-on-a-chip approach is a real technological breakthrough and an extremely useful innovation with a view to reducing the use of animals for the validation of this type of device, as well as making this type of therapeutic approach much more accessible to users.
- The project will start in October 2024. STEP4NAMs partners will develop synergies with MICROPLAITE’s consortium through their common partner (Eurasanté), through events, sharing results as both projects are implemented. (EN), TPI (EN) | Transition Programme for Innovation without the use of animals (TPI) is a programme promoting the transition to animal-free research. A partner programme in which ministries and other organisations work together. The Netherlands aims to become an international frontrunner in creating innovations that make animal testing obsolete. For this reason, the national government is encouraging the development and application of research methods that do not involve animal testing. This is being conducted through the partner programme Transition Programme for Innovation without the use of animals. (EN), EHAB (HORIZON-EIE- 2023-CONNECT-01) (EN) | EHAB - European Hub for Advanced Therapies & Biomaterials is funded by the Interconnected Innovation Ecosystems (2023.1) (HORIZON-EIE-2023-CONNECT-01). The aim is to create an action plan fostering the development of advanced therapies and biomaterials, since biotech companies struggling in financing cost-intensive research and market approval for such new solutions. Additionally, the regulation on biotech-based therapies is still not clear which makes it difficult for companies to enter the European market. EHAB aims to provide recommendations to the policy-makers and regulators to improve the situation for European SMEs. Synergies between EHAB and STEP4NAMs could be the action plan and recommendation to policy and regulators regarding improvement of approval processes, reimbursement and financing of new solutions for the health care sector. (EN), Regmed XB (EN) | The RegMed XB Pilot Factory is one of the largest international infrastructures for regenerative medicine. It brings together all the expertise and infrastructure needed to bring regenerative medicine to the market. The mission is to accelerate the development of new solutions for chronic diseases and to bring affordable regenerative medicine therapies to patients. The Pilot Factory consists of an ecosystem of specialized pilot lines that support universities, research institutes, start-ups and industry with developing, testing, upscaling and producing their new regenerative medicine therapies. The RegMed XB Pilot Factory is a unique infrastructure that consists of facilities covering the entire chain of development and production of stem cells, mini-organs, tissues and smart (bio)materials. Around each pilot line, companies and knowledge institutions work together on the development of (clinical) applications and increasingly better, cheaper, scalable and exportable production equipment and services. The pilot lines are connected and complementary public private partnerships. This has shown to be effective in delivering the highest quality for our clients. The pilot factory facilitates the fast development of organs on a chip. (EN), EUSAAT (EN) | The European Society for Alternatives to Animal Testing (EUSAAT is an association of various interested persons, institutions, companies and organizations. It sees itself as the European 3R-platform and offers know-how, a comprehensive network and also supports corresponding training measures. In close cooperation with NGOs, scientific institutions and relevant companies, it develops and disseminates replacement and supplementary methods to animal experiments in order to implement them in practice.
- EUSAAT is active in all areas of the life sciences that are directly or indirectly involved in animal testing. This also includes the chemical-pharmaceutical industry, the field of cosmetics, basic research and also the field of regulatory and thus legally prescribed tests. (EN), ZIMT (EN) | ZIMT (Zentralstelle für Innovationen in der Medizintechnik) started in May 2024. The project is funded by the German Ministry of Research and Education. The aim is the establishment of a so-called industry-in-clinic-platform, which supports MedTech companies to get access to clinical experts from University Hospital in Tübingen and regional hospitals for co-development of new medical devices. The platform will also serve as a “Marketplace” for service provider related to product development, approval of medical devices according to regulations, data management, access to clinical data for post-market surveillance / post-market clinical follow up. Since this project is mainly focused on products such as new therapies and diagnostic methods it is not in conflict with STEP4NAMs which focus on solutions uptake of NAMs. However, synergies could be used to get involved MedTech companies seeking for new innovative solutions in the preclinical phase. (EN), Wellcome Leap HOPE (EN) | The Human Organs, Physiology, and Engineering (HOPE) program is a $50 million effort that brings experts in the life sciences and engineering together from across universities, foundations, and companies to develop human tissues, organoids, organs, and platforms that accelerate and scale new treatments.
- Focused on replication of complex human organs and immune system interactions, if successful, the HOPE program would have enormous implications for advancing cancer, autoimmune, and infectious disease interventions, and, eventually, to bioengineered, scalable-produced, immune-tolerant organs for transplantation.
- While the primary aim of the Wellcome LEAP HOPE program is to accelerate and scale new treatments for cancer, autoimmune diseases, and infectious diseases, with the potential to eventually produce bioengineered, immune-tolerant organs for transplantation, STEP4NAMs focuses on the broader industrial adoption of NAMs,, including best-practice guidelines, training programs, and pilot studies to integrate these advanced models into industry. The synergy between these projects lies in their shared commitment to improving human health through innovative technologies. STEP4NAMs can leverage the advancements and insights from the HOPE program, particularly in the replication of human organ systems, to further its goal of promoting NAMs across various industries. Additionally, the collaborative networks established by the HOPE program could provide valuable connections and expertise for STEP4NAMs in its efforts to standardize and disseminate these new methodologies. (EN), Wellcome Leap Dynamic Resilience (EN) | The Dynamic Resilience programis a $60 million effort that seeks to identify and validate causal measures and models of health resilience, at multiple scales, with predictive value sufficient to make clinical decisions. Such markers will support the identification of mechanisms, and development and testing of preventative interventions to support health resilience in people at risk of deterioration after a stress event.
- The STEP4NAMs and Wellcome LEAP Dynamic Resilience projects both aim to advance healthcare innovation, but they focus on different aspects of medical research and application. Dynamic Resilience focuses on identifying and validating causal measures and models of health resilience, aiming to develop predictive markers that can inform clinical decisions and preventative interventions for individuals at risk of health deterioration after stress events. In contrast, STEP4NAMs is dedicated to accelerating the industrial adoption of NAMs, including the development of best-practice guidelines, training programs, and pilot studies to integrate these innovative models into industry. The synergy between the two projects lies in their shared goal of improving human health through advanced research and innovative methodologies. STEP4NAMs can benefit from the insights into resilience mechanisms and predictive markers developed by the Dynamic Resilience program, particularly in the context of creating more robust and reliable nonclinical models. Additionally, the focus on preventative interventions in Dynamic Resilience could inform the development of NAMs that better predict long-term health outcomes, further supporting STEP4NAMs' mission to enhance the safety and efficacy of new therapies. (EN), Innovations to accelerate Vaccine Development and Manufacture
- (Inno4Vac) (EN) | Inno4Vac is a public-private partnership that addresses scientific bottlenecks in vaccine development. It proposes to develop predictive biological and mathematical models of vaccine performance and bio-manufacturing. Artificial intelligence combined with big data and computational modelling will be used to build an open-access and cloud-based platform for in silico vaccine efficacy assessment and development. Controlled human infection models and cell-based human in vitro 3D models will be developed to enable early evaluation of vaccine efficacy and prediction of immune protection. Finally, for vaccine bio-manufacturing the goal is to establish an open source in silico simulation platform for guiding the production of vaccine candidates and associated stability testing.
- STEP4NAMs can draw on the technological advancements and insights from Inno4Vac, particularly in the development of human-relevant models and the use of AI for predictive assessments. Furthermore, the open-access platforms and collaborative frameworks established by Inno4Vac could serve as valuable resources for STEP4NAMs as it seeks to promote the widespread adoption of NAMs. Together, these projects contribute to a more ethical and efficient approach to biomedical research and development. (EN), imSAVAR (EN) |
- The vision of Immune Safety Avatar (imSAVAR) is to develop a platform for the integrated nonclinical assessments of safety and efficacy of immunomodulatory therapeutic modalities.
- The imSAVAR project is a pioneering initiative funded by the Innovative Medicines Initiative (IMI), dedicated to enhancing the nonclinical safety assessment of immunotherapies.
- The primary objective is the creation of a platform to significantly improve the prediction of potential side effects and thereby the safety and efficacy of immunomodulatory therapeutics..
- The STEP4NAMs and imSAVAR projects both focus on advancing methodologies for evaluating the safety and efficacy of new therapies, but with distinct areas of emphasis. imSAVAR is dedicated to developing a platform for nonclinical safety and efficacy assessments specifically for immunomodulatory therapeutics. In contrast, STEP4NAMs aims to accelerate the industrial adoption of NAMs more broadly, including best-practice guidelines, training programs, and pilot studies across various therapeutic areas. The synergy between the two projects lies in their shared commitment to improving the safety and efficacy of innovative therapies through the development of advanced nonclinical models. STEP4NAMs can benefit from the insights and methodologies developed in imSAVAR while also leveraging imSAVAR's collaborative framework to strengthen its own efforts in promoting the adoption of NAMs across the industry.
- (EN), Gene Therapy Innovation Training Network (GET-IN) (EN) | The GET-IN network (Gene Therapy Innovation Training Network) will address these challenges through game changing innovations in viral vector production, design of experiments, quality by design, digital twin simulation, CRISPR genome editing and organoid-on-chip engineering, while 10 doctoral candidates will be trained as the next generation of gene therapy innovators and research leaders both in academia and industry.
- STEP4NAMs will benefit from GET-IN’s advancements in organoid-on-chip engineering, which could enhance the development of NAMs. Additionally, the training models and strategies used in GET-IN to cultivate expertise in gene therapy could provide valuable insights for STEP4NAMs as it designs its own training programs for various stakeholders in industry (EN)
Total budget/expenditure: EUR 6 332 365.47
Total EU funding (amount): EUR 3 799 419.27
Total EU funding (co-financing rate): 60.00%
Co-financing sources:
- ERDF: Amount, EUR 3 799 419.27. Co-financing rate, 60.00%.
Investments, deliverables, policy contributions
(bullets are inserted automatically and may be incorrectly placed)
Deliverables:
Programme Common Output Indicator:
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RCO 084 - Pilot actions developed jointly and implemented in projects, Measurement unit:
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RCO 116 - Jointly developed solutions, Measurement unit:
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RCO 083 - Strategies and action plans jointly developed, Measurement unit:
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RCO 085 - Participations in joint training schemes, Measurement unit:
Programme Common Result Indicator:
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RCR 081 - Completions of joint training schemes, Measurement unit:
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RCR 104 - Solutions taken up or up-scaled by organisations, Measurement unit:
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RCR 079 - Joint strategies and action plans taken up by organisations, Measurement unit:
Programme Result Indicator:
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PSR 1: Organisations with increased institutional capacity due to their participation in cooperation activities across borders, Measurement unit: Organisations
Information regarding the data in keep.eu on the programme financing this project
Financing programme
2021 - 2027 Interreg VI-B North West Europe
Last month that data in keep.eu was retrieved from the Programme's website or received from the Programme
2025-09-24
No. of projects in keep.eu / Total no. of projects (% of projects in keep.eu)
70 / 70 (100%)
No. of project partnerships in keep.eu / Total no. of project partnerships (% of project partnerships in keep.eu)
742 / 742 (100%)
Notes on the data