Innovative non-animal human-based tools and strategies for biomedical research
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2024-TOOL-05-06-two-stage
- Programme
- Tools and technologies for a healthy society (Two stage - 2024)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- March 30, 2023
- Deadline
- September 19, 2023
- Deadline Model
- two-stage
- Budget
- €25,000,000
- Min Grant Amount
- €4,000,000
- Max Grant Amount
- €8,000,000
- Expected Number of Grants
- 4
- Keywords
- HORIZON-HLTH-2024-TOOL-05-06-two-stageHORIZON-HLTH-2024-TOOL-05-two-stageBasic medicineHealth sciencesMedical biotechnology
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following Expected Outcomes:
- Researchers utilise tools and strategies that are more relevant to the human situation as compared to the currently used animal models.
- Fewer live animals are used in biomedical research.
- Health technology developers will get access to improved human-relevant tools or strategies allowing for a faster pace of innovation.
- Legislators and regulators will benefit from strengthened EU leadership in non-animal based biomedical research that is socially accepted and sustainable.
- Healthcare providers and patients will benefit from innovative tools or strategies opening up novel biomedical concepts enabling improved disease prediction, prevention and treatment.
The proposal(s) should develop and/or use tools and strategies that address critical areas of biomedical research where animal-models are currently used but are of limited translational value for investigation and development of prevention and treatment. Such advanced tools and strategies should aim at a better understanding of the pathogenesis of disorders that feature a high impact on public health and exhibit a high rate of animal use or severe animal suffering, and enable to develop biomedical concepts with increased translational value, thereby ultimately leading to improved disease prediction, prevention and treatment.
The proposals should address all of the following aspects:
- The innovative tools and strategies should include a variety of technologies and methodological approaches such as –omics and other high-throughput procedures, human-derived cell-based material, organoids, micro-physiological systems, and in-silico models.
- The newly proposed tools and strategies should demonstrably advance the state-of-the-art in specific areas of biomedical research.
- Prospects and avenues for dissemination, knowledge sharing, uptake or translation into health policies of the proposed tools and strategies within the EU should be provided.
- Aspects such as harm and cost-benefit assessment as well as ease of production with respect to current practices should also be considered.
- Criteria for model qualification and standardisation should be developed in well-justified use-case contexts to demonstrate their translational values.
Proposals could consider the involvement of the European Commission's Joint Research Centre (JRC) to provide added-value regarding such aspects as supporting validation of emerging approaches, promotion of research results, and the interfacing with the regulatory community. In this respect, the JRC is open to collaborate with any successful proposal after the selection process has been completed.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.
This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘High quality digital services for all’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘Health technologies, new tools and digital solutions are applied effectively thanks to their inclusive, secure and ethical development, delivery, integration and deployment in health policies and health and care systems’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A competitive and secure data-economy’, ‘Industrial leadership in key and emerging technologies that work for people’, and ‘Good health and high-quality accessible health care’.
Technology is a key driver for innovation in the health care sector. It can provide better and more cost-efficient solutions with high societal impact, tailored to the specific health care needs of the individual. However, novel tools, therapies, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. Emerging and disruptive technologies offer big opportunities for transforming health care, thereby promoting the health and well-being of citizens. Unlocking this potential and harnessing the opportunities depends on the capacity to collect, integrate and interpret large amounts of data, as well as ensure compatibility with appropriate regulatory frameworks and infrastructures that will both safeguard the rights of the individual and of society and stimulate innovation to develop impactful solutions. In addition to existing European Research Infrastructures, the European Health Data Space will promote health-data exchange and facilitate cross-border research activities. Moreover, the European Health Emergency Preparedness and Response Authority (HERA) aims to improve to improve the EU's readiness for health emergencies by supporting research, innovation and development of technologies and medical countermeasures needed against potential cross-border health threats. This destination aims to promote the development of tools, technologies and digital solutions for treatments, medicines, medical devices and improved health outcomes, taking into consideration safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature.
In this work programme destination 5 has a strong focus on the personalisation of health technologies and will address the following issues:
Developing computational systems for point-of-care applications, developing and validating computational models of physiological systems and integrating health data from different sources, for better patient management and improved clinical outcomes;
Fostering translational biomedical research and advancing regenerative medicine approaches into clinical settings and manufacturing;
Preparing for potential cross-border health threats through the development of innovative in-vitro-diagnostics;
Supporting the establishment of the European Health Data Space by designing a data quality label.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health, the European Innovation Ecosystems (EIE) interregional networks on health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the health and other clusters (under pillar II of Horizon Europe), like, for instance, with cluster 4 “Digital, Industry and Space” on digitalisation of the health sector or key enabling technologies.
Expected Impacts
Proposals for topics under this destination should set out a credible pathway towards unlocking the full potential of new tools, technologies and digital solutions for a healthy society, and more specifically to several of the following expected impacts:
- Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in health care is world-class.
- Citizens benefit from targeted and faster research resulting in safer, more sustainable, efficient, cost-effective and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and well-being, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation)[1].
- The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
- The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care.
- Both the productivity of health research and innovation, and the quality and outcome of health care is improved thanks to the use of health data and innovative analytical tools, such as artificial intelligence (AI) supported decision-making, in a secure and ethical manner, respecting individual integrity and underpinned with public acceptance and trust.
- Citizens trust and support the opportunities offered by innovative technologies for health care, based on expected health outcomes and potential risks involved.
Legal entities established in China are not eligible to participate in Innovation Actions in any capacity. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[1] Commission Communication on the digital transformation of health and care; COM(2018) 233 final.
Eligibility & Conditions
General conditions
Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos, nor names of personnel in Part B of their first stage application (see General Annex E).
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025). [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE RIA IA Stage 1) - call-specific application form is available in the Submission System
Standard application form (HE RIA, IA) - call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1)
Standard evaluation form (HE RIA, IA)
Lump Sum MGA v1.0
Information on clinical studies (HE)
Guidance: "Lump sums - what do I need to know?"
Detailed budget table (HE LS)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search Services help you find a partner organisation for your proposal.
Latest Updates
CALL UPDATE: FLASH EVALUATION RESULTS
EVALUATION results
Published: 07.12.2022
Deadline: 11.04.2024
Available budget: EUR 25,000,000
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation the topic HORIZON-HLTH-2024-TOOL-05-06-two-stage are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 15
Number of inadmissible proposals: 0
Number of ineligible proposals: 0
Number of above-threshold proposals: 8
Total budget requested for above-threshold proposals: EUR 63,280,425.10
Number of proposals retained for funding: 3
Number of proposals in the reserve list: 3
Funding threshold[1]: 14.5
Ranking
Number of proposals with scores lower or equal to 15 and higher or equal to 14: 3
Number of proposals with scores lower than 14 and higher or equal to 13: 4
Number of proposals with scores lower than 13 and higher or equal to 12: 1
Summary of observers’ report:
Two independent observers were asked to assist the European Health and Digital Executive Agency (HaDEA) in the evaluation of proposals submitted to 9 single and two-stage calls (covering 14 topics) with deadline on 11 April 2024, which were discussed during 2.5 weeks of consensus meetings. They followed the evaluation in order to assess and report on the implementation of the evaluation procedures, on the conduct and fairness of the evaluation process and on the application of the evaluation criteria. Based on the analysis conducted, the observers give independent advice for improvement of the evaluation process.
The evaluation process was fully transparent. The rules and guidelines to be followed were clearly communicated by documents provided to experts, by online and on-site briefings and by instructions given and, where necessary, repeated by the moderators. This ensured a fair and transparent procedure. The evaluation was conducted in an extremely fair and professional way, thanks to a thorough and meticulous preparation and to the helpful and competent HaDEA staff involved, including the quality checkers and the assistant team.
The lump sum method was used in this evaluation. Despite that the budget tables provided detailed information and that guidance was provided, many experts found it challenging assessing the proposed budgets.
The independent observers were impressed by the high quality of the evaluation, and made some further recommendations, for consideration in setting up the rules for the next framework programme. The most important advice is that a higher weight should be assigned to the Excellence criterion. It has at present a weight of 1/3 of the final score. This should be increased, as scientific excellence is the most important factor that determines the quality of a project. Such a change would be in line with international practices.
For questions, please contact the Research Enquiry Service.[1] Proposals with the same score were ranked according to the priority order procedure set out in the call conditions (for HE, in the General Annexes to the Work Programme or specific arrangements in the specific call/topic conditions).
Call HORIZON-HLTH-2024-TOOL-05-two-stage has closed on 11 April 2024.
15 proposals have been submitted under topic HORIZON-HLTH-2024-TOOL-05-06-two-stage.
Evaluation results are expected to be communicated in July 2024 at the earliest.
In order to best ensure equal treatment, successful stage 1 applicants do not receive the evaluation summary reports (ESRs) for their proposals, but this generalised feedback with information and tips for preparing the full proposal.
Information & tips
- The proposals should address all the individual sub-criteria in each appropriate section of the proposal (Excellence, Impact, Implementation). E.g., the state of the art should be clearly referenced, the methodology and - where relevant – the technical robustness of AI should be clearly described, the pathways to the expected outcomes and impacts, the scale and significance of project’s contributions to the expected outcomes, and all other aspects need to be addressed.
- Justify the extent of clinical testing involved. Explain how your proposal will prioritise measurable outcomes, focusing on saved lives and reduced animal use.
- Outline the practical steps and considerations integral to achieving the proposed objectives to demonstrate your implementation strategies.
- Multidisciplinary, social sciences and humanities (SSH) aspects must be duly considered and convincingly integrated in the methodology, particularly the harm and cost-benefit analysis. The SSH aspect is a cornerstone of this call.
- If your proposal contains clinical studies, please read carefully the definition and guidance on the template ‘Information on clinical studies' published on the call page in the Participant Portal (Information on clinical studies (HE)) and remember to upload the template filled in when submitting your proposal.
- In stage 2 the eligible costs will take the form of a lump sum contribution as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme. To get started, please read lump sum funding and the guide Lump sum funding - what do I need to know, with details on how to complete the Excel workbook. Recommended: Excel 2013 (Windows) / Excel 2016 (Mac OS) or more recent.
In your stage 2 proposal, you have a chance to address or clarify these issues.
Please bear in mind that your full proposal will now be evaluated more in-depth and possibly by a new group of external experts.
Please make sure that your full proposal is consistent with your short outline proposal. It may NOT differ substantially. The project must stay the same.
In accordance with General Annex F of the Work Programme, the evaluation of the first-stage proposals was made looking only at the criteria ‘Excellence’ and ‘Impact’. The threshold for both criteria was 4. The overall threshold (applying to the sum of the two individual scores) was set at 10 points for topic HORIZON-HLTH-2024-TOOL-05-06-two-stage that allowed the total requested budget of proposals admitted to stage 2 be as close as possible to 3 times the available budget of EUR 25 000 000 (and not below 2.5 times the budget).
The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 190
- Number of inadmissible proposals: 2
- Number of ineligible proposals: 5
- Number of above-threshold proposals: 15
- Total budget requested for above-threshold proposals: EUR 109 461 039
We recently informed the applicants about the evaluation results for their proposals.
For questions, please contact the Research Enquiry Service.
First stage of call HORIZON-HLTH-2024-TOOL-05-two-stage closed on 19 September 2023. 190 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2024-TOOL-05-06-two-stage: 190 proposals
Evaluation results are expected to be communicated on 24 January 2024 at the earliest.
First stage of call HORIZON-HLTH-2024-TOOL-05-two-stage closed on 19 September 2023. 190 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2024-TOOL-05-06-two-stage: 190 proposals
Evaluation results are expected to be communicated on 24 January 2024 at the earliest.