Bio-printing of living cells for regenerative medicine
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2024-TOOL-11-02
- Programme
- Tools and technologies for a healthy society (Single stage - 2024)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- October 26, 2023
- Deadline
- April 11, 2024
- Deadline Model
- single-stage
- Budget
- €25,000,000
- Min Grant Amount
- €6,000,000
- Max Grant Amount
- €8,000,000
- Expected Number of Grants
- 4
- Keywords
- HORIZON-HLTH-2024-TOOL-11-02HORIZON-HLTH-2024-TOOL-11Biomedical engineeringHealth-related biotechnologyPersonalised treatmentRegenerative medicineTissue engineering
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:
- Biomedical scientists will access entire bio-printing units for regenerating human tissue.
- Availability of larger-scale bio-printed tissues for biomedical research purposes to both industry and academia.
- Healthcare professionals acquire information on the safe and effective use of advanced therapies.
- Healthcare providers dispose of tools enabling them to treat conditions of unmet medical need.
- Individual patients will benefit from a personalised approach to their respective medical condition thanks to the bio-printed regenerative medicine solution.
Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the "process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function". 3D-printing in general is considered an advanced manufacturing technique and 3D-printing of non-viable biomaterials to serve e.g. as scaffold for cell growth or as structure for medical devices is already broadly used.
However, bio-printing technology involving living cells is still in early stages of development, but has a huge potential for tissue engineering, drug testing and other biomedical applications. Tissue-specific functional 3D bio-printing is a new approach for transplantation applications in regenerative medicine, relying on the fabrication of tissues and organs with respect to the desired shape and function and their delivery and application in vivo. “In-situ bio-printing” known as printing cells and biomaterials directly onto or in a patient, or 4D bio-printing, which introduces a “time” variable that allows 3D printed materials to change shape or function when external stimulus is applied, are recent developments facing multiple additional challenges.
Despite some success of 3D bio-printing with thin tissue, thick tissue and complex organs remain a bottleneck because it is difficult to sufficiently mimic their metabolic needs, and the scientific knowledge about their intimate architecture and interplay with other tissues are not sufficiently elucidated. Next to these limitations are a lack of standardised manufacturing protocols and standardised bio-ink formulations with tuneable properties, unstable cellular behaviour, material biocompatibility and printability, etc. Taken together, 3D bio-printing is confronted with several challenges that currently hamper its large-scale deployment.
To overcome these challenges, researchers should work in multidisciplinary teams with engineers, biomedical scientists, cell biologists and medical doctors and proposals should address most of the following activities:
- Design the best bio-printing strategy for at least one type of tissue thanks to a better understanding of the interconnections of the different cell types inside the chosen tissue or organ
- Develop or improve existing equipment able to print bio-constructs with higher resolution in a shorter time using various biomaterials and different cell types
- Cover all steps of the bio-printing suite, including cell collection, cell differentiation and expansion, imaging, modelling, bio-ink formulation, actual bio-printing, nutrient supply, process monitoring and cell-construct delivery at target site
- Scale-up the chosen bio-printing technology to a GMP-conform manufacturing process
- Combine different bio-printing technologies in order to obtain fully functional synthetic constructs of complex tissues or organs.
Regulatory knowledge of the field is desired and should be documented through contacts with relevant national or international European regulatory authorities.
The chosen medical area (tissue, organ, condition) should be duly justified. Sex differences at the cellular level should be taken into consideration.
Preclinical stage and early clinical development are eligible. The involvement of SMEs is encouraged.
Applicants 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
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.
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.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
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.
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) - call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA)
HE General MGA v1.0
Information on clinical studies (HE)
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
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 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 for the topic HORIZON-HLTH-2024-TOOL-11-02 are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 81
Number of inadmissible proposals: 1
Number of ineligible proposals: 0
Number of above-threshold proposals: 37
Total budget requested for above-threshold proposals: EUR 279,451,174.25
Number of proposals retained for funding: 6
Number of proposals in the reserve list: 0
Funding threshold: 15
Ranking
Number of proposals with scores lower or equal to 15 and higher or equal to 14: 23
Number of proposals with scores lower than 14 and higher or equal to 13: 12
Number of proposals with scores lower than 13 and higher or equal to 12: 2
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 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.
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 for the topic HORIZON-HLTH-2024-TOOL-11-02 are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 81
Number of inadmissible proposals: 1
Number of ineligible proposals: 0
Number of above-threshold proposals: 37
Total budget requested for above-threshold proposals: EUR 279,451,174.25
Number of proposals retained for funding: 6
Number of proposals in the reserve list: 0
Funding threshold: 15
Ranking
Number of proposals with scores lower or equal to 15 and higher or equal to 14: 23
Number of proposals with scores lower than 14 and higher or equal to 13: 12
Number of proposals with scores lower than 13 and higher or equal to 12: 2
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 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.
Call HORIZON-HLTH-2024-TOOL-11 has closed on 11 April 2024.
81 proposals have been submitted under topic HORIZON-HLTH-2024-TOOL-11-02.
Evaluation results are expected to be communicated in July 2024 at the earliest.