Closed

Clinical trials of combined Advanced Therapy Medicinal Products (ATMPs)

HORIZON Research and Innovation Actions

Basic Information

Identifier
HORIZON-HLTH-2023-TOOL-05-01
Programme
Tools and technologies for a healthy society (Single stage - 2023)
Programme Period
2021 - 2027
Status
Closed (31094503)
Opening Date
January 12, 2023
Deadline
April 13, 2023
Deadline Model
single-stage
Budget
€4,000,000
Min Grant Amount
€4,000,000
Max Grant Amount
€4,000,000
Expected Number of Grants
1
Keywords
HORIZON-HLTH-2023-TOOL-05-01HORIZON-HLTH-2023-TOOL-05Biomedical engineeringClinical development, Phase IIClinical trialsGene therapy, cell therapy, regenerative medicineInterventional clinical trialsRegenerative medicineTissue engineering

Description

Expected Outcome:

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:

  • Healthcare providers increase their knowledge on the potential of combined ATMPs and get access to innovative treatment options with demonstrated health benefits for unmet medical needs;
  • Developers and manufacturers of combined ATMPs obtain scientific evidence on the proposed therapeutic approach;
  • Patients benefit from new advanced therapies delivered through the combined ATMPs;
  • EU companies get a better market position in the field of combined ATMPs.
Scope:

The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal Products) according to the definition of the ATMP-regulation (EU 1394/2007, Article 2d). Such combined ATMPs are composed of an ATMP and one or more medical devices or one or more active implantable medical devices, and their cellular or tissue part must either contain viable cells or tissues, or non-viable cells or tissues liable for exerting the primary action on the human body.

The combined ATMPs should be more effective than current state-of-the-art solutions on the European market owing to improved features like personalisation, accuracy, reliability and usability and contribute to long-term sustainability (faster and affordable) of European health systems.

Research should focus on advanced stages of clinical development with regulatory work on the Medical Device part completed and safety studies of the combination product in an advanced stage.

Proposals should address all of the following activities:

  • Phase 2 clinical trials and above of combined ATMPs focussing on:
    • technologies ready to undergo interventional clinical trials in patients/end users assessing the usability and clinical performance, and/or
    • technologies that have demonstrable safety/performance profiles and should undergo clinical validation in view of their inclusion into guidelines for specific clinical pathways.
  • Delivery of safe and clinically validated combined ATMPs that are compliant with current European regulatory requirements. The related regulatory work should be considered as an essential component and the proposed work should involve consultation/interaction with competent regulatory agencies such as the European Medicines Agency (EMA) or national regulatory agency. Applicants are encouraged to seek regulatory and/or Health Technology Assessment (HTA) advice as appropriate.

The topic invites proposals that include innovative treatments for any medical condition excluding rare diseases that are ready to be assessed for clinical efficacy (performance and clinical benefit) in a specific indication on a big number of patient cohorts; already existing market solutions are not in the scope of this topic.

Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors and any other non-health related individual attributes should be taken into consideration. SME participation is strongly 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

General conditions

1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.

 

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.

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

Last Changed: August 9, 2023

Call HORIZON-HLTH-2023-TOOL-05

We recently informed the applicants about the evaluation results for their proposals.

The results of the evaluation are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 170

Number of inadmissible proposals: 1

Number of ineligible proposals: 1

Number of above-threshold proposals: 71

Total budget requested for above-threshold proposals: EUR 634,646,986.

Last Changed: August 9, 2023

Call HORIZON-HLTH-2023-TOOL-05

We recently informed the applicants about the evaluation results for their proposals.

The results of the evaluation are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 170

Number of inadmissible proposals: 1

Number of ineligible proposals: 1

Number of above-threshold proposals: 71

Total budget requested for above-threshold proposals: EUR 634,646,986.

Last Changed: April 13, 2023

Call HORIZON-HLTH-2023-TOOL-05 closed on 13 April 2023. 170 proposals were submitted. The breakdown per topic is:

  • HORIZON-HLTH-2023-TOOL-05-01: 8 proposals
  • HORIZON-HLTH-2023-TOOL-05-03: 65 proposals
  • HORIZON-HLTH-2023-TOOL-05-04: 49 proposals
  • HORIZON-HLTH-2023-TOOL-05-05: 23 proposals
  • HORIZON-HLTH-2023-TOOL-05-08: 24 proposals
  • HORIZON-HLTH-2023-TOOL-05-09: 1 proposals

Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.

Last Changed: January 12, 2023
The submission session is now available for: HORIZON-HLTH-2023-TOOL-05-09(HORIZON-CSA), HORIZON-HLTH-2023-TOOL-05-05(HORIZON-IA), HORIZON-HLTH-2023-TOOL-05-08(HORIZON-IA), HORIZON-HLTH-2023-TOOL-05-03(HORIZON-RIA), HORIZON-HLTH-2023-TOOL-05-01(HORIZON-RIA), HORIZON-HLTH-2023-TOOL-05-04(HORIZON-RIA)
Clinical trials of combined Advanced Therapy Medicinal Products (ATMPs) | Grantalist