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Call: Next generation advanced therapies to treat highly prevalent and high burden diseases with unmet medical needs

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Programme
Acronym HORIZON-HLTH-TOOL
Type of Fund Direct Management
Description of programme
"Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society"

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. 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 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 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). For instance, with cluster 4 “Digital, Industry and Space” such as on digitalisation of the health sector, incl. health technologies, medical devices and key enabling technologies; assisted, autonomous, independent and empowered living; smart homes; decision support systems; health impact assessment (e.g. related to consumer products, working place innovation).

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 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).[[Commission Communication on the digital transformation of health and care; COM(2018) 233 final.]]
  • 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.

Link Link to Programme
Call
Next generation advanced therapies to treat highly prevalent and high burden diseases with unmet medical needs
Description of call
"Next generation advanced therapies to treat highly prevalent and high burden diseases with unmet medical needs"

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, tailored and contributing to all of the following expected outcomes:

  • Competent authorities, researchers and developers use assays for the valorisation and/or assessment of efficiency, delivery, safety, potency or mode of action of novel advanced therapeutic interventions based on either pluripotent stem cells, genome editing or RNA, that are aligned with regulatory standards.
  • Clinicians, researchers and developers test several new advanced therapies based on pluripotent stem cells, gene editing or RNA ready through clinical trials meeting the regulatory requirements.

Scope:

The recent development of advanced therapies has been hampered by the lack of robust research on certain key parameters e.g. safety, upscaling, immunity, potency assays, cost-effectiveness, and early on in development. This topic aims to ensure that the next wave of advanced therapies, based on either pluripotent stem cells, gene editing or RNA, are established in a timely fashion and in accordance with the appropriate regulatory standards for further clinical testing. It will support preclinical research platforms for disorders with high prevalence and burden that tackle the bottlenecks currently encountered in the field, ensuring that promising advanced therapies can reach the market within the next decade. Applicants should justify the disease or disorder to be targeted with its prevalence level, the related burden and unmet needs. Applicants could propose activities in one or several of the following areas, and should take into consideration the Oviedo Convention, eligible actions and ethical principles as defined by the Horizon Europe Framework Programme:

  • Method development for the production and differentiation of pluripotent stem cells (defined as cells that can give rise to cells from all three embryonic germ layers), to include defining appropriate potency assays. Complementary activities to assess mode of action, safety, in vivo validation or upscaling procedures could be considered.
  • Development and validation of biological assays and methods that can demonstrate efficacy, delivery, specificity, and safety (including off-target effects) of genome editing products in targeted cells and tissues (e.g. base editing, prime editing, transcription activator-like effector nucleases, zinc-finger nucleases, clustered regularly interspaced short palindromic repeats). Complementary activities to assess in vivo validation or upscaling procedures could be considered.
  • Development and validation of novel RNA-based therapeutics targeting non-communicable diseases. Complementary activities to assess mode of action, delivery, safety, in vivo validation and/or upscaling procedures could be considered.
  • Study, analysis and tackling of different immune responses, taking into account factors like sex and age, generated by any of the above-mentioned advanced therapies in vivo, facilitating regulatory approval for next phase of research and development.
Link Link to Call
Thematic Focus Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Digitisation, ICT, Telecommunication, Capacity Building, Cooperation Networks, Institutional Cooperation
Funding area EU Member States
Overseas Countries and Territories (OCTs)
United States of America
Origin of Applicant EU Member States
Overseas Countries and Territories (OCTs)
United States of America
Eligible applicants Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association
Applicant details

eligible non-EU countries:

  • countries associated to Horizon Europe
At the date of the publication of the work programme, there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.

  • low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

  • Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
  • EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
  • International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.
Project Partner Yes
Project Partner Details

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

  • at least one independent legal entity established in a Member State;and
  • at least two other independent legal entities, each established in different Member States or Associated Countries.
Call opens 22.06.2021
Call closes 21.09.2021
Further info

Proposal page limits and layout:

The application form will have two parts:

  • Part A to be filled in directly online  (administrative information, summarised budget, call-specific questions, etc.)
  • Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system

Page limit - Part B: 45 pages

Type of Funding Grants
Financial details
Expected EU contribution per projectThe Commission estimates that an EU contribution of around EUR 6.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budgetThe total indicative budget for the topic is EUR 60.00 million.
Typ of ActionResearch and Innovation Actions (RIA)
Funding rate100%
Submission Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.

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