Establishing a European network of Centres of Excellence (CoEs) for Advanced Therapies Medicinal Products (ATMPs)
Scope and expected outcomes
Expected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:
In line with the objectives of the “Strategy for European Life Sciences”[1], the EU successfully translates a strategic priority into an implementable action plan for building technological and innovation leadership on a global stage.
Europe, including regions, profits from an increased capacity, accessibility, coordination of its Advanced Therapies Medicinal Products (ATMP) infrastructures.
The European economy benefits from more ATMP innovations being developed and commercialised in the EU.
Patients across the EU gain faster access to innovative ATMPs thanks to increased and focused public Research and Development (R&D) investment, harmonised policies and strategies for ATMP development and uptake in healthcare systems.
Scope:
ATMPs represent a frontier in medicine, offering groundbreaking treatments such as gene therapies, cell therapies, and tissue-engineered products that hold the promise of addressing complex and previously untreatable conditions. The European ATMP landscape is dynamic and promising, with 28 products having received marketing authorisation and many more in the pipeline[2]. The development of specialised infrastructures in Europe for these cutting-edge therapies is crucial for fostering innovation and ensuring fast and efficient delivery to patients in an equitable way. The report by Mario Draghi[3] on EU competitiveness, highlights that the EU’s share of the fast-growing global ATMP market is small, suggesting that to remain competitive, increased and focused public R&D investment is needed to complement ongoing efforts to streamline regulations and ensure faster pricing and reimbursement. The report recommends building on existing innovation hubs and expanding the capacity of the EU to conduct ATMPs R&D by the consolidation of EU public funds. By strengthening this budding innovation ecosystem, Europe can position itself as a leader in the ATMP sector, ultimately improving patient access to life-saving treatments and stimulating economic growth.
The EU has several scattered ATMP centres with divergent capacities and capabilities[4], limiting its attractiveness for scaling up R&D in the field, calling for a coherent and coordinated approach. The aim of this topic is to establish a European network of Centres of Excellence (CoEs) for ATMPs, building on existing centres and coordinating their further development in synergy with national strategies. The creation of such a Network is key for strengthening the EU’s capacity to develop, scale up and deploy ATMPs across Europe, increasing Europe’s attractiveness for clinical research in the field and supporting the implementation of the “Strategy for European Life Sciences”. The CoEs should directly support the development and manufacturing capacity of ATMP-related biotechnologies, such as cell and gene therapy platforms, manufacturing infrastructure, and scale-up processes.
Each potential CoE should be an existing centre embedded within a vibrant biocluster (i.e. within proximity to pharmaceutical companies and research institutes) and should already benefit from critical infrastructure and services necessary to advance from lab to patient such as knowledge transfer support, state-of-the-art GMP[5] and clinical trials facilities. In addition, the centre should be performing the full spectrum of life sciences research, from discovery to clinical trials and should have demonstrated leadership in the field through a stand-alone research programme. Each CoE is expected to become world-class by further embedding itself in the full value chain and seeking additional political and financial support at regional, national and European level. The network should be limited to no more than 10 CoEs across the EU, with complementary expertise in the various ATMP technologies.
The proposed European network of CoEs for ATMPs should include multiple stakeholders beyond the research community and/or established academic centres, including Member State ministries, regional representatives, funders, regulators and healthcare payers, industry actors, patient organisations and policymakers. The European Commission's Joint Research Centre (JRC) may participate as a member of the consortium selected for funding, bringing its expertise in pre-normative research, standardisation, regulatory advice and access to its research infrastructure.
To align with STEP eligibility, activities supported under this topic should demonstrate how they contribute to either: i) bringing innovative, cutting-edge technologies with strong economic potential to the internal market, or ii) reducing or preventing the Union’s strategic dependencies in the field of advanced therapies.
Proposals should be of limited duration (2027-2030) and cover at a minimum the following activities:
Identify common needs and challenges related to ATMP R&D, as well as develop relevant policy recommendations related to clinical trials, manufacturing, logistics, regulatory (including harmonisation of market access authorisation and reimbursement procedures), public acceptance, policies for transnational care, and coordination with national/regional healthcare systems etc.
Develop a roadmap to ensure that Europe becomes the global leader for ATMP R&I by 2035, with clearly defined milestones, targets and Key Performance Indicators (KPIs). The roadmap should align with national R&D plans and include a long-term funding strategy. Appropriate measures should be considered to expand or widen the network during the roadmap’s implementation.
Create an advisory board with diverse stakeholders, as a forum to provide guidance and advice for ensuring maximum utility of the generated outputs.
Develop common education and training programmes for the next generation of scientists including outreach activities to better inform i) the public and patients on the benefits of ATMPs and ii) the stakeholders about access to the CoEs facilities and support.
Proposals should build on the experiences and outcomes of previous or ongoing actions such as RESTORE[6], Join4ATMP[7], PRECISEEU[8] and T2EVOLVE[9], and liaise with the relevant partnerships such as the co-funded European Partnership on Rare Diseases[10], the co-funded European Partnership for Personalised Medicine[11] and the Innovative Health Initiative Joint Undertaking (IHI-JU)[12] as appropriate.
1. Admissibility Conditions, proposal page limit and layout
Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.
2. Eligible Countries
Eligible countries are 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.
3. Other Eligibility Conditions
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding as a beneficiary with zero funding, or as an associated partner. The JRC will not participate in the preparation and submission of the proposal - see General Annex B.
Other eligibility conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (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.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
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]].
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents:
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