Establishing a European network of Centres of Excellence (CoEs) for Advanced Therapies Medicinal Products (ATMPs)

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[[Committee for Advanced Therapies (CAT) quarterly highlights and approved ATMPs Feb-May 2025: https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-may-2025_en.pdf]]. 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[[The future of European competitiveness, Mario Draghi: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en]] 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[[Advanced Therapy Medicinal Products - EATRIS: https://eatris.eu/atmp]], 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[[Good Manufacturing Practices: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en]] 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[[https://cordis.europa.eu/project/id/820292]], Join4ATMP[[https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/how-to-participate/org-details/999999999/project/101137206/program/43108390/details, https://cordis.europa.eu/project/id/101137206]], PRECISEEU[[https://cordis.europa.eu/project/id/101161301]] and T2EVOLVE[[https://cordis.europa.eu/project/id/945393]], and liaise with the relevant partnerships such as the co-funded European Partnership on Rare Diseases[[https://cordis.europa.eu/project/id/101156595, https://erdera.org]], the co-funded European Partnership for Personalised Medicine[[https://cordis.europa.eu/project/id/101137129, https://www.eppermed.eu]] and the Innovative Health Initiative Joint Undertaking (IHI-JU)[[http://www.ihi.europa.eu]] as appropriate.