PeRsonalised medicine Empowerment Connecting Innovation ecoSystems across EUrope

Project Information

PRECISEU

Grant agreement ID: 101161301

DOI

10.3030/101161301

EC signature date 18 June 2024

Start date 1 July 2024

End date 30 June 2029

Funded under

• European innovation ecosystems

Total cost

€ 22 730 100,00

EU contribution

€ 11 340 050,00

Coordinated by

BIOCAT LA FUNDACIO BIOREGIO DE CATALUNYA
Spain

Periodic Reporting for period 1 - PRECISEU (PeRsonalised medicine Empowerment Connecting Innovation ecoSystems across EUrope)

Reporting period: 2024-07-01 to 2025-12-31

Summary of the context and overall objectives of the project

PRECISEU is a European project that helps regions work together to make personalised medicine more accessible, effective and easier to implement across Europe. It brings together public authorities, clusters, research centres, healthcare actors, companies, patient organisations and innovation agencies to connect regional innovation ecosystems and support the adoption of new health solutions based on health data and advanced therapy medicinal products (ATMPs). The project also includes a Ukrainian partner, reflecting its wider ambition to build resilient and connected innovation ecosystems across Europe.

The project responds to a clear European need. Although Europe has invested heavily in personalised medicine, implementation remains fragmented. Regions differ greatly in their capabilities, data systems, innovation support mechanisms and access to advanced therapies. Important opportunities linked to the European Health Data Space (EHDS), cross-border health-data use, new business models and innovation uptake are still unevenly developed. PRECISEU addresses these gaps by connecting regional ecosystems, aligning regional and European strategies, and creating the conditions for more coordinated progress in personalised medicine. It is closely linked to key European policy priorities, including the New European Innovation Agenda, the European Health Union, the EHDS and the Strategic Research and Innovation Agenda of IC PerMed.

The overall objectives of PRECISEU are to strengthen collaboration between 12 regional ecosystems, map and connect personalised medicine initiatives across Europe, improve readiness for the secondary use of health data, increase visibility and coordination of ATMP capacities, identify barriers to market and patient access, build skills among professionals and policymakers, and launch an innovation support programme for future joint interregional projects. Through this pathway, the project aims to reduce fragmentation, improve regional innovation capacity, support better alignment between policy and practice, and accelerate the adoption of personalised medicine solutions that can benefit patients, healthcare systems and European competitiveness.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During its first reporting period, PRECISEU established the foundations needed to move from project set-up to coordinated implementation. A shared governance and monitoring framework was put in place, including consortium bodies, working procedures, quality control processes, annual planning and an Advisory Board composed of 11 high-level experts. This created the basis for strong coordination across work packages and regions.

On the technical side, PRECISEU delivered a first consolidated mapping of personalised medicine initiatives across Europe, identifying more than 70 initiatives, including 30 international ones, and completed case studies on Hungary, Poland and Denmark. These activities provided a shared evidence base for collaboration, alignment and future policy and innovation actions. In parallel, the project delivered the PRECISEU EHDS Readiness Framework, creating a comparative overview of health-data readiness across participating regions through a common maturity model. This work now supports the preparation of further interoperability and data-governance tools.

PRECISEU also made strong progress in the ATMP field. It delivered the state-of-the-art mapping of the ATMP value chain and established the basis for a pan-European ATMP map, already supported by 130 respondents from 12 countries and developed with input from the European Medicines Agency. At the same time, interviews with ATMP centres and developers started shaping a future multistakeholder infrastructure, including possible service models, governance approaches and access mechanisms.

To address implementation barriers, the project completed a cross-regional analysis of market and patient access issues in personalised medicine. This work was based on 167 stakeholder interviews across ten regions and validation workshops involving 199 participants. PRECISEU also advanced co-creation through hackathon activities, which engaged more than 1,000 participants and generated 75 new precision medicine ideas. In parallel, two editions of the PRECISEU PM School were delivered, the first Best Practice Recognition scheme was implemented, and the design of the policymaker programme was completed. Finally, the project launched its Expression of Interest process for future joint interregional projects, activating a first innovation funnel with 121 registered participants and 29 proposals seeking consortia.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PRECISEU is already generating results that go beyond the state of the art by combining areas that are often treated separately: regional innovation policy, health-data readiness, ATMP infrastructure, market uptake, capacity building and interregional project development. Instead of addressing these topics in isolation, the project has created a single cross-regional framework that links them together in a practical and scalable way. This is particularly relevant in a field where fragmentation remains one of the main barriers to progress.

A first major result is the creation of a common interregional evidence base for personalised medicine. The mapping of initiatives, the case studies and the structured engagement with European and international initiatives provide a more coherent overview of capacities, needs and opportunities than previously existed. A second major result is the creation of a shared methodological basis for EHDS-related progress. Through the readiness framework and maturity model, PRECISEU has provided a comparative and policy-relevant way to assess preparedness for health-data use and future interoperability actions.

A third important result is the emerging European visibility layer for ATMP development and production. The ATMP mapping process and supporting interviews are laying the groundwork for a more connected and transparent infrastructure landscape, which can help innovators find expertise, services and collaboration opportunities more efficiently. A fourth result is the creation of a structured innovation funnel for future joint interregional projects, supported by matchmaking and planned mentoring on regulatory, impact and business-model issues. This helps move promising ideas closer to implementation.

To ensure further uptake and success, several needs have already been identified. The most important are the full launch of the joint interregional project scheme, further validation of tools and frameworks in real settings, continued support for market access and regulatory alignment, strong stakeholder engagement across regions, and a supportive policy and standardisation environment for health data and advanced therapies. Further capacity building for professionals and policymakers will also remain essential for long-term uptake.