Emilia-Romagna at the European Parliament for advanced therapies: a region at the forefront of the future of precision medicine

A regional delegation, an ecosystem spanning the entire region, and a clear message: Emilia-Romagna is ready to make a tangible contribution to Europe’s ambition to make advanced therapies accessible to patients. This is the significance of our region’s presence at the PRECISEU High-Level Meeting held at the European Parliament, a high-level policy dialogue event that brought together EU institutions, European regions, industry, hospitals and patient organisations to discuss Advanced Therapy Medicinal Products (ATMPs) and clinical trials.

From the European stage to the regional reality: what was discussed

Europe is at a crucial turning point in the life sciences: it is no longer simply a matter of defining strategies, but of moving on to implementation. The European Commission’s ‘Choose Europe for Life Sciences 2030’ strategy identifies ATMPs (advanced therapy medicinal products, including gene, cell and tissue engineering therapies) and the clinical trial ecosystem as two priority pillars for maintaining the continent’s competitiveness and ensuring patients have timely and equitable access to innovation.

In this context, the European project PRECISEU – Regional Innovation Valley in Personalised Medicine serves as a platform for connecting European regions: 28 partners from 15 countries working together to translate policy ambitions into concrete action. The event at the European Parliament was designed to showcase the partnership’s capabilities and opportunities, and to issue a call to action to the EU institutions and Member States.

The proceedings were structured around two main thematic sessions. The first addressed the topic ‘ATMPs: From Hospital-Based Innovation to Scalable Access’, exploring bottlenecks along the entire value chain – from research to production, and from market access to reimbursement – and possible solutions to overcome them. The second session focused on European competitiveness in clinical trials, discussing the measures needed to make the European ecosystem more efficient, attractive and patient-centred.

The delegation from Emilia-Romagna

Emilia-Romagna took part in the event with a diverse delegation representing the entire regional ecosystem.

The Emilia-Romagna Region was represented by Julia Gabriela Szyszko from the Pharmaceutical Services Department within the Medicines and Medical Devices Governance Division. Representing ART-ER was Cecilia Maini, Life Sciences Coordinator, and representing Clust-ER Health was Clémence Foltz, Project Manager. Rounding out the delegation was Graziella Pellegrini, full professor of Cell Biology at the University of Modena and Reggio Emilia, where she heads the Cell Therapy Programme at the ‘Stefano Ferrari’ Centre for Regenerative Medicine and is co-founder of Holostem (the company that developed the world’s first approved stem cell-based medicine), with a career dedicated to epithelial stem cell therapies.

The regional contribution: ecosystem and systemic approach

The participation in the European event is not an isolated incident, but forms part of a broader initiative that the Emilia-Romagna region is developing in collaboration with its stakeholders. Driven by the PRECISEU project, the Region, ART-ER, Clust-ER Health and the key players in the ATMP ecosystem are working in a coordinated manner to identify the bottlenecks that hinder the development of and access to advanced therapies at regional or national level, and to define shared priorities and concrete solutions to be addressed systematically. For an in-depth description of the regional ecosystem and the analysis process, please refer to our previous article.

One of the most significant aspects of the region’s participation was the opportunity to engage in direct dialogue with representatives of European institutions, MEPs, industry stakeholders and partners from other European regions – valuable discussions for positioning Emilia-Romagna within the wider European ecosystem. Graziella Pellegrini and Julia Gabriela Szyszko actively participated on behalf of the Emilia-Romagna ATMP ecosystem, asking specific questions and making targeted contributions during the open policy dialogue. During the more informal networking session that followed the event, the delegation was able to demonstrate how a medium-sized region can host a distributed platform of excellence covering the entire value chain of advanced therapies.

This systematic approach has been confirmed by the recent recognition of two players in the regional ecosystem under the STEP (Strategic Technologies for Europe Platform) programme: Cellply and PBL have secured STEP-labelled funding under Action 1.6.2 of the 2021–2027 ERDF, which supports market competitiveness through research and innovation with a specific focus on strategic technologies. STEP represents one of the European Commission’s most recent and ambitious tools for identifying and supporting critical technology sectors (including biotechnology and, consequently, ATMPs), and the inclusion of two companies from the advanced therapies sector on this list is a sign of the quality and strategic importance of the regional ecosystem.

Outlook and priorities for Emilia-Romagna

Speaking on the sidelines of the event, Elisa Sangiorgi – head of the Pharmaceutical Services Department for the Emilia-Romagna Region, emphasised the strategic importance of this European presence:

‘Taking part in this European dialogue is important not only to represent the voice of Emilia-Romagna, but also to link the work we do every day on medicines regulation at regional and national level with the strategic priorities currently being defined in Brussels. ATMPs are no longer just a scientific promise: they are a clinical reality that requires a systemic response, and the regions must play a leading role in this change.’

Paolo Bonaretti – President of Clust-ER Health, is on the same wavelength, placing the cluster’s participation in the event within the broader context of its ambitions:

‘The Emilia-Romagna advanced therapies ecosystem may be small in scale, but it is remarkably comprehensive. What we demonstrated in Brussels is that our region does not merely boast isolated centres of excellence: it has a fully integrated supply chain. And a coherent supply chain that links research, production and clinical practice is exactly what Europe needs to move from strategy to reality.’

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Innovation Council and SMEs Executive Agency (EISMEA). Neither the European Union nor the granting authority can be held responsible for them.