Emilia-Romagna and advanced therapies: a regional ecosystem with its sights set on Europe

Advanced Therapy Medicinal Products (ATMPs), known as advanced therapies (gene, cell and tissue engineering therapies), represent one of the most promising frontiers of modern medicine. They are highly innovative treatments, often with the potential to cure rare and oncological diseases, but their development and patient access require complex infrastructure, multidisciplinary expertise and close collaboration between research, industry and the healthcare system. Emilia-Romagna is one of the few European regions to be able to count on an ecosystem covering the entire supply chain and is actively working to make it even stronger.

A distributed platform of excellence

The regional ATMP ecosystem is a network spanning the entire region that connects clinical expertise, manufacturing capacity, enabling technologies and innovative companies. It is not a single centre, but a platform stretching from Bologna to Modena, from Reggio Emilia to Mirandola, from Meldola to Parma, covering every stage of the value chain. The organisations involved are members of Clust-ER Health and form our ATMPs Working Group, the forum through which the cluster carries out analysis, discussion and strategic positioning within the sector.

The key clinical and translational centres include Sant’Orsola Hospital in Bologna and the University of Bologna, the IRST IRCCS ‘Dino Amadori’ in Meldola, Modena University Hospital, Reggio Emilia Hospital, the Rizzoli Orthopaedic Institute, the Ozzano and Mirandola Technology Parks, and the Advanced Therapies Lab at the University of Ferrara. These are joined by biotech companies and start-ups such as Holostem, Evotec, Biogenera and EIR Biotherapies, and technology and manufacturing enablers such as PBL, Comecer, CellPly, CellDynamics and Stem Sel, which provide the infrastructure and technologies essential for the development and production of ATMPs.

With 27 cleanrooms due to be completed by 2028 and four operational CAR-T centres, Emilia-Romagna stands out not so much for its size as for the comprehensiveness and coherence of its supply chain. A record that has deep roots: it is from here that the world’s first stem cell-based drug approved by the European Medicines Agency originates, developed by Holostem, a spin-off from the University of Modena and Reggio Emilia.

Identifying barriers to develop solutions

Having an ecosystem of excellence does not mean that there are no obstacles. On the contrary: it is precisely the maturity of the regional system that has enabled us to take a clear-eyed look at the barriers that still hinder development and access to advanced therapies: from regulatory complexity to production costs, from the sustainability of the healthcare system to the challenges of industrial scale-up.

To this end, during 2025, Clust-ER Health, in collaboration with ART-ER, launched a structured process of analysis and consultation with the key players in the regional ecosystem, as part of the European PRECISEU project. The first phase involved 13 individual interviews with representatives from hospitals, research centres, biotech companies and institutions, aimed at gathering an in-depth picture of the strengths, weaknesses and priorities perceived by the various stakeholders in the sector.

These reflections were then brought together in a joint workshop held in March 2025, which brought together key players from the ecosystem to discuss, compare and consolidate the findings of the interviews.

A systematic approach, with an eye on Europe

The analysis of the regional ecosystem involved the Emilia-Romagna Region, ART-ER, Clust-ER Health and the main public and private stakeholders in the sector. But it does not stop at the region’s borders. On 4 June 2026, a delegation from Emilia-Romagna will attend the PRECISEU High-Level Meeting at the European Parliament, a high-level policy dialogue event bringing together EU institutions, European regions, industry, hospitals and patient organisations to discuss ATMPs and clinical trials.

PRECISEU, a network of 28 partners from 15 European regions, was established with the aim of connecting European innovation ecosystems to accelerate the development of truly personalised healthcare, by transferring best practices and solutions from region to region and scaling up deep-tech innovations in the fields of advanced therapies and health data.

The delegation will bring the voice and experience of Emilia-Romagna to Brussels, with a view to making a tangible contribution to the European debate on ATMPs, to the definition of future priorities at EU level, and to positioning our region within the EU context.

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.