Header Photo by Biocat, BioRegió de Catalunya, © 2025, licensed under CC BY-NC-SA 4.0. Regions for Health Innovation: Personalised Medicine and ATMPs driving Europe’s Future.
Personalized medicine moves beyond the one-size-fits-all approach of traditional medicine—embracing the unique variability of each individual’s genetics, environment and lifestyle, and tailoring prevention and treatment to their specific needs. This not only improves patient outcomes but also ensures a more efficient use of public resources.
Europe is at the forefront of discovering and developing such advanced technologies. However, this new approach to medicine brings with it a host of challenges, making the journey from innovation to patient far from straightforward. The development, delivery, manufacturing and monitoring of these therapies demand entirely new strategies, unlike anything the sector has relied on before. Access to essential materials for production cannot be taken for granted, either.
PRECISEU is the European consortium dedicated to improving personalized medicine by connecting innovation ecosystems across the continent. As one of the project partners, Biovia took part in a recent meeting at the heart of it all—the European Parliament—to discuss the future of personalized medicine in Europe.
Navigating the regulatory complexity
Perhaps the biggest barrier to transforming Europe’s seeds of innovation into tangible success lies in the complexity of its regulatory landscape. Dr. Rainer Becker, Director of Medical Products and Innovation at the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), acknowledged the challenges many innovators face in his opening address.
“It starts with categorization,” says Becker. “Understanding which regulatory category applies is not easy. And it becomes even more complex when multiple regulations must be navigated simultaneously, such as when combining a medicine with a device.”
Beyond a general shortage of regulatory expertise, slow approval processes pose a major obstacle, particularly at the EMA level. PRECISEU panelists at the event emphasized this point: “In personalized medicine, speed is of the essence; we simply cannot afford losing time on regulatory delays. But unfortunately, this is exactly what is happening.”
“In personalized medicine, speed is of the essence; we simply cannot afford losing time on regulatory delays.” – Rainer Becker
The situation is further exacerbated at the member state level, where fragmented and unaligned national procedures make navigation even more difficult. “As long as this fragmentation is not addressed and unified into a single approval process, we simply cannot compete with other markets, such as the US,” the panel concluded.
According to Becker, a big step toward increasing EU competitiveness in this field will be the pharma reform package. This package represents the first major revision of the EU pharmaceutical laws in over two decades. By strengthening regulatory support, simplifying rules for GMO medicine, and allowing real-world data for medicine authorization, the EU aims to provide better support for innovation in the future.
Connection and collaboration
Regional hubs such as Catalonia and Flanders boast impressive strength in innovation, ensuring that ideas and funding reach the innovative companies and stakeholders that can put them into practice. As Becker noted: “Our regions are not simply implementers of healthcare policies developed elsewhere; they are the true drivers of innovation.”
“Our regions are not simply implementers of healthcare policies developed elsewhere; they are the true drivers of innovation.” – Rainer Becker
Panelists and the audience echoed this sentiment, recognizing clusters as the primary engines of innovation. Yet despite their potential, these efforts often remain isolated, with no coherent European strategy to connect them. “Cross-border collaborations like RegMed XB between the Netherlands and Flanders show what is possible,” stated Kathleen D’Hont, Policy Advisor Department Work, Economy, Science, Innovation, Social Economy at the Flemish Government, during the panel discussion. “Yet building trust and aligning funding across borders takes time and coordination.”
The absence of a clear plan for the internationalization of regional initiatives remains a major flaw. To address this, PRECISEU is working to map regional capacities in advanced therapies and make this information openly available, helping regions connect, collaborate and avoid duplication.
Photo by Biocat, BioRegió de Catalunya, © 2025, licensed under CC BY-NC-SA 4.0. Regions for Health Innovation: Personalised Medicine and ATMPs driving Europe’s Future.
The PRECISEU event: Regions for Health Innovation: Personalized Medicine and ATMPs driving Europe’s Future was organized on 30 September 2025 at the European Parliament in Brussels.
Building talent and expertise
The shortage of trained experts is another pressing challenge in Advanced Therapy Medicinal Products (ATMP) development and translation. Both public and private ATMP hubs face growing challenges in recruiting staff with the right expertise—not only in regulatory affairs, but also in GMP manufacturing, data integration and AI-driven medicine.
Beyond these technical skills, innovators often lack the operational knowledge to support the creation and scaling of innovative companies. Unfortunately, academic training is misaligned with real-world regulatory and industrial needs in personalized medicine.
To bridge this gap, PRECISEU panelists called for specialized upskilling programs: “The regional ecosystems should become training hubs, leveraging local stakeholders to grow the talent pipeline.” In addition to this bottom-up approach, panelists were also of the opinion that the European Union should support these initiatives from the top down, following examples set by the US.
Check out the PRECISEU website for more information on personalized medicine trainings!
Getting your hands dirty
In the fast-evolving field of advanced therapies, regulatory sandboxes are a concrete way to turn policy ambition into practical progress. These controlled environments allow regulators, companies, researchers and patient representatives to test innovative approaches under real-world conditions while remaining within a supervised framework.
As Becker explained, sandboxes can help Europe find the right regulatory framing by enabling stakeholders to gain experience with novel therapies and technologies, such as gene and cell treatments, before formal rules are set. Panelists agreed that this approach could be transformative: rather than debating reforms in theory, stakeholders could learn by doing, identifying regulatory bottlenecks early and co-developing workable solutions.
Beyond their technical function, sandboxes are also trust-building mechanisms, fostering cooperation across sectors and regions. For Europe to remain competitive, such experimental spaces could prove essential in aligning fragmented systems, reducing administrative burdens and ultimately bringing personalized and advanced therapies to patients faster.
At the core of Biovia’s mission
“As a founding member of PRECISEU, Biovia collaborates closely with leading stakeholders to accelerate the adoption of personalized medicine across Europe and to reduce fragmentation,” says Ann Van Gysel, CEO at Biovia. “Through these efforts, we aim to provide our members with access to cutting-edge knowledge and opportunities, while helping the Flemish health innovation ecosystem strengthen its international profile.”
The PRECISEU Best Practice Recognition was created to highlight European pioneers who are advancing personalized medicine through innovative and responsible use of health data. More than just an award, it is a movement that bridges science and society, empowering researchers, entrepreneurs and institutions to deliver life-changing therapies fairly and effectively.
“We invite our Flemish companies to apply and showcase their pioneering work in personalized medicine on this European stage,” says Van Gysel. “It’s a unique opportunity to gain the recognition our ecosystem truly deserves.”
Are you translating cutting-edge science into real-world personalized medicine? Apply now for the PRECISEU Best Practice Recognition!
PRECISEU is co-funded by the European Union’s Horizon research and innovation program.
