Why Patient Access Must Shape ATMP Development
Looking back at your career in advanced therapies and ATMP development, what challenge most shaped your approach to patient access and clinical implementation?
My main driver in the ATMP field has always been patient access, ensuring that patients can truly benefit from transformative therapies capable of changing the natural course of their diseases.
One of the key challenges that has shaped my approach is realizing that scientific innovation alone is not enough. The real breakthrough lies in aligning science, regulation, and clinical implementation from the very early stages.
Throughout my career, I have seen many promising therapies fail, not because of lack of efficacy, but because they were not developed with a clear path to patients in mind. This has fundamentally influenced how I work today: I focus not only on scientific excellence, but on integration, ensuring that development, regulatory strategy, and healthcare system adoption evolve together in a coherent way.
“Scientific innovation alone is not enough. The real breakthrough lies in aligning science, regulation, and clinical implementation from the very early stages.”
Europe’s Biggest Opportunity in Advanced Therapies
As Europe enters a pivotal phase for ATMP regulation and EU pharmaceutical reform, what do you see as the biggest opportunity — and biggest blind spot — for cell and gene therapy developers?
Europe is facing a unique opportunity to position itself as a highly attractive environment for ATMP developers at a global level. However, this requires not only understanding developers’ real needs, but also having the courage to challenge long-established paradigms that are no longer adapted to these therapies.
The opportunity lies in making intelligent use of the new instruments included in the pharmaceutical regulatory package, such as regulatory sandboxes or technological platforms, as well as ensuring that upcoming funding is deployed in a coordinated and strategic manner. It is not just about increasing investment, but about using it wisely.
The biggest blind spot, in my view, remains fragmentation. Without strong coordination, and a certain level of collective responsibility, even generosity, Europe risks missing this window of opportunity. If we fail to act cohesively, we may end up positioning ourselves as a secondary player in the global ATMP landscape rather than a leader.
“Without strong coordination, Europe risks becoming a secondary player in the global ATMP landscape rather than a leader.”
How Barcelona Became a Leading ATMP Ecosystem
Barcelona has become one of Europe’s fastest-growing biotech and advanced therapies hubs. What makes the Barcelona BioRegion such a strong environment for ATMP innovation and clinical translation?
The Barcelona BioRegion stands out because of its strong integration between hospitals, research institutions, and biotech companies. Having leading clinical centers such as Hospital Clínic closely connected to innovation ecosystems creates a particularly dynamic and fertile environment for advanced therapies.
Its greatest potential lies in accelerating translation, efficiently bridging the gap between research and clinical application, and in positioning itself as a reference hub for both clinical development and implementation of ATMPs in Europe.
To fully realize this potential, the ecosystem must continue strengthening collaboration while actively avoiding fragmentation. With the right level of coordination, scalability, and again, a certain degree of generosity among stakeholders, Barcelona can act as a true driver of the European strategy and play a key role not only at the European level, but also globally.
Why Cross-European Collaboration Matters More Than Ever
Why are cross-European conversations around ATMP regulation, commercialisation and clinical adoption especially important right now?
I was particularly motivated to participate in this event because we are at a critical moment for advanced therapies in Europe. The regulatory and strategic decisions being made today will shape the field for years to come.
I am especially interested in exchanging perspectives with peers across Europe while also learning from experiences in other regions of the world. Understanding both national and international approaches is key to identifying shared challenges, but also to recognizing where differences can become opportunities for mutual learning. This broader perspective is essential if we aim to move towards more harmonized, efficient, and globally competitive solutions.
This event represents a unique opportunity to bring together all key stakeholders, regulators, policymakers, developers, academics, SMEs, large pharmaceutical companies, clinicians, and importantly, patients. These conversations are essential if we want to build a truly competitive and sustainable ATMP ecosystem. My hope is that we can collectively translate these discussions into concrete actions, with an impact that goes beyond Europe.
What Developers Need to Change Now
As Europe rethinks its ATMP framework, what should developers change now in their regulatory strategy, CMC planning or evidence generation to stay competitive?
If developers could change one thing today, it would be to fully integrate regulatory, CMC, and evidence generation strategies from the very beginning, designing the development pathway in a holistic way.
Too often, these elements are approached sequentially rather than in an integrated manner. However, within the evolving EU framework, early alignment will be critical to ensure both efficiency and compliance.
At the same time, developers need to be supported in making this shift, not only from a scientific or organizational perspective, but also by having a clear understanding of, and access to, the regulatory and financial instruments that Europe is making available. Tools such as early scientific advice, regulatory support mechanisms, sandboxes, technological platforms, and any new frameworks introduced in the pharmaceutical legislation can significantly facilitate this integrated approach, if used proactively.
Once developers recognize that this model leads to better outcomes, optimizing resources, reducing costs and timelines, facilitating regulatory interactions, and ultimately lowering risk, it becomes a key enabler for attracting investment.
In the end, this approach will allow us to more effectively discriminate which therapies truly work and to bring them faster and more efficiently to patients. Developers who anticipate regulatory expectations, build robust manufacturing strategies early on, and generate meaningful clinical evidence in a coordinated way will be best positioned to succeed in this new landscape.
“Developers who anticipate regulatory expectations, build robust manufacturing strategies early on, and generate meaningful clinical evidence in a coordinated way will be best positioned to succeed in this new landscape.”
Dr Esteve Trias will be speaking at, where biotech leaders, regulators, investors, clinicians, manufacturers and advanced therapy developers will explore the future of ATMP regulation, manufacturing, commercialisation and patient access across Europe.
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