Advanced Therapies Europe 2026: Europe risks losing its cell and gene therapy advantage without urgent action, industry leaders warn

[Barcelona, Spain – September 11, 2026] Industry leaders at Phacilitate’s Advanced Therapies Europe (ATE) 2026 have this week warned that Europe must address persistent barriers to commercialisation, reimbursement, manufacturing scale-up and patient access if it is to maintain its position as a global leader in cell and gene therapy.

Held in Barcelona and attended by stakeholders from across the advanced therapies ecosystem, Phacilitate’s Advanced Therapies Europe highlighted growing consensus that the sector's greatest challenge is no longer scientific innovation alone. Delegates pointed to the need for safer and stronger regulatory, funding and commercial frameworks that can enable promising therapies to reach patients more quickly, efficiently and at scale.

Now in its 23rd year, Phacilitate’s Advanced Therapies Europe 2026 brought together developers, manufacturers, regulators, investors and healthcare leaders to examine how Europe can convert world-class research into sustainable commercial success at a time of increasing competition from the US and Asia. As keynote speaker Professor Jacob George, Chief Medical and Scientific Officer of the MHRA told attendees:

"We want to enable innovation, but we're absolutely clear we cannot lower standards. The goal is not to reduce the regulatory bar, but to modernise how we reach it, combining scientific rigour with greater flexibility so innovative therapies can reach patients more quickly while maintaining confidence in their safety, quality and effectiveness. That means adopting more proportionate regulatory approaches, engaging with developers earlier in the process, encouraging collaboration across regulators, HTA bodies and healthcare systems, making appropriate use of new forms of evidence alongside traditional clinical data.”

His remarks highlighted a central theme of the week: balancing innovation with robust evidence of generation and patient safety, while ensuring regulatory processes support rather than hinder progress.

According to Kimberley Barnes, President of Phacilitate and organiser of Phacilitate’s Advanced Therapies Europe, ATE 2026 highlighted an important shift in industry priorities. While scientific innovation continues to advance rapidly, the sector is becoming increasingly focused on solving the commercial, regulatory and market access challenges that determine whether therapies ultimately reach patients:

"The conversations in Barcelona reflected a sector that is maturing. The scientific promise of cell and gene therapy is increasingly clear, and Europe has already demonstrated its leadership in areas ranging from research and clinical development to advanced manufacturing. The challenge now is turning that innovation into sustainable patient access and commercial success at scale.

Throughout ATE 2026, delegates repeatedly highlighted the need for greater alignment across regulation, manufacturing, reimbursement, and investment. While Europe possesses extraordinary scientific talent, manufacturing expertise and clinical capability, unlocking the full potential of advanced therapies will depend on connecting these strengths more effectively. By creating an ecosystem where innovation can thrive, companies can scale and patients can gain faster access to life-changing treatments, Europe is well positioned to maintain its status as a global leader in cell and gene therapy."

Key shifts emerging from Phacilitate’s Advanced Therapies Europe 2026:

1. Commercial readiness is the sector's next big test

At Phacilitate’s Advanced Therapies Europe 2026, delegates signalled a major shift in priorities, with commercialisation emerging as the sector's defining challenge.

As advanced therapies move closer to mainstream adoption, discussions focused on the need to scale out manufacturing, secure reimbursement and strengthen supply chains. The consensus was clear: future success will depend not just on scientific innovation, but on the industry's ability to deliver therapies efficiently, affordably and at scale.

2. Europe must reform if it wants to capitalise on its scientific leadership

Delegates at Phacilitate’s Advanced Therapies Europe 2026 warned that Europe's world-class scientific capabilities are not being matched by its ability to bring new therapies to market, raising concerns about the region's long-term competitiveness.

Across the conference, speakers highlighted persistent obstacles including funding constraints, reimbursement uncertainty, regulatory fragmentation, manufacturing complexity and challenges in generating clinical data. The consensus was that Europe's biggest challenge is no longer producing innovation but creating an ecosystem capable of translating breakthroughs into commercially successful therapies. Attendees called for greater coordination across industry, regulatory and healthcare stakeholders, arguing that without meaningful reform, Europe risks seeing more innovation being developed locally but commercialised elsewhere.

3. Patient access takes centre stage as the industry's defining priority

Patient access emerged as a defining theme at Phacilitate’s Advanced Therapies Europe 2026, with leaders across investment, manufacturing, regulation and commercialisation united in their view that the industry's success will ultimately be measured by patient outcomes.

As innovation continues to accelerate, delegates stressed that scientific breakthroughs alone are not enough. The real challenge, and opportunity, lies in ensuring transformative therapies reach patients with serious, rare and underserved conditions, making access an increasingly important benchmark for the sector's future success.

4. Leadership as a critical differentiator in an era of uncertainty

A notable undercurrent across the panel sessions was the growing focus on leadership as a competitive advantage. Amid an uncertain operating environment, delegates suggested that boardroom decisions and organisational culture are becoming increasingly influential in determining how effectively companies capitalise on new scientific breakthroughs.

Charlotte Serra, VP, Global Head of Quality Operations, Cell Therapy at Galapagos, and one of the speakers at Phacilitate’s Advanced Therapies Europe 2026, commented:

“From my experience leading quality operations for cell therapy at Galapagos, one of the key lessons is that consistency by design in a decentralised network means standardising what matters from the start – including manufacturing and QC processing - but also decisions, responsibilities and escalation pathways, as well as governing centrally through strong quality and regulatory oversight and a global team, while adapting locally based on risk and Annex 1 principles. Leadership matters just as much: creating clarity, having the courage to make difficult decisions and building trust within the team.”

The view, echoed throughout the event, was that innovation alone is unlikely to guarantee success. Instead, organisations that combine scientific ambition with strategic cohesion and clear execution are expected to be better positioned for long-term growth.

Looking ahead

Phacilitate’s Advanced Therapies Europe 2026 concluded with a clear message: Europe has all the ingredients needed to lead the next generation of advanced therapies, from world-class science and manufacturing capabilities to a thriving clinical research ecosystem. However, delegates warned that leadership cannot be taken for granted.

As global investment and innovation intensify, Europe must address regulatory, reimbursement and market access challenges that continue to slow progress. The consensus in Barcelona was clear: the future success of advanced therapies will be defined not by scientific breakthroughs alone, but by Europe's ability to translate innovation into timely patient access.

For more information about Phacilitate’s Advanced Therapies Europe and future Phacilitate events, visit www.phacilitate.com.

For media enquiries and interview requests, please contact:

Heather Hopkin, Associate Director, TALA at heather.hopkin@teamtala.com
+44 (0)7545 536147
Hannah Ramsden, Account Director, TALA at hannah.ramsden@teamtala.com
+44 (0)7811 168182

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About Phacilitate:

Phacilitate exists to unite the global advanced therapies ecosystem - connecting biotech innovators, investors, pharma leaders, and solution providers across every stage of the commercialisation journey. Through its flagship cell and gene therapy events, digital content, and strategic partnerships, it creates environments where innovation thrives, partnerships form, and breakthroughs happen.

The company produces Phacilitate’s Advanced Therapies Week and Phacilitate’s Advanced Therapies Europe - two of the industry’s most respected events, bringing together global leaders in cell and gene therapy, biotech, pharma, CDMOs, and investment.

• Together, these carefully curated events combine thought leadership, business development, and networking to spark progress across the entire advanced therapies landscape.