Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective

By Jessica Cordes, senior consultant for clinical operations, Clinical Excellence GmbH

The European Commission’s recently announced Biotech and Biomanufacturing Initiative, commonly referred to as the EU Biotech Act, marks a pivotal shift in the regulatory and industrial landscape for biotechnology in Europe. While much of the immediate attention has focused on how the initiative will benefit European life sciences companies, U.S.-based biotech sponsors should also take note, especially those involved in clinical development of advanced therapy medicinal products (ATMPs, also called cell and gene therapies), oncology therapies, or other high-complexity modalities.

This act is more than a policy framework; it is a strategic signal. The EU is positioning itself to become a more competitive, innovation-friendly, and operationally capable region for biotechnology research, development, and manufacturing. For clinical operations and medical leaders in U.S. biotech companies, the implications are both practical and strategic. As Europe increases its attractiveness for biotech-sponsored clinical trials and manufacturing, sponsors need to assess how this may impact site selection, regulatory planning, feasibility strategy, and long-term development road maps.

This article outlines what the EU Biotech Act means, why it matters to sponsors outside Europe, and what steps clinical leaders should consider now to align their clinical trial planning with the evolving European landscape.

The EU Biotech Act: A Strategic Move To Strengthen European Biotech

Europe has long been a vital contributor to biotechnology and pharmaceutical innovation, but it has faced challenges in keeping pace with the U.S. and China, particularly in the development and production of advanced therapies. The EU Biotech Act is designed to change that.

Announced in 2024, the act is part of a broader strategic plan by the European Commission to:

• strengthen biomanufacturing capacity within the EU,
• simplify regulatory pathways for innovative biotechnologies,
• improve access to funding for early-stage biotech companies,
• ensure resilience of supply chains for critical materials and products, and
• promote skills development in biotech-specific areas, including ATMP handling and GMP manufacturing.

From a clinical development perspective, the act reinforces the EU’s commitment to creating an ecosystem where innovation can reach patients faster, with infrastructure, processes, and policy aligned to that goal.

Importantly, this is not limited to European companies. While the act is designed to support EU-based biotech and manufacturing, its downstream effects are likely to benefit any sponsor conducting clinical trials or producing ATMPs in Europe, including U.S. companies.

Why U.S. Biotech Companies Should Pay Attention

For U.S.-based clinical development teams, Europe often represents a critical geography for early-phase patient recruitment, regulatory interaction, and future market entry. With the EU Biotech Act in place, the region may become even more appealing for clinical trial execution, if sponsors are prepared to work within the updated regulatory and operational context.

Faster Regulatory Pathways For Innovative Therapies

The act proposes reducing administrative burdens and aligning national and EU-level agencies on a shared biotech agenda. For clinical operations, this may translate to shorter start-up timelines, especially for therapies addressing unmet medical needs.

When combined with the implementation of the EU Clinical Trials Regulation (CTR), which already introduced streamlined authorization timelines, the act reinforces a shift toward greater predictability and speed in clinical trial initiation.

Improved Infrastructure For ATMP Clinical Trials

The act includes investment plans aimed at strengthening clinical trial infrastructure, particularly for complex products like gene-modified cell therapies. This could expand the number of sites across Europe that meet ATMP-specific criteria (i.e., cryogenic handling, JACIE-accredited apheresis units, and trained personnel).

For sponsors, this may ease one of the key bottlenecks in ATMP clinical trial planning: limited qualified sites.

Strategic Alignment With Market Access Goals

Many U.S. biotech companies plan for a dual launch in the U.S. and Europe. With the EU prioritizing biotech manufacturing sovereignty and local production incentives, sponsors may find increased advantages in partnering or producing in-region, which could feed into more strategic clinical trial designs that align development with future reimbursement and pricing frameworks.

In short: If Europe becomes faster, more supportive, and more infrastructure-ready, the case for placing clinical trials there gets stronger.

Clinical Operations Impact: Site Strategy, Vendor Management, And Feasibility

While the act is still being implemented, its direction is clear, and clinical operations teams should start preparing for the evolving expectations and new opportunities it brings.

Site Feasibility Will Require Updated Criteria

Sponsors running ATMP clinical trials in the EU already know the complexity involved in qualifying a site, from cryogenic storage to interdepartmental coordination. Under the Biotech Act’s influence, more hospitals and institutions may upgrade to meet the requirements, but assumptions about readiness must still be validated.

Feasibility strategies should include:

• early assessment of infrastructure maturity
• documentation of regulatory readiness (e.g., prior experience with ATMP clinical trials under CTR)
• inclusion of apheresis units and lab partners as part of the site evaluation
• evaluation of extended referral networks to meet rare disease recruitment needs.

Vendor Qualification And Oversight May Shift

As more local EU-based CDMOs, logistics providers, and specialty labs receive funding and support under the act, sponsors may have more options for regional outsourcing. This could reduce logistical complexity and allow for tighter control under EU GCP expectations.

However, it also requires a shift in vendor qualification processes, including:

• clear documentation of experience with ATMPs or GMP-grade material
• transparency on regulatory inspection history
• robust onboarding and oversight plans aligned with ICH E6(R3).

Data Strategy And Regulatory Readiness

The EU Biotech Act is expected to work in tandem with digitalization initiatives and data harmonization frameworks. For clinical operations, this means preparing for more regulatory scrutiny of data flows, system interoperability, and audit readiness.

Planning ahead includes:

• aligning with EU data governance expectations, particularly for decentralized or hybrid clinical trial designs
• ensuring eTMF, EDC, and IMP tracking systems are validated and integrated across European sites
• training teams to handle EU-centric documentation and inspection processes.

Strategic Considerations For Clinical Leaders

For chief medical officers and heads of clinical operations in small to midsize U.S. biotech companies, the EU Biotech Act introduces a strategic consideration: Should we increase our clinical footprint in Europe in response to these changes?

Expanding clinical activities in Europe under the EU Biotech Act can offer several advantages, including access to a larger and more diverse patient population, opportunities for earlier engagement with European regulators, and the ability to align with evolving compliance frameworks. For companies focused on ATMPs or rare oncology indications, the new regulatory environment could facilitate faster approvals and more efficient clinical trial operations, provided that sponsors can demonstrate robust data governance and meet GMP and GCP requirements.

However, entering or expanding in the EU clinical trial landscape also presents challenges. Companies must navigate complex regulatory differences between countries, invest in the digitalization and harmonization of clinical trial data systems, and ensure their teams are trained for EU-centric documentation and inspection processes. Strategic planning is needed to address these areas, including validating eTMF and EDC systems, aligning oversight plans with ICH E6(R3), and ensuring transparency in regulatory inspection history.

While not every company will move clinical trials to the EU based on this initiative alone, it should be seen as a trigger to reevaluate current assumptions, especially for ATMP development programs or oncology assets with rare indications.

Ultimately, the EU Biotech Act should prompt U.S. biotech leaders to critically assess their global development strategies. Those considering a stronger European presence should conduct a thorough feasibility analysis, taking into account regulatory alignment, operational readiness, and the potential for innovation-driven growth in the EU market. This proactive approach will help ensure that companies remain competitive and compliant as the regulatory landscape continues to evolve.

Key Questions Clinical Leaders Should Be Asking

Are our clinical development plans aligned with EU regulatory evolution?

• Do we have clear understanding of how the Biotech Act interacts with the EU CTR, ATMP-specific guidelines, and country-level implementation?
• Are we engaged with EU-based experts who can anticipate how national authorities will adapt?

Are we prepared to reassess our feasibility frameworks?

• Are our current site qualification templates still fit-for-purpose?
• Do they reflect ATMP-specific handling requirements, interdisciplinary collaboration, and risk-based oversight principles?

Are our partners and vendors ready for a more regulated and innovation-driven environment?

• Have we updated our oversight processes to meet evolving expectations under ICH E6(R3) and EU-level sponsor responsibilities?
• Are our vendor qualification procedures sufficient for assessing GMP compliance and Biotech Act alignment?

Are we missing opportunities for operational efficiency or cost reduction?

• Could co-location of clinical trials and manufacturing reduce complexity or cost?
• Are there new funding or partnership opportunities emerging from the act that our team could benefit from?

Proactive planning, especially in early development phases, enables sponsors to optimize site selection, de-risk timelines, and prepare for future regulatory success.

A Policy Shift With Operational Consequences

The EU Biotech Act is more than a political declaration. It is a concrete step toward improving the competitiveness of Europe’s biotech ecosystem. While it primarily supports European innovation and infrastructure, U.S.-based biotech companies running clinical trials in Europe stand to benefit, if they are prepared to align.

With increasing focus on risk-based oversight, regulatory harmonization, and fit-for-purpose feasibility, sponsors who understand the operational implications of policy changes will be better positioned for success.

By anticipating how the EU Biotech Act may reshape site infrastructure, regulatory timelines, and vendor ecosystems, U.S. sponsors can strengthen their clinical trial strategies, reduce execution risk, and make more informed decisions about where and how to run clinical trials that meet the demands of tomorrow’s therapeutic landscape.

About The Expert:

Jessica Cordes started her clinical operations career in 2009, working at various companies including Big Pharma and several small to midsize biotech companies. She gained extensive experience on different levels from country study management to global study management and, since 2018, leadership in clinical operations. During her time at Medigene and Immatics, she structured the clinical operations department, built cohesive global teams, and implemented GCP and ATMP-compliant processes. For more than 12 years, she has been working in oncology clinical trials (including hemato-oncology as well as solid tumors) and with ATMPs since 2018. Since 2023, she has been working as an independent consultant and trainer, supporting small companies in building their clinical operations group and setting up their clinical trials for success. She provides a GCP refresher course via her Clinical Excellence Training Academy.