Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)

By Ahmet C. Berkyurek, Ph.D., Cofounder & CEO, CamMed Therapeutics Ltd.

In this two-part series, I share practical insights to help European biotech leaders succeed in the United States, the world’s largest pharmaceutical market. Part 1 focused on regulatory strategy and market entry. Because successfully navigating FDA interactions is only one step in establishing a lasting U.S. presence, in this final article I examine the financial, operational, and organizational decisions that shape long-term success, from fundraising and strategic partnerships to manufacturing, legal considerations, and lessons learned.

If you missed Part 1, read it here.

The U.S. Investment, Fundraising, And Partnership Landscape

U.S. Investment And Fundraising

U.S. life sciences venture funds, particularly those concentrated in Boston and the Bay Area, operate at a scale and cadence that can initially feel disorienting to European companies accustomed to syndicated rounds and longer diligence timescales. Top-tier U.S. RNA-focused investors can move from initial meeting to term sheet in a matter of weeks when they have conviction, and they bring not just capital but operational infrastructure, network access, and management recruitment capabilities.

European companies seeking U.S. VC participation should be aware that U.S. investors will apply U.S. valuation benchmarks and governance expectations and corporate structure requirements. This means accepting board composition norms, information rights, and liquidation preferences that may differ from European practices, and it means being prepared for a pace of investor engagement and reporting that is more intensive than many European companies have experienced.

On the incentive side, U.K. founders are often surprised by how differently U.S. innovation tax policy is structured compared to the U.K.’s R&D tax credits and EIS/SEIS tax incentive schemes. The U.S. does offer a federal R&D tax credit (formally the Credit for Increasing Research Activities under Internal Revenue Code Section 41), but it functions primarily as a tax credit against U.S. income tax rather than a grant-like reimbursement mechanism. It is calculated based on “qualified research expenses” (QREs), which are heavily engineering and payroll driven. This typically includes wages for engineers and technical staff, a portion of contractor costs, and certain supply and cloud-computing expenses used in experimentation. Unlike the U.K. SME R&D scheme (which has historically provided cash refunds to loss-making companies), the U.S. system is more backloaded: it is most valuable once a company has meaningful payroll tax or income tax liabilities.

For early-stage startups, there is an important modification: qualifying small businesses (generally those under $5 million in gross receipts and within their first five years of activity) can apply for up to $500,000 per year of R&D credits against payroll taxes rather than income taxes. This effectively allows pre-profit companies to monetize the credit earlier by offsetting employer Social Security (and then Medicare) obligations. While useful, it is typically more modest and administratively complex than the U.K.’s historical SME R&D refundable credit.

At the U.S. state level, additional R&D credits in jurisdictions such as California and Massachusetts can further supplement the federal system, but they vary significantly in generosity and eligibility. On the investor side, there is no direct U.S. equivalent to the U.K.’s EIS or SEIS schemes, which provide up-front income tax relief, capital gains advantages, and loss relief at the point of investment. The closest analogue is Qualified Small Business Stock (QSBS), which instead rewards long-term success: if investors hold qualifying C-corporation shares (typically for at least five years), they may exclude a significant portion, and in some cases up to the full amount, of federal capital gains on exit. In practice, this creates a very different incentive structure: U.K. schemes encourage early investment through immediate tax relief, while the U.S. system provides comparatively limited up-front incentives but potentially large tax advantages at exit if the company performs well.

Overall, the U.S. approach relies less on investor tax incentives and more on a combination of venture capital depth, university and federal research funding (including SBIR/STTR and NIH programs), and back-ended tax benefits tied to successful outcomes.

Partnerships And Pharma Deals

Large U.S.-based pharmaceutical companies remain the most active acquirers and licensors of RNA platform and program assets globally. A recent example is the acquisition of Orbital Therapeutics by BMS for $1.5 billion. The dynamics of these partnerships reward companies that can demonstrate not just scientific excellence but U.S. regulatory credibility, meaning FDA engagement history, IND experience, and, ideally, U.S. clinical data.

European companies that arrive at business development conversations with a strong EMA track record but no FDA interaction will find the conversation harder. This is a practical argument for early IND filing, even for programs that will ultimately be developed primarily in Europe as this is a signal of U.S. regulatory seriousness.

The structure of U.S. pharma licensing deals also differs from European norms. Up-front payments tend to be smaller relative to total deal value, milestone structures are often more complex, and IP warranty and indemnification obligations are typically more stringent. Beyond deal negotiations, companies should ensure that their intellectual property strategy is optimized for the U.S. market from an early stage. This includes developing a U.S.-specific patent prosecution strategy, evaluating freedom to operate, and considering how claim scope, continuation practice, and portfolio development can maximize long-term value. Engaging experienced U.S. life sciences counsel early, rather than relying solely on a European IP firm’s U.S. affiliate or only seeking advice once partnering discussions begin, can help ensure that patent portfolios are structured to support financing, licensing, and eventual commercialization.

Nondilutive Funding: NIH, BARDA, ARPA-H, And Regional Government Match Funding

One aspect of the U.S. funding landscape that European companies often overlook is the scale of nondilutive U.S. government funding available for RNA therapeutic development. The National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the newer Advanced Research Projects Agency for Health (ARPA-H) collectively deploy billions of dollars annually into biomedical innovation, and RNA therapeutics are an explicit strategic priority.

European companies with U.S. entities are eligible to compete for many of these programs, and success in NIH or BARDA funding is a significant credibility signal for subsequent commercial fundraising. Building relationships with relevant NIH program officers, particularly those within NIAID, NIBIB, and the recently expanded RNA Therapeutics Program, should be a deliberate early priority.

Similar nondilutive grant opportunities are available in the U.K. and EU. For example, UKRI and ARIA are two major nondilutive funding bodies in the U.K. While UKRI grants (Biomedical Catalyst, Future Leaders Fellowship, BioEngineering) require at least 30% match funding from participating businesses, they recently shifted toward more advanced-stage projects close to market entry or clinical validation, leaving early-stage ideas and projects without funding. One other recent development is that UKRI Smart Grants are no longer available for application, leaving the U.K. nondilutive funding scheme with a limited number of programs, resulting in a huge competition among early-stage biotech companies.

While some of the U.K.-based nondilutive grant opportunities are shifting toward more advanced-stage assets, EU-based programs such as EIC and Eurostars still provide the opportunity for early-stage proof of concept studies given that a consortium between independent member state companies is formed.

An alternative strategy for EU/U.K. based companies is to have a U.S. legal and physical presence. Regional governments also give the opportunity of matching investment up to $10 million if a company has either U.S. or EU investors. These programs vary with their degree of being dilutive or nondilutive.

Manufacturing: CDMOs And FDA Expectations

The U.S. RNA CDMO landscape has expanded dramatically since 2020, with significant capacity additions from established players and a growing set of RNA-specialist providers with end-to-end manufacturing capabilities. European CDMOs, including those with whom many European biotechs have established relationships, increasingly maintain U.S. operations, which can ease the transition.

FDA’s expectations around manufacturing site inspections, process validation, and supply chain documentation for U.S. commercial manufacturing are, however, more intensive than EMA requirements in several respects. Early engagement with a CDMO that has a track record of FDA inspection success and, ideally, existing FDA Establishment Registration reduces regulatory risk materially.

For clinical supply, the question of whether to manufacture in Europe and import versus establishing a U.S. manufacturing relationship is a strategic decision with regulatory, logistical, and cost implications. Import of investigational medicinal products under IND is entirely feasible but requires careful attention to FDA’s foreign drug establishment requirements and may complicate comparability arguments if manufacturing processes differ between European and U.S. supply.

Legal And Compliance Infrastructure

U.S. biotech operates within a legal and compliance environment that is more litigious and more heavily regulated in certain respects than European practice. Key areas where European companies frequently encounter surprises include employment law (particularly at-will employment norms and the risks around workforce reductions), IP protection and freedom-to-operate analysis in a jurisdiction with more active patent litigation, and the Foreign Corrupt Practices Act obligations that apply to U.S. entities operating globally.

Building a relationship with a U.S. law firm with genuine life sciences and biotech M&A expertise before needing it urgently is one of the highest-return early investments a European RNA company can make.

Lessons Learned

Common Pitfalls

• Hiring too late, and then too quickly: European companies that delay U.S. hiring until they “have something to show” often find themselves unable to attract the caliber of U.S. executives needed to lead market entry effectively. Strong U.S. candidates typically evaluate opportunities based on science, team quality, and perceived trajectory, and they tend to join early enough to shape strategy rather than simply execute a predefined plan. At the other extreme, building a U.S. organization too early can lead to rapid cash burn before value inflection points are reached. U.S. operating costs are often materially higher than in the U.K. or Europe, frequently on the order of ~two to three times for comparable senior roles and infrastructure, so even successful fundraising can translate into a shorter operational runway than anticipated. The challenge is therefore to stage U.S. hiring carefully, aligning team build-out with clear scientific, clinical, or regulatory milestones that justify local presence and leverage.
• Underestimating cultural translation: U.S. investors and partners operate within a specific cultural register, one that values directness, confidence, and the ability to articulate a clear value proposition succinctly. European founders and executives who present with perhaps more of the hedging, caveats, and qualifications that typify European academic and professional culture may be perceived as lacking conviction in a meeting with U.S. VCs or potential partners. Adapting communication style is not inauthenticity, it is a cultural competence required to succeed in international business.
• Maintaining a European HQ mindset: The temptation to treat the U.S. operation as a satellite of the European headquarters with U.S. hires reporting to European management and strategic decisions made in London, Amsterdam, or Zurich is understandable but counterproductive. U.S. operations that are genuinely empowered, with local decision-making authority and a credible U.S. leadership team, consistently outperform those that are managed as extensions of European headquarters. Alternatively, U.K./EU-based founders and executives should seriously consider relocation to the U.S. site for operational and strategic reasons.
• Sequential rather than parallel regulatory strategy: Regulatory strategy for U.S. entry should be developed in parallel with European regulatory activities, not as an afterthought. Companies that complete their EMA filing and then turn attention to the FDA often find that their data package, manufacturing strategy, and clinical design contain elements that require expensive remediation for U.S. purposes.
• Ignoring the network premium: The network of investors, KOLs, clinical and regulatory advisors, and potential partners that opens doors in the U.S. RNA therapeutics space is geographically concentrated and personally connected. Access to this network through a credible local intermediary, a well-networked board member, scientific advisor, or U.S. GM, is often more important than the quality of the company’s slide deck. Attending industry-specific meetings and conferences, and connecting with founders and executives, is imperative to establishing a strong network in hotspots with RNA biotech expertise such as Boston, San Francisco, and New York. It takes time to establish rapport and communication. European CEOs and founders should start establishing these networks as soon as possible, from the earliest moment in their company’s life.

The opportunity is real but so are the requirements.

About The Author

Ahmet Berkyurek, Ph.D., is cofounder and CEO of CamMed. He completed master’s and doctorate degrees at Osaka University, with a research fellowship from the Japanese government, and a bachelor’s degree from Istanbul Technical University (ITU). Berkyurek continued his scientific career at the University of Cambridge as a research fellow with a Marie-Curie Fellowship and worked in the biotech industry at the intersection of biochemistry, cell biology, RNA biology, oligonucleotide, and vaccine/RNA therapeutics. Berkyurek was a finalist for Researcher of the Year 2023 by Cambridge Independent Science and Technology Awards for his discoveries in RNA therapeutics to prevent SARS-CoV-2 infections and received the CEO of the Year 2025 Award for the U.K. from the Global Excellence Network for his contributions to mRNA therapeutics research.

Additional contributions were made to this article by the following:
Virginia Castilla Llorente, Ph.D., chief scientific officer
Kenny Simmen, Ph.D., board member
Natalie Pankova, Ph.D., board member