By Daniela Caiazza, Acting Managing Director - Europe, Novotech.

Earlier this month, our team joined a select group of investors, biotech leaders and policy experts to talk about the future of European biotech in an open and candid way. By taking an honest look at what is working well and what can be improved, we were able to get a clearer picture on areas where Europe has advantages for clinical trial programs, as well as where there are opportunities to improve and gain strategic capabilities.

Here is a look at what we heard and how it connects to the work Novotech does with biotech and small to mid-sized pharma sponsors.

1. Finance in Europe: Abundant capital, limited risk appetite

The room agreed on one point very quickly. Europe does not lack available capital. It lacks comfort with long-term risk.

Private funds are more cautious. Pension funds are heavily risk-averse. No one wants their name attached to a loss in a pension portfolio, so capital often flows to safer, shorter-horizon opportunities.

Several speakers argued that long-term investors should be encouraged to put more into life sciences through shared-risk structures that still protect beneficiaries. The goal is not to gamble, but to design sensible risk-sharing so research can move forward.

For clinical-stage biotechs, this shows up in tougher questions about:

  • The likelihood of technical and regulatory success.
  • Clarity and efficiency of the development plan.
  • How quickly a program can reach key value inflection points.

Here, strong clinical planning matters. Sponsors who pair good science with realistic feasibility, credible recruitment plans and clean data packages usually have more productive conversations with investors. This is a core area where Novotech supports clients, especially across oncology and complex modalities.

2. EU HTA: early challenges, long-term opportunity

The new EU Health Technology Assessment process is another major shift. Ipsen’s pediatric low-grade glioma therapy is the first test case. The concept is straightforward; one joint assessment that many countries can use, instead of multiple separate exercises.

Execution, at least so far, is more complicated. For a rare pediatric cancer, some national bodies reportedly requested up to 25 comparator arms. That is very difficult in practice.

Despite these early issues, the long-term logic is strong. If countries align more closely around the joint HTA, Europe could:

  • reduce duplicative assessments
  • shorten time to access for patients
  • use public funds more efficiently

For sponsors, this means trial design choices need to anticipate not only regulators, but also HTA bodies and payers across several markets. Comparator selection, endpoints and evidence plans become even more strategic.

Novotech works with sponsors to plan studies that support both regulatory review and future access discussions, across Europe and other key regions.

3. Rights, deals and how partners work together

Another clear trend is the move away from narrow regional rights. Many companies now seek global or near-global rights as the default position.

At the same time, partnership expectations are evolving. Deals are no longer just about assets, milestones and royalties. They increasingly depend on:

  • shared decision-making
  • compatible operating styles
  • transparency and trust at project team level

Smaller biotechs and larger pharma companies often have different cultures and speeds of execution. When this is ignored, collaboration becomes difficult. When it is acknowledged and managed, it can create strong, complementary teams.

In our role as a global CRO, Novotech often sits at this interface. Clear communication, realistic timelines and reliable reporting help bridge expectations and keep programs on track for both sides.

Attending BIO-Europe 2025 in Vienna was an incredible opportunity to connect with global biotechs and gain insights into the future of therapeutic innovation. What impressed me most was the scale and depth of collaboration— over 30,000 one-to-one meetings and discussions focused on rare diseases, advanced therapies, and investment strategies underscored how critical partnerships are for accelerating drug development. For Novotech, this event reaffirmed the value we can provide in supporting sponsors across feasibility, regulatory strategy, and clinical delivery.

-Karen Scalzo-Inguanti, Director - Therapeutic Strategy

4. China: competitor, collaborator and essential part of the picture

China’s presence in global drug development is now firmly established. A significant share of new INDs at the FDA originates from Chinese companies. Many Western companies already partner with Chinese biotechs because the science and clinical productivity are compelling.

For European sponsors, this raises competition for capital and attention, but also introduces more options for co-development and licensing.

A partner with deep experience in Asia-Pacific, including Greater China, can help sponsors:

  • decide if and when to include Chinese sites in a global program
  • identify experienced investigators and centers
  • design trials that support multi-region submissions and approvals

Novotech’s long track record in Asia-Pacific and growing presence in Europe allow us to help sponsors connect these regions in a practical, compliant way.

5. First-in-class, best-in-class and practical differentiation

When asked if they focus only on first-in-class programs, mid-size companies were very clear. They look for a balanced mix of first-in-class and best-in-class opportunities.

Focusing exclusively on high-risk, first-in-class assets can be unsustainable for many organizations. Best-in-class or clearly differentiated entrants in established pathways can be attractive if they show:

  • a meaningful clinical advantage
  • a less crowded competitive space
  • a realistic route to reimbursement

In our work with sponsors, differentiation is rarely about one headline claim. It is about endpoints that matter to clinicians and payers, thoughtful patient selection and strong, consistent execution in trials.

6. Talent and mobility: a quieter constraint in Europe

One question from the audience focused on academic mobility. In the United States, senior researchers often move between institutions and regions several times in their careers. That movement spreads ideas and creates new collaborations.

In Europe, mobility frequently slows after the PhD or postdoctoral stage. Many scientists return to their home countries and stay. Over time, this can reduce cross-border exchange and make it harder to build truly international research teams.

There is, however, a positive shift. More Europe-born professors working in the United States are now considering a return. If European institutions and health systems are prepared to welcome them with room to lead and collaborate, this could be a significant boost.

For clinical trials, investigators with experience in more than one system often bring stronger familiarity with global standards and are more comfortable working with international sponsors. These are precisely the site and investigator profiles Novotech looks for when building networks in Europe and beyond.

7. From cost line to value story

The discussion ended with a simple but important point. In many European debates, medicines are still described mainly as a cost. The wider value story is often overlooked.

A strong biotech sector contributes:

  • skilled jobs and long-term careers
  • tax revenue
  • more resilient health systems in times of crisis

Changing that narrative requires evidence, not slogans. Well-designed clinical trials, thoughtful health economic analyses and clear communication with policymakers all have a role to play.

Novotech’s clients sit at the center of that effort, particularly in oncology and other high-need areas. Our task is to help them generate the kind of data and delivery track record that makes their case locally, regionally and globally.

It was an excellent opportunity to attend 2025 Bio-Europe in Vienna, the premier partnering conference for the global pharmaceutical industry. It offered us and other biopharma professionals an avenue to expand our networks, explore new collaborations and share insights on the latest innovative clinical and drug research and development. Novotech gained valuable insights into the challenges and key priorities facing the biotechnology sector today and contributed to the discussion by sharing our knowledge and expertise on offering global reach and regional expertise to drive and deliver on drug development programs in partnership with our clients and sponsors.

— Daniela Caiazza, Acting Managing Director - Europe

Europe’s next chapter

Europe is not facing collapse in biotech, but it is at a real turning point.

Conservative funding norms, added regulatory layers, limited mobility and rising competition are real constraints. At the same time, new HTA structures may eventually streamline access, academic talent is looking homeward, China and other regions are opening new partnership routes and policy attention to life sciences is increasing.

For biotechs in Europe, the path forward will belong to teams that combine strong science, thoughtful clinical strategy and the right partners.

Novotech is focused on supporting those teams with global trial expertise, a strong footprint in Europe and Asia-Pacific and a clear understanding of what investors, regulators and payers need to see.

If you are planning your next European or global study and would like to explore options, you can talk to a Novotech expert: https://novotech-cro.com/talk-to-an-expert