Unlocking the potential of regenerative medicine in Europe: an interview with Tanja Xenia Pedersen

In this interview, Tanja Xenia Pedersen, Head of Biomedical Research at the Novo Nordisk Foundation (Hellerup, Denmark), dives into a recent report on the current state of regenerative medicine in Europe, the gaps, and the opportunities. Tanja discusses why Europe continues to struggle with translating strong science into therapies, and how a more coordinated, system-level approach could help unlock progress. She also shares key insights from the report’s roadmap, including how stronger hubs, better integration across the value chain, and earlier focus on commercial viability could help bring more regenerative medicine therapies to patients. The report is based on an in-depth analysis of the European regenerative medicine landscape by Catenion (Berlin, Germany), commissioned by the Foundation.

A comprehensive report details strategic roadmap towards advancing regenerative medicine in Europe

Novo Nordisk Foundation releases a strategic roadmap to advance European regenerative medicine.

The report identifies that only a handful of regenerative medicine therapies have been approved in the past two decades. What are the main barriers preventing more therapies from reaching patients?

There isn’t a single barrier – it’s really a combination of challenges across the whole value chain.

In Europe, one of the biggest gaps we see is in translation. Europe produces excellent science, but moving ideas from academia or early-stage companies into clinical development is still very difficult. Funding is a major part of that, particularly when it comes to attracting private investment. Investors understandably need a clear business case and that isn’t always built in early enough.

At the same time, regenerative medicine is inherently complex. We’re working with living cells, which are difficult to characterize, manufacture and scale in a consistent way. That drives very high costs and it makes industrialization challenging.

There are also regulatory and access barriers. Developers often face unclear or evolving approval pathways, and even when therapies can reach the market, reimbursement models are still not well established.

More broadly, the ecosystem is quite fragmented. We lack coordination across the value chain – from discovery to manufacturing to clinical development – which slows progress and reduces investor confidence.

How does Europe’s current position in regenerative medicine compare to global leaders like the United States and Asia?

The report is based – in part – on an in-depth analysis of 350 European bioclusters, as well as successful regenerative medicine bioclusters in Japan, China, Singapore, Canada and the USA. It therefore provides new insights on exactly this question.

If you look across indicators like company formation, clinical trial activity and investment, regions like the United States and increasingly parts of Asia, particularly China, are moving faster. Even the most successful regenerative medicine bioclusters in Europe – for example London, Paris, Cambridge, Medicon Valley (Copenhagen and southern Sweden) and Munich – simply haven’t been as effective at converting scientific excellence into commercial and clinical progress.

A big part of that comes down to differences in funding environments and risk appetite. Venture capital is generally more available – and often more willing to take risks – in the US and in parts of Asia. In Europe, the combination of high costs, regulatory complexity and uncertain returns makes investors more cautious.

The report outlines four priority areas to strengthen Europe’s regenerative medicine ecosystem. What are the most critical actions needed to unlock progress?

The main message is that Europe needs to move from many fragmented efforts to a much more coordinated approach. The report identifies four priorities: choosing hubs that can accelerate the field, attracting private investment by embedding strategic and commercial thinking earlier, improving efficiency through shared infrastructure, and being much more deliberate about project selection, basing it on where there’s the greatest potential for impact.

The first point is about not spreading resources too thinly. Europe already has strong regenerative medicine activity in several places, but no single cluster yet has the depth needed to deliver repeated clinical and commercial successes. So, we need to concentrate effort in hubs with critical mass – places where strong science, clinical expertise, manufacturing, investors and companies can come together.

Second, we need to think about translation much earlier. That means asking: what is the unmet need, can the therapy be manufactured, what might reimbursement look like, and is there a business case? Those questions should shape research direction from the start, not only when a project is ready to leave academia. Attracting public or philanthropic funding early is also crucial in helping de-risk programs, strengthening the case for private investors later.

And finally, we need stronger shared infrastructure and better prioritization. If Europe joins forces around the most promising opportunities, we have a much better chance of creating the clinical and commercial “trigger moments” the field needs.

What would these priorities look like in practice – for example in terms of how research, infrastructure and investment are organized?

In practice, it means building environments where excellent science is surrounded by the capabilities needed to move it forward. The report describes this as creating a kind of microcosm: top science, entrepreneurship, intellectual property strategy, business development and drug-development thinking all integrated much more closely.

One concrete example would be stronger hub-based support. Within selected hubs, projects should have easier access to GMP and CMC expertise, clinical trial infrastructure, regulatory advice and business development networks. That avoids every company or academic spinout having to build everything from scratch, which is especially important in regenerative medicine because manufacturing and cost of goods are such major barriers.

Another example is the “one-stop shop” idea. A project developer should be able to go somewhere and get coordinated guidance on process optimization, GMP scale-up, regulatory consultations, health technology assessment, business development advice and partnership discussions. That kind of structure could help researchers make stronger decisions at critical transition points.

We also need more disciplined prioritization. Disease mapping and pipeline evaluation panels could help identify areas where regenerative medicine can deliver real patient benefit and where the scientific, manufacturing and commercial case is strong enough to attract investment.
So, it’s not about supporting more activity everywhere. It’s about connecting the right capabilities around the right projects, in the places where they have the best chance of success.

How does the Novo Nordisk Foundation approach the development of new initiatives in regenerative medicine?

We tend to start by trying to understand the field – where it’s strong, where the bottlenecks are, and where we as a foundation can make a meaningful difference. This analysis – and the resulting report – is a good example of that. It’s part of a broader effort to map the landscape and identify the key gaps and opportunities before designing new initiatives.

From there, we work very much in a co-creation model. We work closely with researchers, clinicians, and other partners who bring the scientific and technical expertise needed to make projects impactful.

A core principle for us is to think across the value chain. So alongside fundamental and translational research – for example through the Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW (Copenhagen, Denmark; Leiden, Netherlands; and Melbourne, Australia) – we also invest in development and scale-up, such as through Cellerator (Lyngby, Denmark), which focuses on manufacturing and clinical readiness.

We’re also supporting more targeted, flexible mechanisms. One example is our open competition Regenerative Medicine Catalyst Grants, which are designed to help overcome specific translational hurdles and move promising projects forward.

And we’re seeing that this approach across the value chain is working. With support from Cellerator and the BioInnovation Institute (Copenhagen, Denmark), a Foundation initiative supporting life science start-ups, reNEW recently spun out its first company, Ibnova Therapeutics. It’s a really exciting venture developing stem-cell-based heart patches to treat heart failure. It illustrates perfectly how building bridges across critical gaps can accelerate the path towards clinical application.

What would successful implementation of this roadmap mean for patients over the next 5 to 10 years?

It’s important to be realistic here. Regenerative medicine is a long-term field, and bringing new therapies all the way to patients takes time.
That said, if we implement this roadmap successfully, we should start to see some very tangible shifts. One is a stronger, more coordinated European ecosystem, where researchers, companies, clinicians and investors are working much more closely together. We would also expect to see more programs progressing into clinical development.

At the same time, some of the systemic barriers should begin to ease. For example, better coordination across hubs, improved access to infrastructure, and clearer regulatory and development pathways would make it easier to move promising ideas forward.

Ultimately, success would mean that we are closing the gap between scientific promise and real patient benefit – so that over time, more people living with serious or chronic conditions can access new kinds of treatments, potentially even cures.

What gives you the most optimism about the future of regenerative medicine in Europe?

It’s a challenging field, but we are seeing signs of progress. There are more clinical programmes emerging, more companies being built, and some important success stories beginning to take shape.

What’s particularly encouraging is that momentum is building at the ecosystem level. There is growing recognition – both within Europe and globally – that regenerative medicine, and advanced therapies more broadly, are areas where coordinated action is needed. We’re seeing this reflected in major reports, policy discussions, and a stronger focus on how to enable translation, not just discovery.

At its core, the promise of regenerative medicine is incredibly powerful – the idea that we might be able to restore function or even cure chronic diseases, rather than just manage them. And scientifically, that is now much more tangible than it was even a decade ago.

Disclaimer
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of RegMedNet or Taylor & Francis.