"You Cannot Be A Team Player And Keep The Ball All The Time": Europe's ATMP Leaders On What Actually Needs To Change

"Europe's Roadmap: Winning the Next Wave of ATMP R&D" followed directly on from Advanced Therapies Europe 2026's morning regulatory session, and the panel opened by saying, out loud, that it wouldn't repeat the diagnosis everyone already agrees on. Instead, moderator Montse Daban (BIOCAT) pushed each panellist toward a genuine call to action: something specific enough that somebody in the room could actually go and do it.

The panel brought together Miguel Forte (CEO, Kiji Therapeutics), Bo Wiinberg (Chief Business Officer, Novo Nordisk Foundation Cellerator), Jacqueline Barry (Chief Clinical Officer, Cell and Gene Therapy Catapult), Paolo Morgese (VP Public Affairs Europe, Alliance for Regenerative Medicine), and Jim Lund (Chief Business Development Officer, CCRM Nordic). What followed was less a debate and more five different people converging, uncomfortably, on the same conclusion: Europe's problem isn't ambition. It's an unwillingness to give anything up.

Three kinds of success, and the one Europe keeps under-delivering

Forte opened by naming three things that actually count as success in this field: getting a therapy to patients, delivering a business outcome that feeds capital back into the system, and genuine competitiveness, not as an end in itself, but because competition is what prevents complacency.

His four pillars for getting there were funding, collaboration, data generation, and the regulatory-to-market pathway that ultimately delivers patient access. It was his comment on data generation that landed hardest: Europe, in his words, isn't just failing to help itself here, it's actively working against its own interests. His practical fix was refreshingly narrow: fast, flexible, non-dilutive funding for early translational-stage companies moving from idea to proof of concept, and a genuine commitment to sorting out cross-border clinical trials, rather than continuing to treat that as someone else's problem.

The hardest call to action: giving something up

Wiinberg's contribution was the most structurally uncomfortable of the session, and Daban pushed him on it directly. His argument: national governments across Europe are each building their own ATMP infrastructure and capability in parallel, and on a global scale, that doesn't create competitiveness, it dilutes it. Compared with the consolidated resourcing China and the US can bring to bear, a dozen smaller national efforts add up to less than the sum of their parts.

His proposed fix requires something governments rarely volunteer for: stop building new centres of excellence everywhere, and instead invest further in the places that already have critical mass, wherever in Europe that happens to be. As an example, he cited a Danish delegation visit to Berlin the week before the panel, an explicit effort to understand what another country was already building rather than duplicating it in parallel. Denmark, he pointed out, is too small to run every rare disease trial domestically. The only way to reach patients efficiently is genuine cross-border collaboration on multicentre trials, which in turn requires EU-level policy that removes the regulatory friction currently making that hard to set up efficiently.

The view from outside: it looks more unified than it feels

Barry's perspective, as the UK's Cell and Gene Therapy Catapult chief clinical officer, added a useful outside-in check on the room's instinct to focus on fragmentation. From outside the EU, she said, Europe looks like a large, coherent, genuinely attractive single market. The caveat, delivered with some resignation: "if you could get your act together about clinical trials, it would be much more attractive," and this has been said, in various forms, for decades without much changing.

Her sharpest point, though, was a reframe rather than a complaint: most of what happens across European ATMP development is already common ground. It's usually only 5 to 10 percent of process that genuinely differs country to country, and that small remainder is where all the energy and conflict goes. Her suggestion was blunt: focus on the 90 percent that's shared instead of relitigating the 10 percent that isn't. She was careful to note this isn't uniquely a European failing either: even within the UK, getting two hospitals to run a process the same way is its own challenge.

Why there still isn't a single market, and what's starting to change that

Morgese laid out the structural reason Europe still isn't a genuine single market for ATMPs: pricing and reimbursement decisions sit at national level, so no matter how harmonised the regulatory side becomes, the commercial side remains genuinely fragmented country by country.

He was candid about the international pressure driving urgency here. The US has introduced a Most Favoured Nation pricing policy. China continues to move fast on clinical trial and technology regulation. And individual EU member states are now starting to compete with each other on pricing incentives rather than waiting for a coordinated European approach: Germany's proposed "Germany bonus" would apply a mandatory pricing discount (7 percent now, rising to 15.5 percent next year) to every new product launch, with that discount halved for companies that manufacture or conduct research in Germany.

The one genuinely pan-European mechanism Morgese pointed to with cautious optimism is the Joint Clinical Assessment (JCA), where EU countries collectively assess a new therapy's clinical benefit before individual states make their own reimbursement calls. The scheme's first ATMP assessment, an extended indication from Novartis, was published the day before this panel. Morgese noted ARM has been actively pushing the JCA methodology to move away from a rigid refusal of single-arm trial evidence toward something more pragmatic, allowing direct comparison against standard of care where a randomised comparator genuinely isn't feasible. It's a slow shift, but a real one.

The investor case, stated plainly

Lund made the commercial stakes unambiguous: if products can't actually launch and generate revenue in the European market, investor capital will simply go somewhere else. He was equally clear that Europe's underlying assets remain strong, still the world's second-largest pharmaceutical market, with genuinely excellent research foundations, but those assets aren't currently being leveraged into investor confidence.

His framing of the challenge as a team sport was the moment the room's energy visibly shifted. Innovation, he argued, is a team game, and Europe's open question isn't really about winning, it's whether the fragmented pieces can be assembled fast enough to still be invited to compete at all.

Forte picked up the sporting metaphor and sharpened it into the session's most quotable line. Rather than chess, he reached for football: national regulators, however capable individually, can't remain fully sovereign players if Europe wants to compete as a bloc. His line landed cleanly: "you cannot be a team player and keep the ball all the time." The goal isn't uniformity for its own sake, he added, but what he called competitive collaboration, teams within Europe pushing each other toward excellence while still ultimately playing for the same side against the US and China.

Lund grounded that abstraction in hard numbers from a founder's perspective: running preclinical toxicology work in China can cost roughly a third of the European price, in roughly a third of the time, with proportionally cheaper trials to follow. That's the real competitive gap founders are weighing up when they decide where to actually run their programme, and it's not one Europe closes with sentiment alone.

Retention, not protectionism

Wiinberg's closing intervention reframed the entire "where does innovation leak out of Europe" question in one useful sentence: instead of trying to stop companies moving to the US or China, the priority should be making Europe attractive enough that they don't want to leave in the first place.

He named the underlying threat directly: a second funding crunch is already building, with funders demanding more clinical evidence before committing capital, right as capital is what many companies need most to generate that evidence. His proposed EU-level interventions were specific rather than aspirational: sandbox reimbursement for a single therapy to genuinely test open, Europe-wide market access in practice, and have the EU step directly into funding clinical data generation with meaningfully sized tickets, rather than leaving that gap to national programmes alone.

The calls to action, in their own words

True to the panel's opening promise, each speaker closed with a single, deliberately short commitment rather than a summary:

• Jacqueline Barry: work collaboratively.
• Miguel Forte: reasons to fund, a direct riff on ARM's own "Reasons to Lead" initiative, reframed as a challenge to actually put capital behind it.
• Jim Lund: leverage the market Europe already has as a tool, and collaborate to use it properly.
• Montse Daban: don't let Europe be weaker. Being stronger together is what builds the market everyone in the room is actually trying to reach.

Why this matters beyond the room

What made this session different from the usual competitiveness panel wasn't new data, it was five people from genuinely different vantage points, funder, provider, industry body, investor, moderator, refusing to let the conversation settle for another round of "Europe is fragmented" without naming exactly what each of them is willing to give up to fix it. That's a harder conversation than most panels attempt, and a much more useful one.

That kind of direct, accountability-forward discussion is exactly what's worth being in the room for, and it's a preview of the depth Advanced Therapies Europe 2027 will bring back to Barcelona.

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