Getting a therapy approved is only part of the challenge.

Achieving real patient access across Europe’s fragmented health systems requires navigating country-specific pricing, reimbursement processes, and adoption barriers that vary significantly across member states.

The companies making progress are those building commercial strategies that work with payers from the start, not after approval.

Key discussion points:

• Building commercial strategies that align with European payer expectations from day one
• What actually gets therapies reimbursed across different countries
• How to demonstrate economic value alongside clinical efficacy
• From approval to access: making therapies deliverable and financially viable at scale

Manufacturing remains one of the biggest bottlenecks in advanced therapies.

The pressure to shift toward automated, scalable, and cost-efficient production is growing, but doing so without compromising on quality or regulatory compliance is a significant operational challenge.

Getting the economics right at the manufacturing stage is increasingly what determines whether a therapy reaches patients at all.

Key discussion points:

• AAV manufacturing reality: what broke at scale and what had to change
• Engineering cost out of CMC: where process and production choices change the economics
• Building for the long game: what industrialising CGT at scale really takes
• Balancing quality, regulatory requirements, and commercial viability in production planning

Capital is moving more selectively across advanced therapies.

Investors are placing greater emphasis on efficiency, execution, and long-term value over early-stage promise.

For therapeutic developers, that means structuring funding rounds, partnerships, and growth strategies with more rigour than ever before, and making a clearer case for why their programme is worth backing in a tighter market.

Key discussion points:

• How to position your programme for investment in a more selective funding environment
• Choosing the right type of capital for your stage and long-term strategy
• Building partnerships and deal structures that support sustainable growth
• Where investor capital is actively moving in European CGT right now

Innovation across in vivo and ex vivo therapies is moving fast, but turning that science into clinical momentum remains complex.

Site readiness, trial logistics, and cross-border coordination continue to slow programmes that should be moving faster.

Alongside this, AI-driven approaches are beginning to change what is possible in trial design and execution, and Europe needs to move quickly to take advantage.

Key discussion points:

• Improving site readiness and trial logistics to keep programmes on track
• How AI-driven approaches are beginning to reshape clinical development
• Why promising CGTs still stall and how smarter trial infrastructure unlocks flow
• What is accelerating in CGT clinical trials across Europe and what is still stuck

Clinical success alone is no longer a guarantee of patient access.

Payers and health systems are demanding stronger real-world evidence, clearer demonstration of patient benefit, and greater alignment between trial design and the realities of healthcare delivery.

Putting patient outcomes at the centre of development and commercial strategy is no longer optional, it is what gets therapies to the people who need them.

Key discussion points:

• What patients are still telling us about access failures and what needs to change
• Aligning trial design and commercial strategy with healthcare system needs from the start
• Moving beyond clinical efficacy to demonstrate real-world outcomes and patient experience
• How Europe turns allogeneic breakthroughs into therapies patients can actually receive