Advanced Therapies Europe

Deep dive into the regulatory framework that governs CGT across major rejoins, focusing on recent updates, new legislation and how companies can navigate the changing landscape.

• Cutting edge developments in CRISPR, gene editing and cell engineering
• The next wave of in vivo and ex vivo gene therapies
• What breakthroughs are expected to reshape the industry?

• As the pressure mounts to deliver advanced therapies faster, cheaper, and closer to the patient, decentralised manufacturing is stepping into the spotlight. But does breaking away from centralised models really deliver on cost? 

• This panel dives into the economic realities behind the decentralisation trend. Are localised manufacturing hubs the answer to cutting costs, or do they introduce new layers of complexity and hidden spend? From infrastructure investments to regulatory headaches, we’ll separate financial fact from fiction and explore whether decentralisation is a bold leap forward or an expensive detour. 

• Scientific advances and key breakthroughs.
• Safety, efficacy, and regulatory challenges.
• Investment trends and commercialisation potential.

• Balancing technical and financial realities in manufacturing
• When to invest in infrastructure vs outsourcing
• The role of automation in optimising CMC process

• How startups secure investment before reaching human trials 

• strategic and tactical guidance on how to secure the right funding at the right time, from seed rounds through Series A 

• Investor insights into due diligence, risk mitigation and valuation and what good really looks like  

• Transitioning from academic proof of concept to market-ready product 

• Why biotech teams must integrate CMC, regulatory and pharmacology early 

• Avoiding pitfalls of overselling and overpromising 

• Big Pharma loves billion-dollar M&A headlines, but where are they when early-stage innovation needs a lifeline?  

• Why pharma rarely engages before Phase 2, and whether that can change 

• What can early-stage biotechs do to attract big pharma interest? 

• Real-world case studies of early partnerships that defies the trend 

• The manufacturer’s role in proving regulatory feasibility. 

• Case studies of successfully navigating MHRA/GMP challenges. 

• What regulators really want – breaking down assumptions. 

• Best practices for early interactions with EMA, FDA, MHRA etc. 

• How proactive regulatory engagement reduces delays and de-risk trials 

• Lessons learned from companies that successfully navigated approval 

• Why characterisation and analytics remain a major hurdle. 

• Best practices and emerging solutions. 

• Collaborative approaches to tackling technical challenges 

AI is everywhere, but in CGT, real deployment remains limited. This session goes beyond the buzz to explore the tangible opportunities, early wins, and critical barriers to broader adoption. 

We’ll look at where AI is beginning to make a difference and what’s still needed to move from isolated pilots to real impact. What kind of data, infrastructure, and cross-functional collaboration will unlock AI’s full potential in CGT?