Cell and Gene Therapy Conference 2026
Engineering Consistency. Scaling Innovation. Advancing Cell & Gene Therapies.
Day Two: 9th December 2026, London, United Kingdom
09:00 Chairperson Opening Remarks
09:10 Accelerating Gene Therapy Development Through Integrated Process Development, Analytics, and Manufacturing Strategies
This session explores how early integration of process development, analytical development, and manufacturing strategy can accelerate gene therapy programmes from discovery through clinical development. It will examine approaches for improving process understanding, reducing development risks, strengthening scalability, and establishing manufacturing processes capable of supporting reliable clinical and commercial production.
09:25 Question and Answer
09:30 Building Scalable Manufacturing Platforms for Viral Vector Based Gene Therapy Products
This presentation examines the challenges involved in developing scalable and reproducible manufacturing platforms for viral vector gene therapies. Discussions will focus on upstream and downstream processing, process consistency, scalability, productivity, manufacturing capacity, and strategies for transitioning from laboratory-scale processes toward clinical and commercial manufacturing environments.
09:55 Question and Answer
10:00 Improving AAV Vector Production Efficiency, Yield, Quality, and Process Consistency Across Manufacturing Scales
This session focuses on improving the efficiency and consistency of AAV vector manufacturing while maintaining product quality during scale-up. It will explore production bottlenecks, process optimisation, yield improvement, critical process parameters, analytical characterisation, and strategies for reducing variability between development, clinical, and commercial manufacturing campaigns.
10:25 Question and Answer
10:30 Managing Process Development Challenges Across Early Clinical and Commercial Gene Therapy Manufacturing
This talk explores how gene therapy manufacturers can manage evolving process requirements as programmes progress from early clinical studies toward commercialisation. It will address process changes, comparability considerations, technology transfer, manufacturing readiness, process validation expectations, and the importance of establishing robust development strategies early in the product lifecycle.
10:55 Question and Answer
11:00 Networking Tea Break To Connect With Peers, Exchange Insights, And Explore Shared Interests.
11:30 Strengthening Analytical Development and Characterisation Strategies for Complex Gene Therapy Products
This session examines analytical strategies required to characterise complex gene therapy products and support consistent manufacturing. Topics will include assay development, potency assessment, identity, purity, safety-related attributes, analytical comparability, method qualification, and the challenges of generating reliable data throughout development, technology transfer, and commercial manufacturing.
11:55 Question and Answer
12:00 Optimising Upstream and Downstream Processing for High-Quality Gene Therapy Vector Manufacturing
This presentation explores opportunities to optimise both upstream production and downstream purification processes for gene therapy vectors. It will examine process intensification, cell culture performance, clarification, purification, concentration, formulation, recovery, and process robustness while considering how individual manufacturing steps influence overall yield, quality, and scalability.
12:25 Question and Answer
12:30 Establishing Robust Technology Transfer Frameworks Between Gene Therapy Developers and Manufacturing Partners
This session examines the complexities of transferring gene therapy manufacturing processes between development teams, internal facilities, and external manufacturing partners.
12:55 Question and Answer
13:00 Lunch Break
14:00 Overcoming Manufacturing Scale-Up Challenges While Maintaining Gene Therapy Product Quality and Consistency
This talk addresses the technical and operational challenges associated with scaling gene therapy manufacturing processes. It will explore how changes in equipment, facility configuration, process parameters, raw materials, and production scale can affect product quality, while discussing strategies for maintaining process control, reproducibility, manufacturing efficiency, and regulatory readiness.
14:25 Question and Answer
14:30 Developing Effective Supply Chain Strategies for Complex Gene Therapy Manufacturing Materials and Components
This session explores supply chain considerations across gene therapy manufacturing, including critical raw materials, specialised components, single-use technologies, reagents, plasmids, and other manufacturing inputs. It will discuss supplier qualification, material availability, forecasting, inventory strategies, supply continuity, risk management, and collaboration between development, procurement, manufacturing, and external partners.
14:55 Question and Answer
15:00 Networking Tea Break To Connect With Peers, Exchange Insights, And Explore Shared Interests.
DRIVING MARKET ACCESS IN CELL AND GENE THERAPIES
15:30 Unlocking Payer Value: Aligning Cell and Gene Therapy Pricing Strategies with Long-Term Outcomes and Real-World Evidence for Market Access Success
This session explores innovative strategies to align CGT pricing with long-term clinical outcomes and real-world evidence (RWE), addressing payer concerns around value, sustainability, and budget impact. Attendees will gain insights into outcome-based agreements, data-driven value assessments, and collaborative approaches to market access that can unlock payer confidence and ensure timely patient access.
15:55 Question and Answer
16:00 Strategic Stakeholder Engagement to Navigate Payer Skepticism in Cell and Gene Therapy Reimbursement
This session will explore how early, strategic engagement with key stakeholders, including payers, providers, regulators, and patient advocacy groups can help mitigate uncertainty and support more sustainable reimbursement pathways. Attendees will gain insights into best practices for evidence generation, real-world data integration, and value communication tailored to payer concerns. The session will also highlight successful models and collaborative approaches that have improved market access and reimbursement success for CGT innovators.
16:25 Question and Answer
16:30 Indication-Based Pricing: Opportunity, Risk, and Reality in Cell and Gene Therapy Expansion
Indication-based pricing offers promise, but limited implementation raises questions. Learn how policy, payer adoption, and provider reimbursement models impact its future, and what lessons can be drawn from successful pricing model.
16:55 Question and Answer
17:00 END OF THE CONFERENCE