Pre-Conference Day

Discover the science, breakthroughs, and challenges driving momentum in in vivo therapies and what’s next for this rapidly evolving field. Whether you are actively developing in vivo therapies or exploring the space for the first time, this session is designed to build the insight needed to navigate one of the fastest-growing areas in cell and gene therapy.

• Leveraging circular eRNA therapeutics and t-LNPs to drive potent, transient in vivo CAR-T cell engineering
• Revolutionizing the autoimmune treatment paradigm by achieving deep B-cell depletion and “immune reboot” with a non-integrative product
• Replacing ex vivo manufacturing with scalable, off-the-shelf IV-dosed therapy, eliminating the need for lymphoablation

• Discussing the rapid progression of in vivo therapies, considering the impact on COGs and patient outcomes
• Highlighting in vivo innovations to develop more effective, scalable, and accessible therapies
• Evaluating what’s next for in vivo therapies to understand anticipated clinical progress, expanding disease indications and projected advancements for strategic planning

Take a moment to pause with tea, coffee and refreshments, continue initial conversations and exchange fresh perspectives ahead of returning to the bootcamp session.

• Identifying mechanisms of resistance to understand impact in vivo CAR-T durability
• Balancing armored CAR/TCR designs to optimize long-term efficacy while minimizing safety risks
• Evaluating in vivo therapeutic approaches for treating solid tumors in complex tumor microenvironments

• Exploring the underlying pathology of allergic diseases
• Designing CAR-T therapies to eliminate mast cells, the cellular cause of allergic reactions
• Defining the unmet need for mast cell targeting CAR-T cells

Recharge over lunch while reflecting on the morning’s insights and uncovering new perspectives with your peers before heading into the afternoon session.

• In vivo immune cell engineering with ssDNA
• Developing strategies to allow long term persistence and gene expression
• Preclinical evidence and scale up

• Examining lentiviral delivery platforms to understand current industry benchmarks and opportunities for innovation
• Optimizing vector design and production strategies to enhance durable CAR expression
• Evaluating scalability and manufacturing readiness of lentiviral vectors to support sustainable in vivo clinical and commercial deployment

• Optimizing LNP delivery systems for in vivo CAR-T 
• Screening and selection of mRNA cargo 
• Assembly of preclinical data package to support first in human studies

Explore the latest innovations and practical strategies to automate across development phases, overcoming integration challenges and ensuring consistent outcomes to strengthen commercial viability.

For manufacturing experts across all stages of development, looking to the future.

• Discussing strategies to achieve the highest yield with automated manufacturing
• Exploring the stage of development at which to introduce automation
• Showcasing data achieved using automated manufacturing processes in CAR-T and CARNK therapies

• Exploring the adoption of automated manufacturing process to enhance consistency, output and decrease variability
• Examining integration and flexibility challenges in automation to inform realistic implementation strategies
• Analyzing the impact of automation on cost of goods to optimize resource allocation and support sustainable clinical and commercial manufacturing

Take a moment to pause with tea, coffee and refreshments, continue initial conversations and exchange fresh perspectives ahead of returning to the bootcamp session.

• Evaluating where automation delivers the greatest operational value in CAR-T manufacturing processes
• Integrating automated platforms within GMP manufacturing and quality systems while maintaining data integrity and oversight
• Establishing governance and validation strategies to ensure reliability and regulatory readiness as manufacturing scale

Following an inspiring first round of panel insights, and case studies, continue the momentum with expert speakers as they open the floor to deeper, more dynamic discussions. Join this strategy-sharing session to exchange and strengthen ideas, challenge assumptions, and transform insight into actionable value alongside your peers.

Recharge over lunch while reflecting on the morning’s insights and uncovering new perspectives with your peers before heading into the afternoon session.

• Implementing automated reagent and cytokine management to streamline culture maintenance and reduce errors
• Minimizing media changes and manual handling to improve process efficiency and consistency
• Maintaining high-quality products while reducing cost of goods to support future commercialization

• Facilitating early, open conversations with automation and technology vendors to align process needs, instruments, and materials, reducing integration friction
• Leveraging automation for precise analytical tasks to ensure high assay accuracy
• Reducing operator variability through machine-driven processes to improve data robustness

Step into an immersive experience that clarifies the pharma, biotech and regulatory landscapes and fosters genuine cross-disciplinary collaboration.

Amidst evolving regulations, align R&D and GMP early and smooth the regulatory road to clinc. Then shift focus to the commercial drivers that inform a fast move to the clinic as you learn what drives pharma and investor choices, uncover new academic and biotech innovation and connect with promising assets early to unlock stronger partnerships.

• Clarifying CAR-T FDA regulations within existing biologics frameworks to understand current expectations for CMC, preclinical, and clinical development
• Examining FDA regulatory considerations for emerging in vivo and innovative CAR products to highlight where requirements diverge from ex vivo cell therapies
• Adapting development and regulatory strategies to align with evolving FDA guidance, to advance novel cell therapy programs

• A window into the MHRA’s clinical trial application submission process
• Exploring regulations for new cell therapy innovations
• Discussing the MHRA’s decentralized manufacturing process guidelines

• Evaluating long-term adverse event follow-up trends to determine clinically meaningful safety signals while reducing post-approval burden
• Interpreting evolving regulatory frameworks to enable adaptive decisions that balance patient safety, operational feasibility and commercial sustainability
• Aligning biotech, pharma, academia and patient advocacy stakeholders to support efficient commercialization strategies and evidence-driven long-term study design

Take a moment to pause with tea, coffee and refreshments, continue initial conversations and exchange fresh perspectives ahead of returning to the bootcamp session.

• Examining recent acquisitions to identify common characteristics of companies and technologies that attract big pharma interest
• Highlighting deal structures, valuation trends, and strategic priorities to optimize deal readiness and enhance attractiveness for future partnerships or acquisitions

• Interpreting updated cell therapy GMP and advanced manufacturing technology expectations to leverage regulatory flexibility without compromising compliance
• Examining how evolving regulatory guidance influences clinical outcomes and commercialization pathways to align manufacturing quality with long-term market success

Recharge over lunch while reflecting on the morning’s insights and uncovering new perspectives with your peers before heading into the afternoon session.

• Identifying the ideal development stage for engagement to ensure timely and effective collaboration
• Detailing therapies of interest, considering in vivo and beyond to identify high-value opportunities
• Discussing collaboration processes beyond initial interest to secure

• Connect directly with leading experts in an interactive roundtable setting, sharing your work and showcasing your assets in focused, face-to-face conversations
• For pharma and investors, engage with senior leaders from pioneering biotech and academics early to uncover opportunities for collaboration
• For biotech, gain actionable insights by hearing what your peers are developing and understand first-hand the direction of pharma and biotech innovation
• Leave with new connections, strategic alignment opportunities, and practical knowledge to advance your projects