Day Two

• Detailing the development rationale behind dual CAR design to address resistance challenges and broaden therapeutic applicability
• Showcasing positive IIT clinical trial data for JW Therapeutics’ JWCAR201
• Illustrating the potential of dual CAR-T platforms to advance treatment options across oncology and autoimmunity

• Highlighting biomarker data associated with clinical safety, efficacy from Prizlo-cel anti-CD19/CD20 CAR-T therapy
• Showcasing early efficacy results to illustrate how dual targeting improves clinical response
• Utilizing early success to inform next steps towards expanded clinical use

• Learnings on dual CAR-T design, why targeting CD20xCD22 simultaneously
• Rationale for NHL indication
• Present the eti-cel preliminary data

Enjoy Lunch as you build upon the relationships from the summit so far.

• Targeting of PRAME across tumor types with IMA203CD8 leveraging both CD8+ and CD4+ T cells
• Sharing promising clinical results from a PRAME-directed TCR T-cell therapy including proof-of concept in ovarian cancer
• Discussing opportunities for tumor-agnostic development across a broad spectrum of PRAME expression levels

• Exploring predictive patient and donor biomarkers to determine the cell therapy modalities best suited for individual patients and disease contexts
• Identifying pre-infusion and on-treatment biomarker signals to understand response dynamics and guide clinical decision making
• Evaluating immune fitness and safety related biomarkers to identify patients at risk, anticipate challenges, and enhance therapeutic outcomes

• Demonstrating clinical outcomes from phase 1 trials
• Exploring predictive biomarkers to optimize response, safety and trial design in allogeneic therapies
• Showcasing how clinical data enabled regulatory progress and informed pivotal study strategies

Session Chair: Lonza

• Matching critical raw materials, characterization, and clinical response
• Balancing production and COGS
• Developing multi-modality approach to treat resistant cancers

• Transitioning from a viral to non-viral platform for a cell therapy
• Overexpression of genes to enhance CAR-T function using a non-viral strategy for pediatric rare disease

• Measuring CAR targeting and functional activity across diseases to understand indication-specific performance
• Comparing assay approaches assessing binding, functionality and cytotoxicity to ensure cross-indication characterization

Enjoy Lunch as you build upon the relationships from the summit so far.

• Building phase-appropriate quality systems with defined quality indicators to enable earlystage cell therapy development
• Embedding quality indicators into vendor selection and supplier partnerships to protect execution
• Leveraging quality indicators as strategic tools for risk management and operational agility

• Establishing strategic manufacturing processes early to ensure phase one clarity, reduced rework and a scalable foundation for future growth
• Identifying optimal opportunities to optimize processes to improve manufacturing and trial outcomes
• Collaborating with flexible manufacturing partners to embed long term strategy from the beginning to support seamless scale up

• Comparing US and China manufacturing mindsets to understand the impact of cost-first versus science-first development strategies
• Examining how early manufacturing decisions influence scalability, clinical feasibility, and long-term commercial success
• Examining the role of supplier ecosystems, CDMOs, and local infrastructure in enabling low-cost, high-output cell therapy manufacturing

• Exploring how phase-appropriate control strategies differ across CAR-T products, to ensure fit-for-purpose development strategies
• Evaluating potency and functional assays tailored to each modality to guide safe and effective transition from first-in-human through later clinical phases
• Discussing the evolution of control strategies from FIH to BLA to establish regulatory confidence
• Considerations for post-license control strategy revisions

• Optimizing specification ranges to eliminate inefficiencies and ensure consistent outcomes
• Evaluating critical quality attributes (CQAs) and defining release specifications to effectively reflect product quality

• Unravelling regulatory guidance and process characterization approaches to ensure alignment
• Outlining Lyell’s process characterization approach characterization
• Generating actionable data to establish ranges, controls, and a predictable manufacturing process

Enjoy Lunch as you build upon the relationships from the summit so far.

• Exploring FDA draft guidance on potency assurance to clarify approaches for demonstrating product functionality and consistency data
• Evaluating matrix and orthogonal potency strategies to ensure robust measurement across diverse patient groups and clinical contexts

• Exploring rapid sterility testing methods, including ATP release assays and NGS-based microbial detection, to reduce traditional 7-day timelines
• Implementing rapid QC testing to accelerate vein-to-vein time without compromising safety and regulatory compliance
• Highlighting emerging technologies demonstrating rapid, reliable testing to support clinical and commercial qc workflows

• Discussing lessons learned across process optimization, and regulatory alignment to streamline manufacturing and reduce risk
• Leveraging manufacturing strategies to accelerate commercialization and ensure consistent, reliable delivery of therapies