Discussion Topics

What is the future of CAR-T cell therapy?

16–17 June, 2026

The Cell & Gene Therapy Insights Special Interest Group (SIG) brings together leading experts from across the CAR-T ecosystem to address one of the sector's most urgent and timely questions: what comes next for CAR-T cell therapy? This invitation-only initiative provides a trusted, collaborative forum for open discussion and actionable problem-solving — building consensus, defining priorities, and driving meaningful progress for the field.

Central question: What will it take to make autologous CAR-T manufacturing commercially sustainable at the scale the field now needs, across cost, consistency, and access?

• •Is there one manufacturing model – centralized, decentralized, or point-of-care – that will make autologous CAR-T economically viable at the scale the field now needs, or will this decision be based on indication/region?
• •Vector supply and donor variability remain significant cost drivers and volume constraints. What pre-competitive work on raw materials, process standardization, and supplier consolidation could shift the economics? What is already being done?
• •Commercial autologous products increasingly face comparability challenges due to regional requirements and process optimization and evolution during development and post-approval. What would a framework for successful process evolution and life-cycle management be? What is needed from regulators, CDMOs, and sponsors to enable this framework?

Central question: Can allogeneic manufacturing deliver the scale and cost reduction the modality was promised on, and what operational and scientific problems still stand in the way?

• •iPSC-derived and donor-derived platforms have distinct manufacturing trade-offs. Where is the evidence strongest that one can deliver consistent product at clinically meaningful batch size?
• •What about healthy donor-derived starting materials – what does a “good” donor look like?
• •Beyond scale and product consistency, what is the decision matrix for selecting one modality over another, from a manufacturing perspective?
• •Depth and durability of effect remain the clinical questions that gate commercial success. Which manufacturing decisions, from donor selection to process design and targeting, are most likely to influence this?

Central question: As in vivo CAR-T moves from concept toward clinical reality, which manufacturing and supply questions need to be answered now to avoid bottlenecks later?

• •Non-viral and viral vector platforms are maturing at different rates for in vivo delivery. Where are the real manufacturing gaps, and which can be closed with existing infrastructure?
• •Redosing, cost, and durability are the open questions for in vivo CAR-T. Which of these are fundamentally manufacturing problems, and where can better process design or analytics move the needle? What is the effect of the final indication in the decisions?
• •In vivo changes the regulatory, release, and CMC paradigm. What analytical and quality work should start now to support first commercial approvals? What data will be required to demonstrate the required product quality parameters?

Central question: How are advances in delivery technology and CAR construct design reshaping what is possible across CAR-T modalities, and which approaches are closest to meaningful clinical translation?

• •How do the leading in vivo delivery platforms, including EVs, viral vectors, and emerging non-viral approaches, compare on safety, targeting specificity, delivery capability, manufacturing complexity, and indication suitability?
• •When does in vivo CAR-T reach the safety bar for late-stage development, and what does the target product profile need to look like? Does either threshold differ between oncology and autoimmune disease?
• •How is the evolution of gene editing systems changing what is achievable in both ex vivo and in vivo CAR-T, and what are the key remaining technical and manufacturing hurdles to broader clinical application?

Central question: What will it take for CAR-T to achieve durable clinical success in solid tumor indications, and what do the most credible approaches demand from the manufacturing base?

• •Which advances are showing the most credible promise for overcoming the key scientific hurdles in solid tumors, including TME barriers, and where does research need to be directed next?
• •What are the most significant technical and manufacturing hurdles preventing the successful translation of CAR-T therapies into solid tumor indications, and what might the solutions look like?
• •Given the manufacturing complexity and cost of solid tumor development, is ex vivo CAR-T the right modality to lead, or does in vivo offer a more realistic near-term path, and how do their different manufacturing, safety, and efficacy profiles shape the choice?

Central question: Where and how can CAR-T build a compelling, durable value proposition in autoimmune disease, and how will this be scaled to serve much larger patient populations?

• •What does the patient experience need to look like for CAR-T to be clinically and commercially viable in autoimmune settings, and how do considerations around treatment burden and manufacturing turnaround differ meaningfully from the oncology context?
• •What are the priority target indications for CAR-T outside oncology (considering autoimmune disease, allergy, transplant, fibrotic disease, etc.) and what do the population sizes imply for manufacturing capacity, cost of goods targets, and potentially decentralized production?
• •Is the current manufacturing architecture, built for oncology-scale volumes and oncology-scale pricing, fit for an autoimmune future, or does autoimmune demand a fundamentally different operational model?

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Central question: What will it take to get CAR-T to the patients who need it, in the geographies and settings where it is currently unavailable, and how will the field measure whether it is succeeding?

• •Decentralized, regional, and point-of-care manufacturing models are being deployed differently across regions. Which are delivering measurable gains in access, and what evidence would make the case more broadly?
• •Hospital exemption in the EU, and analogous frameworks elsewhere, allow non-commercial access to CAR-T. What role do they actually play in expanding access, and where should the field push for convergence or reform? How do hospital approved therapies factor into this?
• •Access metrics vary widely across sponsors, payers, and regulators. What shared definitions of success, from time to treatment to geographic coverage, would drive more useful comparison? What is the role of Registries?

Central question: How can the CAR-T field engage proactively with regulators to accelerate development pathways without undermining product quality or patient safety?

• •What are the most urgent areas where clearer regulatory guidance is needed, and what are the risks of getting this wrong? Are there any geographies we should look to? (China, Japan, Australia etc.)
• •How should the field respond to the pace of regulatory enablement in China and its implications for innovation in the US and Europe, and what would a coordinated industry position on harmonizing the global regulatory environment require?
• •What are the realistic pros and cons of accelerated regulatory pathways, and how can developers better manage the CMC burden these pathways create, particularly around comparability and process changes post-approval? How will these accelerated timelines affect the CMC quality processes?

Central question: What commercial, pricing, and reimbursement models will make CAR-T sustainable at scale for payers, providers, and developers, without cutting off patient access?

• •Outcomes-based, annuity, and value-based agreements have been piloted across several markets with mixed results. Where has the evidence been strong enough to justify broader adoption, and what is blocking it elsewhere?
• •QALY-based assessment and ICER thresholds sit uneasily with one-time potentially curative therapies. What methodological or policy changes would close the gap, and who in the ecosystem needs to drive them?
• •As indications expand from late-line oncology into earlier lines and into indications with larger patient populations, pricing and reimbursement will face new pressures. How should sponsors and payers prepare, and what precedents help?

Central question: What analytical and QA/QC standards, applied consistently across the field, would meaningfully reduce out-of-specification product, release delays, and wasted manufacturing runs?

• •Potency remains the hardest release parameter to define for cell therapies. Where is a matrix-based approach most likely to gain regulatory acceptance, and how should sponsors build the supporting evidence? Is this the correct approach and can it be standardized to allow inter-product comparisons?
• •Process Analytical Technology and in-line monitoring are advancing unevenly across the field. Which measurements are ready for standardization, and where is pre-competitive method development still needed?
• •Data portability across analytical platforms is a known gap. What work on reference materials, harmonized methods, and reporting formats would make the biggest difference?

Central question: Once a CAR-T product leaves manufacturing, the clinical last mile still loses time, value, and occasionally patients. What operational standards would change that?

• •Methods for traceability and chain of custody vary significantly by site and product. Where would standardized protocols, training, or equipment reduce variability and protect product quality? Could they be mandated?
• •Chain of custody and cold chain from release to infusion remain fragile in many settings. Which operational models, digital or logistical, are proving most reliable at scale?
• •Apheresis-to-infusion timelines are a commercial and clinical constraint. Where in the end-to-end workflow are the largest time gains realistically available?

Central question: How do autologous, allogeneic, and in vivo CAR-T compare across the manufacturing, clinical, and commercial criteria that will determine long-term success, and can they realistically coexist, or will one or two come to dominate?

• •Structured comparison across defined criteria, including indication suitability, patient access and reimbursement potential, manufacturing scalability, safety profile, delivery maturity, and commercial fundability: where does each modality lead, and where does it lag?
• •What is the investment and funding landscape telling us about which modality the market believes in, and does the market’s current view align with the scientific and clinical evidence, or is there a meaningful divergence?
• •Is there a realistic scenario in which all three modalities sustain a durable commercial role, or will consolidation occur, and what should early-stage biotechs, investors, manufacturers, and large pharma each be building toward today?

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