Explore the Agenda
8:00 am Registration & Light Breakfast
8:50 am Chair’s Opening Remarks
Regulating the Future of Pluripotent Cell Therapies to Enable Safe, Scalable iPSC Development
9:00 am From Benchmarking to Regulation: Building Harmonized iPSC QC That Scales Globally
- Leveraging multi‑year, multi‑site quality assessment rounds to generate empirical evidence that regulators can trust
- Identifying OCT3/4, TRA‑1‑60 and SSEA5 as robust, reproducible markers to support consistent release criteria
- Laying the foundation for interoperable iPSC banks that enable regulatory alignment, manufacturing scale‑up, and equitable global access
9:30 am Audience Discussion: Implementing Regulatory Strategies to Enable Post‑Approval Scale‑Out Without Compromising Product Quality
- Designing regulatory frameworks that support commercial‑scale manufacturing expansion, including site additions, tech transfer, and global footprint growth
- Aligning post‑approval change management with cost‑of‑goods reduction strategies, while maintaining comparability and regulatory confidence
- Ensuring consistent product quality across distributed clinical and manufacturing networks, using lifecycle management and data‑driven oversight models
10:00 am Session Reserved for FujiFilm
10:30 am Morning Break & Networking
Preclinical Track
Discovering New Uses for iPSC-Based Therapies & Establishing Early Performance via Clear QC Expectations to Manage Post-Editing Risk
11:30 am Advanced Preclinical Evaluation Frameworks for Autologous iPSC Therapies
- Patient-Derived Complexity: Leveraging bespoke evaluation platforms to navigate the biological diversity of patient-specific iPSC sources
- Non-Editing Solutions: Establishing high-fidelity functional assays to ensure therapeutic consistency and IND readiness in non-gene edited products
- Translation Strategy: Data-driven approaches to bridge the gap between laboratory-scale characterization and clinical-grade therapeutic production
12:00 pm Development of Sustainable Applications for iPSCDerived Cells Beyond Traditional Disease Indications
- Robust, simpler manufacturing technology with a focus on scalable and streamlined approaches
- Better understanding of in vivo cell behavior to improve insight into cell performance and persistence
- Lowering overall cost by reducing cost of goods and improving accessibility
- Considering hES alongside hiPS cells to evaluate their respective roles and applications
12:30 pm Session reserved for Logomix
Process Development & CMC Track
Strengthening Process Development to Transition iPSC Programs into GMP‑Ready, Commercially Viable Manufacturing
11:30 am Manufacturing iPSC Therapies at Scale, Advancing Off-the-Shelf CAR-NK Production
- Establishing clonal iPSC master cell banks and controlled differentiation workflows to ensure product consistency, scalability, and supply security
- Embedding genetic engineering at the iPSC stage to support robust downstream manufacturing, including enhanced persistence and functional stability of CARNK cells
- Advancing CTH 401, an iPSC-derived TAG 72 CAR NK therapy, through manufacturing-led IND enabling activities ahead of first-in-human studies in ovarian cancer
12:00 pm Roundtable: Building Commercial-Ready Cryopreservation & Delivery Workflows to Improve Durability & Reduce Late‑Stage Logistics Failures
- Developing cryopreservation strategies tuned to different iPSC maturity states ensuring stability, functional recovery, and safe administration across global sites
- Embedding transportation, control‑rate freezing, and cold‑chain management early in process development to prevent last‑mile potency loss as trial volume scales
- Aligning supply chain design, and reagent sourcing with commercial cost structures to avoid runaway COGS in late‑phase manufacturing
12:30 pm Session reserved for Sekisui
12:40 pm Lunch & Networking
Understanding Immune Activation & Escape to Build Safer, More Durable iPSC‑Based Products
1:30 pm Replacing the Brain’s Immune System: Novel Brain Conditioning Approaches to Support iPSC‑Derived Microglia Cell Therapies
- Microglia as both therapeutics and immunological gatekeepers
- Designing brain conditioning strategies to enable durable engraftment, drawing parallels to bone marrow transplantation while navigating CNS‑specific safety constraints
- Key preclinical lessons for advancing first‑in‑class brain cell therapies
2:00 pm Fireside Chat: Balancing Immune Evasion with Safety Controls to Prevent Oncogenic Outgrowth & Improve Preclinical Risk Predictability
- Assessing how iPSC‑derived cells may evade or escape immune surveillance, and the implications for uncontrolled proliferation in vivo
- Integrating kill‑switches, regulated elimination systems, and early oncogenicity assays to counter immune‑escape driven safety concerns
- Designing preclinical studies that separate acceptable immune evasion for persistence from high‑risk profiles that could trigger CRS, ICANS or tumor‑like expansion
Building Robust iPSC Expansion Pathways to Prevent Potency Loss & Enable Commercial‑Ready Volumes
1:30 pm Scaling Up iPSC Production to Commercial Volumes Without Re‑Validation Delays or Loss of Potency
- Unlocking true scale‑up beyond single‑litre bioreactors by controlling aggregate size, metabolism and division behavior
- Reducing the re‑validation load at each scale jump by locking critical process parameters early and establishing comparability frameworks that regulators accept
- Addressing the cost and operational barriers of moving from RUO‑scale runs to commercial‑volume manufacturing while maintaining CQAs and batch‑to‑batch robustness
2:00 pm Roundtable: Scaling Up iPSC Manufacturing to Commercial Volumes to Enable Larger Patient Populations Without Quality Trade‑Offs
- Designing a stepwise scale‑up strategy from small‑scale reactors to large, commercial volumes while maintaining critical quality attributes and therapeutic dose requirements
- Integrating cryopreservation, control‑rate freezer capacity, and logistics into the scale‑up plan, so product potency is retained across larger, geographically distributed patient populations
- Coordinating with CDMOs, raw‑material vendors and clinical sites to align manufacturing scale, site procedures and supply chain reliability for late‑stage and commercial delivery
2:30 pm Afternoon Break & Networking
Building Capital Confidence to Advance Scalable, Investable iPSC Programs
3:00 pm Panel Discussion: De-Risking iPSC Therapies by Aligning Investors, Pharma & Stakeholders to Unlock Commercial Success
With iPSC therapies facing high upfront costs, complex manufacturing demands, and evolving investor sentiment, early alignment across pharma, VCs, and funding stakeholders is critical. This panel will explore how to strategically de-risk clinical development, secure funding, and build commercially viable cell therapy programs in a capital-intensive landscape.
- How to engage pharma BD, VCs, and payers early to overcome the “elephant in the room”, high cost of goods and long development timelines
- What investors look for in scalable, robust iPSC manufacturing strategies before committing capital
- Coordinating government funding, venture investment, and pharma partnerships to support sustainable clinical and commercial success
3:45 pm Roundtable: Securing Investment by Demonstrating Scalable iPSC Manufacturing & Early Commercial Credibility
- Sharing real‑world lessons learned from an iPSC developer that unlocked funding by proving manufacturability beyond benchtop scale, including CQA stability, early comparability data, and clear scale‑up rationale
- Highlighting which technical milestones (genomic stability, potency consistency, suspension feasibility, cost‑per‑dose modeling) most effectively shifted investor confidence during due diligence
- Demonstrating how the team aligned CMC, clinical, and commercial assumptions to show a credible path to pivotal readiness, reducing perceived risk, and accelerating successful capital raise