Explore the Agenda
8:00 am Registration & Light Breakfast
8:50 am Chair’s Opening Remarks
Reducing Quality Control & Potency Assay Bottlenecks to Enable Timely Product Release
9:00 am Accelerating TIL Manufacturing Through Automated QC Release Testing & Next-Generation Potency Assays
- Sharing strategies to accelerate product release through automated quality control workflows, rapid sterility testing, and conditional release approaches to reduce manufacturing bottlenecks
- Exploring how automation can improve consistency, scalability, and efficiency across TIL manufacturing while maintaining product quality and regulatory compliance
- Discussing current challenges in developing meaningful potency assays for TIL products and evaluating emerging approaches to better characterize product function and predict clinical performance
9:30 am Roundtable Discussion: Advancing the Field by Confronting Potency & QC Bottlenecks to Reduce Delays Across Development
- Comparing how different organizations experience potency and release testing challenges
- Discussing how regulators view necessary but non-predictive assays
- Exploring whether greater alignment could shorten timelines for the wider field
10:15 am Morning Break & Networking
Leveraging Predictive Biomarkers & Prognostic Signatures to Refine Patient Selection & Enable More Consistent Clinical Responses in TIL Therapies
11:15 am Advancing Clinical Decision Making by Reverse Translating Tumor & T-Cell Biomarker Signals Into Actionable TIL Response Frameworks
- Leveraging PD-1-positive TIL selection strategies as surrogate biomarkers of tumor reactivity in breast cancer solid tumor
- Correlating TCR clonal expansion dynamics with multiomic translational datasets to identify predictive biomarkers of response
- Building translational workflows to integrate TCR sequencing, tumor biology, and patient response data for next-generation TIL and TCR-T development
11:45 am Advancing Precision TIL Therapy Through Functional Biomarkers & Predictive Response Signatures
- Leveraging pre-treatment tumor biopsies and predictive biomarkers to identify patients most likely to benefit from TIL therapy across melanoma and tumors solid tumors
- Moving beyond phenotype-based markers such as PD-1 and CD39 by incorporating functional measures of autologous tumor reactivity and T-cell potency
- Translating tumor and T-cell intrinsic mechanisms of response and resistance into clinically actionable frameworks for patient selection, product optimization, and treatment decision-making
12:15 pm Engineering TIL to Address the Obstacles to Wider Patient Eligibility
- Optimizing manufacturing to enable tumor tissue procurement by core needle biopsy and improve TIL functionality
- Applying membrane-bound IL15 expression to enable a low-dose lymphodepletion regimen
- Removing IL2-related toxicities using localized, regulatable, membrane-bound cytokine delivery
- Evaluating early safety and efficacy signals from engineered TIL in melanoma
12:45 pm Lunch & Networking
De-Risking First-in-Class TIL Therapies Through Regulatory Alignment & Commercial Validation to Secure Investment & Long-Term Success
1:45 pm Advancing First-in-Class TIL Programs Through Uncertain Regulatory & Quality Expectations for Successful Approvals
- Navigating first time interactions with inexperienced review teams
- Defining and defending potency assays for complex cell products
- Applying quality by design concepts to highly variable therapies
2:15 pm Q&A & Panel Discussion: Evaluating TIL Programs Through an Investor Lens to Drive Sustainable Growth
- Examining how TIL leaders are balancing clinical efficacy, manufacturing complexity, and capital efficiency as investors become increasingly selective following capital-intensive cell therapy experiences
- Discussing the strategic decisions CEOs face when prioritizing indications, advancing next-generation platforms, pursuing partnerships, and managing development risk in a constrained funding environment
- Identifying the clinical, operational, and commercial milestones that most effectively rebuild investor confidence, support sustainable financing, and create long-term enterprise value