Explore the Agenda
8:20 am Check-In & Morning Coffee
9:00 am Chair’s Opening Remarks
Aligning on Model Selection to Meet Current & Upcoming Regulatory Shifts
9:15 am Panel Discussion: Selecting the “Right” Tumor Model Amid New Regulatory Pressures – What Truly Drives Predictive Value, Confidence & Decision Making?
- Exploring how drug developers define the “right” tumor model for each decision point: clarifying what level of biological fidelity, readout quality, and mechanistic insight is truly needed to drive confident progression
- Understanding how in silico, in vitro, and in vivo systems complement one another, and when single‑model data is sufficient versus when convergence across multiple platforms is required to strengthen internal decision‑making
- Examining how well different models correlate with real clinical outcomes and what evidence is still needed for regulators and developers to fully trust emerging technologies as credible, decision‑enabling tools
10:00 am Integrating Robust In Vivo Models & a Bio-Scaffold System to Reprogram Cold Tumors & Empower Immuno-oncology Drug Development
- Showcasing a novel drug delivery–driven tumor model approach, using a long lasting (28 day) bio-scaffold that adsorbs therapeutics, enables controlled release into the TME, recruits and activates immune cells, and reprograms tumor cells toward immune stimulatory states
- Demonstrating AI powered design of multimodal drug combinations, integrating human datasets and transcriptomic signatures to predict optimal scaffold loaded permutations that reshape the TME and enhance anti-tumor immunity
- Spotlighting the rationale for in vivo model selection, testing scaffold-based therapies in immunocompetent syngeneic models to better capture immune activation, TME remodelling and translational relevance
10:30 am Poster Competition & Morning Break
Witness some of the latest and greatest research in the tumor modelling field in this spotlight poster session! Visit the website for T&Cs.
Applications in Drug Discovery & Screening
Chaired by: Rosa Ng, Associate Director, Cell Therapy Innovation Medical & Health, Novartis
11:30 am Roundtable discussions: Building a General Consensus on Model Selection Criteria Across the Industry
- What are the pros and cons of the most implemented models?
- Exploring the various questions and contexts of use for each main model type and how translatable and clinically relevant they truly are
- How did you overcome hurdles encountered with your model when trying to better understand your drug/target?
Cell lines; In Vivo CDX, PDX, Transgenic, GEMMs; Ex Vivo/3D cultures; Computational/ In Silico
12:00 pm Leveraging Colorectal Cancer (CRC) Liver-Metastatic Organoid Models to Advance Immunotherapy Development
- Evaluating CRC liver-metastasis organoid models to support immunotherapy discovery
- Engineering an optimized CRC liver-metastasis organoid model
- Applying CRC liver-metastatic organoids to identify and evaluate novel therapeutics and combination strategies
Applications for Efficacy Evaluation & Biomarker Discovery
11:30 am Exploring a Translational Biomarker Framework for Cell & Gene Therapies
- Showcasing the rationale behind selecting biomarkers to answer modality‑specific questions for cell and gene therapies
- Highlighting how PDX models are used to back‑translate clinical observations
- Demonstrating how validated assay outputs directly inform clinical strategy, strengthening patient‑selection, response‑stratification and biomarker frameworks for early‑phase trials
12:00 pm Accelerating T‑Cell Engager & Co‑Stimulatory Therapeutics Through Patient‑Centric Tumor Model Integration
- Showcasing a strategic model cascade across ex vivo, organoid and in vivo systems to map early TCE and co stimulatory biology; defining activation thresholds, uncovering liabilities, and identifying where TME driven suppression limits efficacy
- Spotlighting patient derived explants and tumor derived organoids to capture real human immune suppression, spatial constraints and tumor intrinsic resistance mechanisms; revealing insights that subcutaneous or cell only models routinely miss
- Demonstrating a rigorous validation pathway from ex vivo to PDX, verifying mechanism of action, multi day durability, exposure–response and combination potential in human relevant settings, enabling confident prioritization of next generation TCE and co stimulatory candidates for solid tumors
12:30 pm Lunch Break
Leveraging In Vitro & Complex In Vitro Models to Successfully Support IND Submissions
1:30 pm Building an IND Package Leveraging In Vitro Only Data for Cell Therapy
- Discussing the need to leverage in vitro cell-based models over mouse models
- Showcasing the types of data to gain from these models to determine some aspects of safety profiles
- Sharing how this data supports building an IND package to the FDA to gain approval for FIH studies where safety will be further determined
2:00 pm Roundtable Discussion: Preparing for IND Filing Leveraging Only Complex In Vitro Model Data
- Spotlighting how advanced in vitro and ex vivo systems can build a robust mechanistic evidence package, demonstrating target engagement, pathway modulation and early efficacy signals in human‑relevant biology in place of in vivo data
- Demonstrating strategies to strengthen regulatory confidence, including rigorous model qualification, reproducibility controls, metadata standardization and cross‑platform validation to address questions typically answered by in vivo studies
- Explaining how to map ex vivo and complex in vitro readouts to IND‑enabling requirements, aligning short‑term functional data with safety, exposure and translational expectations to support a defensible submission pathway
2:30 pm Afternoon Break & Poster Winner Announcement
The winning poster will be announced at this time. The winner will receive their award, and have their poster showcased on our website as a downloadable file.
Applying AI & Next-Generation Models to Supercharge Preclinical Decision-Making
3:00 pm Development of a Tumoroid Screening Platform to Empower Oncology Drug Development
- Spotlighting strategies to build a robust tumoroid platform capable of growing large volume 3D cultures in 24 well formats, enabling scalable expansion and consistent generation of physiologically relevant tumor microtissues
- Deploying high throughput compound screening across diverse tumoroid panels, capturing heterogeneity in growth, drug response and pathway dependency to rapidly identify promising agents
- Demonstrate the translational value of tumoroid models, showing how their architecture, cellular diversity and treatment responses more closely reflect patient tumors – and how these insights improve early decision making in oncology pipelines
3:30 pm Building & Validating the Predictive Power of a Patient-Derived Ex Vivo Platform to Guide Bispecific Development & Clinical Strategy
- Showcasing a patient derived ex vivo platform to test drugs and combinations directly in primary tumor material, enabling precise assessment of therapeutic index, responder likelihood and patient selection strategies before entering the clinic
- Spotlighting a PD‑1/TIGIT bispecific case study across lung and head & neck cancers, demonstrating how ex vivo response patterns aligned with clinical outcomes to validate predictive capability and inform indication prioritisation
- Discussing how AI and foundation models are trained on ex vivo datasets to build predictive classifiers that guide clinical trial design, linking molecular signatures, functional drug responses and patient specific biology to real translational decision making