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 From Treatment to Translation: Tailored PDX models from Patients Pretreated with Approved & Investigational Cancer Therapies
- 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 Session & 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, Oncology Biomedical Research, 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
Chaired by: Tony Arulanandam, Chief Executive Officer & Founder, Synaptimmune Therapeutics
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 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