Explore the Agenda
8:55 am Chair’s Opening Remarks
Integrating Reliable Efficacy & PK Modeling to Predict Response of Oncology Therapy
9:00 am Analyzing RNDO-564 Efficacy with Cell Line & Syngenic Mouse Model to Deliver Robust Anti-Tumor Responses
- Harnessing affinity-tuned CD28 costimulation with high-affinity Nectin-4 targeting to maximize localized T-cell activation and potentiate anti-tumor cytotoxicity
- Demonstrating strong in vitro activity through enhanced cytotoxicity and cytokine release against Nectin-4–positive tumor cell lines under signal 1 conditions
- Achieving dose-dependent tumor growth inhibition in syngeneic models and favorable tolerability in primates to validate translational therapeutic potential
9:30 am Advancing Translational Immuno-Oncology: Tumor–Immune Dynamics & Predictive Humanized Models for Immunotherapies
- Highlighting the recruitment dynamics of human immune subsets within the tumor microenvironment in humanized mice
- Harnessing the role of human myeloid and lymphoid cells to investigate tumor biology and therapeutic efficacy
- Showcasing the critical role of myeloid cells in therapy-related immune-related adverse events (IrAEs)
10:00 am Advancing ZW209 Trispecific Design with In Vitro & In Vivo Models to Improve DLL3-Directed Responses
- Incorporating CD28 co-stimulation with DLL3 and CD3 engagement to enhance T cell activation, proliferation, and sustained cytotoxicity beyond bispecific benchmarks
- Demonstrating superior in vitro and in vivo anti-tumor activity through serial challenge assays and xenograft models that highlight efficacy and T cell fitness
- Establishing translational confidence with PK, cytokine release, and safety profiling in primates to support clinical development of ZW209 in DLL3-positive cancers
10:30 am Session Reserved for HUB Organoid
11:00 am Poster Competition & Morning Break
Visit here for T&Cs for submitting a poster.
Addressing Patient Heterogeneity in Tumor Models to Improve Clinical Translation
12:00 pm Turning Tumors into Therapeutic Protein Producers: Non-Viral Gene Delivery to Overcome Patient Heterogeneity & Drive Local Efficacy
- Utilizing a comprehensive multi-omics analysis of cancer and healthy patient’ tissues to design novel tumor-selective synthetic promoters for non-viral therapeutic protein expression
- Validating highly specific and cancer-activated vector expression across diverse PDX models, robustly addressing patient population heterogeneity
- Demonstrating tumor-tropic delivery of engineered nanoparticles, resulting in improved efficacy of expressed immune-modulators in a comprehensive panel of in vivo cancer models
12:30 pm Modeling Tumor Heterogeneity to Capture Variable Patient Responses in Oncology
- Evaluating inter-patient variability by leveraging diverse preclinical models to predict the range of clinical responses and identify potential non-responders
- Incorporating prior treatment history and resistance mechanisms in models to better reflect real-world patient populations and improve translational relevance
- Designing models that address intra-tumor heterogeneity to ensure reproducible and clinically meaningful preclinical efficacy data
1:00 pm Lunch Break & Networking
Implementing Cost-Effective Model Development Strategies to Overcome Resource & Timeline Constraints
2:00 pm Fireside Chat: Optimizing Model Selection for Speed, Cost & Translatability to De-Risk Preclinical Development Under Resource Constraints
- Navigating budget limitations and tight timelines while selecting models with strong translational potential to accelerate preclinical development without compromising predictive accuracy
- Prioritizing model complexity versus practical feasibility across organoids, PDX, and in silico platforms to maximize ROI and clinical relevance within resource-constrained environments
- Implementing tiered model selection strategies that balance throughput, cost effectiveness, and biological fidelity to de-risk candidates faster while maintaining translational confidence
2:45 pm Mastermind Session
This session is your opportunity to share your most pressing challenges, and work as a group to come up with solutions that you can implement right away! Each topic area will have two groups, and each group will have 30 minutes to discuss ways to overcome barriers. Groups will then share their findings with all attendees, giving you maximum exposure to new ideas!
First Session Topic: Providing Guidance to In Vitro Modeling Standards for Toxicity to Align with FDA Expectation & Good Laboratory Practice
- Clarifying FDA requirements with robust in vitro models and refined assays to reduce uncertainty and animal reliance
Second Session Topic: Exploring the Translatability & Reproducibility of In Vitro, In Vivo, Ex Vivo & In Silico Approaches to Improve Clinical Predictability
- Building a comprehensive framework by optimizing diverse preclinical models to improve reliability and predict clinical responses
Exploring FDA-Valued Tumor Models to Ensure Safety Requirements are Met
3:45 pm Poster Winner Awarding Ceremony & Afternoon Break
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.
4:15 pm Applying In Vitro Tissue Models to Evaluate Target Expression & Anticipate Safety of Bispecific T Cell Engagers
- Exploring tumor models in vitro to assess target engagement, cytotoxicity, and mechanistic outcomes beyond primary tumor efficacy
- Profiling target expression across tissues to map potential off-tumor effects and guide tissue panel selection
- Alternative in vitro safety models to anticipate potential toxicity liabilities
4:45 pm Leveraging Retinal Organoids to Advance Animal-Free Drug Testing for Ocular Cancer
- Developing multi-molecular therapeutics to enhance efficacy against late-stage ocular melanoma compared to single-drug approaches
- Harnessing nature-derived compounds to discover novel anti-cancer agents for safer and more effective ocular therapeutics
- Adopting FDA-compliant organoid systems to eliminate animal testing while meeting FDA Modernization Act 2.0 requirements