Day Two

• Using ctDNA clearance timepoints to optimize dose selection and accelerate internal go or no-go decisions across modalities under Project Optimus
• Expanding beyond mutation profiling through multi-omic approaches to better track resistance, cell surface targets, and combination strategy rationale
• Advancing standardization and regulatory alignment for complex assays throughcollaborative initiatives such as BLOODPAC

• Where can methylation-based liquid biopsy create tangible impact in drug development today?
• Can methylation enable earlier and more confident clinical trial decision-making?
• What must happen for methylation to become embedded in mainstream clinical trial design?

Moderated by:

A dedicated window for strategic one-to-one discussions and targeted networking, enabling attendees to strengthen key relationships and have purposeful conversations that drive meaningful outcomes in precision medicine.

• Building alignment across stakeholders on assay performance and interpretation, including diagnostic vendors, biopharma, consortia and others
• Reducing variability through shared standards and best practices, including standardizing parameters
• Enabling broader clinical integration through harmonized approaches

• Align assay performance and pre-analytical validation with regulatory-grade CDx requirements to ensure sample integrity, analytical robustness and global approval confidence
• Standardize collection, handling and laboratory workflows across trial networks to reduce variability, protect data quality and enable reproducible, scalable execution
• Integrate translational biomarker strategy with operational laboratory oversight to bridge early molecular insight with decision-grade, clinically deployable implementation

• Leveraging ctDNA across Phase I and Phase III trials to correlate molecular response with long-term efficacy, including differentiating early progressors from patients achieving multi-year durable benefit
• Using ctDNA to interrogate why certain targeted therapies deliver exceptional outcomes, while identifying resistance mechanisms that inform rational combination strategies
• Challenging current enrollment paradigms by examining variant allele frequency thresholds and co-mutation burden, and exploring how ctDNA insights should reshape regulatory and clinical trial design frameworks

• How clinical use case, risk tolerance, and decision impact should dictate assay design, validation depth, and deployment setting across screening, MRD, and treatment monitoring
• Practical trade-offs between analytical performance, cost, turnaround time, infrastructure, and scalability when moving liquid biopsy tools from trials into routine practice
• Where AI can meaningfully enhance liquid biopsy workflows, and where added model complexity creates validation, regulatory, or adoption challenges without clear clinical gain

• Comparing radiographic response with molecular response across different tumor contexts
• Highlighting scenarios where ctDNA change precedes or diverges from imaging outcomes
• Guiding interpretation of discordant molecular and radiographic signals

• How to integrate emerging diagnostics, including liquid biopsy, with complimentary modalities to generate earlier, higher confidence clinical signals
• What is required to make these technologies decision-grade at scale, including validation, standardization, and operational workflows
• Where integration most accelerates development, improving patient selection, response monitoring, and resistance insight to deliver better therapies faster

• Peripheral DKK1 is elevated in many cancers, often leading to worse clinical outcomes
• DKN-01 in combination with standard of care therapy has demonstrated compelling clinical data in CRC with enhanced activity in patients with elevated plasma DKK1
• CDx development of a plasma DKK1 ELISA assay is undergoing development to support the DKN-01 CRC clinical program