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

• Detection at 1-3 PPM: Leveraging tumor-informed ultra-sensitivity to detect trace molecular signals previously beyond the reach of standard liquid biopsy 
• Enhanced Clinical Endpoints: Identifying therapy responders faster than traditional imaging through validated MRD monitoring across multiple cancer indications 
• Accelerated Drug Development: Streamlining trial enrichment to facilitate the use of MRD as a surrogate endpoint

• 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?

• Learn about the enhanced 523-gene assay, engineered for expanded mutation detection and efficient turnaround times
• Discover how the panel is designed to help track real-time resistance and catch subclonal escape mechanisms
• Gain insights into efficiently utilizing Tempus xF+ sequencing data within the Tempus data ecosystem

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

• Exploring the shift in oncology biomarker discovery from single-analyte, genomics-focused methods to integrated multi-omic strategies
• Highlighting the limitations of genomics-only approaches and demonstrating how combining analyte classes such as cfRNA, proteins, extracellular vesicles, and spatial tumor biology enhances understanding of treatment response and disease progression
• Unlocking practical guidance for designing robust multi-omic biomarker workflows and structuring translational studies for improved clinical relevance

• 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

• Hologic Diagenode empowers biomarker discovery and drug development through advanced epigenomic profiling and AI/ML-driven bioinformatics
• Our newly expanded portfolio extends beyond cfDNA methylation to encompass chromatin and circulating nucleosome quantification, as well as transcriptomics via comprehensive cfRNA profiling from liquid biopsy-derived material
• We will present real-world case studies illustrating how epigenomic approaches can be applied to treatment response monitoring, assessment of drug efficacy, and diagnostic applications

• 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

• Discover how biopharma teams are leveraging Guardant Health’s liquid biopsy platform earlier in development to accelerate Phase 1 insights and optimize trial strategy
• Explore the utility of non-destructive methylation profiling, tumor fraction assessment, and methylation signatures for advancing translational insights in Phase 1 oncology trials
• Learn through real-world case studies how ctDNA and molecular profiling informed dosing, patient selection, and early signal detection

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

• Critical Decision-Making Matrix: Balancing clinical utilities, drug development approaches, and risk mitigation in liquid-biopsy assay selection strategy
• Define best practice for enabling liquid biopsy from clinical trials to routine clinical application: analytical performance, cost, reimbursement, tiered cut-off strategy, operations, regulatory end-to-end CDx integration, etc.
• Embracing and Taming AI: Accelerating real-world, multi-variant liquid-biopsy analytics, while recognizing that model complexity can introduce validation, regulatory, or adoption challenges and potentially diminish immediate 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