8:10 am Morning Networking & Light Breakfast
8:50 am Chair’s Opening Remarks
Maximizing the Impact of Liquid Biopsies to Enhance ADC Safety & Efficacy, Enhancing Precision & Performance
9:00 am Harnessing Liquid Biopsy to Optimize Antibody-Drug Conjugate Development & Treatment Strategies
Synopsis
- How can liquid biopsy improve patient selection and biomarker-driven stratification for ADC therapies?
- What role can ctDNA and other circulating biomarkers play in monitoring ADC efficacy and resistance mechanisms?
- How can liquid biopsy help refine ADC dosing strategies by providing real-time pharmacodynamic insights?
Anti-Body Drug Conjugates
9:30 am Ultrasensitive MRD Detection as a Biomarker for Patient Selection, Drug Efficacy, and Recurrence
Synopsis
- NeXT Personal is an analytically validated, tumor-informed liquid biopsy assay with consistent ultrasensitive 1-3 PPM detection
- Ultrasensitive MRD detection at baseline, landmark, and longitudinal timepoints across multiple cancer indications demonstrates an ability to accurately identify responders quickly, as well as advantages over commonly used endpoint measurements
- NeXT Personal can accelerate decisions in drug development through trial enrichment, dose selection, efficacy evaluation, recurrence monitoring, and surrogate endpoint analysis
10:00 am Next Generation ADCs & Liquid Biopsy CDx Opportunities
Synopsis
- From Mice to NHP: Modulating the efficacy and safety profiles of ADCs through unencumbered site-specific conjugation: why site matters
- CASE: A Blockbuster Opportunity for Liquid Biopsy CDx – rescuing a highly efficacious payload Â
- Multi-Payload ADCs:Â The future focus of liquid biopsy ADC companion diagnostics
Anti-Body Drug Conjugates
10:30 am Morning Networking Break
Accelerating Liquid Biopsy Integration to Improve Targeted Therapy Decision-Making & Drive Standardized Clinical Implementation in Oncology
11:30 am Advancing Liquid Biopsy Applications for RAS-Mutant Cancers to Optimize Targeted Therapy Strategies
Synopsis
- How can liquid biopsy improve the detection and monitoring of RAS mutations to guide targeted therapy decisions?
- What challenges exist in standardizing ctDNA assays for RAS mutation detection across different tumor types and treatment settings?
- How can longitudinal liquid biopsy analysis help track treatment resistance and identify emerging RAS-driven escape mechanisms?
RAS-Mutant
12:00 pm Panel Discussion: Driving Consensus on Analytical Validation Requirements to Expedite Liquid Biopsy Integration in Oncology
Synopsis
- What regulatory and industry collaborations are needed to drive consensus on analytical validation requirements for liquid biopsy in oncology?
- How can we ensure that liquid biopsy assays are validated for their intended use in clinical trials to avoid discrepancies in biomarker interpretation?
- Given the lack of standardization in LBx, what steps should be taken to ensure consistency across platforms?
12:30 pm Lunch & Networking Break
Harnessing Longitudinal Liquid Biopsy Insights to Personalize Treatment, Optimize Dosing & Enhance Response Monitoring
1:30 pm Leveraging Multi-Analyte Liquid Biopsy to Reveal Novel Insights into Treatment Response & MRD Assessment
Synopsis
- Demonstrating the utility of CTCs for biomarker-driven treatment selection and monitoringÂ
- How can we leverage more sensitive assays to enhance CTC applications in the early setting? The cellular residual disease (CRD) concept
- What can a multi-analyte approach offer in the context of MRD detection? Combining MRD and CRD
Novel Analyte
2:00 pm Utility of Circulating Tumor DNA (ctDNA) Assessments to Support Early Clinical Development of Novel Therapeutic Targets
Synopsis
- Examining the role of ctDNA assessments in the early clinical development of the lunresertib and camonsertib combination, with a focus on confirmation rates of enrollment alterations
- Using ctDNA data to support dose and schedule selection for the combination therapy in the Phase I MYTHIC trial
- Correlating early ctDNA kinetics with clinical outcomes to evaluate the effectiveness of the treatment approach
Dosage Regime
2:30 pm Afternoon Networking Break
Clearing the Path to Adoption: Regulatory & Market Forces Reshaping the Future of Liquid Biopsy
3:00 pm Navigating FDA Regulatory Pathways to Accelerate Liquid Biopsy Approval & Adoption
Synopsis
- What are the key FDA regulatory requirements for liquid biopsy assays, and how do they differ for companion diagnostics versus standalone tests?
- How can developers navigate the evolving FDA landscape, including the impact of recent LDT regulations on liquid biopsy commercialization?
- What strategies can companies use to engage with the FDA early, streamline approval pathways, and ensure compliance while maintaining innovation?
3:30 pm Oncology Market Disruptors: What’s Next in the Next 5 Years?
Synopsis
- Therapy Selection: Strong adoption continues to shape precision treatment
- MRD: The next big wave of growth in cancer monitoring
- Screening: The inevitable future of early detection