Conference Day Two
Friday November 22
8:00 am Light Breakfast & Networking
8:40 am Chair’s Opening Remarks
Redefining Patient Monitoring by Enhancing Surrogate Endpoints to Unlock Faster & More Comprehensive Clinical Insights
8:45 am Developing Scientifically Robust “Surrogate” Endpoints Aligned with Regulatory Expectations to Enhance Clinical Trial Execution
Synopsis
• Current efforts to generate the level of evidence necessary to elevate ctDNA modulation as “surrogate” endpoint
• Leveraging liquid biopsies to guide dosage
• How to adapt to the changing regulatory environment to integrate new, ctDNA-based, “surrogate” endpoints into clinical trials?
9:15 am Ultra-Sensitive MRD Utilization to Overcome Challenges in Early-Stage Cancer Recurrence Detection
Synopsis
- NeXT Personal is an advanced tumor-informed liquid biopsy assay with ultra-sensitive detection down to 1 PPM
- Ultrasensitive detection with this bespoke whole genome sequencing based assay improves detection of ctDNA at baseline, and during follow-up, with increased lead time over clinical relapse
- Clinical studies in lung and breast cancer establish a strong correlation of NeXT Personal MRD with patient outcome
9:45 am Advancing Clinical Trials with Liquid Biopsies: From Patient Selection to Potential Intermediate Endpoint
Synopsis
- Exploring the use of liquid biopsies to enhance patient stratification and selection in clinical trials
- Insights into the development and validation of liquid biopsies as potential intermediate endpoint in solid tumor studies
- Addressing the regulatory challenges and technological advancements necessary for the successful integration of liquid biopsies into clinical trial frameworks
10:15 am Advancing Our Understanding of ctDNA Dynamics to Guide Drug Development
Synopsis
- Review published and presented data supporting the role of ctDNA in early relapse detection and therapy response prediction.
- Highlight insights gained from >150 MRD studies involving more >50 biopharma collaborators, encompassing a wide range of therapeutic modalities and tumor types
- Discuss how Natera’s extensive real-world database, encompassing >230,000 patients and >800,000 ctDNA timepoints, can be leveraged to analyze diverse and representative patient populations, deepening our understanding of molecular and clinical responses, including the timing, duration, and depth of response
10:45 am Morning Networking Break
Developing Collaborative Strategies to Enhance the Clinical Utility of Liquid Biopsies & Improve MRD Detection for Patient Monitoring
11:15 am Enhancing Collaboration & Harmonization in Liquid Biopsy Surveillance: A BLOODPAC Perspective
Synopsis
• Highlighting key strategies to foster collaboration among stakeholders in liquid biopsy research
• Introduction to the new lexicon designed to standardize terminology and practices across the liquid biopsy field
11:45 am Next-Gen MRD: Increasing Access to ctDNA Assessment for Biomarker Discovery, Development, & CDx Programs
Synopsis
- A disruptive, low-cost approach to MRD detection and quantification using WGS and a proprietary dPCR platform
- Structural Variants (SVs) are the ideal pan-cancer biomarker for determining MRD status using dPCR
- Increased analytical sensitivity demonstrates improved clinical performance
12:15 pm Panel Discussion: Enhancing MRD-Driven Clinical Trials Through Standardized ctDNA Assay Protocols
Synopsis
• Measuring the impact of standardization on the reproducibility and reliability of LBx tests and studies across different settings
• Collaborating to harmonize pre-analytical, analytical, and patient context variables and terms to advance clinical validation and revolutionize the impact of liquid biopsies
12:45 pm Incorporating MRD Detection & Cell-Free DNA into Clinical Trials: A Comprehensive Overview
Synopsis
- Advanced patient selection strategies in clinical trials: Leveraging cell-free DNA (cfDNA) for precise patient stratification and selection to enhance trial outcomes and personalized medicine
- Innovative detection of minimal residual disease (MRD) and patient surveillance: Utilizing cfDNA as a cutting-edge tool for monitoring MRD and conducting ongoing patient surveillance, improving early detection and intervention
- Technological innovation: Understanding the impact of novel technologies on MRD detection and ctDNA analysis
1:15 pm Lunch & Networking Break
Unlocking Novel Insights with cfDNA & ctRNA Methylation to Revolutionize Precision Oncology
2:15 pm Current Practices & Evolving Landscape of MRD: Next-Generation MRD Solutions in Solid Tumors for Enabling Precision Oncology: A Drug Developers’ Perspective
Synopsis
- Innovative technologies and integrated approaches enhance the detection and quantification of circulating tumor markers
- Cut-off strategy: Fit-for-purpose MRD solutions combined with real-world genomic data mining
- Forward-looking: Leveraging AI and machine learning
2:45 pm Leveraging cfDNA Methylation Status to Predict Response to Therapy & Exploring its Potential for Early Cancer Detection
Synopsis
• cfDNA methylation status: priorities of the field and future landscape
• Case study: use of whole blood methylation status for response to therapy in multiple myeloma
• Use of cfDNA methylation status for cancer-risk prediction in solid
3:15 pm Emerging Roles of ctRNA & ctDNA Methylation for Precision Medicine in Lung Cancer
Synopsis
• Use of ctRNA to improve detection of ALK fusions in non-small cell lung cancer
• Gene expression from ctRNA in oncogene-driven and TKI refractory non-small cell lung cancer
• ctDNA methylation to recapitulate tumor transcriptional phenotypes and tracking of tumor evolution