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 Session Details to be Confirmed
Synopsis
Session hosted by Personalis.
Details to be revealed soon.
9:45 am Advancing Clinical Trials with Liquid Biopsies: From Patient Selection to Surrogate 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 surrogate 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 Session Details to be Confirmed
Synopsis
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 Session Details to be Confirmed
Synopsis
Session Hosted by SAGA Diagnostics.
Details to be revealed soon.
12:15 pm Panel Discussion: Enhancing Collaborative Research through Standardized LBx Protocols to Enrich Harmonization in Clinical Research
Synopsis
• Measuring the impact of standardization on the reproducibility and reliability of research findings across different settings
• Refining clinical validity and analytical validity to revolutionize impact of liquid biopsies
• Demonstrating clinical utility of liquid biopsies
1:15 pm Lunch & Networking Break
Navigating Strategic Pathways to Reimbursement & Regulatory Success for Blood-Based Biomarkers in Oncology
2:15 pm How to Expand Global Market Access for Liquid Biopsies in Oncology Fields
Synopsis
• Evaluating approaches to standardize reimbursement for liquid biopsy diagnostics
• Identifying and overcoming specific challenges in obtaining reimbursement approval for non-oncology companion diagnostics
• Leveraging best-case examples to streamline reimbursement processes for patients needing liquid biopsies
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