Day Two
Thursday, February 20, 2025
7:30 am Light Breakfast & Morning Networking
8:20 am Chair’s Opening Remarks
Navigating Complex Regulatory Landscapes to Overcome Global Barriers & Achieve Ubiquitous Approvals
8:30 am Panel Discussion: Balancing Innovation & Compliance in Diagnostic Testing Amidst the Final LDT Rule to Ensure Patient Access to Great Drugs
Synopsis
- Debating the positive and negative aspects of the Final LDT Rule for liquid biopsy innovation
- Understanding the responsibilities for drug-diagnostic partnerships in ensuring swift approvals
- How can we minimize financial and temporal burdens of complex approvals in the US?
9:30 am Navigating Regulatory Lab Quality for Liquid Biopsies to Adhere to IVDR Compliance
Synopsis
- Simplifying lab compliance with IVDR and emerging LDT regulations to streamline global market access
- Implementing rigorous audit protocols that reveal hidden compliance gaps overlooked by standard inspections
- Developing robust criteria to evaluate lab partners, ensuring top-tier quality for every
- step of the liquid biopsy process
10:00 am Navigating Challenges in Utilizing ctDNA Profiling for Biomarker-Driven Therapy Development
Synopsis
- CtDNA profiling is applicable throughout the drug development and patient journeys
- Innovative ctDNA profiling approaches are enhancing sensitivity and accuracy
- A globalized approach is needed in today's precision oncology landscape
10:30 am Morning Networking Break
Track A: Discovery & Technology Innovation
Harnessing Multi-Analytes to Advance Comprehensive Oncology Understanding to Unlock Deeper Insights into Patient Surveillance
11:30 am Leveraging cfDNA Methylation Status to Predict Response to Therapy & Exploring its Potential for Early Cancer Detection
Synopsis
- Leveraging cfDNA Methylation Status to Predict Response to Therapy & Exploring its Potential for Early Cancer DetectionÂ
- cfDNA methylation status: prioritizes of the field and future landscapeÂ
- Case study: use of whole blood methylation status for response to therapy in multiple myelomaÂ
- Use of cfDNA methylation status for cancer-risk prediction in solid tumors
12:00 pm Session Reserved for Volition
12:10 pm Panel Discussion: Unleashing the Power of CTCs to Revolutionize Biomarker Discovery & Transform Cancer Insights
Synopsis
- How are CTCs currently being utilized to shape precision medicine approaches?
- Exploring the power of exosomes in early cancer diagnostics to improve accuracy in tumour representation
- Leveraging alternative biological fluids to enhance the detection of complementary biomarkers
Track B: Clinical Development & Commercialization
Overcoming Reimbursement Barriers to Enhance Patient Access to Innovative Therapies
11:30 am Bridging the Gap with Strategies for Achieving Consistent Reimbursement of Liquid Biopsies Across Global Markets
Synopsis
- Examining the varying reimbursement policies for liquid biopsies in different regions and their impact on clinical adoption
- Engaging with payers and healthcare regulators to align on coverage requirements
- Outlining approaches for generating robust health-economic evidence to support reimbursement application
12:00 pm Optimizing Tissue-free ctDNA Evaluations with QCT Technology: Enhancing Sensitivity for Therapy Selection & Enabling Quantitative Therapy Response Monitoring
Synopsis
- Employing our patented QCT technology to achieve single molecule resolutionÂ
- Enhanced limit of detection augments sensitivity in low-VAF setting to improve detection of clinically actionable alterations
- Precise therapy Response quantification and clonal profiling through a personalized methylation-based approachÂ
12:10 pm Predicting Oncology Market Trends Over the Next Five Years
Synopsis
- Therapy Selection: Continued strong adoption
- MRD: The next big wave of growth
- Screening: The eventual future
12:40 pm Networking Lunch
Optimizing Biomarker Discovery with Unparalleled Liquid Biopsy Analysis to Enhance Therapeutic Efficacy in Clinical Trials
1:40 pm Revolutionizing Early Bladder Cancer Detection with Urine-Based Genomic Liquid Biopsies
Synopsis
- Utilizing urine samples for patient screening, providing a reliable and patient-friendly alternative that addresses the challenges associated with tissue and plasma-based testing
- Employing a highly sensitive genomic method capable of identifying a broad spectrum of genetic alterations
- Leveraging the robust detection capabilities of urine-based assays to facilitate earlier diagnosis and more personalized treatment strategies
2:10 pm Roundtable Discussion: Maximizing the Impact of Liquid Biopsies in Cancer Care: Collaboration, Clinical Integration, & Cost-Effectiveness
Synopsis
- Strategies to enhance partnerships among researchers, clinicians, and industry stakeholders to accelerate liquid biopsy innovation and implementation
- Approaches to incorporate Minimal Residual Disease (MRD) testing and ctDNA monitoring into clinical guidelines, ensuring their widespread adoption and effective utilization in cancer treatment protocols
- Analyzing the cost-benefit aspects of liquid biopsies, including the use of affordable digital PCR panels versus traditional sequencing methods, and assessing how these technologies can reduce healthcare costs while improving patient outcomes
2:40 pm Molecular Response in Ovarian Cancer
Synopsis
- Reviewing available methodologies and published studies
- Presenting a Case Review from published studies
- Showcasing lessons learnt from azenosertib clinical studies
Accelerating Liquid Biopsy Adoption through Optimal Implementation & Commercialization to Maximize Clinical Impact & Patient Access
1:40 pm Enhancing Collaboration & Harmonization in Liquid Biopsy Surveillance: A BLOODPAC Perspective
Synopsis
- Highlighting key strategies to foster collaboration among stakeholders in liquid biopsy research
- Introducing the new lexicon designed to standardize terminology and practices across the liquid biopsy field
2:10 pm When Samples Fail, Aspyre Lung Prevails: Rapid, Highly Sensitive RNA/DNA Detection for Challenging Tissue Biopsies & Low VAF Liquid Biopsies in NSCLC Trials
Synopsis
- Understand how Aspyre rescues samples not amenable for NGS
- Learn how Aspyre achieves exquisite performance with all sample types including FFPE, FNA washes, pleural effusions, liquid biopsy
- Harness the power of Aspyre to receive results within 2 days
- Optimize patient enrollment by testing both RNA and DNA in a single test
2:40 pm Enhancing Colorectal Cancer Care: Cost-Benefit of ctDNA Monitoring for Wider Adoption
Synopsis
- How does post-surgery ctDNA detection predict recurrence and support timely intervention in CRCLM patients?
- What are the cost-saving benefits of using affordable digital PCR panels over traditional sequencing methods?
- How can treatment adjustment based on ctDNA status reduce over-treatment, improve patient quality of life, and promote adoption in healthcare systems?
3:10 pm Afternoon Networking Break
Enhancing Liquid Biopsy Utilization through Strengthened Compliance & Strategic Partnerships for Global Market Succes
3:30 pm Session Reserved for Oxford BioDynamics
4:00 pm Driving Innovation through Strategic Vendor Partnerships in Precision Medicine Development for Global Success
Synopsis
- How to establish specific, measurable goals for partnerships to ensure alignment and drive focus on shared outcomes
- How to identify and utilize the unique strengths of each partner to create synergistic solutions that accelerate development timeline
- Maintaining flexibility in adjusting strategies based on emerging liquid biopsy findings to ensure rapid responses and capitalize on new opportunities in precision medicine