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?
9:00 am Session Reserved for Natera
9:30 am Navigating Evolving Global (Ex-US) CDx Regulations
Synopsis
- Exploring IVDR challenges and lessons learned in application to clinical trial design
- Discussing China’s CDx rollout
- Tackling Japan and its single-payer system
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
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 CTC’s 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 better 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 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
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 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 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?
2:40 pm Afternoon Networking Break
Enhancing Liquid Biopsy Utilization through Strengthened Compliance & Strategic Partnerships for Global Market Succes
3:30 pm 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
4:00 pm Session Reserved for Oxford BioDynamics
4:30 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