Explore the Agenda
7:50 am Morning Check-In & Coffee
8:20 am Chair’s Opening Remarks
Ensuring Liquid Biopsies Clears Regulatory, Data & Adoption Hurdles to Become a Widely Accepted Tool in Clinical Trials
8:30 am Liquid Biopsy Across the Drug Lifecycle: Discovery, Differentiation & Adoption
- Showing how Amgen leverages ctDNA and other modalities across discovery, clinical development, and commercialization to accelerate differentiation, regulatory approvals, and market adoption
- Highlighting case studies where ctDNA and liquid biopsy analyses informed dose selection, early efficacy readouts, and patient stratification, directly supporting faster decisionmaking and clinical success
- Discussing how Amgen generates the biomarker evidence base needed for regulators, payers, and clinicians to embrace liquid biopsy as a standard tool in advancing precision medicine
9:00 am Caris Assure: Advancing Clinical & Biopharma Insight Through Liquid Biopsy
- Expanding WES-based reporting to incorporate pharmacogenomic and emerging biomarkers (e.g., DPYD)
- CHIP-aware liquid biopsy interpretation to reduce false positives and strengthen variant confidence
- Real-world case studies
9:30 am Panel Discussion: Accelerating the Use of MRD as a Surrogate Endpoint Across Indications
- Leveraging existing MRD evidence from hematology (e.g. multiple myeloma) to inform regulatory and policy pathways in new settings
- Driving alignment on assays, thresholds, endpoints, and timepoints to ensure cross-study comparability and reproducibility
- Building collaborative frameworks and secure data-sharing models to generate the robust evidence required by regulators and payers
10:00 am Clinical Utility of a Pan-Cancer WGS-based MRD Assay
- Explore the latest clinical data which has been generated using ultrasensitive MRD from a major pan-cancer study led in Japan
- Discuss real-world clinical use cases for a pan-cancer WGS-based MRD assay
- Share perspectives on applying ultrasensitive MRD testing in practice
10:30 am Morning Refreshments & Networking Break
Track A: Preclinical Development & Early Translational
From Exploratory Tools to Accepted Endpoints: Unlocking the Path for ctDNA & MRD in Solid Tumors – Chaired by
11:00 am The Evolution of ctDNA Assays – From Initial Clinical & Regulatory Utility to a Potential Innovative MRD Endpoint in Solid Tumor Indications
- Clinical and regulatory utility of first generation ctDNA assays
- The need for innovative endpoints and important advancements of ctDNA assays to serve as MRD assays
- An example of a potential pathway to establish ctDNA for MRD testing in a solid tumor indication
11:25 am From Market Insight to Clinical Impact: Developing an Ultrasensitive ESR1 ddPCR Assay
- Why ESR1 now: ESR1 has become a time-sensitive, longitudinal ctDNA biomarker, enabling earlier insight into endocrine resistance as ER-targeted therapies expand
- Monitoring needs different tools: Reliable resistance tracking requires ultrasensitive, reproducible detection at very low allele fractions, positioning ddPCR as a strong fit for longitudinal monitoring
- From insight to action: A real-world case study showing how market and clinical needs translate into a validated ESR1 ddPCR assay that supports meaningful R&D decisions
11:55 am From Assay to Action – Making MRD a Practical Tool for Treatment Decisions in Hematology
- Bridging assay development and translational research to define clinically meaningful MRD cut-offs and endpoints
- Designing MRD-guided clinical trials to inform treatment decisions, including escalation, consolidation & de-escalation strategies
- Addressing turnaround time, cost and implementation challenges to ensure MRD assays can move from trials into routine practice
12:20 pm KRAS & Beyond: Integrated Liquid Biopsy & MRD Solutions for Global Oncology Drug Development
- End-to-end liquid biopsy solutions supporting KRAS, ADC, Radioligand, and broad oncology drug development programs
- Personalized tumor-informed MRD solutions with or without baseline tissue, alongside tissue-naive methylation-based MRD approaches
- Harmonized tissue and liquid biopsy testing solutions supporting global clinical trials across the U.S. and China
Track B: Clinical Development & Commercialization
Navigating Regulatory & Policy Hurdles to Accelerate Global Adoption of Liquid Biopsies – Chaired by
11:00 am Navigating the Complex, Uncertain Regulatory Environment to Expedite Global Patient Access to Liquid Biopsy Testing
- How to drive global approvals – and expedited approvals – for liquid biopsies
- Understanding evolving global regulatory landscape and call for harmonization
- Emphasizing the importance of early regulatory considerations in clinical studies
11:25 am ctDNA in Oncology Development: From Dynamic Monitoring to Emerging Clinical Endpoints
- Burning Rock’s ctDNA platforms enable real-time assessment of tumor dynamics and molecular evolution, empowering more precise and adaptive clinical development strategies
- Through both tumor-informed and tumor-naïve MRD assays, Burning Rock provides robust solutions for residual disease detection and translational research in solid tumors
- With MRD already accepted as an endpoint in hematologic malignancies, emerging data from solid tumors may soon position ctDNA-based MRD as a surrogate endpoint to accelerate oncology trials
11:55 am Roundtable Discussion: Designing Clinical Trials with MRD as a Patient Identification Tool to Transform Precision Oncology
- What are the biggest opportunities and limitations of leveraging MRD as a patient identification tool compared with its use for monitoring or as a trial endpoint?
- How are pharma and biotech teams approaching assay selection given variability in MRD sensitivity and methodologies?
- What practical challenges – regulatory, operational, or clinical – remain for embedding MRD-driven patient identification into trial design at scale?
12:30 pm Lunch Break & Networking
Track A: Preclinical Development & Early Translational
Unlocking the Potential of CTCs, Extracellular Vesicles, miRNAs & Proteins to Transform Clinical Decision Making
1:30 pm Serial Monitoring with a Tissue-Free, Epigenetic ctDNA Assay Identifies Early Molecular Progression & Improves Prediction of Immune Checkpoint Inhibitor Response
- Early identification of non-responders to immune checkpoint inhibitors is critical, yet radiographic assessments can lag and miss true biological progression
- This study shows that serial monitoring with a tumor-naive, methylation-based ctDNA assay more sensitively detects molecular progression, outperforming RECIST and identifying treatment failure nearly two months earlier
- Longitudinal ctDNA dynamics provide independent prognostic value and enable more timely, informed clinical decisions
2:00 pm Expanding the Role of Emerging Analytes in Liquid Biopsy to Strengthen Translational Oncology Studies
- Exploring how protein, RNA and DNA in circulation can provide value in early-phase solid tumor studies
- Assessing the unique opportunities and limitations of protein based analysis compared with nucleic acids
- How exploratory analytes can complement DNA-based approaches to support ADC development and broader translational insights
Track B: Clinical Development & Commercialization
Advancing Reimbursement, Access & Adoption to Deliver Liquid Biopsies to Every Patient in Need
1:30 pm Pathlight MRD Finding the Right Patients Faster
- SAGA Diagnostics has commercialized Pathlight MRD in early breast cancer and CRC
- We continue to expand Pathlight's footprint across the patient journey but into new indications
- We are further expanding our reach by offering Pathlight MRD for clinical trial referrals, enrollment and global deployment
2:00 pm Empowering Clinicians to Confidently Integrate Liquid Biopsies into Everyday Practice
- Addressing knowledge gaps by providing clear, accessible education on interpreting LBx results and linking them to treatment decisions
- Collaborating with medical societies to embed LBx guidance into specialty guidelines and continuing medical education programs
- Building trusted, ongoing communication channels between diagnostics developers, pharma, and front-line clinicians
2:30 pm Afternoon Networking Break
New Frontiers: Charting the Next Era of Liquid Biopsies to Transform Medicine Beyond Cancer
3:00 pm New Frontiers in Plasma-Based Diagnostics for Alzheimer’s Evaluation
- Advancements in Alzheimer’s Diagnostics: The presentation explores the multi-step process of diagnosing Alzheimer’s Disease (AD), emphasizing the role of various clinicians and the use of CSF testing and PET neuroimaging, and the overall importance of biomarkers in evaluating AD pathology
- Biomarker Innovations and Applications: The presentation delves into the progress towards a biological definition of AD, categorizing biomarkers into amyloid plaques, tau, and neurodegeneration. It discusses the emerging use of blood-based biomarkers (BBMs) for evaluating AD pathology, including their advantages, challenges, and the need for standardization in plasma biomarker testing
- Future Directions and Recommendations: The presentation outlines the rationale for focusing on specific plasma markers like P-tau217, the performance recommendations for BBMs, and the dual cut-point approach to achieve high sensitivity and specificity. It also presents data on commercially available plasma P-tau217 tests and recent updates to guidelines
3:30 pm RNA Liquid Biopsy: A Biological Intelligence Layer Beyond ctDNA for Earlier Intervention
- Novel RNA biomarker discovery using the latest transcriptomic platforms
- Earlier detection and intervention using ultrasensitive RNA biomarkers and AI
- Actionable therapeutic and portfolio insights for enhanced decision-making
4:00 pm Closing Remarks: Liquid Biopsy in Precision Medicine – From Proof-of-Concept to Routine Clinical Practice
- Moving from niche to a routine clinical tool: advancements in liquid biopsy over the last 10 years
- Challenges and opportunities as we look to the next 10 years of liquid biopsy in precision medicine
- Future directions and emerging technologies to address unmet needs