Explore the Agenda
8:00 am Morning Check-In & Coffee
8:20 am Chair’s Opening Remarks
Ensuring MRD Clears Regulatory, Data & Adoption Hurdles to Become a Widely Accepted Surrogate Endpoint in Clinical Trials
8:30 am Translating MRD into Regulatory Evidence: Defining the Approval & Adoption Pathway in Solid Tumors
- Addressing analytical and clinical validation standards required to support regulatory review of MRD assays in oncology drug development
- Integrating MRD into trial design to generate evidence packages that enable regulatory qualification as surrogate endpoints
- Aligning regulatory and payer expectations to accelerate acceptance of MRD as a decision-making tool in routine oncology practice
9:00 am Presentation Details to be Announced
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
10:30 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
11:30 am The Evolution of The ctDNA Assays – From Initial Clinical & Regulatory Utility to a Potential Innovative MRD Endpoint in Solid Tumor Indications • Clinical and regulatory utility of first generation
- 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
11:55 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 cutoffs 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 fri om trials into routine practice
12:20 pm Presentation Details to be Announced
Track B: Clinical Development & Commercialization
Navigating Regulatory & Policy Hurdles to Accelerate Global Adoption of Liquid Biopsies
11:30 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
11:55 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?
12:20 pm Session Available for Partnership
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 RNA Liquid Biopsy Technology for Precision Oncology
- Utilizing nanopore sequencing to discover over 250,000 novel RNA biomarkers of precancer and cancer
- Training machine learning models using novel RNA features to classify precancer and cancer with near perfect sensitivity and specificity
- Discovering novel therapeutic targets and RNA biomarkers for precision oncology
1:55 pm Presentation Details to be Announced
2:25 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
2:50 pm Presentation Details to be Announced
Track B: Clinical Development & Commercialization
Advancing Reimbursement, Access & Adoption to Deliver Liquid Biopsies to Every Patient in Need
1:30 pm Tackling Policy Issues to Ensure Patient Access to Testing & Facilitate Longitudinal Monitoring
- Assessing the limitations of the current policy environment for liquid biopsies, especially for serial monitoring
- How to influence and overcome policy issues preventing patient access to therapeutics
- What are the realistic milestones to hit to expedite better patient access to better drug-diagnostics?
1:55 pm Presentation Details to be Announced
2:25 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
2:50 pm Presentation Details to be Announced
3:20 pm Afternoon Networking Break
New Frontiers: Charting the Next Era of Liquid Biopsies to Transform Medicine Beyond Cancer
3:50 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
4:20 pm Rethinking Strategy: Moving Beyond Disease Stage with AI-Enabled Translational & Retrospective Drug Development
- Challenge traditional disease stage–focused development by adopting strategies that transcend indication silos
- Explore how AI can act as a disruptive enabler to reimagine how translational data is collected, integrated, and applied
- Demonstrate how these combined approaches can retrospectively inform new molecule design and accelerate the next generation of therapies