Day Two

• Identify the limitations of standard-ofcare AML MRD assays: Understand how bulk NGS and multiparameter flow cytometry (MFC) can yield false negatives and false positives due to complex clonal evolution, phenotypic shifts, and overlapping immunophenotypes
• Evaluate comparative clinical data: Single-cell AML MRD clinical study data demonstrates how single-cell multiomics achieves superior sensitivity (93%) compared to traditional flow cytometry (43%) and molecular methods (71%), offering a more accurate stratification of relapse-free survival
• Redefining the future of AML MRD clinical evaluation: Single-cell multi-omics in AML MRD analysis provides the clinical evidence required to anticipate relapse better, establish deciding factors for interventions like treatment consolidation, targeted therapeutic pivoting, and clinical trial stratification

• Presenting examples and key considerations of scientific, operational, and regulatory challenges
• Exploring process and workflow mitigations in drug–diagnostic co-development

Presentation Details to be Announced

• When and how should biomarker evidence maturity trigger formal CDx development to ensure alignment with therapeutic strategy, clinical endpoints, and global regulatory expectations?
• How can organizations define and evolve CDx strategies that align with clinical trial design and biomarker science while accommodating regional variability in regulation, testing infrastructure, and clinical practice?
• What cross-functional models, partnerships, and data strategies are needed to embed CDx considerations seamlessly across the drug development lifecycle and enable synchronized evidence generation and assay readiness?

• Essential attributes of a high‑performing CDx
• Executing complex, multi‑stakeholder CDx programs
• How CDx experience accelerates market, regulatory, and clinical success

• Reviewing critical decision points to ensure Rx-Dx success
• Emphasizing the importance of external market landscaping
• Discussing how to drive alignment across stakeholders in the ecosystem

Inquire about remaining partnership opportunities at sponsor@hansonwade.com

• How can biopharma and diagnostics partners truly synchronize drug-CDx launches to avoid misalignment in assay availability, regulatory timing, and clinical adoption across markets?
• What are the biggest barriers to global drug-CDx adoption at launch, and how can they be proactively addressed within commercialization strategies?
• In an increasingly complex global landscape, how can organizations balance the need for standardized CDx strategies with local market realities to achieve equitable patient access?

Presentation Details to be Announced

• Target expression in indication selection and as potential predictive biomarkers
• Digital pathology approaches and technical challenges
• Optimizing program investment and deciding what data will be enough

• The precision medicine field is producing increasingly complex tissue biomarkers faster than the specialist pathology workforce can support them
• pCR, tumor microenvironment, spatial biomarkers, all require pathologists with specific post-treatment or platform expertise
• Capacity and subspecialty access is the bottleneck nobody is talking about at a program planning level
• What a fit-for-purpose pathology model looks like for biomarker and CDx programs at scale

Presentation Details to be Announced

• Bioptimus has created M-Optimus, the first World Model of Biology, underpinned with the Spatial Tissue Embedding Learning Atlas (STELA)
• By leveraging a massive multimodal repository of patient data, M-Optimus enables mapping of cellular interactions across oncology and immunology at an unprecedented scale
• We will present the latest data demonstrating how this global infrastructure enables researchers to predict high-resolution spatial mapping from standard H&E stained slides, allowing new predictive insights for therapeutic response
• Find out how these multimodal signatures can redefine CDx and de-risk the drug development pipeline

• Discussing efforts to integrate proteomics, metabolomics, lipidomics, imaging, digital phenotyping, longitudinal natural history study data, and patient-reported outcomes into comprehensive biosignatures that provide a multidimensional view of disease progression in rare neurodegenerative disorders
• Exploring how ML approaches enable identification of biologically meaningful biomarker combinations that more sensitively capture disease progression and therapeutic response than traditional single-analyte biomarkers
• Showing future applications ranging from clinical trial readiness and surrogate endpoint development to newborn screening and earlier disease detection in genetically defined disorders

Inquire about remaining partnership opportunities at sponsor@hansonwade.com

• Where do leading technology companies see the greatest unrealized promise and unmet need in precision medicine today, and which technology innovations are required to unlock meaningful clinical and commercial impact?
• How can AI-driven biomarker discovery, precision stratification, and patient-level digital twins be operationalized at scale, and what infrastructure, data strategies, and partnerships are required to make this a clinical reality?