Day Three

• Precision medicine programs increasingly rely on biomarkers to identify the right patients, demonstrate biological activity, and support clinical decision-making. Yet many biomarker strategies encounter significant challenges as programs move from early development into larger global clinical trials
• This presentation identifies common pitfalls that can compromise biomarker-driven clinical development programs.
• It will explain the importance of harmonization across laboratories, assays, and geographies
• Explores fit-for-purpose approaches for biomarker assay development, validation, and global implementation
• Examines considerations for transitioning from exploratory biomarker strategies toward CDx readiness

• Showcasing single-cell approaches for pharmacodynamics and proof-of mechanism
• Reviewing advances in quantitative image analysis and multimodal models

• Explore how early assay assumptions can become patient-selection decision rules before the evidence supports them
• Discuss how clinical studies can be designed to generate meaningful assay insight, including threshold rationale and intended-use alignment
• Review how IVDR performance study requirements impact rare disease trial design, site activation, change management, and adverse event reporting
• Understand why global CDx strategy must account for regional evidence expectations early, including China-specific performance testing requirements

• 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 

• Oncology drug approval timelines are accelerating making contemporaneous development of a companion diagnostic through traditional pathways more challenging
• Our focus will be accelerating early phase development and deployment of novel clinical trial assays, with early access to solutions that enable fast decision making and clinical trial startup
• Integrating digital pathology and AI solutions into IHC assay development to get more bang for your biomarker buck

• Rare New England’s (RNE) broad role in community and policy
• Biomarker-testing from a patient/patient advocacy perspective: Describe the current status of biomarker testing coverage bills across New England and evaluate the impact of these policies on the rare disease community
• What can be done in the future: Explain the role that clinicians and other healthcare professionals can play in facilitating access to care for rare disease patients

Inquire about remaining partnership opportunities at sponsor@hansonwade.com

• Discussing the unique needs of the rare cancer patient community which led to the development of TRACK
• Reviewing the benefits and challenges of decentralized clinical trials
• Providing an overview of data generated in TRACK

Inquire about remaining partnership opportunities at sponsor@hansonwade.com 

Presentation Details to be Announced

• Explore how computational pathology can move beyond cell counting to quantify lymphocyte localisation, tumour-immune interactions and spatial organisation within the tumor microenvironment
• See how LymphoSight has been applied to paired H&E biopsies from a Phase III clinical study to investigate treatment-associated changes in immune contexture
• Learn how pathology-derived spatial features can be translated into interpretable evidence for pharmacodynamic assessment, response biology and biomarker development

• Interpretable and explainable models can teach us about disease and increase user trust
• These goals can be achieved without compromising accuracy
• Showcasing illustrative applications in breast cancer and meningioma

Inquire about remaining partnership opportunities at sponsor@hansonwade.com 

Presentation Details to be Announced

• Botensilimab (BOT), a novel Fcenhanced anti–CTLA-4 antibody, alone or combined with balstilimab (BAL; anti– PD-1), has demonstrated promising clinical activity across immunologically “cold” treatment-refractory cancers
• We assessed systemic, tumor, and clinical features of patients treated with BOT±BAL for metastatic treatment-refractory cancers in the phase 1 C-800-01 trial (NCT03860272)
• In cold and treatment-refractory cancers, clinical outcomes with BOT±BAL appear to depend on the balance between detrimental systemic inflammation and beneficial TME immune activity plus peripheral T-cell differentiation, rather than conventional single biomarkers

Inquire about remaining partnership opportunities at sponsor@hansonwade.com

• Building effective tools to rapidly and accurately harmonize multi-omic data
• Using those tools and direct patient participation to generate high-dimensional data and mine it for discovery
• Narrowing the gap between research and clinical work in rare cancer

Inquire about remaining partnership opportunities at sponsor@hansonwade.com