Day One

• Harmonizing companion diagnostics strategy across Japan, Europe, China, and the US to ensure global clinical and regulatory alignment
• Designing global clinical trials to support CDx development, ensuring coordination between regional diagnostics and global clinical leads

• Exploring how Japan-specific regulatory, clinical, and reimbursement considerations can be aligned with global CDx development strategies
• Sharing practical approaches for selecting CDx partners and designing workflows that balance regional requirements with global launch objectives

Network with your peers during this session to exchange your ideas and generate meaningful industry connections and collaborations with other biomarker and CDx experts

• Lessons from domestic CDx approvals, such as BRAF, and integration of complex biomarkers including TME analysis
• Opportunities and challenges in Japan’s genomic medicine landscape, regulatory approval, and clinical adoption

Myriad Genetics

• Overview of FerroptoCure’s biomarker strategy to support the clinical development of ferroptosis-based cancer therapies
• Current progress and future direction in identifying biomarkers for pharmacodynamic response and clinical utility in refractory cancers such as TNBC

• Join this session, where key voices behind key industry collaborations in the liquid biopsy field will come together to share what it truly takes to translate a global vision into local, patient-level impact.
• Delve into the vision that brought SOPHiA GENTICS and MSK together to bring a best-in-class liquid biopsy assay from one lab to the world, to guarantee equal care across borders
• Understand the evolving landscape of NGS-based liquid biopsy adoption and the remaining barriers to equitable access globally
• Discover how the strategic partnership between SOPHiA GENETICS and A.D.A.M. Innovations is navigating Japan’s regulatory and infrastructural complexities to unlock the full potential of liquid biopsy for patients across the country
• Learn how local partnerships are essential to scaling precision oncology globally, streamlining regulatory pathways and broadening patient access across diverse healthcare settings

• The importance of longitudinal ctDNA monitoring (pre-/on-treatment)
• The challenges of routine implementation under Japan’s current reimbursement framework
• Insights from our mCRC clinical study on how serial ctDNA dynamics may inform patient stratification and CDx utility

• Biomarker assay development, validation & clinical testing solutions tailored for drug programmes
• Flexible platforms, chemistries & technologies for multiple diseases indications
• Support for global regulatory strategies including EU (IVDR) and FDA
• Pharma Case Study: Learn how Almac has supported Global clinical studies

• Generating Japan-relevant clinical data aligned with PMDA requirements for optimized CDx approval
• Coordinating CDx–drug development strategies to bring safe, effective precision therapies to patients in Japan

This is your opportunity to share your work with fellow members of the community, showcasing your biomarker, CDx and clinical data. *Please visit poster session page on website for more details

• MRD detection using ctDNA represents a promising approach for early relapse prediction in breast cancer
• Observational studies showed MRD is a strong prognostic factor consistently across the subtypes and clinical situations
• Interventional MRD-guided trials are now reshaping treatment paradigms