7:00 am Check-In & Light Breakfast
8:00 am Chair’s Opening Remarks
Driving Global Patient Access for IVDs through Strategic Collaboration, Compliance, & Market-Adapted Solutions to Maximize Precision Medicine Impact
8:10 am The Journey of an FDA-Approved CDx for Rare Fusions: Rozlytrek CDx Case Study
- Genentech’s first FDA-approved tumor-agnostic medicine designed to target both ROS1 and NTRK
- Roche/Genentech and Foundation Medicine (FMI) CDx collaboration: Comprehensive genomic testing is critical to identify patients with rare gene fusions
- Understanding of the techniques for NTRK testing in clinical practice
8:30 am Navigating the Complexity of CDx Development: Lessons From the Front Lines
- Leverage early biomarker insights and flexible planning for timely CDx investment decisions
- Align therapeutic and diagnostic timelines to ensure global regulatory readiness
- Use harmonized lab operations and centralized platforms (genomics, flow, APH) for consistent data and insights
- Enable patient access through custom assay development, validation, approval, and launch
9:00 am Panel Discussion: Paving Towards Strategic Drug-Diagnostic Market Entry Across APAC – From Trial Design to Commercial Success
- Which potential challenges in trial design are we aware of?
- Which CDx strategy and testing models are optimal for maximizing market patient access across APAC and how does this differ per region?
- What are the CDx policies and regulations across APAC, and how can we address critical bottlenecks regarding regulatory adherence and commercialization?
- What precision medicine marker developments are currently underway which might change the future testing paradigm? How might this inform vendor selection?
9:30 am Empowering Drug Development with Epigenomic Liquid Biopsy Technologies
- 5hmC is an epigenetic mark that is associated with active genes and regulatory regions that are cell type- and disease-specific, making it highly suitable for oncology biomarker applications
- Virtuoso epigenomic platform provides genome-wide 5hmC profiles to unlock unique insights into transcriptionally active biological programs from plasma samples
- Virtuoso-powered applications include cancer early detection, identification of tissue of origin, predictive and prognostic biomarkers, and disease monitoring
10:00 am Impact of Current Regulations on Patients’ Timely Access to Drug-Diagnostics Clinical Trials & Case Study of a Newly Approved CDx for Qfitlia®
- Streamlining global clinical trials to meet regulatory demands depending on location
- Comparing IVDR and IDE
- FDA Approval of the Innovance® ATIII test as CDx for Qfitlia® (fitusiran) for Hemophilia patients
10:20 am Morning Networking Break
Dedicated One-on-One Partnering ™
Biomarker Discovery & Translational Development
Clinical Biomarker Development
CDx Development & Commercialization
Biomarker Discovery & Translational Development
Biomarker Discovery & Translational Development Track Chaired by Nicole Sheahan
Pioneering Digital & Blood-Based Biomarkers for Early Detection & Tailored Therapies
11:00 am Novel ADC Insights to Inform Your Biomarker & CDx Strategy
Head of Pathology, Nucleai
- New research on how an antibody-drug conjugate (ADC) can bypass internalization, leading to the bystander effect
- How the tumor microenvironment and immune interactions could influence patient stratification and ADC-immunotherapy combo strategies
- How AI spatial proteomics and IHC, H&E-based quantitative biomarker scoring can give deeper insights into the MOA and efficacy of ADCs
11:30 am Plasma DKK1 Levels are Associated with DKN-01 Clinical Activity in Colorectal Cancer
VP, Leap Therapeutics
- Peripheral DKK1 is elevated in many cancers, often leading to worse clinical outcomes
- DKN-01 in combination with standard of care therapy has demonstrated compelling clinical data in CRC with enhanced activity in patients with elevated plasma DKK1
- CDx development of a plasma DKK1 ELISA assay is undergoing development to support the DKN-01 CRC clinical program
11:50 am Session Reserved for Saga Diagnostics
Presentation Details to be Announced
12:20 pm The Integration of Human Genomics & Proteomics to Advance Biomarker Discovery & Patient Stratification
Director & Head of Human Genetics, Eisai Co., Ltd.
- Proteogenomics has become a powerful tool to improve thebunderstanding of disease mechanisms, identify new drug targetsband biomarkers, and facilitate the patient subgrouping
- The emerging proteome resources and cutting-edge analytic approaches provide novel opportunities for proteogenomic studies
- The utilization of AI/ML in building polygenic risk scores and protein risk scores will open a new avenue for disease mechanistic and clinical translation
12:40 pm Leveraging AI Diagnostics for Digital Pathology: Biomarker Screening & Patient Outcome Prediction from Clinical Trials to Clinical Routine
Chief Pathologist, Life Sciences & Diagnostics Markets Group, Agilent Technologies
- AI Solutions for Biomarker Detection and Patient Identification: Explore how Owkin’s AI solutions enable reliable, scalable biomarker screening and patient outcome prediction support patient identification strategies in clinical trials and informing treatment decisions in routine care
- Advancing IHC with Foundation Models and CDx Applications: Discover Owkin IHC approaches geared towards augmenting pathologist interpretations and supporting the development of CDx tools for ADCs, improving patient selection and access to targeted therapies
Clinical Biomarker Development
CDx Development & Commercialization
1:10 pm Lunch Break & Networking
Dedicated One-on-One Partnering ™
Leveraging AI-enabled Platforms, Evidence Generation & Real-World Data for Patient-Centric Precision Medicine Advancements & Effective Care Pathways
2:10 pm Advancing Digital Diagnostics as Medical Devices: From AI Screening to Disease Management
- Exploring how AI and LLM technologies are being translated into regulated digital diagnostics to support disease screening, diagnosis, and long-term patient management
- Sharing considerations for turning algorithmic insights into clinically integrated, compliant software medical devices
- Highlighting key learnings from digital diagnostic tools that support therapeutic decision-making and enable real-world deployment across diverse care settings
2:30 pm Enabling Precision Medicine Beyond Oncology for Complex, Chronic Diseases
- Revealing the hidden disease mechanisms causing the world’s most common and costly diseases
- Introducing rapid, non-invasive genotyping tests to predict lifetime risk of disease, accelerate diagnosis and enrich clinical trial recruitment
- Delivering clinically actionable results to achieve better health outcomes and reduce the costs of care