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 Are We Competing or Failing Together? Rethinking Global Access for Precision Medicine
- How bold, strategic collaborations between regulators, diagnostics, Association and pharma can unlock global patient access to IVD
- Why compliance and market-shaping access solutions must evolve to match the ambition of precision medicine
- The urgent need to redefine our competitive mindset – from siloed wins to shared impact
8:30 am Session Reserved for Labcorp
Presentation Details to be Announced
9:00 am Panel Discussion: Paving Towards Strategic Drug-Diagnostic Market Entry in China – 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 in China?
- What are the CDx policies and regulations across China, 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 IVDR & IDE/LDT Regulations on Patients’ Timely Access to Drug-Diagnostics Clinical Trials
- Streamlining global clinical trials to meet regulatory demands depending on location
- Introducing efficient strategies to manage and reduce the complexity and volume of approval applications within the European regulatory environment
- Comparing IVDR and IDE
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 in Oncology & Neurological Indications
11:00 am Session Reserved for SOPHiA GENETICS
Presentation Details to be Announced
11:30 am Plasma DKK1 Levels are Associated with DKN-01 Clinical Activity in Colorectal Cancer
Vice President, Translational Medicine, 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 Session Reserved for Owkin
Presentation Details to be Announced
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 AI-Driven Precision Medicine Approaches for Complex, Chronic Disease
- Meeting unmet needs in Long COVID, endometriosis, and ALS by characterizing patient sub-groups
- Aligning mechanism-based stratification biomarkers with patient phenotypes
- Post-hoc identification of responder groups based on genetic biomarkers