Biomarkers, CDx & Precision Medicine US 2026
Gaylord Pacific Resort & Convention Center, San Diego, CA
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Agenda
Programme
Day
Baseline Quantitative PET Parameters: Expanding the Biomarker Toolbox for Outcome Prediction
Industry PresentationTranslating Biomarkers from Discovery to Clinical Use
Panel Discussion• Using biomarkers for patient selection
• Choosing and validating biomarker endpoints
• Lessons learnt in oncology for other therapeutics
AI-Enabled Clinical Trial Innovation - From Biomarker Data to Decisions
Panel Discussion• Utilising AI to design, run and interpret biomarker-driven clinical trials
• Combining multi-omics, imaging and digital endpoints in AI models
Illumina Presentation
Solution Provider PresentationBlood And Spatial Tumour Proteomics Inform The Future Precision Prevention Of Cancer
Industry PresentationCerba Research Presentation
Solution Provider PresentationPBL Assay Science Presentation
Solution Provider PresentationCDx Development & Clinical Utility
Industry PresentationCompanion Diagnostic Development Strategies
Industry PresentationDevelopment Of Azenosertib & CDx For CyclinE1 Expression
Industry PresentationMulti-Omic Biomarkers For Use In Clinical Trials & Reverse Translation
Industry PresentationSeer Presentation
Solution Provider PresentationApproaches For Multi-Cancer Early Detection
Industry PresentationTranslational Biomarkers From Preclinical To Clinical Phase Studies
Industry PresentationBiodesix Presentation
Solution Provider PresentationThe Biomarker Patent Journey From Discovery to Protection
Roundtable DiscussionRegulatory Expectations For AI-Derived Biomarkers, Computational Pathology & CDx Development
Panel DiscussionPreclinical Strategies To Define Biomarkers For Clinical Translation
Industry PresentationFlow Cytometry In Patient Monitoring
Industry PresentationNavigating the Evolving Regulatory Landscape for IVDs in Medicinal Clinical Trials: IVDR Challenges and the Path Forward
Industry Presentation• Current IVDR Performance Study Application (PSA) Challenges: An examination of the regulatory hurdles sponsors face under the IVDR when conducting performance studies in the context of medicinal clinical trials.
• EU Proposed Rule – Integrating IVD Submissions into the Clinical Trial Regulation (CTR): An overview of the European Commission's proposal to streamline IVD regulatory submissions by aligning them with the CTR framework, and its potential impact on sponsor strategies and timelines.
• EU Combined Pilot: Insights from the ongoing EU pilot initiative combining IVDR and CTR review processes, early learnings, and what sponsors can anticipate as this approach matures.
Towards Virtual Patient: AI for Accelerating Medical Discovery
KeynoteToday, medical discovery is extremely slow and expensive, which is clearly not sustainable for the precision health era. I’ll present exciting progress in advancing multimodal generative AI to learn the language of multimodal patient journeys and create a virtual patient world model as digital twin to synthesize population-scale real-world evidence and accelerate medical discovery through AI-powered virtual clinical trials.
Biomarkers To Improve Transplant Rejection Diagnosis and Management
Industry PresentationDrug Sensitivity Tests As Universal Personalized Biomarkers
Industry PresentationPros and Cons of cellular drug sensitivity biomarkers vs. genomic biomarkers:
- Pros: Cellular biomarkers can be measured for almost all patients and almost all drugs
- Cons: Live cancer cells are much harder to collect, ship, and test than dead cancer cells
Mission Bio Presentation
Solution Provider PresentationPrecision Medicine, Genomics, Proteomics And Problem Solving
Industry PresentationTranslating LINE-1 Biomarkers into Clinical Practice for Lung Cancer
Industry PresentationAI-Enabled Approaches For Multi-Cancer Early Detection
Industry PresentationInterpretable Multi-Omics at Scale: Advancing Biomarker Discovery and Precision Oncology with Celsus – AI/ML Multi-Omics Framework
KeynoteHawk Biosystems Presentation
Solution Provider PresentationIVDR Regulations And Their Impact
Panel Discussion• Overview of IVDR Compliance requirements
• Impact on Companion Diagnostics Development
• Challenges and Opportunities for Industry Stakeholders
Quanterix Presentation
Solution Provider PresentationPrecision Strategies Targeting Claudin18.2 In Patients With Gastric Cancer
Industry PresentationNovel pathology programs have been developed to facilitate implementation of Claudin18.2 testing into clinical practice
Claudin18.2 has become a validated target for the treatment of patients with advanced/metastatic gastric and gastroesophageal cancers
A multidisciplinary approach to testing is necessary for successful incorporation of a novel targeted therapy
Keeping Patients At The Centre Of Data-Driven Precision Medicine
Panel Discussion• Co-designing studies, endpoints and communication
with patients
• Explaining complex biomarker and AI-driven
decisions in a meaningful way
Integrating AI & Enabling Bioanalytical Tools For Biomarker Translation
Industry PresentationAI Biomarker Hackathon Presentations Pt 1
Industry PresentationThe AI Biomarker Hackathon will provide an interactive forum for cross-disciplinary collaboration in AI-enabled computational pathology and precision biomarker development. Participants will work in teams to design and present innovative biomarker solutions, exploring AI-driven workflows, validation strategies, implementation pathways, and real-world clinical impact through a fast-paced, collaborative challenge format.
AI Biomarker Hackathon Presentations Pt 2
Industry PresentationThe AI Biomarker Hackathon will provide an interactive forum for cross-disciplinary collaboration in AI-enabled computational pathology and precision biomarker development. Participants will work in teams to design and present innovative biomarker solutions, exploring AI-driven workflows, validation strategies, implementation pathways, and real-world clinical impact through a fast-paced, collaborative challenge format.
Start Up Zone Presentations x5
Industry PresentationThe Start-Up Zone at Biomarkers, CDx & Precision Medicine US gives early-stage companies a platform inside one of North America's most significant drug discovery and formulation gatherings, not a side room, not a satellite event. A ten-minute pitch on the main Start-Up Stage, an exhibition space in the heart of the event, and two days alongside over 600 senior scientists, R&D leaders, business developers and investors from pharma and biotech.
If you are building something that belongs in this field, this is where you introduce it.
Biomedical Foundation Models for Single-Cell and Genomic Discovery: From Disease Mechanisms to Therapeutic Hypotheses
KeynoteTherapeutic discovery remains constrained by long timelines, high costs, and limited clinical success. Recent advances in generative and agentic AI are enabling multi-scale representations of human biology and unprecedented in-silico experimentation. This talk will explore biomedical foundation models for multi-omics and other biomedical entities, emerging real-world applications, and future directions toward accelerating target discovery, mechanistic understanding, and development of more effective therapies.
To Be Announced
Industry PresentationFrom Data Deluge to Decision: Are Spatial and Multimodal Biomarker Signatures Ready for Routine Use
Panel Discussion• Translating spatial and multimodal data into clinically actionable biomarker signatures
• Readiness for routine use: validation standards and clinical integration
Elucidate Biotechnologies Presentation
Solution Provider PresentationTo Be Announced
Industry PresentationTo Be Announced
Industry PresentationVizgen Workshop
Solution Provider PresentationSingular Genomics Presentation
Solution Provider PresentationAddressing The Future Needs Of Spatial Multi-Omics
Panel Discussion• Moving towards the practical implementation of spatial findings
• How to translate into precision medicine
RareCyte Presentation
Solution Provider PresentationMulti-Omics, ML/Data Integration Methodology in Drug Development
Industry PresentationHamamatsu Presentation
Solution Provider PresentationTo Be Announced
Industry PresentationExploring The Potential Of AI & Image Analysis In Spatial Biology Research
Panel Discussion• Applications in transcriptomic studies
• Image analysis workflows
• AI-powered biological insights
• Intersection between Spatial Biology and Digital Pathology / Computational Pathology
To Be Announced
Industry PresentationMeteor Biotech Presentation
Solution Provider PresentationTo Be Announced
Industry PresentationTo Be Announced
Industry PresentationTo Be Announced
Industry PresentationTo Be Announced
Industry PresentationFoundation Models In Drug Development: Where Are We Now And Where Are We Going?
Industry PresentationFoundation models are a relatively recent and high impact addition to the digital pathology AI tool kit. Talk will discuss how we use foundation models, why we are cautious about certain applications and where the field may be going.
Diagnexia Analytix Presentation
Solution Provider PresentationComputational Histology & Digital Staining
Industry PresentationPatholytix Presentation
Solution Provider PresentationDeveloping AI/ML-Enabled Computational Pathology-Based Biomarker, A Regulatory Journey
Industry PresentationTo Be Announced
Industry PresentationTo Be Announced
Industry PresentationProscia Presentation
Solution Provider PresentationImage Analysis in Translational Pathology
Industry PresentationGlomerulosclerosis and proteinuria are established endpoints for evaluating preclinical CKD models.
By comparison, quantitative measurements of podocyte effacement provide distinct insight into structural changes in podocyte morphology.
In this study, we assessed the correlation and value of this new technology for evaluating murine glomerulopathy.
From Methods to Impact: How We Build and Validate Medical Imaging AI to Support Biomarkers and Clinical Decision
Industry PresentationBeyond TROP2 NMR – The Future Of Computational Pathology Diagnostics
Industry PresentationQuantitative Continuous Scoring (QCS) is being leveraged to develop the first computational pathology-based CDx: TROP2 Normalized Membrane Ratio (NMR). However, QCS delivers other human interpretable features beyond Normalized Membrane Ratio (NMR) for IHC biomarker Dx development. We will discuss the future of QCS and AI computational pathology in diagnostic development and deployment.
Building Multi-Modal Biomarkers for Precision Oncology: Integrating Molecular and Imaging Data to Understand Therapeutic Mechanisms
Industry PresentationDeploying Digital Pathology And Computational Pathology At Scale
Industry PresentationDeploying Computational Pathology Across the Pharma Pipeline
Panel Discussion• From discovery to preclinical and clinical
• Embedding DP/CP in standard workflows
• Internal build vs external partnerships
• Future of AI-driven pathology
10x Genomics Presentation
Solution Provider PresentationAfternoon Break & Refreshments
End of Event
AI-Powered Precision Medicine
Panel Discussion• The role of AI in personalised medicine
• Challenges of implementing AI in real-world settings
Overcoming Challenges In Deploying Foundation Models, LLMs and Agentic AI For Real world Pathology Workflows
Panel DiscussionLunch Break
Morning Break & Refreshments
Close of Day One & Networking Drinks Reception
Lunch Break
Morning Break & Refreshments
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