Biomarkers, CDx & Precision Medicine US 2026
.png)
Gaylord Pacific Resort & Convention Center, San Diego, CA
.png?width=685&height=180&name=Biomarkers%20CDx%20Pre%20Med%20US%202026%20Logo%20(Dark).png "Biomarkers CDx Pre Med US 2026 Logo (Dark)")
Programme
Day
Seeing the Signal: Quantitative Imaging Biomarkers as Multimodal Predictors in Radioligand
Industry PresentationQuantitative imaging biomarkers provide a non invasive, whole-body readout of tumor burden, target expression, and disease heterogeneity in patients considered for radioligand therapy.
Imaging biomarkers show strong clinical utility for risk stratification, treatment selection, and outcome prediction beyond conventional clinical variables alone.
Combining imaging with clinical and molecular biomarkers enables a multimodal precision-medicine approach that may improve prediction of response, progression, and survival in radioligand therapy.
Translating 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 PresentationBeyond Quantification: Accessing the Forgotten Layer of Biomarker Biology via Aqueous Two-Phase Systems
Industry PresentationStructure Beats Volume: Shifting focus from protein concentration to structural conformation captures critical post-translational modifications missed by genomics and standard immunoassays.
Proven Performance: Cleveland Diagnostics’ FDA-approved, $30M+ IsoPSA® platform utilizes ATPS to detect cancer-specific protein alterations, reducing unnecessary biopsies by 55%.
Future Precision: This framework scales beyond cancer detection into patient stratification, therapy monitoring, and biopharma companion diagnostics.
Cerba 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 PresentationLiquid Biopsies: The Evolving Paradigm For Non-Invasive Disease Management
Industry PresentationShifting the Diagnostic Landscape: Moving from invasive tissue biopsies to simple blood draws, enabling safer and more frequent sampling for patients.
Tracking Cancer in Real-Time: Utilizing ctDNA and circulating tumor cells to monitor treatment response, detect resistance mutations early, and identify minimal residual disease (MRD).
Personalizing Disease Management: Overcoming the limitations of tumor heterogeneity by capturing a comprehensive, dynamic snapshot of a patient's evolving malignancy.
Translational Biomarkers From Preclinical To Clinical Phase Studies
Industry PresentationBiodesix Presentation
Solution Provider PresentationRegulatory Expectations For AI-Derived Biomarkers, Computational Pathology & CDx Development
Panel DiscussionBiomarker Strategies For Novel Cancer Drug Modalities: Does One Size Fit All?
Industry PresentationBiomarker strategy should be anchored in modality-specific biology and mechanism of action.
Emerging modalities require integrated biomarker frameworks spanning target biology, pharmacodynamics, resistance, and longitudinal monitoring.
Successful translation depends on fit-for-purpose assays and incorporation of tumor, microenvironmental, and host-related context.
Flow Cytometry In Patient Monitoring
Industry PresentationNavigating the Evolving Regulatory Landscape for IVDs in Medicinal Clinical Trials: IVDR Challenges and the Path Forward
Industry PresentationCurrent 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 DiscussionCo-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-Powered Precision Medicine
Panel Discussion• The role of AI in personalised medicine
• Challenges of implementing AI in real-world settings
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.
AI For Biomedical Research And Discovery
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.
Building Diagnostic Strategy Across A Pharma Portfolio: What Needs To Be CDx, When, And Why
Industry PresentationFrontage Laboratories Presentation
Solution Provider PresentationBuilding Integrated Precision Diagnostics Of The Future – Uniting Biomarkers, CDx, Spatial Biology & AI
Panel Discussion• Integrating pathology, spatial and multi-omics data
• AI and foundation models for multi-modal diagnostics
• Bridging discovery, CDx and clinical deployment
Liquid Biopsy In Precision Medicine: Lessons From The Past, Applications Today And Future Directions
Industry PresentationSpatial Transcriptomic Analysis In Fibrosis
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 PresentationLeveraging Spatial Biology & AI To Strengthen Our Understanding Of The TME
Industry PresentationHisToSpatialCNV: An Interpretable Deep Learning Method Predicting Spatial Copy Number Variations From Histopathology Images
Industry PresentationWe introduce HisToSpatialCNV, a multi-scale deep learning framework that integrates histopathological features from H&E-stained images to infer spatial CNV patterns.
HisToSpatialCNV outperformed existing methods in a variety of cancer datasets for spatial gene expression inference and showed strong concordance between predicted CNVs and gene expression.
By connecting histopathology to spatial genomics, HisToSpatialCNV offers a powerful, cost-effective tool for studying intratumor heterogeneity using only routine pathology images.
Vizgen 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 Presentation10x Genomics Presentation
Solution Provider PresentationHamamatsu Presentation
Solution Provider PresentationDesigning Robust Multimodal Biomarker Signatures
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 PresentationEnabling Precision Medicine Through Combining Spatial Biology & ADCs
Industry PresentationAI In Multi-Omics Case Study
Industry PresentationSpatial Biology Image Analysis Dealing With Overlapping Cells As Spatial Spillover Of Protein Markers
Industry PresentationQuantum Information Processing For Network Inference In Single-Cell RNAseq Data, And Other Directions In Spatial Biology
Industry PresentationFrom Diseased Tissue Profiling to Target Discovery For Cardiovascular Disease
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 PresentationQuantifying A Picture That Is Worth A Thousand Words: Computational Pathology In Preclinical Drug Discovery And Development
Industry PresentationDiscuss the unique challenges in early stage drug development that involves diverse animal models, highly heterogeneous and sparse data, and rapid turnaround times.
Present case studies to illustrate algorithm development and deployment and show real-world evidence of algorithm performance.
Examine implementation issues, scalability, and life-cycle management.
The New Pathology Playbook: Multimodal Computational Approaches To Enable Precision Medicine-Driven Clinical Trials
Industry PresentationComputational pathology (CP) is transforming tissue-based biomarker discovery and patient selection in drug development. Real-world examples will highlight the synergy of multimodal data integration across histology, artificial intelligence, spatial omics, and data standards and highlight how pathology can generate deeper insights into tumor biology, support scalable precision medicine, and improve clinical trial design and outcomes.
Proscia Presentation
Solution Provider PresentationThe Biomarker Patent Journey From Discovery to Protection
Roundtable DiscussionFrom 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
Computational Pathology Diagnostic Solution Hackathon - Presentations, Judging, & Winning Team Announcement
Industry PresentationOvercoming Challenges In Deploying Foundation Models, LLMs and Agentic AI For Real world Pathology Workflows
Panel DiscussionIntegrating image, text and workflow models
Validation, governance and clinical trust
Workflow orchestration and human oversight
Designing sustainable AI strategies for the next 5–10 years
Computational Pathology Diagnostic Solution Hackathon - Team Discussions & Presentation Prep
Industry PresentationThe Computational Pathology Diagnostic Solution Hackathon will bring together clinicians, pathologists, AI experts, pharma biomarker teams, diagnostics partners, and regulatory stakeholders to develop practical computational pathology diagnostic solutions for real-world biomarker and clinical decision-making challenges.
The session will focus on four key questions:
1. What unmet patient or diagnostic need are we solving?
2. Is the right data available to build the model?
3. How could the model support biomarker or diagnostic development?
4. What regulatory, workflow, and deployment factors must be considered?
5. Clinical Validity
Structure
• Welcome & Objective by Hackathon Chair (10 mins)
• Team Sprint Challenge Session (50 mins)
• Final team presentations (4 x 10 mins – 40 mins)
• Judging & Feedback (10 mins)
• Next steps – Post event report created by Oxford Global and follow-up opportunities identified
The New Pathology Playbook: Multimodal Computational Approaches To Enable Precision Medicine-Driven Clinical Trials
Industry PresentationComputational pathology (CP) is transforming tissue-based biomarker discovery and patient selection in drug development. Real-world examples will highlight the synergy of multimodal data integration across histology, artificial intelligence, spatial omics, and data standards and highlight how pathology can generate deeper insights into tumor biology, support scalable precision medicine, and improve clinical trial design and outcomes.
Building Reliable AI For Biomarker Discovery: Training Sets, Trust And Molecular Research Applications
Industry PresentationAI-Assisted Pathology Workflows: From Model Performance To Pathologist Adoption
Industry PresentationEvaluation of Quantitative Podocyte Effacement Measurement in Pre-Clinical CKD Models
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.
AI-Assisted Cancer Diagnosis In The Real World: What Pathologists Actually Need From Clinical AI
Industry PresentationMaking Pathology Images Measurable: Reproducible Morphology, Biomarker Discovery and Predictive Modelling
Industry PresentationBridging Digital Pathology AI And Sequencing Workflows For Precision Medicine
Industry Presentation
Afternoon Break & Refreshments
End of Event
Lunch Break
Morning Break & Refreshments
Close of Day One & Networking Drinks Reception
Lunch Break
Morning Break & Refreshments
Building Reproducible Multi-Omics Pipelines for Translational Biomarker Analysis in Clinical Trials
Industry PresentationNo sessions found matching your filters.
.jpg?length=600&name=1048e2c3-e8c7-4b49-9c34-abc9914eac2c-2-11764368speaker_photo-Jutta-Eichler-(2).jpg)
.png?length=600&name=1.GenScriptCorporation_Logo_EN_Horizontal_FullColor%20(2).png){kind=logo}
.png?length=600&name=9eaa81ee-5bbe-4b99-86f7-23f16ccb27a8-2-5668375logo-PersonalisCorporateLogo-(2).png)
.jpg?length=600&name=74dfee8e-75c7-46e0-9f51-31b709af2ede-2-5668375logo-Nanion_logo_black_RGB_300dpi-(2).jpg){kind=logo}
.jpg?width=2819&height=1174&name=74dfee8e-75c7-46e0-9f51-31b709af2ede-2-5668375logo-Nanion_logo_black_RGB_300dpi-(2).jpg){kind=logo}
