Biomarkers, CDx & Precision Medicine US 2026
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Gaylord Pacific Resort & Convention Center, San Diego, CA
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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 DiscussionThe panel of current FDA regulators and drug and diagnostic regulatory leaders explores a future in which foundation models, large language models, and generative AI are integrated into computational pathology-based and multimodal approaches. It examines how to develop biomarkers with confidence, supported by biological plausibility and data-driven evidence, and addresses regulatory expectations, validation pathways, pharma-diagnostic co-development, and innovative trial design.
Biomarker 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.
Building the Next Generation of Precision Transplant Medicine
Industry PresentationOrgan transplantation is entering a new era in which precision diagnostics and artificial intelligence are transforming the detection, prediction, and treatment of allograft injury. Traditional approaches rely on serum creatinine and invasive biopsies that often detect injury only after irreversible damage has occurred. Our work has focused on developing an integrated precision medicine platform that combines non-invasive molecular diagnostics, multi-omics, systems biology, and computational drug discovery to enable earlier intervention and individualized therapeutic strategies.
Drug 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 Presentation• The highly invasive procedures typically required to obtain specimens for the clinical evaluation of lung cancers pose significant risks and delays in patient care.
• Long INterspersed Element-1 (LINE-1) mRNA is readily detectable in plasma exosomes across all non-small cell lung cancer stages and correlates with histological subtype, tumor stage, tumor size, lymph node involvement, distant metastasis, and smoking status in both males and females.
• The strong diagnostic and prognostic performance of this liquid biopsy platform underscore its potential to advance the clinical evaluation of patients with lung cancer.
AI-Enabled Approaches For Multi-Cancer Early Detection
Industry PresentationThe Celsus Approach: State Representations And Interpretable Multi-Omics Models For Predicting Cancer Response To Therapeutic Interventions
Keynote• Understanding the nature of the oncogenic state and how individual cancer cells respond to different therapeutic interventions, demands a highly sophisticated and comprehensive conceptual and modeling framework that can effectively capture and summarize complex molecular data across a group of cancers at multiple levels.
• We propose a cancer modeling strategy focused on learning state representations at the cellular and tumor population levels to reduce dimensionality and manage the complexity of cancer by encoding relevant information about the system's components and their relationships in a structured and compact manner.
• Celsus' strategy is to first generate high-level multi-omics features (unsupervised) that either summarize overall behavior or represent specific hallmarks of a universe of cancer samples, and then select some of them, as determined by Information-Theoretic metrics, as input to Bayesian Weight of Evidence (WoE) predictive models.
Hawk 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
From Bench To Bedside: Unifying Biomarker Translation Through A Connected Data Platform And Agentic AI
Industry Presentation- The biomarker translation bottleneck is a data and handoff problem, not a science problem.
- A unified platform brings biomarker, PK/PD, and multi-omics data science under one governed, reproducible environment.
- Agentic AI closes the discovery-to-decision loop — turning a plain-language question into a governed, reproducible insight in minutes.
AI-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.
Diagnostic Strategy For Drug Development
Industry Presentation• Diagnostic strategy and diagnostic operating models in drug development are related but distinct concepts.
• Pharmaceutical companies must own Dx strategy because the optimal strategy for drug development often differs from the optimal strategy for a standalone diagnostics business.
• This presentation proposes a pharmaceutical Dx strategy framework centered on preserving optionality deep into development, fit-for-purpose approaches, and commercialization readiness.
Frontage 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 Biopsies In Oncology Drug Development - The Past, Present & Future Outlook
Industry PresentationBiomarker Identification In Rare Cancers
Industry PresentationThe Companion Diagnostic Journey For Sotorasib: From Trial Strategy To Market Implementation
Industry PresentationBlood Biomarkers To Reflect Health State Transitions
KeynoteBio-Techne Spatial Presentation
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 Presentation-Microscopy projects light from 3D tissue sections into a 2D images. 3D cells become overlapping 2D objects. Segmentation that explicitly allows these overlaps preserves the morphology of the cells (overlap removal distorts morphology).
-This results in morphology and texture measures more accurately predicting patient outcomes in a large 600 core lung cohort study. Resulted in detection of biologically relevant sex-based differences in lung tissue (molecularly verified).
-Knowing which parts of nuclei and cells overlap enables more accurate correction for cell marker spillover, improving recognition of nuclei, cell types and spatial neighbourhoods in highly multiplexed data sets.
Quantum Information Approaches To Understanding And Interpreting Multi-Modal, Multi-Scale Biology
Industry PresentationBiological systems operate through interacting networks of molecular programs, cellular states, and spatially organized processes that are increasingly measurable through single-cell, spatial, imaging, and multi-omic technologies.
In this talk, I will introduce ideas from quantum information processing that may provide useful new perspectives on these challenges. Rather than focusing narrowly on specific algorithms, the presentation will explore how concepts such as state representations, interaction operators, and Hamiltonian models can be used to think about network inference, multimodal coupling, and spatial organization in biology.
From Diseased Tissue Profiling to Target Discovery For Cardiovascular Disease
Industry PresentationFireside Chat: Google Research
Fireside ChatSpatial Multi-Omics to Develop our Understanding of th Tumour Micro-Environment: Therapeutic & Inhibitor Resistance
Industry PresentationThe Life Science Investment Landscape - Funding Priorities and Partnership Models
Panel Discussion• Recent changes and outlook
• Translating breakthrough science into investible ventures
• Navigating regulation, reimbursement, and real-world
Spatial Transcriptomics for Neuro Mouse Models
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 PresentationThe presentation traces the regulatory journey of developing an AI/ML-enabled computational pathology-based predictive biomarker, from establishing a regulatory pathway for digital pathology to a novel predictive biomarker. It considers how foundation models, large language models, and generative AI derive biomarker signals from tissue across computational pathology-based and multimodal approaches, and the regulatory challenges these raise for drug and CDx development.
Quantifying 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 PresentationPathologist vs. The Machine – Integrating AI And The Human Expert Into The Translational Pathology Lab In Drug Development
Industry Presentation•Where expert humans (pathologists & technicians) and AI fit into the overall workflow & how they best work together.
•Discovery through translational – how novel assays and algorithms are developed & used to best to select indications & therapeutic candidates.
•Translational through proof of concept (Ph1/Ph2)- selecting and translating the best assay/algorithms into clinical trials for MOA, PD, and prediction. How AI can help make this easier through the use of H&E predictive models.
Deploying 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 five 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 PresentationTransform Pathology Practice From Traditional H&E Slide To Direct-To-Digital MUSE (Microscopy Utilizing Ultraviolet Surface Excitation) Technology
Industry Presentation-Introduce MUSE technology
-Comparing pathological diagnosis for MUSE vs regular HE for breast tissue – preliminary studies
-Comparing MUSE processed tissue vs paraffin embedded tissue for DNA/RNA extraction on prostatic specimen
-Discuss potential applications of MUSE
Opportunities And Challenges In Clinical Translation Of Artificial Intelligence In Computational Pathology
Industry PresentationAI-Enabled Companion Diagnostics: Evidence & Commercialization
Panel DiscussionFrom Silos to Alliances – Rethinking Collaboration in Precision Medicine
Panel Discussion• How pharma, diagnostics, academia, hospitals, vendors and CROs work together
• What makes collaborations succeed or fail
• Strategies to build sustainable, high-impact partnerships
Afternoon Break & Refreshments
End of Event
Lunch Break
Morning Break & Refreshments
Lunch Break
Morning Break & Refreshments
Building Reproducible Multi-Omics Pipelines for Translational Biomarker Analysis in Clinical Trials
Industry Presentation
Biomarkers USA - 10-year Celebration
Optimizing Liquid Biopsies MCED & MRD For Analysis & Clinical Decision Making
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