7:00 am Morning Coffee
8:20 am Chair’s Opening Remarks
Creating Clinical Buy-In for Biomarkers
8:30 am What Makes a Good Biomarker?
Synopsis
• Millions are spent on biomarker research in academia and industry but only a tiny fraction, less than 2%, achieve clinical adoption with the rest stalling or failing
• This talk will consider where we are failing in biomarker research and how academia and industry can work better together to discover, validate and implement the biomarkers we need to improve patient care
• It will also consider what features of biomarkers make them most likely to succeed
9:00 am Beyond Biopsy Maximising the Value of ctDNA Technology Today Within the Biopsy Model of Precision Medicine
Synopsis
• Untapped potential that new ctDNA-dependent technologies present, and the Guardant’s 3.0 suite
• What makes Guardant, Guardant and why that matters
• Simplification and shared innovation with ctDNA and why that will accelerate global impact of medicines on patients’ lives
9:30 am Development of a Novel Breast Cancer Subtyping and Proliferation Gene Expression Diagnostic Test
Synopsis
• A RT-qPCR nucleic acid-based CE-IVD test for the detection and relative gene expression quantification of human mRNA target genes from pre-operative CNB or resected FFPE breast tumour tissue from patients with invasive breast cancer
• Breast cancer subtyping performance of the CE-IVD test is determined by concordance to that assigned by the current histopathology IHC reference methodology
• A novel ‘proliferative signature’ has been identified and included that allows for discrimination of Luminal A and Luminal B subtyping tumours over MKI67 alone
10:00 am Morning Networking Break
Synopsis
• An opportunity to network, discuss and collaborate with like-minded leaders!
10:30 am EATRIS-Plus: The Development of a Multi-Omic Tool Box for Performing High-Quality Research in Personalised Medicine
Synopsis
• Efficient advancement of personalised medicine depends on the availability of validated patient-targeted biomarkers
• In order to turn the multi-omic promises into a reality, systemic bottlenecks impacting the biomarker field needs to be overcome
• EATRIS-Plus project aims to develop a multi-omics toolbox to support crossomics analysis and data integration in clinical samples with a quality and reproducibility perspective
• The multi-omics toolbox is the engine to enable high-quality and reproducible research in the context of patient stratification and accelerate the implementation of personalised medicine.
11:00 am More Bang for Your Buck. Leveraging Lab Developed Tests to Accelerate CDx Development
Synopsis
• NeoGenomics has extensive experience with Lab Developed Tests (LDTs) to support early phase CDx programs across multiple technologies and therapeutic classes
• Use of LDTs allows for faster development cycles and can significantly lower costs for early-phase CDx programs, but this approach presents risks for downstream commercialization
• Here we give an overview of best practices (including a case study) to ensure LDTs are fit for purpose for early phase studies and have an optimal yet practical pathway for partnering with an IVD manufacturer for final Phase 3 support, regulatory approval, and commercial launch
11:30 am Developing Translational PD Biomarkers in Idiopathic Pulmonary Fibrosis
Synopsis
• The generation of translational pharmacology data packages using systems and biomarkers that can be linked to the clinical setting is pivotal for successful drug development
• This is especially challenging in the field of fibrosis where models have questionable translatability and there are limited approved therapies for pre-clinical benchmarking, however, with appreciation of the limitations of pre-clinical models and an understanding of the key questions it is possible to map a path to the clinic
• Example cases studies will be presented focussing on small molecule therapies targeting integrins and lectins for idiopathic pulmonary fibrosis highlighting the opportunities and challenges encountered during biomarker development
12:00 pm Networking Lunch
Synopsis
• Pre-Scheduled Meetings with Your Current & Future CB & CDx Partners: Networking with market leaders pioneering exciting advances in the biomarker-driven drug development space
• Tech Scouting in Exhibition Hall: Meet a diverse array of industry solution providers to find out what new innovative solutions could create positive progress for your pipeline
Developing Biomarkers to Define Your Patient Population with Superior Efficacy
Analysing Genomic Drivers Predicting Patient Responses
Track Chair
Track Chair
1:00 pm Whole Genome Sequencing Transforming Precision Medicine
Synopsis
• The role of whole genomes in precision diagnosis in rare disease
• The role of genomics in precision cancer care and COVID-19
• The role of pharmacogenomics in healthcare
1:30 pm The Power of Quantification of Circulating Nucleosomes and Histone Variants in Epigenetic and NETs Treatment Strategies
Synopsis
- Patented Nucleosomics™ technology enabling the quantification and analysis of circulating nucleosomes from the blood in a robust and cost-effective way
- Circulating nucleosomes direct quantification in blood: choosing the right Clinical Biomarkers to support NETs treatment strategies
- Rapid epigenetic profiling for biomarker discovery in oncology: towards personalized therapy
1:40 pm Patient-First Drug Discovery Using Primary Patient Tissues and AI
Synopsis
- The use of primary tissues from cancer patients in translational research provides disease-relevant model systems
- High-content microscopy, transcriptomics, and AI are powerful tools to enable single-cell interrogation of drug and target function within diseased tissue, harnessing potential inter-patient response heterogeneity for preclinical biomarker prediction.
- Our methodology for assessing functional drug response has been clinically validated through the prospective clinical study EXALT-I prioritising therapy for late-stage haematological cancer patients.
2:10 pm Panel Discussion: Non-Invasive Patient Stratification with Quantitative Image Analysis
Synopsis
• Using standard medical images to guide treatment decisions by identifying the patients that are likely to respond or at high risk to develop adverse events
• Analysing quantitively the inter/intra-heterogenicity of the total tumour load via Radiomics, offering technically robust and clinically actionable insights
• Imaging-based companion diagnostics offers the ability to reach a level beyond personalized treatment towards a lesion specific treatment
2:40 pm The Application of Computational Pathology & AI to Identify Patient Populations with Superior Efficacy
Synopsis
• Incorporating and integrating multiple sources of data, including protein markers, to go beyond genomics to identify patient responders to ADC treatment
• Improving clinical decision making and patient outcomes
• Showcasing how computational pathology is being approached to unlocking the potential innovative therapies can have for biomarker-defined patient populations
Drug-Dx Co-Development & Commercialisation Planning for Maximised Access
Addressing the Reimbursement Paradigm in Dx Testing to Maximise Access to Precision Medicines
Track Chair
1:00 pm Interactive Session: Advancing Diagnostics Access – Diagnostics Reimbursement Challenges & Potential Solutions in Europe
Synopsis
• Why diagnostics reimbursement and access matters
• Key diagnostics reimbursement, access challenges in Europe
• How can various stakeholders collaborate to overcome those challenges, advancing access?
3:00 pm Afternoon Networking Break
Synopsis
• Your final opportunity exchange business cards to takeaway meaningful and long-lasting connections beyond this year’s event – We look forward to hearing about your progress next year!
Bioanalytical Assay Validation
3:30 pm Fit-for-Purpose Biomarker Assay Validation Strategies
Synopsis
• UCB’s approach to fit-for-purpose biomarker assay validation
• How biomarker context of use impacts assay decisions in order to fulfil the need in a clinical trial
• Examples across the use of ligand binding assay, flow cytometry and qPCR assays
4:00 pm The Human Immune System as a Source of Biomarkers
Synopsis
- Introduction to Sengenics
- Overview of technology
- Specific examples of disease-specific biomarkers
4:10 pm Combining the Power of Multiplexed Immunofluorescence & AI for Spatial Phenotyping in Clinical Trials
Synopsis
• How multiplexed Immunofluorescence and AI-powered image analysis can bridge translational research and clinical Dx?
• What is spatial phenomics and why is it so important?
• How to accelerate biomarker programs or derive meaningful insights from spatial biology?
4:40 pm From Longitudinal Data Analysis to Biomarkers & Patients Analytics
Synopsis
• Longitudinal data that could be used for biomarker validation for a given population
• From longitudinal data to analytics
• How to get to more robust and comprehensive biomarker readouts
Chair’s Closing Remarks
Diagnostics for Future Investment
3:30 pm Mechanisms to Analyse the Value of Biomarkers & their Link to Reimbursement
Synopsis
• The analysis of the value of biomarkers can not be separated from the treatment to which they are associated
• There is a need for a holistic approach to determine the benefits to introduce and reimburse a biomarkers’ diagnosis
• Health systems should define a better framework for reimbursement of biomarkers that enable an equitable access to them
4:00 pm Addressing the Debate: Panel Size & Access
Synopsis
• Playoff between larger panels and smaller and the impacts on reimbursement and access to diagnostic testing
• How is the current reimbursement system affecting partnering and panel design decisions which may be to the detriment of the technical functioning of panels used for biomarker detection?
• Centralised biomarker testing models – where do we see the future of CDx development?
4:30 pm Turning the Question Around: How Can Patients Support Precision Medicine?
Synopsis
• The development of clinically meaningful and patientrelevant biosignatures can be a long and cumbersome process. When we include patients’ input from the start it may become easier and faster
• The objective of predicting responders and nonresponders may not always require the most complex and comprehensive biosignature but ultimately the optimised benefit-risk needs to be demonstrated to regulators, physicians and patients
• Examples from disease areas like heart failure, atherosclerotic cardiovascular disease, multiple sclerosis and psoriasis will illustrate specific precision medicine opportunities and challenges
• The future is precision medicine, let’s make sure we don’t lose common sense and the human touch
Chair’s Closing Remarks
Close of the 12th Clinical Biomarkers & CDx Summit Europe 2022
