8:00 am Morning Coffee

8:50 am Chair’s Opening Remarks

Creating Clinical Buy-In for Biomarkers

9:00 am What Makes a Good Biomarker?

  • Christopher Peters Clinical Senior Lecturer & Consultant Upper GI Surgeon, Imperial College London


• 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

9:30 am EATRIS-Plus: The Development of a Multi-Omic Tool Box for Performing High-Quality Research in Personalised Medicine

  • Emanuela Oldoni Scientific Programme Manager, European Infrastructure for Translational Medicine


• 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.

10:00 am Developing Translational PD Biomarkers in Idiopathic Pulmonary Fibrosis

  • Rob Slack Vice President & Head of Pharmacology , Galecto


• 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

10:30 am Tech Slam: Live Demonstrations Featuring Today’s Cutting Edge Biomarker Tech


• Hear latest biomarker discovery, development & diagnostic solution advancements in a succession of quick demonstrations followed by networking
• Get acquainted with the newest innovations to remain up to speed with latest progress and technologies reaching the market

11:00 am Morning Networking Break


• An opportunity to network, discuss and collaborate with like-minded leaders!

Developing Biomarkers to Define Your Patient Population with Superior Efficacy

Analysing Genomic Drivers Predicting Patient Responses
Track Chair:

11:30 am The Application of Computational Pathology & AI to Identify Patient Populations with Superior Efficacy


• 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

12:00 pm Whole Genome Sequencing Transforming Precision Medicine


• 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

Drug-Dx Co-Development & Commercialisation Planning for Maximised Access

Addressing the Reimbursement Paradigm in Dx Testing to Maximise Access to Precision Medicines

11:30 am Mechanisms to Analyse the Value of Biomarkers & their Link to Reimbursement


• 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

12:00 pm Addressing the Debate: Panel Size & Access

  • Michael Hubank Director, Clinical Genomics Research, The Royal Marsden NHS


• 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?

1:00 pm Networking Lunch


• 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

Bioanalytical Assay Validation

2:00 pm Fit-for-Purpose Biomarker Assay Validation Strategies


• 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

2:30 pm From Longitudinal Data Analysis to Biomarkers & Patients Analytics

  • Igor Rudychev Vice President of Enterprise Analytics , Horizon Therapeutics


• 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

Diagnostics for Future Investment

2:00 pm Interactive Session: Advancing Diagnostics Access – Diagnostics Reimbursement Challenges & Potential Solutions in Europe


• 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


• 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!

Future Thinking for Decentralised Biomarker Testing

3:30 pm Validating a Digital Biomarker


• AI & wearable technology approaches being used to advance non-invasive means of biomarker testing to select a patient population
• How can we look at large datasets to identify risk factors for disease earlier on and develop predictive diagnostics to better understand the digital fingerprint of patients?
• Digital biomarker validation showing concordance with physical samples of biomarker readouts – achievements in validating biomarkers by collecting digital pieces of information and looking at correlations between liquid and digital readouts

4:00 pm Turning the Question Around: How Can Patients Support Precision Medicine?


• The development of clinically meaningful and patient-relevant 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 non-responders 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

4:30 pm Chair’s Closing Remarks & End of Day Two: Close of the 12th Clinical Biomarkers & CDx Summit Europe 2022