Wednesday 9th April, 2025

7:30 am Check In & Light Breakfast

8:20 am Chair’s Opening Remarks

Shaping the Future of Precision Oncology with Genomic Initiatives & Liquid Biopsy to Tackle Hard-to-Treat Cancers for Unmet Patient Need

8:30 am Advancing Faster Diagnosis of Pancreatic & Biliary Tract Cancers with Liquid Biopsies to Improve Clinical Impact & Optimise Patient Treatment Outcomes

  • Naureen Starling Medical Oncologist GI & Director of the Royal Marsden’s Clinical Trials Unit, NIHR Professor of Gastrointestinal Oncology, The Royal Marsden NHS Foundation Trust

Synopsis

  • Pancreatic and Bile Duct cancers can be associated with protracted diagnostic pathways
  • Both diseases are associated with high levels of ctDNA detection
  • Showcasing the potential for a liquid biopsy enhanced diagnostic pathway for faster, safer, accurate diagnosis of these challenging cancers

8:50 am Session Reserved for Foundation Medicine

Synopsis

Presentation Details to be Announced

9:20 am Using the National Genomic Research Library Clinico-Genomic Data for Biomarker Discovery – Genomics England Use Cases

Synopsis

  • National Genomic Research Library holds one of the largest collections of whole genome sequencing (WGS) data linked to clinical records across 200+ rare disease disorders and over 16 cancer types for consented participants
  • NHS Genomics Medicine Service has commissioned WGS as standard of care for a number of indications, enabling future growth of the dataset 
  • Genomics England unique model, enabling use of consented data for clinical and research applications, enables true translation of research back to the clinic, driving the future of precision medicine in UK and around the world

9:40 am Session Reserved for Guardant Health

Synopsis

Presentation Details to be Announced

10:10 am Morning Break & Structured Networking

Synopsis

An opportunity to network, discuss and collaborate with like-minded leaders of the biomarker and CDx community

Bolstering the Equitable Access of Precision Therapies Through Innovative Trials & Sequencing Initiatives to Reduce Treatment Disparities & Improve the Standard of Care for All Patients

11:10 am Developing Blood-Based Biomarkers to Stratify Alzheimer’s Patients & Deploy Improved Neurodegenerative Treatments using Exploratory Biomarker Panels

Synopsis

  • Using blood based biomarker to understand the pathological processes in the brain
  • Validation of assays making them fit for the intended purpose
  • Understanding the ability of staging patients based on biomarkers and not imaging or scoring tests
  • Establishing multi-institutional and cross-sector collaboration to accelerate the clinical adoption of blood-based biomarkers for Alzheimer’s

11:30 am Discover How SOPHiA GENETICS is Empowering Pharma Companies to Advance Precision Medicine with Next-Generation Genomics Solutions, Improving Patient Access to Innovative Therapies

  • Jess Lambe Vice President & Managing Director - BioPharma Business Development, SOPHiA GENETICS

Synopsis

  • Learn how to unlock the potential of SOPHiA DDMâ„¢ to optimise late-stage clinical development by designing and deploying genomics solutions at scale
  • Gain insights into the regulatory pathway of the SOPHiA DDMâ„¢ Platform and its validation path for broadening access to precision therapies
  • Understand SOPHiA GENETICS’ market-leading lab footprint and ability to truly democratise genomics
  • Hear how SOPHiA GENETICS and AstraZeneca are joining forces to shape healthcare’s future by standardising and decentralising a best-in-class liquid biopsy assay on a global scale

12:00 pm Addressing Testing Disparities to Reduce Health Inequalities & Reinforce Equitable Patient Access

  • Andrea Stevens Senior Director - Precision Medicine Access, Johnson & Johnson Innovative Medicine

Synopsis

  • What are the best practices to engage with diverse patient communities and ensure successful enrolment of under-represented groups?
  • Adopting inclusive recruitment strategies that overcome biases in clinical trials and improve patient access to testing and monitoring
  • What is the role of technology in overcoming healthcare access barriers for marginalised populations in the context of diagnostic testing?

12:30 pm Session Reserved for Illumina

Synopsis

Presentation Details to be Announced

1:00 pm Lunch Break & Networking

TRACK A: Biomarker Discovery & Clinical Development

Leveraging Advanced Computing & AI to Enhance Predictive Accuracy & Bolster Scalable & More Cost-Effective Biomarker Development

2:00 pm Paving a Pathway Towards Computational & Digital Pathology for Enhanced Interpretation & More Targeted Intervention

  • Huw Bannister Senior Director of Digital & Computational Pathology, AstraZeneca

Synopsis

  • What is the role of Pharma in the adoption of computational pathology?
  • Where has co-development been leveraged to create integrated digital pathology platforms?
  • Navigating commercial implications regarding the need for computational algorithms for treatment identification, scanner deployment, site distribution, and expected market penetration

2:20 pm Session Reserved for Diagnexia

Synopsis

Presentation Details to be Announced

2:50 pm From Real-World Patient Data to Precision Therapeutics: A Case Study in Applying AI-Enabled Patient Endotyping & Multiple Omics Modalities to Diabetic Nephropathy

  • Robert Thong Co-Founder & Chief Executive Officer, MultiOmic Health

Synopsis

  • What are the challenges of assembling real world patient cohorts and datasets to generate relevant multi-omics data?
  • Identifying patient subpopulations using machine learning in a way that remains meaningful to physicians
  • How AI-enabled techniques can enable patient stratifying biomarker models with high predictivity
  • What are the key hurdles to determining drug targets that will be most relevant to specific patient subpopulations?

3:10 pm Session Reserved for Bio-Techne

Synopsis

Presentation Details to be Announced

TRACK B: CDx Development & Commercialisation

Improving Access with Novel CDx & Real-World Data for Effective Care Pathways

2:00 pm An In Vitro Diagnostic Test for Dose Maintenance Setting in Patients Treated with Concizumab

Synopsis

  • Concizumab is an anti TFPI monoclonal antibody intended for all haemophilia A and B types
  • Treatment with concizumab require dose maintenance setting based on concizumab exposure levels 4 weeks after treatment initiation using an IVD
  • A ConcizuTrace ELISA test access solution provides a complete service portal for CDx test ordering and CDx test result provision

2:20 pm From Liquid Biopsy to Dynamic Monitoring: ctDNA Empowering Cancer Treatment Optimisation

  • Xinru Mao Vice President, Biomarker & CDx, Burning Rock Dx

Synopsis

  • Explaining the unique value of liquid biopsy in patient selection and therapeutic monitoring
  • Showcasing clinical applications of Burning Rock‘s CanCatchTM for MRD-guided treatment adjustments
  • Sharing real-world examples of ctDNA monitoring in evaluating therapeutic response and enabling personalised treatment strategies
  • Presenting case studies, including sensitive urinary cfDNA assays for bladder cancer detection and monitoring

2:50 pm Genomics & Diagnostic Data for Disease Population Sequencing Using Secondary Health Data

Synopsis

  • Purpose-built repositories for real-world data use
  • Linking between registries for granular analysis of health data
  • Use cases of integration of genomic and diagnostics into RWE study designs

3:10 pm Developing Biomarker Assays With Commercialisation in Mind

  • Scott Reid Vice President & Global Head of Companion Diagnostics, Discovery Life Sciences

Synopsis

  • Many therapeutics require co-development of a diagnostic test to select and enrich for biomarker-positive patient populations
  • Discovery’s approach of utilising laboratory-developed tests to support early phase development permits rapid development and deployment to support patient management
  • We will present a brief overview of the Discovery process with an emphasis on regulatory compliance and commercial foresight if a regulated CDx is required

3:40 pm Afternoon Networking Break

Synopsis

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

Shaping the Future of Patient Selection & Monitoring to Inform Treatment Regimes for Best-in-Class Cancer Therapies

4:10 pm Roundtable Discussion: Advancing Patient Selection & Monitoring Across Therapeutics Modalities in Precision Oncology for Improved Clinical Outcomes

  • Sharon Liang Executive Director, Head of Precision Medicine & Digital Health, Bristol Myers Squibb

Synopsis

  • How can you optimise the use of tumour and blood-based biomarkers for dynamic patient selection and treatment monitoring in oncology clinical trials? How does this vary between therapeutic modality?
  • Addressing the challenge of biomarker heterogeneity within solid tumors and its impact on accurate patient stratification for oncology therapies
  • Why is biomarker assay standardisation critical for clinical adoption, and what collaborative efforts between biopharma, diagnostics, and regulatory agencies can streamline this process?

4:30 pm Session Reserved for Panakeia

  • Sharon Liang Executive Director, Head of Precision Medicine & Digital Health, Bristol Myers Squibb

Synopsis

Presentation Details to be Announced

4:40 pm Strategic Development of a Selection Test for Targeted Therapy: A Case Study

  • Anne-Laure Bauchet Immunohistochemistry Team Manager & Translational Medicine Lead, Sanofi

Synopsis

  • Test development process: selection of appropriate tool and platform; analytical validation
  • Determination of positive cut-off and its iterative refinement to adapt to emerging data throughout development
  • Bridging the test across development phases to ensure consistency and compliance with trial and regulatory requirements

Strengthening Co-Development Partnerships for Rapid Market Access to Maximise Therapeutic Reach

4:10 pm Panel Discussion: Advancing Partnerships within Novel & Digital Technologies to Ensure Compliant, Scalable Solutions for Global Precision Medicine Applications

  • Monika Lamba Saini Global Translational Pathology Leader & Education Committee Member, ADC Therapeutics & Digital Pathology Association
  • Shane McGann Vice President, Regulatory Affairs, Mythic Therapeutics
  • James Duboff Director, Strategic Partnerships, Genomics England

Synopsis

  • What is the role of strategic partnerships in effectively utilising advanced computing tools in clinical and healthcare settings?
  • How can we ensure the integration of advanced technologies in compliance with global regulatory standards for precision medicine applications?
  • What does the reimbursement of digital and novel technological infrastructure entail?

4:40 pm A Match Made in Oncology: Optimising Co-Development Partnerships for the Accelerated Approval of Precision Oncology Therapies

  • Antje Lukas Senior Director, Regulatory Affairs Companion Diagnostics, Daiichi Sankyo Europe

Synopsis

  • How soon should biopharma and diagnostic providers initiate collaboration to optimise the development of companion diagnostics for precision oncology?
  • How and when to initiate performance studies to collect and establish data for the CDx
  • What are the key challenges in scaling up co-development partnerships for precision oncology therapies, and how can these challenges be mitigated?
  • What is the impact and opportunity of dual-pharmaceutical alliances on the co-development of precision therapies?

5:10 pm Chair’s Closing Remarks & End of Day One

6:00 pm Sip & Sail Hosted by Roche – Celebrating 15 Years of World Clinical Biomarkers & Companion Diagnostics Summit Europe