DAY ONE
Wednesday 9th April, 2025
7:30 am
Check In & Light Breakfast
One-on-One Partnering™ Zone Opens
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
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 Identifying Key Blind Spots in Your Diagnostic Strategy: Considerations for Defining Complex Biomarkers
Synopsis
- Explore key considerations for defining biomarkers as part of your CDx strategy
- Gain insights into the complexity of defining biomarkers like TMB, MSI, HRDSig, and CH
- Uncover potential blind spots in your CDx strategy and identify factors to consider in choosing a diagnostic partner
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 Advancing Precision Oncology in Europe with a Globally Validated Liquid Biopsy – Guardant360
Synopsis
- Comprehensive biomarker testing and precision oncology uptake in Europe face adoption challenges due to regulatory, reimbursement and data hurdles
- Guardant Health’s partnerships with leading cancer centers in the EU have accelerated Guardant360 adoption, expanding access to high-quality testing
- Guardant’s successful UK pilot with The Royal Marsden demonstrates how local implementation of Guardant360 drives clinical adoption and improves patient access
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 From Precision Medicine to Personalised Medicine in Oncology: Predicting Effective Treatments Based on Complex Tumour Gene Signatures Using a Novel In Vivo Screening Technology
Synopsis
- Genetic complexity: Tumours are driven by a network of oncogenic genetic alterations and tumour signatures are incredibly diverse across patient population
- Drosophila avatars: a rapid and cost-effective generation of in vivo models with genetically engineered complex tumour signatures for large-scale drug screening
- Utilising whole-exome sequencing and in vivo drug screening to uncover actionable insights into tumour-specific vulnerabilities: from standard of care ranking to novel combinations
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
Synopsis
- Learn how to unlock the potential of SOPHiA DDM™ to optimise late-stage clinical development by designing and deploying genomics solutions at scale
- Gain insights into the regulatory pathway of the SOPHiA DDM™ 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 & Reinforcing Patient Access to Care for All
Synopsis
- What are the best practices to engage with patient communities and ensure successful enrolment of under-represented groups?
- Adopting 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?
12:20 pm Precision Medicine at Scale: Innovation, Efficiency & Global Reach
Synopsis
- Learn about how Illumina can help drive success of your drug development pipeline, from discovery to commercialisation
- Learn about how the global reach of Illumina, from our instrument placements to the uptake of our TruSight Oncology comprehensive genomic profiling solution, can drive precision oncology at scale
- Learn about the benefits of a companion diagnostic partnership with Illumina – accessing our product development teams to drive innovative solutions, leveraging our clinical development teams to ensure uniform testing throughout the world and utilising our experienced regulatory teams to navigate the ever-changing global regulatory environment
12:50 pm
Lunch Break & Networking
Dedicated One-on-One Partnering™
TRACK A: Biomarker Discovery & Clinical Development
Chair:
Leveraging Advanced Computing & AI to Enhance Predictive Accuracy & Bolster Scalable & More Cost-Effective Biomarker Development
1:45 pm Paving a Pathway Towards Computational & Digital Pathology for Enhanced Interpretation & More Targeted Intervention
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
2:05 pm An Expert Pathology Network for Biomarker Development: Leveraging Digital Innovation for Scale & Precision
Synopsis
- Expert Pathology Network Integration: Leverage our global network of board-certified pathologists to deliver precise, high-quality biomarker insights
- Advanced Digital Pathology Analytics: Utilise state-of-the-art imaging and AI-driven analytics to streamline and enhance biomarker discovery
- Scalable & Cost-Effective Solutions: Accelerate clinical research with a tailored, scalable platform that reduces time-to-insight and optimises development costs
2:35 pm From Real-World Patient Data to Precision Therapeutics: A Case Study in Applying AI-Enabled Patient Endotyping & Multiple Omics Modalities to Diabetic Nephropathy
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?
2:55 pm Ensuring Global Patient Care: Evaluating Strategies for CDx Development & Regulatory Approvals in Precision Medicine Programs
Synopsis
- Developing effective biomarker strategies: technical and platform considerations
- Navigating regulatory changes and achieving compliance with IVDR
- Strategic commercial considerations for emerging market access
TRACK B: CDx Development & Commercialisation
Chair:
Improving CDx Development Through Co-Development Partnerships for Effective Care Pathways
1:45 pm An In Vitro Diagnostic Test for Dose Maintenance Setting in Patients Treated with an anti-TFPI antibody
2:05 pm From Liquid Biopsy to Dynamic Monitoring: ctDNA Empowering Cancer Treatment Optimisation
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
2:35 pm Roche RxDx Collaboration in Oncology: Achievements in Drug/CDx Co-Development
Synopsis
- Roche RxDx partnerships are the cornerstone of our R&D strategy
- Roche and Foundation Medicine (FMI) collaborate on drug and CDx co-development through shared expertise in oncology and cancer genomic profiling
- Case Study: ITOVEBI (inavolisib), an isoform-specific PI3K inhibitor, received US FDA co-approval with FMI’s FoundationOne Liquid CDx assay after a positive Ph3 readout
2:55 pm Developing Biomarker Assays With Commercialisation in Mind
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
3:25 pm
Afternoon Networking Break
Dedicated One-on-One Partnering™
Shaping the Future of Patient Selection & Monitoring to Inform Treatment Regimes for Best-in-Class Cancer Therapies
3:55 pm Roundtable Discussion: Advancing Patient Selection & Monitoring Across Therapeutics Modalities in Precision Oncology for Improved Clinical Outcomes
Synopsis
- How can you optimise the use of tumour and blood-based biomarkers for dynamic patient selection?
- How to address the challenge of biomarker heterogeneity within solid tumors and its impact on accurate patient stratification
- Why is biomarker assay standardisation critical for clinical adoption, and what collaborative efforts can streamline this process?
4:15 pm H&E-Based Molecular Profiling: From Bench to Bedside in the Era of Precision Medicine & AI
Synopsis
- Revolutionising molecular diagnostics: AI analysis of H&E images delivers biomarker insights in minutes, preserving tissue while reducing turnaround times
- Platform versatility: Applications spanning drug discovery, clinical trials, and patient care to address diverse stakeholder needs
- Real-world impact: Case studies highlighting validation, regulatory success, and implementation demonstrate the transformation potential for precision medicine
4:25 pm The Renaissance of Circulating Tumour Cells (CTC) for Translational Research & Clinical Trials
Synopsis
- The Renaissance was a period in Europe, from the 14th to the 17th centuries, marked by a "rebirth of art, culture, and learning”. Today, CTCs are experiencing a “rebirth in clinical research” due to the increased sensitivity of downstream analysis methodologies
- In the era of HER2 targeted therapies including ADCs, detecting HER2 status changes in previously HER2-negative primary breast cancer patients may identify patients who could benefit from HER2-targeted treatments despite their primary tumour's HER2-negative status
- 16–40% of Glioblastoma patients are classified as inoperable and ctDNA is found in less than 10% of glioma patients. CTCs isolated using the Parsortix system can enable genetic, transcriptomic, and proteomic profiling to help classify patients into molecular subgroups for targeted therapies and enrollment into clinical trials
- Longitudinal pan-cancer NGS analysis of CTC-DNA and cfDNA from a single blood sample, demonstrates multi-parametric utility to capture tumour heterogeneity, reveals tumoral evolution, and provides indicators of cancer resistance mechanisms in clinical trials
4:55 pm Strategic Development of a Selection Test for Targeted Therapy: A Case Study
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
5:15 pm Progress on Multiplexed IHC CDx
Synopsis
- After long promise, multiplexing has matured from research to selection device driven by several late-stage clinical programs
- The combination of staining reagents and digital quantitation with advanced controls and calibrants have yielded systems that are highly reproducible and accurate
- This evolution has the potential to address the coming wave of new targeted ADC/IO therapies, positively improving trial outcomes and patient care
Strengthening Co-Development Partnerships for Rapid Market Access to Maximise Therapeutic Reach
3:55 pm Panel Discussion: Advancing Partnerships with Novel & Digital Technologies to Ensure Compliant, Scalable Solutions for Global Precision Medicine Applications
Synopsis
- What is the role of strategic partnerships in effectively devising biomarker and CDx strategies?
- How can we ensure the integration of testing technologies in clinical and healthcare settings?
- What is the future of novel and digital technologies?
- How can you ensure the compliance and scalability of pathology?
4:25 pm Overcoming IVDR Compliance Challenges in Early Clinical Development
Synopsis
- IVDR requires robust scientific validity, analytical performance, and clinical performance data, with pharma sponsors now needing to conduct a performance study in parallel to their phase I/II clinical trial in all EU member states participating in the IMP trial
- This more complex technical package is coupled with an expanded documentation file per device and subsequently requires increased specialist regulatory knowledge and capacity within the sponsor’s project team and/or additional external support
- To address these pain points, ARC has established a boutique accredited laboratory and sponsor delegation service, capable of analytical validation and sample analysis from global patients, across a range of technologies, with regulatory compliance and patient safety at the forefront
4:55 pm A Match Made in Oncology: Optimising Co-Development Partnerships for the Accelerated Approval of Precision Oncology Therapies
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?
5:15 pm A Laboratory Evaluation of a Simple, Rapid NGS-Based LBx Kitted Assay to Profile NSCLC
Synopsis
- Review the importance of LBx testing to help guide access to precision therapies and clinical trials for NSCLC
- Discussing relevant laboratory criteria when considering an NGS assay for in-house LBx testing
- Review a performance evaluation and workflow assessment of Pillar Biosciences’ oncoReveal® Essential LBx kit