Explore the Agenda

7:30 am Check In & Morning Coffee

8:20 am Chair’s Opening Remarks

Executive Director & Head, Precision Medicine Laboratory Operations & Companion Diagnostics, Regeneron

Driving Precision Medicine in the General Population Through Improved Diagnostics & Strategic Partnerships

8:30 am Equitable Biomarker Testing: Findings from the Delivering Accurate Real-Time Biomarker Testing (DART) Research

Strategic Adviser Cancer Care, Macmillan Cancer Support
  • Understanding barriers to biomarker testing from the Delivering Accurate Real-time biomarker Testing (DART) research
  • Implications for patients and the workforce
  • Does genomics widen health inequalities

8:50 am Clinical Validation of Myriad Genetics’ Ultra-Sensitive pan-cancer WGS-based Precise MRD assay

Chief Scientific Officer, Myriad Genetics
  • Understand how ultra-sensitive, tumor-informed MRD testing is being applied across clinical and development settings
  • Walk away with a clear view of where ultra-sensitive MRD testing delivers value today and how to apply it across your own programs

9:20 am Treating on MRD Result: A New Paradigm for MRD-Guided Adjuvant Therapy

Vice President, Clinical Biomarkers & CDx Partnering, Natera

Presentation details to be announced

9:50 am Improving Rare Disease Diagnostics With Multiomics

Chief Scientific Officer, Genomics England
  • Short-read whole genome sequencing has revolutionised the diagnosis of rare diseases in clinical services, but nonetheless still only 25-30% of patients achieve a diagnosis
  • New ‘omics approaches including long-read sequencing and epigenetic profiling, transcriptomics, proteomics, and metabolomics offer the potential to increase this proportion, including in non-European ancestry patients
  • Genomics England’s rare disease program pilot analyses suggest that using combinations of these approaches may lift the overall proportion of rare disease patients receiving a genetic diagnosis to over 40%, of great benefit to the families concerned

10:10 am Accelerating Clinical Timelines with Submission-Ready MRD Regulatory Infrastructure

Senior Vice President, Quality, Regulatory & Clinical Compliance, Personalis
Director ctDNA & Epigenomics Oncology Translational Medicine, AstraZeneca
  • Benefits of Ultrasensitive ctDNA: Discover how NeXT Personal utilises whole genome sequencing and tumor-informed personalised panels, tracking up to 1,800 high-quality variants to optimise signal-to-noise ratios in plasma timepoints
  • Evidence-Based Drug Development: Hear from James Hadfield of AstraZeneca to discuss specific use cases and key highlights from the CALLA Phase III trial in cervical cancer
  • Streamlined Global Regulatory Strategies: Discover a "least burdensome" regulatory approach for drug development

10:40 am Accelerating Precision Medicine Through Illumina’s Global Ecosystem

Senior Director, Head of Clinical Business Development, Illumina
  • Expand global patient access through Illumina’s commercial and regulatory expertise
  • Enable custom CDx development through Illumina’s network of assay development partners
  • Utilise TruSight Oncology Comprehensive to drive biomarker identification, clinical validation, and oncology patient access throughout the world

11:10 am Morning Break & Networking & Refreshments

TRACK A: Biomarker Discovery & Translation

Chaired by:

Director Translational Medicine, Immunocore

Exploring Biomarker Strategies for Immunotherapy & Novel Conjugate Therapies to Refine Treatment Decisions

12:00 pm PD-L1 as a Biomarker for Immunotherapy; Imperfect but Important

Executive Director, Head of PMB Immuno- Oncology (IO) Franchise, AstraZeneca
  • Reflecting on the immuno-oncology Dx landscape
  • Discussing challenges for integrating CDx in immuno-oncology trials
  • Navigating what’s next for immunotherapy CDx?

12:20 pm Delegates are welcome to attend presentations in the other tracks

12:50 pm Establishing a Biomarker-Driven Approach to Guide Patient Selection for pre|CISION® Peptide-Drug Conjugates Using Tumour Targeting/Release & Payload Sensitivity Biomarkers

Associate Director, Clinical Science & Translational Medicine, Avacta Therapeutics
  • Avacta’s pre|CISION® peptide-drug conjugates comprise a peptide moiety bound to a cytotoxic payload by a linker that is specifically cleaved by FAP, a protease selectively overexpressed in the tumour microenvironment of many solid tumours
  • AVA6000 (FAP-activated doxorobucin) is completing Phase 1b and has shown promising results, whilst AVA6103 (FAPactivated exatecan) is due to enter the clinic in Q1 2026
  • A pan-cancer evaluation of FAP expression across multiple datasets supports the identification of tumour types most likely to benefit from FAP-activated pre|CISION® therapeutics
  • Pan-cancer evaluation of DNA-damage response pathways enables identification of patient subsets most likely to benefit from payload-driven therapeutic activity
TRACK B: Clinical & CDx Development
TRACK C: Rx-Dx Commercialisation & Adoption

1:10 pm Lunch Break

1:40 pm 1:1 Meetings & Structured Networking

TRACK A: Biomarker Discovery & Translation

Integrating High Sensitivity Biomarkers for More Accurate Prediction & Tailored Disease Management in Chronic & Neurological Indications

2:00 pm How to Develop a Translational Assay for Target Engagement to Support Preclinical Drug Development in Neurodegenerative Disorders

Translational Science, Bioassays & Biomarkers Expert Formerly, AviadoBio
  • Reviewing the concept of translation assay development
  • Showcasing tools available
  • Optimising design principles

2:20 pm Digital Biomarkers for Precision Neuroscience

Executive Director, Co-Founder & Chief Scientific Officer, Monument Therapeutics
  • Neuroscience drug development has historically suffered a low success rate, in part due to a lack of diagnostic specificity
  • We are entering a new era of precision medicine in psychiatry and neurology, enabled by novel digital biomarkers
  • Monument Tx is a clinical-stage biotech company developing stratified therapeutics for schizophrenia and neuroinflammation, exemplifying this approach
TRACK B: Clinical & CDx Development
TRACK C: Rx-Dx Commercialisation & Adoption

2:40 pm Afternoon Break

Optimising Biomarker Testing Infrastructure for Faster Clinical Decisions & More Confident Early-Stage Rx-Dx Developments

3:10 pm Building Resilient Biomarker Infrastructure: From Pandemic Preparedness to Clinical Testing Excellence

Director of Clinical Biomarkers, Moderna
  • Accelerating biomarker delivery through integrated assay platforms – how Moderna’s UK Clinical Biomarker Laboratory is enabling rapid, compliant deployment of immunoassay, cytometry, and molecular methods for global clinical programs
  • Embedding automation and AI in sample and data workflows – leveraging robotic biobanking, and digital traceability to enhance efficiency, reproducibility, and data integrity
  • Pandemic preparedness and translational resilience – establishing high-containment and rapid-assay transfer capabilities to respond to emerging pathogens and future public-health challenges

3:30 pm IVD Regulatory Implications for Gene Therapies

Executive Director, Regulatory Affairs, In Vitro Diagnostics, Regeneron
  • Showcasing early readouts of PD activity to support dose selection is critical-Gene therapy is an increasingly expanding therapeutic modality that has the potential to reach patient populations with high unmet medical needs
  • Several key characteristics of gene therapies require careful selection of patients both during clinical trials and after regulatory approval
  • These patient selection strategies may trigger the requirement for a companion diagnostic, either to identify patients with preexisting immunity to AAV capsids or with specific genetic variants
  • Companion diagnostics have regulatory implications throughout development as well as marketing implications after approval

3:50 pm Closing Remarks & End of 16th World CB & CDx Summit Europe