7:00 am Check-In & Morning Coffee
8:00 am Chair’s Opening Remarks
The Future of Precision Medicine Adoption: Establishing National & Global Trial & Testing Initiatives to Supporting Wider, Equitable Access
8:10 am Expanding Access to Precision Cancer Care with the Precision Cancer Consortium CGP Implementation Guide
- Advancing Access to Precision Oncology: The Precision Cancer Consortium developed The Pathway to Precision Cancer Care, a strategic and operational guide to help health systems embed comprehensive genomic profiling (CGP) into routine cancer care and expand patient access globally
- The Impact of Limited CGP Capacity: Without coordinated action, patients miss opportunities for accurate diagnosis, targeted therapies, and clinical trials; costs rise due to inefficiencies; results may be delayed or misinterpreted; and patients and families lack information for shared decision-making
- Clinical & Economic Value at Risk: Limited access to CGP constrains patient outcomes and prevents health systems from realizing the wider economic value that precision oncology can deliver beyond healthcare
- Practical, Adaptable Solutions: The freely available, interactive guide provides actionable steps, tools, and real world examples to help health systems initiate, scale, and strengthen CGP programs. This session highlights how it is being used to improve access to optimal treatments
8:30 am Session Reserved for Illumina
- Understand the value of a distributed MRD solution for drug development
- Explore Illumina’s path from an MRD service in 2027 to a comprehensive MRD solution
- Get the latest updates on TruSight Oncology IVD
9:00 am Panel Discussion: Mobilizing Precision Cancer Care Through the Precision Cancer Consortium to Standardize Testing Pathways & Reduce Access Barriers
- How can multi‑company collaboration accelerate global access to comprehensive genomic profiling, particularly in regions where testing infrastructure and reimbursement remain limited?
- What operational barriers most constrain CGP adoption, and what tools can help standardize processes across health systems?
- How can harmonized testing pathways, shared training resources, and coordinated industry engagement reduce variation in CGP turnaround times and improve diagnostic quality globally?
9:20 am On the Right TRACK: Building a Patient Driven, Decentralized Precision Medicine Trial in Rare Cancers
- Discussing the unique needs of the rare cancer patient community which led to the development of TRACK
- Reviewing the benefits and challenges of decentralized clinical trials
- Providing an overview of data generated in TRACK
9:50 am Session Reserved for GSK
Presentation Details to be Announced
10:10 am Morning Break & Refreshments
10:50 am One-to-One Meetings & Structured Networking
Biomarker Discovery & Translation
Clinical & CDx Development
Digital Pathology & Spatial Biomarkers
Multimodal & AI-Enabled Precision Medicine
Biomarker Discovery & Translation
Translating Early Biomarker Insights into Scalable Operations & Adaptive Validation for Precision Therapeutic Development
11:00 am Rethinking the Pharma-Diagnostic Partnership: How Specialist Oversight Can Reduce Complexity, Manage Risk & Optimize the Clinical Trial Lifecycle
Director of Corporate affairs, ARC Regulatory
- Simplify complex IVD study responsibilities with clearer ownership and accountability across the clinical trial lifecycle
- Reduce handovers, gaps and duplication across diagnostic partners, vendors and workstreams
- Strengthen oversight and coordination across multiple diagnostic partners and activities
- Reduce risk, save time and ease pressure on internal teams through a more integrated approach
11:30 am Building a CDx Ecosystem Inside a Therapeutics Company
Manager, Clinical Diagnostics, Regeneron
- Early biomarker and assay identification and development
- Considering global operations to ensure future agility
- Vendor engagement strategies to improve biomarker and diagnostic operational delivery
11:50 am Beyond Maximum Tolerated Dose: Using a Dynamic Pharmacodynamic Biomarker, TKa, for Oncology Drug Development
Global Head of Clinical Development, Medical Affairs, & Clinical Operations, Biovica
Principal Scientist, Biology, BioTheryx
- Explore how longitudinal TKa can provide an early functional readout of biological drug activity and pathway suppression
- See clinical Phase 1 data from BTX-9341 illustrating how TKa was incorporated into development of a next-generation CDK4/6 degrader
- Learn how dynamic proliferation monitoring can support biologically informed dose optimization, patient stratification, and development decisions
12:20 pm A Single-Cell Platform for Linking CRISPR-Edited Variants to Transcriptional Outcomes
Senior Scientist, Merck & Co
Functionally characterizing disease associated genetic variants in relevant cellular contexts remains a critical bottleneck in translating genomic associations into therapeutic opportunity. To address this, we developed a custom targeted DNA and RNA assay using the Tapestri® Single-Cell Platform, enabling simultaneous capture of CRISPR-edited genotypes and downstream transcriptional responses in primary human immune cells. Using isogenic CRISPR-edited cells, this approach isolates the effect of a single nucleotide change from background genomic variation, providing a more direct link between variant and biological mechanism than population-level association studies alone. We benchmarked three CRISPR editing strategies — prime editing, base editing, and HDR — across disease associated loci in PBMCs and T-cells, demonstrating editor-specific differences in on-target precision, off-target activity, and downstream transcriptional impact. Using this platform, we show that single-nucleotide changes at autoimmune-implicated loci produce disease-relevant, stimulation-dependent transcriptional consequences in primary immune cells, establishing a proof-of-concept for functionally connecting genetic variation to disease mechanism at single-cell resolution
Clinical & CDx Development
Digital Pathology & Spatial Biomarkers
Multimodal & AI-Enabled Precision Medicine
12:40 pm Lunch Break & Networking
Evolving Precision Medicine Strategies in ADC Development: Balancing Biomarker Use With Clinical Outcomes
1:40 pm Assessing Histologic Biomarkers of Response to Micvotabart Pelidotin (MICVO), the First-in-Class ADC Targeting the Tumor Extracellular Matrix Protein Extradomain-B of Fibronectin
- MICVO binds to extradomain-B of fibronectin (EDB+FN) in the tumor extracellular matrix where the linker is cleaved by extracellular cathepsins to allow free auristatin payload to diffuse into and kill cancer cells directly, via the bystander effect, and by eliciting immunogenic cell
- Pyxis Oncology developed an exploratory immunohistochemistry assay and scoring system to measure the intensity and distribution of EDB+FN in the extracellular matrix of the tumor stroma of preclinical and clinical samples
- Biological drivers, in addition to EDB+FN target expression, may confer sensitivity to MICVO, suggesting a multi factorial biomarker approach to understanding tumor responsiveness to treatment
2:00 pm Panel Discussion: Fit-for-Purpose CDx Strategies: Matching Testing Approaches to Development & Patient Access Needs
- The CDx market is growing rapidly as precision medicine gains momentum and more targeted therapies enter clinical development
- While many pioneering biomarker programs begin in centralized laboratories, the long-term commercial vision often requires models to evolve to allow greater scalability and geographic accessibility
- This discussion will explore how sponsors are balancing scientific complexity, operational realities, and commercial goals as they navigate the transition from centralized testing toward decentralized and distributable CDx approaches
2:30 pm Deciphering Mechanisms of Resistance to ADC Therapy
- What is an optimal framework to define ADC mechanism of action?
- How does ADC mechanism of action inform potential evolution of resistance?
- What are key mechanisms of resistance and how do they impact future treatment strategies?