Explore the Agenda
7:00 am Check-In & Light Breakfast
8:10 am Chair’s Opening Remarks
Advancing Breakthrough Precision Medicine Trials Revealing Earlier, Actionable Treatment Signals & Delivering More Personalized, Impactful Patient Care
8:15 am Enabling Access to Novel Computational Biomarkers: From Innovation to Impact
- Discussing how computational pathology can move beyond the limits of the human eyesight and the light microscope
- Examining real-world performance of the TROP2-NMR QCS algorithm
- Enabling global access to computational pathology
8:35 am What Becomes Possible Combing MRD, Multi-Omics & RWD Insights
- Explore how combining MRD with multi-omics and real-world data can provide a more complete view of disease biology, treatment response and patient outcomes
- Examine how integrated longitudinal insights can support earlier development decisions, more efficient clinical trials, and the advancement of ctDNA-based endpoints
- Consider what becomes possible for oncology drug development as these data sources converge from improved patient selection and trial design to faster evidence generation and more personalized treatment strategies
9:05 am Valuing Academic Precision Medicine Industry Partnerships
- Defining the shared value of academic–industry precision medicine partnerships across research, education, and real-world impact
- Evaluating common risks (e.g. IP, data ownership, conflicts of interest) and strategies to mitigate them
- Reviewing case examples of successful collaborations in digital pathology
9:25 am Breaking Barriers in Precision Oncology: One Global Companion Diagnostic Platform Across Liquid & Tissue
- Guardant Health will highlight our latest global CDx regulatory approvals and advancements toward a unified platform spanning both liquid and tissue testing
- This session will showcase how Guardant Health is enabling a more streamlined, scalable, and globally consistent approach to precision oncology by delivering integrated CDx solutions across technologies, indications, and geographies
9:55 am Morning Break & Refreshments
10:20 am One-to-One Meetings & Structured Networking
A dedicated window for strategic one-on-one discussions and targeted networking, enabling attendees to strengthen key relationships and have purposeful conversations that drive meaningful outcomes in precision medicine
Developing Practical Drug-Diagnostic Co-Development Playbooks Across Translational, Clinical, Regulatory & Commercial Teams to Ensure Scalable, patient-Focused Precision Medicine Programs
10:40 am More Than a Diagnosis: A Patient’s Perspective on the Power of Precision Medicine
- Eve, an ovarian cancer patient, shares her story of navigating diagnosis, understanding biomarker status, and receiving targeted therapy
11:10 am From Strategic Partnering to Orchestrated Partnering: Navigating the Next Era of Precision Medicine
- The next breakthrough in precision medicine may not come from a new biomarker or a new diagnostic technology. It may come from how effectively organizations coordinate them
- As companion diagnostics evolve into broader ecosystems spanning AI, liquid biopsy, MRD, digital pathology, and real-world evidence, traditional partnering approaches are being tested in new ways. As complexity increases, partnering must evolve
- This session explores how J&J is adapting to increasing complexity and what the future of collaboration may look like across pharma, biotech, and diagnostics
11:30 am A Dual Tissue & Liquid Biopsy Strategy: The TEPMETKO® Companion Diagnostic Journey
- Discover insights from Merck KGaA and Foundation Medicine’s innovative collaboration leveraging real-world evidence for CDx regulatory approval
- Explore how creative approaches to overcoming sample limitations enabled approval for a NSCLC CDx for TEPMETKO® (tepotinib)
- Learn how the right CDx partnership can reduce risk and accelerate patient access to therapy
12:00 pm Multiple Diagnostic Pathways to Expand Patient Reach
- This high‑level talk challenges the outdated, one‑size‑fits‑all diagnostic paradigm in precision medicine. It demonstrates how co‑developing both LDT and CDx pathways simultaneously can dramatically expand patient access and de‑risk drug development timelines
- Attendees will discover how leveraging extensive clinical trial capabilities and commercial networks can help maximize the global reach of novel therapeutics
12:30 pm Panel Discussion: Companion Diagnostics from Biomarker Discovery to Global Launch: Building Better Partnerships Across Science, Regulation, & Commercialization
- At what point in therapeutic development should a sponsor begin thinking seriously about a CDx strategy and what are signs that teams may already be late?
- How do you navigate the evolving global regulatory landscape (FDA, EU IVDR, and more)
- How are technologies such as digital pathology, NGS, liquid biopsy, multiplex testing, AI-enabled analysis, or bioinformatics changing the traditional CDx development model?
- What needs to change in how pharma and diagnostic companies collaborate to make CDx development more efficient, globally scalable, commercially successful, and ultimately better for patients?
1:00 pm Lunch Break & Networking
1:00 pm Lunch & Learn Hosted By Quest Diagnostics
*Invitation only
1:30 pm One-to-One Meetings & Structured Networking
Orchestrating the End-to-End Rx-Dx Lifecycle: Advancing Co-Development, Clinical Integration & Access to Deliver Scalable, Patient-Centric Precision Therapies
2:00 pm Panel Discussion: Single-Cell Becomes a Reality: The Next Generation of Therapy Selection Biomarkers
- Advances in wet lab and bioinformatics enabling single-cell use in the clinic
- Clinical programs currently developing single-cell biomarkers
- Outlook on single-cell deployment in the clinic and as CDx
2:30 pm Integrating Science & Strategy to Advance Companion Diagnostic Development for Optimal Patient Treatment
- Discussing how CDx offer the ability to select optimal treatments for each patient based on biology, while the field continues to expand rapidly amid technological and regulatory change
- CDx development must balance optimal test performance, ideal technologies, and innovative approaches with global accessibility, testing paradigm fit, development and test cost, while fulfilling regulatory requirements
- Showcasing how technologies such as digital pathology with AI and ML-based interpretation, ctDNA, and multiplex assays offer the potential for increased accuracy in supporting optimal treatment selection for each patient, but each presents its own challenges
2:50 pm Beyond Detection: The Role of Multi-Cancer Early Detection (MCED) in Advancing Oncology Trial Execution
- Emerging Galleri clinical evidence and its relevance to oncology development
3:20 pm Do We Need Enrichment? Clinical & Translational Learnings from Amgen T-Cell Engagers
- Tarlatamab and xaluritamig (STEAP1) demonstrate clinical activity across a broad range of target expression levels, with no clear IHC cut-off for response
- Beyond tumor antigen expression, what alternative determinants may drive response or resistance?
- To what extent might factors such as the tumor microenvironment, immune cell fitness, or other non-target antigen features influence clinical benefit?
3:40 pm Panel Discussion: Liquid Biopsy at the Point of Care: Making ctDNA Actionable for Treatment Selection
- Where We Are Today: Real‑world use of liquid biopsy across biomarker selection, resistance detection at progression, and treatment response/MRD monitoring
- What’s Holding Adoption Back (And Where it’s Worst): Evidence and guideline clarity, reimbursement and logistics, workflow integration, and report interpretability, with a focus on medically underserved settings and populations
- How We Move the Needle: Oncologist perspectives on what would most increase willingness and ability to order, interpret, and act on results, with practical actions for biopharma, diagnostics, and health systems
4:10 pm Afternoon Break & Dedicated One-to-One Meetings
Building Clinically Actionable Precision Oncology: Standardized & Modular CGP, ctDNA, MRD Infrastructure Across the Drug Development Continuum
4:40 pm Clinical Validation of Myriad Genetics’ Ultra-Sensitive Pan-Cancer WGS-Based Precise MRD Assay
- 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
5:10 pm Panel Discussion: The Role of AI in the Future of Companion Diagnostics
- Companion diagnostics have traditionally relied on single-gene or single-analyte biomarkers to identify the right patients for a therapy. The field is now evolving toward RNA expression, complex signatures, digital pathology, multi-omic data, and AI-enabled approaches to patient selection
- This panel will explore the future of companion diagnostics as biomarkers become increasingly complex, multimodal, and AI-derived. Importantly, how AI-enabled CDx can be developed, validated, and regulated without compromising the rigor required for treatment decisions
5:40 pm The Power of Modular CGP: Enabling Precision Oncology Across Drug Development
- Explore the origins of MSK-IMPACT® and its real-world impact on patient care
- Gain insights into the assay’s robust analytical performance at scale, enabling decentralized sites across the world to generate concordant and high-quality data
- Understand how a flexible, future-proof CGP infrastructure helps pharma keep pace with an evolving biomarker landscape, and how SOPHiA GENETICS is already delivering this across the drug development continuum through hands-on partnerships with key diagnostic players
6:10 pm Panel Discussion: Strengthening Tumor‑Informed MRD Assays with Standardized Analytical Validation to Ensure Reliable Detection & Confident Clinical Interpretation
- What factors define intended use for MRD at predefined post-surgery time points and how to align study designs to qualitative detection endpoints?
- How to design precision repeatability and reproducibility across instruments, operators and sites under clinical sample scarcity?
- How can assay accuracy be robustly established when orthogonal reference methods are less sensitive than the MRD assay?
6:30 pm Evening Drinks Reception
6:30 pm Closing Remarks & End of Conference Day One
7:30 pm Dinner Conversations in Partnership with Myriad Genetics & SOPHiA GENETICS
Improving Patient Access to Precision Medicine: Developing & Delivering a CDx Solution Globally Using the Liquid Biopsy Solution MSK-ACCESS® powered with SOPHiA DDM™
In this engager, we demonstrate how MSK-ACCESS® powered with SOPHiA DDM™ is being used to deliver liquid biopsy results to patients globally. We will also discuss how this assay has served as the foundation for a groundbreaking industry collaboration which has resulted in the rethinking of current CDx approaches through a hybrid model designed for rapid scalability and access to precision medicine.
- Hear from laboratories and renowned experts who have implemented the liquid biopsy solution, MSK-ACCESS® powered with SOPHiA DDM™, and are currently offering it to their patients and using it in partnerships with pharma companies
- Discover SOPHiA GENETICS’ and Myriad Genetics’ first-of-its-kind CDx partnership model to unlock scale, regulatory compliance, and access to precision diagnostics and therapies, and how this model is being used to gain greater efficiency and to improve the timeliness of commercialization