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 Session Reserved for Natera
Presentation Details to be Announced
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 Partnering Models that Accelerate Precision Oncology from Development to Delivery
- Exploring Johnson & Johnson’s Pharma–Diagnostics Partnership Model: An overview of how J&J structures and enables early, aligned collaboration between drug and diagnostics teams and external partners to support integrated decision making, development strategies, and regulatory readiness
- Showcasing Insights from Successful Precision Oncology Programs: Learnings drawn from delivering CDx-enabled oncology programs, highlighting the partnership approaches that help translate scientific innovation into meaningful real-world impact
- Looking Ahead – How Precision Medicine Partnerships are Evolving Across the Industry: A broader perspective on where pharma-diagnostics partnering is headed, and key considerations for delivering CDx-enabled therapies at scale across patients, clinicians and health systems
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 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
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 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 Access & Optionality: 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
4:10 pm Afternoon Break & Dedicated One-to-One Meetings
Building Standardized ctDNA & MRD Strategies to Strengthen Clinical Development Rigor & Provide High‑Integrity, Actionable
Patient‑Response Insights
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: Has Companion Diagnostics Outgrown Its Origins?
Presentation Details to be Announced
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 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