Explore the Agenda
7:00 am Light Breakfast & Networking
7:15 am CDx Strategy Breakfast Hosted by *By Invitation Only
8:00 am Chair’s Opening Remarks
From Early Detection & Patient Selection to Long-Term Care: Expanding the Role of Digital Pathology & Liquid Biopsy from Bench to Bedside
8:10 am Computational Pathology – Clearing the Way for More Robust IHC Biomarker Diagnostics
- Computational pathology is the next revolution in pathology enabling the development of more robust and accurate biomarker diagnostics
- QCS (Quantitative Continuous Scoring) was developed to quantify both target protein expression and spatial heterogeneity of target expression
- Discussing how AstraZeneca are leveraging QCS to quantify target expression to predict response of our oncology therapeutics, including Datopotamab deruxtecan (TROP2)
8:30 am Harnessing the Power of Ultra-Sensitive ctDNA Detection For Molecular Response & Endpoint Across All Phases of Clinical Development
- Personalis is the pioneer of ultra-sensitive tumor informed whole genome based ctDNA testing, and NeXT Personal remains the leader in the field with robust clinical validation/evidence generation
- Learn how NeXT Personal can play a pivotal role in ctDNA biomarker-driven clinical development, and how Personalis can be a partner for endpoint analyses thereby improving decision making to advance patient care
9:00 am Advancing AI-Driven HER2 Assessment: Findings from the Digital PATH Project
- Presenting novel findings from a multi-partner evaluation of AI-based HER2 scoring tools in breast cancer
- Demonstrating variability in model performance and the application of reference standards to evaluate consistency and reliability
- Exploring strategies to support validation and build regulatory confidence in AI-driven diagnostics for precision oncology
9:20 am From Concept to Practice: Enabling the Next Generation of MRD & Biomarker-Guided Trials
- Recently announced topline results from a prospective, randomized Phase III trial showed that Signatera-positive patients treated with an investigational therapy experienced statistically significant and clinically meaningful improvements in DFS and OS, demonstrating the feasibility of MRD-guided trial designs in an adjuvant setting
- Natera has since expanded beyond ultra-sensitive tumor-informed and tissue-free MRD assays to offer comprehensive genomic profiling (CGP), methylation, and trial support services enabled by real-world data and AI
- Together, these capabilities help sponsors design and execute MRD- and biomarker-guided trials with greater confidence and efficiency, offering broader optionality to tailor biomarker strategies across indications
9:50 am Panel Discussion: Navigating the Common Pitfalls in Digital Pathology to Streamline CDx Development & Adoption
- What are the key strategies to overcome barriers to widespread adoption of digital pathology? And how can organizations build the necessary infrastructure to support digital pathology at scale?
- What are the commercial challenges facing digital pathology as a companion diagnostic and how can companies address these obstacles?
- What are the current regulatory challenges in getting digital pathology technologies approved for use as CDx, and how can these be addressed moving forward?
10:20 am Morning Break & Networking
An opportunity to network, discuss and collaborate with like-minded leaders of the precision medicine community
Biomarker Discovery & Translational Development
Clinical Biomarker Development
CDx Development & Commercialization
Biomarker Discovery & Translational Development
Biomarker Discovery & Translational Development Track
Vice President, Translational Sciences, Ipsen Pharma
Leveraging Cell-Based, Omics & Functional Assays in Biomarker Discovery to Capture Dynamic Biological Responses & Improve Diagnostic Accuracy
11:20 am Driving Drug Development with Integrated Multi-Omic Insights: Unlocking Precision Medicine with Biodesix’ Comprehensive Service Offerings
Senior Manager - Business Development, Biodesix
- Integrated multi-omic services accelerate therapeutic discovery and development
- Biodesix’ end-to-end service offerings simplify complex translational workflows
- Actionable, high-resolution data to power precision medicine
11:50 am Developing a Companion Diagnostic for a SMARCA2 Direct Degrader in Cancer
Chief Medical Officer & Executive Vice President - Clinical & Translational Development, Plexium Inc.
- SMARCA4 mutations are a heterogeneous group of genomic abnormalities in cancer, some of which create a dependency on its paralog, SMARCA2
- Prospective identification of patients who would benefit from treatment with a selective SMARCA2 degrader will require a comprehensive analysis of data from ongoing clinical studies and pre-clinical models
12:10 pm Panel Discussion: H&E-Based Molecular Profiling: From Bench to Bedside in the Era of Precision Medicine & AI
Founder & Chief Executive Officer, Panakeia Technologies
Vice President, Science Policy, Friends of Cancer Research
Senior Director & Head, Computational Pathology Strategic Partnerships, AstraZeneca
Chief Scientific Officer, Precede Biosciences
Executive Director, The DDx Foundation, Founder & Chairman, Lumea
- AI-enabled H&E-based molecular profiling has the potential to transform the diagnosis and treatment pathway for cancer and beyond by overcoming key challenges of traditional wet lab methods – such as high cost, time-consuming processes, limited scalability, and variability in reproducibility – through rapid, scalable, and data-driven analysis
- The panel will discuss the enormous potential of utilising AI-enabled H&E-based molecular profiling in Clinics, Drug development and Drug discovery/Research
12:40 pm Analytical & Translational Approaches Supporting Clinical Development of mRNA Based In Vivo CAR Products
Vice President, Head of Translational Medicine, Capstan Therapeutics
- Leveraging preclinical drug product mechanism of action data to inform on FIH clinical pharmacology analytical strategy
- Fit-for-purpose qualification and validation strategies for FIH to support a recommended dose regimen for Phase 2/ 3 evaluation
- Refinement of analytical approaches and translational strategy in Phase 2/ 3 to support regulatory activities
1:00 pm From Lab Developed Test to Kitted IVD: A CDx Journey
Vice President & Global Head of Companion Diagnostics, Discovery Life Sciences Inc
- We will present an overview of utilizing lab developed tests to get prototype assays deployed quickly and inexpensively to support early phase clinical studies
- A case study demonstrating successful transition from lab developed test to kitted solution with an in vitro diagnostic partner will be summarized
Clinical Biomarker Development
CDx Development & Commercialization
1:10 pm Lunch & Networking Break
Dedicated One-on-One Partnering ™
1:10 am Lunch & Learn Hosted by Sophia Genetics
*By Invitation Only
Biomarker Discovery & Translational Development
Clinical Biomarker Development
CDx Development & Commercialization
Biomarker Discovery & Translational Development
Biomarker Discovery & Translational Development Track
Vice President, Translational Sciences, Ipsen Pharma
Advancing Dynamic Tumor Profiling & Gene Signatures for Real-Time Clinical Decision- Making & Guided Adaptive Treatment Strategies
2:10 pm From Foundation Model to Real-World Impact: Transforming Clinical Diagnostics with Multimodal AI
Vice President - Scientific Programs, Aignostics
- With foundation models, companies like Aignostics are building truly generalizable AI products that can be used in real world settings
- One example is Atlas H&E TME: a comprehensive, scalable product for tumor microenvironment profiling in H&E images
- The next generation of multimodal foundation models will usher in even more sophisticated AI products
2:40 pm The Multifaceted Role of GEF-H1 in Cancer & Its Immune Activation by Plinabulin
Chief Scientific Officer, BeyondSpring Pharmaceuticals Inc.
- Revisiting the role of the microtubule-associated RhoA activator GEF-H1 in cancer
- GEF-H1 activation by plinabulin in DC maturation and anticancer immune responses
- The potential of GEF-H1 based biomarker approach for plinabulin combined with chemotherapy/ radiation and a checkpoint inhibitor
3:00 pm Bridging the Gap: A Hybrid Deployment Model for Scaling Innovation in Oncology
Vice President & Managing Director - BioPharma Business Development, Sophia Genetics
- Discover SOPHiA GENETICS’ unique framework to shape healthcare’s future by standardizing and decentralizing MSK-ACCESS® powered with SOPHiA DDM™, at a global scale
- Learn how blending centralized and decentralized models can expand patient access while ensuring test accuracy and alignment with regulatory requirements
- Dive into SOPHiA GENETICS’ groundbreaking cross-industry collaborations to validate a best-in-class liquid biopsy solution, while supporting centralized confirmatory testing in clinical trials
3:30 pm Panel Discussion: Improving Patient Monitoring through Innovations in Liquid Biopsy Analysis
Chief Medical Officer, Relay Therapeutics
Assistant Professor, Harvard Medical School & Medical Oncologist, Dana-Farber Cancer Institute
Head of Clinical Genomics, EMD Serono, An affiliate of Merck KGaA, Darmstadt, Germany
Senior Vice President - Clinical Development, Population Health & Biostatistics, GRAIL
- What are the recent innovations in liquid biopsy derived markers and how to integrate these into clinical trial designs?
- How can we build successful liquid biopsy collaborations to pioneer future trial design?
4:00 pm Integrated Liquid Biopsy Solutions to Accelerate Global Clinical Trials & CDx Development
Vice President, BioPharma Partnerships, Predicine
- Genomic profiling using blood and urine to enable global clinical trials and CDx development
- Epigenomic methylation profiling for enhanced detection of therapy response dynamics and resistance mechanisms
- RNA profiling to advance next-generation drug development through transcriptomic insights
Clinical Biomarker Development
CDx Development & Commercialization
4:10 pm Afternoon Networking Break
Dedicated One-on-One Partnering ™
Improving Patient Stratification with Emerging Modality CDx Strategies to Optimize Trial Enrollment
4:40 pm Accelerating Patient Stratification with Ella: An Automated Benchtop Immunoassay Platform for Clinical Trial Readiness
- Obtain robust and reproducible answers across multiple users and multiple sites
- Get unparallel biomarker precision and accuracy
- Generate high-quality biomarker data to support clinical decisions
5:10 pm Exploratory Biomarker Analysis in ADC Clinical Trials
- Overview of the DXd ADC technology
- Discussing considerations of exploratory biomarker analysis
- Exploring representative examples
5:30 pm From Assay to Access: Building Diagnostics That Drive Therapeutic Success
- Assay Development Excellence: How early integration of CDx assay design with clinical strategy can reduce trial risk, accelerate timelines, and ensure clinical utility
- Regulatory Strategy Alignment: Applying coordinated regulatory and global strategies to pursue parallel submissions that can accelerate availability of both therapies and diagnostics
- Market Access & Adoption: Approaches to optimize reimbursement, drive physician adoption, and expand patient access to ensure commercial success of precision medicines
6:00 pm Biomarker-Driven Phase 3 Clinical Trial Enrollment With a Hybrid Approach of Qualified Local & Central Laboratory Developed Tests
- The ENHANCE-02 trial enrolled Acute Myeloid Leukemia subjects with TP53 mutation
- Assay concordance was estimated for the collection of local LDTs and a planned CDx assay
- Effects of this approach on enrollment speed and simulated trial efficacy analysis were examined