Explore the Agenda
7:00 am Light Breakfast & Networking
8:00 am Chair’s Opening Remarks
Advancing a Clinically Ubiquitous Pathway Towards Computational Pathology Workflows, Models, & Adoption Strategies to Improve Diagnostic Accuracy in Precision Oncology
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 Session Reserved for Personalis
Presentation Details to be Announced
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 Session Reserved for Natera
Presentation Details to be Announced
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 & CDx Connect 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 Chaired by Nicole Sheahan
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, 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 Session Reserved for Panakeia
Presentation Details to be Announced
12:40 pm Analytical & Translational Approaches Supporting Clinical Development of mRNA Based In Vivo CAR Products
Vice President - 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 Session Reserved for Discovery Life Sciences
Presentation Details to be Announced
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 Chaired by Nicole Sheahan
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 Regulatory 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 Session Reserved for Nucleai
Presentation Details to be Announced
3:30 pm Panel Discussion: Reserved for ZS Associates
Presentation Details to be Announced
4:00 pm World-Wide Clinical Trial Ready Assays as Distributed Kits: A Manufacturer’s Perspective of a Strategic Partnership Model
Chief Science Officer & Founder, EntroGen - Inc
- Collaborative Protocol Design: Engage at the trial-planning stage to co-develop biomarker assays that fit seamlessly into your study, maximizing data quality and regulatory alignment
- GMP-Grade CTA Supply: Manufacture and ship clinical trial assay kits to central labs worldwide, ensuring consistent performance and on-time delivery across all sites
- Seamless Commercial Scale-Up: Transition your validated CTA into FDA- and IVDR-approved companion diagnostic kits, leveraging our regulatory know-how and global distribution network for rapid market launch
Clinical Biomarker Development
CDx Development & Commercialization
4:10 pm Afternoon Networking Break
Dedicated One-on-One Partnering ™
Improving Patient Stratification with Biologic & ADC Drug-CDx Strategies to Optimize Trial Enrollment
4:40 pm Session Reserved for BostonGene
Presentation Details to be Announced
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 Session Reserved for Quest Diagnostics
Presentation Details to be Announced
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