Explore the Agenda

7:00 am Light Breakfast & Networking

8:00 am Chair’s Opening Remarks

VP PMBATS, Bristol Myers Squibb

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

Senior Director & Global Head Computational Pathology Translational Science, AstraZeneca
  • 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

Senior Analyst & Vice President - Science Policy, Friends of Cancer Research
  • 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

Senior Director - Digital Pathology, Oncology Precision Medicine Leader, Bayer
Senior Director & Global Head Computational Pathology Translational Science, AstraZeneca
Director, Commercial Diagnostics, CDx Lead, Pfizer
  • 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

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 & Executive VP, 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 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 From Lab Developed Test to Kitted IVD: A CDx Journey

Vice President and Global Head 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

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 SOPHiA Genetics

Presentation Details to be Announced

3:30 pm Panel Discussion: Reserved for ZS Associates

Session Details to be Announced

4:00 pm Session Available for Partnership

Chief Science Officer & Founder, EntroGen - Inc

Inquire About Partnership Opportunities

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 Beyond One-Size-Fits-All: Moving from Rigid Partnerships to Dynamic IVD Collaborations

Director - Business Development & Companion Diagnostics, Bio-Techne Corporation
  • Navigating multiple clinical objectives and biomarker strategies requires a flexible diagnostic partner equipped with a comprehensive range of technologies
  • The ideal partner should be experienced in oncology diagnostics with established infrastructure for developing tests such as ESR1 LBx and BCR-ABL
  • Leveraging a trusted IVD company ensures essential expertise, reliability, and globally accessible CDx and clinical assay development solutions

5:10 pm Exploratory Biomarker Analysis in ADC Clinical Trials

Head Of Functional Excellence & Clinical Biomarker Oncology Department, Daiichi Sankyo
  • 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

Executive Director, Biomarker-Research, Gilead Sciences
  • 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

6:20 pm Chair’s Closing Remarks & End of Day Two

VP PMBATS, Bristol Myers Squibb