Explore the Agenda
8:00 am Check In & Light Breakfast
8:50 am Chair’s Opening Remarks
8:59 am Leveraging Predictive Biomarkers to Advance Patient Selection & Monitoring in Precision Oncology for Improved Clinical Outcomes
9:00 am Multimodal Machine Learning Model Effective at Predicting Response to CDK4/6 Inhibitors in HR-positive, HER2-negative Breast Cancer Patients
- The evolving role of clinical-genomic integration in metastatic breast cancer management
- Machine learning-driven risk stratification: uncovering patterns in patient outcomes
- Understanding how genomic and clinical variables together enhance predictive accuracy
- Implications for treatment optimization and patient monitoring
9:20 am Session Reserved for Guardant Health
Presentation Details to be Announced
9:50 am Innovative Diagnostic Solutions: Maximizing Opportunities in Bladder Cancer Treatment
- Reviewing strategies to address tissue insufficiency
- Showcasing urine based liquid biopsy for patient selection and monitoring
- Exploring a histopathology-based AI algorithm for FGFR detection
10:10 am Breakthroughs in Companion Diagnostics: Industry Transformation & Improved Patient Care
Presentation Details to be Announced
10:40 am Morning Networking Break
Dedicated One-on-One Partnering ™
Optimizing Co-Development Strategies & Testing Partnerships to Bolster Drug-Diagnostic Regulatory Adherence, Adoption & Streamline Global Market Access
11:10 am Panel Discussion: Assessing Biopharma Partnership Selection Strategies in Precision Medicine to Strengthen Strategic Partnerships & Accelerate Clinical Success
- What capabilities, compliance, or market experience drive appetite to collaborate with a particular vendor? And how do different pharma companies prioritize vendor selection considering these criteria?
- What is the role of cross-functional teams in efficient vendor evaluation across pharma organizations?
- What is the significance of global vendor footprint in the context of co-development and large scale manufacturing?
- How are testing decisions around centralized or decentralized testing determined in each market?
11:30 am Session Reserved for Foundation Medicine
Presentation Details to be Announced
12:00 pm Panel Discussion: Reserved for Caris Life Science
Panel Details to be Announced
12:20 pm Session Reserved for Agilent Technologies
Presentation Details to be Announced
12:50 pm Dedicated One-on-One Partnering ™
Dedicated One-on-One Partnering ™
12:50 pm Lunch & Learn Hosted by Foresight Diagnostics
*Please note, attendance at this Lunch & Learn session is subject to availability and approval by Foresight Diagnostics. Visit the website for full terms and conditions.
From Bench to Bedside: Enhancing Cancer Detection & Disease Monitoring through Innovations in Molecular Profiling & Genomic Sequencing
1:50 pm Advocacy Efforts to Increase Access to & Understanding of Biomarker Testing
- Reporting on advocacy research on barriers to patient and caregiver biomarker testing and patient understanding of test results
- Sharing the work on the creation of a patient and caregiver Precision Medicine Plain Language Lexicon to break down barriers to care
- Providing a brief overview of state and federal level advocacy efforts on biomarker testing access
2:00 pm ctDNA Response: A Tool for Early Proof-of-Concept in Phase I Drug Development
- Liquid biopsy has become an integral component of early oncology drug development
- CtDNA response offers accelerated insights into drug effect, complementing radiographic response
- Intentional steps are needed to effectively operationalize ctDNA response for accelerated development insights
2:20 pm Session Reserved for Thermo Fisher Scientific
Presentation Details to be Announced
2:50 pm The Journey of an FDA-Approved CDx for Rare Fusions: Rozlytrek CDx Case Study
- Genentech’s first FDA-approved tumor-agnostic medicine designed to target both ROS1 and NTRK
- Roche/Genentech and Foundation Medicine (FMI) CDx collaboration: Comprehensive genomic testing is critical to identify patients with rare gene fusions
- Understanding of the techniques for NTRK testing in clinical practice
3:10 pm Precision Medicine at Scale: Innovation, Efficiency, & Global Reach
- Learn how Illumina can help drive success of your drug development pipeline, from discovery to commercialization
- Learn how the global reach of Illumina, from our instrument placements to the uptake of our TruSight Oncology Comprehensive genomic profiling solution, can drive precision oncology at scale
- Learn about the benefits of a companion diagnostic partnership with Illumina – accessing our product development teams to drive innovative solutions, leveraging our clinical development teams to ensure uniform testing throughout the world, and utilizing our experienced regulatory teams to navigate the ever-changing global regulatory environment
3:40 pm Afternoon Networking Break
Dedicated One-on-One Partnering ™
Navigating Diagnostic Regulatory Challenges to Support Clinical Trials & Accelerate Patient Access Across Global Markets
4:10 pm Beyond One-Size-Fits-All: Moving from Rigid Partnerships to Dynamic IVD Collaborations
- 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
4:40 pm Providing Clarity on the IVDR CDx Procedure: Lessons from the First CDx Product Certification
- Providing a background on IVDR and differences in CDx definition between IVDR and US FDA
- Sharing key points and experience from the first CDx Product Certification
- Partnerships between IVD manufacturers and Notified bodies to accelerate CDx Product Certification
5:00 pm Session Reserved for Q² Solutions
Presentation Details to be Announced
5:30 pm Panel Discussion: Why Diagnostic Regulation Matters in Pharmaceutical Development, & Current Best Practices
- Identifying the role of diagnostics in pharmaceutical development and the corresponding levels of regulatory expectation
- Providing a high-level summary and comparison of related regulations globally
- Outlining best practices for aligning diagnostic and therapeutic development processes to foster innovation and ensure patient access to precision therapies
5:50 pm Chair’s Closing Remarks & End of Day One
6:00 pm Evening Thought Leadership Engager Hosted by Natera
*Please note, attendance at this engager session is subject to availability and approval by Natera. Visit the website for full terms and conditions.