Explore the Agenda
8:00 am Check In & Light Breakfast
8:50 am Chair’s Opening Remarks
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 Accelerating Therapy Success with Guardant Health: Proprietary Multiomic Insights, Distinguished Global Footprint, & Personalized CTA/CDx Solutions
- Position your clinical development program for success: Guardant Health offers flexible, personalized solutions for every stage of clinical development
- Power your next breakthrough with Guardant Infinity™ — a novel multiomic platform with epigenomics that delivers insights from liquid and tissue biopsies
- Guardant also provides multimodal real-world data, an expansive global commercial footprint and global CTA/CDx services with an industry-leading team of experts to streamline your therapy's pathway to success
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 Automated Tissue Chemistry (ATC): A Personal Story of Invention, Patient Care and the Importance of Companion Diagnostics
- How the invention of ATC brought on targeted therapy and precision medicine
- A Patient Story: A patient with malignant melanoma whose 42 immunotherapy infusions were directed by ATC
- The global consequences of ATC
- The future need to expand targeted therapy beyond diagnosis to treatment prediction
- Why we do what we do: a personal anecdote
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 partner? And how do different pharma companies prioritize partner selection considering these criteria?
- What is the role of cross-functional teams in efficient partner evaluation across pharma organizations?
- What is the significance of global partner 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 Collaborating through Complexity: A Case Study in Global, Pan-Tumor CDx Development
- Explore insights from Eli Lilly & Company and Foundation Medicine’s partnership to develop a pan-tumor companion diagnostic for Retevmo
- Discover the power of expertise, collaboration, and creative validation strategies for overcoming complexities such as sample limitations and diverse global regulatory requirements
- Learn how the right partnership can accelerate patient access to therapy
12:00 pm Evolving Companion Diagnostics: From Targeted Markers to Full-Stack Multi-Omic Partnerships
- Beyond the Biomarker: From reactive testing to platform-driven strategy
- Partnering from IND to Launch: Diagnostics as a strategic asset
- Unlocking RNA and proteomics for IO, ADCs, and emerging modalities
12:30 pm The Approval Gap: Strategies to Synchronize Drug and Diagnostic Approvals for Commercial Success
- Understanding the regulatory and strategic framework/circumstances for asynchronous approvals
- Explore how to develop a joint strategy to address the misalignment
- Ensure adherence and support for joint execution to reach the approval goals
1:00 pm Lunch Break & Networking
Dedicated One-on-One Partnering ™
12:50 pm Lunch & Learn Hosted by Foresight Diagnostics
*By Invitation Only
From Bench to Bedside: Enhancing Cancer Detection & Disease Monitoring through Innovations in Molecular Profiling & Genomic Sequencing
2:00 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
2:10 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
2:30 pm Enabling Patient Access to Targeted Therapies with Rapid & Accessible NGS CDx Solutions
- A decade of CDx development and commercialization
- How we address the needs of rapid and accessible testing globally
- A new era of rapid decentralized global NGS CDx solution for pharma
3:00 pm Are We Competing or Failing Together? Rethinking Global Access for Precision Medicine
- How bold, strategic collaborations between regulators, diagnostics, Association and pharma can unlock global patient access to IVD
- Why compliance and market-shaping access solutions must evolve to match the ambition of precision medicine
- The urgent need to redefine our competitive mindset – from siloed wins to shared impact
3:20 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
3:50 pm Creating Order from Chaos – The Path to Standardizing Minimal Residual Disease (MRD)
- Learning from history: Over the past 10 years the CDx space has seen the entry of numerous novel biomarkers whose results are more nuanced that the binary YES / NO of a traditional genetic test. PD-L1, TMB and MSI provide great examples of the challenges that novel biomarkers have faced when entering the market, especially with regards to standardization and uptake
- Understanding the present: MRD is a novel biomarker that helps to monitor the risk of relapse in oncology post treatment. Although MRD shows great potential, inconsistencies and a lack of standardisation with regards to methods, procedures, sensitivity and interpretation of results, make the implementation of MRD an ongoing challenge.
- Shaping the future: Learning from previous analogues can help us to understand how to plot a path towards the standardization of MRD more quickly and efficiently, providing greater clarity for physicians and better outcomes for patients
4:00 pm Afternoon Networking Break
Dedicated One-on-One Partnering ™
Navigating Diagnostic Regulatory Challenges to Support Clinical Trials & Accelerate Patient Access Across Global Markets
4:30 pm Session Reserved for Myriad Genetics
- Presentation Details to be Announced
5:00 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
5:20 pm Impact of Regional IVD Regulations on Global Therapeutic Trials
- Regional IVD Regulations
- Test Harmonization for Global Studies
- Requirements for Regulatory Services
5:50 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
6:10 pm Chair’s Closing Remarks & End of Day One
6:15 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.
This session will take place at a separate location 5 minutes' walk from the conference venue. Eddie Merlot's, Merlot Room, 505 Congress St, Boston, MA 02210