CONFERENCE DAY TWO
7:30 am Light Breakfast
8:20 am Chair’s Opening Remarks
Addressing Early Considerations & Challenges in Establishing Effective Drug–Diagnostic Co-Development Models with Patients in Mind
8:30 am Delivering the Promise of Precision Medicine in a Complex and Dynamic US Testing Landscape: A Medical Affairs Perspective
Synopsis
- Understanding the evolving diagnostic journey and barriers to enable an optimal testing strategy
- Bridge the testing practice and access gap by supporting scientific evidence
- Building biomarker awareness, availability and access to enable CDx adoption
8:50 am How Signatera MRD testing is Transforming Cancer Care & Drug Development
Synopsis
- The Signatera ctDNA MRD assay is shifting the paradigm of cancer management; ~40% of US oncologists ordered Signatera in Q1 2024 and to-date, over 175,000 real-world patients have been tested across 700,000+ longitudinal timepoints
- Increasingly, Signatera is being integrated into the physician-patient shared decision-making model across tumor types and practice settings
- Among 20+ studies prospectively using Signatera, several randomized Phase 3 trials are expected to report findings over the next 12 months, with potentially practice-changing implications
- This presentation will review the current state of the MRD field and areas where more effective therapies are needed for high-risk populations
9:20 am Integrating the Patient Perspective in Clinical Biomarker Development & Companion Diagnostics for Enhanced Patient Impact
Synopsis
- Highlight the importance of incorporating patient feedback to ensure research addresses real-world patient experiences and needs
- Explore strategies for improving communication between researchers and patients, ensuring patients understand the implications and benefits of biomarker research
- Discuss how ongoing collaboration between researchers, clinicians, and patient advocacy groups can lead to better patient outcomes and more effective treatments
9:40 am GRAIL: A Tissue-free Platform to Revolutionize Cancer Care
Synopsis
- GRAIL’s methylation solution is uniquely suited for the detection, quantification, and classification of cancer through a non-invasive blood draw
- New data demonstrate platform utility across the patient care continuum to advance biopharma therapeutic strategies
- A novel Clinical Trial Assay leveraging GRAIL methylation for risk stratification in Stage I Lung Cancer
10:10 am Equity, Diversity & Inclusion (ED&I) Panel: Achieving Equitable Access to Testing Required for Precision Medicine, Irrespective of Geography, Socio-Economic, or Care Settings to Enable Enhanced Patient Outcomes
Synopsis
- How can we address disparities in access to companion diagnostics across different patient populations and geographies, irrespective of wealth or location?
- What steps are being taken to identify and mitigate potential biases in the data used to develop companion diagnostics, ensuring the tests are accurate and effective for all patients?
- How can we ensure that clinical trials for companion diagnostics include diverse patient populations, that accurately reflects the disease state, to reflect the real-world application of the tests?
10:35 am Morning Refreshments & Speed Networking
Synopsis
As the clinical biomarkers and CDx community unite once more, this valuable session will ensure that you can connect with your peers in the room to make new and lasting connections. All attendees will have the opportunity to meet and network with their industry peers.
TRACK A: Biomarker Discovery & Translational Development
Enhancing Biomarker Discovery to Accurately Translate into the Clinic for Better Disease Management
11:35 am Navigating Complexity in Disease Diagnosis & Treatment to Identify Robust Biomarkers
Synopsis
- Investigating the intricate interplay of biological pathways and variables in biomarker discovery
- Integrating proteomics data and advanced technologies to decipher biomarker signatures
- Validating biomarkers in translational studies
- Implementing strategies to translate biomarker findings into clinical applications for improved disease management
11:55 am De-Risk your Biomarker Journey. A Follow-the-Clone Case Study Tracking PRAME from Bench to Bedside
Synopsis
- The discovery process and challenges faced at each stage
- Addressing specificity, sensitivity, and throughput to shorten the transition at each stage
- A detailed case study
12:25 pm Discovering Non-Invasive Biomarkers to Transform Precision Medicine in Inflammatory Bowel Disease
Synopsis
- Exploring the impact of non-invasive biomarkers in IBD treatment
- How can biomarkers be used for disease monitoring to treat IBD?
- Towards personalized medicine in inflammatory disorders
12:45 pm Increasing Access to ctDNA Assessment for Biomarker Discovery, Development, & CDx Programs
Synopsis
- A disruptive, low-cost approach to MRD detection and quantification using WGS and a proprietary dPCR platform
- Structural Variants (SVs) are the ideal pan-cancer biomarker for determining MRD status using dPCR
- Increased analytical sensitivity demonstrates improved clinical performance
12:55 pm Networking Lunch
Innovative Approaches in Predictive Biomarkers & Precision Oncology: From Mechanistic Insights to Clinical Implementation
2:00 pm Characterizing the Predictive Value of Cyclin E1 Protein Expression to a WEE1 Inhibitor, Azenosertib (ZN-c3)
Synopsis
- CCNE1 gene amplification is a prevalent oncogenic driver in high grade serous ovarian cancer (HGSOC) and is associated with platinum resistance and poor patient outcomes. Importantly, Cyclin E1 overexpression can also occur in both the presence and absence of gene amplification
- Increased levels of Cyclin E1 results in accumulation of replication stress markers and showed greater antitumor effects in Cyclin E1high ovarian cancer models than Cyclin E1low models in vitro and in vivo
- Cyclin E1 positive status is highly prevalent in HGSOC patients with no CCNE1 amplification, and shows promising trends as a predictive biomarker for patients treated in a study of azenosertib in combination with chemotherapy
2:20 pm Leverage Single-Cell Multi-Parametric Datasets to Advance Heme Oncology Pipelines
Synopsis
- Leverage single-cell multi-modal analysis to get a more comprehensive view of multiple myeloma disease progression, therapy response and resistance, and therapy safety/efficacy
- Integrate SNVs, zygosity, CNVs, VDJ clonotype, and surface immunophenotype at the single-cell level, while measuring the transduction efficiency and vector copy number of potential CAR-T therapies
- Assess genome integrity through genome-wide CNV analysis at the single-cell level and leverage cohort-level analysis to guide therapeutic and clinical development
2:50 pm Developing & Executing Proof of Mechanism Strategies to Increase the Speed & Quality of Decision-Making
Synopsis
- The use of circulating free DNA and its methylation status to infer tumor gene expression and treatment response
- Insights into the mechanism of action and efficacy of radio-ligand therapy, a targeted radioactive treatment for cancer
- Leveraging epigenetic markers in blood samples and their correlation with treatment outcomes
3:10 pm Development of an NGS-based ecDNA Detection Solution into a Clinical Trial Device Targeting Oncogene Amplification
Synopsis
- Delve into the development and validation path to transform access to innovative precision therapies
- Learn about SOPHiA GENETICS’ unique ability to harmonize data derived from diverse genomic instruments and deploy as a robust, standardized solution enabling a decentralized model for clinical trial testing
- Hear how the integration of ecDNA technology will impact the journey of patients with oncogene-amplified cancers
TRACK B: Clinical Biomarker Development
Empowering Clinical Studies with Digital Biomarkers & Spatial Biology to Catalyse Transformative Advances in Patient Care
11:35 am Regulatory Considerations for the Use of Healthcare Technologies for Patient Selection, Monitoring & Endpoint Analysis in Medicinal Product Clinical Trials
Synopsis
- Use of a healthcare technology in a clinical trial (similarities and differences between IVDs and digital technologies)
- Distinction in regulatory pathways between enrollment/ selection methods and endpoint validation
- Considerations for pharma companies in assessing regulatory capabilities of partners with innovative digital technologies
11:55 am Global Reach, Rapid Results: Accessible Companion Diagnostic Solutions
Synopsis
- A decade of NGS CDx experience and results in advancing precision medicine
- Decentralized in-country CDx solutions with easy patient access to support therapy launches
- Accelerating time to treatment with NGS biomarker results available in as little as 24 hours from tissue and liquid biopsies
12:25 pm Panel Discussion: Leveraging Digital Biomarkers & Spatial Biology to Revolutionize Precision Medicine
Synopsis
- How can we standardize and integrate diverse digital biomarker data for comprehensive patient monitoring?
- How can predictive analytics with digital biomarkers enhance personalized treatment plans?
- How should biopharma form effective partnerships to pioneer new technologies, such as AI-driven digital pathology?
12:50 pm Spatial Biology to Enhance Targeted Therapeutics
Synopsis
- Evolution of Precision Medicine
- New approaches for biomarker discovery through spatial biology
- Applying spatial biology to support ADC development
1:00 pm Networking Lunch
Accelerating Clinical Implementation of Sensitive Liquid Biopsies in Global Trials for Robust Treatment Decision Making to Improve Patient Outcomes
2:00 pm Leveraging ctDNA-based Molecular Response Monitoring to Accelerate Clinical Development
Synopsis
- How does the integration of ctDNA as a molecular response biomarker in early clinical trials improve patient risk stratification
- Investigating case studies that demonstrate how molecular response assessment using ctDNA can predict clinical outcomes
- Harnessing ctDNA data alongside radiographic imaging for informed early Go/No Go decisions in clinical trials.
2:20 pm Comprehensive Epigenomic Profiling from Plasma to Inform Drug Development & Patient Selection in Oncology and Non-oncology
Synopsis
- Liquid biopsies are highly valuable assays for cancer diagnostic and treatment but going beyond genomics is key
- Epigenomics measures dynamic gene expression changes in cancers that can yield novel insights into cancer biology, pathways and targets
- Precede has developed an epigenomics profiling method of cancer from 1 ml plasma providing a genomic wide measurement of promoters and enhancers activation as well as methylation
2:50 pm Leveraging Novel Liquid Biopsy Technology to Accelerate Translational Research: Circulating Free DNA 5-hydroxymethylcytosine Profiling in Patients with Pancreatic Neuroendocrine Tumors Treated with [177Lu]Lu-DOTA-TATE
Synopsis
- The use of circulating free DNA and its epigenomic status to infer tumor gene expression
- Insights into the mechanism of action of radioligand therapy, a targeted radioactive treatment for cancer
- Leveraging epigenomic status in blood samples to identify predictive biomarker candidates
3:10 pm The Rise of cfHPV-DNA as a Biomarker for HPV-Associated OPSCC
Synopsis
- Assess patients’ trial eligibility, by determining patients’ HPV status and subtype with a simple blood draw.
- Gain real-time insights into treatment response, by assessing dynamic changes in cfHPV-DNA quantitatively over the course of treatment.
- Detect recurrent disease — including distant recurrence — early, with detection that precedes the current standard of care.
TRACK C: CDx Development & Commercialization
Navigating Regulatory Pathways to Streamline Approval Strategies for Optimized CDx Development
11:35 am Enhancing Clarity in the Regulatory Milestones to Streamline Approvals
Synopsis
- How should translational studies incorporate regulatory considerations to prevent bottlenecks in clinical trials?
- Understanding the biotech perspective for regulatory strategies
- Refining CDx relationships to optimize CDx development with regulatory considerations
11:55 am How to Overcome EU IVDR Challenges when Utilising Clinical Trial Assays to Accelerate Global CDx Trials
Synopsis
- Challenges associated with the EU IVDR regulation
- Solutions to help overcome some IVDR hurdles for Global Clinical Trials
- Key considerations when planning for CDx trials with EU sites
- Where to look for key information required for CPS submissions
- EU Country-Specific Regulatory Intelligence
12:25 pm Impact of IVDR & IDE/LDT Regulations on Patients Timely Access to Drug-Diagnostics Clinical Trials
Synopsis
- Streamlining global clinical trials to meet regulatory demands irrespective of location
- Introducing efficient strategies to manage and reduce the complexity and volume of approval applications within the European regulatory environment
- Comparing IVDR and IDE
12:45 pm The Nuances of Biomarker Implementation in a Clinical Trial: A Regulatory Perspective
Synopsis
- Define the intended use of a clinical trial assay (CTA) versus a CDx-ready assay
- Compare implementation of biomarker strategy in US and EU
- Understand implications of study design on regulatory requirements US v EU
12:55 pm Networking Lunch
Advancing Future Opportunities for Precision Medicine with Novel Technological Breakthroughs for Unparalleled Treatment Options
2:00 pm Overcoming Development Hurdles for Rapid Advancement & Implementation of Digital Pathology (DP) in Precision Medicine
Synopsis
- What are the key challenges associated with the development and approval of a CDx DP algorithm?
- How should industry stakeholders collaborate with regulatory agencies to streamline the approval process of DP algorithms?
- What should the requirements be for demonstrating clinical utility of CDx DP algorithms?
2:20 pm Transforming Pathology: Insights from Clinical Trials on an FDA-Cleared Digital Pathology Scanner
Synopsis
- Understand the clinical trial methodology and design used to evaluate the efficacy and safety of Leica’s FDA-cleared digital pathology scanner
- Explore the key findings and outcomes form the clinical trials, including accuracy and precision studies
- Discuss the potential impact of the FDA-cleared digital pathology scanner on biomarker development, diagnostic accuracy, workflow efficiency and patient care in clinical settings
2:50 pm Wielding Antibody-Drug Conjugates & Companion Diagnostics to Revolutionize Patient Care & Optimize Cancer Treatment
Synopsis
- Biomarker assays to predict response to antibody-drug conjugates
- Immunohistochemistry assay development for impactful ADC companion diagnostics
- Clinical utilization of companion diagnostics to tailor treatment for improved patient outcomes
3:10 pm Exploring Innovations in Flow Cytometry as a MRD and CDx Modality
Synopsis
- Join our talk and panel discussion to delve into the latest updates and developments in the use of flow cytometry as a MRD and companion diagnostic (CDx) modality.
- This session will provide insights into the decision-making process, highlighting when flow cytometry is the optimal choice for biopharma companies in their drug development journey.
- Discover how this powerful tool can enhance precision medicine and accelerate the path to successful therapies.
3:40 pm Afternoon Break
Harnessing the Power of MRD Detection & Comprehensive Assays to Refine Therapeutic Strategies for Personalized Treatment Options
4:10 pm Implications of Enabling Ultra-Sensitive MRD Detection in Early-Stage Lung & Breast Cancer
Synopsis
- Patients who previously report MRD negative with less-sensitive technologies are not truly negative and experience recurrence
- NeXT Personal is a tumor-informed ultra-sensitive ctDNA assay that enables detection down to 1PPM
- Could earlier detection be possible to enable earlier patient intervention
4:40 pm Leveraging MRD to Develop Personalized Treatment Options
Synopsis
- Integrating ctDNA, MRD, and real-world data to define patient populations and improve outcomes
- Developing algorithms to improve patient stratification
- Insights from tumor-informed and tumor-naive testing
5:00 pm Future Forward: From Advanced Diagnostics to Therapeutic Discovery with a Single Comprehensive Assay
Synopsis
- Importance of Comprehensive WES / WTS / IHC Testing
- Bias Reduction Through the Examination of all 23,000 Genes
- Preparing for Future Diagnostics and Therapeutic Discovery
5:30 pm The Dynamic Landscape of Global Deployment of Liquid Biopsy in Enabling Precision Medicine Minimal Residual Disease (MRD) Monitoring, Early Cancer Screening, and Personalized Treatment
Synopsis
- Fast-evolving liquid biopsy technologies and matrix (ctDNA, cfRNA, etc.)
- Clinical utilities and applications for minimal residual disease, early detection, etc.
- Harmonized assays and planning across varied regional regulations for global deployment
- AI/ML and real-world genomics data mining
5:50 pm Chair’s Closing Remarks & End of Conference Day Two
6:00 pm Cirque du Sip Drinks Reception hosted by Roche
Synopsis
Join us for an unforgettable evening, hosted by Roche, of Cirque du Sip—where entertainment, networking, and a touch of circus magic await!
