7:30 am Registration & Morning Networking Coffee
8:25 am Chair’s Opening Remarks
Revolutionizing Technology to Deliver Promising Solutions for Better Patient Stratification & Outcomes
8:30 am Pivotal Trials for Applications for ctDNA as Agnostics & End Points for Patient Stratification & Treatment Response Assessment
Synopsis
• Showcasing working projects and publications
• What it takes to develop a profile to deliver the data package to achieve proof of concept
• Combining and co-developing tests and drugs to bring forward to market
• New ways to define patient populations and disease especially in lung cancer
9:00 am Beyond Genotyping & Tissue: Leveraging a Liquid Biopsy, Methylation-Based Platform Across the Cancer Care Continuum
Synopsis
- GRAIL’s methylation technology overview and clinical studies
- Overview of Tumor Methylation Fraction (TMeF) for molecular response, risk stratification, prognosis/prediction and MRD
- Application focus: The use of GRAIL’s methylation technology in early-stage NSCLC prognosis and hematological cancer
9:30 am The Use of ctDNA MRD in Clinical Development
Synopsis
- Backed by >50 peer reviewed publications and >200 congress presentations, Signatera’s prognostic and predictive capabilities has been demonstrated across tumor histologies
- Signatera has been shown to identify high-risk patients who may benefit from investigational/novel therapies; more interventional trials are needed for these populations
- Rapid growth in Signatera utilization, especially in colorectal, breast, and bladder cancers, offers a unique opportunity to leverage real-world data for insights into molecular persistence and relapse, as well as clinical trial matching
10:00 am Transforming Clinical Trials with Urine Assay Technology: A Promising Solution
Synopsis
- Detection in urine provides a non-invasive screening approach and mitigates certain challenges with tissue testing
- Early detection with urine-based assays in bladder cancer can lead to earlier treatment, better patient outcomes, and potentially a higher chance of cure
- Tumor markers in urine can also be utilized for disease monitoring and longitudinal response to treatment
- Urine offers rapidity, simplicity, and sensitivity in the mission of personalized medicine in bladder cancer
10:30 am Utilizing Novel ctDNA Profiling Solutions for Enhanced Sensitivity & Accuracy Throughout Drug Development
Synopsis
- Labcorp Precision Oncology capabilities – globalized approach
- Addressing challenges in cfDNA applications across the patient journey
- Matched normal, MRD, and monitoring applications
11:00 am Scientific Poster Session and Morning Networking Break
Track A : Early Translation
Chair: Kristina McGuire, Executive Director & Head of CDx & Clinical Laboratory Operations, Regeneron
Investigating Disease-Driving Biomarkers Using Genomics & Proteomics to Establish Biomarker-Disease Correlations & Optimize Therapeutic Strategies
12:00 pm Precision Diagnosis & Prognosis Enabled by Mechanism-Driven Protein Conformational Biomarkers Case Studies
Synopsis
- Protein confirmational changes commonly precede onset of human diseases
- Detection and quantification of nonnative protein structures using proteomics of disease-driving protein may serve as diagnostic and prognostic biomarker
- Importance of establishing biomarker correlation with clinical outcome
- Case studies of Transthyretin Amyloidosis and Systemic Amyloidosis
12:30 pm Fireside Chat: Unlocking Precision Medicine in Early Clinical Translation: Integration of Genomic Correlations with Peripheral Immune Response for Dose Optimization in CIT
Synopsis
• Correlating the changes in ctDNA with peripheral immune response
• Fine-tuning dose optimization through combinatorial strategies for maximising therapeutic efficacy
• Combination of each drug and readouts and how to incorporate the genomic data
• How can this data be used to support precision medicine?
1:20 pm Novel Liquid Biopsy – Chromatin immunoprecipitation (ChIP) of Circulating CTCF Transcription Factor-DNA Nucleoproteins from Plasma Isolates Pure Tumor Derived ctDNA Sequences for Analysis by PCR
Synopsis
- Tumor derived ctDNA relating to cancer associated gain of occupancy CTCF binding sites circulates as CTCF-DNA nucleoproteins in cancer patients but as nucleosomes in all other patients
- Pure ctDNA gain of occupancy CTCF binding site sequences are isolated by CTCF ChIP with removal of all non-tumor derived nucleosome covered cfDNA fragments
- Liquid biopsy of the isolated pure ctDNA sequence by PCR is an accurate, low cost, rapid, automatable method for detection of early stage solid and liquid cancers
Track B: Clinical Development & Commercialization
Chair: Kara O’Brien Executive Director, Precision Diagnostics Market & Ecosystem Shaping Novartis
Accelerating Commercialization of Liquid Biopsy Tests to Ensure Global Patient Access at Early Stages
12:00 pm Investigating Already Commercialized Liquid Biopsy Tests to Inform Best Practice to Commercialize Novel Tests for Improved Market Access for Patients
Synopsis
• Leveraging lessons from existing liquid biopsy tests to expand the next wave of liquid biopsies
• Extracting insights and best practices to streamline the introduction of novel tests
• Enhancing patient access to innovative liquid biopsy solutions through strategic commercialization approaches
12:30 pm Panel Discussion: Steering Global Commercialization Landscapes to Usher Liquid Biopsy Assays from Innovation to the Patient to Improve Global Commercial Reach
Synopsis
• How to ensure liquid biopsy assays are being adequately regulated in the EU vs US vs Japan vs China?
• What are regulatory agencies looking for to design the assays?
• What are the challenges to bring liquid biopsy technologies to market, related to regulatory approval based on country-specific requirements?
• What are the different pathways to commercialize liquid biopsies?
1:30 pm Lunch & Networking Break
1:40 pm
Leveraging Liquid Biopsy Biomarkers for Innovative Drug Development to Advance Early Oncology Pipelines
2:30 pm Driving Innovative Technology Applications to Advance Oncology Assets
Synopsis
• Utilizing emerging technologies to enhance cancer treatment efficacy by identifying suitable patients and monitoring response to therapy
• Discussing pharmacodynamic biomarkers for early stage assets
• Addressing life cycle management opportunities and moving into early-stage disease applications using MRD assays
• Managing development of assays to broaden worldwide accessibility for clinical trials and commercialization
3:00 pm Comprehensive Epigenomic Profiling of Cancers from Plasma to Inform Drug Development
Synopsis
- Epigenomic changes in cancer involve DNA methylation but also dynamic changes in regulatory regions in the genome controlled by histone modifications of gene promoters and enhancers
- Precede Biosciences has developed a method and informatics to quantitatively measure tumor changes in promoters , enhancers and methylation form 1 ml of plasma
- Utilization of this novel approach in profiling cancers and potential therapy selection will be presented
3:30 pm Expediting Oncology Drug Development Using Liquid Biopsy Biomarkers
Synopsis
- Overview of liquid biopsy applications in drug development and clinical practice
- Recent advancements and breakthroughs in this field with examples
- Challenges and limitations of the current technologies; Potential future directions to overcome these obstacles and expand the utility of liquid biopsy
Navigating the Reimbursement Landscapes to Expand Access to Biomarker Testing
2:30 pm Advancements in Minimal Residual Disease (MRD) Diagnostics set the Stage for Novel Clinical Trial
Synopsis
• Overview of the unmet need in early line large B-cell lymphoma (LBCL) patients
• MRD status as prognostic indicator of patient outcomes
• Novel trial utilizing innovative biomarker for patient selection
3:00 pm cfDNA-based Machine Learning Models for Precision Medicine in Lung Cancer
Synopsis
- Robust Prediction of Clinical Outcomes with cfDNA
- Machine-learning driven identification of liquid biopsy biomarkers and characterization of tumor status
3:30 pm The Journey of Liquid Biopsy from Clinical Development to Adoption to Reimbursement
Synopsis
• What the evidentiary state did, does and have to do to serve as a common ground to make policy cover decisions and contracting decisions
• Differentiating between companion diagnostic designation for liquid biopsy tests and how those are treated
• Evidentiary state of each individual liquid biopsy test and panels
4:00 pm Afternoon Networking Break
4:30 pm MRD Market Insights
Synopsis
- MRD in drug development stages
- Considerations in choosing assays for MRD investment trends in MRD
5:00 pm Panel Discussion: Facilitating Industry & Academic Collaborations to Enhance Data Access Approaches to Resolve Precision Oncology Needs
Synopsis
• Enabling the fast creation of liquid biopsy technologies to solve high-value clinical problems through deep collaborations driven by unmet diagnostic needs
• Delving into the complexities of forming partnerships to deliver precision medicine
• Addressing the challenges in forming public-private networks for precision medicine to leverage data networks that could resolve liquid biopsy bottlenecks
• Accelerating the development of needed data through the collaboration between clinicians, researchers, regulatory figures and other stakeholders
5:45 pm Creating a Public-Private Partnership to Support the Development of Treatments for Ultra-Rare Tumor Indications
Synopsis
- Addressing plans for creating a public-private partnership to guide and support development of new treatments for patients with ultra-rare cancers
- Discussing the market appetite for collaborative efforts to achieve significant breakthroughs in oncology treatments that are not economically feasible for a single organization to develop
- Understanding if there are sufficient resources between public and private sources to create a drug development platform and process for these indication