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

  • Bill Cance Distinguished Scientist, Medical Affairs, GRAIL

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

  • David Weingeist Scientific Director, Johnson & Johnson Innovative Medicines

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

  • Xin Jiang Vice President - Biology, Protego Biopharma

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

  • Chunming Ding Associate Director, Fudan University Shanghai Cancer Center
  • Jonathan Baden Executive Director, Bristol Myers Squibb
  • Kara O’Brien Executive Director - Global Precision Diagnostics Market & Ecosystem Shaping, Novartis AG

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

  • John Beeler Business Development Search & Evaluation Lead - Innovative Technologies - Translational Medicine, Bristol Myers Squibb

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

  • Hua Gong Senior Vice President & Global Head Of Translational Medicine & Clinical Biomarker, Zai Labs

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

  • Paul Robbins Vice President, Translational Sciences, Allogene Therapeutics

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

  • Eugean Jiwanmall Senior Research Analyst for Medical Policy & Technology Assessment, Independence Blue Cross

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

  • James rienow head of intelligence, Hanson Wade Intelligence

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

  • Aarti Tarkar Associate Director, Experimental Medicine Unit, GSK
  • Peter Krein Vice President - Precision Medicine, BoundlessBio
  • Jean-Francois Martini Executive Director - Translational Oncology, Global Product Development & Oncology Lead, Pfizer

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

  • Stacey Adam Associate Vice President, Foundation for the National Institutes of Health

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

6:15 pm Chair’s Closing Remarks

6:20 pm End of the 8th Liquid Biopsy for Precision Oncology Summit