Day One

Wednesday February 15, 2023

Day Two

Thursday February 16, 2023

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

  • Darren Hodgson Executive Director & Head of Site, Translational Medicine Strategy, Oncology & Global Project Leader, AstraZeneca

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 Natera

9:30 am Grail

10:00 am Transforming Clinical Trials with Urine Assay Technology: A Promising Solution

  • Michelle Quiroz Scientific Director of Oncology Diagnostics (ODx) Lead, 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 Labcorp

11:00 am Scientific Poster Session

Track A : Early Translation

Chair: Kristina McGuire, Executive Director & Head, CDx & 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 Translational 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?

Track B: Clinical Development & Commercialization

Chair: Michela Garofalo, Principal Scientist, Boehringer Ingelheim Advanced Research Company

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

  • Jonathan Baden Executive Director & Head of Solid Tumor Oncology Diagnostics, Bristol Myers Squibb

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, Department of Pathology, Fudan University Shanghai Cancer Center
  • Lee-anne Zinetti Senior Director - Global Precision Medicine, Novartis AG
  • Jonathan Baden Executive Director & Head of Solid Tumor Oncology Diagnostics, Bristol Myers Squibb
  • Keith Earley Associate Director - Clinical Assays & Companion Diagnostics, Seagen

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

Leveraging Liquid Biopsy Biomarkers for Innovative Drug Development to Advance Early Oncology Pipelines

3:00 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

3:30 pm Expediting Oncology Drug Development Using Liquid Biopsy Biomarkers

  • Hua Gong SVP, Translational Medicine and 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

3:00 pm Understanding & Bolstering the Reimbursement Challenges of Fragmented LDT Systems

Synopsis

• Conveying what happens in LDT based markets

• Highlighting the challenges that link the operational issues that labs face in LDT markets vs reimbursement

• Providing people with insight into what is required to manage all the stakeholders in an LDT market

3:30 pm The Journey of Liquid Biopsy from Clinical Development to Adoption to Reimbursement

  • Eugean Jiwanmall Senior Analyst - Research, Medical Policy and Technology Evaluation, 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

4:10 pm
Fostering Innovation & Collaboration to Weaponize Liquid Biopsy Studies & Improve Data Access

4:40 pm Panel Discussion: Facilitating Industry & Academic Collaborations to Enhance Data Access Approaches to Resolve Precision Oncology Needs

5:10 pm Agilent

5:40 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

6:10 pm Chair’s Closing Remarks

6:10 pm End of the 8th Liquid Biopsy for Precision Oncology Summit

DAY ONE
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