January 30-31, 2018
San Diego, CA

Day One
Tuesday, January 30, 2018

Day Two
Wednesday, January 31, 2018

08.20
Chairs’ Opening Remarks


The Evolving Role of Liquid Biopsy in Cancer: IO & Oncology Case Studies

08.30
Utilizing ctDNA to Predict and Inform Response to Immune Targeted Therapeutics

  • Razelle Kurzrock Chief, Division of Hematology & Oncology, Director, Center for Personalized, Cancer Therapy & Clinical Trials Office, UCSD

Synopsis

  • Examining the mutational and antigenic load to advise immuno-oncology treatment
  • Utilizing liquid biopsies to study host immune responses, T-cell repertoires and antigen profiles
  • Understanding and monitoring the inflammatory response to immunotherapy treatment

08.55
Circulating Tumor DNA and Oncology Immunotherapy – The Next Frontier

  • Daniel Simon Vice President, BioPharma Business Development, Guardant Health

Synopsis

  • Adopting ctDNA to support development of oncology immunotherapies
  • Discussing ctDNA applications, including positive and negative selection of patients, monitoring for rapid insights into patient response
  • Developing new, larger, panels to support evaluation of a broader set of genes and tumor mutational burden

09.25
Analysis of RAS Mutational Status by ctDNA and Clinical Outcomes for Patients with Metastatic Colorectal Cancer Treated with Panitumumab

Synopsis

  • Liquid biopsies allow for detection of mutations over-time and may provide global mutation status of patients undergoing therapy
  • Clinical utility remains to be further explored

09.50
Networking & Morning Refreshments

10.20
Predictive Biomarkers for Immunotherapeutic Response in Cancer

  • Sandip Patel Medical Oncologist & Assistant Professor of Medicine , UCSD

Synopsis

  • Discussing the nuances in the development of PD-L1 assays
  • Evaluating the development of alternative predictive biomarkers to better determine patient response to immune checkpoint modulation
  • Analyzing the next generation of cancer immunotherapeutic currently under development, including cell-based approaches

10.45
ctDNA Solutions Across the Oncology Drug Development Continuum

  • John Simmons Director, Translational Sciences & Diagnostics, Personal Genome Diagnostics

Synopsis

  • Discussing PGDx ctDNA approaches from biomarker discovery to IVD
  • Exploring clinical trial enrollment strategies using tissue and/or liquid biopsy in a decentralized model
  • Addressing ctDNA companion diagnostic development

11.15
Why Molecular Diagnostic Testing is Important in Lung Cancer

  • Hatim Husain Assistant Professor of Medicine, UCSD Moores Cancer Center

Synopsis

  • Exploring the early detection and analysis of lung cancer patients harnessing liquid biopsy testing
  • Discussing the initial genotyping and characterization of tumors and implications for treatment
  • Understanding how we can develop algorithms and metrics to measure tumor response and evaluating the dynamics in how genotyping changing over time

11.40
Session Q&A

  • Razelle Kurzrock Chief, Division of Hematology & Oncology, Director, Center for Personalized, Cancer Therapy & Clinical Trials Office, UCSD
  • Sandip Patel Medical Oncologist & Assistant Professor of Medicine , UCSD
  • Hatim Husain Assistant Professor of Medicine, UCSD Moores Cancer Center
  • Daniel Simon Vice President, BioPharma Business Development, Guardant Health
  • Agnes Ang Principal Scientist, Amgen
  • John Simmons Director, Translational Sciences & Diagnostics, Personal Genome Diagnostics

Synopsis

  • Q&A with the sessions speakers
  • How can liquid biopsy improve the testing of complex combination treatments in immuno-oncology
  • Discussing future developments in the IO space and the role circulating biomarkers will have in the selection of potential responsive cohorts

12.25
Lunch & Networking


Regulation, Reimbursement & the End Result for Patient Welfare

13.25
Regulatory Considerations for ctDNA as Biomarker Candidates Into Companion Diagnostics

Synopsis

  • Evaluating the promise of ctDNA for improving cancer diagnosis and monitoring as well as drug development and utility as companion diagnostics
  • Discussing the unique set of regulatory concerns with this technology, particularly in establishing analytical and clinical validity
  • Considering challenges and opportunities in analytical and clinical study design

13.45
Proving Value for Reimbursement: The Bottleneck to the Impact of Liquid Biopsies on Personalized Healthcare?

Synopsis

  • What data do we need to prove the clinical utility of liquid biopsy tests? How does this differ from LDT to IVD?
  • Strategies for improving the quality and “completeness” of data to more persuasively prove the case for impact on clinical outcomes
  • Building a level of standardization across insurers to benchmark the evidence needed for sufficient value demonstration

14.10
Session Q&A

Synopsis

  • Q&A with the sessions speakers
  • IVD or LDT: What is the best path for commercial success, and more importantly, for maximizing patient benefit?
  • The black box of concordance: How do we approach a difference in readout between tissue and liquid samples and what do we need to do to validate such a scenario?
  • How do we engage payers with the clinical utility we are currently demonstrating to improve the income stream needed to support future R&D and commercialization of liquid biopsy tests?

14.40
Chairs’ Closing Remarks

14.45
End of Day Two & Close of 2nd Precision LBx Summit