Workshop on Circulating Tumor DNA Assays in Clinical Cancer Research

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• Key Note: Biology and Background for ctDNA; Advantages and Drawbacks of Assays Currently in Use; Knowledge Gaps.
  Luis Alberto Diaz, Jr, MD, Associate Professor of Oncology, Johns Hopkins University

• Session I: Clinical Utility of ctDNA
  Eric J. Bernhard, PhD, Branch Chief, Radiation Research Program, NCI
• Clinical Applications of ctDNA Assays for Cancer, Pharmacodynamic Assessment of Drug Response.
  Geoffrey R. Oxnard, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School
• Capturing Tumor Heterogeneity and Clonal Evolution Using ctDNA Analysis
  Muhammed Murtaza MD, PhD, Assistant Professor and Co-Director of the Center for Noninvasive Diagnostics, Translational Genomics Research Institute, Mayo Clinic Arizona
• Deep Sequencing of Circulating Tumor DNA for Cancer Detection and Monitoring.
  Maximilian Diehn MD, PhD, Assistant Professor of Radiology Oncology, Stanford University
• Statistical Considerations for Trials Designed to Determine Clinical Utility of ctDNA Assays.
  Lisa M McShane, PhD, Chief of the Biostatistics Branch, National Cancer Institute
• Utility of ctDNA Monitoring in Metastatic Melanoma Disease Surveillance.
  David Polsky, MD, PhD, Director, Pigmented Lesion Section, NYU School of Medicine

• Session II: ctDNA Assay Technology
• EFIRM Liquid Biopsy (eLB)
  David T.W. Wong DMD, DMSc, Professor, Associate Dean for Research, UCLA
• Translating Nanotechnology and Microfluidics for Analysis of DNA Methylation
  Jeff T.H. Wang, PhD, Professor, Dept. of Mech. Engineering, Johns Hopkins University
• Patch PCR: A Targeted Sequencing Approach to Quantify Breast Cancer ctDNA
  Katherine (K-T) Varley, PhD, Assistant Professor, Oncological Sciences, University of Utah
• Detection of Tumor-specific Mutations in Circulating, Cell-free DNA: Potential for a Biomarker in Esophageal Adenocarcinoma.
  Tony E. Godfrey, PhD, Associate Chair, Associate Professor of Surgery, Boston University
• Advantages and Disadvantages of ctDNA vs CTC Assays
  Julie E. Lang, MD, Director, Breast Cancer Program, University of Southern California
• Genomic Analysis of Circulating Tumor DNA: Pushing the Limits for Cancer Applications
  Nitzan Rosenfeld, PhD, Senior Group Leader, University of Cambridge, UK; CSO, Inivata Ltd UK
• Pre-analytics: Collection, Storage and Stability of Liquid Biopsies for Use in Clinical Trials
  Peter Kuhn, PhD, Dean's Professor of Biological Sciences and Professor of Medicine, Biomedical Engineering, University of Southern California

• Session III: Analytical Validation of ctDNA Assays
• Analytic Validation of ctDNA Assays: General Principles.
  Mickey Williams PhD, Director, Molecular Characterization Laboratory, Frederick National Laboratory
• Challenges for the Validation of ctDNA for Use in Clinical Trials.
  Christopher D. Gocke, Associate Professor of Pathology, Director of Molecular Pathology, Johns Hopkins University

• Session IV: Industry Perspective of ctDNA Validation.
• Martin Horlitz, Manager Molecular Diagnostic Development, Qiagen
• Travis Clark, PhD, Senior Scientist, Molecular Biology & Sequencing, Foundation Medicine
• Kelli Bramlett, Director, R&D, Thermo Fisher Scientific
• Theresa Zhang PhD, Vice President, Research Services, Personal Genome Diagnostics
• Richard B. Lanman MD, Chief Medical Officer, Guardant Health, Inc.

• Session V: Clinical Validation of ctDNA
• Role of Circulating Tumor DNA Profiling in Cancer Management
  Shivaani Kummar, MD, Director, Phase I Clinical Research Program, Division of Oncology, Stanford School of Medicine
• Regulatory Aspects of ctDNA as Companion Diagnostic
  Reena Philip, PhD, Division Director, Division of Molecular Genetics and Pathology, FDA
• Clinical Utility Needs of ctDNA Assays Versus Research Utility
  Gary Spitzer, MD, Director Clinical Validity and Clinical Utility Evaluation, MolDx, Palmetto GBA