Wednesday, October 12, 2016

NCI's September 29-30 Workshop on Circulating Tumor DNA: Agenda

While I could not personally attend the September 29-30 NCI workshop on Circulating Tumor DNA in Clinical Cancer Research, feedback on the quality of the meeting has been excellent.  Although decks or streaming media are not available, this is a link to the workshop website (while it is still up) and I have clipped the agenda for the meeting permanently here, below the break.

Workshop on Circulating Tumor DNA assays in Clinical Cancer Research NCI Shady Grove Sept 29-30, 2016

The purpose of this conference is to discuss and understand how to show clinical utility, clinical and analytical validation and the potential use of circulating tumor DNA (ctDNA) assays in NCI supported clinical trials.

There are three goals of this conference: (1) to discuss potential means for clinical and analytical validation of ctDNA assays; (2) to define how clinical utility (e.g. Use of ctDNA in therapy response, treatment monitoring etc.) must be understood as it is incorporated into the Clinic; and (3) to inform how to enable appropriate integration of ctDNA assays into clinical trials.

Topics of discussion:
  • Clinical applications of ctDNA assays for cancer.
  • Should ctDNA assays be used to change therapy? What evidence is needed.?
  • Use of ctDNA assays for treatment monitoring, response to therapy and resistance.
  • Statistical considerations for trials designed to determine clinical utility of ctDNA assays
  • Use of ctDNA assays for pharmacodynamic assessment of drug response.
  • Use of ctDNA assays for surveillance after curative therapy
  • Current technologies for ctDNA analysis and Potential technology advances for ctDNA profiling on the horizon.
  • Challenges for the validation of ctDNA for use in clinical trials
  • Analytic and clinical validation of ctDNA assays
  • Regulatory aspects of ctDNA as companion diagnostic


Thursday September 29, 2016

8:30 - 8:40 AMRegistration
8:40 - 8:45 AMWelcome: Miguel R. Ossandon, MS, Program Officer, Cancer Diagnosis Program, NCI
8:45 - 8:50 AMOpening Remarks
Barbara A. Conley MD. Associate Director, Cancer Diagnosis Program, NCI
8:50 - 9:30 AMKey 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
9:30 - 9:35 AMQuestions
9:35 - 12:05 PMSession I: Clinical Utility of ctDNA
Eric J. Bernhard, PhD, Branch Chief, Radiation Research Program, NCI
9:40 - 10:15 AMClinical 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
10:15 - 10:40 AMCapturing 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
10:40 - 10:50 AMCoffee Break
10:50 - 11:15 AMDeep Sequencing of Circulating Tumor DNA for Cancer Detection and Monitoring.
Maximilian Diehn MD, PhD, Assistant Professor of Radiology Oncology, Stanford University
11:15 - 11:40 AMStatistical Considerations for Trials Designed to Determine Clinical Utility of ctDNA Assays.
Lisa M McShane, PhD, Chief of the Biostatistics Branch, National Cancer Institute
11:40 - 12:05 PMUtility of ctDNA Monitoring in Metastatic Melanoma Disease Surveillance.
David Polsky, MD, PhD, Director, Pigmented Lesion Section, NYU School of Medicine
12:05 - 1:05 PMLunch Break
1:05 - 3:50 PMSession II: ctDNA Assay Technology.
Chair: David T.W. Wong DMD, DMSc , UCLA; James V. Tricoli, PhD, NCI
1:10 - 1:35 PMEFIRM Liquid Biopsy (eLB)
David T.W. Wong DMD, DMSc, Professor, Associate Dean for Research, UCLA
1:35 - 2:00 PMTranslating Nanotechnology and Microfluidics for Analysis of DNA Methylation
Jeff T.H. Wang, PhD, Professor, Dept. of Mech. Engineering, Johns Hopkins University
2:00 - 2:25 PMPatch PCR: A Targeted Sequencing Approach to Quantify Breast Cancer ctDNA
Katherine (K-T) Varley, PhD, Assistant Professor, Oncological Sciences, University of Utah
2:25 - 2:35 PMCoffee Break
2:35 - 3:00 PMDetection 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
3:00 - 3:25 PMAdvantages and Disadvantages of ctDNA vs CTC Assays
Julie E. Lang, MD, Director, Breast Cancer Program, University of Southern California
3:25 - 3:50 PMGenomic 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
3:50 - 4:15 PMPre-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
4:15 - 5:00 PMDiscussion Panel
Jeffrey A. Moscow, MD, Medical officer, Cancer Therapy Evaluation Program, NCI.
All speakers are invited to participate in the panel discussion.
5:00 - 5:05 PMInstructions for next day, adjourn

Friday September 30, 2016

8:30 - 8:35 AMSummary of day 1:
Brian S. Sorg PhD, Program Officer, Cancer Diagnosis Program, NCI
8:35 - 9:30 AMSession III: Analytical Validation of ctDNA Assays
Chair: Tawnya McKee PhD, NCI
8:40 - 9:05 AMAnalytic Validation of ctDNA Assays: General Principles.
Mickey Williams PhD, Director, Molecular Characterization Laboratory, Frederick National Laboratory
9:05 - 9:30 AMChallenges for the Validation of ctDNA for Use in Clinical Trials.
Christopher D. Gocke, Associate Professor of Pathology, Director of Molecular Pathology, Johns Hopkins University
9:30 - 11:40 AMSession IV: Industry Perspective of ctDNA Validation.
Chair: Theresa Zhang PhD, Personal Genome Diagnostics; Lokesh Agrawal, PhD, NCI
9:35 - 10:00 AMMartin Horlitz, Manager Molecular Diagnostic Development, Qiagen
10:00 - 10:25 AMTravis Clark, PhD, Senior Scientist, Molecular Biology & Sequencing, Foundation Medicine
10:25 - 10:50 AMKelli Bramlett, Director, R&D, Thermo Fisher Scientific
10:50 - 11:15 AMTheresa Zhang PhD, Vice President, Research Services, Personal Genome Diagnostics
11:15 - 11:40 AMRichard B. Lanman MD, Chief Medical Officer, Guardant Health, Inc.
11:40 - 12:30 PMLunch Break
12:30 - 1:50 PMSession V: Clinical Validation of ctDNA
Chair: Shivaani Kummar, MD, Stanford School of Medicine; Tracy Lively, PhD, NCI
12:35 - 1:00 PMRole of Circulating Tumor DNA Profiling in Cancer Management
Shivaani Kummar, MD, Director, Phase I Clinical Research Program, Division of Oncology, Stanford School of Medicine
1:00 - 1:25 PMRegulatory Aspects of ctDNA as Companion Diagnostic
Reena Philip, PhD, Division Director, Division of Molecular Genetics and Pathology, FDA
1:25 - 1:50 PMClinical Utility Needs of ctDNA Assays Versus Research Utility
Gary Spitzer, MD, Director Clinical Validity and Clinical Utility Evaluation, MolDx, Palmetto GBA
1:50 - 2:45 PMDiscussion Panel
Moderator: Mickey Williams PhD, Frederick National Laboratory
Special guest: Sudhir Srivastava, PhD, MPH, NCI
All speakers are invited to participate in the panel discussion.
2:45 - 2:50 PMAdjourn


Online Archive of the speakers' bios, here.