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:
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
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Thursday September 29, 2016
| 8:30 - 8:40 AM | Registration |
| 8:40 - 8:45 AM | Welcome: Miguel R. Ossandon, MS, Program Officer, Cancer Diagnosis Program, NCI |
| 8:45 - 8:50 AM | Opening Remarks Barbara A. Conley MD. Associate Director, Cancer Diagnosis Program, NCI |
| 8:50 - 9:30 AM | 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 |
| 9:30 - 9:35 AM | Questions |
| 9:35 - 12:05 PM | Session I: Clinical Utility of ctDNA Eric J. Bernhard, PhD, Branch Chief, Radiation Research Program, NCI |
| 9:40 - 10:15 AM | 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 |
| 10:15 - 10:40 AM | 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 |
| 10:40 - 10:50 AM | Coffee Break |
| 10:50 - 11:15 AM | Deep 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 AM | Statistical 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 PM | Utility of ctDNA Monitoring in Metastatic Melanoma Disease Surveillance. David Polsky, MD, PhD, Director, Pigmented Lesion Section, NYU School of Medicine |
| 12:05 - 1:05 PM | Lunch Break |
| 1:05 - 3:50 PM | Session II: ctDNA Assay Technology. Chair: David T.W. Wong DMD, DMSc , UCLA; James V. Tricoli, PhD, NCI |
| 1:10 - 1:35 PM | EFIRM Liquid Biopsy (eLB) David T.W. Wong DMD, DMSc, Professor, Associate Dean for Research, UCLA |
| 1:35 - 2:00 PM | Translating 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 PM | Patch 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 PM | Coffee Break |
| 2:35 - 3:00 PM | 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 |
| 3:00 - 3:25 PM | Advantages and Disadvantages of ctDNA vs CTC Assays Julie E. Lang, MD, Director, Breast Cancer Program, University of Southern California |
| 3:25 - 3:50 PM | 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 |
| 3:50 - 4:15 PM | 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 |
| 4:15 - 5:00 PM | Discussion 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 PM | Instructions for next day, adjourn |
Friday September 30, 2016
| 8:30 - 8:35 AM | Summary of day 1: Brian S. Sorg PhD, Program Officer, Cancer Diagnosis Program, NCI |
| 8:35 - 9:30 AM | Session III: Analytical Validation of ctDNA Assays Chair: Tawnya McKee PhD, NCI |
| 8:40 - 9:05 AM | Analytic Validation of ctDNA Assays: General Principles. Mickey Williams PhD, Director, Molecular Characterization Laboratory, Frederick National Laboratory |
| 9:05 - 9:30 AM | 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 |
| 9:30 - 11:40 AM | Session IV: Industry Perspective of ctDNA Validation. Chair: Theresa Zhang PhD, Personal Genome Diagnostics; Lokesh Agrawal, PhD, NCI |
| 9:35 - 10:00 AM | Martin Horlitz, Manager Molecular Diagnostic Development, Qiagen |
| 10:00 - 10:25 AM | Travis Clark, PhD, Senior Scientist, Molecular Biology & Sequencing, Foundation Medicine |
| 10:25 - 10:50 AM | Kelli Bramlett, Director, R&D, Thermo Fisher Scientific |
| 10:50 - 11:15 AM | Theresa Zhang PhD, Vice President, Research Services, Personal Genome Diagnostics |
| 11:15 - 11:40 AM | Richard B. Lanman MD, Chief Medical Officer, Guardant Health, Inc. |
| 11:40 - 12:30 PM | Lunch Break |
| 12:30 - 1:50 PM | Session V: Clinical Validation of ctDNA Chair: Shivaani Kummar, MD, Stanford School of Medicine; Tracy Lively, PhD, NCI |
| 12:35 - 1:00 PM | 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 |
| 1:00 - 1:25 PM | Regulatory Aspects of ctDNA as Companion Diagnostic Reena Philip, PhD, Division Director, Division of Molecular Genetics and Pathology, FDA |
| 1:25 - 1:50 PM | Clinical 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 PM | Discussion 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 PM | Adjourn _____ Online Archive of the speakers' bios, here. |