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WEDNESDAY, AUGUST 21
7:30 am Problem Solving Breakout Discussions with Continental Breakfast
Concurrent Problem Solving Breakout Sessions are interactive, topic-specific discussions hosted by a moderator. These sessions are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners. See website for topics.
Use of Next Generation Sequencing in the Clinic
Moderator: Gary Palmer, M.D., J.D., MBA, MPH, Senior Vice President, Medical Affairs and Commercial Development, Foundation Medicine
How practical is it to use NGS in the clinic?
How does NGS as a test for molecular markers compare to other techniques (hot spot testing, panels, etc.)?
What are the challenges of performing NGS on clinical samples?
What are the challenges in interpreting the data for clinicians?
What have we learned so far from performing NGS in the clinic?
Overcoming Barriers in Biomarker-Driven Therapies in Cancer
Moderator: Filip Janku, M.D., Ph.D., Assistant Professor, Investigational Cancer Therapeutics, (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center
• Patient selection and biomarker screening
• Turnaround times for biomarker technologies in clinical practice
• Availability of Targeted Therapies Matching Selected Biomarker
• Tumor Heterogeneity and Mixed Response
• Secondary Resistance and Longitudinal Molecular Profiling of Cancer in Real Time
Liquid Biopsies: Circulating Tumor Cells and DNA
Moderator: Seth D. Crosby, M.D., Director, Alliances and Partnerships, Department of Genetics, Washington University School of Medicine
o CTC vs ctDNA: which to pursue
o How prognostic compared to existing biomarkers?
o How to overcome the sensitivity problems?
o Are there new paradigms in isolation and enrichment?
8:25 Chairperson’s Opening Remarks
Joseph M. Carroll, Ph.D., Associate Director, Business Development, Knight Cancer Institute, Oregon Health & Science University (OHSU)
8:30 Molecular Markers for Clinical Decision-Making
Scott Cameron, M.D., Ph.D., Oncology Director, Clinical Research Physician, Novartis Institutes for BioMedical Research, Inc.
Personalized or precision medicine in clinical trials provides significant benefits by identifying populations of patients more likely to benefit, by reducing risk to those less likely to benefit, and potentially by allowing earlier decisions about the promise of new therapies. I will discuss examples where biomarkers have been employed in Novartis studies and how we are using them in discovery efforts.
9:00 Designing and Managing Clinical Studies Based on Circulating Tumor Cell Biology
Robert McCormack, Ph.D., Head, Technology & Innovation Strategy, Veridex LLC
This presentation will provide an overview of using these elements of CTC biology in drug clinical trials, from substantiating inclusion/exclusion criteria, to understanding outcomes of the study.
9:30 NGS Biomarkers in Prospective Trials
Seth D. Crosby, M.D., Director, Alliances and Partnerships, Department of Genetics, Washington University School of Medicine
NGS data intended for treatment decisions must be generated in a clinically certified lab. The challenges of validating and reporting a clinical NSG panel are quite distinct from that of translational research. I will describe our CAP/CLIA validated oncology panel and the Clinical Genomicist Workstation, a tool we have created for converting NGS data to a clinical report.
10:00 Panel Discussion: Overcoming Bottlenecks
Moderator: Joseph M. Carroll, Ph.D., Associate Director, Business Development, Knight Cancer Institute, Oregon Health & Science University (OHSU)
- Discussion of I-SPY Breast Cancer Clinical trial
- How do we link diagnostics and therapeutics early in development?
- How do pharma companies use biomarkers in development? Why is it a challenge? What obstacles are there? How are they overcome?
- Cost - How do you pay for cancer biomarkers in drug development?
- Are we looking at the right cells? Biomarkers are a surrogate for treatment. What are the driver mutations that biomarkers correspond to?
- Is genetics the end-game?
10:30 Coffee Break
11:00 PLENARY KEYNOTE DISCUSSION
Perspectives on Evaluating Novel Diagnostics for Reimbursement
Moderator: Andrew C. Fish, Executive Director, AdvaMedDx
- Levels of evidence needed to support novel diagnostics
- Health economics
- Analytical issues
- CMS policy
- Rate schedule
Aaron D. Bossler, M.D., Ph.D., Clinical Associate Professor, Director Molecular Pathology Laboratory and Molecular Genetic Pathology Fellowship Program, University of Iowa Hospitals and Clinics and Co-Chair, AMP Economic Affairs Committee
Dwight Denham, MBA, Director, Clinical Research, Beckman Coulter, Inc.
Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA
Lee H. Newcomer, M.D., Senior Vice President, Oncology, Genetics and Women's Health, United Healthcare
12:30 pm Close of Conference
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