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U.S. National Institutes of Health
Last Updated: 05/17/12

Next-Generation DNA Sequencing as a Tool for Clinical Decision-Making in Cancer Patient Management

Hyatt Regency Bethesda
7400 Wisconsin Avenue
Bethesda, MD 20814

May 3 – 4, 2012

Agenda

Thursday, May 3, 2012

Session Time Topic Time Title Presenter
7:30-8:00 a.m. Registration
8:00-8:15 Welcome and Opening Remarks
Goals of the Meeting and Charge for the Breakout Sessions
Barbara Conley, M.D. and
Mickey Williams, Ph.D.
8:15-8:45 Keynote Address
Translating NGS Data Into a Clinically Actionable Assay
Elaine Mardis, Ph.D.
8:45-10:45 Assay Development and Performance
Session Chairs: Richard Press and Mark Raffeld
8:45 NGS in the Clinic — Considerations for Molecular Pathologists Jane Gibson, Ph.D.
9:05 Clinical-Grade Next Generation Sequencing: Assay Design & Validation Richard Press, M.D., Ph.D.
9:25 Lessons Learned From Sequencing Clinical Specimens Maureen Cronin, Ph.D.
9:45-9:55 BREAK
9:55 Utility of Multi-analyte Assays for Mutation Detection John Iafrate, M.D., Ph.D.
10:15 Establishing Clinical-grade Assays for Support of Drug Trials Patrick Hurban, Ph.D.
10:35 Panel Discussion
10:50-11:45 Bioinformatics and Analysis
Session Chairs: John Quackenbush and Jack Collins
10:50 The Road to Personalized Medicine is Paved With Data and Information John Quackenbush, Ph.D.
11:10 Comprehensive Detection of Variation in Thousands of Whole Genome Sequences Stephen Lincoln
11:30 Panel Discussion
11:45-1:30 LUNCH
1:30-3:50 Clinical, Regulatory, and Ethical issues
Session Chairs: William Pao and Barbara Conley
1:35 Challenges in Incorporating Integral NGS Into Early Clinical Trials Shivaani Kummar, M.D.
1:55 So Now What Do We Do? Deciding on Use of NGS in the Clinical Laboratory Stanley Hamilton, M.D.
2:15 CLIA Hurdles for NGS — CAP Perspective Sashikant Kulkarni, M.S., Ph.D.
2:35 Regulatory Considerations for Investigational Assays — Planning for Success Elizabeth Mansfield, Ph.D.
2:55 Direct to Consumer Sale Pamela McAllister, Ph.D.
3:05 Can I Really Give INFORMED Consent If I Don't Know What It Means? NGS From the Patient Perspective Elda Railey
3:15 Panel Discussion
3:30-3:50 BREAK
4:00-6:00 Breakout Groups
Each group will highlight key issues and brainstorm solutions.
Waterford: Assay Development and Performance — 1A Richard Press, M.D., Ph.D. and
Paul Meltzer, M.D., Ph.D.
Embassy/Potomac/Patuxent: Assay Development and Performance — 1B Mark Raffeld, M.D. and
Mickey Williams, Ph.D.
Diplomat/Ambassador: Data Analysis — 2 John Quackenbush, Ph.D. and
Jack Collins, Ph.D.
Old Georgetown: Clinical, Regulatory, and Ethical Issues — 3 William Pao, M.D., Ph.D. and
Barbara Conley, M.D.

 

Friday, May 4, 2012

Session Time Topic Time Title Presenter
8:00-8:45 a.m. Keynote Address
Tumor-Genome-Directed Anti-Cancer Therapy: Using Lung Cancer and Melanoma as a Paradigm
William Pao, M.D., Ph.D.
8:45-11:45 Presentations by Breakout Groups
25 minutes plus 15 minutes floor discussion for each
8:45 Assay Development and Performance — 1A Richard Press, M.D., Ph.D.
9:25 Assay Development and Performance — 1B Mark Raffeld, M.D.
10:05-10:25 BREAK
10:25 Data Analysis John Quackenbush, Ph.D.
11:05 Clinical, Regulatory, and Ethical issues William Pao, M.D., Ph.D.
11:45-Noon General Floor Discussion and Wrap-Up Barbara Conley, M.D. and Mickey Williams, Ph.D.
Noon ADJOURN

We thank the Association for Molecular Pathology for their assistance in planning this program.