Session Time | Topic Time | Title | Presenter |
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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. |
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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 |
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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 |
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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 |
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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. |
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Waterford: Assay Development and Performance — 1A | Richard Press, M.D., Ph.D. and Paul Meltzer, M.D., Ph.D. |
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Embassy/Potomac/Patuxent: Assay Development and Performance — 1B | Mark Raffeld, M.D. and Mickey Williams, Ph.D. |
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Diplomat/Ambassador: Data Analysis — 2 | John Quackenbush, Ph.D. and Jack Collins, Ph.D. |
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Old Georgetown: Clinical, Regulatory, and Ethical Issues — 3 | William Pao, M.D., Ph.D. and Barbara Conley, M.D. |
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 |
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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.