Symposium: Conference Schedule
Download a complete Symposium Program here
(updated on November 5, 2010, 3:00 PM)
| Sunday, November 21, 2010 | ||
| 5:00–7:00 PM | Early Symposium Check-In and Registration Grand Ballroom Prefunction Area, 2nd Floor |
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| 7:00–9:00 PM | Speakers’ Dinner (by invitation only) Cirrus Room, 35th Floor |
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| Monday Morning, November 22, 2010 Grand Ballrooms C/D and Prefunction Area, 2nd Floor |
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| 7:00–8:00 AM | Continental Breakfast, Check-In and Registration, Prefunction Area | |
| 8:00–8:15 AM | Formal Welcome and Opening Remarks Thomas Fleming, Bruce Weir and Howard Frumkin, University of Washington |
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| Session 1, “Biomarkers: Role in the Design and Interpretation of Clinical Trials” | ||
| 8:15–9:15 AM | Ross Prentice FHCRC, UW |
Keynote Address: Biomarkers as Mediators of Clinical Trial Results: The Women’s Health Initiative Clinical Trial (Introduction by Bruce Weir) |
| Invited Sessions moderated by Scott Emerson | ||
| 9:15–9:45 AM | David DeMets Wisconsin |
Role and Potential of Surrogate Outcomes |
| 9:45–10:15 AM | Laurence Freedman Gertner Institute |
Nutrition Biomarkers in Chronic Disease Prevention Research |
| 10:15–10:45 AM | Steve Self FHCRC/UW |
Biomarkers in Vaccine Development and Evaluation |
| 10:45–11:00 AM | Break, Prefunction Area | |
| Session 2, “Issues in Multi-Regional Clinical Trials (MRCT)” | ||
| 11:00–11:30 AM | Janet Wittes Statistics Collaborative |
Multi–Regional Clinical Trials: To Whom Do Their Results Apply? (Introduction by Lee Hooks) |
| 11:30 AM–12:30 PM | Invited Panel: Overview: Issues in Multi–Regional Clinical Trials Moderator: Henry Fuchs Panelists: Bruce Binkowitz, Christy Chuang–Stein, Janet Wittes, Robert Temple, and Robert O’Neill |
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| 12:30–2:00 PM | Luncheon, Grand Ballrooms A/B, 2nd Floor | |
| Monday Afternoon, November 22, 2010 Grand Ballrooms C/D and Prefunction Area, 2nd Floor |
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| Session 3, “Biomarkers: Issues in Individualized Therapy” | ||
| 2:00–3:00 PM | Robert O’Neill FDA |
Keynote Address: Recent Developments in the Use of Clinical Trials to Support Individualizing Therapies: A Regulatory Perspective (Introduction by Michael Ostland) |
| Invited Sessions moderated by Michael Ostland and Bruce Weir | ||
| 3:00–3:30 PM | Margaret Pepe UW/FHCRC |
Metrics for Quantifying and Comparing Markers Used for Treatment Selection |
| 3:30–4:00 PM | Break, Prefunction Area | |
| 4:00–4:30 PM | Rich Simon NCI |
Clinical Trials for Predictive Medicine: New Paradigms for Design and Analysis |
| 4:30–5:00 PM | Bruce Weir UW |
Using SNPs to characterize genetic effects in clinical trials |
| 5:00–5:30 PM | John Whittaker GSK |
Frontiers beyond patient selection for enhanced efficacy |
| 6:00–8:30 PM | Mixer, Grand Ballrooms A/B, 2nd Floor Poster Session, Willow Rooms A/B, 2nd Floor |
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| Tuesday Morning, November 23, 2010 Grand Ballrooms C/D and Prefunction Area, 2nd Floor |
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| 7:00–8:00 AM | Continental Breakfast, Prefunction Area | |
| 8:00–8:10 AM | Opening Remarks, Susan Ellenberg, UPenn | |
| Session 4, “Safety” | ||
| 8:15–9:15 AM | Robert Temple FDA |
Keynote Address: Past, Present and Future of Product Safety Assessments (Introduction by Susan Ellenberg) |
| Invited Sessions moderated by Nathalie Ezzet and Dominic Labriola | ||
| 9:10–9:40 AM | Thomas Fleming UW/FHCRC |
Identifying and Addressing Safety Signals in Clinical Trials |
| 9:40–10:10 AM | Christy Chuang-Stein Pfizer |
Quantitative Risk/Benefit Assessment |
| 10:10–10:40 AM | Break, Prefunction Area | |
| 10:40–11:10 AM | Jesse Berlin Johnson & Johnson |
Meta-analysis and Other Strategies for Pooling, Not Drowning, Including T2DM Interventions and ESAs |
| 11:10–11:40 AM | Bill DuMouchel Oracle Health Sciences |
Data Mining in Clinical Trials |
| 11:40 AM–12:40 PM | Invited Panel: Overview: Issues in Identifying and Addressing Safety Signals Moderator: Susan Ellengerg Panelists: Janet Wittes, Dominic Labriola, Robert Temple, Thomas Fleming, Christy Chuang-Stein, Jesse Berlin, and Bill DuMouchel |
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| 12:40–12:55 PM | Closing Remarks, Thomas Fleming, Symposium Chair | |