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Symposium: Program

(updated on April 1, 2015, 1:00 AM)

Sunday, November 21, 2010
5:00–7:00 PM Early Symposium Check-In and Registration
Grand Ballroom Prefunction Area, 2nd Floor
7:00–9:00 PM Speakers’ Dinner (by invitation only)
Cirrus Room, 35th Floor
Monday Morning, November 22, 2010
Grand Ballrooms C/D and Prefunction Area, 2nd Floor
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
Session 1, “Biomarkers: Role in the Design and Interpretation of Clinical Trials”
8:15–9:15 AM Ross Prentice
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
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
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
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
Session 3, “Biomarkers: Issues in Individualized Therapy”
2:00–3:00 PM Robert O’Neill
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
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
Clinical Trials for Predictive Medicine: New Paradigms for Design and Analysis
4:30–5:00 PM Bruce Weir
Using SNPs to characterize genetic effects in clinical trials
5:00–5:30 PM John Whittaker
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


Tuesday Morning, November 23, 2010
Grand Ballrooms C/D and Prefunction Area, 2nd Floor
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
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
Identifying and Addressing Safety Signals in Clinical Trials
9:40–10:10 AM Christy Chuang-Stein
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
12:40–12:55 PM Closing Remarks, Thomas Fleming, Symposium Chair


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