Keynote Address (Monday Evening)

K-1 (05:00 p.m.)  Controversial Issues in Clinical Trials
Presented by: Shein-Chung Chow, Duke University School of Medicine

Tutorials (Monday 8:00 AM - Wednesday 12:00 noon)

M-1 (08:00 a.m.)  Dose Finding in Oncology Clinical Trials Based on Unit Probability Mass
Presented by: Yuan Ji, The University of Texas M.D. Anderson Cancer Center

M-2 (09:00 a.m.)  Implementing Response-Adaptive Randomization in Multi-Armed Survival Trials
Presented by: Alex Sverdlov, Bristol Myers Squibb

M-3 (10:10 a.m.)  Evaluating Probability of Success in Oncology Clinical Trials
Presented by: Martin King, Abbott

M-4 (11:10 a.m.)  Design and Analysis of a Cancer Prevention Trial: Plans and Results
Presented by: Matthew Somerville, GlaxoSmithKline

M-5 (01:30 p.m.)  Comparing Conditional and Predictive Power to Assess Futility in a Phase III Program with Two Studies
Presented by: Greg Cicconetti, GlaxoSmithKline

M-6 (02:30 p.m.)  Setting Alpha Levels for Testing Key Secondary Endpoints in Trials with Interim Assessments When the Primary and Secondary Endpoints are Correlated
Presented by: Rebekkah Brown, GlaxoSmithKline

M-7 (03:40 p.m.)  Efficient Sampling of Inverse Correlation Matrices and its Applications in Bayesian Modelling of Gene Interaction in Early Phase Genomic Experiments
Presented by: Nitai D. Mukhopadhyay, Virginia Commonwealth University and Sarat C. Dass, Michigan State University

T-1 (08:00 a.m.)  The Mean Ain’t What It Used To Be
Presented by: Stephen J. Ruberg, Eli Lilly and Company

T-2 (09:00 a.m.)  Subgroup Data Analyses of Clinical Trials-Issues and Methods
Presented by: Karl E. Peace, Jiann-Ping Hsu College of Public Health, Georgia Southern University

T-3 (10:10 a.m.)  Analyses to Aid Dose Selectioni in Phase 2 Virology Clinical Trials
Presented by: Larry Leon, Bristol Myers Squibb

T-4 (11:10 a.m.)  Statistical Graphics for Exploratory Review and Reporting in Clinical Trials
Presented by: Michael O'Connell, TIBCO Software, Inc.

T-5 (01:30 p.m.)  Statistical Assessment and Analyses of Suicidality Data in Clinical Trials – Current Challenges
Presented by: Cristiana Gassmann-Mayer, Johnson & Johnson and Nathalie Richard, GlaxoSmithKline

T-6 (02:30 p.m.)  Using Statistical Principles to Implement FDA Guidance on Cardiovascular Risk Assessment for Diabetes Drugs
Presented by: David Manner, Eli Lilly and Company

W-1 (08:30 a.m.)  Life-cycle Planning for Product Safety Evaluation in Support of Benefit-Risk Activities
Presented by: George Rochester, Food and Drug Administration

W-2 (09:30 a.m.)  On Methodologies Associated with Meta-analysis
Presented by: Antonio Paredes, Food and Drug Administration

W-3 (10:40 a.m.)  Targeted Maximum Likelihood Super Learning: Application to Causal Effects in Safety Analysis
Presented by: Mark van der Laan, University of California, Berkeley

Short Courses (Wednesday 1:00 PM -- Friday 12:00 noon)

  Recent Developments in Practical Bayesian Methods for Clinical Trials
Presented by: Peter F. Thall, University of Texas, M.D. Anderson Cancer Center

  Bioequivalence and Statistics in Clinical Pharmacology
Presented by: Scott Patterson, Wyeth Research and Development and Byron Jones, Pfizer Global Research and Development

  Fundamental Training for Clinical Trial Statisticians
Presented by: Naitee Ting, Boehringer-Ingelheim and Scott R. Evans, Harvard School of Public Health