Program

 

Please see additional information about the symposium schedule below

Time	Room	Schedule for October 22, 2015
8:15am – 4:45pm	Great Hall	Short Courses 1-4
5:00pm-6:30pm	6th floor	Social Mixer
Time	Room	Schedule for October 23, 2015
8:15am – 9:00am	Great Hall	Registration and Breakfast
9:00am – 9:30am	Great Hall	Opening Remark: Elizabeth DeLong (Duke) WELCOME from the Department of Biostatistics and Bioinformatics (B&B) Duke University School of Medicine
9:30am – 10:30am	Great Hall	Keynote Address: Yi Tsong (FDA) Duality of Significance Tests and Confidence Intervals in Drug Development
10:30am – 10:45am	Great Hall	Break (Coffee and Tea)
10:45am – 12:00pm	Great Hall	Parallel Sessions 1-3
		Session 1: Bioequivalence and Biosimilars Organizers: Victoria Chang (Boehringer-Ingelheim) and Yi Tsong (FDA) Chair: Yi Tsong (FDA) Victoria Chang (Boehringer-Ingelheim) "Sample Size Determination for a Three-Arm Equivalence Trial of Poisson and Negative Binomial Responses" Meiyu Shen (FDA) "Distributional assumptions for AUC, Cmax and Tmax" Jean Pan (Amgen) "Statistical Considerations in Biosimilar Clinical Development" Cassie (Xiaoyu) Dong (FDA) "Statistical Approaches to Demonstrate Analytical Similarity of Quality Attributes"
		Session 2: Bayesian Non-Inferiority Trials Organizer: Guochen Song (Quintiles) Chair: Brad Ferguson (Quintiles) Guochen Song (Quintiles) "Controlling Frequentist Type I and Type II Error in Bayesian Non-inferiority Trials: a Case Study" Fanni Natanegara (Eli Lilly) "Bayesian considerations for non-inferiority clinical trials with case examples" Sujit Ghosh (NC State University and SAMSI) "Robust Bayesian Methods for Non-Inferiority Tests Based on Dichotomous Data"
		Session 3: Data Monitoring Committees Organizer: Michael Pencina (Duke) Chair: Michael Pencina (Duke) Karim Anton Calis (FDA) "Challenges and Opportunities in Data Monitoring and Trial Oversight" Frank Rockhold (GSK) "Benefit to risk considerations and methods applied to the ongoing monitoring of clinical trials" Bob Bigelow (Duke) "Interim data analysis: Distinguishing signal from noise" Susan Halabi (Duke) “Group Sequential Design: Uses and Abuses”
12:00pm – 1:30pm	6th floor	Lunch and Poster Session
1:30pm – 2:45pm	Great Hall	Parallel Sessions 4-6
		Session 4: Randomized Concentration-Controlled Trials Organizer: Russell Reeve (Quintiles) Chair: Shein-Chung Chow (Duke) Seth Berry (Quintiles) "Pharmacokinetic/pharmacodynamic modeling and simulation in the design and analysis of RCCTs" Russell Reeve (Quintiles) "Efficiency of randomized concentration-controlled trials relative to randomized dose-controlled trials, and application to personalized dosing trials" Michael Hale (Baxalta) "Practical Reasons Your Randomized Concentration Controlled Trial Might Flop"
		Session 5: Subgrouping Analysis Organizer: Xuan Liu (Abbvie) Chair: Xuan Liu (Abbvie) Martin King (Abbvie) “IIdentifying Subgroups in Product Labeling: Two Recent Case Studiesdentifying Subgroups in Product Labeling: Two Recent Case Studies” Michael Rosenblum (Johns Hopkins University) “Optimal, Two Stage, Adaptive Enrichment Designs for Randomized Trials, using Sparse Linear Programming” Shuai Chen (University of Wisconsin) “A Flexible Framework for Treatment Scoring in Clinical Studies”
		Session 6: Biosimilars II Organizer: Lanju Zhang (Abbvie) and Guochen Song (Quintiles) Chair: Guochen Song (Quintiles) Lanju Zhang (Abbvie ) "Statistical Considerations for biosimilarity assessment" Thomas Gwise (FDA) "Points to Consider for Biosimilar Clinical Studies" Sujit Ghosh (NC State University and SAMSI) "Dynamic Model Based Methods to Test for Biosimilarity"
2:45pm – 3:00pm	Great Hall	Break (Coffee and Tea)
3:00pm – 4:30pm	Great Hall	Parallel Sessions 7-9
		Session 7: Advanced Survival Analysis Organizers: Marlina Nasution (Parexel) and Changbin Guo (SAS) Chair: Marlina Nasution (Parexel) Peter Jakobs (Parexel) “Analysis of Recurrent Adverse Events of Special Interest: an Application for Hazard-Based Models” Audrey Boruvka (University of Michigan) “Understanding the effect of treatment on progression-free survival and overall survival” Changbin Guo (SAS) “Current Methods in Survival Analysis Using SAS/STAT® Software”
		Session 8:  Enrichment Design for Clinical Trials Organizer: Jane Qian (Abbvie) Chair: Jane Qian (Abbvie) Yijie Zhou (Abbvie) "Enrichment Design with Patient Population Augmentation" Shu-Chih Su (Merck) "A Population-Enrichment Adaptive Design Strategy for Vaccine Efficacy Trial" Hui Quan (Sanofi) "Adaptive Patient Population Selection Design in Clinical Trials"
		Session 9:  Dose Finding and Selection in Clinical Phase Organizers: Qiqi Deng (Boehringer-Ingelheim) and Joshua Betcher (Quintiles) Chair: Susan Wang (Boehringer-Ingelheim) Rebhi Bsharat (Quintiles) "Using utility index to evaluate risk-benefit of several doses to help in dose selection" Li Wang (Abbvie) "Enhanced understanding of MCPMod in Dose-ranging Studies" Qiqi Deng (Boehringer-Ingelheim) "A robust method using ordinal linear contrast test to design dose ranging study" Yaning Wang (FDA) "Regulatory Application of Exposure-Response Analyses in Dose Selection"
4:30pm – 5:00pm	Great Hall	Panel Discussion Closing Remarks