8:00-8:30AM Continental Breakfast
8:30-8:40AM Welcome
8:40-9:35AM Session I: "Biomarkers and Trial Design"
Ed Korn, NCI, “Biomarker-adaptive clinical trial designs” [Abstract]
Xiaofei Wang, Duke, “Biased sampling and its applications in biomarker validation” [Abstract]
9:35-10:30AM Session II: "Pharmacogenetic/Pharmacogenomic Analysis"
Jung-Ying Tzeng, NC State, “A gene-trait similarity regression method for gene-level pharmacogenetics analysis” [Abstract]
Todd Auman, UNC, “Pharmacogenomic interrogation of colorectal cancer using next-generation whole exome sequencing” [Abstract]
10:30-10:45AM Break
10:45AM-12:30PM Session III: "Design and Analysis Involving Complex Time-to-event Data"
Jason Fine, UNC, “An overview of competing risks data, with applications in clinical trials” [Abstract]
Zhiguo Li, Duke, “Fitting Cox models with doubly censored data using spline-based marginal likelihood” [Abstract]
Donglin Zeng, UNC, “Estimating treatment effects with treatment switching via semi-competing risks models: An application to a colorectal cancer study” [Abstract]
Liddy Chen, UNC, “Design consideration for complex survival models” [Abstract]
12:30-1:40PM Lunch
1:40-2:35PM Session IV: "Adaptive Trial Design"
H.M. James Hung, FDA, “Utilities and challenges of adaptive designs in drug development” [Abstract]
Giovanni Parmigiani, Harvard, "Adaptive randomized trial design for patients with recurrent glioblastoma" [Abstract]
2:35-2:55PM Break
2:55-3:50PM Session V: "Assessment of Drug Safety"
Mark Levenson, FDA, “Safety decision-making with multiple sources and different types of studies—recent examples from FDA Advisory Committees” [Abstract]
David Madigan, Columbia, “Drug safety in spontaneous reports, observational databases, and clinical trials: Can we do better?” [Abstract]
3:50-4:10PM Break
4:10-5:30PM Session VI "Statistical Methods for Discovery of Individualized Treatment"
Marie Davidian, NC State, “A robust method for estimating optimal treatment regimes” [Abstract]
Yingqi Zhao, UNC, “Estimating Individualized Treatment Rules Using Outcome Weighted Learning” [Abstract]
Eric Laber, NC State, “Adaptive inference after model selection” [Abstract]
5:30PM Adjourn
