2014

BASS XXI Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Inna PerevozskayaAdaptive Group-Sequential Multi-regional Outcome Studies in Vaccines
M-2Vlad DragalinComplex Adaptive Designs in Drug Development
M-3Kyle WathenUtilizing Prediction and Simulation to Guide Clinical Trial Design
M-4Stephanie GreenOptimizing Phase 1 and 2 Clinical Trials Design
M-5Vivian Shih and Paul GalloViewpoints on Setting Clinical Trial Futility Criteria
M-6Bob NoblePhase 2B Design Considerations Assessing Dose Response Modeling
M-7Changlu LiuA Decision-Theoretic Bayes Factor Approach for Dose Finding in Phase I Oncology Trials
M-8Frank RockholdAccess to Anonymised Patient Level Data: Experiences from GSK
Keynote AddressShaAvhree Buckman-GarnerLeveraging Innovation and Change through Regulatory Science Initiatives
T-1Joe CappelleriInterpretation of Patient-Reported Outcomes
T-2Jesse BerlinHarnessing Next-Generation Informatics for Personalizing Medicine: Personalization of Care and Research
T-3Kevin GanAn Extended Longitudinal Model and Graphic for Benefit Risk Analysis
T-4Richard SimonAn Overview of Adaptive Biomarker-driven Clinical Trial Designs
T-5Lisa McShaneAssessment of Omics-based Predictor Readiness for Use in a Clinical Trial
T-6Edward KornDesign of Phase II Clinical Trials with a Potential Predictive Biomarker
T-7Boris FreidlinPhase III Design Considerations for Molecularly Targeted Agents
T-8Lisa LaVange, Lisa McShane, Dionne Price, Rajeshwari Sridhara, Shenghui TangMaster Protocols and their Role in Drug Development
W-1Mohammad Huque and Kathleen FritschMultiplicity Problems in Clinical Trials – A Regulatory Perspective