BASS XVIII 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 ← 2010 2012 →