| Title | Presenter | Presentation |
| Using PK/PD Modeling to Simulate Impact of Manufacturing Process Variability | Alan Hartford | Download |
| Bayesian Adaptive Designs for Dose Escalation Studies | Anna McGlothlin | Download |
| High Throughput Screening | Antara Majumdar | Download |
| An Alternative to the Peto Analysis for 2-year Carcinogenicity Studies and to Tarone’s Test for Trend in Censored Survival Data | Art Roth | Download |
| QbD and Applied Biopharmaceutics for Patient Benefit | Arzu Selen | Download |
| Analysis of Stability Data with Equivalence Testing for Comparing New and Historical Processes Under Various Treatment Conditions | Ben Ahlstrom | Download |
| Uncertain Standards With Standard Uncertainties | Bill Porter | Download |
| The 'Local Control' Approach (Observational Studies) | Bob Obenchain | Download |
| Power Priors for Adaptive Incorporation of Historical Information in Clinical Trials | Brad Carlin | Download |
| Connecting the Dots: Accelerating Clinical Development by Integrating Non-Clinical Aspects in the Plan | Bruno Boulanger | Download |
| Impact of observations below the limit of quantitation on PD predicitons | Celine Dartois | Download |
| Sigmoid curves and a case for close to linear nonlinear models | Charles Tan | Download |
| Is the Confirmatory Approach in PK/PD Modeling Possible? | Chuanpu Hu | Download |
| Stability for Dissolution for a Modified Release Product | Dave LeBlond | Download |
| Challenges in Transforming Observational Data for Analysis | Don Griffin | Download |
| Discussion of "Propensity Scoring and Beyond: Why? and How?" | Gerhardt Pohl | Download |
| Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials | Haijun Ma | Download |
| The use of Hybrid Chemical/Biological Descriptors in QSAR Modeling Improves the Accuracy of In Vivo Chemical Toxicity Prediction | Hao Zhu | Download |
| A Meta-Analytic Model for Alzheimer's Disease Incorporating Both Summary-Level and Patient-Level Data | James Rogers | Download |
| Multi-Institutional Studies Using Observational Data: Opportunities and Challenges | Jeff Brown | Download |
| Propagation of Uncertainty in Process Models and Product Performance Models Using Monte Carlo Methods | John Kauffman | Download |
| In-Vitro Screening for Combination Drug Discovery | John Peterson | Download |
| Pharmacometrics/Modeling and Simulation | Kenneth Kowalski | Download |
| A Clinical Trial Simulation System, Its Applications, and Future Challenges | Kuenhi Tsai | Download |
| Confounding adjustment: concepts and heuristic ideas | Lingling Li | Download |
| Response Optimization in Oncology In-Vivo Studies Using a Multi-Objective Modeling Approach | Max Pashkevich | Download |
| The Role of Pharmacogenetics in Safety Assessment | Michael Mosteller | Download |
| Type-1 Error Control in Cumulative Meta-Analysis | Mingxiu Hu | Download |
| On the Identifiability Issues in Physiologically Based Toxicokinetics (PBTK) Models | Munni Begum | Download |
| A Bayesian Approach to Estimation of Shelf Life | Oscar Go | Download |
| The Role of Data Mining in Evidence Based Medicine | Pamela Brandt | Download |
| The Observational Medical Outcomes Partnership | Patrick Ryan | Download |
| Quantitative Clinical Pharmacology Applications for Efficient Drug Development | Pravin R. Jadhav | Download |
| A Flexible Bayesian Method to Model Adverse Event Hazards | Quan Hong | Download |
| Graphical Displays of Safety Data | Richard Heiberger | Download |
| An Overview of Bayesian Methods in Clinical Trials | Scott Berry | Download |
| Risk/Benefit Considerations | Scott Evans | Download |
| Using the Clinical Data Repository for Pharmacovigilance | Shawn Murphy | Download |
| Everything is Dangerous, A Controversy | Stan Young | Download |
| A Pre-Processing Step for High Content Screening Data | Stan Young | Download |
| Large-Scale Observational Studies: Are We in A Post-Statistical Era | Stephanie Reisinger | Download |
| Quality Risk Assessment: A Lifecycle Approach in Evaluating Quality Attributes for Bioproducts | Suntara Cahya | Download |
| Some Statistical Considerations and Challenges in Open Dish Studies | Tim Kramer | Download |
| Power and sample size considerations for mixed models | Walter Stroup | Download |
| Linking CMC and Toxicology: The Use of Cumulative Carcinogenic Risk for Multiple Genotoxic Impurities Criteria | Wherly Hoffman | Download |
| Confounding Adjustment: Ideas in Action – A Case Study | Xiaochun Li | Download |
