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THE 32nd ANNUAL MIDWEST BIOPHARMACEUTICAL STATISTICS WORKSHOP MAY 18 – 20, 2009 • BALL STATE UNIVERSITY ALUMNI CENTER, MUNCIE, INDIANA Final Program MONDAY , MAY 18 8:30 AM – 4:30 PM WORKSHOP REGISTRATION FEE: $150 until May 1 ($60 for students), $180 after May 1 9:00 AM – 1:00 PM SHORT COURSE (Separate Registration Fee: $60) Presenter: MICHAEL O’CONNELL, TIBCO Topic: Statistical Graphics for Clinical Data Analysis 2:15 PM – 2:30 PM INTRODUCTION AND WELCOME ALAN MENIUS, GlaxoSmithKline SHERYL STUMP, Chair, Department of Mathematical Sciences, Ball State University 2:30 PM – 3:30 PM PLENARY SESSION Speaker: SCOTT EVANS, Harvard University Topic: Benefit/Risk Considerations 3:30 PM – 4:30 PM PLENARY SESSION Speaker: PAUL STANG, Johnson & Johnson Topic: The Observational Medical Outcomes Partnership MONDAY NIGH T MI XER Alumni Center 5:00 PM – 7:00 PM TUESDA Y MO RN ING, MA Y 19 CONCURRENT SESSIONS 8:30 AM – 11:30 AM B. Advances in Animal Models and Statistical Modeling for Toxicology Organizer/Chair: Kjell Johnson, Pfizer 1. “The Relationship Between Biochemical and Morphological Findings in Rat Liver Injury”, Kay Tatsuoka, GSK 2. “The use of Hybrid Chemical/Biological Descriptors in QSAR Modeling Improves the Accuracy of In Vivo Chemical Toxicity Prediction”, Hao Zhu, UNC 3. “An Alternative to the Peto Analysis for 2-year Carcinogenicity Studies and to Tarone’s Test for Trend in Censored Survival Data”, Art Roth C. Propensity Scoring and Beyond: When and How? Organizer/Chair: Robert Obenchain, Risk Benefit Statistics 1. “Why go Beyond Propensity Scoring”, Gerhardt Pohl, Lilly 2. “Confounding Adjustment: Concepts and Heuristic Ideas”, Lingling Li, Harvard University 3. “Confounding Adjustment: Ideas in Action – A Case Study”, Xiaochun Li, Indiana University 4. “The ‘Local Control’ Approach”, Robert Obenchain, Risk Benefit Statistics 5. “Discussant”, Gerhardt Pohl, Lilly D. Stability Analysis Organizer/Chair: Jyh-Ming Shoung, Johnson & Johnson 1. “Some Statistical Considerations and Challenges in Open Dish Studies”, Tim Kramer, Suntara Cahya, Jeff Hofer, Lilly 2. “A Bayesian Approach to Estimation of Shelf Life”, Oscar Go, Johnson & Johnson 3. ”Analysis of Stability Data with Equivalence Testing for Comparing New and Historical Processes Under Various Treatment Conditions”, Ben Ahlstrom, Rick Burdick, Laura Pack, Leslie Sidor, Amgen 4. “Stability for Dissolution for a Modified Release Product”, David LeBlond, Abbott 5. “Discussant, Stan Altan, Johnson and Johnson TUESDA Y EV ENI NG BAN QUET Robert Morris, Dean of the Graduate School Ball State University Announcement of Student Winner of Charlie Sampson Poster Award Speaker: STAN YOUNG, NISS Topic: Everything is Dangerous A. Quantitative Safety Assessment Organizer/Chair: Jonathan Schildcrout, Vanderbilt University 1. “Type-1 Error Control in Cumulative Meta-Analysis”, Mingxiu Hu, Millenium/Takeda 2. “Graphical Displays of Safety Data”, Richard Heiberger, Temple University 3. “A Flexible Bayesian Method to Model Adverse Event Hazards”, Quan Hong, Lilly 4. “The Role of Pharmacogenetics in Safety Assessment”, Michael Mosteller, Arlene R. Hughes, Sara H. Hughes, Mathew R. Nelson, GSK B. Nonlinear and Mixed Effect Models Organizer/Chair: David Stock, Bristol Myers Squibb 1. “The Impact of Observations Below the Limit of Quantification on Pharmacodynamic Predictions: A Preclinical Example Using New Features of NONMEM VI”, Celine Dartois, Novartis 2. “Sigmoid Curves and a Case for Close-to-Linear Nonlinear Models”, Charles Tan, Merck 3. “Power and Sample Size Considerations for Mixed Models with Non-normal Data”, Walter Stroup, Univ. of Nebraska C. Post-Approval Data Mining Opportunities Organizer/Chair: Patrick Ryan, GlaxoSmithKline 1. “Large-Scale Observational Studies: Are We in a Post-Statistical Era”, Stephanie Reisinger, ProSanos 2. “Comparison of Data Mining Algorithms for Measuring-Drug Event Associations in Longitudinal Healthcare Data ”, Bill DuMouchel, David Fram, PhaseForward 3. “Machine Learning for Predicting Adverse Events”, David Page, Univ. of Wisconsin 4. “The Role of Data Mining in Evidence Based Medicine”, Pamela Bradt, Abbott D. Analytical Chemistry Organizer/Chair: Gregory Steeno, Pfizer 1. “Uncertain Standards With Standard Uncertainties”, Bill Porter, Abbott 2. “Propagation of Uncertainty in Process Models and Product Performance Models Using Monte Carlo Methods”, John Kauffman, FDA 3. “Quality Risk Assessment: A Lifecycle Approach in Evaluating Quality Attributes for Bioproducts”, Suntara Cahya, Lilly 4. “Discussant”, Abbie Gentry, J&J Consumer Co. 11:30 AM – 1:00 PM LUNCH BUFFET TUESDA Y AFT E RNOON, MAY 1 9 POSTER SESSION 12:00 PM – 1:30 PM Chair: Krishna Padmanabhan, Wyeth Posters will be considered on any biopharmaceutical statistical topic. Abstracts must be received by April 20, 2009. Students may qualify for the Charlie Sampson poster award if abstract, poster panels, and a paper briefly describing the poster are received by April 20. For more information contact Krishna Padmanabhan at [email protected] Phone: (484)-865-2084 TUESDA Y AFT E RNOON, MAY 1 9 CONCURRENT SESSIONS WEDNE SDAY M ORNING, MAY 2 0 CONCURRENT SESSIONS 8:30 AM – 11:30 AM A. Bayesian Methods in Drug Development Organizers/Chairs: Karen Price, Haoda Fu, Lilly 1. “An Overview of Bayesian Methods in Clinical Trials”, Scott Berry, Berry Consultants 2. “Bayesian Adaptive Designs for Dose Escalation Studies”, Anna McGlothlin, Lilly 3. “Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials”, Haijun Ma, Amy Xia, Amgen 4. “Power Priors for Adaptive Incorporation of Historical Information in Clinical Trials”, Brad Carlin, Brian Hobbs, University of Minnesota B. Statistical Methods in Drug Discovery Organizer/Chair: Jun Cao, Bristol, Myers Squibb 1. “High Throughput Screening”, Antara Majumdar, Bristol Myers Squibb 2. “A Pre-Processing Step for High Content Screening Data”, Stan Young, NISS 3. 4. “In-Vitro Screening for Combination Drug Discovery”, John Peterson, GSK “Response Optimization in Oncology In-Vivo Studies Using a Multi-Objective Modeling Approach”, Max Pashkevich, Phil Iverson, Lilly C. Issues for Observational Studies Organizer/Chair: J. Marc Overhage, Regenstrief Institute 1. “What Does it Take to Normalize Data in a Health Information Exchange?”, Marc Overhage, Regenstrief Institute 2. “Using the Clinical Data Repository for Pharmacovigilance”, Shawn Murphy, Partners Healthcare 3. “Multi-Institutional Studies Using Observational Data: Opportunities and Challenges”, Jeff Brown, Harvard Pilgrim Heath Care/Harvard Medical School 4. “Challenges in Transforming Observational Data for Analysis”, Don Griffin, CSC D. QBD: Challenges in the Clinical/Non-Clinical Link Organizer/Chair: Jeff Hofer, Lilly 1. “Using PK/PD Modeling to Simulate Impact of Manufacturing Process Variability”, Alan Hartford, Agensys, Tim Schofield, Biologics Consulting Group 2. “Connecting the Dots: Accelerating Clinical Development by Integrating Non-Clinical Aspects in the Plan”, Bruno Boulanger, UCB-Group 3. “QbD and Applied Biopharmaceutics for Patient Benefit”, Arzu Selen, FDA 4. “Linking CMC and Toxicology: The Use of Cumulative Carcinogenic Risk for Multiple Genotoxic Impurities Criteria”, Wherly Hoffman, Daniel Ness, Elan Pharmaceuticals Inc., Cindy Lee, Joel Bercu, Lilly 11:30 AM – 1:00 PM Closing Remarks Alan Menius, GlaxoSmithKline LUNCH BUFFET 1:30 PM – 4:30 PM A. Pharmacometrics/Modeling and Simulation Organizer/Chair: Melvin Munsaka, Takeda 1. “Quantitative Clinical Pharmacology Applications for Efficient Drug Development”, Pravin Jadhav, FDA 2. “A Meta-Analytic Model for Alzheimer's Disease Incorporating Both Summary-Level and Patient-Level Data”, James Rogers, Metrum Research Group 3. “Is the Confirmatory Approach in PK/PD Modeling Possible? ”, Chuanpu Hu, Centocor 4. “A Clinical Trial Simulation System, Its Applications, and Future Challenges”, Kuenhi Tsai, Merck, Peter Westfall, Texas Tech University 5. “Discussant”, Kenneth Kowalski, The Ann Arbor Pharmacometrics Group FOR MORE INFORMATION ON THE WORKSHOP, please contact DALE UMBACH, Ball State University, (765) 285-8657, Email: [email protected] or MELVIN MUNSAKA, Takeda Global Research & Development, (847) 582-3533, Email: [email protected].