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Sunday, 08/01/2010
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The Value and Need of Academic-Industry Partnerships: Two Case Studies
Charles Tan, Merck Research Laboratories; Boris Iglewicz, Temple University
3:05 PM
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Two-Stage Adaptive Design for Bioequivalence: Methods and Application
Yi-Lin Chiu, Abbott Global Pharmaceuticals Research and Development; Yannis Jemiai, Cytel Inc.; Charles Locke, Abbott Laboratories; Pralay Senchaudhuri, Cytel Inc.
4:25 PM
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Sequential Analytic Methods for Prospective Drug Safety Surveillance
Lingling Li, Harvard Medical School/Harvard Pilgrim Health Care Institute
4:30 PM
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Empirical Comparison of Different Drug Safety Signal Detection Assays Based on Incident User Designs
Maurice Alan Brookhart, Brigham and Women's Hospital/Harvard Medical School; Eric Brinsfield, SAS Institute
4:55 PM
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Monday, 08/02/2010
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Health, Disability, and Employment Status Effects of a Diabetes Management Life Coaching and Pharmacist Counseling Intervention
Tammy Tom, The University of Hawaii
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Correcting an Incorrect Statistical Practice in Pharmacokinetics and Related Fields
Jingyuan Wang, Millennium Pharmaceuticals, Inc.
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Statistical Considerations on Validating Microarray Platform in Clinical Development
Guang (Gary) Chen, Merck & Co., Inc.; Christopher Ramsborg, Merck & Co., Inc.; Yue Wang, Merck & Co., Inc.; Miho Kibukawa, Merck & Co., Inc.; Joel A. Klappenbach, Merck & Co., Inc.
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Preparation of Statisticians for the Needs of Industry Roundtable
Guowen (Gordon) Sun, sanofi-aventis
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Cross-Pharma Statistical Innovations
Herbert Thijs, I-Biostat; Herbert Thijs, I-Biostat
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Designing Experiments for Biopharmaceutical Process Development
Julia O'Neill, Merck & Co., Inc.
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Doing Better Than Average: Tailored Therapeutics in Drug Development
Stan Young, National Institute for Statistical Science; Stephen J. Ruberg, Eli Lilly and Company; Frank Rockhold, GlaxoSmithKline; Sue-Jane Wang, FDA; Stephen Senn, University of Glasgow
1:00 AM
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Relationship of Statistical Software Through Pharmacokinetics (PK)
Jagannath Ghosh, Bausch and Lomb; Camille Granville, Novartis Pharmaceuticals Corporation
8:50 AM
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SAS Programming for Pharmacoepidemiology Studies
Ying Su, Merck & Co., Inc.
9:35 AM
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Identifying Random-Effect Parameters in Nonlinear Mixed-Effect Models by Stepwise Forward Selection
Yaming Hang, Merck & Co., Inc.
10:35 AM
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Statistics in Biopharmaceutical Research: Application of Biomarkers in Drug Development
Aloka Chakravarty, FDA; Mark Rothmann, FDA; Rajeshwari Sridhara , FDA
2:05 PM
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Choice of Multiple Comparison Procedure in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product: Power and Aesthetics
Brian L. Wiens, Alcon Laboratories, Inc.; Alex Dmitrienko, Eli Lilly and Company
3:05 PM
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Overcoming the Winner's Curse to Identify Biomarkers with Clinical Relevance in Drug Development
Lei Shen, Eli Lilly and Company; Haoda Fu, Eli Lilly and Company
3:20 PM
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Tuesday, 08/03/2010
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A NONMEM Population Approach to Modeling the Pharmacogenetics of Atazanavir and Ritonavir in HIV-Negative Adults
Deidre A. Kile, Colorado School of Public Health, University of Colorado Denver; Samantha MaWhinney, Colorado School of Public Health, University of Colorado Denver; Joseph E. Rower, University of Colorado, Denver; Peter L. Anderson, University of Colorado, Denver
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Preparation of Statisticians for the Needs of Industry
Amarjot Kaur, Merck & Co., Inc.
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Statistical Programmers in the Pharmaceutical Industry
Chengying (Nancy) Wu, sanofi-aventis
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How Do Statisticians Become Members of the Development Team from the Beginning of the Lifecycle?
Jeffrey Alan Davidson, Octagon Research Solutions, Inc.
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Reference and Prediction Regions in Medical and Pharmaceutical Research
Robb Muirhead, Statistical Scientist
9:25 AM
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A Leadership Development Program for Statisticians in the Pharmaceutical Industry
Paul H. Berg, Eli Lilly and Company; Christopher M. Glitzer, Eli Lilly and Company; Walter W. Offen, Eli Lilly and Company; Shanthi Sethuraman, Eli Lilly and Company; Gary R. Sullivan, Eli Lilly and Company; Yoko Tanaka, Eli Lilly and Company; Sandra L. Toledo Marquette, Eli Lilly and Company; Ilker Yalcin, Eli Lilly and Company; Aarti S. Shah, Eli Lilly and Company
10:50 AM
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Approaches for Preparing CDISC Compliant Clinical Data: An Experience Within a Pharmaceutical Company
Xiao Li, Takeda Pharmaceutical Company Limited
11:35 AM
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Pharmacokinetics (PK) Comparability for Follow-On Biologics
Jason Liao, Merck Research Laboratories
2:25 PM
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Optimal Designs for Pharmacokinetic Models
Holger Dette, Ruhr-Universität Bochum; Tim Holland-Letz, Ruhr-Universität Bochum
2:55 PM
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Optimal Design in Bioequivalence Studies Analyzed with Nonlinear Mixed Effects Models
France Mentre, Universite Paris-Diderot; Thu Thuy N'guyen, Universite Paris-Diderot/INSERM; Anne Dubois, Universite Paris-Diderot/INSERM; Caroline Bazzoli, Universite Paris-Diderot/INSERM
3:20 PM
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Wednesday, 08/04/2010
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Genomics in the Pharmaceutical Industry: Where Is It Headed?
Dhammika Amaratunga, Johnson & Johnson; James Colaianne, Johnson & Johnson
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Bayesian Dose Escalation Using PK as a Covariate
Arun Krishna, Novartis Oncology; Venkat Sethuraman, Novartis Oncology; Lu-May Chiang, Novartis Pharmaceuticals Corporation
10:35 AM
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The Statistical Analysis of Pharmacological fMRI Data, with an Application to a Study of Expectancy-Based Enhancement of Opioid Analgesia
Martin Lindquist, Columbia University; Lauren Atlas, Columbia University; Tor Wager, University of Colorado
2:25 PM
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