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Activity Details

522 Wed, 8/1/2012, 10:30 AM - 12:20 PM CC-Sails Pavilion
Contributed Oral Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Jianwei Chen, San Diego State University
01: Did Adult Liver Transplant Recipients Who Had Hepatitis C Prior to Transplant Receive Antiviral Therapy, January 1997 to June 2009 Feifei Wei, University of Arkansas for Medical Science ; Robin R. Whitebird, HealthPartners Research Foundation
02: Multivariate Statistical Methods Used for Lymphoblastoid Cell Lines Drug Response Shows Promise in Pharmacogenomics Gene Discovery Chad C Brown, North Carolina State University ; Tammy Havener, The University of North Carolina at Chapel Hill ; Ronald Krauss, Children's Hospital Oakland Research Institute ; Marisa Wong-Medina, Children's Hospital Oakland Research Institute ; Kevin Long, The University of North Carolina at Chapel Hill ; Howard McLeod, The University of North Carolina at Chapel Hill ; Alison Anne Motsinger-Reif, North Carolina State University
04: Development of Software for Simulation and Implementation of Optimal Response-Adaptive Randomization Designs in Time-to-Event Trials Oleksandr Sverdlov, Bristol-Myers Squibb ; Yevgen Ryeznik, Kharkov National University of Economics ; Weng-Kee Wong, University of California at Los Angeles Fielding School of Public Health
05: Precision Study for a Qualitative Assay Paul Hshieh, FDA/CBER ; Tie-Hua Ng, FDA/CBER
06: Comparability of CTCAE Grading and Clinical Significance in Abnormal Clinical Laboratory Results — Brian Hetzell, Rho, Inc. ; Ashley Marie Pinckney, Rho, Inc. ; Katharine Marie Poole, Rho, Inc.
07: Methods for Responder Analysis of Patient-Reported Outcomes Alexandra I. Barsdorf, Pfizer Inc. ; Kelly Zou, Pfizer Inc. ; Martin M Carlsson, Pfizer Inc. ; Joseph Cappelleri, Pfizer Inc.
08: Study at a Glance: Old Wine in a New Bottle William Coar
09: Estimators of a Dose-Reduction Factor: A Comparison Study Reid Landes, University of Arkansas for Medical Sciences ; Shelly Y. Lensing, University of Arkansas for Medical Sciences ; Ralph L Kodell, University of Arkansas for Medical Sciences ; Martin Hauer-Jensen, University of Arkansas for Medical Sciences
10: A General Approach for Estimating Stopping Probabilities of Large Group Sequential Trials in Life-Threatening Conditions Monitoring Binary Efficacy and Safety Outcomes Yanqiu Weng, Medical University of South Carolina ; Wenle Zhao, Medical University of South Carolina ; Yuko Palesch, Medical University of South Carolina
11: Escalation with Overdose Control Using Ordinal Toxicity Grades for Cancer Phase I Clinical Trials Galen Cook-Wiens, Cedars Sinai Medical Center ; Mourad Tighiouart, Cedars Sinai Medical Center ; Andre Rogatko, Cedars Sinai Medical Center
12: Matching-Adjusted Indirect Comparison Using Bootstrapping for Comparative Effectiveness: Individual Patient Data vs. Published Aggregated Data Daniel Parks, GlaxoSmithKline ; Xiwu Lin, GlaxoSmithKline ; Alan J Menius, GlaxoSmithKline ; Kwan R. Lee, GlaxoSmithKline
13: Analyzing Hypoglycemia Events eith Negative Binomial Regression Model — Junxiang Luo, Eli Lilly and Company ; Yongming Qu, Eli Lilly and Company
14: A Comparison of Multivariate Methods for Measuring Change from Pre-Test to Post-Test Justin Rogers, Abbott Laboratories ; Daniel Mundfrom, Eastern Kentucky University
15: Zero-Inflated Poisson and Negative Binomial Models Applied to the Analysis of Colorectal Polyp Prevention Trial Data Christopher Davidson, University of Arizona ; Chiu-Hsieh Hsu, University of Arizona
16: Sample Size Considerations When Using the Synthesis Method for Non-inferiority Trials Huei Wang, Amgen, Inc. ; Guanghui Wei, Amgen, Inc.
17: Simulation Study on Bioequivalence Tests Under Several Variability Conditions Denka Markova, Axio Research Inc. ; Dean Young, Baylor University
18: An Application of Adaptive Randomization to Guide Dose-Finding in a Large Multicenter Phase I Clinical Trial Alison Marie Graham, Abbott ; Wijith Prasantha Munasinghe, Abbott Laboratories ; James Bolognese, Cytel Inc. ; Yi-Lin Chiu, Abbott Laboratories
19: 1 Plus 1 Equals 3: Searching for In Vivo Synergy Mandy Bergquist, GlaxoSmithKline ; Jonathan Hommel, University of Texas Medical Branch ; Andrea Acker, GlaxoSmithKline ; Mark Paulik, GlaxoSmithKline
20: Aligned Rank Tests: An Application to Clinical Trials John Kloke, University of Wisconsin-Madison ; Tom Cook, University of Wisconsin-Madison
21: Evaluating Oncology Phase II Study Designs Zhuying Huang, PPD ; Hui Liu, PPD ; Lindsey Lian, PPD
22: On the Problem of Identifiabilityof the EMAX Model Ha Nguyen, Pfizer Inc. ; Birol Emir, Pfizer Inc. ; Javier Cabrera, Rutgers University ; Feihan Lu, New York University
23: Power and Sample Size Investigation for Correlated Binary Data — Dar Shong Hwang, BRSI ; James Lee, Daiichi Sankyo Pharma Development ; Chyi-Hung Hsu, Janssen Pharmaceuticals, Inc.
24: An Extension of the Bland-Altman Plot Tie-Hua Ng, FDA/CBER
25: Power and Sample Size Estimation in Clinical Trials with Multiple Co-Primary Endpoints Zuoshun Zhang, Celgene Corporation
26: Estimating Pharmacokinetics Parameters Using Meta-Analysis and Nonlinear Mixed Effects Model Wijith Prasantha Munasinghe, Abbott Laboratories ; Balakrishna Hosmane, Abbott Laboratories ; Rajendra Pradhan, Abbott Laboratories ; Yi-Lin Chiu, Abbott Laboratories
27: Case-Cohort Data Analyses with an Application in Vaccine Trial Shu-Chih Su, Merck Research Laboratories ; Guanghan Liu, Merck Research Laboratories ; Ivan Chan, Merck
28: Methods for Pairwise Comparison of Treatment Levels in a Functional Data Setting Olga Vsevolozhskaya, Montana State University ; Mark Greenwood, Montana State University ; Dmitri Holodov, Voronezh State University
29: Predicting a Binary Outcome with Dose-Response Data Yang Zhang, University of Pittsburgh
31: Generalized Estimation of the Treatment Effects in Mixed-Effects Model: A Comparison with ML and REML Ching-Ray Yu, Pfizer Inc. ; Kelly Zou, Pfizer Inc. ; Martin M Carlsson, Pfizer Inc. ; Samaradasa Weerahandi, Pfizer Inc.
32: A New Tool for Flagging Adverse Events of Potential Clinical Interest Li Zhou, Axio Research Inc. ; David Kerr, Axio Research Inc.
33: The Optimal Thresholds of Biomarkers by Maximizing Various Metrics Kelly Zou, Pfizer Inc. ; Martin M Carlsson, Pfizer Inc. ; Kezhen Liu, State University of New Jersey ; Ching-Ray Yu, Pfizer Inc.
34: Incorporating Continuity Corrections When Illustrating Noninferiority with Binomial Proportions Brianna Bright, University of Nebraska ; Julia Soulakova, University of Nebraska
35: Considering Efficacy in Tumor Genotypes in a Two-Stage Adaptive Design for Oncology Trials Jinwei Yuan, ICON Clinical Research
36: Creating a Better, Shorter DMC Report: A Stack of Needles, Not a Needle in a Haystack David Kerr, Axio Research Inc. ; William Coar ; Shannon Grant, Axio Research Inc.

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