|
Monday, 08/02/2010
|
Development of Imaging Biomarkers for Clinical Trials: Applications in Glioblastoma Multiforme
Hyun (Grace) Kim, University of California, Los Angeles; Jing Huo, University of California, Los Angeles; Matt Brown, University of California, Los Angeles; Jonathan Goldin, University of California, Los Angeles
|
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.
|
Development of Imaging Biomarkers for Clinical Trials: Applications in Rheumatoid Arthritis
Grace S. Park, Amgen Inc.
|
Surrogate Endpoint: New Statistical Definition and Evaluation
Yongming Qu, Eli Lilly and Company
8:35 AM
|
Quantile Regression for Longitudinal Data with Left-Censoring and Informative Dropouts
Minjae Lee, University of Pittsburgh; Lan Kong, University of Pittsburgh
9:35 AM
|
Semiparametric Transformation Models for Multiple Biomarkers in ROC Analysis
Eunhee Kim, Brown University; Donglin Zeng, The University of North Carolina at Chapel Hill
9:35 AM
|
Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges
Daniel Sargent, Mayo Clinic; Sumithra Mandrekar, Mayo Clinic
10:35 AM
|
Landmark Prediction of Survival
Layla Parast, Harvard University; Tianxi Cai, Harvard School of Public Health
10:35 AM
|
A Case Study of Using a Genomic Assay to Predict the Benefit of Chemotherapy in Treating Breast Cancer: Testing, Prediction, and Study Planning
William E. Barlow, Cancer Research and Biostatistics (CRAB); Carl Yoshizawa, Genomic Health, Inc.
11:00 AM
|
Measuring the Performance of Markers Used to Select Patient Treatment
Holly Janes, Fred Hutchinson Cancer Research Center
11:25 AM
|
Evaluating Markers for Treatment Selection
Xiao Song, The University of Georgia; Margaret Sullivan Pepe, Fred Hutchinson Cancer Research Center; Xiao-Hua Zhou, University of Washington
11:50 AM
|
Statistics in Biopharmaceutical Research: Application of Biomarkers in Drug Development
Aloka Chakravarty, FDA; Mark Rothmann, FDA; Rajeshwari Sridhara , FDA
2:05 PM
|
Optimal Weight in Estimating the Receiver Operating Characteristic Curve Area Using Longitudinal Data
Yougui Wu, University of South Florida
2:05 PM
|
Evaluating Correlation and Some Misuses for Biomarker Qualification Within a Causal Correlation Framework
Yue Wang, Merck & Co., Inc.; Robin Mogg, Merck & Co., Inc.; Peter H. Hu, Merck & Co., Inc.; Jared Lunceford, Merck & Co., Inc.; Peggy Wong, Merck Research Laboratories
2:05 PM
|
Detecting a Cutoff Point for Predictive Biomarkers in Clinical Trials Using Contrast Tests
Jianliang Zhang, MedImmune
2:20 PM
|
Using Logistic Model with Measurement Errors in Covariates to Assess Baseline Biomarkers Association with Treatment Response
Dion Chen, Centocor R&D, Inc.; Jiandong Lu, Johnson & Johnson
2:35 PM
|
Design and Analysis of Discrete-Time Survival Studies with Pooled Biomarker Assessment
Paramita Saha, National Institute of Environmental Health Sciences; Clarice R. Weinberg, National Institute of Environmental Health Sciences
2:45 PM
|
An Orthogonal Transformed Aggregation Statistic to Test Gene Regulation with Prespecified Gene Sets or Pathways
Shuyan (Sabrina) Wan, Merck Research Laboratories; Nanshi Sha, Columbia University; Peggy Wong, Merck Research Laboratories
2:50 PM
|
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
|
Issues on Threshold Selection in Predictive Biomarker Analysis
Li-an Xu, Bristol-Myers Squibb
3:20 PM
|
Dimension Reduction Through Variable Selection: A Fibrosis Case Study
Katja Sabine Remlinger, GlaxoSmithKline
3:35 PM
|
Estimating Incremental Value in Marker Combinations Using a Two-Stage Study Design
Aasthaa Bansal, University of Washington; Margaret Sullivan Pepe, Fred Hutchinson Cancer Research Center
3:35 PM
|
|
Tuesday, 08/03/2010
|
Can Spread of Data Be Used for Discrimination?
Borko D. Jovanovic, Northwestern University; Angela Fought, Northwestern University; Mary Kwasny, Northwestern University
|
Application of Intersection-Union Tests for Identifying Metabolite Biomarkers for Diagnosis and Prognosis
Kyoungmi Kim, University of California, Davis; Stanislav O. Zakharkin, Cadbury North America
|
Statistical Analysis Strategies for Shotgun Proteomics Data
Ming Li, Vanderbilt University School of Medicine
8:35 AM
|
Developing Targeted Protein Measurement for Label-Free Multiple Reaction Monitoring
Dean Billheimer, The University of Arizona
8:55 AM
|
Mixed-Effect Models for High-Throughput Mass Spectrometry-Based Proteomic Profiling Experiments
Timothy Clough, Purdue University; Ching-Yun (Veavi) Chang, Purdue University; Olga Vitek, Purdue University
9:15 AM
|
A Bayesian Adaptive Design with Biomarkers for Targeted Therapies
Jens C. Eickhoff, Colorado State University; KyungMann Kim, University of Wisconsin-Madison; Jill M. Kolesar, University of Wisconsin-Madison; Jason R. Gee, Lahey Clinic Medical Center
10:35 AM
|
Applying Covariate-Adjusted, Response-Adaptive Randomization to Medical Device Studies
Thomas E. Gwise, FDA; Gene Anthony Pennello, FDA
10:55 AM
|
I-SPY2: Identifying Biomarker Signatures for Therapeutic Agents in Neoadjuvant Breast Cancer
Donald Arthur Berry, MD Anderson Cancer Center; Kyle Wathen, MD Anderson Cancer Center; Nebiyou Bekele, MD Anderson Cancer Center; Laura Esserman, University of California, San Francisco
11:35 AM
|
Principal Stratification Methods for Evaluating Immunological Surrogate Endpoints in a Vaccine Efficacy Trial
Peter Gilbert, Fred Hutchinson Cancer Research Center
2:45 PM
|
Robust ROC Analysis Using Auxiliary Variables in the Presence of Missing Biomarker Values
Xiaoxi Zhang, Pfizer Inc.; Qi Long, Emory University
3:05 PM
|
Assessing the Improved Discriminatory Power of a New Biomarker in Prognostic Models
Mei Liu, MD Anderson Cancer Center; Carol J. Etzel, MD Anderson Cancer Center; Asha Kapadia, The University of Texas School of Public Health
3:05 PM
|
|
Wednesday, 08/04/2010
|
Genomics in the Pharmaceutical Industry: Where Is It Headed?
Dhammika Amaratunga, Johnson & Johnson; James Colaianne, Johnson & Johnson
|
Accuracy of Biomarker Testing and Its Impact on Targeted Therapy Validation
Meijuan Li, FDA; Estelle Russek-Cohen, FDA; Rong Tang, FDA
9:15 AM
|
Evaluating Diagnostics Hypotheses in Proof-of-Concept Clinical Trials
Jane Fridlyand, Genentech
9:55 AM
|
A Nonparametric Bayesian Approach to Biomarker Discovery
Peter Mueller, MD Anderson Cancer Center; Alejandro Jara, Pontificia Universidad Católica de Chile
11:15 AM
|
Exponential Failure-Time Mixture Model for Evaluating Efficacy in the Presence of a Biomarker: KRAS Validation
Kallappa M. Koti, FDA
2:35 PM
|
Methodological Challenges in Linking NHANES Biomarker Data with Ambient Air Data and Surrogate Measures of Traffic-Related Air Pollution
Sorina Eftim, University of Maryland; Amir Sapkota, University of Maryland; Jennifer Parker, National Center for Health Statistics
2:35 PM
|
Diffusion Tensor Imaging (DTI) as a Potential Biomarker of Autism
Moo K. Chung, University of Wisconsin
3:05 PM
|
|
Thursday, 08/05/2010
|
Coherent Analysis of Longitudinal Changes in Biomarkers in the Presence of Attrition Due to Competing Risks
Tom Greene, The University of Utah
8:35 AM
|
Biomarkers in Clinical Trials in the Development of Biologics and Risk Assessment
Samir Lababidi, FDA
8:50 AM
|
A Review of Time-Dependent ROC Curve for Evaluating the Prognosis Capacity of Biomarkers and Semiparametric Regression Methods
Nan Hu, The University of Utah; Xiao-Hua Zhou, University of Washington
8:55 AM
|
Using Cardiovascular Disease Risk Functions in Public Health and Clinical Trial: The Framingham Study Experience
Ralph B. D'Agostino, Sr., Boston University
9:25 AM
|
Comparing Biomarkers as Principal Surrogate Endpoints
Ying Huang, Columbia University
11:15 AM
|
Parsimonious Models for Classifying Proteomic MS Data
Chris Fraley, Insilicos LLC; Bryan Prazen, Insilicos LLC; Mark Seligman, Insilicos LLC
11:20 AM
|
|