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Validation of Toxicogenomic Technologies
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Tenth meeting of the Committee on Emerging Issues and Data on Environmental Contaminants
 
"Validation of Toxicogenomic Technologies: A Focus on Chemical Classification Strategies"
 
July 7, 2005
 
8:30 Introduction
Kenneth S. Ramos, University of Louisville
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8:45 Description of Workshop Concept and Goals
John Quackenbush, Harvard University
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PART 1: Current Validation Strategies and Associated Issues
 
9:00 Experimental Design of DNA Microarray Studies
Kevin Dobbin, National Cancer Institute
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Audio Clip Part 1 | Audio Clip Part 2
 
9:30 Multiple-laboratory Comparison of Microarray Platforms
Rafael Irizarry, Johns Hopkins University
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10:00 Break
 
10:20 Statistical Analysis of Toxicogenomic Microarray Data: Hypotheses, Analysis Methods, and Multiplicity Issues
Wherly Hoffman, Eli Lilly and Company
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10:50 Diagnostic Classifier - Gaining Confidence Through Validation
Weida Tong, FDA, National Center for Toxicological Research
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Audio Clip Part 1 | Audio Clip Part 2
 
11:20 Toxicogenomics: ICCVAM Fundamentals for Validation and Regulatory Acceptance
Leonard Schechtman, The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM); FDA, National Center for Toxicological Research
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11:50 Questions and Discussion
 
12:10 Lunch
 
PART 2: Case Studies: Classification Studies and the Validation Approaches
 
1:10 Presenter: Hisham Hamadeh, Amgen
Hamadeh HK. Bushel PR. Jayadev S. Martin K. DiSorbo O. Sieber S. Bennett L. Tennant R. Stoll R. Barrett JC. Blanchard K. Paules RS. Afshari CA. 2002. Gene expression analysis reveals chemical-specific profiles. Toxicological Sciences. 67(2):219-231.
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1:40 Presenter: Kyle Kolaja, Iconix Pharmaceuticals
Kramer JA. Curtiss SW. Kolaja KL. Alden CL. Blomme EA. Curtiss WC. Davila JC. Jackson CJ. Bunch RT. 2004. Acute molecular markers of rodent hepatic carcinogenesis identified by transcription profiling. Chemical Research in Toxicology 17(4):463-470.
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2:10 Break
 
2:25 Presenter: Guido Steiner, Roche
Steiner G. Suter L. Boess F. Gasser R. de Vera MC. Albertini S. Ruepp S. 2004. Discriminating different classes of toxicants by transcript profiling. Environmental Health Perspectives 112(12):1236-1248.
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2:55 Roundtable discussion
Moderator: John Quackenbush, Harvard University
Discuss the strengths and limitations of the current validation approaches and methods to strengthen these approaches.
Audio Clip Part 1 | Audio Clip Part 2 | Audio Clip Part 3
 
3:55 Summary Statements and Conclusions
Kenneth Ramos, University of Louisville
Audio Clip
Summary of ideas and themes from the presentations, case studies, and discussion.
 
4:30 Adjourn
 
NOTE: These are unedited files of the Tenth Meeting of the Committee on Emerging Issues and Data on Environmental Contaminants and is not an official report of National Academy of Sciences, National Academy of Engineering, Institute of Medicine, or National Research Council (collectively “National Academies”). Opinions and statements are solely those of the individual persons or participants at the symposium, and are not necessarily adopted or endorsed or verified as accurate by the National Academies.
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