Validation of Toxicogenomic Technologies
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| Tenth meeting of the Committee on Emerging Issues and Data on Environmental Contaminants |
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| "Validation of Toxicogenomic Technologies: A Focus on Chemical Classification Strategies" |
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July 7, 2005 |
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| 8:30 |
Introduction |
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Kenneth S. Ramos, University of Louisville |
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Audio Clip |
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| 8:45 |
Description of Workshop Concept and Goals |
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John Quackenbush, Harvard University |
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Audio Clip |
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| PART 1: Current Validation Strategies and Associated Issues |
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| 9:00 |
Experimental Design of DNA Microarray Studies |
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Kevin Dobbin, National Cancer Institute |
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Audio Clip Part 1 | Audio Clip Part 2 |
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| 9:30 |
Multiple-laboratory Comparison of Microarray Platforms |
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Rafael Irizarry, Johns Hopkins University |
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Audio Clip |
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| 10:00 |
Break |
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| 10:20 |
Statistical Analysis of Toxicogenomic Microarray Data: Hypotheses, Analysis Methods, and Multiplicity Issues |
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Wherly Hoffman, Eli Lilly and Company |
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Audio Clip |
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| 10:50 |
Diagnostic Classifier - Gaining Confidence Through Validation |
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Weida Tong, FDA, National Center for Toxicological Research |
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Audio Clip Part 1 | Audio Clip Part 2 |
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| 11:20 |
Toxicogenomics: ICCVAM Fundamentals for Validation and Regulatory Acceptance |
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Leonard Schechtman, The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM); FDA, National Center for Toxicological Research |
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Audio Clip Part 1 | Audio Clip Part 2 |
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| 11:50 |
Questions and Discussion |
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| 12:10 |
Lunch |
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| PART 2: Case Studies: Classification Studies and the Validation Approaches |
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| 1:10 |
Presenter: Hisham Hamadeh, Amgen |
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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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Audio Clip Part 1 | Audio Clip Part 2 |
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| 1:40 |
Presenter: Kyle Kolaja, Iconix Pharmaceuticals |
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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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Audio Clip |
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| 2:10 |
Break |
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| 2:25 |
Presenter: Guido Steiner, Roche |
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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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Audio Clip Part 1 | Audio Clip Part 2 |
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| 2:55 |
Roundtable discussion |
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Moderator: John Quackenbush, Harvard University |
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Discuss the strengths and limitations of the current validation approaches and methods to strengthen these approaches. |
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Audio Clip Part 1 | Audio Clip Part 2 | Audio Clip Part 3 |
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| 3:55 |
Summary Statements and Conclusions |
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Kenneth Ramos, University of Louisville |
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Audio Clip |
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Summary of ideas and themes from the presentations, case studies, and discussion. |
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| 4:30 |
Adjourn |
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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. |