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Validation of Toxicogenomic Technologies: A Workshop Summary (2007)

Chapter: Appendix B: Workshop Agenda

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Suggested Citation:"Appendix B: Workshop Agenda." National Research Council. 2007. Validation of Toxicogenomic Technologies: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11804.
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APPENDIX B
VALIDATION OF TOXICOGENOMIC TECHNOLOGIES:AFOCUS ON CHEMICAL CLASSIFICATION STRATEGIES

WORKSHOP AGENDA

Thursday, July 7, 2005

8:30 am

Introduction (Kenneth Ramos, University of Louisville)

8:45 am

Description of Workshop Concept and Goals (John Quackenbush, Harvard University)

PART 1: Current Validation Strategies and Associated Issues

9:00 am

Experimental Design of DNA Microarray Studies

Speaker: Kevin Dobbin, National Cancer Institute

9:30 am

Speaker: Rafael Irizarry, Johns Hopkins University

10:00 am

BREAK

10:20 am

Statistical Analysis of Toxicogenomic Microarray Data: Hypotheses, Analysis Methods, and Multiplicity Issues

Speaker: Wherly Hoffman, Eli Lilly and Company

10:50 am

Diagnostic Classifier—Gaining Confidence Through Validation

Weida Tong, FDA, National Center for Toxicological Research

Suggested Citation:"Appendix B: Workshop Agenda." National Research Council. 2007. Validation of Toxicogenomic Technologies: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11804.
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11:20 am

Toxicogenomics: ICCVAM Fundamentals for Validation and Regulatory Acceptance

Leonard Schechtmann, The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM); FDA, National Center for Toxicological Research

11:50 am

Questions and Discussion

12:10 pm

LUNCH

PART 2: Case Studies—Classification Studies and the Validation Approaches

[Presenters to provide an overview of the study emphasizing the validation strategies employed in this research]

1:10 pm

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.

1:40 pm

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.

2:10 pm

BREAK

2:25 pm

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.

2:55 pm

Roundtable discussion (Moderator: John Quackenbush, Harvard University)

Discuss the strengths and limitations of the current validation approaches and methods to strengthen these approaches.

Suggested Citation:"Appendix B: Workshop Agenda." National Research Council. 2007. Validation of Toxicogenomic Technologies: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11804.
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3:55 pm

Summary Statements and Conclusions (Kenneth Ramos, University of Louisville)

Summary of ideas and themes from the presentations, case studies, and discussion.

4:30 pm

ADJOURN

Suggested Citation:"Appendix B: Workshop Agenda." National Research Council. 2007. Validation of Toxicogenomic Technologies: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11804.
×
Page 79
Suggested Citation:"Appendix B: Workshop Agenda." National Research Council. 2007. Validation of Toxicogenomic Technologies: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11804.
×
Page 80
Suggested Citation:"Appendix B: Workshop Agenda." National Research Council. 2007. Validation of Toxicogenomic Technologies: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11804.
×
Page 81
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Beginning in the early 1980s, new technologies, began to permit evaluation of the expression of individual genes. Recent technological advances have expanded those evaluations to permit the simultaneous detection of the expression of tens of thousands of genes and to support holistic evaluations of the entire genome. The application of these technologies has enabled researchers to unravel complexities of cell biology and, in conjunction with toxicologic evaluations, the technologies are used to probe and gain insight into questions of toxicologic relevance. As a result, the use of the technologies has become increasingly important for scientists in academia, as well as for the regulatory and drug development process.

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