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OCR for page 79
Validation of Toxicogenomic Technologies: A Workshop Summary 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

OCR for page 79
Validation of Toxicogenomic Technologies: A Workshop Summary 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.

OCR for page 79
Validation of Toxicogenomic Technologies: A Workshop Summary 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