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 |
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. |