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.



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