title: The utility of genetically modified mouse assays for identifying human carcinogens: a basic understanding and path forward. The Alternatives to Carcinogenicity Testing Committee ILSI HESI.
abstract: The Alternatives to Carcinogenicity Testing Committee of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) conducted a large-scale, multinational collaborative research program to evaluate several genetically modified mouse assays for assessing the human carcinogenic potential of compounds. The data from this testing program have made an important contribution to the general understanding of how these models can be best applied in hazard identification; however, questions still exist regarding methodology and data interpretation. To address these issues, ILSI HESI hosted a February 2003 workshop on the Utility of Transgenic Assays for Risk Assessment. The purpose of this workshop was to reach an understanding of how data from genetically modified mouse models are viewed by different regulatory bodies in the pharmaceutical sector and, based on this understanding, to identify areas in which more experimental work may be needed to increase the utility of data derived from these assays. In the course of discussions, various data gaps related to model selection and protocol issues were identified. Based on the outcome of the workshop, various studies are proposed to provide data to improve the utility of currently available assays for cancer hazard identification and risk assessment purposes.
authors.affiliation: Schering-Plough Research Institute, Kenilworth, New Jersey 07033, USA.
authors.forename: James
authors.initials: J
authors.lastname: MacDonald
authors.forename: John E
authors.initials: JE
authors.lastname: French
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Gerson
authors.forename: Jay
authors.initials: J
authors.lastname: Goodman
authors.forename: Tohru
authors.initials: T
authors.lastname: Inoue
authors.forename: Abigail
authors.initials: A
authors.lastname: Jacobs
authors.forename: Peter
authors.initials: P
authors.lastname: Kasper
authors.forename: Douglas
authors.initials: D
authors.lastname: Keller
authors.forename: Amy
authors.initials: A
authors.lastname: Lavin
authors.forename: Gerald
authors.initials: G
authors.lastname: Long
authors.forename: Bruce
authors.initials: B
authors.lastname: McCullough
authors.forename: Frank D
authors.initials: FD
authors.lastname: Sistare
authors.forename: Richard
authors.initials: R
authors.lastname: Storer
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: van der Laan
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D015197:Carcinogenicity Tests / Q000379:methods* / Q000592:standards; D002273:Carcinogens / Q000633:toxicity; D016158:Genes, p53; D011905:Genes, ras; D006801:Humans; D051379:Mice; D018345:Mice, Knockout; D008822:Mice, Transgenic; D023421:Models, Animal; D018570:Risk Assessment
chemical_list: D002273:Carcinogens