Workshop: Genomics in Cancer Risk Assessment

Toxicological assessments of chemical compounds and drugs currently rely heavily on extrapolation from animal studies to human health risks. A wide range of in vitro assays has been devised to complement animal experiments to better understand potential risks from exposures, with the ultimate goal of replacing in vivo experimentation altogether. While a few in vitro cell-based or tissue-based assays have been developed that provide significant insight into organ-specific toxicities, the integration of toxicogenomic information into these assays has recently provided substantial improvements in hazard identification and predictive organ toxicity. One area that holds particular promise in utilizing toxicogenomics information is that of evaluating cancer risk associated with exposures to drugs and chemicals in our environment. The current testing paradigm consists of a short term genetic toxicity testing that detects damage to the genetic material of the cell, followed by carcinogenicity testing that relies on a chronic exposure of mice and rats via 2-year bioassays. Because of technical limitations of 2-year rodent bioassays, the data from the genetic toxicology testing battery is used for evaluating carcinogenic potential of drugs in early clinical development and of most industrial chemicals. Although the role of genetic damage in cancer development is well understood, the relationship between genetic toxicity testing and cancer development is imprecise due to limitations of these assays such as their over-sensitivity or their inability to detect non-genotoxic mechanisms of carcinogenesis. Furthermore, technical and ethical concerns associated with carcinogenicity testing in animals including the significant difficulty of the translation of results from in vivo rodent carcinogenicity results to the actual cancer risk to human populations provide challenge to industry and regulatory agencies. Therefore, a better understanding of carcinogenic mechanisms including their relevance to humans would significantly facilitate human cancer risk assessment. In this symposium we will discuss emerging genomic-based approaches applicable to toxicity and cancer hazard identification and risk assessment. A special emphasis will be given to development and evaluation of alternative in vitro models that have the potential to significantly reduce the use of laboratory animals. The participants will interact with leading experts from academia, industry, and governmental research and regulatory agencies. The outcome of the symposium is to identify promising approaches and identify gaps that need to be addressed in order to implement genomic approaches into a new safety evaluation strategy for drugs and chemicals that will satisfy current and future demands.Registration: http://www.hesiglobal.org/Committees/TechnicalCommittees/Genomics/Genomics_CRA_Venice.htm(opens in new window)