S06: US FDA and US EPA voluntary submission of genomic data guidance: Current and future use of genomics in decision making

Abstract

Appropriate utilization of data from toxicogenomic studies is an ongoing concern of the regulated industries and the agencies charged with assessing safety or risk. An area of current interest is the possibility of toxicogenomics to enhance our ability to develop higher or high-throughput models for predicting potential safety concerns or for rapidly identifying biomarkers of exposure or effect. These models could be developed to predict potential health concerns, prioritize testing strategies, or establish prognostic markers by helping to identify exposure to effect linkages. The US Food and Drug Administration has developed a guidance for voluntary submission of genomic data in support of investigative new drug or new drug or biomarker applications. US FDA considers this approach to be a way to share information, realizing that most genomic data are currently used for exploration or research. The value to submission is to provide an opportunity for regulatory scientists to become familiar these data and to develop approaches for proper interpretation. The US Environmental Protection Agency has developed a draft guidance for submission of genomic data. Like the US FDA, these data are not required, but the opportunity to submit these data in an organized way allows both the regulated community and the agency to develop useful procedures for interpreting this new science. Currently, the value of this information has been in confirming biological or toxicity pathways and developing predictive models for prioritizing further testing. Establishing methods for application in safety and risk assessment are in the early stages of development. [This abstract of a proposed presentation does not reflect the policy or opinion of the US EPA]