Institute for Chemical Safety Sciences
Develop toxicity testing strategies, modeling methods, and quantitative analytical tools to improve chemical safety assessments in order to enhance product stewardship and responsible care efforts.
The Hamner Institute for Chemical Safety Sciences aims to support and advance new human systems biology based approaches to chemical safety assessment. These approaches involve the development of new assays that use human cells or cells lines to characterize major “toxicity pathways,” dose response models to quantify when perturbations in toxicity pathways result in adverse events in cells and tissues, and in vitro to in vivo extrapolation tools to predict the level and duration of exposure that is likely to result in adverse events in humans. The outcome of this research will be a revolutionary change in toxicity testing by focusing on the prediction of true windows of safety for chemicals at which adverse events can be avoided based on quantitative data and human biology. A significant effect of this paradigm shift will be the reduction in the use of animals and a more conscientious use for targeted testing. The Hamner Centers for Genomic Biology and Bioinformatics, Dose Response Modeling, and Human Health Assessment work together to achieve the goals of the Institute for Chemical Safety Sciences. Overall, the Institute will enhance chemical product stewardship and responsible care efforts, as well as create the necessary tools to move the field of toxicology forward into a new era.
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Institute for Chemical Safety Sciences
Melvin E. Andersen, CIH, Ph.D., DABT, FATS, Director
Melvin E. Andersen, CIH, Ph.D., DABT, FATS, serves as Director of The Institute for Chemical Safety Sciences, Chief Science Officer, and is a Hamner Senior Investigator. He is also the inaugural Charles E. Hamner, Jr. Distinguished Fellow. During his 40-year career in toxicology and risk assessment, Dr. Andersen has developed biologically realistic models pertaining to the uptake, distribution, metabolism, and biological effects of toxic chemicals and drugs, and applied these models to safety evaluations and quantitative health risk assessments. His research has pioneered new uses of pharmacokinetic and mechanistic data in risk assessment programs. In 2002, Dr. Andersen was recognized as a “highly cited” scientist by the Institute for Scientific Information. He has served on numerous committees and advisory boards, including the Committee on Toxicity Testing and Assessment of Environmental Agents at the U.S. National Academy of Sciences (NAS) that produced the report: Toxicity Testing in the 21st Century: A Vision and A Strategy. Dr. Andersen received his Ph.D. in Biochemistry and Molecular Biology from Cornell in 1971. He is the author of 400 published papers and book chapters and has co-edited two books on quantitative modeling, Physiologically Based Pharmacokinetics: Science and Applications in 2005 and Quantitative Modeling in Toxicology in 2010.
Rebecca A. Clewell, Ph.D., Associate Director
Rebecca A. Clewell, Ph.D., serves as Associate Director of The Institute for Chemical Safety Sciences, and is a Hamner Associate Investigator. Dr. Clewell’s research is focused on developing in vitro and in silico tools that will aid in the interpretation of the human relevance of animal-based toxicity studies. By collecting and integrating data on chemical dose-response, pharmacokinetics, mechanism of action, she seeks to characterize the differences or similarities between the studied species and the human with regard to both target chemical dose and biological effect. Dr. Clewell is currently leading efforts to map the dose response for chemicals that interfere with two important cellular signaling pathways: steroidogenesis and DNA repair. Her laboratory combines in vivo, in vitro, genomic, protein and small molecule assays to study the underlying biology of these signaling pathways as well as the mechanism and dose-dependence of chemical disruption of normal function. Dr. Clewell received her Ph.D. in Environmental Science and Engineering from the University of North Carolina at Chapel Hill. She has received awards from the Biological Modeling and Risk Assessment Specialty Sections of the Society of Toxicology and the Genetics and Mutagenesis Society. She has authored or co-authored over a dozen journal articles, as well as three book chapters on analytical techniques for perchlorate analysis and physiologically based pharmacokinetic modeling of environmental chemicals.