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Saturday, June 27, 2009

Toxicogenomics & Molecular Biology.




Toxic tort claims, health risk assessments, biomonitoring, crime-scene investigations, and intellectual property cases are increasingly relying on techniques that fall under the realm of molecular biology-based science or "Toxicogenomics." Staying abreast of the rapidly evolving, cutting-edge science in this field is essential to understanding and interpreting health claims and in assessing health risks when molecular biology techniques are being used. Exponent scientists have experience in evaluating and conducting studies in the field of molecular biology, including genomics approaches such as DNA array (gene chip), real-time Q-PCR, cloning, transgenics, stem-cell therapeutics, RNA anti-sense, knock-outs, and knock-downs; and proteomics approaches such as, recombinant protein expression, cytokine assays, ELISA, radioisotope and immuno-labeling, and protein purification and identification through 1 and 2-D electrophoresis, and column chromatography.
Increasingly, "Gene Array" or DNA profiling and Cytokine arrays are being applied in an effort to understand disease mechanisms at the molecular level. In toxic tort claims, this technology is also being exploited in an to attempt to assign genetic profiles, "footprints," or "molecular signatures” to various chemical exposure scenarios, such as benzene and asbestos in order to validate an injury claim. In many cases there are considerable limitations to the design and interpretation of the scientific studies being used to support these claims. Our strong understanding of biochemistry, molecular interactions, and fate of chemicals in the body ensures a thorough scientific evaluation of molecular biology based approaches used to identify and quantify exposure and potential health effects. As part of an overall review of the science supporting a claim, Exponent scientists can critically evaluate the relevance of molecular mechanisms and techniques that are being invoked in a selected scenario. As understanding of the molecular mechanisms behind toxicity evolves, government agencies are re-evaluating previously derived regulatory limits, and considering molecular biology-based data in deriving regulatory limits for new chemical compounds. Understanding the new molecular biology–based technology used to evaluate and assess risk of exposure to these chemicals is essential for conducting a weight-of-evidence review to determine new regulatory standards. As biotechnology patent applications increase, the need for third-party expert review is important for maintaining protection of intellectual property and "Freedom to Operate" in commercial research and development programs. Exponent scientists with experience both in the new molecular biology techniques and in regulatory toxicology can evaluate the science that will be used by regulatory agencies to derive these new limits and standards for patent protection. Regulatory agencies and expert panels of scientists are recommending research and development of tools in the emerging field of "Toxicogenomics" for use in exposure assessment. A National Research Council committee on biomonitoring for environmental chemicals recently recommended the use of molecular biology-based biomonitoring approaches, in order "… to move beyond the traditional approaches of exposure assessment-based on one exposure to one chemical in one environmental medium" to assess multiple exposures and multiple biologic-response pathways using genetic markers of exposure and response

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