Emerging Safety Science: Workshop Summary (2008)

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

References Almenoff, J. 2007. Signal management through the product lifecycle. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD. Butcher, E. 2007. Drug evaluation in human cell systems-based models of physiology and disease. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Sci- ence, April 23, 2007, White Oak, MD. Cockett, M. 2007. Toxicogenomics and assessment of drug pharmacology using microarrays. Speak- er presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. DiMasi, J. A., and H. G. Grabowski. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28(4–5):469–479. DuMouchel, W. 2007. Statistical issues in the analysis of spontaneous report databases. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD. FDA (Food and Drug Administration). 2004. Innovation or stagnation: Challenge and oppor- tunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/ criticalpath/whitepaper.pdf (accessed July 11, 2007). FDA. 2006. Innovation or stagnation: Critical path opportunity list. http://www.fda.gov/oc/ initiatives/criticalpath/reports/opp_list.pdf (accessed October 25, 2007). Frazier, K. 2007. ALK5: Targeted investigations of a targeted therapy using laser capture microdis- section, flow cytometry, immunohistochemical approaches and genomics. Speaker presenta- tion at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Frueh, F. 2007. The transition from preclinical to clinical application of safety related genomics. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Sci- ence, April 23, 2007, White Oak, MD. GAO (Government Accountability Office). 2006. Drug safety: Improvement needed in FDA’s postmarket decision-making and oversight process. http://www.gao.gov/new.items/d06402. pdf (accessed January 17, 2008). 115 

116 EMERGING SAFETY SCIENCE Halbert, D. 2007. Application of toxicogenomics to drug discovery and to preclinical safety assess- ment. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. IOM (Institute of Medicine). 2007. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: The National Academies Press. Krall, R. 2007. Summing up: Improving safety science to make better medicines. Speaker presenta- tion at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD. Lai, E. 2007. Pharmacogenetic investigation of drug associated adverse events. Speaker presenta- tion at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. MacDonald, M. L., J. Lamerdin, S. Owens, B. H. Keon, G. K. Bilter, Z. Shang, Z. Huang, H. Yu, J. Dias, T. Minami, S. W. Michnick, and J. K. Westwick. ���������������������� 2006. Identifying off- target effects and hidden phenotypes of drugs in human cells. Nature Chemical Biology 6(2):329–337. MacLaughlin, P. 2007. Integration of preclinical, clinical, and postmarketing safety data. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Milburn, M. 2007. Metabolomics as an emerging technology in drug safety assessment. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Spear, B. 2007. Practical application of toxicogenomics in early drug discovery. Speaker presenta- tion at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Vonderscher, J. 2007. Biomarker of drug induced kidney injury qualification for regulatory decision making. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Westwick, J. 2007. Tapping the power of cellular networks for improved drug discovery. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD.