Director:  Donna L. Mendrick, Ph.D.

The Division of  Systems Toxicology supports the development of new technologies and works to facilitate integration of data from multiple technology platforms for application to questions associated with the FDA's Critical Path Initiative that are in direct support of the FDA mission. Six Centers of Excellence comprise the Division of Systems Toxicology, including the Centers for Functional Genomics, Proteomics, Metabolomics, Hepatotoxicity, Toxicoinformatics, and Chemistry. The emphasis of this Division is to provide technical expertise and guidance for the inclusion of omics and in silico data into the review process.

Our research is focused on novel technology development for FDA's Critical Path research that can lead to personalized medicine. The move toward personalized medicine requires that more global analysis of the phenotypes of individuals on the health-disease continuum that can be ascertained through an integrated systems-biology approach using information from microarray analysis, metabolomics, and proteomics. Because these new technologies generate a great deal of data, a strong informatics underpinning is required. The systems-biology approach to toxicity testing can provide FDA with data that are more easily extrapolated to humans, making data interpretation more facile and relevant.

An important function of FDA is to use risk management to provide the most health promotion and protection at the least cost to the public. Presently, this is accomplished by safety assessment of FDA-regulated products in surrogate organisms and, to a lesser extent, in humans.

The Division has a program in mass spectrometry-based analyses in counterterrorism, as well as a significant effort in sensor and nanotube technology. In addition, the Division provides computational — including artificial intelligence — approaches to predictive toxicology.

The goal of the Division is to use proof-of-concept protocols to identify new disease markers and (adverse) drug targets that will aid in the design of biomedical products to prevent, diagnose, and treat disease that have a better efficacy, a lower risk of adverse events, and can be applied in the move toward personalized medicine.

The NCTR Research Plans and Accomplishments Document contains information on the latest accomplishments and plans for the Division of Biochemical Toxicology as well as project and publication listings.