November 17-18, 2009: Science Advisory Board to NCTR—Summary of Division Reviews
On November 17 and 18, 2009, the National Center for Toxicology Research (NCTR) will hold a meeting of its Science Advisory Board in Jefferson, Arkansas. Three Subcommittee Review Reports will be presented at the meeting. These Subcommittee Review Reports present the findings for each of three division reviews listed below:
Division of Systems Toxicology
The first Subcommittee Review Report presents the review findings of the Division of Systems Toxicology Subcommittee which occurred in February 2009. The Division of Systems Toxicology supports the development of new technologies and works to facilitate integration of data from multiple technology platforms for scientific application to questions that are in direct support of the FDA mission. Six Centers of Excellence comprise the Division of Systems Toxicology:
- Functional Genomics
- Innovative Technologies
The Subcommittee noted the capable leadership, strong scientific expertise of the staff and well-equipped laboratories within the Division. The Subcommittee confirmed that the research being conducted within the Division is highly aligned with the FDA mission and has a major emphasis for impacting the areas of biomarker development, adverse-event detection and translation of both of these from preclinical to clinical models. The Site Visit Team members identified a number of general recommendations to help guide and advise the Division as it plans a strategy for developing future research programs at NCTR and noted that the full potential of systems toxicology required working across the Centers of Excellence as a fully integrated multidisciplinary team.
Division of Genetic and Reproductive Toxicology
The second Subcommittee Review Report presents the review findings of the Division of Genetic and Reproductive Toxicology which occurred in July, 2009. The Division of Genetic and Reproductive Toxicology conducts fundamental and applied research to address specific high-priority issues related to the induction of genetic damage. Division research is directed toward developing and validating new methods or improving existing methods for the identification of potentially hazardous food additives, human and animal drugs, biological therapies, and medical devices. The Subcommittee was uniformly positive regarding the overall strategic directions and accomplishments of the Division of Genetic and Reproductive Toxicology. The Subcommittee concluded that the overall program is appropriately focused on research areas that are highly valued by its regulatory clients, and has positioned the division as a well recognized and respected leader in the global regulatory and research genetic toxicology communities.
Division of Personalized Nutrition and Medicine
The final Subcommittee Review Report presents the review findings of the Division of Personalized Nutrition and Medicine which occurred in August, 2009. The Division of Personalized Nutrition and Medicine is charged with developing strategies, methods, and resources needed to improve public health by focusing on the individual. The research in this Division seeks to develop an evidence-based understanding of how the unique genetic identity of each individual contributes to the wide array of biochemical, physiological, and morphological phenotypes in human populations. The Subcommittee was strongly supportive of the research activities of the Division and noted that the research conducted within the Division will provide FDA with information and validated protocols that are critical for FDA to understand the health and safety implications of environmental factors including nutrition, nutritional supplements, and drugs for individuals. Based on this understanding, the FDA will be able to develop the guidance and best practices needed to regulate the application of personalized medicine to public health.