The Animal Core, along with Environmental Health and Safety, Emergency Response and the Occupational Medicine Cores, is integrated with campus-wide services under the direction of the Office of Research Compliance and as part of that office are supported by leadership, administrative and technical resources well beyond those identified in the budget and program submission. The organizational chart for the Office of Research Compliance is available at www.bu.edu/orc/files/2010/12/ORC-Org-Chart.pdf. The animal core will provide animal husbandry and pathology services and technical procedural support for all animal models used in research undertaken in the NEIDL. Additionally, the animal core will participate in developing and validating animal models to meet the Food and Drug Administration (FDA) ?two animal? requirement for selected classes of therapeutic and preventative compounds. The ?Animal Efficacy Rule? provides a mechanism whereby ?certain human drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions may be approved for marketing based on evidence of effectiveness from appropriate animal studies when human efficacy studies are not ethical or feasible.? Reference: 21 CFR 314.600 - 650 and 21 CFR 601.90, ?Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible?, ?Animal Efficacy Rule.?
Animal studies are critical to the scientific mission of the NEIDL Institute and the Animal Core works closely with all integrated service center cores and with the Environmental Health and Safety Core to support both institutional and NEIDL culture of safety requirements and activities.. Animal studies are well suited to research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious diseases. Virtually every research project undertaken at the NEIDL that explores pathogenesis of various human and animal pathogens or investigates treatment and prevention strategies will involve animal studies.
|LeDuc, James W; Anderson, Kevin; Bloom, Marshall E et al. (2009) Potential impact of a 2-person security rule on BioSafety Level 4 laboratory workers. Emerg Infect Dis 15:e1|