BTB Support - The Biological Testing Branch Support Group is responsible for providing information relating to the preclinical chemistry and pharmacology of new anticancer agents identified by the Developmental Therapeutics Program. The analysis of drug candidates in biological fluids involves creating, applying, and validating methodology for each drug candidate. This analytical methodology then permits investigation into possible inter-relationships between dose, bio-fluid (such as plasma or urine) concentration, and bio-effect. The results of such studies may lead to a better understanding of drug activity as well as suggest the best route and dose schedule for administration. Such efforts requires extensive knowledge of high performance liquid chromatography (HPLC), gas chromatography (GC), and molecular spectroscopy such as ultraviolet (UV), fluorescence, and all forms of mass spectrometry. Additionally, this group was charged with providing pharmacological support to the recently implemented NCI-sponsored Phase 0 clinical trials. In addition to the scientific studies supported by this effort, this group is also responsible for providing administrative support to the DCTD Animal Production Program. This program supplies rodents to the NCI, NIH, USAMRIID, FDA and other government agencies. In addition, surplus animals are provided to NIH grantees on an as-available basis. This effort supports many of the preclinical studies required to develop drugs to treat cancer, HIV and other viral diseases, bacterial and toxin-induced diseases, metabolic diseases including diabetes, immunologically induced conditions including autoimmune conditions, and other disease states supported by Federal research funds. DTP Animal QC - Animal models of human disease continue to play a pivotal role in our understanding of disease progression and treatment. As part of the support to the diverse array of animal model studies, DCTD has animal production contracts that provide rodents to the NCI, NIH, FDA, USAMRIID, other Federal agencies as well as NIH grantees on an as available basis. As part of this effort, DCTD routinely assesses the health status of the animals being distributed so as to assure the research community of the quality and biosecurity of the research animals they receive. To this end, the Laboratory Animal Sciences Program (LASP) provides diagnostic services for routine and special-need assessments of the health status of the animal production colonies. These assays include murine antibody production (MAP) tests which identify occult viral infections, PCR-based assays for Helicobacter and certain viral agents as well as bacteriological assessment of rodent and fomite-derived samples to assure the status of the production colonies. In addition, this laboratory monitors the health of all rodent colonies at NCI-Frederick which further protects the DCTD Animal Production Program by identifying and eliminating possible sources of infection within the Frederick campus. Animal Health Diagnostic Laboratory (AHDL) - The Animal Health Diagnostic Laboratory (AHDL) is responsible for monitoring the health of all rodents at NCI-Frederick, NCI-Bethesda, NCI-DTP Rodent Producers, and several NCI contract facilities. The AHDL also provides diagnostic resources to several other NIH facilities and USAMRIID. The major focus of the diagnostic services includes microbiology, parasitology, serology, and health-monitoring necropsies. The AHDL has been a consistent resource to the scientific community for more than 30 years. BTB Animal Care Support - SAIC-Frederick, Inc., and NCI Bethesda are among the 730 organizations, institutions, and companies worldwide that are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International). The animal support areas of LASP consist of the Animal Health Diagnostic Laboratory (AHDL), Animal Molecular Diagnostic Laboratory (AMDL), Receiving and Quarantine (R&Q), Laboratory Animal Medicine (LAM), and NCI animal facilities. The Laboratory Animal Sciences Program provides animal care support to the BTB in vivo preclinical testing effort as well as the PK studies group. This includes direct animal care at the individual cage level as well as support for cage washing and autoclaving as well as maintaining facility supplies of animal care related materials.
