The Regulatory Services Core (RSC) provides oversight and coordinafion for all functions within the GNL required to support and conduct studies in accordance with the FDA's G LP regulations, as outlined in the Code of Federal Regulations, Titie 21, Part 58 (21 CFR Part 58), and associated guidance documents. It is anticipated that these studies will involve development and validation of animal models for biodefense and emerging infectious disease agents, as well as pre-clinical testing of candidate vaccines and therapeutics, including tesfing under the FDA Animal Rule (21 CFR Parts 314 and 601) and/or generafion of safety and efficacy data that might support licensure under an Emergency Use Authorizafion. The RSC will be responsible for coordination of efforts amongst individual investigators, other core laboratories (both within and outside the GNL), GNL management, UTMB's Institutional GLP program office, the NIH, the FDA and industry, to ensure the quality and integrity of data generated in these studies.

Public Health Relevance

The activities of the RCC are essential to the mission of the GNL. The development of vaccines, therapeutics and diagnosfic assays for use against biodefense-related infecfious disease agents will require that these products be tested and evaluated under high biocontainment conditions in a manner compliant with the GLP regulations, particuiariy in instances where product approval by the FDA will occur via the

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
National Biocontainment Laboratory Operation Cooperative Agreement (UC7)
Project #
5UC7AI094660-02
Application #
8376442
Study Section
Special Emphasis Panel (ZAI1-PRJ-M)
Project Start
Project End
Budget Start
2012-05-01
Budget End
2013-04-30
Support Year
2
Fiscal Year
2012
Total Cost
$874,097
Indirect Cost
$269,447
Name
University of Texas Medical Br Galveston
Department
Type
DUNS #
800771149
City
Galveston
State
TX
Country
United States
Zip Code
77555
Mire, Chad E; Geisbert, Joan B; Borisevich, Viktoriya et al. (2017) Therapeutic treatment of Marburg and Ravn virus infection in nonhuman primates with a human monoclonal antibody. Sci Transl Med 9:
Mire, Chad E; Cross, Robert W; Geisbert, Joan B et al. (2017) Human-monoclonal-antibody therapy protects nonhuman primates against advanced Lassa fever. Nat Med 23:1146-1149
Thi, Emily P; Mire, Chad E; Lee, Amy Ch et al. (2017) siRNA rescues nonhuman primates from advanced Marburg and Ravn virus disease. J Clin Invest :
Satterfield, Benjamin A; Cross, Robert W; Fenton, Karla A et al. (2016) Nipah Virus C and W Proteins Contribute to Respiratory Disease in Ferrets. J Virol 90:6326-43
Mire, Chad E; Geisbert, Thomas W; Feldmann, Heinz et al. (2016) Ebola virus vaccines - reality or fiction? Expert Rev Vaccines 15:1421-1430
Agrawal, Anurodh Shankar; Tao, Xinrong; Algaissi, Abdullah et al. (2016) Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus. Hum Vaccin Immunother 12:2351-6
Thi, Emily P; Lee, Amy C H; Geisbert, Joan B et al. (2016) Rescue of non-human primates from advanced Sudan ebolavirus infection with lipid encapsulated siRNA. Nat Microbiol 1:16142
Mire, Chad E; Geisbert, Joan B; Agans, Krystle N et al. (2016) Oral and Conjunctival Exposure of Nonhuman Primates to Low Doses of Ebola Makona Virus. J Infect Dis 214:S263-S267
Cross, Robert W; Mire, Chad E; Branco, Luis M et al. (2016) Treatment of Lassa virus infection in outbred guinea pigs with first-in-class human monoclonal antibodies. Antiviral Res 133:218-222
Olsen, Michelle E; Filone, Claire Marie; Rozelle, Dan et al. (2016) Polyamines and Hypusination Are Required for Ebolavirus Gene Expression and Replication. MBio 7:

Showing the most recent 10 out of 54 publications