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FBO DAILY ISSUE OF JUNE 09, 2011 FBO #3484
SOLICITATION NOTICE

A -- GLP Safety Testing of Anti-viral Monoclonal Antibodies Developed by Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and Manufactured for Clinical Trial Use - RFP S11-215

Notice Date
6/7/2011
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
541990 — All Other Professional, Scientific, and Technical Services
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, Science Applications International Corporation (SAIC), 92 Thomas Johnson Drive, Suite 250, Frederick, Maryland, 21702
 
ZIP Code
21702
 
Solicitation Number
S11-215
 
Archive Date
8/15/2011
 
Point of Contact
Jessica L. Reed, Phone: 3012284021
 
E-Mail Address
reedjl@mail.nih.gov
(reedjl@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
Sample Agreement Document for RFP S11-215 The mission of the Vaccine Research Center (VRC) is to facilitate the development and testing of new vaccine strategies, with primary focus on prevention of Human Immunodeficiency Viruses (HIV-1). Investigators at the VRC are working to develop a number of different vaccine product candidates and have discovered broadly cross-reactive monoclonal antibodies that neutralize ~90% of HIV-1 strains and clades. The target of the lead human monoclonal antibody is the CD4 binding site on the gp120 envelope protein of HIV. The materials to be tested for this requirement are investigational anti-viral human monoclonal antibodies. The mission of the Vaccine Research Center (VRC) is to facilitate the development and testing of new vaccine strategies, with primary focus on prevention of Human Immunodeficiency Viruses (HIV-1). Investigators at the VRC are working to develop a number of different vaccine product candidates and have discovered broadly cross-reactive monoclonal antibodies that neutralize ~90% of HIV-1 strains and clades. The target of the lead human monoclonal antibody is the CD4 binding site on the gp120 envelope protein of HIV. The materials to be tested for this requirement are investigational anti-viral human monoclonal antibodies. The Contractor shall perform Food and Drug Administration (FDA) mandated safety testing and characterization of clinical grade investigational anti-viral human monoclonal antibodies. The safety tests in animals must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The studies should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2), S6, S6(R1), and S7A documents and other relevant guidance from FDA and ICH.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/contractor/S11-215/listing.html)
 
Record
SN02466540-W 20110609/110607235336-4374cadcd0794466c742207e48ce99fc (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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