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FBO DAILY ISSUE OF AUGUST 10, 2011 FBO #3546
SOLICITATION NOTICE

A -- Manufacturing and Testing pDNA Drug Product (Malaria Vaccine) Appropriate for Preclinical Toxicology and Phase I Clinical Studies.

Notice Date
8/8/2011
 
Notice Type
Presolicitation
 
NAICS
325412 — Pharmaceutical Preparation Manufacturing
 
Contracting Office
N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
 
ZIP Code
00000
 
Solicitation Number
N6264511R0028
 
Response Due
9/22/2011
 
Archive Date
10/7/2011
 
Point of Contact
Thomas Hood 301-619-8894
 
Small Business Set-Aside
N/A
 
Description
The Navy Component of the US Military Malaria Vaccine Program (USMMVP) at NMRC is developing plasmid DNA (pDNA)-based malaria vaccines. USMMVP plans to bio-manufacture three (3) pDNAs for FDA-approved Phase I clinical testing. The NMRC is seeking a CMO capable of manufacturing and testing pDNA drug product appropriate for preclinical toxicology and Phase I clinical studies. The CMO must utilize a process sufficient to meet FDA guidelines for Phase I studies and provide the required U.S. FDA IND-supporting product documentation. The CMO must have a proven track record of manufacturing such products and be able to demonstrate that their clinical products were used successfully in human clinical testing. The Government envisions a single award contract. This requirement is a full and open competition with no set- asides. A solicitation will be posted on or about 8/24/2011 to the Naval Medical Logistics Command ™s website at http://www.nmlc.med.navy.mil/DBU-RFP.asp. Pre Solicitation notices are posted to FBO.gov and NECO.gov with a link to the website where the solicitation will be posted. Solicitations are to be downloaded from the website and no solicitations will be mailed. All proposals shall be sent to the address specified in the solicitation. The point of contact for the solicitation is Thomas Hood, at e-mail: thomas.hood@med.navy.mil. Please email any concerns to Mr. Hood. No phone calls or faxes will be accepted. The Government reserves the right to change any of this information.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264511R0028/listing.html)
 
Place of Performance
Address: Naval Medical Reserach Center, Silver Spring, MD
Zip Code: 20910
 
Record
SN02525387-W 20110810/110808235142-798dfe51c3316cbc7980503b6bc2dbeb (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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