Loren Data's SAM Daily™

FBO DAILY ISSUE OF DECEMBER 18, 2004 FBO #1118
SOLICITATION NOTICE

B -- Adenoviral Vector Vaccines Expressing Modified Ebola Gene Products

Notice Date

12/16/2004
 

Notice Type

Solicitation Notice
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
 

ZIP Code

20817
 

Solicitation Number

NIAID-VRC-05-38
 

Response Due

1/31/2005
 

Point of Contact

Terrie Nestor, Contract Specialist, Phone 301-402-6790, Fax 301-480-0689,
 

E-Mail Address

tnestor@niaid.nih.gov
 

Description

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has a sole source requirement for the production of clinical-grade adenoviral vector vaccines expressing modified Ebola gene products. Materials produced will be used to conduct clinical trials regulated by the Food and Drug Administration (FDA). Crucell Holland BV of Leiden, Netherlands has been identified as the only responsible source for this procurement. Crucell is the source of a proprietary packaging cell line (Per.C6) that has a demonstrated safety profile in the production adenoviral vectors for use in human clinical trials. In addition, product produced under the current NIAID contract by Crucell will be used in a Phase I clinical trial in 2005. Assuming a successful Phase I clinical trial, NIAID will require the production of additional material for Phase II trials. Regulatory requirements dictate that the material for Phase II trials be produced in the same cell line as used for the Phase I studies, or else the Phase I trial must be repeated. Switching to another manufacturer and ultimately another cell line would require a repeat of the Phase I trial at a significant and unnecessary duplicative cost to the government. All responsible sources may submit a capability statement for evaluation. Any questions or capability statements should be forwarded to Terrie Nestor, tnestor@niaid.nih.gov, by 2:00pm on January 31, 2005. See Note 22. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (16-DEC-2004); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/AMOB/NIAID-VRC-05-38/listing.html)
 

Place of Performance

Address: Leiden

Country: Netherlands
 

Record

SN00722550-F 20041218/041216212817 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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