Wednesday, August 6, 2014

B -- Gap Analysis for Ebola and HIV Vaccine Candidates

B -- Gap Analysis for Ebola and HIV Vaccine Candidates

Solicitation Number: NIAID-VRC-06-34
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy & Infectious Diseases/AMOB
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NIAID-VRC-06-34
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Sources Sought
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Added: September 22, 2005 Modified: November 15, 2005Track Changes
The Vaccine Research Center (VRC)/National Institutes of Allergy and Infectious Diseases (NIAID), Acquisitions and Operations Branch (AMOB) has an unrestricted requirement for the creation of a gap analysis for an HIV vaccine candidate. The contractor shall examine existing VRC documentation, meet with VRC personnel and conduct phone interviews with VRC collaborators to develop a product development plan/gap analysis for the vaccine. The analysis will address the development process from initial research through commercial licensure. Marketing analysis and external research (other that described above) are not required. Offerors must be able to develop a gap analysis addressing the research, development, manufacturing, clinical and regulatory gaps which must be overcome in progressing a vaccine from the bench to licensure. Offerors must have a minimum of 10 years of experience developing gap analyses for biopharmaceutical products, specifically vaccines which have ultimately been licensed by the US FDA or other world regulatory authorities. Consultants which the offeror assigns to the project must have a minimum of 5 years of prior work experience in the biopharmaceutical industry, preferably in vaccines. Offerors must have demonstrated expertise in the fields of technology transfer, commercial scale-up, clinical development plans, partnering with biotechnology companies, and FDA compliance and regulatory filings. Offerors must demonstrate adequate resources to develop product development plans/gap analyses for both the HIV and Ebola vaccines in parallel. It is anticipated that the Request for Proposal (RFP) will result in a cost reimbursement contract with a twelve (12) month period of performance commencing on or about January 15, 2005. The solicitation will be available for download from www.fedbizopps.gov on or about November 30, 2005. No hard copies will be distributed. Questions should be forwarded in writing to Terrie Nestor at tnestor@niaid.nih.gov.
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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
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TBD
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Terrie Nestor, Contract Specialist, Phone 301-402-6790, Fax 301-480-0689, Email tnestor@niaid.nih.gov
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