SPECIAL NOTICE
99 -- Request for Information - Alternative Botulinum Vaccine Candidates
- Notice Date
- 2/24/2005
- Notice Type
- Special Notice
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- USA-SNOTE-050224-001
- Archive Date
- 4/25/2005
- Description
- This is a request for information only no contract will result from responses received for this RFI. The Department of Defense through the Chemical Biological Medical Systems Joint Project Management Office is seeking companies/organizations with Botulinum toxin vaccine candidates. This is not a Request for Proposal, an Invitation to Bid, or a Request for Quotation. Therefore, this RFI is not to be construed as a commitment by the Government to enter into a contract nor will the Government pay fo r information provided in response to this RFI. Information Desired: The Joint Vaccine Acquisition Program is analyzing alternatives to its current recombinant botulinum effort in preparation for an acquisition decision to enter into the System Development and Demonstration Phase of product development . In order to compare candidates, JVAP requests that the vaccine summaries contain the following information: 1. Candidate description type of vaccine, serotypes included in vaccine 2. Overview of manufacturing capability scale, yield, stability data, and status of manufacturing process validation 3. Overview of non-clinical studies animal species used, vaccination dose and schedule, challenge dose (if applicable), and neutralizing antibody concentrations 4. Overview of clinical studies number of patients vaccinated, vaccination dose and schedule, serious adverse events, and neutralizing antibody concentrations 5. Overview of regulatory submissions including, date estimates for IND submission and BLA submission if those events have not occurred Please submit information packages to Kathleen Berst, JVAP Vaccine Manager, 64 Thomas Johnson Drive, Frederick, MD 21702 or via email kathleen.berst@det.amedd.army.mil.
- Web Link
-
Kathleen Berst
(http://www2.eps.gov/spg/USA/SMDC/DASG60/USA%2DSNOTE%2D050224%2D001/kathleen.berst@det.amedd.army.mil)
- Record
- SN00757882-W 20050226/050224212413 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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