SOURCES SOUGHT
A -- CBMS-JVAP REQUEST FOR INFORMATION - Development of Multivalent Equine Encephalitis Vaccine to Food and Drug Administration (FDA) Approval
- Notice Date
- 1/18/2012
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- ACC-APG SCRT - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-12-S-0004
- Response Due
- 2/17/2012
- Archive Date
- 4/17/2012
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
ACC-APG SCRT - Natick (SPS)
(richard.totten1@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. BACKGROUND: Chemical Biological Medical Systems - Joint Vaccine Acquisition Program (CBMS-JVAP) is the DoD organization responsible for developing, producing and stockpiling FDA-licensed vaccine systems to protect the Warfighter from biological agents. The current CBMS-JVAP portfolio includes vaccines at varying stages of clinical development in addition to Food and Drug Administration (FDA) licensed vaccines. PURPOSE AND OBJECTIVES: CBMS-JVAP has a new requirement for a pre-exposure prophylaxis multivalent equine encephalitis vaccine that provides balanced onset and duration of protection for administration to healthy individuals. The multivalent equine encephalitis vaccine must provide broad spectrum protection against exposure to Venezuelan, eastern and western equine encephalitis viruses. Because the incidence of natural occurrence is low, this vaccine will likely be developed under the Animal Rule. The primary objective of issuing this RFI is to gather information that will assist in determining a suitable contract solution that efficiently, effectively, and economically provides and maintains a high standard for CBRN medical countermeasure advanced development, manufacture, and production to meet DoD's objectives. CBMS-JVAP is seeking companies with a vaccine candidate to protect against exposure to multiple species of equine encephalitis viruses. This includes both companies that own or have access to Intellectual property (IP) and companies that do not own or have access to IP. As such, the Government is researching information on current industry capabilities and interest via responses to the questions below: A.Describe your company's current vaccine candidate under development expected to achieve FDA licensure. 1.What is the current stage of development? 2.Include explanation of product type. Examples include small molecule therapeutic, large molecule therapeutic, vaccine, etc. 3.Specifically describe your nonclinical (animal studies), manufacturing and clinical progress. B.Please explain the Technology Readiness Level (TRL) of your candidate base on the attached TRL definitions. C.As these candidates will likely be developed under the Animal Rule, what animal species, if any, have been selected and/or used? Has the FDA accepted the species used to support the Animal Rule? D.Does your company own or have a license to intellectual property (IP) related to a multivalent equine encephalitis vaccine? If so, please describe the state of your company's rights to the IP. If your company is not a manufacturer, how do you intend to manufacture the product? E.Describe your company's manufacturing capabilities. Are the vaccine candidates manufactured in house or subcontracted? Does your company oppose technology transfer to a DoD funded advanced manufacturing facility? F.Indicate company business size (based on the NAICS size standard), business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business, etc.), and date of incorporation. In addition to providing the information requested above, respondents are invited to provide materials explaining their capabilities to fulfill the CBRN prophylactic requirement specified above, including: a description of their candidate which clearly supports its prophylactic potential; specific capabilities related to the development of the candidate; program management structure; and intellectual property availability. Respondents should indicate if their level of interest is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within 5 days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received within thirty (30) days of issuance of this RFI. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Mr. Larry Mize; (3) be minimum 11 font on 8.5" X 11" paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to US the Contracting Office Address and Point of Contact identified below. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Contracting Command, Aberdeen Proving Grounds Natick Division ATTN: Larry Mize, 1564 Freedman Dr., Ft Detrick, Maryland 21702 Point of Contact(s): Lawrence.Mize@us.ARMY.MIL
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/3755554443a297fef355e28e34b866b8)
- Place of Performance
- Address: ACC-APG SCRT - Natick (SPS) ATTN: Contracting Ft Detrick MD
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN02656369-W 20120120/120118234608-3755554443a297fef355e28e34b866b8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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