SOLICITATION NOTICE
A -- CBMS-JVAP REQUEST FOR INFORMATION Development of Filovirus Vaccine (s) to Food and Drug Administration (FDA) Approval
- Notice Date
- 1/15/2010
- Notice Type
- Presolicitation
- 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
- W9113M-10-S-0005
- Response Due
- 2/1/2010
- Archive Date
- 4/2/2010
- Point of Contact
- Lawrence Mize, 301-619-9813
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(lawrence.mize@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- CBMS-JVAP REQUEST FOR INFORMATION Development of Filovirus Vaccine (s) to Food and Drug Administration (FDA) Approval 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 filovirus vaccine that provides balanced onset and duration of protection for administration to healthy individuals. The vaccine must provide broad spectrum protection against exposure to multiple species of the Ebola and Marburg viruses. Because of the incidence of natural occurrence, 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 DoDs objectives. CBMS-JVAP is seeking companies with experience and the capability to develop, manufacture and produce a vaccine to protect against exposure to multiple species of Ebola and Marburg viruses. This includes both companies that own or have access to Intellectual property (IP) for filovirus vaccines and companies that do not own or have access to IP. Specific functional capabilities include, but are not limited to, (1) program management of technically complex efforts to include partnering or subcontracting with innovative companies, (2) integration of multiple functional disciplines, (3) technical expertise in pharmaceutical product development, (4) regulatory interactions with the FDA leading to product approval/licensure under the Federal Food, Drug and Cosmetic Act or Section 351 under the Public Health Service Act, and (5) experience with product development under 21 CFR 314 Subpart I or 601 Subpart H (i.e. Animal Rule) is desired. As such, the Government is researching information on current industry capabilities and interest via responses to the questions below: A.Describe your companys experience working with the FDA and engaging in meetings and completing submissions to the FDA. B.Describe your companys product(s) taken to FDA Licensure, including product type. Examples include small molecule therapeutic, large molecule therapeutic, vaccine, etc. C.Describe your companys current products under development expected to achieve FDA licensure. What is the current stage of development? Include explanation of product type. Examples include small molecule therapeutic, large molecule therapeutic, vaccine, etc. D.With regards to the products in Items B and C above, provide details of your companys experience manufacturing clinical material and the clinical phase (s) for which the material was manufactured, i.e. Phase 1, Phase 2, and / or Phase 3. Describe the manufacturing efforts performed in-house and those subcontracted. If subcontractors were used, describe what the percentage of the work outsourced to subcontractors, type of contract(s) used (i.e., cost-type or fixed price) and the business size of those subcontractors (including number of total employees). "Describe your companys in-house capabilities/facilities in the following areas. If these capabilities are typically outsourced, describe what the percentage of this work has been outsourced to subcontractors and the business size of those subcontractors (including number of total employees) "Current Good Manufacturing Practices (cGMP) compliant manufacturing capabilities "Good Laboratory Practices (GLP) compliant non-clinical testing capabilities "Management of Good Clinical Practices (GCP) compliant clinical studies "Quality Assurance "Regulatory Affairs E.Describe your companys future strategy for conducting work in-house or outsourcing. Are you planning to bring currently outsourced functions in-house, continue to outsource, or continue to conduct work in house? F.Describe your company's experience in subcontracting work not included in any of the items above, including: "The business size of those subcontractors (including number of total employees) "Examples of your companys approach to integrating subcontracting efforts into an overall program to ensure the cost and schedule were maintained (program management tools used, type of contract(s) used). G.Describe your companys experience competing for Government contracts negotiated and awarded based on best value tradeoffs. H.Describe the size of your companys largest single contract, in terms of dollar amount and period of performance, with requirements similar to development of an FDA approved pharmaceutical product. I.Does your company have experience working on contracts with Earned Value Management (EVM) requirements, and if so, provide a description on the level of experience (i.e., what was the contract dollar value) Does your company have Defense Contract Audit Agency accepted accounting, estimating, purchasing, and EVM systems? If so, please provide the date that your systems were last audited. J.Does your company own or have a license to intellectual property (IP) related to filovirus? If so, please describe the state of your companys rights to the IP. If your company is not a manufacturer, how do you intend to enable another party to manufacture the product? K. 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 no later than 4PM EST, January 20, 2010. A new Industry Day announcement and draft Request for Proposal (RFP) are expected to be released in late 2QFY10. SUBMISSION INSTRUCTIONS: All written responses must be received by 4PM EST, February 1, 2010. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to CBMSFiloRFP@AMEDD.ARMY.MIL; (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 Army Space & Missile Defense Command, ATTN: Larry Mize, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801 Point of Contact(s): CBMSFiloRFP@AMEDD.ARMY.MIL
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-10-S-0005/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Zip Code: 35807-3801
- Record
- SN02043086-W 20100117/100115234927-608c86035669b83eddbccfdfdf67eea2 (fbodaily.com)
- Source
-
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