MODIFICATION
A -- MCS-JVAP REQUEST FOR INFORMATION – Development of Marburg Monovalent Vaccine to Food and Drug Administration (FDA) Approval
- Notice Date
- 6/16/2016
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-16-S-0010
- Archive Date
- 7/30/2016
- Point of Contact
- Jessica, Phone: 3016198457
- E-Mail Address
-
jessica.l.ely.civ@mail.mil
(jessica.l.ely.civ@mail.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: Medical Countermeasure Systems - Joint Vaccine Acquisition Program (MCS-JVAP) is the DoD organization responsible for developing, producing and fielding FDA-licensed vaccine systems to protect the Warfighter from biological agents. The current MCS-JVAP portfolio includes vaccines at varying stages of clinical development in addition to Food and Drug Administration (FDA) licensed vaccines. PURPOSE AND OBJECTIVES: MCS-JVAP has a requirement for a pre-exposure prophylaxis Marburg monovalent vaccine that provides balanced onset and duration of protection for administration to healthy individuals. Because the incidence of natural occurrence is low, this vaccine will likely be developed under the Animal Rule. MCS-JVAP is seeking companies with a vaccine candidate to protect against exposure to Marburg virus. 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 vaccine type. Examples include recombinant, live attenuated, etc. Include any previous advanced development experience for your platform. 3. Specifically describe your nonclinical efficacy (animal studies) including route of viral exposure, stage of manufacturing and clinical progress. B. Please explain the Integrated Medical Technology Readiness Level (IM-TRL) of your candidate based on the attached IM-TRL definitions (Attachment A). Please provide insight into what additional studies are needed to reach IM-TRL 6. 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 Marburg monovalent 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 enable another party 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 of 541712), business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business, etc.), and date of incorporation. G. Describe your company's experience with government contracting. Indicate your company's willingness to use Other Transaction Authority, as defined by 10 U.S.Code § 2371, for this effort. OTs are used to attract nontraditional government contractors to stimulate innovation in the areas of research and development. They are flexible funding instruments, other than procurement contracts, grants, or cooperative agreements. OTs reduce normal contractual barriers by providing greater flexibility in cost accounting standards, intellectual property rights, certification requirements, and subcontractor management. Specific benefits of OTs include: • Provisions that allow for the use of Generally Approved Accounting Procedures, rather than Government Cost Accounting Standards • Cost and pricing data and certifications are negotiable, rather than mandatory • Intellectual property provisions are more commercially friendly • Increases the ability to establish innovative business arrangements, which include cost or resource sharing, establishment of Government-Contractor consortia In addition to providing the information requested above, respondents are invited to provide materials explaining their capabilities to fulfill the Chemical, Biological, Radiological, and Nuclear (CBRN) prophylactic requirement specified above, including: specific capabilities related to the development of the candidate; program management structure; experience in subcontracting management; and experience developing a vaccine toward FDA licensure. 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 e-mail address listed below within 10 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 Ms. Jessica Ely; (3) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (4) include a single company point of contact with name, title, address, telephone and e-mail address(es); and (5) 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 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: Jessica Ely, 110 Thomas Johnson Drive, Frederick, Maryland 21702 Point of Contact(s): jessica.l.ely.civ@mail.mil
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