SOURCES SOUGHT
99 -- The DoD is seeking information from biologics manufacturers with advanced, adaptable vaccine manufacturing platforms with the goal of identifying one or more developers whose platform(s) are amenable to targeting known antigens for use as a prophylaxis.
- Notice Date
- 5/31/2016
- Notice Type
- Sources Sought
- NAICS
- 325199
— All Other Basic Organic Chemical Manufacturing
- 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
- EEEV2016
- Archive Date
- 7/15/2016
- Point of Contact
- Nathan C Jordan, Phone: 5082336169
- E-Mail Address
-
nathan.c.jordan.civ@mail.mil
(nathan.c.jordan.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI) for market research 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: The Defense Threat Reduction Agency - Joint Science and Technology (DTRA-JSTO) and Joint Project Executive Officer - Chemical and Biological Defense (JPEO-CBD) are the DoD organizations responsible for discovering, developing, producing, and stockpiling Food and Drug Administration (FDA)-licensed biological prophylaxis systems to protect the Warfighter from biological warfare agents. Programs within the DoD utilize test case biological targets to advance platform technologies capable of rapid, flexible and agile biological prophylaxis applications. As part of an Advanced Technology Demonstration (ATD), the DoD is conducting market research with the goal of identifying one or more vaccine developers who have advanced manufacturing platforms which are adaptable to incorporating known antigens for use as a prophylaxis against weaponizable biological agents. REQUIREMENT: The DoD is seeking information from biologics manufacturers with advanced, adaptable vaccine manufacturing platforms with the goal of identifying one or more developers whose platform(s) are amenable to targeting known antigens for use as a prophylaxis. The DOD intends to use Eastern Equine Encephalitis virus (EEEV) as a test case. The DoD encourages responses to this RFI by manufacturers with the capability to develop processes and deliver filled/finished material in accordance with current Good Manufacturing Practices (cGMP) that is suitable to support non-clinical Investigational New Drug (IND)-enabling studies and for use in humans up through Phase 2 clinical trials under an IND application. Specifically, the DoD is seeking information from manufacturers with a high level of control over their manufacturing platform processes and, at the appropriate time, the willingness to partner with the DoD to potentially transfer the manufacturing process to the DoD Advanced Development Manufacturing Capability (ADMC) facility, currently residing at Nanotherapeutics Inc in Alachua, Florida. PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information from manufacturers with the experience and capability to leverage their advanced vaccine platforms, operational resources, and quality systems to fill, finish, and release biological prophylaxis drug products. Respondents are also expected to have experience and expertise in method development, qualification, and validation. The DoD will provide information and materials pertaining to the protective antigens, critical reagents for identity testing, non-clinical challenge models, immunogenicity assays and reagents, and challenge materials. The DoD has developed animal challenge models and assays for efficacy testing, which will be used for evaluating vaccine materials. The DoD has also capabilities to test safety, tolerability and immunogenicity of vaccine/pretreatment materials in volunteer trials to support an Investigational New Drug application. As such, the DoD has an interest and is researching information about current industry capabilities via responses to the areas listed below: Program Boundaries: A. Technology transfer of protective antigens (purified antigens and sequences) and critical reagents from the DoD or other government laboratory; B. Producing and demonstrating drug substance and drug product identity, purity, potency and stability using the offeror's manufacturing platform; C. Producing delivering engineering-run or cGMP material to support nonclinical testing (i.e., animal proof-of-concept, Good Laboratory Practice toxicology, dose-down efficacy and duration studies ) D. cGMP manufacturing drug product in support of phase 1 and phase 2 clinical testing E. Technology transfer of manufacturing and testing to the DoD Advanced Development Manufacturing capability. To respond to this RFI, the offeror shall provide a white paper not to exceed 3 pages using no less than 11 point font and 1 inch margins on US letter-size pages describing the following: A. CMC o Manufacturing platforms (one or more) with applicability to vaccines against infectious diseases, including the typical scale and yield for production lots of formulations containing one or more protective antigens; o A statement regarding the offeror's freedom to operate using the intellectual property associated with the above referenced manufacturing platform(s); o Facility description to support production of phase 1 and commercial scale DS and DP. o If applicable, state willingness to technology transfer all CMC activities to the DoD Advanced Development Manufacturing capability. B. Non-Clinical o Data demonstrating immunogenicity of antigens and protection against one or more targeted infectious microorganisms in laboratory animals of biological prophylaxis drugs developed utilizing the platform being offered; o Describe optimal dosing strategies to elicit an effective response to the target antigen and to maintain protection against the target infectious disease after initial immunity declines; o Outline how the platform will be applicable toward developing vaccines/pretreatments under aegis of FDA Animal Rule; C. Clinical o Overview of clinical safety and effectiveness of product produced using the manufacturing platform described in section A; o Willingness, capability and experience in being the product Investigational New Drug sponsor through the end of phase 2 clinical trials; o Data demonstrating immunogenicity/potency in humans with one or more products using the offeror's platform; o D. Research and Development o Describe research and development envisioned to improve the platform capability, such as strategies to enhance robustness of manufacturing, to increase immunogenicity for dose sparing and/or prolong protection, or to develop thermally stable formulations. E. Describe any of your company's capabilities required to manufacture the platform technology described in section A above that are subcontracted to third party operators. The offeror shall indicate "Not Applicable" or "No information available" where appropriate. It is recommended that the offeror provide separate white papers to describe independent platform technologies pertinent to this RFI. The Government will retain comments and information received in response to this RFI. Questions regarding this RFI should be forwarded to the point of contact address listed below within 15 days after RFI release. Submission Instructions: All written responses must be received no later than June 30th, 2016. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to nathan.c.jordan.civ@mail.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 20 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 Point of Contact at the Contracting Office Address provided below. Point of Contact(s): nathan.c.jordan.civ@mail.mil Contracting Office Address: ACC-APG NCD ATTN: Nathan Jordan 110 Thomas Johnson Drive Frederick, MD 21702 Point of Contact(s): Nathan Jordan, 508-233-6169 Nathan.c.jordan.civ@mail.mil
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