SOURCES SOUGHT
A -- Request for Information - Antiplaque Chewing Gum
- Notice Date
- 7/27/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-RFI-APCG
- Archive Date
- 9/10/2016
- Point of Contact
- Greggory Housler, Phone: 301-619-2956, Dana M. Kavitski, Phone: 3016198987
- E-Mail Address
-
greggory.j.housler.civ@mail.mil, dana.kavitski.civ@mail.mil
(greggory.j.housler.civ@mail.mil, dana.kavitski.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission to develop medical products to protect and sustain the Warfighter, this request for information is seeking entities interested in developing an Antiplaque Chewing Gum (APCG) that consists of a proprietary antimicrobial decapeptide, KSL-W, for reducing plaque formation. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 DESCRIPTION: The USAMMDA's mission is to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active duty personnel in the operational environment. As part of the U.S. Combat Casualty Care Research Program, USAMMDA has been developing an Antiplaque Chewing Gum (APCG). This chewing gum product consists of a proprietary antibacterial compound, which contains an antimicrobial decapeptide, KSL-W, and a cationic surface active agent.. In vitro studies and animal model studies have shown that KSL-W augments the natural immune response to prevent and disrupt biofilm formation such as dental plaque. USAMMDA and the U.S. Army Institute for Surgical Research (USAISR) have manufactured clinical-grade lots of APCG and performed phase 1 and phase 2 clinical studies (proof-of-concept studies) under a US Investigational New Drug (IND) application. The Phase 1 proof of concept study demonstrated a relatively adequate safety profile with few mild adverse events reported, while the Phase 2a study indicated preliminary APCG efficacy against plaque formation after 2-4 weeks of active treatment. The Government believes that with additional incremental effort APCG can be licensed and brought to U.S. market. To accomplish this goal USAMMDA is seeking a commercial partner who is willing and able to perform all aspects of development, including (but not limited to) the following: • perform market analysis • accept a patent licensing agreement for the technology • assume regulatory sponsorship of the APCG for FDA licensing in the U.S. • manufacture new clinical lots • conduct clinical development of the APCG, demonstrating safety and efficacy for human use • develop marketing and commercialization strategies to ensure market sustainability of the FDA licensed APCG product • make the APCG available in the commercial market for use in United States The Government is seeking to formalize a license agreement with qualified and interested industry sources who have an interest in continuing and completing the development of the APCG. Although we have exhausted Department of Defense funding programmed for this effort, we do have considerable in-house technical, regulatory, and clinical expertise that can be provided as part of a co-development effort. Subsequent to discussions with a qualified partner, the Government intends to formalize the collaboration with a Cooperative Research and Development Agreement (CRADA) issued under the Federal Technology Transfer policies and procedures. Under a CRADA, the Government can contribute (in-kind) personnel, services, intellectual property, the data package, or other resources, BUT NOT FUNDING. The partner, in turn, can reciprocate and also may provide funding to the Government. Teaming arrangement approaches will considered. 4.0 SUBMISSION CONTACT INFORMATION: Any commercial partner who has interest in collaborating with USAMMDA on the APCG program is encouraged to contact Mr. Greggory Housler at greggory.j.housler.civ@mail.mil or 301-619-2956 to schedule a meeting or teleconference no later than the close of business 26 Aug 2016. Mr. Housler will be glad to answer any questions and provide more details as appropriate.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-RFI-APCG/listing.html)
- Place of Performance
- Address: To Be Determined, United States
- Record
- SN04198856-W 20160729/160727235628-c82e18d9a821401fc8a7434142ef2531 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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