SOURCES SOUGHT
A -- NSMRL SAHAP DISK SAMPLING STATIONS
- Notice Date
- 4/11/2018
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- ADVFY18RD00008
- Archive Date
- 5/11/2018
- Point of Contact
- Jennifer M. Reed, , Thomas L. Hood,
- E-Mail Address
-
jennifer.m.reed20.civ@mail.mil, thomas.l.hood26.civ@mail.mil
(jennifer.m.reed20.civ@mail.mil, thomas.l.hood26.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice The Naval Medical Logistics Command (NMLC) is seeking sources to continue previously supported advanced development of a cell-based wound therapy for treatment of eye trauma resulting from combat injuries. Cell-based therapies derived from a natural cell secretome show promise for addressing these complicated injuries given the presence of naturally occurring transmembrane and secreted proteins that play important roles in cell migration, signaling, and communication. Treating combat injuries with this type of therapy may lead to faster, more effective wound healing, enabling the warfighter to return to the battlefield. The goal of this program is to develop and attain FDA approval of a cell-based wound therapeutic that uses amnion-derived stem cell secretome for treatment and improved healing of eye trauma wounds. NMRC-AMD has funded related contracts in prior years, for similar projects. The first sponsored project, using the same biological products, investigated treatment of blast injuries and burn wounds. Additional projects investigated periodontitis and traumatic brain injury indications. Collecting and assessing data from previous studies provided essential knowledge and early clinical results demonstrating the potential of use of amnion-derived stem cells to improve healing for eye trauma resulting from combat injury. that can conduct research that utilizes Amnion-derived Multi-potent Progenitor (AMP) cells and their secreted cytokine solution ST266 (also known as Amnion-derived Cellular Cytokine Solution (ACCS)) to decrease loss of tissue, obtain more rapid wound healing, and decrease scarring for eye injuries. It is expected that the benefits of therapies developed to care for wounded service men and women will immediately be applicable to civilian patients and that successful development and deployment of this therapy may lead to other applications across a broad spectrum of needs that range from burn victims to adults afflicted with the slow-healing wounds typical of Type II diabetes. The proposed contract builds upon Noveome's (formerly Stemnion, Inc.) successful completion of pre-clinical animal trials and Phases 1 and 2 human clinical studies. Noveome has completed eight clinical trials in three indications including two in ocular diseases, two in oral health, and four in dermal diseases. To date, 233 subjects have been exposed to the platform technology drug, ST266. ST266 has been shown to be safe when applied topically to skin, the eye, and the oral cavity and the FDA has given approval to proceed. The proposed contract efforts include: • Manufacturing activities, including production of materials for clinical trials and preparation of facilities for Phase 3 clinical trials and commercial production • Phase 3 clinical trial for treatment of inflammation and pain post cataract surgery, analogous to the military-specific application for treating eye trauma • Regulatory affairs, quality assurance, and quality control activities The period of performance for the proposed contract is anticipated to be 14-months from 01 Apr 2018 - 31 May 2019. If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (One source) to Noveome, Inc., 100 Technology Dr., Ste. 200, Pittsburg, PA, to provide the described requirement. This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 17:00 PM Eastern Time, 16 April 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following addresses: jennifer.m.reed20.civ@mail.mil and thomas.l.hood26.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/ADVFY18RD00008/listing.html)
- Place of Performance
- Address: Naval Medical Research Center (NMRC), Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN04885408-W 20180413/180411230714-1f715f3429cd1163e011c8c5825b9376 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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