SOURCES SOUGHT
A -- Research and Development Sources Sought - Burn Treatment and Skin Repair Phase 2 Clinical Trial
- Notice Date
- 4/25/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in 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-16-S-DK01
- Archive Date
- 5/25/2016
- Point of Contact
- Dana M. Kavitski, Phone: 3016198987, Barry Sayer, Phone: 3016192375
- E-Mail Address
-
dana.kavitski.civ@mail.mil, barry.g.sayer.civ@mail.mil
(dana.kavitski.civ@mail.mil, barry.g.sayer.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Research and Development Sources Sought - Burn Treatment and Skin Repair Phase 2 Clinical Trial 1.0 GENERAL INFORMATION: The following notice constitutes a Sources Sought Notice and a Notice of Intent to sole source in accordance with FAR 5.203(a), 5.205 and 19.202-2. The government is seeking responses from potential sources to meet this requirement, however, if no other capable sources are identified, it is the Government's intent to award a sole source contract to Stratatech Corporation, 510 Charmany Drive, Ste 169, Madison, WI 53719-1262, for the requirement outlined in this notice. This is a notification that the US Army Medical Research Acquisition Activity (USAMRAA) in support of the US Army Medical Materiel Development Activity (USAMDAA) intends to award a sole source contract under statutory authority 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy the Agency Requirements. The associated North American Industry Classification System (NAICS) code for this procurement is 541711 with a size standard of 1,000 employees. 2.0 DISCLAIMER: This request for information (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 SUBJECT: In support of the USAMMDA's mission to develop medical products to protect and sustain the Warfighter, this request for information is seeking entities interested in performing a phase 2 clinical trial to evaluate the safety and efficacy of an allogeneic skin substitute containing both an epidermal and dermal layer for the treatment of complex, full-thickness skin injuries. 4.0 DESCRIPTION: Military operations pose a risk of skin injury from thermal, chemical, or mechanical insults which have not abated over the course of the last several conflicts to include the Global War on Terrorism (GWOT). Weapons with an incendiary component or high energy transfer (i.e., improvised explosive devices [IED], grenades, or high velocity rounds), comprise the obvious threat during conflicts. However, non-combat causes of injury in the deployed environment are a persistent challenge as well (e.g., burning refuse, handling volatile fuels, regular use and maintenance of generators, and handling explosives such as ammunition, flares, and grenades). While burns may be the prevalent skin injury, other types of injury present substantial challenges for skin coverage. High velocity weapons and explosive devices have the potential to cause very large avulsion wounds as energy transfer from the weapon to the body strips away soft tissue. The Service Members (SMs) with such injuries may not have healthy donor sites with enough remaining tissue to provide adequate skin coverage of their wounds using the current standard of care, autografting. Severe skin injuries are medical-resource intensive injuries requiring specialized personnel for management, prolonged hospital stays and costly treatments. Further, the disabilities incurred result in losses of unit-fighting strength. These high costs, in combination with the commitment to restore wounded SMs to health, are driving the imperative to find new technologies, particularly skin replacement and regeneration capabilities, for improving the treatment of these wounds and their outcomes. This request for information is seeking entities interested in performing a phase 2 clinical trial to evaluate the safety and efficacy of an allogeneic skin substitute containing both an epidermal and dermal layer for the treatment of complex, full-thickness skin injuries. Specifically, the Government is seeking a company with established and successful experience in late stage clinical testing of complex biologic products. The Government expects that the interested entity will either manufacture or be able to procure a full-thickness, allogeneic skin substitute that has sufficient clinical safety data to support proceeding into a phase 2 clinical trial. The product must be universal, off-the-shelf and have sufficient stability data to support execution of the phase 2 clinical trial. The Government expects initiation of the Phase 2 clinical trial no later than October 2016. 5.0 SUBMISSION INSTRUCTIONS: All responses to this notice shall be via e-mail to the point of contact below. Telephone questions or inquiries will not be answered or accepted. Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to perform the tasks described above, and a Rough Order of Magnitude (ROM) estimate of the cost to perform the services. Companies responding to this notice must provide complete contact information (Company name, Address, Point of Contact, telephone, email address, CAGE Code and DUNS number). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. Responders must have an active profile in in the System for Award Management (SAM) and must have current representations and certifications uploaded into their active SAM profile. See https://www.sam.gov for details/instructions. Responses must be sent to later than 4:00PM Eastern Time on 10 May 2016. 6.0 SUBMISSION POINT OF CONTACT: Interested entities shall forward submissions to Dana Kavitski, Contract Specialist, at dana.kavitski.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-16-S-DK01/listing.html)
- Record
- SN04094863-W 20160427/160425234554-5322be01f77574e18aa1d17ec3e54c6d (fbodaily.com)
- Source
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