SOURCES SOUGHT
A -- To identify Nontraditional Defense Contractors who believe they have viable candidate drugs or biologics that can be expeditiously developed and will provide a safe and effective medical countermeasure against radiation injury.
- Notice Date
- 4/17/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M-07-S-0003
- Response Due
- 5/2/2007
- Archive Date
- 7/1/2007
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice. The purpose of this announcement is to identify nontraditional defense contractors (A nontraditional Defense contractor is one that for a period of one year has not entered into or performed on any contract in excess of $500,000 to carry out prototype projects or to perform basic, applied, or advanced research projects for a Federal agency that is subject to the Federal Acquisition Regulations) that believe they have viable candidate drugs or biologics that can be exp editiously developed and will provide a safe and effective medical countermeasure against radiation injury. The Department of Defense, through the Medical Identification and Treatment Systems (MITS) Joint Product Management Office, is gauging interest of industry, especially nontraditional defense contractors, in the Advanced Development of therapeutic medical countermeasures to treat acute radiation syndrome (ARS) using award instruments other than procurement contracts. Drugs or biologics proposed shoul d, when administered following exposure to ionizing radiation, decrease incapacity and prolong survival by treating the gastrointestinal (GI) syndrome of ARS. Specifically, when administered following exposure to ionizing radiation, the medical countermea sure should either prevent or reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation or restoration of the anatomic integrity and normal physiologic functioning of the GI tract. The Award Recip ient will be responsible for conducting Technology Development and System Development activities and selecting and managing Subcontractors capable of conducting various activities associated with drug or biologic development in manners that are consistent with eventual approval by the U.S. Food and Drug Administration (FDA). Depending on the technical maturity of the proposed technology, activities may include process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant smal l scale manufacturing and testing of the product, Good Laboratory Practices (GLP)-compliant acute toxicology testing in animals, filing of an Investigational New Drug (IND) application, and Phase 1 and Phase 2 clinical studies conducted in accordance with FDA Good Clinical Practices (GCP) regulations and guidelines. These therapeutic medical radiation countermeasures are being developed in response to a requirement to treat service members for the effects of radiation injury and to allow commanders to sust ain and continue operations in the event of nuclear or radiological attacks on U.S. Forces. Prospective products should have substantiated in vivo safety and efficacy data that clearly demonstrate the potential for further development into a FDA-approved drug or biologic. This is not a request for competitive proposals, however, parties interested in responding must furnish, in writing, a 1-2 page synopsis of their candidate which clearly supports its therapeutic potential and the ability of the Responden t to perform the tasks associated with Advanced Development. The inclusion of in vivo data in the synopsis is encouraged. MITS is contemplating the use of funding instruments such as grants, technology investment agreements, or other transactions. The re sponse should indicate the type of award instrument of interest. Any information received in response to this Sources Sought Notice that is marked proprietary will be handled accordingly. This information may be submitted via mail, e-mail, or fax. All re sponses shall be submitted by no later than May 2, 2007 by 4:00 pm EDT in order to be accepted for review. All paperwork must be sent to U.S. Army Space and Missile Defense Command, ATTN: Shelley Marken, 64 Thomas Johnson Drive, Frederick, MD 21702, Fax ( 301) 619-5069 or by e-mail to shelley.marken@det.amedd.army.mil. The NAICS code is 541710. This notice should not be construed as a Request for Proposal or an obligation on the part of the U.S. Government and cannot be accepted by the Government to form a binding contract.
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Country: US
- Zip Code: 35807-3801
- Record
- SN01275145-W 20070419/070417221540 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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