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A--Advanced Development of Medical Radiation Countermeasures

Solicitation Number: W9113M07S0001
Agency: Department of the Army
Office: Army Contracting Command
Location: U. S. Army Space and Missile Defense Command
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W9113M07S0001
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Sources Sought
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Added: November 14, 2006
This is a Sources Sought Notice. The purpose of this announcement is to identify companies that believe they have viable candidate drugs that can be expeditiously developed and will provide a safe and effective countermeasure against radiation injur y. The Department of Defense (DoD), through the Chemical Biological Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) Joint Product Management Office, is seeking Prime Contractor(s) for the advanced development activities associate d with therapeutic products to treat acute radiation syndrome (ARS). It is anticipated that the products, when administered following exposure to ionizing radiation, will decrease incapacity and prolong survival by treating the gastrointestinal (GI) syndr ome of ARS. Specifically, when administered following exposure to ionizing radiation, the products should either prevent/reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation/restoration of t he anatomic integrity and normal physiologic functioning of the GI tract. A Prime Contractor will be responsible for conducting the advanced development activities and selecting and managing subcontractors capable of conducting various activities associat ed with drug 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, cu rrent Good Manufacturing Practices (cGMP)-compliant small-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, Phase 1 clinic al studies conducted in accordance with FDA Good Clinical Practices (GCP) regulations and guidelines, follow-on clinical studies, and definitive animal studies (assumes use of the FDA 'Animal Rule' 21 CFR 314.600 Subpart I) and appropriate non-clinical stu dies leading to eventual FDA approval of the product. MITS anticipates that the Prime Contractor will file the New Drug Application (NDA) and hold the license for the product. These therapeutic products are being developed in response to a requirement to treat service members for the effects of radiation injury and to allow commanders to sustain 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/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 candid ate which clearly supports its therapeutic potential. The inclusion of in vivo data in the synopsis is encouraged. 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 responses are to be submitted by no later than December 1, 2006 by 4:00 pm EST in order to be accepted for review. All paperwork must be sent to U.S. Army Space and Missile Defense Command, ATTN: Shelley Mar ken, 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. Gover nment and cannot be accepted by the Government to form a binding contract.
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US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
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US Army Space and Missile Defense Command, Deputy Commander 64 Thomas Johnson Drive Frederick MD
21702
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