This announcement seeks to identify sources for an upcoming solicitation to be released in June or July of 2005. The Department of Defense (DoD), through the Chemical Biological and Medical Systems (CBMS), Medical Identification and Treatment System Joint Product Management Office (MITS JPMO) is seeking a contractor to develop a prophylactic product to be used in humans against organophosphorus nerve agents. Currently, MITS JPMO is developing, in cooperation with the Department of Health and Human S ervices, plasma-derived human butyrylcholinesterase as the first increment of a nerve agent prophylaxis development program. Because of the limited supply of human plasma, the MITS JPMO seeks to develop an alternative product. The product should be capab le of strongly binding or degrading organophosphorus nerve agents before they can exhibit their toxic effects. Potential candidates might include recombinant human butyrylcholinesterase or acetylcholinesterase, other recombinant proteins, or other compoun ds that have the property of binding or degrading nerve agents and/or preventing inhibition of acetylcholinesterase. The contractor will be responsible for conducting development activities and selecting and managing subcontractors that are capable of conducting various activities associated with drug/biologic development in manners that are consistent with eventual appr oval or licensure with the U.S. Food and Drug Administration (FDA). Initial activities will include process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant small-scale manufacturing and testing of the candidate product , Good Laboratory Practices (GLP)-compliant toxicology testing in animals, filing of an Investigational New Drug (IND) application, and conducting a Phase 1 clinical trial in accordance with FDA regulations and guidelines. There will be an option for cont inuing advanced development through FDA approval (or licensure) of the product following the successful completion of the Phase 1 clinical trial and Government reviews. MITS anticipates that the contractor will file the New Drug Application and hold the l icense for the product. The process development efforts will be directed at development of a scalable process that yields a reproducible product amenable to safe use in humans (i.e., manufactured according to current Good Manufacturing Practices) and in s ufficient quantities for completion of efforts through the Phase 1 clinical trial. The DoD acquisition process for this effort requires expeditious performance so that the Phase 1 clinical trial is completed within 3 years of contract award, which is anticipated in December 2005. Therefore, consideration will be given only to candidate s for which there are preliminary safety and efficacy data in vivo (note that these preliminary studies do not need to be GLP compliant). Please respond by providing a short statement that describes your product and its characteristics. This short statem ent can include a two-page letter or white paper, links to a relevant Web site, a brochure, or similar documentation. Please forward this information to the attention of Greg Florey, Contract Specialist, [email protected], Phone: (301) 619.84 27

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