SOURCES SOUGHT
A -- Proposed Title: Advanced Development and Manufacturing of Biological Countermeasures
- Notice Date
- 2/17/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- 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-10-S-0007
- Response Due
- 3/24/2010
- Archive Date
- 5/23/2010
- Point of Contact
- Drake Russell, 301-619-8472
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(drake.russell@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Sources Sought No.: W9113M-10-S-0007 Proposed Title: Advanced Development and Manufacturing of Biological Countermeasures This is a Qualified/Capable Business Sources Sought Notice (SSN). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is published for market research purposes only to obtain information regarding: (1) the availability and capability of all qualified business sources; (2) whether they are small businesses; HUB Zone small businesses; service-disabled, veteran-owned small businesses; (a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. This notice is open to qualified business sources of all sizes. The North American Industry Classification System (NAICS) Code 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for the Advanced Development and Manufacturing of Biological Countermeasures. BACKGROUND AND MISSION: Synopsis: The Department of Defense (DoD) through the Joint Program Executive Office (JPEO) for Chemical Biological Defense and the Medical Identification and Treatment Systems Joint Product Management Office (MITS-JPMO) has a requirement to develop and license a second generation prophylactic product, Bioscavenger, to be used in humans against nerve agents. The product should be capable of strongly binding or degrading nerve agents before they can exhibit their toxic effects. Potential candidates might include human butyrylcholinesterase (other than plasma-derived), other proteins, or compounds that have the property of binding or degrading nerve agents. PURPOSE AND OBJECTIVES: Development of the nerve agent prophylactic product shall require a Contractor to coordinate and manage the activities associated with advanced development of the product. The Contractor will be responsible for conducting the various activities associated with drug/biologic development in manners that are consistent with eventual approval or licensure by the FDA, to include management of any subcontractors. Activities will include manufacturing process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant small-scale manufacturing and testing of the Bioscavenger product, Good Laboratory Practices (GLP)-compliant acute 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 continuing advanced development through FDA approval (or licensure) of the product following the successful completion of the Phase 1 clinical trial and Government reviews. These follow-on advanced development activities may include, but are not necessarily limited to, large-scale manufacturing, process-validation, definitive animal efficacy and expanded safety studies, conduct of a Phase 2 and/or 3 clinical trials, and filing of a New Drug Application/Biologics License Application. There will be a 2nd option for the production up to 350,000 doses of the product, to be exercised following the successful licensure or approval of the product and successful government reviews. The DoD will only consider those Bioscavenger candidates for which preliminary in vivo safety and efficacy data already exist. Due to urgent need and a stringent timeline, consideration cannot be given to chemicals or proteins for which there are no proof of concept data in relevant animal models. (These preliminary studies should be substantial but do not need to be compliant with Good Laboratory Practices.) Offerors will be requested to submit a proposal that clearly represents technical and regulatory approaches. Participants must demonstrate the ability to provide Good Laboratory Practice (cGLP), current Good Manufacturing Practice (cGMP), and Good Clinical Practices (GCP) compliance related to the development of the product for use in pre-clinical and clinical studies. The requirements for successful execution encompass a broad range of capabilities. Offerors are encouraged to partner or subcontract with contract manufacturers, clinical research organizations, etc. as necessary to span these capabilities. REQUIREMENTS: Sources having the capability and/or concept to meet these requirements are invited to respond to this SSN. Responses should be limited to twenty five (25) pages for any given concept, not including cover page, cover letter and table of contents. Any and all information submitted in response to this notice is strictly voluntary and in no way obligates the Government or otherwise make a contract award. Submitted data and information will not be returned. Input on technical aspects of the responses may be solicited by JPEO from non-government consultants/experts who are bound by appropriate non-disclosure requirements. For all SSN responses, an additional, non proprietary cover page is also requested identifying your company name, technical point of contact, and contact information. Respondents to this notice must provide, as part of their response, a statement regarding their capabilities. Respondents must include their DUNS number, organization name, address, point of contact, size and type of business. SUBMISSION INSTRUCTIONS: Respondents should provide responses: (1) using Microsoft Word or Adobe PDF using single space, 11 font minimum and 8 x 11 size paper; (2) organizing material in such a manner that clearly identifies and addresses capability and concept statement; (3) including technical and administrative points of contact, with names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (4) not exceeding twenty five (25) single sided pages in total (not including cover page and cover letter, sent via email to: drake.russell@us.army.mil; (no later than Wednesday March 24, 2010 at 2:00 PM EST. DISCLAIMER AND IMPORTANT NOTES: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Contracting Office Address: USASMDC, ATTN: SMDC-RDC-EB, CBMS 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialist, JPEO CBD; email address: drake.russell@amedd.army.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-10-S-0007/listing.html)
- 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
- Zip Code: 35807-3801
- Record
- SN02066623-W 20100219/100217234422-068ff563704889be6f6332e3b9c58a78 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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