SOURCES SOUGHT
A -- Development of Medical Countermeasures for Botulinum Neurotoxin Intoxication Focused on Therapeutics and Neurogenerative Medicines.
- Notice Date
- 6/4/2014
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- 14DTRABOTIAA
- Response Due
- 6/18/2014
- Archive Date
- 8/3/2014
- Point of Contact
- Brandon Roebuck, 301-619-9207
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(brandon.m.roebuck.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1. RFI Number: 14DTRABOTIAA 2. Sources Sought Title: Development of Medical Countermeasures for Botulinum Neurotoxin Intoxication Focused on Therapeutics and Neurogenerative Medicines. 3. Agencies: United States Army Medical Research Institute of Chemical Defenses, Defense Threat Reduction Agency 4. Office: United States Army Medical Research Institute of Chemical Defenses 5. Contracting Office: U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Frederick, MD 6. Location: United States Army, Medical Research Institute of Chemical Defense, Aberdeen Proving Ground, MD 21010. 7. Synopsis: In accordance with Federal Acquisition Regulation (FAR) 15.201 quote mark Exchange with industry before receipt of proposals quote mark and (FAR) 52.215-3, quote mark Request for information or Solicitation for Planning Purposes, quote mark this Sources Sought Notice is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation or commitment by the Government nor will the Government pay for information solicited. The information resulting from this Sources Sought Notice will determine if there are qualified non-personal service providers available in the marketplace to pursue a competitive procurement. This Sources Sought Notice does not restrict the Government to an ultimate acquisition approach. No evaluation letters and/or results will be issued to the respondents. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. Offerors not responding to this Sources Sought request will not be precluded from responding to the solicitation if offered. If there is a solicitation that is released, it will be synopsized in Federal Business Opportunities (FedBizOpps) at https://www.fbo.gov. It is the responsibility of any potential Offeror to monitor this site for the release of any solicitation or synopsis. 8. Background: Botulinum neurotoxin (BoNT) is a Tier 1 threat agent capable of causing mass casualties and widespread disruption of infrastructure. The available treatments (infusion of antitoxin and intensive care) are generally considered to be inadequate in a bioterrorist or biowarfare situation. Thus, there is a compelling need for a post-exposure therapeutic. Discovery of effective medical countermeasures for intoxication by BoNT has proved difficult. In spite of nearly two decades of research, there are no candidates ready for submission to the FDA or even for transitioning to advanced development. The lack of progress is due in part to the difficulty of inhibiting such a highly specialized toxin, and in part to the absence of a coherent strategic approach. Many laboratories that were engaged in discovery of BoNT inhibitors lacked essential capabilities such as a robust medicinal chemistry infrastructure or a full-range of in vitro, cell-based and in vivo model systems or absorption, distribution, metabolism, excretion and toxicity (ADMET) capability. Moreover, drug discovery paradigms were generally based on academic rather than pharmaceutical industry models. This has resulted in laboratories relying predominantly on cell-free assays for screening and refining of inhibitors, leading to compounds with poor pharmaceutical characteristics. In addition, in vivo tests were typically performed with little or no knowledge of compound serum levels, duration of action or systemic toxicity of inhibitor candidates. It is therefore not surprising that these efforts failed to identify even a single lead compound for treatment of botulism. 9. Scope and Purpose: The proposed program has two main components: discovery and development of LC protease inhibitors and discovery and development of regenerative strategies for accelerating recovery from muscle paralysis. The scope of each project is identified in more detail in each of the attached Performance Work Statements, but they are as follows: 9.1 Discovery and Optimization of Botulinum Neurotoxin Protease Inhibitors: The contractor shall synthesize quinolinol and other suitable small molecule inhibitors for structure-activity studies in a tiered set of drug screens at the laboratory of the COR. Following evaluation of efficacy by the COR, the contractor shall perform studies on promising compounds to assess their absorption, distribution, metabolism, elimination and toxicity (ADMET). ADMET studies will be followed by a new round of synthesis and evaluation to improve the pharmaceutical characteristics of the lead compounds. 9.2 Development of Small Molecule Drug Candidates against Botulism: The contractor shall screen compounds from chemical and natural products libraries to discover candidates suitable for the treatment of intoxication by botulinum neurotoxin (BoNT) serotypes A, B and E in the form of a drug. The selection of compounds and their evaluation for suitability for advanced drug development will be carried out as described in the PWS for this action. 9.3 Provide Novel Inhibitors for the Catalytic Domain of Botulinum Neurotoxin: The contractor shall provide an alternative to traditional inhibitors through development of small single chain shark antibodies (VNARs) as potential inhibitors of LC catalytic activity. 10. Draft Performance Work Statements (PWS). As there are three separate actions within this potential consortium, three Draft PWS (Attachments 1 through 3) are included with this Sources Sought Notice for informational purposes and identifies the scope of work. Each final PWS will be released with the solicitation IF it is released. 11. North American Industry Classification System (NAICS) Code. The NAICS code for this requirement is 541711 with a size standard of 500 employees. 12. Capability Statement. The Government encourages all qualified firms to submit a comprehensive and fully integrated Capability Statement that addresses the scope of work in each PWS. The Capability Statement should demonstrate the Offeror's experience, knowledge of, and participation of support services required in each PWS. The Offeror shall state whether they are best suited for an individual project or all three projects identified in the provided Performance Work Statements. The possible Consortium project will select one Offeror for each project specified in the PWS. The Offeror shall state the need to subcontract and approach. The Offeror shall include with the Capability Statement relevant experience from three (3) contracts within in the last five (5) years that demonstrate relevant past experience in similar size, scope, and complexity. 13. Anticipated period of performance: June 2014 through June 2019 14. Response Due Date: Qualified business firms should submit the Capability Statement in response to this Sources Sought Notice electronically by 3:00 pm (EST) 18 June 2014 via e-mail to Brandon Roebuck at brandon.m.roebuck.civ@mail.mil. NO PHONE CALLS PLEASE. 15. Questions: All questions pertaining to the Sources Sought are due by 1:00 pm (EST) 11 June 2014. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained. 16. Instructions to Responders: 16.1. The Government appreciates responses from all capable and qualified business sources. 16.2. The subject header of the e-mail for submission of questions and/or the Sources Sought Notice response shall be: USAMRICD, Development of Medical Countermeasures for Botulinum Neurotoxin Intoxication. 16.3. Interested firms should submit a ten (10) page response (Capability Statement) that demonstrates the Offeror's ability to perform the scope of work in the Draft PWS. 16.3.1. The Capability Statement should adhere to the following formatting and outline instructions: 16.3.1.1. Capability Statement shall not exceed ten (10) typed pages; additional sheets for cover page, table of contents, tables, and charts will not be counted toward page limitation. 16.3.1.2. Format specifications include 12 point font, single spaced, single sided, 8.5 by 11 inches paper with 1 inch margins. All submissions must be made electronically (as described above) and in one of the following formats: Microsoft Word or Adobe PDF. a. Cover Page (1 page) i.Title ii.Organization iii.Responders technical and administrative points of contact (names, addresses, telephone, fax number and e-mail addresses) iv.Topic area(s) addressed b. Current Technical Expertise, Knowledge, and Management Capability i.Executive Summary ii.Discussion of capabilities / challenges / approach iii.Technical Expertise response, the breadth of disciplines and experience, relevance of Offeror's expertise that demonstrates a full understanding of the specialized and unique nature of all functional technical task requirements to be performed as applied to the mission of USAMRICD and its partners. iv. Management Capability response, the basis of the processes and methodologies required to manage an effort of this size, techniques and managerial skills to perform the scope of work. c.Brief summary of relevant experience from three (3) contracts within the last five (5) years pertaining to the requirement, could be Government or commercial. 16.4. Complete the below table and submit with response to this Sources Sought Notice. Question Answer Solicitation Number Company Name Company Address Point of Contact Telephone Number E-mail Address Tax Identification Number (TIN) DUNS Company Web Page Company Location(s) Company is / is not a Small Business If Company is a small business, are they an 8(a) business? Company is / is not registered in SAM Other Classifications (e.g. HubZone, Woman-Owned, Veteran-Owned, Service-Disabled Veteran-Owned) 17. Disclaimer and Important Notes: The purpose of this Sources Sought Notice is to gain market knowledge. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 organization's solution and 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, the Government will consider releasing a pre-solicitation synopsis and solicitation published in FedBizOpps at https://www.fbo.gov; however, responses to this notice will not be considered adequate responses to a solicitation. 18. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in the Offeror's response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/14DTRABOTIAA/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03385604-W 20140606/140604235335-ebc0f0ad871314c03a038cd8481b7626 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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