SOURCES SOUGHT
A -- Request for Information for antiviral therapeutic medical countermeasures against Filoviridae viruses.
- Notice Date
- 2/12/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-15-S-BDTX
- Response Due
- 2/26/2015
- Archive Date
- 4/13/2015
- Point of Contact
- Jessica Ely, 301-619-8457
- E-Mail Address
-
ACC-APG - Natick (SPS)
(jessica.l.ely.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI) issued for planning purposes, as defined in Federal Acquisition Regulation (FAR) 15.201(e). This is not a solicitation for proposals, proposal abstracts, or quotations. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. 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. A similar RFI was posted April 2, 2014 under Announcement Number HDTRA1-14-JPM-0001 and previous responders to that posting are asked to send confirmation of continued interest and a completed maturity level form, Attachment I. Background: The Emerging Infectious Diseases Therapeutics (EID Tx) is a program under the Joint Product Manager Biological Defense Therapeutics (JPdM-BDTX). The JPdM-BDTX is part of the Joint Project Manager Medical Countermeasures System (JPM-MCS). JPM-MCS is a subordinate activity of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD). The JPdM BDTX EID-Tx Program mission is to deliver a U.S. Food and Drug Administration (FDA) approved medical countermeasure (MCM) protecting the Warfighter against viral Biological Warfare Agents (BWAs) and emerging threats. Purpose and Objectives: The EID Tx program is seeking to develop an antiviral therapeutic medical countermeasure (MCM) effective against naturally occurring or biologically engineered Filoviridae virus. Specifically, EID Tx is interested in an antiviral therapeutic that addresses one or more Filoviridae (Ebola Zaire, Ebola Sudan, Marburg) with the potential of addressing additional Biological Warfare Agents (BWAs) beyond the Filoviridae indication targeting the following virus families: Arenaviridae (Lassa Fever, Junin), Bunyaviridae (Hantaan), Filoviridae (Tai Forest, Bundibugyo), Togaviridae (Eastern Equine Encephalitis, Western Equine Encephalitis, Venezuelan Equine Encephalitis). Interested parties should fully describe their medical countermeasure and provide information as requested in this RFI. At a minimum, 1) maturity level form - Attachment I and, 2) the areas listed below A-I, shall be addressed and/or provide an explanation/factors as to why it is not addressed: A. Completion of Pharmacokinetic/Pharmacodynamic (PK/PD) and biodistribution studies B. Route of administration (oral, intramuscular, inhalation, other) C. Synopsis of any relevant experience with the FDA (including Investigational New Drug (IND) or response to emergency Investigational New Drug (eIND) requests). Clinical trials that used proposed MCM for any indication or IND application with the proposed MCM or other drug under development D. Shelf life (in years) of drug product supported by Non-Good Manufacturing Practice (Non-GMP) stability studies E. Describe studies completed in animal models in agents targeted to include route of challenge F. Storage requirements as demonstrated by studies (room temperature, refrigerated, frozen) G. Number of treatment courses produced in a single manufacturing run H. Estimated cost per treatment course I. Any associated intellectual property rights or patent coverage Response Requirements: Sources having a potential therapeutic solution in line with the above EID Tx program objectives are invited to respond to this RFI. Responses shall be limited to 1) completed Attachment I - maturity level form, and 2) fifteen (15) expounding pages that address sections A-I. Attachment I - Maturity Level Form - Responders are to complete the Use Microsoft Word or Adobe PDF (or other text searchable format) is requested. Responses shall be organized to provide concise information to respond directly to the points given in Attachment I- maturity level form, as well as directly answer sections A-I. Respondents may include additional information, such as supporting test reports or pertinent journal articles as desired. Cover Page: For all responses, the additional, non-proprietary cover page is required, and shall include: (1) Company name (2) DUNS number and/or CAGE code (3) Business size in accordance with NAICS code 541711 (4) technical and administrative points of contact, with names, titles, addresses, telephone and, and e-mail. Proprietary information, if any, should be minimized and must be clearly marked. To aid the Government, please segregate proprietary information. Submitted data and information will not be returned. No classified or sensitive information should be included in your response. The Government reserves the right to use the non-proprietary technical information in any resultant solicitation(s). Respondent packages shall be sent via email to: Jessica.l.ely.civ@mail.mil, Monesha.r.mitchell.ctr@mail.mil and jay.y.wang.civ@mail.mil no later than February 26, 2015 at 4:00PM EST. Any questions should also be directed to the emails above.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/5a766cb4b6a2f478594c9f04f6a61581)
- Place of Performance
- Address: ACC-APG - Natick - Frederick Office ATTN: Jessica Ely, 110 Thomas Johnson Drive, Ste 240 Frederick MD
- Zip Code: 21072
- Zip Code: 21072
- Record
- SN03641985-W 20150214/150212235805-5a766cb4b6a2f478594c9f04f6a61581 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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