SOURCES SOUGHT
A -- The additional manufacturing, non-clinical, and clinical activities that are required for FDA licensure of HuBChE under the Bioscavenger Program
- Notice Date
- 7/24/2017
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-17-S-0016
- Archive Date
- 8/23/2017
- Point of Contact
- JENNIFER S. BASSETT, Phone: 3016198401
- E-Mail Address
-
JENNIFER.S.BASSETT.CIV@MAIL.MIL
(JENNIFER.S.BASSETT.CIV@MAIL.MIL)
- Small Business Set-Aside
- N/A
- Description
- MARKET SURVEY REQUEST: THIS IS A REQUEST FOR INFORMATION ONLY for market research and planning purposes only, as defined in FAR 15.201(e). This is not a solicitation or request for competitive proposals. 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 Notice. 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, and the Government will not reimburse respondents for preparation of the response. Response to this Notice is strictly voluntary and will not affect future ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The Department of Defense (DoD) Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (MCS-CDP) Joint Product Management Office (JPMO) has a requirement to develop and deliver FDA licensed butyrylcholinesterase (BChE) developed from human plasma derived source material. This Bioscavenger program will continue the development of the current prophylactic candidate. In order to remain compliant with the current Critical Path Schedule for Licensure, the following activities will need to be included as part of the Technical Data Package (TDP) Transfer: A. Ability to design and conduct non-Good Laboratory Practices (GLP) as well as GLP-compliant testing sufficient to support the filing of an Investigational New Drug (IND) application for clinical testing in humans. B. Experience conducting the following types of research and development studies: efficacy studies; genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; absorption, distribution, metabolism and excretion (ADME) studies; safety pharmacology analysis; mechanism of action studies. C. Experience with designing and developing well characterized animal models, and the ability to manufacture current Good Manufacturing Practices (cGMP)-compliant clinical material to support Phase 1 and/or Phase 2 clinical studies. D. Experience with performing chemistry, manufacturing, and controls (CMC) studies and activities to include: standard characterization; assay development and validation; process development and validation; process scale-up assessments; preparation of technology transfer packages; formulation preparation and analysis; clinical trial formulation development; clinical dose delivery; container closure/extractable/leachable/compatibility and sterilization. E. Estimate small and large-scale cGMP-compliant manufacturing capability, and implement International Conference of Harmonization (ICH) stability test programs to establish product shelf life, storage conditions and stability; experience conducting stability and compatibility testing of the pharmaceutical with the delivery device. F. Ability to manage and conduct clinical study activities, Phase 1 dose escalation/pharmacokinetic studies and Phase 2 expanded safety/drug-drug interaction studies, in accordance with FDA regulations and Good Clinical Practices (GCP) guidelines. G. Experience designing GCP-compliant clinical protocols, informed consent forms, and case report forms sufficient for submission to the Human Subjects Research Review Board (HSRRB). H. Experience managing day-to-day clinical study operations, to include study drug and study supplies inventory management, severe adverse event management, safety monitoring board management, clinical study data management, and archiving and final study report generation. I. Experience with the design and conduct of the bioanalytical and pharmacokinetic (BA/PK) aspects of human clinical trials as well as with the analysis and evaluation of BA/PK data from human clinical trials. J. Experience with statistical planning and analysis to include developing a detailed statistical analysis plan, developing a subject randomization scheme, conducting interim and final analyses, and preparing a final statistical report. K. Experience in designing clinical protocols to evaluate a multi-drug prophylactic regimen. (i.e., evaluate drug-drug interactions for concomitantly administered pharmaceuticals), and the ability to evaluate and incorporate enabling technologies critical to enhance and/or prolong the drug product shelf life. L. Ability to provide a Technical Data Package (TDP) that includes all current and necessary documentation and technical data for the Government, or its designee, to continue the development or production of the HuBChE product. Although delivery of a technical data package is anticipated upon granting of FDA licensure, the contractor will negotiate for delivery of a technical data package comprising the current state of development that includes all necessary documentation and technical data for the Government, or its designee, to continue the development or production of the product should this contract terminate prior to licensure for any reason. If at any time the product ceases to be marketed and is retired, or in the event the Contractor defaults and fails to remedy said default before or after approval, the Contractor shall transfer the TDP to the Government or its designee. The Contractor shall also assist in the technical transfer. SUBMITTALS: Interested parties shall respond by specifying if they have a current commercially fielded product that expressly meets the parameters listed above. Interested Parties shall submit a short summary (no more than 5 pages total) describing their products' capabilities in each of these areas. Interested Parties shall provide business size status based upon NAICS code 541712, Small Business Size Standard of 1,000 Employees, and CAGE CODE as registered at SAM.gov. Interested Parties may include item brochure information with the summary package by the Government's requested date of submittal of August 8th, 2017. Interested parties shall submit information in response to this RFI to: Jennifer.s.bassett.civ@mail.mil. Responses shall be submitted and received via Email no later than 3:00pm EST August 8th, 2017. Documents shall be electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. Questions concerning this RFI may be addressed by contacting: Jennifer.s.bassett.civ@mail.mil. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers for contract and will not be used by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Vendors having products that they believe would be suitable for military operations as described herein shall submit all supporting documentation requested by this RFI to the POC noted above. Please provide information on your organization in the following areas: 1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address. 2. DUNS Number and Cage Code 3. Confirmation of Current Active Registration in System for Award Management (SAM) 4. Primary NAICS Code(s) and Business Size (i.e., small/large) 5. GSA Schedule, If Available 6. Commercial Price List, if GSA schedule is Not Available 7. Product Specific Brochures Literature PROVISIONS AND CLAUSES: 52.215-3 -- Request for Information or Solicitation for Planning Purposes. Request for Information or Solicitation for Planning Purposes (Oct 1997) (a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. (b) Although "Proposal" and "Offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. (c) This solicitation is issued for the purpose of: Market Research and Planning Purposes Only. (End of Provision)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/994955f3e2898ae41cb4314c75df89b3)
- Place of Performance
- Address: FREDERICK, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN04593508-W 20170726/170725085940-994955f3e2898ae41cb4314c75df89b3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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