Clinical Trial Materials for Virus Vaccines
This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method.
This is a re-competition of Contract No. HHSN272201100002I
Background
The National Institute of Allergy and Infectious Diseases (NIAID) is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases. One of the key components of NIAID’s mission involves the rapid advancement of promising vaccine candidates from the laboratory to the clinic.
The Division of Intramural Research (DIR) within NIAID has a long history of studying the etiology and pathogenesis of infectious viral diseases, and of developing effective means of preventing or treating these diseases. NIAID DIR has advanced to clinical trials multiple vaccine candidates, including both live-attenuated and inactivated virus formats. These formats have several advantages, including the ability to elicit a strong immune response with only one administration of vaccine. A primary objective of DIR remains the development of safe and effective vaccines against several disease-causing viruses including influenza, respiratory syncytial virus (RSV) and related pediatric respiratory viruses, dengue virus (DENV), and West Nile virus (WNV). A live-attenuated tetravalent dengue vaccine is currently undergoing Phase III trials in Brazil through a licensing agreement with the Butantan Institute. Live-attenuated RSV vaccine candidates are in a Phase I/II trial through a Cooperative Research and Development Agreement with Sanofi Pasteur, Inc. In recent years, one of the major areas of DIR's continuing research is the development of live attenuated vaccine candidates effective against newly identified or emerging viruses, such as Zika virus (ZIKV). The capability to rapidly advance candidates for emerging viruses into clinical testing is now a critical component for NIAID DIR’s mission.
The purpose of this acquisition is to establish an appropriate current Good Manufacturing Practice (cGMP, FDA regulation) contract manufacturing organization (CMO) to support rapid vaccine development by manufacturing vaccine Clinical Trial Materials (CTM) for trials of live-attenuated virus or inactivated virus vaccine candidates. Vaccine ancillaries or other biologics required to advance to clinical trials, such as virus challenge stocks, diluents, cell lines for use in the production of the vaccines, test materials, etc., are also within this requirement.
Purpose and Objectives
The purpose of this acquisition is to provide Clinical Trial Materials (CTM) for virus vaccines that are produced by growing live virus. The actual vaccines will be live attenuated virus or inactivated virus (treated after growth and harvest to eliminate infectivity). This acquisition will establish a contract with an appropriate current Good Manufacturing Practice (cGMP, FDA regulation) contract manufacturing organization (CMO) to support rapid vaccine development by manufacturing vaccine CTM, including vaccine candidates and the associated ancillary products, testing, and activities required under cGMP. The CMO shall need to have capability to produce viruses in both cell culture and specific-pathogen-free (SPF) eggs. The CMO will be required to effectively produce, test, fill, and qualify vaccine candidates, vaccine ancillaries, or other biologics for NIAID clinical research. The vaccine candidates, which are suspensions of live attenuated virus or inactivated virus, will have been selected in part by NIAID based on evaluation in vitro and in vivo which demonstrated they are promising candidates for use in immunoprophylaxis of human infectious diseases. Vaccine ancillaries or other biologics required to advance to clinical trials, such as virus challenge stocks, diluents, cell lines for use in the production of the vaccines, test materials, etc., are also within the requirement. All activities required to comply with cGMP production and product management such as documentation, testing, storage, shipping, stability testing, etc. will also be required.
Options on this contract throughout the seven year task ordering period may include adding virus suspensions not identified at this time, or adding one or more additional cell lines as the substrate for virus production. The mission of NIAID includes rapid response to newly identified or newly emerging viral infections. Therefore, it is reasonable that, during this contract, additional viruses not identified in the initial contract might become a target of NIAID vaccine research. Virus suspensions of other viruses are an option for this contract. Other viruses must meet the requirements of BSL 2 and production in cell culture or SPF egg
Requirements
The Contractor shall follow the NIAID provided process for virus production and purification.
The Contractor shall be required to prepare, at the request of the Government Contracting Officer or Designee(s), suspensions of viruses that are needed for evaluation of effectiveness of immunoprophylaxis or pathogenesis studies.
The contractor shall have the ability to support the Government’s request of up to eight (8) virus suspensions to be grown in cell culture (e.g., Vero cells) or SPF eggs within any twelve (12) month period. Other cell lines for production may also be required. Therefore, the Government may also require up to one cell line per year to be produced as a Master Cell Bank (MCB) or Working Cell Bank (WCB).
Vaccine or challenge stock shall be provided by NIAID to the Contractor as a pre-GMP Accession Virus Bank (AVB). The AVBs are generally DNA-derived viruses recovered from transfected C6/36 mosquito cells or Vero cells qualified for use in the preparation of viruses to be given to humans. The Contractor shall confirm microbial sterility of material provided by NIAID before initiating virus production.
Generally, the Contractor will be tasked to create a single cGMP lot initiated from the AVB that is sufficiently large to fill 1400 – 4000 vials. Approximately 400 vials of this cGMP material may serve as a Master Virus Bank (MVB) and Working Virus Bank (WVB), 200 vials each. The remainder shall be used to support testing and as CTM. The Contractor might also be asked to produce additional cGMP lots initiated from the WVB.
The virus suspension (candidate vaccine or challenge stock) lot will be produced, processed, filled, flash-frozen, by the Prime Contractor.
Anticipated period of performance
March 1, 2021 through February 29, 2028.
Capability Statements
Interested qualified organizations should submit a tailored Capability Statement not to exceed twenty (20) pages. Respondents should not include resumes at this time but should synopsize: (a) key personnel education and experience and availability; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, (f) teaming agreements or other related information which can be used to evaluate the respondent’s capacity to perform the work as noted above.
Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe).
Required Business Information:
DUNS.
Company Name.
Company Address.
Company Point of Contact, Phone and Email address
Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.
Do you have a Government approved accounting system? If so, please identify the agency that approved the system.
Type of Company (i.e., large business, small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).
Respondents should also include the following on the inside of the cover or within the 1st page of their capability statement: size and small business status of the organization pursuant to the applicable NAICS code (541715) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1.
Number of Copies:
Please submit one (1) electric copy of your response as follows:
All inquiries and Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Patrick Wilson, Contract Specialist at wilsonpm@mail.nih.gov no later than 12:00pm EST, January 6, 2020. Capability statements must be submitted in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify the Sources Sought Reference Number: 75N93020R00008. Facsimile responses will not be accepted. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.
Disclaimer and Important Notes
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 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.
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).”
75N93020R00008 Department of Health and Human Services National Institutes of Health
12/16/19, 1:44 PM RevMedx Inc’s XSTAT®
The U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, on behalf Program Manager Special Operations Forces – Survival, Support, and Equipment Systems (PM-SOF SSES) intends to award a sole source firm fixed price Research, Development, Technology and Engineering (RDT&E) follow-on contract for development of a “sponge pouch”. This contract will be awarded under the authority of Federal Acquisition Regulation (FAR) Subpart 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The contract will be established with a two (2) year period of performance. The Government intends to negotiate on a sole source basis with RevMedx Inc., a Small Disadvantaged Business operating out of Wilsonville, OR.
RevMedx Inc’s XSTAT® family of devices are proprietary, Food and Drug Administration (FDA) approved hemorrhage control devices, used for treatment of non-compressible hemorrhaging. The required research and development will include design and development of the “Sponge Pouch” to include product validation testing, biocompatibility and sterilization reporting, and conduct of associated FDA regulatory activities and compliance, thereby improving performance by increasing the effectiveness of XSTAT® as it pertains to efficient/complete removal of sponges in the operating theater and/or upon arrival at definitive care facilities.
The North American Industry Classification System (NAICS) code is 541715 and the Small Business Size Standard is 1,000 employees. This is not a Small Business Set-Aside. This notice will be posted for ten (10) days, after which time it is the Government’s intent to award one (1) contract. No solicitation package will be available. Due to the proprietary nature of the XSTAT® family of devices, RevMedX Inc. is the only source capable of meeting the Governments requirement. However, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. If no affirmative written response is received by 3:30PM EST, December 2, 2019, the contract will be issued without further notice. A determination by the Government not to compete this contract is based on this notice and is solely within the discretion of the Government. Any questions shall be made in writing and directed to: Ms. Yvette M Daltorio, Contract Specialist, via email at yvette.m.daltorio.civ@mail.mil.
PANAPG20P0000003402 Department of the Army Materiel Command Army Contracting Command Aberdeen Proving Ground
11/20/19, 3:23 PM