RFI - Adenovirus.docx

Request for Information (RFI)

RFI Number: W81XWH-20-RFI-TJK4

1. RFI Title: Adenovirus Vaccine Activities for Military Sustainability

2. Agency: United States Army Medical Research and Development Command (USAMRDC)

3. Office: United States Army Medical Materiel Device Activity (USAMMDA)

4. Location: Fort Detrick, MD

5. Subject: USAMMDA is currently seeking information on a services contract for the purpose of evaluating the operations and processes of the Adenovirus vaccine manufacturing for areas of improvement and increased efficiencies. Actions considered necessary to ensure sustainability of an U.S. Food and Drug Administration (FDA) licensed Adenovirus vaccine for Military use.

The US Army has a requirement to sustain an Adenovirus vaccine product in accordance with the Department of Defense (DOD) Acquisition System, FDA regulations and guidelines, and industry best practices. In direct support of the USAMMDA product development effort, the Government is seeking to obtain a plan which outlines the activities necessary to implement process improvements and efficiency enhancements necessary to sustain the viability of an Adenovirus vaccine.

6. Disclaimer: In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time, and shall not be construed as a solicitation or as an obligation on the part of the USAMRDC, or collaborative Department of Defense (DoD) activities. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

7. Background: USAMMDA is a unique and multifaceted organization that is the DoD’s primary product developer of advanced medical materiel solutions. The Activity’s mission is to develop and deliver quality medical capabilities to protect, treat, and sustain the health of our Service Members.

Adenovirus (Types 4 and 7) infection is a frequent cause of epidemic acute respiratory disease (ARD) in all military recruit training facilities in the Army, Navy, Air Force, Marines and Coast Guard and, as such, poses a significant threat to military readiness, especially during times of large-scale mobilization. ARD is a debilitating febrile disease that frequently results in severe pneumonia, hospitalization, loss of training time, and occasionally, death. There are no Food and Drug Administration (FDA) approved drugs for human adenovirus infection. Adenovirus types 4 and 7 accounted for approximately 60% of all acute respiratory disease in military recruits.

This vaccine was FDA approved in 2011 and the DoD began immunizing military recruits in October of that year. Thus far, ~1.8M doses have been distributed to all services including the Coast Guard. The vaccine has proven to be 99% efficacious in preventing Febrile Respiratory Illness caused by Adenovirus types 4 and 7 in recruit training camps.

8. Information Requested:

· Provide their capabilities and previous experience manufacturing a FDA licensed Adenovirus 4 and 7 vaccine.

· Describe their capability to conduct Regulatory Affairs compliance requirements to meet all FDA guidelines for a licensed Adenovirus 4 and 7 vaccine.

· Describe the company’s previous FDA experience with BLA approvals for live oral vaccines.

· Describe commercial viability of this technology

9. North American Industry Classification System (NAICS) Code: The NAICS code for this potential action is 541714 - Research and Technology in Biotechnology (except Nanobiotechnology) with a Size Standard of 1,000 employees.

10. Capability Statement: To be eligible for submitting any future proposal, contractors must have experience working within the industry, and in related government sector(s), and be thoroughly familiar with medical research and guidelines. Respondents must provide proof of experience if requested. The offeror shall include with the Capability Statement relevant experience from three (3) contracts within the last five (5) years that demonstrate relevant past experience with developing and manufacturing adenovirus vaccines.

11. Anticipated period of performance: Twelve (12) Months.

12. Response Due Date: Interested parties should submit the attached RFI response electronically by 3:00 pm (EST) December 11th 2019 via e-mail to Timothy Kelly at timothy.j.kelly169.civ@mail.mil or Peter Mitchell at peter.d.mitchell8.civ@mail.mil. Please request confirmation of receipt.

13. Instructions to Responders:

15.1 The Government appreciates responses from all capable and qualified sources.

15.2 The Government welcomes input and will accept questions pertaining to this RFI; however, the Government reserves the right to answer or not to answer (?) all questions pertaining to this RFI. Questions pertaining to the RFI are due by 1:00 PM EST on 2 December 2019. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained. Answers to the questions will be provided by 3:30 PM EST 4 December 2019 and posted as an attachment as part of a modification on https://beta.sam.gov.

15.3 The subject header of the e-mail for submission of questions and/or the RFI response shall be: Adenovirus Vaccine Activities for Military Sustainability

15.4 Interested firms should submit a response (Capability Statement) that demonstrates the Offeror’s ability to perform the scope of work identified in this RFI. The Capability Statement shall not exceed fifteen (15) typed pages; additional sheets for cover page, table of contents, tables and charts will not be counted toward page limitation.

15.4.1 Format specifications include 12 point Arial font, single spaced, single sided, 8.5 by 11 inches paper with 1 inch margins. All submissions must be made electronically (as described below) and be 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, phone, fax number and email addresses)

iv. Topic area(s) addressed

b. Current Technical Expertise, Knowledge and Management Capability

i. Executive Summary

ii. Discussion of capabilities/challenges/ technologies

iii. Technical response, the breadth of disciplines and experience, relevance of Offeror’s expertise that demonstrates a full understanding and experience in developing Adenovirus vaccines.

c. Brief summary of relevant experience pertaining to the requirement (for example government, academia or industry experience).

d. List of citations and other relevant documents describing experience and past performance

15.5 Fill in the below table when respond to this Sources Sought / RFI.

RFI Number

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

Cage Code

DUNS

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Classifications (e.g. 8(a), HubZone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program.

14. Disclaimer and Important Notes: The purpose of this RFI notice is to gain market knowledge. The Government is not obliged to award a contract or otherwise pay for the information provided in the responses received. 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 responses are complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Responders are advised that the Government is under no obligation to acknowledge receipt of the information received, or to provide feedback to respondents regarding any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on System for Award Management, Beta at https://beta.sam.gov. Responses to this notice will not be considered adequate responses to a solicitation.

15. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in submitted responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).