ETEC RFI Doc.docx

RFI No.: HT9425-24-RFI-TJK-01 Manufacturing of an Enterotoxigenic Escherichia coli (ETEC) Vaccine for the Treatment of Bacterial Diarrhea for Use in Pivotal Clinical Trials

REQUEST FOR INFORMATION

REQUEST FOR INFORMATION (RFI) NO.: HT9425-24-RFI-TJK-01

RFI ISSUE DATE: 13 August 2024

1.0 RFI TITLE: Manufacturing of an Enterotoxigenic Escherichia coli (ETEC) Vaccine for the Treatment of Bacterial Diarrhea for Use in Pivotal Clinical Trials

2.0 AGENCY: United States Army Medical Research and Development Command (USAMRDC), Fort Detrick, MD

3.0 OFFICE: United States Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care Project Management Office (WPAC PMO), Fort Detrick, MD

4.0 CONTRACTING OFFICE: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD

5.0 SUBJECT: WPAC PMO seeks to clinically evaluate and achieve U.S. Food and Drug Administration (FDA) licensure of a multivalent vaccine to induce active immunity against ETEC for the prevention of traveler’s diarrhea to protect the Force (population 18-55 years of age). USAMRAA is conducting market research to determine whether a commercial solution can be provided to meet requirements for developing a FDA licensed ETECV for the prevention of bacterial-induced diarrhea. This market research may also assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: In accordance with Federal Acquisition Regulation (FAR) 15.201 “Exchange with industry before receipt of proposals,” and FAR 52.215-3, “Request for information or Solicitation for Planning Purposes,” 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. This RFI is not a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. This notice is for information and planning purposes only and is not to be construed as a commitment by the Government. 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. 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. 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. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information requests. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. Additionally, questions concerning the composition and requirements for a future request for proposal will not be entertained.

If a solicitation is released, a synopsis may be posted in “Contracting Opportunities” (formerly FedBizOpps [FBO]) at https://sam.gov/. It is the responsibility of any potential vendor to monitor “Contracting Opportunities” for the release of any solicitation or synopsis. NO PHONE CALLS PLEASE.

7.0 DESCRIPTION: The mission of USAMRDC is to “Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter”. Accordingly, it is the mission of USAMMDA WPAC PMO to develop and deliver vaccines, drugs, diagnostics, and hemorrhage control and resuscitation products to protect, treat, and sustain the health, readiness, and lethality of our U.S. Service Members.

Bacterial diarrhea is the number one infectious disease threat to U.S. Warfighters yet there is no FDA-licensed vaccine for prophylaxis. Sanitation and hygiene are the current standard of care for prevention and antibiotics remain the only viable therapy. A 2008 analytical model of the impact of bacterial diarrhea on Warfighter readiness and effectiveness concluded that the U.S. military suffers from approximately 33,000 vaccine preventable events each year due to ETEC. USAMMDA is seeking advanced development of a multivalent vaccine against ETEC as a solution to a significant, unmet medical need for the safe, efficacious, and durable prevention of bacterial diarrhea in adults prior to travel to endemic areas.

The project scope includes the development, manufacturing, clinical studies, and regulatory requirements to support the submission of a Biologics License Application (BLA) to the FDA. The respondent MUST:

a) Own, license, or otherwise have lawful rights to manufacture and clinically test the investigational product(s) (IP);

b) Have already demonstrated manufacturing processes, quality management, and IP maturity to support use in a pivotal clinical trial and a BLA submission to the FDA;

c) Already have obtained clinical evidence in human use studies of the potential for the IP to prevent the clinical manifestation of ETEC-induced diarrhea in Western adults traveling to endemic areas; and

d) Already have obtained clinical evidence that the IP is safe for human use (adult indication).

7.1 Technical Aims

7.1.1 Clinical Studies: Conduct the required clinical study(ies) to demonstrate efficacy and safety required for BLA submission and FDA licensure for an adult indication. The Performer shall be required to prepare human use protocols and submit to relevant human use regulatory agencies including the local institutional review board (IRB) and the Office of Human Research Oversight (OHRO), U.S. Army Medical Research and Development Command (USAMRDC).

7.1.2 Manufacturing and Quality Management: Manufacture and characterize (e.g., identity, content, purity, potency) a sufficient quantity of multivalent ETEC vaccine to support the required clinical studies for FDA licensure for an adult indication, quality release, stability testing, and other testing required for human use in compliance with applicable Title 21 Code of Federal Regulations or other activities required for FDA licensure. The product should demonstrate at least two years stability. Complete the necessary optimization and processing development, manufacturing validation, manufacturing stability tests for commercial availability.

7.1.3 Regulatory Strategy and Development: Develop, maintain, and manage all regulatory submissions to the FDA, including the Investigational New Drug (IND) application, and provide to the Government for review and comment. Develop and execute a regulatory strategy for the ETEC vaccine describing the Offeror’s regulatory pathway to FDA licensure for an adult indication. The regulatory strategy shall include a Target Product Profile (TPP) using the FDA TPP guidelines.

7.2 Management Objectives: The management objectives are to allow the Contractor the maximum flexibility to innovatively manage the project schedule, performance, risks, subcontracts, and data to provide a product that satisfies the government’s performance requirements.

7.2.1 Program Management Objectives: Integrate all qualified and trained personnel, facilities, equipment, supplies, materials, services, quality oversight, and related administrative and information technology necessary to accomplish all the objectives and requirements and comply with applicable Title 21 Code of Federal Regulations. Participate in meetings with the government in meetings to effectively manage the program.

7.2.2 Contract Management Objectives: Establish effective contract and subcontract management processes to achieve government performance requirements and comply with cGMP standards. Ensure government access to subcontract technical data rights as required to meet program objectives. Provide flexibility to adapt to changes in schedule, requirements, and FDA guidance.

7.3 Optional Task Objectives: Low-rate initial production (LRIP) of a to be determined quantity of FDA approved ETECV available to order until a Defense Logistics Agency (or similar Government entity) contract/agreement can be put in place.

The period of performance is estimated to take no longer than thirty-six (36) months.

8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a white paper, a rough order of magnitude (ROM) cost estimate, and contact information table (provided below). Interested firms are requested to submit a response that demonstrates their ability to perform the scope of work identified in this RFI. The submission shall not exceed ten (10) pages; additional sheets for cover page, table of contents, tables and charts will not be counted towards the 10-page limit.

Format specifications include: Times New Roman 12-point font, single-spaced, single-sided, 8.5 x 11-inch pages with 1-inch margins. Electronic files shall not exceed 3 MB. All submissions must be made electronically and be in one of the following formats: Microsoft Word or searchable Adobe PDF. All submissions become Government property and will not be returned.

NOTE: All ‘Proprietary’, ‘Classified’, ‘Confidential’, or ‘Sensitive’ information shall be marked as Controlled Unclassified Information (CUI) at the top and bottom of each page. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Submission shall include the following information:

a. Cover Page

i. Title;

ii. Organization;

iii. Responder’s contractual, technical, and administrative points of contact (names, addresses, phone numbers, and email addresses);

b. Current Technical Expertise, Knowledge and Management Capability

i. Executive Summary (i.e., synopsis of the responder’s capability to perform the tasks described herein);

ii. Discussion of capabilities/challenges/technologies;

iii. The breadth of disciplines and relevant experience pertaining to the requirement (for example: government, academia or industry experience). Please also include information regarding favorable experience working with the FDA. Additionally, please provide a list of citations and other relevant documents describing experience. Technical response, relevance of responder’s expertise that demonstrates a full understanding and experience in performing the technical aims and objectives described in paragraph 7.0; and confirmation of:

The respondent MUST:

a) Own, license, or otherwise have lawful rights to manufacture and clinically test the investigational product(s) (IP);

b) Have already demonstrated manufacturing processes, quality management, and IP maturity to support use in a pivotal clinical trial and a BLA submission to the FDA;

c) Already have obtained clinical evidence in human use studies of the potential for the IP to prevent the clinical manifestation of ETEC-induced diarrhea in Western adults traveling to endemic areas; and

d) Already have obtained clinical evidence that the IP is safe for human use (adult indication).

iv. ROM estimate of the cost and schedule to perform the scope of work. The respondent should assume work would begin on 25 September 2024.

c. Contact Information Table Fill in the below contact information table and submit with your response to this RFI.

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

CAGE Code

System for Award Management (SAM) Unique Entity ID (UEI)

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Socio-Economic Classifications (e.g., 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

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

Company does / does not have a Defense Contract Audit Agency (DCAA) determined acceptable cost accounting system

9.0 SUBMISSION DUE DATE & TIME:

The subject header of the email for submission shall be: “Response to RFI for ETECV Development.”

Interested entities shall forward submissions electronically to:

Timothy Kelly at timothy.j.kelly169.civ@health.mil

RESPONSES DUE: No later than 3:00 PM ET on 28 August 2024.

Telephonic communication will not be considered as submission nor receive a response. The Government appreciates responses from all capable and qualified sources.

(End of RFI)