W911SR-24-S-ADTX RFI.pdf

ARMY CONTRACTING COMMAND, ABERDEEN PROVING GROUND

EDGEWOOD CONTRACTING DIVISION

W911SR-24-S-ADTX

AGENT DIRECTED THERAPEUTICS (AD TX)

REQUEST FOR INFORMATION

The Army Contracting Command−Aberdeen Proving Ground (ACC-APG) Contracting Center, Edgewood Contracting Division, Ft Detrick, in support of the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO CBRND), Joint Program Manager, Biological Defense Pharmaceuticals (JPM BDP), hereby issues a request for information (RFI) for Agent-directed therapeutics (AD TX) program.

The purpose of this RFI is to provide potential vendors insight into the requirements of the AD TX program and to solicit feedback to gain needed market research on the specific objectives set forth below, which will help guide the program. The draft Statement of Objectives (SOO) below outlines the requirement. This RFI should not be construed as a commitment by the Department of Defense (DoD) nor will the DoD pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI.

REQUIREMENT:

I. PROGRAM OBJECTIVE:

The Agent Directed Therapeutics (AD TX) program is a capability that will provide various broad-spectrum antiviral therapeutic medical countermeasures (MCMs) by leveraging different antiviral strategies, such as mechanisms of action (MoA), against highly contagious threats to the warfighter.

The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Joint Project Manager Chemical, Biological, Radiological and Nuclear Medical (JPM-CBRN Medical) is seeking information on possible agent-directed therapeutic (also referred to as ‘direct-acting antivirals’ therapeutics) solutions that could be perused for continued advanced development activities for potential U.S. Food and Drug Administration (FDA) licensure.

DoD JPEO-CBRND, JPM-CBRN Medical is seeking responses from private or public entities (academic, non-profit, and commercial) outlining their current agent-directed antiviral therapeutic candidates.

Responses are due no later than 30 May 2024 1600 EST. Following market research, the program is estimated to span from October 2024 to September 2029. Dates may change due to actual award data and other relevant events/ conditions.

II. PERFORMANCE OBJECTIVES:

For this specific effort, the objective is to survey possible agent-directed therapeutics that could be taken into advanced development for potential U.S FDA licensure, as treatments against Nipah virus (NIV) and/ or Lassa virus (LASV).

The following topics are specific topics to be addressed in responses:

a. PRODUCT OVERVIEW:

i. Vendors should provide summarized status of product candidate development process for agent-directed (or ‘direct-acting antiviral’) therapeutics used to treat either Nipah virus (NIV) and/or Lassa virus (LASV). Responses should address the following:

i. Summarize the mechanism of action for product candidate.

ii. Summarized data from in vitro and in vivo studies demonstrating potential as a broad-spectrum therapeutic

b. RESEARCH TESTING:

i. Vendors should provide summarized status of product candidate research process for agent-directed (or ‘direct-acting antiviral’) therapeutics used to treat either Nipah virus (NIV) and/or Lassa virus (LASV). Responses should address the following:

i. Summarized status of preclinical research to include:

1. In vitro studies

2. In vivo studies to include proof-of-concept studies in relevant animal models

ii. Summarized status of clinical research to include:

1. Status of product safety and dosage studies

2. Status of efficacy studies

ii. Vendors should provide summarized status on relevant assays needed to evaluate product candidate. Responses should address the following:

i. Status of assay development to include development, qualification, and/ or validation phases in corresponding animal models.

ii. Status of assay development to include development, qualification, and/ or validation phases in corresponding human models.

c. MANUFACTURING:

i. Vendors should provide information on whether or not the drug product (DP) and active pharmaceutical ingredient (API) are produced in U.S.

ii. Vendors should provide summarized information on corresponding manufacturing process. Responses should address the following:

i. Status of laboratory scale experiments to test feasibility of laboratory scale manufacturing processes.

ii. Status on Bulk Drug Substance (BDS) development needed for good manufacturing processes (GMP).

iii. Summarized status on drug manufacturing to include qualification and/or validation.

d. REGULATORY:

i. Vendors should provide information on status of U.S. FDA Pre-Investigational

New Drug (Pre-IND) process. Responses should address the following:

i. Whether or not an IND has been submitted.

ii. Regulatory strategy and estimated corresponding timeline for product development

iii. Vendor history of FDA engagements and any relevant FDA regulatory exposure.

III. RFI STRUCTURE AND REQUIRMENTS:

The Respondents should provide the following in their reply to this RFI, should be between 5 – 7 pages; not to exceed 7 pages in total.

a. Company Description

i. Provide a brief description of company mission statement and objective.

ii. Provie a brief description on company’s vision for next five years.

iii. Provide a brief description on company’s history emphasizing experience on therapeutic developments.

b. Project Development Plan

i. Respondents to this RFI should address the points set forth in the above Performance Objectives (Section III above).

ii. Responses should also provide a non-binding Rough Order of Magnitude cost for any unfunded activities listed in Section III above.

iii. Provide a description of the design framework and methods to be used in this effort along with high level development schedule.

iv. Any associated intellectual property rights or patent coverage

c. Past Performance (1 page maximum)

i. Respondents should provide relevant past performance outlining previous work with DoD or Industry in the advanced development of therapeutics and/or MCMs, and FDA submissions.

ADMINISTRATION:

The Government will retain comments and information received in response to this RFI.

Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses should be received by 1600 EST on 30 May 2024. Responses should ONLY be sent by e-mail to ALL THREE of the following email addresses with Subject Line of Responding Organization and RFI Title:

usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil

Joseph Mccaffery: joseph.w.mccaffery2.civ@army.mil

Keith Pereira: keith.d.pereira.civ@army.mil

Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI, the first choice for an acquisition vehicle, if appropriate, will be an Other Transaction Agreement (OTA) issued by the Chemical, Biological, Radiological and Nuclear Defense (CBRND) Broad Agency Announcement (BAA) 22-01.

Respondents interested in the Medical Countermeasures Broad Agency Announcement (BAA) may obtain additional information in SAM.gov, keywords CBRND- 22-01. For questions related to this RFI, please e-mail ALL THREE of the following email addresses:

usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil

Joseph Mccaffery: joseph.w.mccaffery2.civ@army.mil

Keith Pereira: keith.d.pereira.civ@army.mil