Drug Countermeasures against Bacterial Biowarfare Agents

Objective:

This is a Joint Request for Information (RFI) for the Joint Science & Technology Office (JSTO) and the Joint Product Manager Biological Defense Therapeutics (JPdM-BDTX), issued for planning purposes, as defined in Federal Acquisition Regulation (FAR) 15.201(e). This is not a solicitation for proposals, proposal abstracts, or quotations. 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 RFI. 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.

Background:

JSTO and BDTX are directed to develop a Food and Drug Administration (FDA) approved medical countermeasure that is efficacious against one or more threats. The medical countermeasure must, at a minimum, demonstrate non-GLP in vivo efficacy consistent with the product's intended use in a suitable animal model targeted at one or more of the following pathogens:

o Bacillus anthracis (Anthrax)
o Brucella spp. (Brucellosis)
o Burkholderia mallei (Glanders)
o Burkholderia pseudomallei (Melioidosis)
o Coxiella spp. (Q Fever)
o Francisella tularensis (Tularemia)
o Yersinia pestis (Plague)

The Joint Science and Technology Office is responsible for discovery and development of a translational pipeline with the advanced developer (JPdM-BDTX) for medical countermeasures (MCM) for Multi-Drug Resistant bacterial biological warfare agents.

Requirements:

The purpose of this RFI is to solicit information about the developmental status of any next-generation or novel antibiotics/anti-infectives with activity against BW agents.

The Government is surveying the market to identify potential sponsors that can perform all required activities to support preclinical development, IND-enabling, filing of the Investigational New Drug (IND) application, and advanced development through approval of a New Drug Application (NDA) / Biologics License Application (BLA) by the FDA, and all activities for regulatory approval of medical countermeasure (MCM) candidates. The Government is seeking companies with expertise in the performance of preclinical development, safety and tolerability trials in humans, and studies to show efficacy against an aerosol challenge in a validated animal model. Familiarity with Animal Rule Guidance for development of MCMs against biowarfare threats and the ability to demonstrate efficacy against an aerosol challenge is highly desirable.

Performance Objectives:

The Government requests that potential performers provide up to a 3 page response that fully describes their medical countermeasure(s) and provides information as requested in this RFI.

At a minimum, 1) maturity level form - Attachment I and, 2) the areas listed below A-I, shall be addressed. Please explain what areas have not been addressed, and how the gaps in knowledge will be filled.

a. Completion of Pharmacokinetic/Pharmacodynamic (PK/PD) and bio-distribution studies

b. Route of administration (oral, intramuscular, inhalation, other)

c. Synopsis of any relevant experience with the FDA (including Investigational New Drug (IND) or response to emergency Investigational New Drug (eIND) requests). Clinical trials that used proposed MCM for any indication or IND application with the proposed MCM or other drug under development

d. Shelf life (in years) of drug product supported by Non-Good Manufacturing Practice (Non-GMP) stability studies

e. Describe studies completed in animal models in agents targeted to include route of challenge

f. Storage requirements as demonstrated by studies (room temperature, refrigerated, frozen)

g. Number of treatment courses produced in a single manufacturing run

h. Estimated cost per treatment course

I. Any associated intellectual property rights or patent coverage

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 must be received by COB on 3 November 2017. Responses should be sent by e-mail to: [email protected], with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired.