Amendment 19: DRIVe EZ Broad Agency Announcement

BAA-22-100-SOL-00003

Amendment #019

Office of Biomedical Advanced Research and Deveopment Authority Division of Research, Innovation & Ventures (DRIVe)

Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003

The purpose of Amendment #019 is the following:
1) Reopen the following Area of Interest (AOI):

AOI #15: ReDIRECT

2) Revise the following Area of Interest:

AOI #15: ReDIRECT

BAA-22-100-SOL-00003

Amendment #019

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

Under this Amendment, DRIVe is doing the following:
1)

Reopening the following research Area of Interest (AOI):

AOI #15: ReDIRECT

2)

Revising the following research Area of Interest (AOI):

AOI #15: ReDIRECT

We are seeking abstract submissions for the following AOI: AOI #15: ReDIRECT (Repurposing Drugs In Response to Chemical Threats)

The availability of effective medical countermeasures (MCMs) against chemical threats is critical in the treatment of their acute health effects. Necessary attributes of effective MCMs against chemical threats include ease of administration during a mass-casualty situation and rapid efficacy as a post-exposure therapy. Drug repurposing is a strategy that is used to identify new uses, outside of their original clinical indication, for Food and Drug Administration (FDA) approved or late-stage investigational therapeutics. The identification of existing compounds for repurposing as MCMs holds the potential to expand current response capabilities to chemical threats, as well as potentially mitigating the costs and risks associated with conventional drug discovery.
Biomedical Advance Research Development Authority (BARDA) is requesting abstract submissions for projects that repurpose existing therapeutics as MCMs against chemical threats (cyanide, opioids, nerve agents, chlorine, sulfur mustard, etc.). These therapeutics should have a strong mechanistic justification for potential use as MCMs. Ideal candidates should have a known safety profile from previous clinical indications or development and be safe and effective for the entire population, including at-risk populations such as pediatrics, geriatrics, pregnant women, and immunocompromised individuals. MCM candidates should:
1) Be FDA-approved or in advanced clinical development for a conventional indication like the pathophysiology associated with exposure to a chemical agent; and 2) Utilize delivery routes or mechanisms that improve ease of administration (including, but not limited to, reformulation of existing products) to large numbers of exposed individuals during