Amendment 2: DRIVe EZ Broad Agency Announcement

Office of Biomedical Advanced Research and Development
Authority (BARDA) Division of Research, Innovation & Ventures

(DRIVe)

Amendment 002 Issuance for Easy Broad Agency Announcement

(EZ-BAA) BAA-22-100-SOL-00003

The purpose of this Amendment is the following:
1) Add the following Areas of Interest (AOI):

AOI #24: REPAIR

2) Clarify an administrative error

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

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

Add the following research Area of Interest (AOI):

AOI #24: REPAIR

We are seeking abstract submissions for the following AOI:

AOI #24: REPAIR

Repurposing and Advancing Innovations Against Rad/Nuc Threats (REPAIR) Exposure to ionizing radiation can result in a spectrum of injuries known as Acute Radiation Syndrome (ARS). Due to multiple organ involvement, medical countermeasures (MCM) that treat the systemic nature of the injury or multi-organ pathologies are needed. These MCMs need to be effective when given 24 hours or later post-exposure to be consistent with current deployment expectations. Commercially available products should be familiar to end users, as well as be potentially available at multiple points of care such as pharmacies and hospitals. This ensures MCMs are available immediately when and where they are needed, while resources are deployed from stockpiles.
Repurposing existing FDA-approved and late-stage development therapeutics as potential MCMs for radiological and nuclear events could expand treatment options as well as support the concept of pre-deployed MCMs. The clinical data needed to reach these stages of development can also enable development under FDA’s Animal Rule. This includes safety data, stage appropriate manufacturing, and a well-defined mechanism of action. BARDA is seeking abstracts that describe repurposing of therapeutics to be used as MCMs to treat ARS. Candidate MCMs should either be FDA approved or have successfully completed (met the primary endpoint) their phase 2 trial.
This Program is focused on repurposing therapeutics for the following: Cell Death: Development of MCMs to counteract loss of tissue/organ cellularity resulting from exposure to ionizing radiation injury. These treatments should either aim to maintain cellular populations, replenish, or preserve stem/progenitor cell population. Vascular Injury: Development of MCMS that treat vascular injury by targeting the vascular endothelium and prevent further injury to blood vessels resulting from exposure to ionizing