Amendment 10: DRIVe EZ Broad Agency Announcement

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

(DRIVe)

Amendment 010 Issuance for Easy Broad Agency Announcement

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

The purpose of this Amendment 010 is the following:
1) Revise the following Area of Interest (AOI):

AOI #24: REPAIR

2) Update the closing date for the following Area of
Interest (AOI):

AOI #24: REPAIR

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

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

Revising the following research Area of Interest (AOI):

AOI #24: REPAIR

We are seeking abstract submissions for the following AOI: 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. Optimally, MCMs would be commercially available products that are familiar to end users, as well as be potentially available at multiple points of care such as pharmacies and hospitals. This availability ensures MCMs are immediately accessible when and where they are needed, while additional resources are being deployed from stockpiles.
Repurposing existing FDA-approved and clinical-stage therapeutics through label expansion as potential MCMs for radiological and nuclear events could expand treatment options as well as support the concept of pre-deployed MCMs. The data collected to reach these stages of clinical development could aid development of the MCM indication under FDA’s Animal Rule and must include a well -defined mechanism of action (MOA), clinical safety data, and stage appropriate manufacturing. BARDA is seeking abstracts that describe repurposing through label expansion of therapeutics to be used as MCMs to treat ARS. Candidate MCMs should either be FDA approved or be currently in a Phase 2 clinical trial or further, having successfully completed their Phase 1 trial for their commercial indication with an acceptable risk: benefit assessment in the target or intended population, with a defined mechanism anticipated to have efficacy for ARS.
This Program is focused on repurposing therapeutics expansion of their label for the following: