Biomedical Advanced Research and Development Authority (BARDA)Biomedical Advanced Research and Development Authority (BARDA)HHS/ASPR
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), manages the procurement and advanced development of medical countermeasures for CBRN threats, pandemic influenza and other emerging infectious diseases.
In addition, BARDA manages the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and oversees all of HHS’s Project BioShield procurements. BARDA was established via the Pandemic and All-Hazards Preparedness Act of 2006.
Key threats funded for countermeasures include anthrax, botulism, radiation, viral hemorrhagic fevers and smallpox. Most recent BARDA funding opportunities are available here.
CBRN agent countermeasures lack a significant commercial market as incidents occur infrequently. The funding phases and guaranteed federal market structure for finalized products overseen by BARDA is a critical national security effort to bring about countermeasure development.
A major component of the BARDA effort is to establish flexible multi-use manufacturing and core service partnerships that will assist companies in many aspects of developing and licensing a product, while providing medical countermeasure manufacturing and surge capacity.
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BARDA plans to support a Phase 2 platform clinical trial that investigates multiple immune modulators or other host-directed therapeutics in hospitalized adult patients with acute respiratory distress syndrome (ARDS). In this trial, BARDA will evaluate the safety and efficacy of novel threat-agnostic and host-directed therapeutics that could address ARDS caused by known or unknown health security threats such as pandemic influenza, COVID-19, other emerging infectious diseases, and chemical, biological, radiological, and nuclear (CBRN) incidents.
The funding supports the development of over-the-counter molecular diagnostics capable of delivering lab-quality results in 15-30 minutes while approaching the cost of antigen tests.
Sabin Vaccine Institute receives $35 million from BARDA with potential of up to $214 million for Medical Countermeasure Development against Marburg and Sudan ebolavirus diseases.
BugSeq Bioinformatics, a biotech company developing next-generation microbiology assays, has entered a public-private partnership with the U.S. Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation, and Ventures (DRIVe) to develop a new diagnostic that covers all existing and new respiratory RNA viruses in a single test.
Development of the vaccine and antibody candidates is currently being funded in whole or in part by the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA). Texas Biomed has been awarded more than $35 million in new subcontracts to run detailed studies required by the FDA to determine if Sudan ebolavirus vaccines and therapies are effective.
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