Biomedical Advanced Research and Development Authority (BARDA)
U.S. government authority within HHS/ASPR that funds and manages advanced research, development, acquisition, and manufacturing scale-up of medical countermeasures (vaccines, therapeutics, diagnostics, devices, and non-pharmaceutical products) for public health emergencies and chemical, biological, radiological, and nuclear (CBRN) threats. Operates competitive solicitations and pre-submission engagement, provides nonclinical and clinical development support, invests in domestic manufacturing and diagnostics infrastructure, and executes procurement and stockpiling for national preparedness.
Industries
Nr. of Employees
large (251-1000)
Biomedical Advanced Research and Development Authority (BARDA)
Washington, District of Columbia, United States
Products
Biothrax
Licensed anthrax vaccine for pre- and post-exposure prophylaxis (post-exposure in combination with antibiotics).
AV7909
Next-generation anthrax vaccine candidate designed as a two-dose post-exposure prophylaxis to reduce the number of doses required and time to onset of protection.
Raxibacumab
An antibody-based therapeutic that binds to the B. anthracis protective antigen (PA) to treat inhalational anthrax toxemia.
TPOXX (tecovirimat) Oral capsule
An oral capsule smallpox antiviral drug approved by the FDA in July 2018, developed and stockpiled for treatment of smallpox infections.
Licensed Ebola Zaire Vaccine
Vaccine against Ebola Zaire virus, licensed and used in ongoing outbreak responses.
Utebzi (tebipenem pivoxil)
UTEZBI is a penem antibacterial indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain susceptible microorganisms in adult patients with limited or no alternative oral treatment options.
Biothrax
Licensed anthrax vaccine for pre- and post-exposure prophylaxis (post-exposure in combination with antibiotics).
AV7909
Next-generation anthrax vaccine candidate designed as a two-dose post-exposure prophylaxis to reduce the number of doses required and time to onset of protection.
Raxibacumab
An antibody-based therapeutic that binds to the B. anthracis protective antigen (PA) to treat inhalational anthrax toxemia.
TPOXX (tecovirimat) Oral capsule
An oral capsule smallpox antiviral drug approved by the FDA in July 2018, developed and stockpiled for treatment of smallpox infections.
Licensed Ebola Zaire Vaccine
Vaccine against Ebola Zaire virus, licensed and used in ongoing outbreak responses.
Utebzi (tebipenem pivoxil)
UTEZBI is a penem antibacterial indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain susceptible microorganisms in adult patients with limited or no alternative oral treatment options.
Services
Competitive solicitations for R&D proposals with multi-stage submission, technical evaluation, and award negotiation across BARDA program areas.
Acquisition services including contract formulation, award execution, other transaction agreements, portfolio management, and procurement support to enable development, manufacturing, and stockpiling of medical countermeasures.
Integrated clinical services including project management, study start-up, site selection and monitoring, lab services, regulatory/IRB support, data management, statistical analysis, and biospecimen storage provided via vetted CRO partners.
Funding and technical support to develop diagnostics, build domestic manufacturing capacity for rapid test production, and support deployment across laboratories, point-of-care, and home settings.
Confidential preclinical evaluation services (e.g., efficacy testing for specific threats) provided through program contracts to evaluate candidate activity across relevant models and serotypes.
Competitive solicitations for R&D proposals with multi-stage submission, technical evaluation, and award negotiation across BARDA program areas.
Acquisition services including contract formulation, award execution, other transaction agreements, portfolio management, and procurement support to enable development, manufacturing, and stockpiling of medical countermeasures.
Integrated clinical services including project management, study start-up, site selection and monitoring, lab services, regulatory/IRB support, data management, statistical analysis, and biospecimen storage provided via vetted CRO partners.
Funding and technical support to develop diagnostics, build domestic manufacturing capacity for rapid test production, and support deployment across laboratories, point-of-care, and home settings.
Confidential preclinical evaluation services (e.g., efficacy testing for specific threats) provided through program contracts to evaluate candidate activity across relevant models and serotypes.
Expertise Areas
- Advanced development and funding management for medical countermeasures
- Clinical trial network operations and CRO management
- Preclinical model and assay development for threat-specific evaluations
- Diagnostics and device development, scale-up, and rapid response manufacturing
Key Technologies
- Metagenomic next-generation sequencing (mNGS) for pathogen-agnostic detection
- Point-of-care and at-home diagnostic platforms
- Direct-from-specimen antimicrobial resistance testing
- mRNA and nucleic acid vaccine modalities
News & Updates
Annual events presenting BARDA priorities, division briefings, funding vehicle overviews, and lightning talks to engage stakeholders and communicate technical expectations.
Guidance on market research abstracts, quad charts, TRL assessment, and technical/cost proposal requirements for BAA submissions.
Initiative to build biothreat diagnostic portfolios and leverage domestic just-in-time manufacturing to rapidly produce tests at scale; launched March 2024.
Cumulative count of FDA approvals, licensures, and clearances for products supported by BARDA across multiple threat areas.
Organization-reported portfolio count of products that achieved FDA regulatory approval, licensure, or clearance as reported during industry briefings.
Annual events presenting BARDA priorities, division briefings, funding vehicle overviews, and lightning talks to engage stakeholders and communicate technical expectations.
Guidance on market research abstracts, quad charts, TRL assessment, and technical/cost proposal requirements for BAA submissions.
Initiative to build biothreat diagnostic portfolios and leverage domestic just-in-time manufacturing to rapidly produce tests at scale; launched March 2024.
Cumulative count of FDA approvals, licensures, and clearances for products supported by BARDA across multiple threat areas.
Organization-reported portfolio count of products that achieved FDA regulatory approval, licensure, or clearance as reported during industry briefings.