Revitalizing preparedness by accelerating the development
of innovative technologies against drug-resistant infections.
BARDA is now seeking partnerships to develop broad-spectrum next-generation antifungal drugs to treat high-priority fungal infections following a public health emergency.
Modern medicine, as we know it, has been made possible by the advent of antimicrobials. Health outcomes in the clinic as well as in the community during emergencies or outbreaks rely on effective treatments. Recognizing the challenges facing product development in the antimicrobial space and the global threat of antimicrobial resistance, the Antimicrobials Program removes barriers to antimicrobial drug development through public-private partnerships that provide non-dilutive funding and subject matter expertise. Our goal is to provide clinicians with therapeutics to prevent and treat biological threat agent infections, drug-resistant secondary infections, and hospital-associated and community-acquired infections.
BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics. By funding preclinical development through regulatory approval and post-marketing commitments of therapeutics and diagnostics, BARDA ensures patients have broad access to these lifesaving medical countermeasures. BARDA’s proven public-private partnership model has supported the development of over 130 antimicrobial products through a combination of direct investment and its partnership with the Combatting Antibiotic Resistant Bacteria Accelerator (CARB-X) program.
Click play to view the progression of our portfolio.
In 2016, BARDA, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and Wellcome, launched the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) with the mission to “accelerate a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding, expert support, and cross-project initiatives.” Over the last six years, CARB-X has built on BARDA’s initial $200 million investment by expanding the partnership to include additional funders and growing to become the world’s largest public-private partnership dedicated to early development of antimicrobial resistance (AMR) products. Since its inception, CARB-X has funded the advancement of over 100 innovative projects in 12 countries as part of a scientifically diverse portfolio.
In 2022, BARDA committed an additional $25 million to continue supporting CARB-X, with options to provide up to $300 million over the next 10 years. Through CARB-X, BARDA is revitalizing the pipeline of early-stage AMR candidates from which the U.S. government or international advanced development programs may select for future funding.
In 2014, the United States Government released the National Strategy for Combating Antimicrobial Resistant Bacteria. A component of the National Strategy was to establish a “biopharmaceutical incubator” for combating antibiotic-resistant bacteria, a novel concept proposed by BARDA, to revitalize the pipeline of product developers focused on preclinical and Investigational New Drug (IND)-enabling research and development. The proposed concept was designed to provide wrap-around services and early development activities that would help progress candidate therapeutic and vaccine products from the hit-to-lead stage through Phase 1 development, and support diagnostics products through early development. In 2016, CARB-X was launched.
Based out of Boston University, CARB-X now represents the world’s most diverse preclinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and preventatives, including microbiome and vaccine candidates. CARB-X continues to diversify their portfolio through contributions from Germany’s Federal Ministry of Education and Research, the UK Government’s Global Antimicrobial Resistance Innovation Fund, the Public Health Agency of Canada, the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. CARB-X also provides support to projects through their Global Accelerator Network and subject matter experts, many of whom have held senior positions at the U.S. Food & Drug Administration, emerging biotechnology companies, global pharmaceutical companies and academia. This international partnership oversees a unified investment strategy that identifies and fills gaps in critically needed antibiotics and other life-saving products to combat the most dangerous drug-resistant bacteria. As of July 2022, CARB-X has invested nearly $400 million and supported many successful candidates, including 11 products in first-in-human studies. Two companies have gone on to receive BARDA advanced research and development funding following the conclusion of their CARB-X contract.
Drug candidates demonstrating substantial improvements over existing antimicrobial products are important to the Antibacterials Program.
Priority is given to first-in-class compounds with novel mechanisms of action, including non-traditional modalities (e.g., bacteriophage, host-directed immunotherapeutics, etc.). Candidates need to address an unmet medical need and if possible, target a biothreat pathogen. Antibacterials within existing classes must demonstrate a significantly meaningful improvement over marketed products – for example, a broader spectrum of activity or reduced toxicity.
Visit the Broad Agency Announcement (BAA) page to learn more.
Similar to the challenges we face with antibiotic-resistant bacteria, there is also a need for new safe and effective therapeutics to treat drug-resistant fungal infections that are increasing in prevalence and can arise as secondary infections during a public health emergency. In addition to the rise of drug-resistance, available legacy treatment options have tolerability challenges, limited routes of administration, and/or narrow spectrum of activity.
We are supporting the development of novel, safer, next-generation antifungal candidates to address the emerging threat of drug resistant high-priority fungal pathogens (e.g., Candida spp. and drug-resistant Aspergillus fumigatus), to ensure the U.S. government is adequately prepared to respond to any public health emergency.
Visit the Broad Agency Announcement (BAA) page to learn more.
We are supporting the development of drugs for the post-exposure prophylaxis and treatment of biothreat pathogens. We are interested in antibacterial candidates with activity against one or more of the following biothreat agents: Bacillus anthracis, multidrug-resistant Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei.
Recognizing financial and development challenges persist following product approval, we support the late-stage development and post-marketing requirements of products for post-exposure prophylaxis and treatment of pathogens. Development activities can include: post-marketing commitments, label expansion studies, and studies in underserved patient populations like pediatrics [birth to 16 years], when scientifically and ethically appropriate.
In 2016, BARDA, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and Wellcome, launched the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) with the mission to “accelerate a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding, expert support, and cross-project initiatives.” Over the last six years, CARB-X has built on BARDA’s initial $200 million investment by expanding the partnership to include additional funders and growing to become the world’s largest public-private partnership dedicated to early development of antimicrobial resistance (AMR) products. Since its inception, CARB-X has advanced the development of over 100 innovative projects in 12 countries as part of a scientifically diverse portfolio.
In 2022, BARDA committed an additional $25 million to continue supporting CARB-X, with options to provide up to $300 million over the next 10 years. Through CARB-X, BARDA is revitalizing the pipeline of early-stage AMR candidates from which the U.S. government or international advanced development programs may select for future funding.
In 2014, the United States Government released the National Strategy for Combating Antimicrobial Resistant Bacteria. A component of the National Strategy was to establish a “biopharmaceutical incubator†for combating antibiotic-resistant bacteria, a novel concept proposed by BARDA, to revitalize the pipeline of product developers focused on preclinical and Investigational New Drug (IND)-enabling research and development. The proposed concept was designed to provide wrap-around services and early development activities that would help progress candidate therapeutic and vaccine products from the hit-to-lead stage through Phase 1 development, and support diagnostics products through early development. In 2016, CARB-X was launched.
Based out of Boston University, CARB-X now represents the world’s most diverse preclinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and preventatives, including microbiome and vaccine candidates. CARB-X continues to diversify their portfolio through contributions from Germany’s Federal Ministry of Education and Research, the UK Government’s Global Antimicrobial Resistance Innovation Fund, the Public Health Agency of Canada, the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. CARB-X also provides support to projects through their Global Accelerator Network and subject matter experts, many of whom have held senior positions at the U.S. Food & Drug Administration, emerging biotechnology companies, global pharmaceutical companies and academia. This international partnership oversees a unified investment strategy that identifies and fills gaps in critically needed antibiotics and other life-saving products to combat the most dangerous drug-resistant bacteria. As of July 2022, CARB-X has invested nearly $400 million and supported many successful candidates, including 11 products in first-in-human studies. Two companies have gone on to receive BARDA advanced research and development funding following the conclusion of their CARB-X contract.
Drug candidates demonstrating substantial improvements over existing antimicrobial products are important to the Antibacterials Program.
Priority is given to first-in-class compounds with novel mechanisms of action, including non-traditional modalities (e.g., bacteriophage, host-directed immunotherapeutics, etc.). Candidates need to address an unmet medical need and if possible, target a biothreat pathogen. Antibacterials within existing classes must demonstrate a significantly meaningful improvement over marketed products – for example, a broader spectrum of activity or reduced toxicity.
Visit the Broad Agency Announcement (BAA) page to learn more.
Similar to the challenges we face with antibiotic-resistant bacteria, there is also a need for new safe and effective therapeutics to treat drug-resistant fungal infections that are increasing in prevalence and can arise as secondary infections during a public health emergency. In addition to the rise of drug-resistance, available legacy treatment options have tolerability challenges, limited routes of administration, and/or narrow spectrum of activity.
We are supporting the development of novel, safer, next-generation antifungal candidates to address the emerging threat of drug resistant high-priority fungal pathogens (e.g., Candida spp. and drug-resistant Aspergillus fumigatus), to ensure the U.S. government is adequately prepared to respond to any public health emergency.
Visit the Broad Agency Announcement (BAA) page to learn more.
We are supporting the development of drugs for the post-exposure prophylaxis and treatment of biothreat pathogens. We are interested in antibacterial candidates with activity against one or more of the following biothreat agents: Bacillus anthracis, multidrug-resistant Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei.
Recognizing financial and development challenges persist following product approval, we support the late-stage development and post-marketing requirements of products for post-exposure prophylaxis and treatment of pathogens. Development activities can include: post-marketing commitments, label expansion studies, and studies in underserved patient populations like pediatrics [birth to 16 years], when scientifically and ethically appropriate.
