Public Health Emergency - Leading a Nation Prepared
BARDA has become a leader in the development of antibacterial medical countermeasures (MCMs) by forming unique public-private partnerships with industry. The goal is to drive innovation off the bench and into the hands of physicians to treat emerging biological health security threats, including antibiotic-resistant bacterial infections that the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have determined to represent a serious global health threat.New and better antibiotics with novel mechanisms of action are urgently needed to combat antibiotic resistance, enhance U.S. healthcare readiness, and strengthen national health security. BARDA is addressing that need by supporting the end-to-end development of products (early research through licensure and commercialization) and providing capital and technical expertise to pharmaceutical companies with novel antimicrobial drug candidates.
BARDA plays a critical role in the federal government’s National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB), 2020-2025. Because making new antibiotics is difficult, expensive, and low profit for innovative companies, BARDA supports the world’s largest antibacterial portfolio through public-private partnerships. These partnerships incentivize companies to focus on antibiotic development by providing non-dilutive funding to offset high research and development (R&D) costs and technical assistance to reduce R&D risk.Along with supporting antimicrobial products from development through marketing approval, BARDA is working to ensure that antibiotics used to treat infections from biothreat pathogens are appropriately stockpiled.
Co-founded by BARDA, CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership funding new antibiotics, vaccines, rapid diagnostics, and other products to prevent, diagnose and treat life-threatening bacterial infections.CARB-X’s Global Accelerator Network provides business, scientific, and technical expertise to CARB-X-funded product developers to support their antibacterial research projects focused on the most serious drug-resistant bacteria identified by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC).
In March 2020, Wellcome Trust, in partnership with CARB-X, launched a comprehensive Stewardship and Access Plan Development Guide to help product developers strategize and facilitate faster, broader access to innovative antimicrobials while fostering stewardship.The Stewardship and Access Plan Development Guide provides product developers with innovative guidance to promote effective stewardship and equitable access for antibiotics, helping to prepare the world to effectively respond to current and evolving bacterial threats.
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