Public Health Emergency - Leading a Nation Prepared
Author: Mark Albrecht, Ph.D., Branch Chief, Anti-Bacterial Program, ASPR/BARDA Division of CBRN Countermeasures; Cameron Bess, Ph.D., Biologist and Project Officer Antibacterials Program, ASPR/BARDA Division of CBRN Countermeasures; and Jessica Swenson, MPH, Program Analyst, Antibacterials Program, ASPR/BARDA Division of CBRN Countermeasures. Published Date: 6/8/2021 7:09:00 PM
Category: Medical Countermeasures; Innovations;
Although the battle against COVID-19 has been a primary focus over the past 16 months, the Biomedical Advanced Research and Development Authority (BARDA) has remained committed to developing solutions against a wide range of other threats as well.
One critical area of focus is the development of antibacterial medical countermeasures to combat antimicrobial resistance (AMR) through a variety of mechanisms including a global accelerator program BARDA co-founded. This non-profit partnership funds early-stage research of innovative and transformational technologies for the diagnosis, prevention and treatment of life-threatening, AMR bacterial infections to tackle this growing global threat.
As the current effort approaches the end of its planned five-year period of performance, BARDA is reaffirming its support for early-stage AMR product development. Building off the first accelerator’s successes over the past five years ($333 million invested in 89 innovative projects, 59 of which are currently active in 11 countries), BARDA is announcing its commitment to invest in a second iteration of a global AMR accelerator program.
This program maintains BARDA’s commitment to revitalize the pre-clinical pipeline and ensure that the most innovative and impactful diagnostics, vaccines and drugs are made available to prevent and treat infections caused by the most serious strains of multidrug-resistant (MDR) bacteria. Continued support of this program is critical to ensure that the United States, and the world, does not lose the race against AMR bacteria that threaten both our health and economic security.
According to the 2019 Centers for Disease Control and Prevention (CDC) Report on Antibiotic Resistance Threats, each year more than 2.8 million Americans develop a drug-resistant infection and more than 35,000 die from them. A recent Infectious Diseases Society of America (IDSA) report estimated that the combined cost to treat these community and healthcare associated infections in the US was $4.6 billion in 2017. According to the 2019 report to the Secretary-General of the United Nations, No Time to Wait: Securing the Future from Drug-Resistant Infections, over 700,000 people are killed every year from drug resistant infections globally, and that number could increase to 10 million without proper efforts to contain AMR.
Developing new antibiotics is difficult, expensive, and typically has a too-low return on investment in the current market paradigm. These factors have played a key role in manufacturers shifting their efforts away from the development and manufacture of new antibiotics to focus their efforts on more financially lucrative therapeutic areas.
Experience shows that effective emergency response for pandemics and other public health emergencies requires effective therapeutics to treat and care for victims following mass casualty incidents; this includes the prevention and treatment of secondary bacterial infections that can arise in these patients as a result of their injuries or illnesses caused by the main incident. The impact of these infections is more pronounced when they are caused by MDR bacteria, which can complicate any public health emergency response, requiring even more resources and patient care than the incident alone would have required.
In addition to founding and supporting a global partnership to accelerate research and development (R&D) of antimicrobial products, BARDA provides non-dilutive funding to offset high R&D costs and technical assistance to reduce R&D risk. Combined, these benefits incentivize and enable companies to focus on the R&D of truly transformative antibacterial candidates for which a stable market does not yet exist.
Through the antibacterial program, BARDA has supported 28 public-private partnerships with industry since 2010, ranging from small biotechnology firms to global pharmaceutical companies, and currently has a portfolio of 16 antibacterial drug candidates across all phases of development including preclinical, Phase 1, Phase 2, Phase 3, and post-approval.
These 16 candidates target drug-resistant bacterial pathogens identified by the CDC in the Antibiotic Resistance Threats in the United States, 2019 (2019 AR Threats Report), as “urgent” threats, as well as a majority of those threats categorized as “serious.” Recognizing the importance of investing in diverse approaches, the BARDA portfolio includes a mixture of traditional small molecule antibiotics as well as non-traditional candidates.
The BARDA Antibacterials program recently passed the 10-year anniversary mark and will continue to invest in transformative, next-generation antimicrobial approaches. We will build on the foundation of investments of over $1.5 billion to date (partner cost-share in excess of $3.5 billion) and three U.S. Food and Drug Administration (FDA) approvals of new antibiotics.
Recognizing the capital-intensive nature of post-approval requirements and clinical trials supporting the use of antibiotics in underserved patient populations like pediatrics, the program will work with companies to support these studies and improve the chance of success following a product’s approval and commercial launch.
Every year, hundreds of thousands of Americans are harmed as a result of antibiotic resistance. Even during the ongoing COVID-19 pandemic response, the U.S. government is prioritizing the health security threat posed by AMR bacterial infections.
BARDA remains committed to expanding the development pipeline and accelerating the progression of products that address medical needs and combat AMR infections to save lives. We encourage biotech, pharmaceutical, academic, and healthcare organizations to join us in these efforts, and if your organization meets the criteria for our next antibacterial accelerator, apply under our BARDA broad agency announcement (BAA) Amendment #25, Special Instructions Issuance for the Area of Interest #3.4 Antibacterial Accelerator (PDF) of the BARDA BAA (BAA-18-100-SOL-00003).
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