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U.S. Department of Health and Human Services

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Project BioShield: Enhancing Preparedness, Ensuring Treatment Options

Author: Brian Tse, Oxana Selivanova, Claiborne Hughes, and Mark Albrecht
Published Date: 5/13/2019 9:42:00 AM
Category: Public Health Preparedness; Medical Countermeasures; National Health Security;


Stockpiling Novel Antibiotics Safeguards Nation, Sustains Commitment to Industry

Bacteria evolve and change, becoming more dangerous and deadly, and often developing resistance to existing medical countermeasures. Consider some of the resistance problems we face today. In recent years, we’ve seen increasing incidences of multi-drug resistant salmonella, gonorrhea, and typhoid, just to name a few examples. Now, think about what would happen if evolution or terrorists created antibiotic-resistant strains of biothreat agents, such as anthrax, plague, tularemia, melioidosis, or glanders. A bioterrorism attack or outbreak of drug-resistant forms of any of these agents could lead to a catastrophic loss of life.

Within ASPR, BARDA is working with its partners in private industry to support biothreat-focused antibacterial research and the development of medical countermeasures (MCMs) to overcome antibiotic-resistant infections, enhance U.S. healthcare system preparedness, and strengthen national security.


The Never-Ending Journey

Unfortunately, the enterprise of maintaining an effective antibacterial armamentarium is a never-ending journey; the importance of that point cannot be understated. The emergence of antibiotic-resistant bacteria means that existing antibiotics, long considered reliable medications, may not be effective. Moreover, the rapid progression of biotechnology means that antibiotic-resistant bioterror agents have been, or are increasingly accessible to, our adversaries.

In addition, antibacterials serve as a foundational element of our modern healthcare system, preventing or treating secondary opportunistic infections. Simply put, in order to save lives in a public health emergency, it is not enough to provide medical interventions for the primary injury or exposure – you must provide for the full continuum-of-care through to full patient recovery.

As part of ASPR’s broader mission to save lives and protect Americans from modern, evolving health threats, the Strategic National Stockpile (SNS) secures a variety of antibiotics that may be deployed nationwide as targeted medical countermeasures against these infectious agents.

We must continue to recognize that antimicrobial resistance is, in-and-of-itself, a threat to our national security, whether of deliberate or natural origin. To this end, the 2018 National Biodefense Strategy specifies a need to “reduce the emergence and spread of antimicrobial-resistant pathogens domestically and internationally,” with a specific call to “accelerate basic and applied research and development of new antimicrobials, novel preventatives and therapeutics, vaccines, and diagnostic tests.”

In response to the growing concern over biothreat agents, the strategy also makes a specific call to “prioritize the development and procurement of MCMs with the highest potential to reduce severe morbidity and mortality,” as part of a broader goal to “enhance MCM development, sustainment, and availability.”


BARDA partnerships drive results

BARDA is charged with preparing the nation for public health emergencies by directly supporting the development of new antibacterial products. Since 2010, BARDA has provided over $1.2 billion in non-dilutive funding, including grants, contracts, and other transactional agreements, to companies with antibiotic candidates that have the potential to address bioterrorism pathogens and the unmet medical needs created by antimicrobial resistance. Through these partnerships, BARDA has helped make possible the FDA approval of three new antibiotics (Rempex’s VABOMERE, Achaogen’s ZEMDRI, and Tetraphase’s XERAVA), all of which are available now on the commercial market to clinicians.

Taking advantage of the potential within the current antibacterials landscape, BARDA now is seeking to support late stage development and procurement of promising antibiotics to counter biothreat agents of concern. Such newly developed antibiotics hold the potential ability to overcome known mechanisms of resistance, and therefore augment drugs currently held in the Strategic National Stockpile (SNS). Through Project BioShield, BARDA partners with industry to support the necessary studies that may achieve a threat-specific indication and to procure initial supply of these antibiotics for the SNS.

By supporting biothreat-focused research of antibacterials, including those specifically designed to overcome antibiotic-resistant infections, BARDA can better prepare the U.S. healthcare system to respond to future public health emergencies.


The next step: advanced development under Project BioShield

BARDA is seeking antibiotics that can be used under Emergency Use Authorization (EUA) pre-approval or receive FDA marketing authorization to treat a biothreat pathogen (Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) for delivery to the SNS. The Request-for-Proposal (RFP) announced today describes the specific criteria involved in Project BioShield contract awards for advanced development of new antibiotics.

Any contract (or contracts) awarded will be designed specifically to support necessary late-stage development activities including non-clinical studies and Phase IV post-marketing commitments that will support approval of the agent(s) for a biothreat indication.

As substantial investments in biothreat-focused medical countermeasures, Project BioShield contracts also signal a commitment to private industry, which plays a vital role in biodefense by taking risks to bring new products to market. By acting as a potential buyer of critically-needed medical products, the government ensures that the SNS will remain relevant, robust and effective by way of sustained innovation.

Ultimately, BARDA’s acquisition of vital antibacterials using Project BioShield will enhance the biomedical preparedness of the nation by supporting and incentivizing the development of products for biothreat pathogens.


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