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U.S. Department of Health and Human Services


Building a Better Pipeline of Candidate Products for Project BioShield

Author: By Rick A. Bright, Ph.D., BARDA Director
Published Date: 7/31/2019 9:38:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Project BioShield has revolutionized the way we protect Americans from 21st century health security threats. Our ultimate goal is to save lives during a national disaster; we prepare for this eventuality by pursuing FDA approval and availability of countermeasures in preparation for such emergencies. The government alone cannot fill the need for medical products to save lives in public health emergencies and disasters; public-private partnerships are essential every step of the way.

BARDA’s approach to public-private partnerships is remarkable. We reduce business risk, we provide non-dilutive cost-sharing, and we offer technical expertise from our deeply experienced staff within BARDA. We partner with pharmaceutical and biotech companies across the spectrum, from some of the world’s largest companies to small, promising startups. Together, we’re seeing record success in developing products under Project BioShield that otherwise wouldn’t exist.

Project BioShield isn’t just a funding mechanism; it’s a commitment to Americans and a commitment to our industry partners.  Moving a medical countermeasure from a good idea to an FDA approved product takes a strong commitment in time, expertise, and long-term investment. Yet in implementing the Project BioShield Act, we discovered another gap:  a lack of products in research and development that were advanced enough to become candidates for late-stage development and purchase through Project BioShield.

Over the last 15 years, BARDA has leveraged unique partnerships, funding, strong technical expertise and interagency coordination to strengthen the medical countermeasure pipeline so products reach late-stage development support and, ultimately, become available to protect Americans and save lives.

Partner with Private Sector on Advanced Research and Development

Many of the projects currently funded under Project BioShield received BARDA support for their advanced research and development. In 2006, the Pandemic and All-Hazards Preparedness Act authorized BARDA to “accelerate countermeasure and product advanced research and development”. Today, BARDA awards advanced research and development funds based on proposals submitted under our rolling BARDA Broad Agency Announcement (BARDA BAA). 

Under the BARDA BAA, companies, large or small, can apply for advanced research and development funding for vaccines, therapeutics, diagnostics, and devices to address chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases – a total of 17 areas of interest. Once these products mature, some may be supported by Project BioShield, subject to the availability of funds and national health security needs. Some products also may be supported by the private sector for common medical needs in the commercial market.

Combat Biothreats with Global Partnerships

We know antimicrobial resistance poses not just a public health threat but also a national security threat, either because the infections caused by biothreat agents could be resistant to antibiotics or because antibiotic resistant infections develop in people exposed to many threats, regardless of their nature. In 2010, we recognized research and development of new antibiotics had collapsed in the private sector and that no products to combat this threat were advanced enough for Project BioShield.

To help stimulate the industry and revitalize the pipeline, BARDA began supporting development of novel antibiotics – three of which are now FDA approved – to combat antimicrobial resistant infections and biothreats, and co-sponsored the world’s largest public-private partnership to combat antibiotic resistance:  CARB-X.

Today, CARB-X supports nearly 30 products in its portfolio, and CARB-X partners continue to fund new, innovative technology and products to combat antibiotic resistance. In the process, CARB-X partners are revitalizing the early stage antibiotic pipeline, which strengthens the pool of potential candidates from which NIAID’s early R&D and BARDA’s advanced R&D programs may select. From there, these products could become candidates for Project BioShield funding. Development also can be completed by private companies.  This year, due to progress made under advanced research and development, BARDA released the first request for proposals under Project BioShield for antibiotics to combat biothreats. 

Coordination between Federal Agency Partners

Some of the products BARDA has supported under Project BioShield transitioned to BARDA after companies had collaborated with the Department of Defense or the National Institutes of Health on early phases of research and development. This multi-agency pipeline approach began with a smallpox vaccine, available now only because of two decades of federal support and industry collaboration.

The vaccine transitioned from discovery and early development with support from DoD and NIH to advanced development support from BARDA with late-stage development under Project BioShield. This smallpox vaccine is not only part of our national health security but also part of the U.S. commitment to develop vaccines and treatments against smallpox infections to protect global health security.

BARDA continues to work with its partners throughout the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to ensure smooth transitions between federal agencies involved in medical countermeasure development. The PHEMCE Multiyear Budget details the funding priorities for the near-, mid-, and long-term.

The Path Forward

Under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA).  PAHPAIA, Congress reauthorized Project BioShield’s Special Reserve Fund and authorized 10-year funding for product development.

With such strong federal commitment, the Project BioShield portfolio continues to grow and evolve. We will continue to forge strong partnerships to develop next-generation medical countermeasures in response the ever-changing threats to biosecurity. If your company is interested in partnering with BARDA on medical countermeasures to strengthen health security, join us for a TechWatch meeting to discuss your product ideas and check out our broad agency announcement.


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