BARDA Releases Five-Year Plan to Combat CBRN Threats

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The U.S. Biomedical Advanced Research Development Authority (BARDA) has released a five-year strategic plan that, among other forecasts, anticipates there will be a number of new projects to combat biological and chemical threats ready for regulatory review in the next few years.

BARDA has presently a robust development pipeline of more than 70 medical countermeasures for chemical, biological, radiological and nuclear threats, according to Robin Robinson, PhD, Director for the Biomedical Advanced Research and Development Authority and Deputy Assistant Secretary for the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response.

The mission of BARDA is to develop and provide countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases by product development, stockpile acquisition/building, manufacturing infrastructure building, and product innovation.

“BARDA must provide a Strategic Plan to comply with the Congressional mandate in the Pandemic and All-Hazards Preparedness Act of 2006 that created BARDA,” said Dr. Robinson. “The BARDA Strategic Plan 2011-2016 provides five broad goals and interest on several new specific medical countermeasures including host immuno-modulators as mitigation measures in the absence of the identity of a specific biothreat pathogen.”

The five goals BARDA sets forth in its Strategic Plan are:

1) An advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs, emphasizing innovation, flexibility, multi-purpose and broad spectrum application, and long-term sustainability

The strategies to pursue this goal include promoting the development and acquisition of needed medical countermeasures by maintaining—and where appropriate, expanding—the portfolio of medical countermeasures against CBRN threats and pandemic influenza, and establishing a program to support the development of platforms and countermeasures to address the threats of emerging infectious diseases and antimicrobial resistance. 

 2) A capability base to provide enabling core services to medical countermeasure innovators

 BARDA plans to provide core product development services by establishing the Centers for Innovation in Advanced Development and Manufacturing (CIADM), which will have the capability to support analytical testing, scale-up manufacturing, manufacturing process optimization; provide regulatory and quality expertise and analytical and process validation support; and produce clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots for stockpiling; developing and qualifying animal models through the new Animal Models Development Program; and performing GLP efficacy evaluation and testing of CBRN countermeasures in qualified animal models.

3) Agile, robust and sustainable U.S. manufacturing infrastructure capable of rapidly producing vaccines and other biologics against pandemic influenza and other emerging threats

Strategies to be pursued by BARDA are to speed the delivery of pandemic influenza vaccines following the emergence of an influenza virus with pandemic potential by developing improved vaccine seed strains, sterility tests, and potency reagents and testing; expanding the number of FDA-licensed influenza vaccines, to include cell-based products; supporting the development of faster, more scalable next-generation recombinant influenza vaccines;  completing the development and evaluation of adjuvanted pandemic influenza vaccines; an d optimizing the BARDA emergency manufacturing response.

4) Responsive and nimble programs and capabilities to address novel and emerging threats

To achieve this goal BARDA plans to develop a formal methodology to identify medical countermeasure projects that are appropriate for inclusion in the BARDA Emerging Infectious Diseases portfolio, and implement a long-term strategy to address previously undefined threats by expanding BARDA’s Broad Spectrum Antimicrobials and Innovations programs, emphasizing the development of multipurpose and/or broad-spectrum products, Investing in capabilities (platforms and facilities) for the rapid development and production of countermeasures, and investing in the development of host- directed therapeutics, such as small molecule immune modulators, anti-inflammatory agents, and regulators of innate immunity.

5) A ready capability to develop, manufacture and facilitate distribution of medical countermeasures during public health emergencies

BARDA’s strategies here are to refine BARDA planning and readiness capabilities by drawing on the many lessons learned during the pandemic, and in concert with the ASPR Office of Preparedness and Emergency Operations and in close coordination with CDC, FDA, and other U.S. Government departments and agencies, develop comprehensive plans that will facilitate the response to future pandemics, CBRN events, and emerging epidemics.

Robin Robinson, PhD, is the Director for the Biomedical Advanced Research and Development Authority and Deputy Assistant Secretary for the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response.  He will be speaking at IDGA's 7th Annual CBRNe Defense conference, to be held from Jan. 30-Feb. 1, 2012 in Washington, DC.

Contributor:   Christopher Dauer

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Report Abuse   beth.roberson 12/15/2011 2:16:09 PM EST ATTN Editor: Please re-post this article to include all content as only goals 4 and 5 are shown. Thanks. Replies (0) Post a reply Sign in or Sign up to post a comment