Public Health Emergency - Leading a Nation Prepared
September 21, 2010: The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) announced the first eight contract awards under an initiative to help modernize and improve the nation’s infrastructure for producing medical countermeasures that protect against natural and man-made biological threats.
The contracts help advance innovative tools and techniques that reduce the time and cost of development, testing, and production of medical countermeasures and that improve the safety, efficacy, and ease of use of these products. These contracts total $55 million for the initial phase and up to $100 million over three years.
Identifying innovative solutions to the challenge of preparing for and responding to public health emergencies is a key focus for BARDA under its authorizing legislation, the Public Health Service Act as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA).
The importance of fostering innovation was strongly emphasized in Public Health Emergency Medical Countermeasure Enterprise Review released by HHS Secretary Kathleen Sebelius in August 2010, which reviewed the federal government’s system for producing medical countermeasures. The review found that new technologies and approaches that allow the system to operate more efficiently are needed to overcome current bottlenecks and restrictions that can delay and limit an effective countermeasure response.
The eight contracts will support the development and evaluation of technologies that can apply to specific countermeasures, but may also have broader applicability and thus enhance the capabilities of the overall countermeasure infrastructure.
Recipients of the contracts are VaxDesign Corporation, Orlando, Fla.; PATH, Seattle, Wash.; Infectious Disease Research Institute (IDRI), Seattle, Wash.; Pfenex, Inc., San Diego; Novartis Vaccines and Diagnostics, Cambridge, Mass.; Rapid Micro Biosystems, Bedford, Mass.; 3M, St. Paul, Minn; and Northrop Grumman Security Systems, Baltimore, Md.
The contracts support the following innovations:
VaxDesign will further develop its MIMIC platform, an in vitro (test-tube-based) human immune system mimetic designed to accelerate evaluation of candidate and stockpiled vaccine safety and effectiveness by supplementing animal testing.
PATH will test multiple innovative formulation chemistries and strategies to increase the shelf-life of influenza vaccines, which has implications for the national vaccine stockpile as well as cold-chain requirements domestically and in developing countries.
IDRI will develop and evaluate innovative adjuvant formulations to enhance influenza vaccine immunogenicity and cross-protection to make them more effective against novel viral strains that may cause the next pandemic.
Pfenex will apply its innovative Pfenex Expression Technology Platform to the development of optimized bioprocesses for high yield production of a stable candidate anthrax vaccine.
Novartis Vaccines and Diagnostics will address a critical issue in the time required to begin manufacturing of influenza vaccine against a newly identified strain by investigating techniques for the rapid development of optimized influenza seed virus.
Rapid Micro Biosystems will address a critical issue in the time required for release of influenza vaccine after manufacturing by developing methods for accelerated sterility testing. Together, these improvements could shave weeks off the influenza vaccine manufacturing and product release schedule.
3M and Northrop Grumman will develop integrated diagnostic capabilities for rapid, high-throughput surveillance and molecular diagnostics.
In addition to fulfilling BARDA’s mandate for innovation under the Public Health Service Act, several of these awards also directly address recommendations in the report from the President’s Council of Advisors on Science and Technology on Reengineering the Influenza Vaccine Production Enterprise. Specifically addressed are technologies for influenza surveillance, seed virus generation, and sterility testing, as well as continued support of egg-based and adjuvant technology.
These contracts were awarded using a contracting tool called a broad agency announcement (BAA). The Innovations BAA solicits proposals for work in four broad categories of medical countermeasure development: technology to accelerate evaluation of candidate vaccines and therapeutics; formulation chemistry, protein stabilization, and vaccine delivery technology; innovative methods in bioprocess development and manufacturing; and methods and technology to advance development of diagnostic tests for rapid diagnosis of human infections.
A focus of the broad agency announcement is to identify “platform” technologies that have the potential to apply to multiple products and programs. Many technologies are first introduced to BARDA via its web portal, www.medicalcountermeasures.gov, and its TechWatch program, which provides an opportunity for external organizations to meet with the federal government to discuss their new and innovative medical countermeasure technologies.
These meetings provide the federal government with the latest information about emerging technology and inform strategic and programmatic planning for effective public health emergency response.
BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, and pandemic influenza, and emerging infectious diseases.
The Public Health Emergency Medical Countermeasure Enterprise Review is available at http://www.phe.gov/preparedness/mcm/enterprisereview/pages/default.aspx and Reengineering the Influenza Vaccine Production Enterprise can be found at http://www.whitehouse.gov/administration/eop/ostp/pcast.
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