Public Health Emergency - Leading a Nation Prepared
The nation has endeavored over the past ten years to become better prepared for the medical consequences of catastrophic events such as bioterrorist events and pandemic influenza. During that time period Project BioShield, The National Strategy for Pandemic Influenza, and the Biomedical Advanced Research and Development Authority have emerged to support the development and acquisition of medical countermeasures (MCMs) and the domestic manufacturing capacity to prepare for and respond to an emergency. Where very limited medical countermeasures were available in 2001, there are now vaccines, therapeutic drugs, and diagnostic devices for anthrax, smallpox, botulism, and pandemic influenza and a robust pipeline of products in development for these and other threats. While only one manufacturing site existed in the U.S. during the influenza vaccine shortage of 2004, now there are three with more on the way. Yet there is much more work to be done, and a clear path is needed to guide the way.
Thus I am pleased to provide an update of the BARDA Strategic Plan for 2011-2016. The Plan describes our strategic goals and vision to accomplish BARDA's mission over the next five years and beyond to develop and provide medical countermeasures for Chemical, Biological, Radiological, and Nuclear threats, pandemic influenza, and emerging infectious diseases. The implementation measures to achieve these strategic goals include support of product advanced development, stockpile acquisition, manufacturing surge capacity infrastructure building, and product innovation. These medical countermeasures include vaccines, biological and small molecule therapeutics, antiviral drugs and antibiotics, diagnostics, respiratory devices, and other medical supplies.
As BARDA completes its fifth year of existence, the results of our advanced development support are becoming evident with a robust product development pipeline for nearly all threats. Many of these products in the development pipeline will become mature enough for acquisition and regulatory review over the next five years. Initiatives recommended by the 2010 Public Health Emergency Medical Countermeasure Enterprise Review are expected to enable more of the MCM products to become available as FDA-licensed approved or cleared products. BARDA will lead several of these initiatives including the establishment of Centers for Innovation in Advanced Development and Manufacturing and the Medical Countermeasures Strategic Investor. Greater emphasis on multi-purpose MCMs and more flexible and innovative manufacturing technologies will make improved and greater quantities of MCMs available sooner. MCMs and manufacturing capabilities that afford the nation the ability to respond immediately to known and unknown threats will be high priorities.
The BARDA Strategic Plan is a dynamic process with the steadfast aim to enhance national MCM preparedness and the flexibility to adopt better technologies, meet unforeseen challenges, and avoid unnecessary risks. MCM preparedness and response and this Plan are the results of the dedicated professionals at BARDA, ASPR, and across federal, State, local, and industry sectors. I wish to thank them for their tireless efforts to ensure that ours is "a nation prepared."
Robin A. Robinson, Ph.D., Director
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