People in the United States and across the globe can be affected by new infectious diseases, by a virus that spreads globally – a pandemic – or by bioterrorism. These threats to the health of every one of us, our families, friends and neighbors can be catastrophic to our nation’s economy and way of life.
The most recent pandemic – H1N1 – wasn’t as severe as some health professionals and scientists know pandemics can be. Yet H1N1 reminded scientists, government officials, and pharmaceutical companies that there are still formidable challenges in developing, manufacturing, and distributing the medications, vaccines, medical tests, equipment and supplies – known as medical countermeasures – needed to combat catastrophic health threats. To protect health and save lives, we needed a better way to develop, produce, distribute, and license these medical countermeasures.
During the 2009 H1N1 pandemic, the Secretary of Health and Human Services called on the Assistant Secretary for Preparedness and Response (ASPR) to lead a review of the entire medical countermeasure enterprise – from discovering a possible medical countermeasure to licensing the products – to bring the nation the nimble, flexible surge capability needed to develop, test, and produce more and better medical countermeasures sooner in the face of any attack or threat, whether known or unknown, new and unique or reemerging, natural or intentional. The report was released in August 2010 and focused on five major initiatives.
Over the past year, federal agencies have improved the way the nation develops these products. The federal government is working collaboratively to ensure that the medical countermeasure enterprise is more strategic and integrated than ever before and is moving forward to serve our nation in protecting health and saving lives.
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21st Century Regulatory Science
The medical countermeasure review found that we needed to do more to promote regulatory innovation and invest more in regulatory science and provide private sector partners with more access to regulators and greater clarity about the pathways to product approval. Learn More >> |
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Centers for Innovation in Advanced Development and Manufacturing
The review found that many developers of medical countermeasures for biothreats were inexperienced in the complete lifecycle of complex countermeasure development, manufacturing and licensing. Learn More >> |
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Concept Acceleration
The review found that the nation needed to develop a new capacity to identify and incubate promising research or discoveries to better fuel the medical countermeasure pipeline. Learn More >> |
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Flu Vaccine Manufacturing Improvements
The review also found that the federal government needed to do more to increase the timely production of influenza vaccines in sufficient quantity and potency to protect the nation against novel strains of virus. Learn More >> |
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Establish a Strategic Investor
The medical countermeasure review also found “start up” companies have difficulty finding investors willing to support development of medical countermeasures. Learn More >> |