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Colleagues,

SourceLink: GenomeWeb

... HHS has unveiled a new multi-point plan aimed at better preparing the US to combat health emergencies such as the H1N1 flu, including development of nucleic acid-based technologies, new centers for medical research, partnerships with industry, enhancing manufacturing capabilities, and other approaches..


... The plan stemmed from a review of US medical countermeasure (MCM) capabilities that HHS Secretary Kathleen Sebelius called for in late 2009 – as a response to the H1N1 flu pandemic – that led to a new report loaded with recommendations for several US agencies...


... The review found that the US needs to: upgrade science and regulatory capacity at the Food and Drug Administration; develop manufacturing processes that can be used to produce more than one type of countermeasure; and that “some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing,” ...


... In response to those points, HHS plans to “make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market,”...

...HHS also plans to release a solicitation in the coming weeks to fund one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will support new manufacturing platforms to develop a range of countermeasures and would help meet demand for such facilities in the US ...Another response will be to use the center(s) as a resource for new companies by helping to bring MCM products to market...

... HHS also said that the government must be better at nurturing new discoveries in their early phases, and so it will create new teams at the National Institutes of Health to identify promising research and to help move it forward..


Read on at:  The Public Health Emergency Medical Countermeasure Enterprise Review:
Transforming the Enterprise to Meet Long Range National Needs
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CC

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