President's Council and HHS Call for Overhaul of Pandemic Response Programs - - BioPharm International


President's Council and HHS Call for Overhaul of Pandemic Response Programs

BioPharm Bulletin

The US Department of Health and Human Services (HHS) and the President’s Council of Advisors on Science and Technology (PCAST) have called for an overhaul of the nation’s pandemic response system.

In separate documents, the two organizations recently detailed ways to increase manufacturing ability for vaccines and other medical countermeasures against infectious diseases. These include moving from egg-based vaccine production to cell-culture-based systems, expanded use of attenuated viruses, and further research of adjuvants.

There were a number of areas target for improvements, including better surveillance to accelerate the detection of emerging viruses, the development of stock seed viruses to allow faster production of specific virus strains, developing better sterility tests, developing more reliable potency-test reagents, and enlarging the fill–finish capacity of vaccine production.

The HHS report found that there is a need for manufacturing processes that can be used for multiple purposes, not just one type of countermeasure. This finding resulted in a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing that will focus on manufacturing platforms that can produce a variety of products.

The HHS report also found that the most promising research on countermeasures was being performed at small biotechs that had no experience with large-scale manufacturing. Therefore the Centers of Innovation also will serve as a resource for these small biotechs, to help them bring their products to market.

The PCAST report states that annual investments of $1 billion or more for several years is justified. “Federal investments in influenza pandemic response would speed development of technical platforms and production facilities that would support medical countermeasures against a variety of other dangerous pathogens,” the report says.

Both the PCAST report, Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza, and the HHS report, The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs, were prepared as a result of the H1N1 pandemic.

The HHS report can be found on the Public Health Emergency web site

and the PCAST report can be found on the PCAST web site.

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