the-scientist.com
By John Dudley Miller
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NEWS
New U.S. biodefense agency signed into law
BARDA aims to facilitate product development by filling the funding gap between testing and commercialization
[Published 11th January 2007 02:11 PM GMT]
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Last month, U.S. President George Bush signed into law the US Biodefense Advanced Research and Development Authority (BARDA), designed to speed up the development of biodefense countermeasures by funding products in the so-called advanced development stage, between the end of initial testing and commercial manufacture. However, many details about how the new entity will operate -- and its potential effect on existing drug research and development -- have not yet been entirely settled.
BARDA, a program of the Department of Health and Human Services (HHS), is intended to reinvigorate Project Bioshield, the HHS agency created in July 2004 to stockpile anti-bioterror drugs and vaccines. Project Bioshield has been criticized by large pharmaceutical companies who claim its provisions make biodefense manufacturing too risky and not profitable enough, while smaller companies interested in bioterror research say they have lacked the financial backing to develop these products.
One example of a company that might have been helped by BARDA is VaxGen, the small California biotech whose $877.5 million contract to create a new anthrax vaccine was cancelled by HHS in December because its vaccine broke down too quickly to survive long storage. VaxGen, a small biotech with limited funds, could not afford to try a different formulation; under BARDA, VaxGen might have been eligible for periodic payments to find a solution.
It is not yet clear how BARDA will distribute its anticipated funding ($1.07 billion through fiscal year 2008). Although Senator Richard Burr (R-NC), the legislation's Senate sponsor, has said that BARDA will act as an "aggressive venture capitalist," HHS spokesman Bill Hall told The Scientist the BARDA legislation doesn't give his agency the authority "to start infusing cash into organizations in a fashion akin to ?venture capitalists,'" who typically invest money in return for partial ownership in companies.
Sen. Burr has also suggested that BARDA could fund universities and research institutions to do advanced development -- in effect, to become drug manufacturers themselves. Although this novel opportunity could point to more profits for universities, it might also spell trouble, according to some experts. Anthony Sinskey, co-director of the Program on the Pharmaceutical Industry at the Massachusetts Institute of Technology Sloan School of Management, said, "University people can't do [manufacturing] well. They think they can but they can't." Mani Subramanian, who is overseeing the construction of a small biologics manufacturing plant at the University of Iowa, agreed. "The university is not a good place to develop large-scale process and manufacturing."
The BARDA legislation was designed so there would be little overlap with the National Institutes of Health -- NIH will handle basic research, and BARDA will develop and manufacture the drugs. "So I really look at it very much so as a complimentary thing, not that they're going to be encroaching on our turf at all," said Tony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).
Since September 11, 2001, NIAID has been in charge of deciding what basic bioterror research the nation will fund. According to a spokesperson for Sen. Burr, NIAID will keep that role, and the BARDA director will be "much more of a requirements-driven person," creating products public health officials want. So could there someday be a conflict, with BARDA disagreeing with NIAID about which research to fund? "I would imagine that that may happen," she said. "But what I'm not saying is that NIH is going to completely change their course of business." NIH will still make the final decisions, she said.
Diane Griffin, president of the American Society for Microbiology, agreed the new agency likely won't butt heads with NIH. "I don't think people are too concerned that that this is going to happen," she told The Scientist.
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