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New U.S. Organizations to Support Bioterrorism Medical Preparations

VaxGen laboratory technicians display an experimental anthrax vaccine in 2006. The U.S. Health and Human Services Department on Monday launched three centers intended to facilitate the development and production of vaccines and drugs for countering potential bioterrorism incidents and natural disease outbreaks (AP Photo/Benjamin Sklar). VaxGen laboratory technicians display an experimental anthrax vaccine in 2006. The U.S. Health and Human Services Department on Monday launched three centers intended to facilitate the development and production of vaccines and drugs for countering potential bioterrorism incidents and natural disease outbreaks (AP Photo/Benjamin Sklar).

Several organizations launched in the United States on Monday are intended to harness government and independent resources in preparing and producing medical products for treating deliberate and natural disease outbreaks, the Health and Human Services Department said (see GSN, May 29).

The Centers for Innovation in Advanced Development and Manufacturing would supply the nation's "first major domestic infrastructure" suited to generate drugs for biological terrorism defense and other public health purposes, an HHS press release states. The department's Biomedical Advanced Research and Development Authority would supervise the execution of funding arrangements with the three newly created groups; the deals would provide $400 million in their early stages and could remain in place for as long as 25 years under included extension measures.

Each of the three entities would create new production sites or update present locations with adjustable mechanisms able to generate multiple medical goods. Up-to-date cell- and recombinant-based vaccination systems would be operated at the sites, enabling possible generation of vaccines at lower costs and faster speeds, the department said.

Nongovernmental participants in the groups would supply 35 percent of early stage construction funds, and the department would underwrite later activities and sustainment efforts. The entities would incorporate novel approaches from biological technology companies; personnel preparation knowledge from education and research entities; and production know-how associated with well established drug companies, the document states.

“Establishing these centers represents a dramatic step forward in ensuring that the United States can produce lifesaving countermeasures quickly and nimbly,” Health and Human Services Secretary Kathleen Sebelius said in the statement. “They will improve our ability to protect Americans’ health in an emergency and help fill gaps in preparedness so that our nation can respond to known or unknown threats” (U.S. Health and Human Services Department release, June 18).

One of the three entities would operate under Maryland-based biopharmaceutical firm Emergent BioSolutions with support from Michigan State University, Kettering University in Michigan and the University of Maryland, the Center for Infectious Disease Research and Policy reported on Monday. Emergent said the government would provide $220 million for the group in the first eight years; the department, though, said it would supply $163 million over the same period.

Novartis would tap its vaccine production site in North Carolina as leader of the second entity, which would also involve North Carolina State University and Duke University in the state. The group is set to receive $60 million in a 48-month period.

Texas A&M University would head the third operation, which would also involve GlaxoSmithKline Vaccines, Lonza Houston and Kalon Biotherapeutics. The department is set to provide the group with $176 million across five years.

A 2010 HHS assessment of U.S. biological defense preparations advocated arrangement of such entities. The President’s Council of Advisers on Science and Technology that year issued separate advice also informing the new program (Center for Infectious Disease Research and Policy release, June 18).

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