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PATH pays FDA for vax development

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The nonprofit group PATH is seeking help from the FDA to develop a vaccine against diseases caused by the Streptococcus pneumoniae bacteria, which kills almost 1 million children each year. And the group is willing to pay $480,000 for the agency's expertise.

The collaborative project, which is expected to run for two years, is being conducted under the Cooperative Research and Development Agreement program. Under the agreement, PATH will help the FDA obtain materials needed for the agency to develop the conjugate vaccine technology. The group then will pay the agency for the development of both the conjugation technology and certain tests, according to an FDA statement.

If the vaccine technology proves successful, the CRADA permits transfer of the technology to the China National Biotec Group's Chengdu Institute of Biological Products, and eventually to groups in other developing countries.

The New York Times notes that while it's unusual for a government agency to be paid by a charity, the work is being done under a law that lets federal laboratories speed outside research in some cases. "The collaboration with PATH is an example of how the FDA applies technologies it develops to public health issues in the United States and throughout the world under the agency's Critical Path Initiative," Karen Midthun, acting director of the FDA's CBER, says.

- read the FDA announcement
- check out the NYT coverage

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Big Pharma maps out a global vaccine strategy

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