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Adding the 'Rapid Response' to Vaccine Development for Emerging Pandemics
Distinguished NSF-, NIH- and USDA-Sponsored Panel Invites CHORI's Terrance Leighton, PhD, to Participate in a Study on Rapid Response Vaccine Development

A variety of government agencies, including the National Science Foundation (NSF), National Institutes of Health (NIH), National Institute of Standards and Technology (NIST) and the United States Department of Agriculture (USDA) have joined forces to establish a panel of experts charged with the task of addressing ways in which to make rapid vaccine development, manufacture and distribution a reality. The need for such a study is based on the concept that while any disease that emerges anywhere in the world is but one day away by international travel, it currently takes 14 years to produce a new vaccine that would protect against emerging epidemics.

By investigating research trends, leading-edge innovations, chocking points in the process, needs and gaps, the panel hopes to be able to reduce the time it takes from the first isolation of a new virus to the mass availability of a vaccine from 14 years to 6 months.

"There haven't been many studies that tried to this kind of end to end process assessment, identifying new opportunities and innovations, what barriers currently exist, and how they can be addressed, either by science and technology or by some type of imaginative regulatory approach," says CHORI principal investigator Terrance Leighton, PhD , one of only 2 basic scientists asked to be on the 6 member panel.

Previous attempts have been hampered by either addressing the problem primarily from the basic science perspective without taking engineering and production into account, or visa versa. This is the first time that all the agencies involved in vaccine development, end to end, have been brought together to address the issue from a systemic perspective.

"They are all individuals who have rich and deep experience in particular areas," says Dr. Leighton of the study panel members. "Some have had careers at major pharmaceutical manufacturers, some are people who have managed vaccine development for federal agencies, and some are basic science people like me."

A premier researcher in CHORI's Center for Immunobiology and Vaccine Development, a national expert on new medical countermeasure technologies to address pathogen exposure, and having served as the lead biologist for the Environmental Protection Agency (EPA) Emergency Response Team's anthrax remediation efforts, Dr. Leighton brings formidable expertise to the distinguished panel. Along with his efforts, the panel so far has discovered a number of significant findings that have been presented at scientific and policy forums in January and March of 2007.

"We've determined that we generally do a good job in the United States at the basic science discovery and innovation stages, but connecting those elements to production of products that are demonstrably effective in humans is not nearly as efficient here as in Europe," explains Dr. Leighton.

Preliminary findings suggest this is due to the fact that there are much closer alliances between universities, research institutes and commercial vaccine developers in Europe than in the U.S., and Europe could provide a model for how to move forward. The panel is expected to produce a final report within a few months that will help define new areas of high promise and the potential for innovation in science, engineering and protocols for regulatory approval.

"It's clear that there are some pieces of the puzzle that we have, some that the Europeans have, and the best outcome would be to try to merge those strengths to the general advantage of public health protection," says Dr. Leighton.

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Monday, May 16, 2011 11:33 PM

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