New facility to test drugs, vaccines for FDA approval

The Medical Countermeasure Test and Evaluation Facility, scheduled to be completed in 2018, will be built at the north end of Fort Detricks biodefense campus.

The federal government is working on a new area at Fort Detrick to research and test new drugs and vaccines on animals for military and civilian purposes.

An environmental impact study has been ordered for the Medical Countermeasure Test and Evaluation Facility, which is expected to be completed in 2018.

The $584 million, 460,000-square-foot facility will be used for the testing of medical countermeasures on animals, the final step before Food and Drug Administration approval of drugs and vaccines. Non-human primates will be primary test subjects, but a secondary species -- most likely rodents -- will also be used for testing.

The facility, to be located on the north side of Detrick's biodefense campus, will be overseen by the military and other government agencies but run and staffed largely by contractors.

About 275 civilian employees will eventually work in the building.

George Ludwig, civilian deputy principal assistant for research and technology at Fort Detrick, said the project will represent a new level of research there.

"It fulfills the development process for medical countermeasures," Ludwig said. "Most of the work that's currently being done on post right now is the early stage development -- understanding the basic biology of the threat agents, understanding what types of countermeasures might be available, and developing prototypes of those countermeasures. The next step in that process is actually the FDA approval process, so once you have a product that's ready for approval, then you have to prove it's effective."

Ludwig said researchers at the facility will likely start out working on vaccines for filoviruses such as Ebola and Marburg, as well as new anthrax vaccines.

"A lot is going to depend on what's available when the facility opens in 2018," he said.

The project is being designed to meet the product research and development needs of both the Department of Defense and the Department of Health and Human Services. In many cases, both agencies work on drugs or vaccines for the same disease, Ludwig said.

"Depending on how those various products mature, both of them or one or the other could be the product that gets tested," Ludwig said. "The facility is designed to meet a broad national need for countermeasure development. They would prioritize the work based on the current need."

The facility will have the capability to produce viruses in aerosolized form that would simulate a potential biological attack on the test animals. Ludwig said aerosol is the means of exposure researchers are most concerned with given its implications to battlefield and homeland defense.

Ludwig said he expects some trepidation from residents about viruses that will be stored at the research center.

"It's another facility that has biocontainment capabilities, and there's a segment of the population that has concerns about additional containment laboratories anywhere," he said. "I think it's likely to be an area that generates some discussion."

Construction of the new facility is planned for 2013. Ludwig said he doesn't foresee any funding issues standing in the way of completion.

"There is a high priority on this project, so it will get funded."

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