Gaps in the line: Pentagon spurs its biological and chemical defense programs.

The Pentagon is trying to buttress the military's defensive posture against biological and chemical weapons by focusing on the development of advanced vaccines and improved therapeutics, Department of Defense officials said.

Acknowledging areas that are seen as lagging, officials highlighted steps such as a reorganization within the Pentagon and dedication of new money to speed up the evaluation of products. Defending citizens and soldiers against mass casualty attacks is a centerpiece goal of the Pentagon's ongoing review that drives strategy and funding.

"The Quadrennial Defense Review is really all about weapons of mass destruction," said Klaus Schafer, deputy assistant for chemical and biological defense, during a recent conference. "There are tremendous changes going on in this area. "

A surge in money is fueling this effort. For the department's proposed 2006 budget, $1.5 billion has been allocated for chemical and biological defense. The budget also slates $2.1 billion from 2007 to 2011 for Pentagon chem-bio defense programs.

The money is being spent on joint programs in an effort to reduce redundancies and lower prices. "The all-service agreements brought a little consternation among the services, who thought they had control over these things," Schafer noted.

Leonard Izzo, the technical director for chem-bio defense for the Joint Requirements Office, said that JRO is now in the lead at the Pentagon for coordinating all purchases of chemical, biological, radiological and nuclear equipment. "It's increased our workload significantly," Izzo said.

He noted that the office needed more funds, but "received about half the current increase we felt we needed ... We feel that, with the QDR, we will have the chance to improve our procurement funding situation."

He added that senior officials believed that soldiers had the gear to get their current jobs done, and were not eager to commit too much money on paraphernalia when better advances may be available down the road.

"Instead of kicking (products) back to the tech base for improvement, the Department of Defense looks to see if an incremental increase in capability is good enough," he said. "We've been doing that more lately ... We are over-designed for traditional agents and deficient against emerging threats."

Also addressed in the QDR is the question of who gets the equipment: Should it be dedicated to certain units or embedded into all forces? Another balance that needs to be addressed is the correct mix of equipment between active and reserve forces, Izzo said.

The Pentagon is conducting a study of the rate of consumption of expendable items, such as rubber gloves, that are critical during a biological or chemical emergency, Izzo added. This study has the potential to reshape some procurement strategies.

Schafer said that interagency cooperation and international research agreements would go a long way to help reduce risk and make better use of investments. As examples, he cited efforts to reach out to the Department of Homeland Security to set shared equipment standards and coordinate research and governmental approval of new drugs with the United Kingdom. He also praised cost reductions coming from outsourcing. For example, most clinical trials for countermeasure medicines are done in India. But much heavy lifting is needed in federally run labs, officials said. Investments in the military's infrastructure are necessary to speed the delivery of vaccines, said John F. Glenn, technical director of the U.S. Army Medical Research Institute of Infectious Diseases.

Many government experts cited a bottleneck at USAMRIID, which tests new products developed by a multitude of agencies, including the departments of Energy, Homeland Security and Defense, as well as academic sources. Since each product must be tested at USAMRIID, delays can ensue before orders can be placed.

USAMRIID has unique capabilities to experiment and treat outbreak pathogens in its biosafety level 4 facilities. Located at Fort Detrick, Md., the institute intends to benefit from the creation of an interagency Biological Defense University at the base. New facilities for a variety of agencies will be located there, to streamline similar operations and foster collaborations.

These expansions could reduce the bottleneck. "It's not just a lot of ideas with very little money," Glenn said. "It's a lot of ideas and not enough facilities."

Current programs include cutting edge techniques for producing vaccines. The focus of immediate efforts will center on alternative vaccine delivery methods, such as a ricin skin-patch vaccine, and an oral dose of smallpox treatment, cidofovir.

A nerve agent antidote previously derived from human plasma now uses genetically modified goats to produce the medicine. New blister agent treatments are also showing promise, Glenn said, adding that the premise that damage from such weapons is irreversible is "not exactly true."

An increasingly popular concept, Glenn said, revolves around developing multiple vaccines delivered in a single shot. "It's difficult enough for the Food and Drug Administration to approve a vaccine against a single disease," Glenn said.

At the Defense Threat Reduction Agency, where countermeasures for forward-deployed soldiers are developed, changes in procurement policy are raising expectations for better business deals. Officials there for the first time are deferring decisions on whether to contract a private lab or partner with a government-owned facility. "Before, we had to commit to one or the other before we wanted to," said Charles Galloway, director of chem-bio defense at the Joint Technology Office at DTRA.

Combatant commanders and front line troops have urgent requirements, he said. "Biological standoff detection is still our number one priority," he said. "The reason is, we have no capability in that area." Ultraviolet florescence techniques, he added, have "a long way to go, and we may never get there."

But DTRA also is pursuing pre-treatments and therapeutics, and is seeking ways to protect and treat troops in the field. Funds for "bioscavengers'--agents injected into the human system to neutralize pathogens or toxins when they are introduced--are increasing, with the goal being multiple short-term immunities to a host of potential biological agents. The objective of that project, Galloway said, is "still elusive."

"Right now the bad guy has the advantage because it takes us too long to develop a countermeasure," Galloway warned.

One reason for the slow pace, cited by several officials, is the approval process demanded by the Food and Drug Administration. The FDA must approve each vaccine and countermeasure for human use. Despite new safety regulations that grant greater value to the results of animal testing, Galloway said, the process remains "a time consuming, cumbersome process." He also warned that the recent spate of commercial drugs being pulled from shelves for previously unknown side effects might make approval even tougher.

That has encouraged researchers from separate agencies to combine their efforts to field new products. In the case of bioscavengers, for example, the Department of Defense plans to hand off the product it is designing to the Department of Health and Human Services, which will shepherd it through FDA licensure.

"That's a model you may well see play out in the future," said Army Col. Stephen Berte, joint program manager for chemical and biological medical systems. He added that the Pentagon is considering buying a smallpox treatment that is being developed by DHHS, scheduled to be approved by 2007.

However, Berte noted that requirements between agencies often differed. Unique requirements necessitate some parallel efforts. "The Defense Department's focus is on prophylaxis, keeping people from getting sick," he said. "DHHS tends to focus more on treatment."