CHEM BIO PROTECTION
Chemical-Biological Defense Office to Kick Off Dozens of New Programs
The Joint Program Executive Office for Chemical and Biological Defense will have money to spend in these lean budgetary times. The perceived threat from these deadly agents, along with a renewed emphasis in the Pentagon on guarding against weapons of mass destruction, has pushed the office to begin a series of new programs.
There will be about $3.5 billion from fiscal years 2013 to 2018 to spend on everything from new vaccines and protective gear to information technology that will create a global early warning system for infectious diseases, said Carmen Spencer, the joint program executive officer for chemical and biological defense.
“Everything is locked in Jell-O,” he cautioned, referring to the continuing resolutions and budget uncertainties that have plagued the Defense Department of late.
“Because of the world situation as it is today and the emerging threats, there is much more scrutiny in our ability to protect our armed forces, [and] to prevent WMD proliferation around the globe,” Spencer told reporters at an advanced planning briefing for industry day at Aberdeen Proving Grounds, Md.
The new Defense Department strategic guidance released in January 2012 said, “In partnership with other elements of the U.S. government, DoD will continue to invest in capabilities to detect, protect against and respond to WMD use, should preventive measures fail.”
The U.S. military is currently overhauling the way it researches, develops and procures chem-bio defense technologies.
The guidance prompted the office of the deputy assistant secretary of defense for chemical and biological defense to ask the National Academies of Science to take a hard look at the way the Defense Department acquires and prioritizes its science and technology investments in these fields.
The report, “Determining Core Capabilities in Chemical and Biological Defense Science and Technology” found that these twin threats are evolving rapidly, but the means in which Defense Department agencies obtain new protective devices, vaccines and sensors to counter them are not keeping up.
“The threat is unpredictable, changing and dependent on the nature of the conflict,” the report stated. The department’s chemical and biological defense program “cannot rely on breakthroughs in intelligence on adversaries’ chemical or biological terrorism or warfare programs to inform how its investments are prioritized,” it continued.
The Defense Department chem-bio enterprise has depended on combatant commanders to help write its requirements. But the report pointed out that field officers are not well informed on what their potential adversaries can do, and that they rely on historical data.
Gerald Parker, deputy assistant secretary of defense for chemical and biological defense, said the report’s findings resulted in a new strategic plan that was signed in the summer of 2012. A technology development roadmap is in the works.
“For too long the program has been fragmented and decentralized, and we are changing that to bring a much better unity of effort,” he said.
The report emphasized that the nation can’t afford to deal with all potential threats on an individual basis, and it has to prioritize which problems to solve.
Parker said: “The bottom line: We simply must employ more cost effective, efficient, agile capabilities to close current gaps and prevent against future surprise.”
Requirements originating from combatant commanders that call for 100 percent protection results in programs that never reach their goals, and therefore, never reach the field, the report said.
“We must develop and field integrated, net-centric, multi-mission capabilities to rapidly detect, identify and communicate, correlate, analyze and inform the common operational picture used by decision makers to direct resources and respond to minimize the effects of a [WMD] attack,” Parker said.
The challenge the department has is to identify threats before they emerge.
“The footprint needed by an adversary to pursue — particularly a biological weapon — is so small and is so hard to detect, it could literally be carried out by a handful of individuals,” Parker said.
JPEO-Chemical Biological Defense will be launching dozens of new programs.
The National Academies report pointed out that most of the research-and-development capabilities in chem-bio defense lies outside the U.S. military.
Right now, all the preliminary work for the new programs is being done within the joint office. That will change as contracts are awarded in the coming years.
“You will see those programs grow … We are going to need some help,” Spencer told representatives from hundreds of potential vendors that participated in the industry day.
He went through a list of dozens of new programs centered around preventing, detecting and — if those fail — responding to chem-bio attacks.
The prevention piece centers around vaccines.
The “one bug, one drug” paradigm will have to shift to “one drug, many bugs,” Parker said.
In that respect, the time it takes to develop new vaccines for diseases that may be unleashed on U.S. troops, allies and civilian populations takes too long, Parker said. That prompted the White House and, in turn the deputy secretary of defense, to issue memos calling for faster and more effective responses to biological threats and infectious diseases.
The Defense Department and the Food and Drug Administration generally take about 15 years and an average of $280 million to develop one vaccine.
“Both systems are laborious, and there is duplication,” Spencer said.
The Defense Department and FDA have developed hybrid models of their different approval processes that shaves years off them, but also meets all of the military acquisition requirements, he added.
“And time is money,” Spencer said. “It significantly reduces the cost.” Depending on the drug, the goal is to cut the 15 years in half, he said.
The Defense Department has unique challenges developing vaccines for lethal infectious diseases that big pharmaceutical companies don’t have. For one, they can’t be tested on people. “To get FDA approval when you have never tested on humans is a giant leap,” Spencer said.
Researchers must develop complex animal models, which creates a whole new layer of R&D, he said.
“The animal models and the accuracy has to be [in the] 99.99s in order to determine ... that this is safe for human consumption,” he added.
The joint program office will be spearheading the creation of an advanced development and manufacturing facility, which will be dedicated to fielding medical countermeasures. Awards totaling $359 million are expected in the second quarter of fiscal year 2013.
Opportunities are abound for small businesses, Spencer said.
“The bottom line is in our business, when you are looking for protection of the armed forces, Big Pharma is just not interested,” he said. Companies in that industry want to produce a billion doses of a vaccine and the military orders quantities in the 100,000 range, he added.
In the realm of detection, not all new monies will be slated for new sensors. There will be next-generation chemical detector and joint biological tactical detection system contracts, however, there is a large information technology program centering around the global countering WMD situational awareness system. This is envisioned as drawing in and fusing data streams in order to give decision-makers advanced warning of threats.
The need for such a system was seen when U.S. and South Korean forces conducted a four-day biological attack response tabletop exercise in May called Able Response. There were many problems observed during the simulated assault, Parker said.
One of the primary lessons learned was the need to be able to share information rapidly and gain situational awareness from multiple data streams, not just traditional sensors, but clinical health, law enforcement, intelligence, social media and the cloud, Parker said.
The acquisition, fusion and transmission of the data and the required infrastructure needed to carry out these tasks were some of the identified shortcomings, he said.
The long-standing goal is to allow U.S. forces to continue fighting even after suffering a chemical or biological attack. That requires technologies that enable forces to withstand and recover from WMD incidents.
Joint Guardian is a suite of technologies that will be in place to respond to any chem-bio attack, as well as nuclear and radiological threats. Program officials will be looking for containerized systems such as labs that can be easily moved to disaster or combat zones.
That is in line with the new strategic guidance that calls for agile forces, Spencer said.
Some radiological detection programs will also come under the joint program office’s umbrella.
The previous decade has seen little in terms of advancement of nuclear-radiological detection devices, and Spencer said there will be a new push to update them.
There is an emerging threat from improvised radiological dispersal devices, better known as “dirty bombs,” where an adversary finds easy to acquire radiological materials — such as those found in medical instruments — and packs them with conventional explosives.
Current sensors were developed with “a Cold War” mentality back when nuclear threats came from bombs held by only a few nations.
Forces on the ground will need new radiological-nuclear detectors that are more attuned to the dirty bomb threat, Spencer said.
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Topics: Chem Bio Protection, Health Affairs