Chemical-Biological Program Speeds Up Acquisition Process

EDGEWOOD, Md. — “It’s unfortunate. But we’re in a growth business,” said Carmen Spencer, joint program executive officer for chemical and biological defense.

Islamic State militants recently used mustard gas against Kurdish opponents. The joint program office sent 67 members of its staff on a ship it designed to destroy Syria’s chemical weapons stockpile. And then there was the Ebola outbreak in Libya, followed by an Army scandal where live anthrax was inadvertently shipped to 183 locations.

Whenever there is a crisis somewhere in the world related to chemical, biological or radiological weapons or accidents, “the first phone call comes to us,” Spencer said in an interview with National Defense.

When it comes to these threats, the organization is trying to be “left of the boom,” to borrow a metaphor from the explosive ordnance disposal community. It wants to be able to meet threats before they emerge, which he admitted is difficult to do working with a Defense Department acquisition process that can take seven years to field an item.

And the JPO’s mandate is broad, with three different threats that are often lumped into the same category, but are in fact very different. It must: sense and predict the employment of chemical, biological, nuclear or radioactive weapons; protect warfighters from them when they are used; and recover from their effects in the event of exposure. That entails developing everything from sensors and protective gear to medical products such as diagnostic equipment, vaccines and therapeutics.   

Spencer said the joint program office enjoys strong support from both sides of the aisle, both houses in Congress and the White House, “and I don’t see that changing in the short term.” Its budget remains relatively flat, but during a time of fiscal austerity, he considers that a victory.

The reason is because the threats are real, he said. “We’re not trying to paint the threat as 200 feet tall because there are real-world examples that are occurring all the time.”

ISIS’ recent confirmed use of mustard gas is one example. The intelligence community hasn’t determined how the terrorist organization acquired the deadly agent — whether it was old stock or newly manufactured — but U.S. forces are in the area, Spencer noted.

In terms of protecting troops from chemical weapons, the JPO is in the process of revamping some of its requirements that date back to the Cold War.

Standards are based on “the Soviet horde coming across the Fulda Gap with massive rocket and artillery attacks with chemical warheads and soldiers swimming in chemicals,” he said.

Ten grams per liter squared of nerve agents is the number that drives personal protection in this scenario. “Where on the planet are we going to see the potential for that amount of the threat?” he asked.

Korea comes close, he said, answering his own question. But is it necessary to outfit every soldier, sailor, airman and Marine with personal protection that meets the worst-case scenario? Probably not. A great deal of money could be saved by reducing the amount of protection for those who serve in lower risk areas, Spencer said.

“I think we have to relook at all of our assumptions,” he said. “We can divert hundreds of millions of dollars and put it toward the next-generation [gear], or save the money and put it toward higher priorities.”

As for the Korean Peninsula, the joint program office is in the middle of deploying a system of databases and environmental sensors to alert the armed forces there if they have been the target of a biological attack. The JPO first determined the baseline health of every medical facility — military, civilian, U.S. or local — in South Korea. If, for example, 15 patients come in on a normal day for flu like symptoms to a clinic, what happens when it suddenly takes in 50 or 1,000? he asked.

Environmental sensors, training and data combine to determine if an attack has happened. The authorities can reconstruct what they think may have occurred and immediately provide the capability to counter it.

“It’s people dependant. In this business, the human being is going to be the canary for a while,” Spencer said.

“U.S Forces Korea is going to be the most prepared force on the planet when we walk away,” he said. The JPO is sustaining the program for two more years and tweaking it.

“We are leaving behind trained people with trained equipment, trained systems that can be exercised on a regular basis where they can run it by themselves,” he said.

On the medical prophylactic and therapeutic side, the JPO is trying to jump ahead of the problem by investing in a contractor-owned, contractor-operated facility where vaccines and medicines can be produced quickly and on demand.

Communicable disease outbreaks have shown how slow the Defense Department acquisition process is to react. If a vaccine is needed in high quantities, it must release requests for proposals, wait for bids, negotiate a contract and so on, Spencer said.

The Alchua, Florida-based facility scheduled to open in 2017 will be built and equipped using Defense Department dollars and have more capacity than it will ever need. When there is no demand, the operator, Nanotherapeutics, can use the facility to produce whatever it wishes. But if there is an epidemic of some kind and more vaccines are needed, JPO Chem-Bio has priority and the factory can begin producing vaccines immediately.  

“We are guaranteeing them so much work every year to keep it going … but in a phone call I can tell them: ‘We need you geared up to produce this,’” Spencer said.

As for developing new vaccines, it is a slow process and the JPO doesn’t receive much help from big pharmaceutical companies because the military isn’t a large enough customer for them. The Defense Department acquires doses in the hundreds of thousands and they deal in the billions. Nevertheless, the JPO is looking at how “big pharma” does business in hopes that it can learn how to speed up the development process for vaccines, therapeutics and diagnostics.

“We’ve been working on a plague vaccine close to 20 years. It takes so long and hundreds of millions dollars,” Spencer said. The JPO recently asked a panel of retired pharmaceutical company executives to examine the way it does its acquisitions.

Both JPO Chem-Bio and the private sector companies have to have Food and Drug Administration approval for everything they produce. Yet the companies are more agile. “Granted, big pharma companies don’t have to deal with the acquisition regulations, but they do have to deal with FDA just like I have to work with FDA,” Spencer said.

One of the panel’s conclusions is that the JPO must do risk analysis up front. It should choose a path and stick to it, and if it fails, it must have the courage to walk away and start over.

Pharmaceutical companies “cut the umbilical cord much, much sooner than we do. It’s hard for DoD to kill a program. But we have to have that intestinal fortitude,” Spencer said.

“We’ve got some changes we’ve got to make,” he added. The ultimate goal is to shave four years off the typical seven-year acquisition cycle, he said.

Another recommendation was to bring in FDA on day one to help the JPO shape its program. The office may also go to the drug companies and ask them for help. They might be receptive if there is something in it for them, he said.

“Maybe we can piggyback on some of the things they are doing and pay them for it,” he said.

On the radiological side, the JPO is updating some of its detection technology, including Geiger-counters, also known as radiation detection, indication and computation devices, which haven’t been updated since the 1970s. It is now in the final stages of selecting a new handheld device that uses the latest technology. It’s much smaller, doesn’t require radioactive material inside to work and is simpler for operators to use.  

“That was easy to do because we had the best practices out of industry. We didn’t have to do a lot of development to get this ready,” he said.

And a new wristwatch-sized dosimeter, the DT-236, tells wearers in either occupational or tactical scenarios how much radiation they are absorbing.

The development of both devices took lessons learned from Operation Tomodachi, the U.S. response to the Fukushima Daiichi nuclear disaster.

Spencer outlined some of the tough problems that he is looking to solve and is open to ideas from outside companies or organizations.

One is decontamination, which he admitted, has not been one of the JPO’s top priorities. But with the proliferation of chemical weapons and toxic industrial chemicals that can be used as improvised devices, it’s a growing concern. Decontaminating the surface of a tank, or other flat surfaces, is relatively easy. “We can do that,” he said. But wiping away toxins inside a high-performance aircraft with its delicate and sophisticated electronics, still poses a problem. The decontaminants are very caustic, he said.

“We’ve been working on this, but we have a long way to go,” he added.

Another technological hurdle has been the development of a prophylactic pill that can protect troops from nerve agents without them needing a protective suit.

They have developed a possible solution, but it has to be taken intravenously.

“That’s not practical on the battlefield. It’s also expensive. We need a technological breakthrough where we can get a tablet for 10 bucks. That’s worth a large investment,” Spencer said.

Another tough nut to crack is stand-off biological and chemical cloud detection and identification.

“We can track a cloud and we know where it is going, but we can’t tell you what’s in it. Is it biological, or is it chemical? Exactly what is it we need to defend against?”

An idea has been proposed to dispatch a small unmanned aerial vehicle to investigate a cloud and return with samples, but the gasses often move too quickly.

The JPO wants to hear from small businesses that have good ideas. Spencer, who came from the private sector before taking the program executive officer job, knows how hard it is to get a foot in the door with government customers.

Not only will his program managers listen, they can provide some support for testing and evaluation. Everything they produce must be validated, but that is expensive when working with chemical and biological agents. The JPO has specialized labs it can make available to help small businesses cut costs, he said.

“We can help them if it is promising,” he added.

Topics: Chem Bio Protection, Homeland Security