Previous IFPA-Fletcher Conferences

National Security Strategy and Policy:
Planning for and Responding to Threats to the U.S. Homeland

October 28-29, 2004
Ronald Reagan Building
and International Trade Center
Washington, D.C.

Dr. Charles Gallaway
Director, Chemical Biological Defense Directorate
Defense Threat Reduction Agency

Introduction By: Dr. Charles M. Perry

Dr. Charles Gallaway: Good morning, it’s a pleasure to be here. My name is Chuck Gallaway. I have the pleasure of leading the Department of Defense’s Science and Technology program in combating chemical and biological warfare. Because of this, what I'd like to talk to you today about is a scientific perspective of where we are on chemical and biological defense, but primarily biological defense for today. I want to talk a little about threat, what we the scientific community can bring as far as opportunities to combat it, and then finally I'd like to issue a couple challenges to our colleagues in the regulatory and policy communities.

First, let me start with threat. We’re not in the good, old days anymore. Used to be we had a nice list of biological threat agents we had to worry about. We would push on the community to better define them, and then we could work on ways to defeat them. We’re presented by a whole variety of novel threat agents. Dr. Hughes did a good job of explaining the opportunities that are out there. Folks are coming up with very novel ways that you can introduce pathogenicity into the human being. When it really comes down it, there are an unlimited number of possibilities,

So the bad news, from my perspective, right now, is the perceived advantage goes to the perpetrator. That’s the bad news. Now, I want to moderate it just a little bit, because I think it’s a lot harder to do some of the exotic things than we really acknowledge in public, because we often talk about any high school kid can go off and do these things, and it’s not quite as easy as some folks make it out to be.

But our challenge is still great, and what it means to us, I think, in our community now is that we have to be able to develop capabilities that can work against unknown pathogens, because no one’s going to be able to tell what we’re going to come under attack from. So that’s our big challenge to the scientific community. But the good news is we’ve just had a revolution, an explosion of advances in biology, especially microbiology, in chemistry, in physics, and what we need to do is harness this in a way that we can use for our bio defense challenges.

What I'd like to do is talk in kind of two areas. One is awareness of threat. Many of you immediately think when we talk about awareness of threat of detection, but it’s really more than that, as a couple of the speakers mentioned. What we’re really all about is not detection, it’s about information, something actionable that somebody can use. If we were trying to protect all of us here in this meeting, what we’d most likely do is put out some type of dry filter unit, essentially a vacuum cleaner. We’d pull down a sample, we’d go off, we’d analyze the sample, and a couple days from now we would know we had come under some kind of a biological attack. By that time, we’re all over the world, it’s going to be hard to run us down. By the time they get a hold of us, therapeutic options are probably pretty limited. So not a good way to do business.

We have some real time detectors, but they're large, they cost a tremendous amount, so most likely you're not going to put one in here. And even if it gets an answer, it’s probably going to come down after the meeting’s over this afternoon, and it won’t be of much value, and it has a lot of false positives, so are we going to really react to the results or not?

So what we’re working on in our program, first and foremost, is to be able to, in almost real time, tell you, do you have a threat or not in front of you. That then offers the onsite folks the ability to make some decisions that are actionable.

Unfortunately, as we do that, wet chemistry, which is what we currently use today-- we’re at the limits of wet chemistry. What we can do is make things a little smaller, cheaper, maybe knock down the false alarm rate, but we’re really at limits of web chemistry. So now we’re starting to look at some physical attacks on the problem, such as using bio mass spectroscopy or terahertz spectroscopy, so we’re actually looking down at the biological agents.

Anyway, so that’s where we’re kind of going with the idea of real time detection. A couple of speakers talked about medical surveillance. I think Dr. Hughes mentioned this a couple times. We have some really neat things coming along where we can do micro arrays, where we can take some type of bodily fluid, put on this little microchip, and it can tell if you’ve had some type of gene or protein expression of something that’s influencing you. So by doing some clever pattern recognition, we can use that to tell very quickly, while you're sitting in front of the person who’s doing the diagnostic on you, whether you’ve come under attack or not.

So that’s half the problem, knowing that we’ve come under attack, but then what we need are medical countermeasures to be able to help us if we have in fact been attacked. I'm going to blur the line between prophylaxis and therapeutics during this discussion, but let’s think about prophylaxis for a moment. When I mention that, most of you probably immediately think towards vaccines. We’re all used to the anthrax vaccine, the smallpox vaccine. And we’ve got a variety of them in the pipeline, we’ve got seven or eight in the pipeline. We’re using some novel techniques like naked DNA, virus-like particles, replicons, vector vaccines. That can help make those a little better, but they're still one vaccine against a threat agent. I don’t think we’re ever going to get there because the list and the opportunities are too long. In addition, we also have the challenge that folks don’t typically like to be vaccinated ahead of time for something that is fairly unlikely. We just had a court order shutting down the DoD program once again on the anthrax vaccination. So a lot of challenges in that dimension.

So I think we need to be thinking a couple other areas. Instead of doing acquired immunity, which is what vaccines do, what we ought to be thinking about is maybe energizing our innate immunity. We have a couple novel ideas on how to do that using some of the total receptors, one of them that looks pretty promising, TLR-4. If we can do it, it’ll up regulate against respiratory viral infections where you can get a whole class of potential pathogens that we could protect against. So that’s really looking promising.

But at the end of the day, my sense is what we really need to do is be able to treat people after the fact. What we need is good therapeutics. What we need to do is go beyond this idea of one therapeutic per pathogen and look towards something that could help us in more of a general sense. What we’re looking at are ways to protect ourselves against a group of known pathogens--

END OF TAPE 7
TAPE 8

And this is really, for those of us in the physical world, it’s more like pattern recognition, is what that’s all about. But at the end of the day, that’s still against known pathogens. What we need to do is develop techniques that are going to help us against an unspecified threat. My sense is that to do that we've got to change our whole paradigm. Instead of looking towards the pathogen and thinking about how ways to defeat pathogens, what we've got to do is turn it the other way. We’ve got to look at ourselves, the human being, and find out as we as human beings can protect ourselves, because there are a variety of pathways in which a pathogen can get into a human body. What we need to do is understand and block those so that we’re not susceptible to any class of pathogens.

As you can tell, I'm pretty optimistic about this. We are employing some of the brightest folks in this country and around the world to work on these problems. Unfortunately, it's going to take a fair amount of time. There’s a lot of science that we’ve got to do to get this done, and it’s relatively expensive, so it’ll take an investment. But what I ask of the community is, you’ve got to be patient. We’ve got to start on this journey and, at the end, I think we will have much better capability to offer to the bio defense community.

But that’s only the beginning of what I think we need to take on. The other part of our challenge is the regulatory and policy community, and I’ll issue a kind of plea for help from the folks in the audience from that community. Most of the things I mentioned are medical in nature, which means they take FDA approval before we can use them on a human being. The good news, the FDA came up with a process in which you can use the two-animal rule model for us to license our medical products. This was really a big advancement for us, really has helped us a bunch. What I would encourage the regulatory community to think towards is more novel ways to do that, where we don’t have to go through these very lengthy and very expensive animal testing processes; maybe we can do it through something else in the laboratory, or ultimately harness the computational power that is coming in where we could model the human being and do some of our trials through that technique. Anyway, we need to think outside the box, which would really help us.

The second area as far as help from the community I'd like is this whole issue of civilian/military interface. It’s a big challenge to us. Right now, we have a variety of collectors around our military installations. When we pull that sample out, we will take it to a Department of Defense laboratory, we will analyze, and if we pick up a pathogen during that analysis, we will start a series of procedures to react to it. The community on the other side of the fence, and you heard repeatedly this morning, biological agents don’t care where they are, on which side of the fence, that sample would have to go to one of the Lab Response Network laboratories that we were just talking about, and have to be analyzed before the civilian sector would start mobilizing similarly. In time of crisis, that’s not what you’d want to do. Unfortunately, it’s probably the same way with us, within the Department of Defense. If they get a hit, we’re going to be reluctant to take it at face value.

We have a program between the Department of Homeland Security and the Department of Defense where we’re trying to work a variety of these issues. My personal opinion is, at this point what we need is a policy direction that says “Hey, guys, get together, let’s get one set of assays that all of us think are accurate and let’s use them.” Time of crisis would be a terrible time for us to be sorting those kinds of things out.

You’ve also heard repeatedly from the speakers about situational awareness, graphical interfaces. Right now, the ones we use in the Department of Defense are completely different from the ones that are being used by the civilian response community. Why not get us together and work on a similar picture, so I could walk into an emergency operations center on either side of the fence and know what I'm looking at.

Then finally, when you wrap all this together, I think we’ve got a challenge in front of us. If we’re coming under attack, we’ve got a good set of sensors out there, we know what’s happening, we can save a bunch of folks by just getting them out of the way, doing some precautionary things. The few folks that happen to be exposed, we’ve got good countermeasures so we could treat them, we’d have no casualties. We’re still left with potentially an economic disaster, because we’ve now got a large contaminated area. The rigmarole that we went through to clean up the Hart Building and the Brent Post Office was minor compared to the possibilities if you were to spread pathogens around a large geographic area.

What we’re doing in the technical community is working on the technical underpinning to help with some of these decisions. We’re working on the environmental fate of biological agents so we know what happens with the function of time and weather and all the influencing factors. We are looking at understanding the toxicity more effectively of biological agents, and also understanding the detection limits that are out there.

If you put all that together, I think we’re going to have the data to present to the policy community, which ultimately has to do the risk trade to understand what the standards are, because my opinion is we can’t cling to an absolute standard where we have no biological agent left. We’re going to have to moderate that so we don’t have an economic disaster.

So to to put all that together, I'm very optimistic that we in the scientific community can contribute to this problem. I ask a little patience because it’s going to take a while for us to pull down the ultimate answers on many of these things, so what we’ve got is a near-term solution set that we’re working on to try to help you immediately, and then we’ve got some long-term things that we’re starting into, a lot of science to do, a lot of hard work for some really dedicated folks. But I'm optimistic that we’re going to help solve the problem. [Applause]