tv Key Capitol Hill Hearings CSPAN May 28, 2015 5:30am-7:31am EDT
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we've seen upon the outbreak, we seem use of chemical weapons and we've seen nuclear. we were able to predict any of those. for example, when it came about as good of an ebola, it could've been something else. we have to be prepared for all of it. the challenges that my group faces is the when it comes to developing these countermeasures we do this in partnership with commercial companies. these are companies that are driven by return on investment. fcat to make money. the business model that exists is tremendously challenging.
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we want you to work with us and make these countermeasures that you are probably not make any money doing it. that's the reality of the business we're in. its extremist difficult and so when you're an outcry from the folks in west africa hey where with the drugs and vaccines? they should've been here. we agree with that. however, it's incredibly challenging. and the fact is that over a number of years it's the u.s. government department of health and human services with nih and barda and it's been a deity with our laboratories and our advance areas developing research that goes into the development of these products. that's a fundamental point. i'll get back at the end with my comments about the challenge of getting these countermeasures actually commercialized and available. so back to virus detection with a couple of assays with
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diagnostic. were trying to prepared to respond to upwards of 20-13 for threats. it would be cost prohibitive to develop fda approved assays for everything in the near term. we have not able to do everything we want but we had is we had assays that were pretty position with the fda that the data that showed there was safe and effective and when this ebola outbreak it, in less than 30 days were able to get fda approval under an emergency use authorization to use these assays. and there was a tremendous accomplishment and that allowed us to move our assays forward throughout the u.s. work with the cdc where they were available to detect a bowl in those patients. when it comes to ebola treatment, obviously there are no currently fda approved therapeutics. that's a widely known story. they just don't exist. it is a hard business when you take a viruslike ebola which is highly lethal is a 50% 90%?
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it's difficult to say but we know it's highly lethal. seeking out and this is where usamriid comes into play, we have great candidates but the challenge comes as i said how big it is approved by the fda with a commercial partner on board? a story that is frequently lost is biological defense therapeutics, they had found the development of a number of promising candidates. the commercial partners. they have some data that show these products were effective and safe but not enough to get full fda approval. so by working with the fda we were able to take some of these compounds, and they were put into patients in the u.s. on emergency use basis and with the full support of our fda. answer to compounds listed here
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in the portfolio, a compound that was developed by the japanese for influenza but it's effective against a wide range of viruses. so our team has been working on getting the data to show this works against influenza but also against ebola. so we are able to work with the fda. this would be to i believe a total of 13 patients here in the u.s. at this point we can't say for sure that this product work in those patients because they were getting a whole smorgasbord, a cocktail treatments of which this is one of them. the second compound is something that's interesting because it's called a platform technology. so what this means is you have a platform that's capable of speaking out a product on pretty short notice. you could have a platform established and if something pops up like ebola, in short order your able to identify the
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threat, sequence the genome type and produce a compound that will hopefully be able to treat it. and in this case we have a product that we were developing that was really for ebola zaire that was sounded to quit. it turns out that string of virus is different from one that is currently circulating in west africa. working with a commercial partner in a span of 262 to three months there were able to identify this sequence and develop a candidate product that was specific for the virus in west africa. there are some ongoing tests of this compound in west africa, not done with us but done with the european consortia. this highlights once again the fact of the relationships that are needed to keep these products under development and keep moving forward it's just not dod, it's not even just the u.s. government. in many ways they are international efforts. and the last tier of our three areas to work on his prevention
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some of the vaccine were. we begin working on ebola vaccines back in 2010. and so that's our group in advanced development but in the tech-based laboratories -- laboratories they been working on a far longer than that. we have a trivalent vaccine effort ongoing. that was a vaccine intended to treat not just ebola zaire but ebola sudan and marburg virus as well. at the start of this outbreak when it became clear we are dealing with ebola zaire, working with the dod and hhs there were efforts to identify is there a vaccine candidate that could treat the disease circulating in west africa, and you've all heard about up with what's called delta vaccine candidate and that, the testing is gone. nih was involved.
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you'll hear more i think colonel thomas will touch upon that in your talk. so what i tried to highlight is that when we talk about medical countermeasures, each march more than just the sites that has to take place. it's getting the commercial partners. it's a business model that exist. i don't know if any of you are fully with the fda priority voucher program. a number of years ago it was recognized that we were not delivering medical countermeasures to some of those threats that occur in the less developed parts of the world. where diseases occur that there's just a commercial market. into the u.s. congress establish fda priority voucher system that would incentivize industry to work on diseases, these neglected diseases that were seen as very important. we face the same situation occurs to chemical, biological, nuclear threats that we recognize they are important
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osha difficult time getting to commercial partners to work with us because of the lack of incentive. that makes this business incredibly challenging. so at that point key points here you've heard about how our organization has a long history working with other partners. you've heard more about and will continue working with the other agencies and our ability to deal directly with this outbreak, and my final point is the need to really be proactive about looking at medical countermeasure development, whether it's for ebola or other threats that face our nation. and with that i'm going to turn over to colonel thomas. >> okay good afternoon. glad to be a particular much. on to talk about the walter reed army institute of research, who we are, what we do not both of those were leverage to pursue put that into ebola response. this is a picture of the rare. is located in silver spring,
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maryland, just inside the beltway. we were established in 1883 just over 120 years, a very long time. we have the dod's largest biomedical research facility. ashford before reverend 2100 euros government military foreign service national and contract employees working not only in silver spring but a number of locations around the world. we work in two main areas. the first area would be behavioral health and brain health. we work on issues like traumatic brain injury post-traumatic stress disorder. we work on sleep and interface between sleep and performance. and the working area of infectious diseases and that's what i'm going to highlight for you today. as long as we've had an army and a nation, infectious disease have posed a threat not only to be a service member but also to the system. that a person peacetime and at war. it occurs both your locally as well as overseas. it's been the organization that i work for our charge to try
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and develop countermeasures to mitigate or to eliminate that threat to the service member and to the nation. and we have done that successfully for a number of years and i list a couple of examples of just vaccines that we have developed. these make a difference not only in military recruits but those people that deploy overseas into harm's way. we have done that successfully in the past working on and figure out solutions to pass problems but we're also looking at current threats and with future threats may be. and just a couple of examples there, things like hiv malaria and, of course the ball falls into that category as well. reduce because we are an institution of competencies and capacities and research platforms. where people are not only experts in infectious diseases but they also know how to get research and development and combined those two things is
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important for strategic. and in addition to the expertise that we have in the domestic platforms that we have would also have a large network of overseas research capabilities. we have a behavioral health unit in germany which is currently in the process of transitioning to washington state. we have a relatively new unit in the caucuses just outside of georgia and we have long-standing presence in africa and in southeast asia. these are very deep and enduring partnerships with host nations where we identify common threats and common interests, and then work together. at the government level, at the civil society level and at the committee level to try to come up with countermeasures that serve both of our needs. as you will hear these platforms are encoded important for the u.s. military after countermeasure development activities. so that's who we are. and that's where we are and that's what we did.
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how is this all leverage for the ebola response next the first of all record over two, was the testing a vaccine. when these vaccine complete the early development testing at places like usamriid eventually need to be tested in humans and that's the core competency we have. we do that both domestically as well as overseas. some of the defense threat reduction agency came to us and asked if you want to participate and were able to do the first human trial of his ebola vaccine candidate. we were very pleased to be part of that and we do that. we did it very quickly and were able to do that because we are agile and were able to redirect personnel and other resources to acute needs that arise. so in a very short period of time and in a small number of volunteers we were able to demonstrate that the vaccine was safe and that it produced the immune response that would want to do. but we didn't do that in isolation but we work with dr. fauci and doctor lane's team
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at the nih to help them with a parallel study that they were doing at the same time at the same vaccine candidate. we jointly published those results in the last couple of months. but it didn't stop at the us government. we'rewe working with the world health organization because there were other groups that were also doing the small safety trials. together we are able to take off the blood samples send them to usamriid and then usamriid is able to generate the data that was required to make informed decisions about what vaccine does need to be used in west africa. you have probably seen the lay press, those trials are ongoing right now. as colonel coleman mentioned it's not just dod, not just total u.s. government. it's an international effort. our vaccine trials that we were doing in the u.s. were also being done overseas. and in fact, the vaccine trial we did at the rare this past year was the first time we've
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done an ebola vaccine trumpet building on the military hiv research program which is not present in uganda for many years in collaboration in uganda for many years we did the first that i'm aware of human vaccine trial on the continent of africa starting back in 2008. those results which is published as well. they just finished enrolling in a second ebola vaccine trial in uganda. and we are scheduled to start an ebola vaccine trial in nigeria. i think this is a prime example of how the dod is very good at expeditionary medicine, but more than that expeditionary research and development. i think that is a key characteristic of our organization. so that was the vaccine testing story, but we responded in other ways as well to support operation assistance and to support domestic ebola preparedness. this was a different kind of operation than the 101st airborne and other operational
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groups that had been unfolding before. so it was important to provide them pre-deployment training so that they understood what the threats and risks were. in my mind ebola was not the number one in infectious diseases threat to the deployment force to it was malaya, the most severe form of malaria. so we conducted a lot of pre-deployment infectious diseases threat briefings with the southern regional medical command and brooke army medical center to offer deploying troops. you remember me telling you about the behavior outside of our institution. we also sent behavioral health teams deploying troops to gain their understanding and perspectives about the operation they were about to undertaken to understand what the specific mental-health stressors may have been on that group. we also looked at control monitoring for that group at that data is coming in and we are analyzing it now. if you remember back to that map a large presence we have
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been africa and the large presence we have in southeast asia those nations had travelers returning from west africa that they need to test. and they need to understand if ebola was being imported into their borders. we got 50 or 65 years collaborate with some of these nations a we provided technical assistance to them. again and mutually beneficial relationship we've had again in some cases for over half a century. what you've heard is activities that allowed level and maybe at the program level but i can take this as being tracked at the highest levels of the government. so the dod ebola working group which was occurring in assistant secretary shop policy policies, they were responsible for coordinating the dod response in west africa, and some they coordinated dod activities in support of the primary
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responder. i got all the different stakeholders together in dod and we ran through on a weekly basis all the issues that were confronting dod and the interagency. represent the dod with the joint staff at white house lead meetings, and they worked with congress to make sure people were remain informed of what they were doing and why we were doing it. the point here though is that they were tracking very very closely on a weekly basis all of his work that we were just telling you about. they wanted to know what was a vaccine trials, what were the results come what were the drug trials, where are they when can they be deployed. all this information was going up to the president. so that's a summary of what the walter reed army institute of research, what their contributions were to supporting operation united assistance in
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support of domestic ebola preparedness, and i think they do with all the other talks you for decades are pretty good idea of what the department of defense was doing. site thank you for your time and i'm going to turn it over to our host. >> thank you very much. first i want to commend you on not evolving into military acronym speak, which i know is easy for folks to do. look, a few questions and i want to open it up to the entire room. and this term may not be a term of you have any army but in the navy we have a term, you may notice because you served in the navy, hogwash. hogwash is one after do something about you have an evolution, as they do deployment of et cetera, you get all the stakeholders together and you sit around a table or room or a conference and you figure out what worked, what didn't work what went wrong, how to sort out
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in the best way forward. i assume you've had some version or multiple versions of hogwash not only within your various components but across the dod and i was surprised to learn they played the role they did as i think that's interesting i think, but solwick makes sense to colleges like to go down the road here and ask you what are the one to come at the most three top lessons learned from the perspective through the ebola response crisis management way forward? colonel, i'll start with you. >> i think the biggest lesson for us as dod was no one agency will within the federal government has all the answers. it is a whole of government responds to any type of global
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crisis, and when it comes to something like a biological incident like ebola there are no borders. and it's not a dod issue. it's a public health issue and dod has resources and can assist but we don't have all the answers and we must work as part of the whole of government team to provide the capabilities that we can provide. >> colonel woollen? >> one of the phrases you hear almost to a point where you get tired of hearing it when you're a student in the u.s. army war college is the term jimm, joint interagency and comer multinational. students are encouraged to start thinking that area to have it already before the coming. this outbreak rolled all that
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together. this has to be a joint interagency and intergovernmental multinational type of solution. there can be no single agency that can respond to this type of an outbreak and bring to bear the resources that are needed to ruby able to render a positive solution rapidly. the other thing, and i talk a lot about this in my presentation is that we cannot be still piping our thinking. as we develop solutions in the name of biodefense we have to be thinking about how else can it be used and how else should this be used. and an infectious disease outbreak is a classic example of how something that is being developed for a relatively specific intent and purpose have tremendous ability to be cross leveraged for other purposes as well. >> colonel coleman?
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>> on a similar threat by training i make preventative medicine officer and i think most people know how it works but it's underappreciated and sometimes physicians for several more time spent on treating rather than preventing. but we know that prevention works at in this case i think we saw the value of the investments made over a many year period where we tried to be prepared for any contingency that might occur whether it's actually going in infectious diseases all right bioterrorism event. we saw the benefit of that investment, that prevention the people at the foresight for and that we really were well-positioned to provide support to this outbreak when it came to the r&d investments that resulted whether diagnostics vaccines or therapeutics. >> i guess the lesson learned for me is that once again it's been proven that the world is a really small place and when you can get anywhere from one location to another in less than
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24 hours, it is very possible for what is a west africa issue to become a global issue. and i can have incredible certainly morbidity and mortality from vacations and financial ramifications and political revocations. so to me i think the requirement to enhance our bio surveillance networks globally, are of incredible importance. and it is not just the ability to identify and detect and characterize the pathogen but when you build bio surveillance you are building public health infrastructure. it's a dual purpose which, of course i think if the west african nations had not been so challenge in those areas there may have been a different, a different outcome. so that's the main lesson that i've gotten from it.
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>> so before i opened it up, the last question i have is so let's assume for the sake of the question that there is a verifiable outbreak in a west african country of what people highly suspect because of bio surveillance is ebola. it happened this morning, this is a hypothetical of course, but not beyond the realm of possibilities. walk us through to the extent you can share, what each of your organizations it does day one. what happens? dod in your lane -- >> inand my lame the first thing that would happen is russ and i would be on the phone together for a nice long phone call and getting the best and the brightest minds that we have
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together and basically wargaming. what do we know what don't we know, what are the capability gaps, what do we have on the shelf, where do we need to put investment in the short term to get the biggest bang for the buck. and strategizing what's going to happen over the next few weeks and how are we going to be prepared and ready to meet that challenge. colonel would be one of these guys because these guys are making it happen. that's what my organization will be doing. >> but i assume that in addition to phone calls and whatnot there's going to be personnel eventually put in that area american military personnel or doctors or is civilians or somebody. because i think the public, especially people who are not experts like you guys assume and they could be wrong that we're going to have people on the ground here they are pretty
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quickly to figure out what it really is how important, how widespread it is, et cetera. so come is that wrong? >> that's not wrong at that level is going to admit within the office of the secretary of defense, within the office of the joint chiefs of staff, and we will react to the warning ordered that they produce. and they're going to be asking us a lot of questions. and so that's why we get the best minds available to respond to the questions to include what would it take to provide a response. and in the case of ebola, one of the first things are going to want to know and why we want smart people on the ground as soon as possible, as has been mentioned twice already come is to get a dna sample to determine what strain were dealing with. ebola is not gone today. it is a dormant today and it will come back but it will morph. and it will be something different every time we see it
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and we need to find exactly what that is to determine the best and the most efficacious therapeutics that we can provide an diagnostic assays. >> i've been through this three times now with ebola, and it's basically been the same each time and that is until we get a request for assistance, we are not doing anything. the current people operate with a little bit different i say we are not doing anything many are not pushing people out the door but what we are doing is having meetings, discussing that task list of the to talk about. what capabilities we possess that could be brought to bear on the problem if asked to assist. and that's a standard. whenever the first news of an outbreak hits our commander starts convening of those meetings. and it doesn't even sometimes
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take a committed to initiate that. people that have a vested interest work in the daily start thinking about what do we have available that could be brought to bear if asked to do that. but it all hinges on that request for assistance before we can't engage. this one was different because we have a presence in west africa. we have people on the ground as part of a cooperative biological engagement program to build host nation capability capacity for these types of diagnostic. we were already over there doing there. when people hit they rapidly transitioned specifically to ebola diagnostics both in sierra leone and in liberia. >> i think i will build upon colonel woollen's comment. our mission really is to support dod and for dod operation a if an academic like occurs in west africa that's not a traditional dod mission and that's what initially evolved, before it became operational united
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assistant. i've got to look at what my capabilities are but then i got take out a way how do i legally provide that support. we had a look at who our partners were and how they would be operating. so for example cdc responsible for homeland defense in many ways diagnostics and so forth. we have the mechanisms in place that allow us to provide cdc would think that we've been working on. when it came to those patients in the u.s. how we provide our therapeutics that are u.s. government owned to respond. we have to look at those mechanisms and figure how can we provide the support. those were conversations that took place with spencer and levels higher as well. >> i think you for a couple times now it's not just the desire to go but it is asked. at ask has to there usually diplomatic channels into the department of defense.
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if they ask is coming from say africom or africa command, in my particular organization what we can do it again because we did expedition research and development come we can take the drug candidates or the vaccine candidates and we can relatively quickly deploy, if you will to start doing trials to demonstrate in the population of interest safety and potential for clinical benefit. my organization is a research organization. that's one of the things we could bring to bear. and again in the process of doing that you are setting up public health infrastructure. you are setting up surveillance systems. you are educating the local communities who are then force multiplier's if you will in helping you achieve your mission spent anything anyone else wants to add on the panel to respond
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or add to anything any of the other panelists have said? negative response you're all right. if you had a question we would be delighted to hear. simply raise your hand and one of my colleagues with a microphone will come to you and please identify yourself by name and organization and ask your question. the lady in the front, please. >> victorino from the commerce department. thank you so much for your work. i feel a lot safer with you. thank you very much. my question because i'm from commerce department my questions are going to be more on the r&d and commercialization of the product you're working on. i would assume that you not you know come in addition to the voucher system, a fast-track system where you're probably going to get fast review of an extension with patents, are there
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