look at that and say -- we try to be in that kind of situation we're going to set ourselves up for failure. complete dispensing is is measured in sick and dieying people. so, i'm going to cut kind of short the rest of this, but just to kind of tie it all together is need to have somebody in charge of driving architecture to the federal level that has a single set of measures that we can try to wind to. people can make better decisions within their own scope of control, but we can at least understand the impacts of those and we can try to medicate that or if necessary try to press upon those folks the consequences of those decisions. thank you. >> thank you.

>> i'm the acting director of policy and planning. national concept operations was created in initial request in december 2003 from the executive of office of the president to u.s. postal service to deliver oral antibiotics during large catastrophic events, especially the outdoor release of a biological agent. the postmaster general made the decision this could be done voluntarily. if health, safety and security were provided. in february of 2004 the secretary of health and human services secretary of the department

department of homeland security antiagreement to establish policies for oral antibiotics. later in 2004, the city's initiative federally funded program led by hhs to launch in u.s. cities to respond to a large scale health emergency. the primary objectives are to avert mass casualties and dispensing antibiotics within 48 hours of -- the postal concept because an -- offering an additional method of drug distribution to the general population. commands were tested as well as as -- in october 2008, the u.s. food and drug administration

approved a request for a unique emergency use authorization. it allowed postal participants to receive small quantities of oral antibiotics at their homes to be used by themselves and members of their households as directed by health authority in the case of a postal plan and for find lg amendments in 2009 and 2011. president obama issued an order in 2009 measures falling in bio tech. this recognized the capacity of volunteers to deliver to every american household as a unique national resource. developed and submitted a model in response to the national security counsel staff who

approved that national postal model in 2010. the postal service informed a joint enterprise through the establishment specific postal plans. in 2011 they orred granted to five cities to fund these initiatives. minneapolis st. paul capabilities were established in 2010. louisville, kentucky established in 2012. philadelphia, pennsylvania and boston massachusetts also in 2012. the objective of the national postal model personnel equipment, facilities to provide quick strike capable thety to deliver oral antibiotics from the strategic national stockpile to residential addresses within a single day as part of local and state mass dispensing plans.

the model was designed to augment augment, not displace. formal activation at the federal level to postmaster general based on the declaration of a public health emergency response to request from the government of the affected state. career letter carriers would be activated. antibiotics at in a local, state authority would be delivered to all residents in a set area. in the area other than delivery of the drug to be suspended. those would not receive mail that day. normal postal operations would not resume to do so by local public health. operational capability in five cities were complete.

volunteer outreach and recruitment, health, safety support, security, training and a copy of the postal plan. a pool of carriers, delivery, management, district and emergency management team members and inspection personnel was done in each city. the number of volunteers was met and exceeded. recommendations for health safety were developed based on osha regulations. the process included screening. conditioning of individual antibiotic kits mass provision to the participants themselves. that gives -- in the entire region. commitment officers provide carrier escort and perimeter security as outlined in each city's plan. and acknowledged again during

tactile planning. security was done primarily to local and state law enforcement. for postal trips to pick up antibiotics, at post offices themselves for perimeter security and experts for the carrier ons the streets making deliveries. focused training is put in play to specific day of responsibility and comprehensive postal plans were created for all five cities that included activation command and control, distribution, delivery operations, security public information, demobilization and recovery steps. for minneapolis st. paul 25,000 residential addresses would have been served under the plan. 266 were in play in that city. we need 172 security personnel

in order to affect the mission n. louisville, 244,000 residential addresses would have been served. 291 active postal participants with 191 is security escort requirements there. >> all in a single day? >> all in a single day. >> thank you. ask you to summarize. >> i'll skip over the some of the operational statistics for the other cities and just say for exercises, key element with the program with design and development in a series of exercises in each location, tips on exercises, a full scale exercise in st. paul and functional exercises in all five cities. program expenditures were pretty slight. over the course of time, postal service was allocated approximately $6 million. $10 million appropriation and trs still money in the budget. current status.

all five all med kits in all five cities were set to expire march 31st in 2015. they require replacement. at that time leadership advise is no longer funded including the provision of med kits. instead, they recommended that the usps work with local partners. for example usp participants receive event provisioning on oral antibiotics. now, this was not only contrary to the original agreement, but solid evidence of efficacy, so they deemed it unacceptable. all usps program participants have been placed in a suspension status. they are kept op the roster in hopes of future program revival.

if the program is restarted lack of funds to maintain operation were explained to each of the five cities placed in a suspension state. >> thank you. appreciate it. i know you had to abbreviate. you haven't talked that fast in a long time. it's a very important panel. just going to defer my colleagues first. i'm sure you have questions. dr. parker. >> thank you. excellent presentations and let me try to pull a couple of thoughts together here. first, tomorrow, dr. redletter at our lunch talk, random act of preparedness. what we're hearing here right now is we have the space of the need for innovation. and the challenge status quo. we need the private sector involvement in this space in a big way.

and we need to proper incentives for the private sector to be involved in this space. we also need innovative ways to actually, if we make something, to be able to get it to the population quickly and in time. and even though the postal system doesn't sound like innovation, it is in this regard. we have imposed on us and this system, whether you're in the program and government or whether you're in the private sector trying to serve the public good in this space -- it becomes very risk averse to the business model of medical countermeasures developing and we need all this to be able to, we need innovation to drive change. we need that collaboration. do we need for any of the

panelists, a manhattan style type project to really make us more effective? to drive in, bring the innovation, bring better participation of prift private sector and to bring new thinking about how to get countermeasures to where they're needed and also enable effective collaboration of the private sector as opposed to the competitive nash that the process actually encourages, which is kind of counter to what we need if we're going to tackle this program. >> who wants to start responding? who wants to start first? >> you know, i think my colleague from emerging did a wonderful job of talking about the pluses in the program that has been introduced over the years. there have been some really important advances.

i still think that innovation in vaccines need to take place and it will benefit a lot of people and cancer rack seens, we're looking at therapies that use the technologies we described. why aren't we making that available in the bio space as well. i think a manhattan style project is not in place. these are innovations on the cutting edge that can build on an existing infrastructure of production that can be put to work to solve this problem. sxwl and we talked last week, we don't wabt to throw the baby out with the bath water. >> go down the line if you care to comment. >> that was going to be my first comment. don't throw the baby out with the bath water because there have been so many successes and i think tremendous progress has been made, particularly in defense and i think there's much, much better coordination between the civilian agencyies and department of defense. the resources across the government are really phenomenal in terms of the science that's being done, the development and funding that might be available.

i see real deficiencyies in getting industry more active is we need longer term contracts, we need a much longer horizon in the way in which we think about setting up the special reserve fund. it was originally a ten-year fund as you might recall. the latest is down to five years. the return on that investment has been phenomenal. both in terms of protecting the nation and setting up a dynamic where we have a growing now bio defense market. we need to keep that momentum going. i'm not against the manhattan project. i don't know what the end result is designed to achieve. i think if we have a specific objective, maybe a manhattan style project is the way to get there, but i think we need to continue to build on some of the successes we have. >> their second motivation is probably some research showing almost all value added in the

last 20 years actually come frs the process around getting the innovation into the hands of people that use it. first innovation is critical. expanding that so that you get the most bang for your buck. so i think whether it's manhattan project or just how do you work and innovate around it, introduce programs to maybe expand the way bart operates but then make certain it's getting utilized, that you're getting the most leverage out of every envaigs and when we look at the trade space in the countermeasures, you've got leadership issues. technologies that include information technologies, drugs, dog dig nosices, your behavior. if we focus only on the technology aspect without understanding how it gets through that gives better tools to leadership to make better decisions, gives better use of

the risk and also gives you better results of your population, we've got to look at it all together and i think we tend to look at the technologies being the on answer but we have to look across that space. >> unless the post office has a part in this, i'm going to let you pass on this one. go ahead. >> i have a question for you about the post program. you were talking about the security concerns and the fact that the program is under -- i was at hrkhs, the postal union objected as mail carriers as dispensers because of the concern that they wanted a public safety officer assigned to each postal carrier, which struck me as an unrealistic request given our times in national emergency. so, how do you think the security concern can be handled and do you think there is a practical way of going forward? >> we've been dealing with this

security question from day one. when this first came up. and the, the need for both health, safety, support in terms of preevent provisioning and the need for law enforcement experts on the street, those were original requirements. we went into each one of these five cities. in fact part of the grant process, those had come forward with the means to meet this security commitment and they did so. that's how they ended up receiving those grants and how they were able to afford in those five cities. it is a doable proposition. when you look at the number of law enforcement officers within a particular city and the number of carriers that we need on the street to effect delivery in the entirety of a city, even talking in some of these some of our cities that we went to, we covered the entire city. and we worked with them ahead of

time to determine who can you put in place as far as security was concerned. so in order for us to have a plan in the first place in order to say that we had operational capableility. we had to have established that commitment with law enforcement so that was meant for those and we see the same thing going forward. if we were to reengage on this, which would take a certain amount of political push at this point. went into this because we were asked to come into it. pro to provide this last smile service, which we do really for the entirety of the country, whether it be -- so, we look at it as this is just a requirement that needs to be met in order for the safety and security of the people on the street. we also think it's just a good idea. if you're going to have it's better to have a team concept,

someone out there paying attention to conditions on the ground and someone else who's paying attention in terms of the delivery function. >> where would this political push to reengage have to come from and how heavy of a push would it have to be? >> at this point in time i wouldn't want to put words in the mouth. >> one of the things we're referring to it's one thing to distribute in times, in normal time, but if there's a crisis in a community, we're going to use most of law enforcement for more traditional responsibilities, so it's one thing again, i'm fairly certain you'd be comfortable delivering, oral continue september contraceptives, i'm not sure, if it was in the middle of a crisis, something we have to address because there is no good answer. i mean, the bottom line is that the time of crisis it could be

traditional responsibilities to law enforcement in helping you deliver a much needed vaccine that the population may not be their highest priority. >> ken. >> you mentioned that the decision was made to -- that it would only be a voluntary assignment and care yours could opt out and you already have for every house an every company in the country a human being assigned -- assigned to go deliver there and ideally say that person is going there and that person can then take the counter-measures to that house or that country in that time of need. if that carrier can opt out it seems like it defeats that purpose and my question is why was it made involuntarily?

was it not a concern? >> we operate in a unionized environment and so it was not part of the collective bargaining agreement in that situation where you have a public health emergency where people are being asked to shelter in place and then go to a local point of dispensing and so being outside of those collective bargaining agreements the decision was made, can we approach the union and speak with them and talk about recruiting individuals to join the program and becoming participants of the program and that was why. >> and in the cities where you try to roll it out, how complicating has it been that people opt out? is that a problem? >> we went in and recruited. we recruited to whatever we could, whatever the maximum. we went shooting for a particular target in x number of postal routes we need to meet so we are taking on all

participants in that regard. and through the recruitment process, we were able to provide for coverage based on the coverage area in the case of minneapolis, st. paul, had decided on. >> does the post person go to the door or put it in the mailbox? >> they are going to mail receptacles because that is the way our routing is based. >> right. i think this is part of an overall strategy i prefer the drug distribution in the united states because i think it is secure and it's -- it has an i.t. system that you can track it but part of an overall

solution you can use a social security office, they probably have more people that show up there. >> and they know where to find it too. >> question for the doctor. you are highly educated deeply experienced, award-winning physician and scientist and you proposed repeatedly a paradigm shift in the way we develop vaccines and you say we have no traction and no one is responding to you positively. so i'm trying to understand why that is because it seems like it is a fairly straightforward scientific section. >> but she wants to do it without going through the long fda process. she wants the fda process -- we have to talk about safety. you want the fda process cut? >> i think the fda process can be revised. >> oh, it has been revised. you can do a fast track fda process. they did it for aids drugs.

>> actually that is a great example. there are ways to look into the way to process the way it is been done now, can we find delivery. and with influenza viruses the trojan virus, we find the flavor of the moment. we can certainly do that for bio terror. so we are one of many companies proposing that but we have to rethink the way we approve the vaccines. and with all due respect for the animal rule the type of vaccines cannot be tested in animals because human responses are different. there are new models available that should be evaluated before -- >> so is the fda process the only impediment to your proposal? >> i think another significant

impediment is the way the work is funded. we work through the system that has been cut dramatically in the last few years for reasons as people are well aware of and we had grants that had extremely good scores that were not funded, and even though -- for pathogens that were considered bio terror threats and we could not get funded because of the situation in place. that should be a priority. barta, which does a great job, cannot reach across the invisible line that separates it from the nih to grasp those interesting projects because they are considered r&d. maybe we should cut it off of proof of principal in animals and re-set the technical level

of readiness and set projects that are innovative but not yet ready for the clinical trial because the companies like mine don't have the funding to get them to the clinical trial. >> thank you. >> panel do you have anything? all right. >> i was going to say that is a relatively easy thing to do. but it is easier than it should be. but that is something that can be part of the recommendation. >> it can be done. >> i've heard that rephrased many time. i want to talk about the flexible manufacturing. your testimony about vaccine on demand and clinical trials and you don't have the manufacturing capability and is it conceivable is that a venue or that the government should primarily fund to build a flexible

manufacturing facility or venue that the small companies could use or big companies could use in response to a crisis. it is interesting that concept of flexible manufacturing, not only to the individual companies but to the broader community, particularly the entrepreneurs and let's face it most of the innovation comes from the small companies and that is the way it works in this country and to move this along do we need flexible venues to take advantage of what is out there. >> that is a great concept and it is not funded solely by the government. the private industry is funding part of it and the government is funding part of it and it is designed as you state. search capacity for developments in the clinic so we can scale them up and make them more readily avar able. that is the paradigm.

there are three today. could they be expanded across the country. sure. part of the problem my colleague is experiencing is the paradigm she doesn't have the money and they are saying it is too high risk and how do we know the government will get behind this and so the paradigm is how do we get the companies like hers to get funding in partnership with nih with funding so these type of technologies can have a more appropriate, fair hearing and those are the types of things that i would respectfully submit should be priorities for the panel because if you want industry involvement -- and agree with your point about innovation being an industry, we need to figure out ways for this market to grow, to be sustained and to be viewed across large and small companies as a very attractive opportunity for business growth. >> i would just -- >> it is a fundamental question of what should government be doing and when does it profit

share. and we are talking about vaccines in which the market is smaller than other kinds of drugs so it is a complicated question. >> well this applied broadly beyond bio-defense so i think vaccine are a good investment for various reasons and i would add to the wonderful comments from my colleague and what we need is this innovative step. so that is where we've been having trouble getting r&d to move forward. we also have been able to look at existing vaccines and say, wait a minute, we don't think this is a good idea. there should be a place for us to say that where it is going to be heard and there is no one i can talk to. my experience during h1n1 and n 19 is people don't want to hear that. people don't want to hear the vaccines they are going to make the vaccine we have today is the least effective vaccine ever made. we told you that in 2013 when

the virus was published. >> when the virus was what -- >> when the virus was published. we published a paper saying the vaccine was a stealth virus and that new vaccines would be ineffective and less than ten months later we were proven right. >> any more questions? clearly you talked about inertia in government and we've been doing things the same way a long time and if you had intel related to a particular pathogen particularly nothing on the shelf to deal with, and what is the quickest way to design the components and test it quickly and get it out and the three to five year process is not going to work for that. the panel would be interested if you had specific recommendations with regards to companies dealing with nih and cdc we would love to see them because your type of companies are at

the epi center and you have great new types of pharma companies and this panel would like to see both. >> i'm sympathetic but i want you to address the safety issues because the public will not tolerate particularly on widespread vaccines something that hasn't been appropriately tested. >> i think that that's going to be addressed. >> i'm not looking to shortcut safety measures. i think the whole process can be truncated. i think it is too long. >> i think when we are working with the tools, we have addressing safety and there are things we're learning about vaccines that we can improve the safety of existing vaccines. so we can hold the doors open to innovation while, as i agree with the secretary that safety will remain a very important issue. >> and it is still the number one priority. >> yes. >> we just think we can condense it?

>> absolutely. >> we thank you very much. folks we are going to take a five minute break, not a ten-minute break, and we'll have the next panel up here by 3:00.

>> thank you, ladies and gentlemen. our fourth panel involves recovery and mitigation and dr. burger, and michael hoff meyer from an conventional hoff meyer and dr. ken stanley cuply, former department assistant secretary and department of state for bio-defense policy and homeland security to defense for president bush. we are behind schedule but we

won't truncate your opening remarks. >> can you define counter proliferation for me. >> sure. the way in which we prevent the -- [ inaudible ]. >> the easiest way to define counter proliferation would be to prevent the transit of illicit materials from one actor to another. >> okay. >> so first, thanks very much for the opportunity to -- >> what about nuclear arms in iran's hands? >> thank you very much for the opportunity to present here. i appreciate it. first, i would like to give a couple of framing remarks both on context and then how response and recovery i think are interrelated in the bio-event. so first as everyone here is aware, when outbreaks occur, whether they are natural or come from an intentional release can cause a massive loss of life and even when the loss of life is limited, of course diseases

could effect a relatively large amount of people and economic loss and disruption. and even events on the other side of the globe can effect the homeland. i'll be speaking today in the context of recent events whether that is h 1 n 16, or mers or ebola. and the events today don't represent the worse case. but if the pathogens were more easily transmissible or more pathogenic, our response would have been more complex and substantial. and more words about the connection in my mind between response and recovery during a bio event. in the context of an infectious

disease of a bio event where the illness spreads from community to community, some will reoccur and recovery in other communities and it can occur in the same breath. i think about rebuilding capacity in the system to the extent it's degraded and second establishing a new normal and third restoring public confidence and fourth reviewing and updating the response plans and activities you've put in place. so by way of saying all of that i think recovery in many ways is dependent upon the response that is undertaken and the intensity of the rebuilding effort and the efforts to restore public confidence in many ways depend on the response of your initial response. so in my remarks i want to underscore the importance of response which indicate

recovery. i'll highlight what i've seen in best practices in three areas. first effective decision making and accountability. second capabilities required during response and recovery and third activities during recovery. and first, when you think about effective decision making during a response and recovery, two best practices to highlight for you, are first a clear articulation of accountability in terms of roles and responsibilities during the response and recovery phase of bio net and second exercises to practice and define decisions and execution. when we think about accountability we have made great strides. the original epidemic and pandemic act provided us with decision making and response but from my government service and since best practices indicate we

could further articulate the lead individuals and agencies for health response during both domestic and international health kriess. when we think about things on the international stage we think about hhs and cdc and when we think about domestic responsibilities we think about the way in which dhs would play a much larger role. i think there is an opportunity to improve decision-making processes during these events. so i think the decision making process is very different than the business as usual decisions. in business as usual times, we have an element that addresses all concerns but during an emergency, you are much better off over time to come to a better out come eventually and i think there is an opportunity based on best practices to

conduct additional drills and preparedness activities, particularly with the leadership involved in early decisions for both response and recovery in order to refine our ability to make those decisions because i think just from a -- from a certain organic perspective, decision-making like this doesn't come naturally to most institutions and the more we what can do to put that kind of decision-making at the fore the more powerfully we can respond to the events. the second thing i want to touk about is -- to talk about is the capability to mount a recovery. there are two emerging best practices to highlight here. first, the full time capability to respond to and recover from bio events. and second a strengthening of reserve capacities for surges in response and recovery. so when i think about response,

i think about really three primary objectives. to find appropriate treatment for patients suffering from disease while minimizing the impact on the system over all and second is using epidemiological to stop the spread and third trying to contain. so limit the transmission based on the understanding of the disease or the event. there are four pertinent observations i'll make givens the objectives i've outlined. first, we have difficulty deploying resources to the field quickly. and many of you are aware of the recent piece by bill gates. he highlights the challenges during the ebola response to quickly recruit and deploy human resources to the field. the networks and the part-time responders that we've developed

with a great deal of care were overwhelmed in our most recent crises. the second observation is the knowledge that you need, the types of expertise you need when you have, with increased scale of response, are increased. so with increased scale comes increased complexity and increased capabilities when you have a response like this. the third observation i would make is one i made at the outset as well. so we have recent examples of bio events both domestically and internationally but we should keep in mind what we may face in the future must be much more clear and complex. and the fourth point is there are many more responses of health over time and the scale of the responses have increases. so i'll go back to the two best practices then. i think we already -- we could

consider additional full-time capabilities to the -- to be on call for a response during a medical event and that would include people like planners, lodgist ises and medical responders. i think we have made great strides in reserving capabilities. we could, when think about best practices, we could seek out on-call responders who can be trained on an interim basis with the skills necessary for those that are needed for a short notice for some extended period of time. the third area i'll peek about is -- i'll speak about is most explicit recovery. >> and i'm going to ask you to expedite. >> you got it. one of the recovery capabilities

is updating plans and activities. so i'll confine my suggestion here to considering recovery in the context of replanning. so at the acute stage of any crisis you have the opportunity to actually take concrete steps to actually increase your level of preparedness. and i would just highlight that you can focus on planning equipping, training and then exercising in a much more concrete way at a best practice at the conclusion of the events. so i know that our time is short so i'll thank you very much for your time and -- >> any final conclusions in the area of recovery. just a couple of principles to share with us? >> no, i'll leave it there. >> thank you. please. >> thank you very much for inviting me to speak. i am going to focus on some of my remarks on science and technology advances that can enhance threat awareness and detection of biological events because both are central to risk

and threat mitigation and recovery and both -- a key aspect of both is that advanced planning to minimize potential vulnerabilities in that prevention detection and response recovery pathway and maximize the key response resources such as medical counter measures and detection technology is extremely important. and so as part of my remarks, i will highlight some of the vulnerabilities but i want to have you think more about the whole system from prevention to response and mitigation to recovery. by way just of background, for the past five or six years i've been working closely with the fbi, especially agent ed yu who you had as a panelist last time and most recently we produced a product on national and

transnational security data in the life sciences and that opened the doors to a lot of very interesting capabilities and problems that arise from biology relying on digital technology and how that might not only create risk but might help detect and help prevent the risk. and in addition to that, the work i've done in the middle east has been on risk mitigation and risk identification. and so it is from that perspective that i speak to you today. so the context in which all of this is occurring. you know very well about the public health emergency counter measure enterprise and the strategic stockpile and the issuance of several national strategies from counter threats to presidential directives on public health and the [ inaudible ] and regulations and now bio risk managements

which is laboratory safety and security both in the united states and abroad and the global health security agenda launched last year which builds on the 2005 international health regulations and the u.s. government policy on bio surveillance. this is the system in which we are working when it comes to prevention and response. and new advances in science and technology are providing some really new, interesting opportunities to both detect incidents -- biological incidents early and mitigate risks before they transform into threats and respond to incidents through a variety of different means but three of which i'm going to speak to today -- about today. which is dig data -- big data anna listityics and cloud base and capabilities. whether the threat is an if actor expressed interest in carrying out a terrorist act whether or not they are using biological agents or the threat

is an outbreak or accidental release of a harmful pathogen. and they also provide insight into detection or characterization of in infectious disease that would develop -- development and model of decontamination strategies to facilitate response and recovery. so big data analytics, what is it? it is the analysis of data generated and collected from a number of distinct sources and from more than one data set at a rapid speed and at rapid different times. it is large in volume but not necessarily individual pieces being large and has a high degree of uncertainty. the data can be deliberately deposited into daisa bases such as genome or internet search

terms and purchasing preferences. it can be born such as search data or converted from observation to digital information such as data published in scientific literature. it can be using a number of different technologies all of which government and other technologies are investing in. these are data mining speech image recognition, social media analysis and mathematical statistic analysis. i want to provide two examples of how big data has actually played a role already in the prevention and detection of sort of the biological threat. so one example is the global terrorism data base which uses social media to provide a picture of which actors pose a threat and which individuals and groups have expressed interest

in using biological agents as a means to cause harm and with this knowledge security officials can be better equipped to determine whether certain nonstate actors are acquiring the expertise materials to carry out an attack. with the biological agent or to employee strategy that minimize the likelihood that an attack will be successful. and another example is health maps, and news outlets clinical data bases to depect potential ly outbreaks. and an outbreak -- it is important when doing response activities. and with these early warnings, security officials can employ measures to both control the current outbreak and prevent further infection and disruption. this is not the only program that does this. there are several different

networks that try and build on some of the large data sets and different sources of data. examples include the global public health intelligence network, the global outbreak and response network which is part of who, google flu friends and denga trends sand agent studies which is something nih supports. all of this is to say that forecasting and prediction of an outbreak is catching on and i saw a paper about two days ago that said that china wants -- or china has described the benefits of using data analytics. so this is not just a u.s. or w.h.o. thing. so another sub-example of this is 2013 the cdc launched a predict the influenza challenge

which was for flu prediction and they used as a data set the 2013-2014 flu season. so looking to the future where can the technology add to our capability to detect the threat early and to mitigate it or respond to it. several examples include forensic analysis and attribution and identifying broadly acting counter measures determining whether function of biological components with be determined through sequence analysis and evaluating the damage of an actual biological incident identifying possible discrepancies in confidence-building measures at the convention predicting malicious information from a broad set of information or evaluating the lessons learned from natural or man-made events. but despite the potential events, big data analytics is

vulnerable because it depends on compute systems an daisa bases and so -- data bases so vulnerable to hacking and exploitation. over the last decade it is no surprise that computer systems and data bases are prime targets for hackers and nonstate actors. the u.s. is concerned about protecting critical infrastructure through cyber attack and that is a conversation we've had for many years. people's personal -- the public is concerned about protection of their personal information and privacy because of hacking of health care networks and being able to identify people and i just sort of want to point out in the last -- i think the last six to nine months three individual hacking events of health systems or information has occurred in 2014, the health organization was attacked and in

2014 anthem, 79 million records were released and prime era was attacked and that was 11 million records and it included medical records. so this is a pretty big problem. and combine that with having patient genomic information part of the medical records, the situation, some can get beyond the individual problem. several technologies do exist to prevent unauthorized users to gaining access to the computer system, yet nonstate actors and states are still conducting cyber attacks to disrupt computer systems and spying. as you know last year, the president's counsel of advisers of science and technology issued recommendations on technology to

protect vulnerability and enhance privacy and we've had for many years huge investment in cyber and work horse and response and yet the u.s. is not well structured to address science and technology sectors where the insult is in the cyber realm and the output is in the release of biological outputs or theft of proprietary information about counter measures in which the u.s. is investing. >> i'll have to ask you -- we'll get to your testimony. if you could draw conclusions. we'll more interested in the q&a. >> sure. i won't go into the 3-d printing or the -- but i want to quickly talk about cloud-based sharing. in 2011 we were able to, as a global scientific community, identify a 2011 e-coli outbreak in germany and france as one

that was natural and not man-made just by -- within 12 hours by sequences being posted on the cloud and scientists being able to download that and sequence it and do analysis on it and it's through the cloud-sharing and the cloud-based analytics that we were able to do that. so those are all capabilities but we do come with vulnerability and the conclusion i would leave you with is we need to think more strategically about the cross-domain threats and the multi disciplinary threats they offer and that we are not really well set up to be able to look at the risk and the benefit compare the risk and the benefit that is risk and benefits. >> we'll talk about that cod based information when we get back to you. sir. >> thank you.

in the interest of time, i'll limit my remarked with two points. >> we'll intrigued with unconventional concepts so we're all ears. >> so i'll do my best to keep you entertained. first, refrain through bio-defense or any unconventional threat or incident if you will, the requirements, resources, training skills, capabilities needed to respond. perfectly justifiable and reasonable. but i think we miss a key question in this. which is more importantly, what is the best that we can do with what we already have. almost, without exception any event and occurrence we have we have a long list of required materials, oftentimes funding needed to prepare for that incident whether it is response mitigation or any aspect, however, almost equally without exception, we never have all of those materials. we very seldom meet all of the requirements we have. in fact arguable will youe ablable

-- arguably never. and we almost never meet the requirements. but the question is how do we optimize the use of the resources and capabilities that we actually do have. that tends to lack in prepared preparedness and planning and the entire spectrum of response to an incident. for example, very few people are aware that in the realm of response for veterinary medicine, those drugs are almost identical to those used for human beings. they are manufactured in the same plants for human beings. they are packaged differently. the dosage for a five or six pound cat for a bull is different for a human being but the drugs in and of themselves are the same but i have never seen a plan that looks at reaching out to leverage the

pharmaceutical supplies for the agricultural arena to make up the short comings in a human event. so the first point i would leave you with is that while i do not advocate replacing the list of requirements that we need, frankly that provides money and resources, jobs and other things, we need to also add to these key questions and this key base of how to optimize the use of the resources that we have. given we have nothing more what is the best we can do. the second issue equally important is there tends to be not unjustifiably so there is a focus on the professional responder and response community. again, incredibly important. but to put things in context depending on how you put together the numbers, there is 1.5 million, to 2 million maybe 2.5 million first responders, police, fire and medical related

resources. under the best of resources that is one first responders and we look at how do we empower the people to care for themselves. and it goes well beyond public service announcements. an excellent example in my mind is the aed or automatic external defibrillatored. it used to require a trained nurse and a cardyologist or an emergency room to provide the care but as a result we lowered that barrier and if you are bright enough to operate a fire extinguisher you can defip ril ate somebody. and the response first started in california and as many things have done, it is based on the fact that the true first

responder is very seldom the trained professional. in the case of this room today, if any of us had a heart attack or would choke, the first responder would not be an emtor police officer it would be the person sitting next to that person. and whether we like it or not, the population will care for itself. it may not do a particularly good job, but that is a failing on the part of policy makers for not preparing for that realistically and the short coming there is we continue to try and focus again reasonably on the professional responder but we lose sight of the opportunity to truly empower the public and that can we done through two basic means. one, training educating and improving the capabilities of the public organically to care for and provide its own support and two using the benefits and powers of science and technology to lower the barrier of entry to provide care.

it does not require a physician for example, to diagnose a case of ebola in west africa, when you come in you are bleeding and coughing and running a fever. at that point you have a presumptive diagnosis. there, how can i train the people to provide a greater level of care, somewhat analogous of what we do in the fire fighting community. when we have large fires out of control, we don't train firefighters. we get a random unit from the military and we have training and equipment in three to five hours we can train personnel one, not to kill those around them and themselves but we haven't been able to take it to the public to provide care and support to themselves in a bio defense arena. and with that gentlemen and ma'am, i'm done.

>> very good. thank you. thank you. we'll start with dr. alexander. >> thank you very much. you answered some of my initial questions. how to optimize the efforts to reduce the risks. for example, should we expand the security culture in terms of training the individual i think you mentioned so empower the people people. that is one area. what concerns me is looking at the terrorist and their intentions and what they are planning to do there is no end to their evil intentions. for example, can we provide better accounting for some of the bio-materials similar to the way we try to follow the money

on the financing area or should we for example strengthen surveillance and detection or should we strengthen the bio nonproliferation you are working on, the bio weapons conventions. so in other words there are a series of questions inter-related in order to try to bring down the risk level. if you could respond to that? >> yes, sir. first, i would note there is a term in the military a robust defense in depth, which is looking at a variety of factors all integrated to function together as a system. all of the points that you made and many more, i think can be strengthened and through information-sharing can improve our capability to protect against them. but that is one half of the

problem. the other half, regardless of what the cause of the bio incident is, a natural emerging disease or an intentional release of an agent i think there are a number of things that the population itself can do to detect early that there is an event and an anomalous event and reduce the spread of that event. and many are nonmedical counter measures that don't require a structure for vaccines and drugs and don't require logistics to distribute them or training to make them available and usable. the example i gave earlier, an aed used to be purely the area of a trained medical professional and because of technology improvements, rather than trying to make the effort to train the public how to use it, we accepted the fact that the public, from a pragmatic point of view, isn't going to learn. regardless of the reason they simply won't, so taking that as

a boundary, new technologies were developed to deal with that as a real-world condition. does that answer your question? >> yes. thank you. >> advisory panel? i'll refer to my colleagues up here. gentlemen? >> i would like to follow up. your thoughts about empowering the people. in the biotech context, what would be the actions that you want the people to be prepared to do. when you think about the '50s and the fallout shelters and the duct tape and doug still probably gets them in his christmas stocking every year, and we've seen these things -- i love the idea. i'm enamored with the idea of professionalized the populous, but what specific things would you train them or us to do? >> i can give you an example.

i was on the staff with dr. carmona when he was u.s. surgeon general. we talked about standard of care versus appropriate care and developed a phase change in population care or population health maintenance. but let us assume for the sake of discussion that the brownies we had here today had cholera in them and five or ten people come down with it and not saying that we have. but each one of the people would end up in an icu welcome back the next two to three days and have ten to 12 medical professionals caring for them and every professional doc would come and look at them being miserable. if you had 10 -- 20 -- cholera is very unpleasant. not from personal experience i assure you. if you had 20 to 30 people we would scale up and clear out icu's and do the same thing.

if we had 5,000 cases, you couldn't do it. you would have a fundamental transition where the population would be told here is how you make a cholera bed so to keep you well hydrated and take anti-biotics and basic treatment and where i've had training por the population to care for its own people. that does not work for every case but works in many cases with we start with the underlying tennant that i'm not having everybody report to a hospital but what are the basic skills an training and the basic capabilities that the population needs to provide for itself that may not meet the standard of care but in an environment like that meet the standard of sufficient or appropriate care. does that make sense? >> yeah. i'm struggling with what specific things you do. i think the things in the past were all advise ability --

advisable. but they did not get traction. and it is not clear whether there is that much that can be done medically by lay persons in the bio or chem attacks. >> in that environment, i don't necessarily disagree. as i mentioned we have aed's and that is for a specific malady, but if you look across the board. it is the a.b.c.'s, airway, breathing and -- circulation, thank you. and those are the basic things that have to be maintained. through a combination of technology and preparedness to allow people to be supported and supported by those around them and nearby, you don't necessarily need professional medical care or medical care at all but it has to be not a model of how do i train the population to do it but the other half of the problem is how do i prepare

technology and infrastructure and the basic expectation they will have to do it and enable them to do it. so a different point of view. >> i have a question. jim greenwood, please. >> i don't know if you answer this or not, but having the public as informed and as empowered only. this is only a test, if this was a real emergency, we would have told you what to do. and it is making me wonder whether -- whoever that is actually knows what to do. [ laughter ] and in these type of events. >> that is an excellent point. i've lectured and taught on crisis points in the past. when i've lectured on it and i believe most training for crisis is wrong. we try to tell the population what the quote, right thing to do is. we go into that knowing full

well that frankly most people are either going to screw it up or do something intentionally different. katrina is a great example. evacuate, some people stayed home and some people went to the superdome. the proper thing to communicate to the population is to try and get the most people to do something predictable. and the reason for that is, if they are doing something that is predictable, i can now plan for that. i cannot plan for chaos. there is the old song 20% of the population requires 80% of the resources. it is probably a little farther along than that. it is something definite, and assuming we know what the right thing is and frequently we doan. and it is trying to get as many people to do something predictable as possible so we can respond to that.

again, the superdome and in katrina, we would have had water there and encouraged people, rather than if you can't evacuate, go here and we'll have supplied. instead we have the worst situation. the population showed up where we weren't prepared for. and well more than 10,000 were scattered over thousands of square miles and had to be addressed individually. >> and i'm sorry. my question and maybe you don't know if there were a biological terror attack in washington, d.c. now, and all of a sudden our televisions and radios started saying beep beep, we've had an attack, do you have an idea as to whether the advice coming forward after that beep is the right information? >> it is highly scenario-dependent. i go back to anthrax and a

former secretary of health and human services who indicated that the first case of anthrax was accidental from drinking contaminated water. >> it wasn't me. >> no. [ laughter ] >> it was highly dependent on the situation and the individual and frankly in many cases we may not know. >> dr. burger you had a comment to make. share it with us. >> so i just wanted to make two comments. one, is there is a recent push in a public engagement on a wide range of public topics and this is a prime topic to engage with people, particularly if you start with measles and disney world or disneyland and you walk away from that to something more unpredictable like a bio terror attack and how you would prepare your families and workplace and so on. the other thing is that i do believe we'll get some of the predictability by the mobile health and smart health apps

that we now have on phones and watches and all sorts of gadgets all over the place, as well as internet of things, as more and more of our lives go somewhere in data bases. we have a better ability to predict what people are doing so that is a good thing and a bad thing. but in terms of being able to plan what are people -- what are people doing at different times of the day, how might they react if they see an alert on their watch that says your temperature has just increased by so many or whatever -- these technologies are being developed and they are being used in all sorts of mobile applications and smart devices and that is something we should think about harnessing. >> doctor staley. >> thanks. to build on the comments you've been made. i think when we think about recovery, we are think being a way in which we are rebuilding our capacity, right.

so if you think about a continuum of supply and demand, we have a set supply of medical -- the ability to deliver medical measures to a population and depending on the severity of the event if we have our build over time we have the ability of cape asity over time. but we have the levels to take on care that would otherwise be taken care of in a more professional setting. when you think about the tools you have to enhance recovery, i think on one end of the spectrum when you think about a severe incident when the capabilities are overwhelmed, you need to think about empowering inging individuals as we've discussed already. and on the other side you can think about attempts we can take

now for recovery. and a great example of what is going on now and can we expanded over time is the immediate bed availability program that the hospitals are doing. so they've looked at challenges we might have during a major medical event and said, we want to try to find a way that hospitals could release 20% of their patients within four hours to have the ability to surge patients from an emergency to that system. so they worked as a process of planning and drilling and they worked to find processes that can quickly on an ongoing basis find the patients in the system and find ways to off-load the patients using a reversed -- a reversed triage system and upload patients from an existing emergency. so i think when you think about ways to impact recovery, you are looking at a spectrum of tools. part of it is thinking at the very extreme end again about empowering individuals.

on the other side i do think it comes down to a deliberate process, a preparedness process that heaps you -- helps your institutions become more resilient. >> i have a quick question from dr. burger i want to point out as university president, i'm not worried about cholera in brownies -- >> not on campus. >> dr. burger you have done a lot creating table top exercises and that's been used for a long time and what are the benefits of table top exercises versus the new apps and other types of things? >> so they are inherently different. >> yes. right. >> we have -- so the biggest limitation that we've always encountered with table top exercises is people come with

their preconceived notions and that is how they play and it is hard to get people to think about what is the role of -- some other function and how do i fit with that other function in my daily life. and so developing the exercises and facilitating the exercises out of their own skin and into somebody else's to see how you would interact with different functions and how they relate to your own is really important. the mobile devices that is a fascinating thing to see -- to watch happen. it is fascinating to me to see how much information is collected and it is fascinating for me to sort of think about where is that going and how is that information going to be used in any sort of decision-making capacity from an individual health perspective to a community health perspective to even a national health perspective. so when we think about how do we take all of the information that

we have available to us from all sorts of different sources and provide that in a way to decision-makers to say this is an issue and this is the location of the issue and that is what you need to do to deal with that issue in a real tangible meaningful way we are still away from that. but certainly the tools are being developed to try and do that. >> okay. yes. >> go ahead. >> can i ask ken for just a second. just to follow on the point about exercises. you mentioned concerns you have on decision making process and crisises in the response and gave us a teaser that there are best practices that can be disseminated and best practices but can you put more meat on the bones and can you explain how

the response can be better than it is now. >> sure. to take it from a best practice program, in my awareness of how of the structure is now is opaque. if you think about the process that brought people together to put them around the table to discuss a buyio event you want to take a process like that and have leaders put into drilling situations where they can make decisions with imperfect information and the way in which they would commit resources. i think in order to be moreective, you -- more effective, you want to make that part of the comprehensive preparedness program as part of the best practice. so think about the different types of threats you are worried about and the different types of capabilities you want to exercise and leaders to be able to have at their disposal and then test those over time. >> so you are the advocates of

more exercise. >> yes. >> i agree with you. >> dr. burger, you identified the big data to inform us from gio location to the the very appropriate use of technology to inform us from geo location to type of potential pathogen out there. i think you used an example in germany. was it e. coli? >> yes. i sort of described that in terms of cloud herring. in 2011 hundreds of people got ill from e. coli infection. cases in france somewhat sporadic. turns out causes were natural, came from seeds from egypt. but the interesting piece of this was a chinese company bgi sequenced, threw it on the cloud, german scientists able to

do analysis very quickly and look how they are related to other related bacteria and could say it was natural not man made made. that situational awareness with law enforcement so on so forth. >> thank you for clarifying that. that was very helpful. anybody else on the advisory board? yes, sir. >> i think somehow pulling all this toregether, it comes back to letting more people be involved in this effort by defense. i think chinese pulled e. coli out because they wanted to be the fastest to do that. some other people never involved in that world got to play with it. like you're saying let the public. i think part of our leadership challenge is defense, you know, like a secret thing and only we can do it or is it a societal thing and we engage everybody

and get the public engaged and kind of belief most americans want to do good things. how do we take advantage of that is what you're saying too. how do you get more people engaged in these things. the last meeting maybe people can have doxacicline or cipro, engage them, hour them. long-term has to go back to early childhood education. we start teaching people about awareness and health and how to help society. >> i think there's an important nuance there. it's not a question of letting people be involved. people will do something. heard of cattle is going to go forward whether you want them to or not. not that people are cattle --

had to clarify that -- they will be involved and want to do something. the question is do we give them information to do something less bad than they would have lacking that information? >> so i would actually like to make two quick points, we we take into account aspects of how we reach out to different people. we're such a diverse culture of people that we need to be able to first and foremost say we respect you and respect where you come from and then go from there. that's sort of what the public engagement and science efforts start doing now is to start with that as a premise. the second piece of it is that there are actually board games and apps now that allow people to play role-playing games where you get to save the world from a pathogen of some sort. that in and of itself may be make way of sensitizing people to thinking about how you would deal with certain issues in

bioterrorism. it's just something to think about. >> any further comments? >> no. >> we thank you very much for your contribution. we very much appreciate your testimony. got prepared in march, hope leaving with the team, like to go over them. after you've left, we'll go over them. >> thank you very much. >> you bet. tonight on c-span a week long series on congressional freshman starting with republican steve russell of oklahoma. he talks about his career in the army, new life in congress and childhood experience. a different profile each night at 9:00 eastern. with congress on break, it's american history tv in prime time starting at 8:00 eastern with daniel ellsberg who become consultant to the defense

department on matters concerning vietnam war. he talks about his motivation leaking pentagon papers and his opinions on vietnam. that wouldish followed by interview, followed by counsel to the president. he talks about his early assignments, watergate and people behind the 1972 break-in at headquarters. american tv prime time tonight and all this week starting at 8:00 eastern here on c-span3. >> tonight on the communicators author vincent moscow on cloud storage and big data and how the government is using it. >> national security agency is building one of the world's largest clouds data centers in a secure mountain facility in utah. it's doing so because it's

surveillance needs require that degree of storage and security. the u.s. government's chief information officer three or for years ago ordered u.s. government agencies to move to the cloud. and as a result even civilian agencies are turning to cloud services. >> tonight at 8:00 eastern on the communicators on c-span 2. >> we return to blue ribbon panel in washington, d.c. examining leadership and organizational structures needed to effectively address biological and chemical threats. this is just under an hour. >> the final panel of this fourth day of public testimony we hope will -- we think is going to deal with an issue we

wrestled with every time we've had a public meeting and that's the question of leadership and organizational structure. there's a lot of organizations and individuals to play in biodefense, multiple jurisdictions, private sector. a very experienced panel appropriately concludes the final day of this public testimony. i'd like to introduce, ken bernard with president bush, former senior adviser to president bill clinton for security and health. rear admirable, admirable admiral admiral. retired u.s. health service. bob, you weren't here but we already cloned you. so many people talked about the work before, deputy staff director for united states

select committee on intelligence former special assistant to president bush for health and defense retired air force i would say at the epicenter for bioterrorism discussions in both administrations. i'm most familiar with the work he did when i had the privilege of serving with president bush. also lisa gordon-haggerty, security council for president bush and president clinton. a week after i got to the white house we had the first anthrax and i had to deal with her and her team how we deal publicly. we experienced in the first couple of weeks a lot of concerns that have been addressed by previous testimony not just today but in the three panels. how do you coordinate an efficient response in order to deal with that crisis. so we kkz the panelists and ladies first. >> thank you.

good afternoon, everyone. thank you for the privilege to speak before this important panel today. i certainly support your mission and given my prior experience i'm hopeful my opinions will serve the purpose. i'm also grateful to be in the company of my two dear friends with whom i share much in common and work towards fixing endless battle of interagency coordination but most importantly leadership. my perspective comes from having served as career civil servant once again department of energy director for technical response to all nuclear and radiological emergencies. after a few years i moved to the white house for weapons of mass destruction preparedness prior to and after 911 serving two administrations. therefore i hope to offer interagency and white house perspective of what should have been accomplished many years ago but what i believe can still be

accomplished now for the future. finally in the event my opinions might serve to be dated i've been fortunately part of serving more than three years as the national academy's institute of medicine standing committee on health threats resilience, workforce resilience national security department of health affairs whose focus has been biothreat preparedness, response and recovery. i also work for small business whose primary focus on interagency disciplinary support for state and local responders for ieds, shooters and weapons of mass destruction. when i began participating in the 1990s through interagency process known as then classified coordinating subgroup known as counter-terrorism security group supported national policy combatin