attacks, it is not particularly surprising that we face the growing, ever-changing threat from violent extremists. the department of homeland security stood up in the wake of thok%@@@@@@ @ @ @ @ @ @ @ @ @ a v efforts of our dedicated law enforcement intelligence and homeland security professionals who helped defend against that threat. there are other constants in that we, too, have a duty we must remain vigilant. we must's vigilant to ensure that those who bear the brunt of detecting, identifying,

disrupting and dismantling efforts by terrorists to strike at us, our citizens, our homeland and our allies have adequate resources and tools to do so. we must be vigilant that we do not slip back into a september 10, 2001 mentality regarding the sharing of information. no matter how we say it, knowing what we know connecting the dots, getting the right information to the right people at the right time, we're talking about the same thing. and an environment in which information is shared is an environment in which better decisions can be made, and ultimately one in which people are safer. finally, we must also be vigilant thant we are doing everything we can to break the link between these groups and individuals they are grooming for violence. we both law enforcement and our communities must keep a watchful eye open for people like von

brohm, smoty, but we smuft also be vigilant that those efforts resources and tools are applied consistently in ways that respect the privacy and civil liberties of american citizens, and do not sacrifice our nation's values. but i'm very glad that we have witnesses here before us this morning. i hope your insights will help us maintain both our vigilance and our ideals. welcome to you all and i thank you for being here. >> i thank the chairman for his remarks and would note other members of the subcommittee are reminded under committee rules, opening statements may be submitted for the record. i am now, it is now really my privilege to welcome our witnesses this morning. we will start with dr. jim zogby

who is the president and founder of the american arab institute and who appears today because i called him and urged him to fit this hearing into his very busy plans for the month. aai serves as a political and policy research arm of the arab-american community since 1992 dr. zogby has written a weekly column called "washington watch" currently published in 14 arab and asian countries. authored a number of books including "what ethnic americans really think "and what "arab this: values beliefs and concerns." in 2001 he was appointsed to the exec tick committee of the democratic national committee and in 2006 named co-chair of the dnc's resolutions committee. he has advised me personally and numbers of us here for years on the muslim community and i think it's very important as we review

this subject again that we understand the fact that most members of the muslim community are law-abiding citizens and really want to help us get this right. dr. mccloud ball is the acting director of the aclu at the washington legislative office. his office works with congressional offices on a non-partisan basis to ensure american civil liberties be protected. he held roles in the political community including serving on presidential campaigns. his works is an attorney afforded him the opportunity to argue significant cases on privacy and federal regulatory authority, and before this hearing, before his testimony here, he wrote the subcommittee a very thoughtful letter, which i have reread in preparation for this hearing on how to understand this problem and hopefully thousand get right and he has reviewed some draft legislation on approvement we

are considering, and i very much appreciate your cooperation with us. dr. wine is a professor of psychiatry and responses to could as it trophies as the university of illinois at chicago currently serves at the principal investigator of the national institute of mental health sponsored study on add lessant refugees from siberia in the united states, authored several articles and book including "testimony in catastrophe," he was awarded a career scientist award from the nimh on scientist based with refugee families. finally dr. craigin, a professor at the university of maryland, focusing on terrorist related issues. served three months on general petraeus' staff in iraq in 2008 and her iran publications include "the terrorist, dynamic terrorist threat" sharing the dragon's teeth" and exchange of new technologies.

without objection the witnesses full statements will be inverted -- inserted in the record. and i welcome first dr. zogby. welcome, dr. zogby. >> thank you, madam chairman and members of the committee. the issue before us is indeed a critical one. it concerns our national security to be sure, but it also represents a grave challenge to our national character. i come at this exploration from several vantage points, some as you mentioned, an american arab leader, having worked with those and other arab communities as well. at a ph.d. in islamic studies and also someone who did postdoctoral work on the impact of religion in societies under stress, as a pollster with my brother john spog buy intensively polled communities of interest both here in the

united states and europe and across the middle east and as a participant leader in ethnic coalitions in this country that has brought me into close contact with new and not so new americans watching them move from exile politics into the american mainstream. let me begin with a simple observation. despite real concerns that we all share about recent cases involving the arrests of some young men seeking association with dangerous international terrorist activity and the arrests of others who appear to be on the verge of carrying out such activity, we are not europe. our situation here is fundamentally different than that face by countries on the continent for several reasons. first and foremost is that america is different in concept and reality. i've heard and talked to third generation kurds in germany or al geeians or pakistanis in england who will continue to

remain on the margins of their society. they're turks, they're arabs, or they are pakis. they do not become british or german or french. on the other hand, becoming american is a very different process. it's brought countless numbers of immigrant groupings into the mainstream. it is not through possession of a single ethnic community or a single ethnic group has the right to define american with generations diverse communities and religious people of different religious background from every corner of the globe have become american, and the important thing is that not only do they become american, but america becomes changed as well. because of this rich experience, recent immigrants from arab and muslim countries come to this country in effect with the table set for them. and they find it to be a fertile ground for the ever-broadening definition of being american. another important difference between our situation and europe is that people here do not stay

on the imaginal. in fact, because of the extraordinary social and economic mobility available to immigrants, they in fact move into enterprise, the yemeni community in calf i first met 30 years ago picking grapes in the valley are today business owners throughout the country and their children are in colleges and in fact becoming quite successful. it is true we have a problem. but i think we need to put the problem into context. the arrests of these young men that we have seen is certainly one that we must consider, and we must consider not only the impact on our country but also the impact on the communities affected. let me say the following -- we're engaged in the conflict internationally. no question about it. and it has repair cushion repercussions here at home. those who sought to exploit it, cast it as an irreversible clash

of civilization. just as there are some religious and political leaders and maybe a figure in the muslim world who sought to taint america way broad brush of irredeemable evil, there are counterparts here in this country who tried to do the same with islam. all of this exacerbates tension and creates problem on all sides. despite this, the vast majority of american muslims and arab-americans rejected this fermenting clash. they have worked with the political process available to them, they have fought discrimination, they've combatted hate crimes and they've voiced differences in the u.s. as citizens not as aliens. nevertheless it is a fact that some alienated young men from these communities have become susceptible to anti-social radicalization. this is not new. we've seen it before. in the past four decades that i've been involved in politics, we've witnessed recruitment into

white supremacist and christian nation and militia organizations. the black panthers, jewish defense league, the i.r.a. the fact is that the allure of certain ideology and romanticized machismo complete with weapons, training and acts of bravado does provide for some of these young men a dangerous cure to the alienation and feeling ofpowerlessness they experience. i've looked at cases up and down. there are multiple differences and we have to look at the multiple difference and see what they are. they can't all be painted at one phenomena. what leads to violent action assess a cure to that alienation seems to run through them all, and this is has we must address. i believe that we must address

it with a scalpel and not a sledgehammer. if we in fact take a swipe at the whole community we increase the alienation and change the character of who we are marking it more difficult for us to deal with the problem. let me just come to a close by saying that we have to understand what we're doing right. not only what is wrong, but what is being done right. recruitment will remain. we have to find a way to make young men less susceptible to recru recruitment and if we look at what is going on right, we have leading organizations activity responding to efforts to deal with the problem. i can cite the work of the muslim public affairs committee as an example reaching out to law enforcement working with their communities, in particular with young people to create political alternatives to voice their differences with the policies that lead to the aggravation in a way as citizens seeking recourse. law enforcement is also working with these communities and doing so quite effectively, and as the

situation in minneapolis, or here in northern virginia shows, the work of the fbi or u.s. attorneys can be productive and helpful in this situation, and finally, we have a president who is creating a different atmosphere and space for discourse with the muslim world. this is very important. the answer is not to change who we are or how we react. but to be more of who we are and to continue to do what we do best. >> thank you, dr. zogby. thank you. mr. mccloud-ball. >> thank you, madam chairwoman. good morning, chairwoman harman. thank you very much, ranking member mccaul and other members of the subcommittee. thank you for inviting the aclu to testify about speech rights while examining violent ex-freedomism. 1964 barry goldwater said extremism in the defense of liberty is no vice. extremism is nothing more than a chosen set of beliefs and as

such protectedeneder the first amendment. an extremist ideology in and of itself must not bring on government censure. violent acts deserves condemnation. this hearing is entitled "violent extremism." violent is inherently harmful. extremism is not. linking an examination of the two implies an extremist viewpoint leads to violence and that violence associated with it is more worthy of examination than non-ideological violence. even though the latter is more frequent and caused more lasting damage. we will examine the events which may explain while individuals choose violence as a means for political change. we will steadfastly oppose efforts to examine and thus cast official disapproval upon any minority belief system. in time of national crisis we have often failed to live up to our democratic ideals. during the palmer raids, government created 150,000

secret files on those who held radical views or associations or voice anti-government policies. lawyers who complained about this were subject to investigation themselves. the lusk committee in the new york legislature in the '20s produced a report smearing libertarians as agents of international communism. and senator joseph@@@@@@@ @ @ @4 the security threat then was no less real during the first red scare and during the cold war,

yet government abused its power in responding to those threats. there is some cause for similar concern today. a flawed 2007 new york police report claimed terrorists acts are linked to the adoption of certain beliefs and there is a uniformed four step radicalization process from belief to association to terrorism. but the report was based on just five cases, and ignored the fact that millions of people progressed through some or all of these very same steps without ever committing an act of violence. ignoring those flaws the virginia fusion center cited the same report in deg nating the state's universities as nodes of radicalization requiring law enforcement attention. a 2008 report by the senate homeland security committee also restated the same flawed theories in arguing for national strategies to counter's it influence of the ideology. more recently, however, counterstunned studies have begun to appear. a united kingdom analysis concluded there is no single

pathway to extremism. facing racism, identified a key factor making an individual receptive to extreme it ideology. a 2008 national terrorism paper cited america's greater diversity and civil rights protections to explain lower levels of homegrown terrorism here. in senate testimony one terrorism expert blamed moral outrage at abuses of detainees and the perception of a war against islam as the primary cause of violence, not ideology. he recommended against any measure that would tend to alienate the muslim community. and this subcommittee, i would say, is show be admirable sensitivity to the issue just by holding this hearing. we don't question whether you should examine this but rather how to do so. singling out for examination violent actions committed by adherence to a particular ideology for scrutiny would pre-determine an outcome that would unfairly cast suspicion on all those who share any part of that belief or ideology.

it would perpetuate a perception of alienation fueling the violence. instead our best defense lied in a renewed dedication to the protection of associational speech and religious rights. congress should focus the government's anti-terrorism research on actual terrorist acts and those who commit them rather than on an examination of those who have particular beliefs or who express dissent. fear should not drive our cost policies, protecting our first amendment freedomless honor our values and keep us safe. thank you for consideration of our views and i want to pay special thanks to the chairwoman for her constant outreach to our office on these issues. >> thank you very much. we will now hear testimony from dr. weine. >> ranking member mccaul, chairman thompson, distinguished subcommittee members thanks for the opportunity to temperature before you today. i'm a psychiatrist, as you

heard, who works lab rative with refugee and migrant communities to address priority needs in those communities. over the past two years a group of minnesota somalis crossed the line to violent radicalization through their involvement in al sha bobb. they went to somalia, attended camps and conducted operations. the recruits were males between the ages of 17 and 30, they were born in somalia, raised in refugee camps in kenya then came as refugees to the united states as children and were raised in an impoverished divided community. they included high-achieving high school and college students, in all other ways, the recruits were indistinguishable from the other members of their community. what motivated them? their movement toward radicalization could be explained by multiple push and pull factors. most of the somali community in minnesota are subject to push factors that distinguish them from other american muslims.

such as war exposure, forced displacement. living in refugee camps, poverty, ghettoization, secondary migration, inadequate services and family instability. poll factors also played a key role. internet exposure to violence in somalia and to extremist political and ideological views, the somali warrior tradition, the 2006 ethiopian invasion of somalia bp all of these factors were skillfully ma anyone lated by recruiters who are former el sha bobb fighters who reached out to recruits through special networking and face-to-face contact. the results at least 18 somalis left home in minnesota and flew to somalia without telling their parents. serve hadn't been killed, four in custody and seven are believed to be in somalia. can violent radicalization occur with more somali americans? in my opinion, u.s. somalis remain highly susceptible to

violent randiccalization as long as el shabob is active in somalia. recruiters previous success in convincing the best and brightest young men from that community to go their way showed how susceptible these young americaning are. now, the fbi's success in apprehending some recruiters and preventing more from mobilizing is encouraging, but several key concerns remain. others may have been radicalized and recruit but did not mobilize and they're still there. wannabe or lone wolves could emerge. no broader preventive efforts have tried to lessen the susceptibility to recruiters. there is a stark disconnect between counterterrorism and both community policing and service provision in these refugee communities. recent events have shown that young men from muslim refugee and migrant groups from other failed states of violent

extremism are also susceptible to radicalization. what steps could help? as a prevent researcher with refugee and migrant communities i know that prevention like terrorism itself is local. families and communities, local police and service providers, they all need to be centrally involved. they're in the best positions to identify who is most at risk. but in order to provide help, they require guidance and support. we should draw upon psychosocial and public health expertise and apply it to preventing home-grown terrorism. i recommend the following steps -- one, conduct research to identify the protective resources in families and communities that mitigate against violent radicalization. two, develop and implement parenting education initiatives to protect against radicalization and recruitment. three, develop and implement community-level prevention that increases community support for

at-risk youth, such as mentoring especially where rue creters are known tore active and, four, strengthen the collaborations between at-risk communities and local police and service providers. now, to take these steps, we need scientifically rigorous conceptually based of how radekization ever occurred. journalistic reports are helpful but not enough to develop prevention. we started to work with fames to gather preventive interventions and spread those around, but, of course, the needs for this type of reventive work can be found in several communities throughout the u.s. the problem is this -- presently no government entity exists committed to sponsoring this research. we need a multidisciplinary commission or institution that would develop and sponsor investigation into the family and community dimensions of

violent radicalization in the u.s. and work with governmental, nongovernmental and community part pers's in conclusion, the recruitment of united states somalis oh examples of home-grown terrorism demonstrate in addition to intelligence gathering and law enforcement we need new approaches in counterterrorism for managing those risks through working with communities and families, if not, recruiters will continue to know better how to find and help potential recruits than we will. >> thank you, doctor. i can't help but observe that you described the motivation behind our bill of two years ago, the one that passed the house of 404-6. dr. craigin, please summarize your testimony in five minutes. >> i'd like to thank the chair and ranking member and the subcommittee on intelligence information sharing for inviting me to testify on the subject of this inside the united states. and also to take this opportunity to commend the

committee for recognizing the importance of this topic. over the past 14 years i've explored what motivates individuals to become terrorists as well as what influences communities to sympathize with sayre rift groups. this research can be found in two rand publications including dissuading terror and social science for counterterrorism and would be happy to speak further about other studies in a classified session. unt fortunately recent events brought this topic to the forefront. as you know last week five young american men were raeted in pakistan allegedly trying to make they're way to training camps along the pakistan/afghanistan border. although we have yet to learn fully about the intentions of these five men they appear to be one of several reasons examples of u.s. citizens and residents who have been susceptible to recruitment by al qaeda and associated movements. indeed examples exist of americans traveling abroad to fight as well as participating in training camps abroad in anticipation of conducting attacks here at home. what happens in these training camps? another individual arrested on

terrorism charges described activities in a camp as follows. an introduction to the ak-47 and other guns followed by a 15-day course how to make suicide bombs and rocked propelled grenades and then graduation. so how do people end up in the training camps? research conducted at rand and elsewhere suts no single pathway towards terrorism exists making it difficult to determine precisely how and why individuals are is a spentable to recruitment. having said that for the remainder of mire testimony i will address two questions. first, how do individuals generally progress from articulating sympathy to actively participating in terrorism? and second what can we do about it? to answer the first question, it's useful to explore the radicalization processes that clusters of individuals and individuals have gone through understood as having three phases. the first phase, termed availableability. environmental factors make them susceptible to appeals from

terrorist groups and might inclues peer group influences or frustration with foreign policy. the first phase can occur on the internet, the second phase term recruitment usually occurs after contacting individuals and a planned assigned group. that is our research as well as others suggest recruitment works best when virtual contact is strengthened through social linkages. approved from even criminal gangs in prisons. third phase of the process yields a commitment to action on the part of certain individuals. the final step has been the most difficult to isolate in research and in some instance as specific grievance appears to have acted as a final trigger. another common factor at least for communities appears to participate in a training camp abroad. i'm asked what motivates terrorism? ideology, politics, and the answer is yes to all. how can we intervene? determines ow individuals become

terrorists is difficult and derives strategies even more problematic. research suggests we best intervene before individuals depart for training camps, because these experiences tend to harden their commitment towards violence. yet in many instances individuals have not engaged in illegal acts prior to departure. these circumstances have proven to be the most difficult. i would like to focus on them for the rest of my testimony. first, beyond u.s. borders the u.s. government can work with partner nations to pressure those recruiters who have sewn success at reaching americans opinion well known al qaeda is interested in recruiting new fighters in the united states. this is not a new phenomenon. so as partner nigss work towards learning recruiters who reached successful individuals with their other countries the u.s. could encourage them to extend programs to focus on western recruits. second, with the united states, the u.s. government should work with local community leaders to develop programs that reduce susceptibility to messages articulated by al qaeda and associated movements. the case of the five arrested in

pakistan last week reportedly just brought to the attention of u.s. authorities through muslim community leaders and i cannot imagine how difficult was for the community leaders to call u.s. authorities regardless of outcome. we owe that a great deal of respect and gratitude. nonetheless, more can be done. in singapore, a group of scholars worked with individual arrest and terrorist charges and their families to help reintegrate them back into the community. similar model could be used for u.s. citizens and residents refusing to participate in training camps abroad. which brings me back to the original question how and why individuals become terrorists. clearly more needs to be done to get a bedder understanding. i urge you not leave it at that. as we move forward we need a better understanding how al qaeda and associated movements retain the loyalty of the recruits. and perhaps more importantly, why individuals choose not to become terrorists. for if we are truly going to develop bearers to al qaeda

recruitment in the united states it is equally important we understand motives of those who reject al qaeda's overtures. thank you. >> thank you very much, doctor craigin and thank you to all witnesses. i think this testimony is extremely helpful. we will now proceed to questions, and i yield myself five minutes. to all the witnesses, let me just read a list here. john@@@@@@ g recently the five in alexandria,

virginia. this is a long list. i don't want just to liftie arab-americans or muslim-americans, but this is a long list of u.s. residentses or u.s. citizens in most cases who are somehow experimenting with terror, and while i agree with you, mr. zogby, we need a scalpel not a sledgehammer and i agree that we should focus on actual terrorist acts, and not someone's belief system i truly agree with that, we need to do something here. we need to intervene. hopefully we will not intervene after the fact, but we will find exactly the right place to intervene to prevent these terror actions. so our second two witnesses, dr. weine and dr. craigin suggested ways to learn more. i'd like to ask our first two

witnesses what strategies do you think we, the united states government, this subcommittee, should undertake to intervene at the right moment to prevent acts of terror by people like the list i just read against the united states? >> thank you, chairman harman. i think there are a lot of good ideas expressed by all of the witnesses here today. today. i would reiterate our point that you start with the violence and not the ideology. adding to the list, we could add any number of ku klux klan whether underground, or any examples of terrorist action within our country. by starting with the ideology and saying you will define and examine those acts, you are

predetermining the outcome and your conclusions will cast dispersions on the muslims. >> i agree with the definition of the problem. what's the solution? >> to start with a different universe of actions. you look at what moves different people in different contexts from a nonviolent to a violent situation. that is the best way you are looking at actual historical events and not making assumptions about the future, but also by definition, if you are starting with a different universe of people, you are not predetermining a focus on the muslim community. >> doctor? >> you asked the question of the hour and it is the critical one. let me make a couple of observations. they are broken up into different groups, but with the

exception of two, they will all stop because we were doing things right. cooperation with the muslim community and the outreach and the significant work of law enforcement using the tools that are available to them and working with the communities has been effective in every one of the instances. in the case of nadal that is a horrific act of terror and an awful incident, law enforcement failed and we have to say that. there was a failure to connect the dots and because our hands were tied because of restrictive ways we approach gun laws and gun information, the fact that he bought a weapon that is not to be used for hunting and sharp shooting, but had records of this man in contact with someone that we have on a terrorist

watch list? you have all the information that you gave us of his questionable activities while in the military. yet the dots were never connected and the agencies were not talking to each other. that is a problem that i think we will have to look more closely at. what to do about it? we are doing things right. we are stopping the people and invigorating the cooperation in the communities and changing the tone of the debate in our country that i think is bringing more people forward and ready to cooperate. that's why people have turned in people and working with law enforcement to stop the problem. >> thank you very much. my time expired. i want to observe that the doctor said we ought to say thank you to the law-abiding member who is do turn in family members or point law enforcement with the problem. i think that's a good suggestion

and i would like to say thank you to those community members. we have a full group of members because this hearing is so interesting and i would like to ask unanimous consent can sit with us after the other members. any objection? so ordered. i yield five minutes to mr. mccall. >> behind me is an illustration of homegrown terrorists in 2008. this picture really says it all in why this hearing is so important and madam chair, thank you for holding this. this is a threat. i was a federal prosecutor and a thought is not a violation of the law. the ideology is not a

prosecutable offense. also a experience requires an overt act and that's the first step towards completing that spnchs that does make it a violation of the law. however, it starts with an ideology and begins with a radical idea or belief that eventually does come to fruition. not in every case, but in the cases that we have seen. we have been able to stop a lost these cases fortunately, but some have not. this case is a good illustration of a case that failed. it was a whole failure of law enforcement as you said. that was absolutely correct. when we had a major in the army, the united states army, the largest military installation of the united states north of my district, having communications

foreigning top al questioned recruiters, this was in the hands of the terrorism task force in washington. one of the members from the department of defense. if that information was not shared with the base where the major resided. don't you think general cohen who i talked to at the memorial service, we buried 13 soldiers and i talked to the wounded who said he shot us. don't you think he would like to have that information? he had a major who was communicating with the top recruiter in yemen? that didn't happen and that information was not shared with the military and ft. hood. i know that is on point because this man radicalized.

we don't know if he did on his own or had help from the outside. what can we do and i have so many questions i can bring up, but that case is a classic case of failure. what can we do better it ensure that there no more hasans out there? how many more out there that are a threat to our united states military because we know al qaeda targets the military. they targeted ft. dix. they bring back the playbook again and again like the world trade center and will probably try to do with the capitol. how can we stop another case from happening again? i will direct that to anybody. anybody who would like to tackle that. >> sure. i can start. i would like to get away from

the term. there some examples of that and there was a mentor term involved. during my testimony and one thing to start focusing attention on these mentors. that doesn't have to be in law enforcement, but that is one way to do it. unfortunately, timothy mcveigh was one of them. that's an unfortunate reality that we are facing today. >> anybody else on the panel? >> yes, i think that prevention is the right word. the question is how you think about prevention. not strictly from a law enforcement point of view, but community policing point of view

and from a public health point of view where we try to establish relationships and change behavior upstream before they go too far down the line. we are not doing that right now. counter terrorism in the microcosm of the somali community is limited to fbi criminal investigation and with all due respect to the people who do that important work, i think there still shortcomings in the area of community policing and preventive approach. there parents and community leaders who want to support the efforts, but they are not involved and engaged. that's what i think we have to do more. >> i worked as a federal prosecutor.

one thing we need to do is get involved in the community where we can identify the 1% or less of potential threats. >> let me respond to the question briefly. let's try to stay strictly to the five minutes to be fair to everybody. >> ideology is the paint on the surface that is already there. he meant i'm going to kill you. i hate you. i am angry. really angry. when i used to teach religion, i used to say the meaning of a word is how it's used. if somebody said jesus christ, that doesn't mean they are a devout believer. it usually means they are angry. when they say jesus christ! i'm excited.

we cannot use it to mask purpose and take our attention off of what is going on. that is why i agree, you judge the action, not the language. in another era as peter bergen said on cnn, major hassa may have turned to another ideology, but the language of the moment to describe anger and the conflict we are having and the deep alienation i'm feeling is the language of religion. do not let them confusion us with what the real thing that is going on. that's when we use the sledge hammer. as i watch the media and cnn covering the problem of what happened in pakistan showing muslims on the mall on service day when they were committing themselves to service to our country, praying. that was the backdrop. they said they are dangerous and we have to be careful. judge the action.

the susceptibility will be there. we have to deal with the susceptibility and not the language they use. >> thank you. i yield five minutes to the chairman, mr. thompson. >> thank you very much, madam chair. excellent panel and i thank all of you for your testimony. one of the things i want to do is try to broaden the discussion. we just saw a broad panel of where arrests have taken place. it only focused on a very narrow type of arrests for certain kinds of things. one of the things i want us to do as a committee is look at act acts of violence and extremism in its totality and not a very

narrow focus. we can understand that the bait here is important, but it's a part of a broader debate we need to take as a committee@@@@@@@ @ with white supremacy movements, there is a lot of chatter and

danger and a lot of concern. i think that is an area that is something we have to look at. the susceptibility in an economic downturn and in time of war and especially now with this sense of revenge about government is a problem. i think we have to take a close look and continue to look at it. it's the other language used today. >> thank you. >> i want to say this in the right way. i don't want to name groups and cast dispersion by naming them in this context, but historically there many groups in our country and many are referenced in my previous answer. there remnants left today or people who believe the same things and act to further the beliefs. >> i guess and i accept that,

but if you can talk about the ideology rather than the name of the group, if that would give you a little -- >> let me go about it this way. does timothy mcveigh have more in common with an islamic terrorist or a christian believer? most people would say with islamic terrorists. it's not the belief that is the defining moment. that's the paint that may be present. it may be present in any situation. you start with the propensity for violence, however that may be caused. you add the background material that gives the person the basis for going forward after he or she has the propensity for violence. i'm reluctant to talk about it in that way. i think it starts with the

factors that create the propensity for violence that the other witnesses mentioned in their testimony. >> thank you. i'm concerned about the place where three broad processes interact. one is failed states. people who come from failed states where there violent extremement movement and organizations and three is they now exist in migrant communities in this country that face challenges of daily life. the somalis certainly fit that. so do several other communities that we have to be concerned about. i think this is very challenging. the other broad thing that concerns me is the issue of movement. migration. secondary migration within the united states. i would like to share this back

with you. there presently about 84,000 somalis and 20,000 resettled there. 20,000 came from another state where they were resettled. this represents a short coming in the system. when they moved they don't come with services attached. this is a set up for underserved refugee community. we might think about what other populations in the u.s. that fit that pattern. >> thank you. >> in my written testimony, if

you were to broaden the community with the radicalization process, it would include criminal gains and colts. that's one way of broadening it without ideology or naming specific groups. >> thank you, mr. chairman. five minutes. >> i will start to dr. zogby. my regards to your cousin, charles. we are told the united states is less susceptible to terrorists than european nations. do you believe that is still the case and if the united states is less susceptible, can you go into why. >> the important thing to understand here is having dealt with and talked to these groupings in europe, actually it was the state department and

another program i did with bbc who were interested in seeing the differences in what is going on here and there. the degree of alienation is different there than here. here it exists on the margins and there it is much more widespread. they didn't tell their parents. the pakistani kids here in northern virginia didn't tell their parents. that tells you something right away. the community base of support in europe for this problem of radicalization is very different than here where the problem as i said exists on the margins and the parents actually turn them in or their pierce will turn them in. the process of becoming american is determinative and the more compelling force and the antidote to this radicalization and a sense of alienization.

at the end of the day, what we have to do is more of what we do and do it better instead of less. >> the reason i asked the question, when you saw the recent incidents around the country, i was under the impression that europe is more susceptible and given what happened in the recent weeks and months, i started to question that. >> that's why i suggest if you look at each one and take them apart and see where the patterns are, the ft. hood is different than minneapolis. i would say that one of the things from somali experts and people in the community said since the withdrawal of ethiopian forces, the lure has gone down and the parents turned them in. the u.s. attorney had the full cooperation of the parents and the parents looked upon it as a

relief because the people who were preying on their kids were gone. we were doing it well and it is not the mainstream. it's the margin and we have to make sure it stays on the margin. >> we received a variety of mixed opinions to address the issue of radicalization. some say there should be increased cooperation between law enforcement and muslim clergy and religious teens. we want to deter the teens from going down the path of radicalization. it causes voices we hope to encourage to be discredited as pop ganda. do you believe the government and officials should actively engage with muslim religious and clergy leaders and how can it be done without discrediting? >> i will start by saying one

thing and to agree with dr. zogby in that i don't think we see the susceptibility as we do in europe. one thing that's common between the two of them is a separation of the cells or bunch of guys from their own muslim community. it makes law enforcement and relying on muslim community to interact with law enforcement more problematic. they are not separating from american society, but even separate for example their own muslim community. this makes this engagement even more problematic. i tend to think that engaging like the way our law enforcement are with leaders is the way to go in this area. if you want to protect civil liberties and you are not wanting interest of law enforcement tactics, the way to go is engage the leaders. like we have done successfully, we have really great examples of

how this worked. >> thank you. do you believe that domestic radicalization is a threat in the united states? >> there many threats and that is one among them. we are talking abouty semantic issues. we had 1.3 million violent crimes in the united states reported in 2008. certainly it's a threat. part of that threat is what you mentioned. some people are motivated through ideology and many people were motivated through something other than ideology. the threats, sure. they exist. we ought to be investigating those along with the other threats.

>> thank you very much. five minutes. >> thank you, madam chair. you stimulate so many questions, this will be a long series of hearings i hope at some point. dr. zogby, i appreciate your making the distinction. i would like your opinion though. do you think the case of somalia is somehow different than those who are recruited to span? >> it may very well be. that does not mean that we should not have taken measures to protect these kids from recruitment and engagement in activities to who we are and what we want. there is a fundamental problem

and if i can take a moment to look at it, it's a problem of exile politics. ultimately we have to make a decision as a country. i remember growing up in a situation where there was no such thing as dual citizenship. now you can have it with many countries all over the world and now vote in elections in countries all over the world while you are in this country as an american citizen and now, you can be a bush administration official in the department of a.i.d. and run for office in lebanon for parliament and decide whether or not you want to come back to the united states or not. the issue here and i spoke with the jdl before and these guys floating back and forth, i think we have issues here we have to look at as a country. i grew up when i saw the pictures of george washington crossing the delaware, i was on the boat with him. when i saw lewis and clark, i was with them. it was my story.

we are inhibiting that story from being the dominant narrative when we are in a situation where we encourage dual citizenship and people voting in other elections and then ethiopia invaded my country. i will go and defend my country. when our department of state funded the elections in iraq in this country and the cochair of the republican party of san diego is quoting the l.a. times saying at last for the first time in my life i get to vote, i said what the heck is going on. you just voted in the presidential election in this country. that's your country here. make a choice. we have to look at that. i'm not going to be popular with both parties and even people in my own community, but if we do not take the issue of becoming american and take it seriously and make it work with all that it means, we are running down a road that will get us in trouble

everywhere, not just in the mideast, but as conflicts emerge everywhere around the world, people say that's my fight. that's my fight. arabs, that's my fight. pakistan, that's my fight. that's not a good situation to be in asd we have to work with full gambit of institutions that policies that worked to make these kids fully participate. the fact that if we hire more americans in government and open to their rank and do more, the overseas will pass by them completely and make sure they are part of it and identify with

it fully. >> i want to switch gears and si >> i have a question concerning potential motive of hundreds of gitmo detainees to illinois. and this is for all of you actually. is that going to have some kind of impact on recruitment do you think? will it be a damper to recruitment? what's your opinion on the transfer of the detainees? >> i know that there's a bigger political dialogue taking place in illinois about that, and i'm really not in a position to comment on that. i think that -- >> i didn't ask you about the political. i asked your professional opinion. will does have some kind of impact on recruitment? >> i think that recruiters are very clever, and recruiters are always looking for a way to manipulate events to their advantage. and i'm sure that recruiters

will find a way to manipulate that to their advantage. that doesn't mean that that shouldn't be done. moving gitmo detainees into illinois are not. i think that should be a lightweight at a different level, but i think that the point in terms of prevention is we need to find ways to stay one step ahead of where recruiters are. >> although i'm not a psychologist, i would like to add unless the movement of the detainees also includes a commitment to due process and to actually provide rides to all of the detainees to determine definitively what their status is, then i think that would serve as a basis for recruiters seeking 2.2 united states, treating folks with something other than justice. >> dr. cragin? >> i have all you can favor of

shutting down guantanamo bay because it has been used as a big rhetorical device in the al qaeda media. but i would agree that whatever you decide to move it, you would want to give the detainees due process in order to camp down as much of that rhetoric in the future of. >> thank you. >> the gentleman's time has expired. mr. brown of georgia is recognized for five minutes. >> thank you, madam chairman. dr. zogby, your last testimony was extremely refreshing to me, and i have long been a believer that the-his vision of america is one of the biggest problems we have with radicalization and all these other things. i think it's true in europe because if you look there, you see the radicals coming out of community that is not only did to their own country, or not even a legion to the european

union, but is a legion to that radical elbit within a community and i think a common language, english is official language of america is absolutely critical for us to help further exactly what you're saying. i think stopping the dual citizenship is critical, and all those things that i appreciate your testimony in that regard, because i could not agree with you any further. >> i did not mean some of that, and let me just to claim what i do mean. what i do mean, i do oppose the dual citizenship and i think we have to move from people from exile into the mainstream. but it is wonderful that i am an arab american. american is the noun. arab is the adjective that i have a heritage i am proud of the. it gives me no end of joint -- >> i apologize for interrupting you but just for the sake of time, we all come from different

backgrounds. we have different beliefs. we have different heritage. that being an american is the most important thing, in my opinion, for all of us. >> and that meaning of being american is that we eat spaghetti, and others and this diverse culture of people that have all become america and america has become change. >> i agree with you. >> and would focus on that anti-american story. i agree with you wholeheartedly. >> i was glad to hear you, your earlier testimony. but nowhere is the threat more real in the homegrown terrorism. fort hood was a horrible example of radicalization, turning from ideology, and ideological expression to terrorism, and an act. dr. cragin, it appears that political correctness is a

tremendous roadblock to addressing radicalization and homegrown terrorism. i would very much like to hear your thoughts on how we can address that issue. >> spirit ionizer had people say that maybe for political correctness is a roadblock to addressing the issue of radicalization. i would say in my experience that that's not necessarily the case. there is some disconcerting and even with the term of ideology. but in this sense twomey ideology is i think as of this panel has suggested, is sort of a broad brush or a rhetorical device that tends to be used. but when it comes down to individual motivation, ideology doesn't end up being -- research would indicate it doesn't end up being one of the primary motivating factors in most cases. to me political correctness if there's a bit of sensitivity may be, but i wouldn't say political correctness necessary has been a

barrier, at least in the academic community to address this problem. it's been more an interpretation of what does ideology mean. >> i disagree with you. i think on the fort hood incident, it was the biggest bear to preventing that terrorist attack that occurred down the. it is a very tragic terrorist attack. one of the soldiers that was killed was from mike district and i think political correctness was very much in play there. changing tracks, i just throw the. i have just one minute left. i believe here firmly that on the ground human intelligence within various community, whether it's within the radical muslim community, whether it is within the radical act of terrorist troops whether with the radical animal protection groups, or the others that have been mentioned, i would like your comment on my belief that

on the ground, human intelligence i think is going to be one of the best ways, if not the very best way, of preventing the radicalization to stop the process before it gets to a point of actually causing a terrorist act. so i just throw it out for the few seconds i have left. mr. macleod-ball? >> thank you. i think i disagree and agree in part with you. i don't think we can make -- be making decisions based on individual associations with groups, no matter how bad the reputation may be. however, if law-enforcement acting properly determines that there is -- that it has probable cause to believe that a particular set of individuals are appropriate to investigate, because they anticipate or have committed unlawful acts, then certainly they ought to go and

investigate. >> you want to wait until you actually commit the terrorist act or break the law before we intervened, and we've got to intervene before that. >> not necessary. when you have probable cause to investigate, it doesn't necessarily mean that an unlawful act has already been committed. we're sort of talking hypotheticals here. but the law-enforcement community has a fairly rigid set of procedures that has a basis for determining when to open a file, which opened an investigation into a particular set of circumstances. and those rules have been in place, policies have been a place for quite some time. in members of this committee i am sure are aware of those procedures better than i am, having worked in the law-enforcement committed in the past. >> my time has expired but i would appreciate a written response regarding that question. thank you, madam chairman. >> that request is acceptable to all of you? thank you very much. now i yield five minutes to mr. green of texas.

>> thank you, madam chairman, and i thank the witnesses for appearing today. there are words from south pacific that are important, i think, the song has the words you have got to be taught, and it. you are not born an evil person, a terrorist. you have to be taught. so you do have some injury that takes place along the way. and in the process of being taught to hate, we have the opportunity to negate this process, but we cannot do it inconsistently. we really have to develop consistency in dealing with

hate. hate speech, hate crimes. we are right to talk about how persons of a repute from other places can do the dastardly deed. but we must also, with an equal degree of fervor, condemn those who are born right here, who have been terrorizing people for scores of years. we have to use the same language when we talk about the kkk, and talk about the evil that they represent. and be as committed to eliminating the kkk and its evil as we are to eliminating others who would perpetrate evil.

the consistency has to be there. and having lived under circumstances where fear was something i had to cope with, i know that we have not done enough to be consistent with our rhetoric. and we cannot allow a certain amount of tolerance of hate to exist for some and expected to overwhelm others with our desire to do good. dr. king reminded us it's not just the work of evil people, the actions of the evil people, but the inaction of good people that really can make a difference. and what we do. and good people, people of goodwill have to use the free speech just as people of evil will, will use free speech.

free speech has to have a price when it has hate any. the price doesn't have to be incarceration. the price has to give people of goodwill stepping forward and saying, this is wrong. this is hate that you are preaching. and we've got to get people to a point where they will do this, and it has to permeate the entirety of the community. so my question to all of you is this. how do we make sure, or how do we protect a process that is consistent and approach to to be the build and not allow home-grown evil to receive less attention than evil that may come from out that is equally as

bad? and the kkk, i say to you, is an evil organization, with evil intent. rarely will you hear it said as i have said it, but we have no problems condemning other evil. evil is evil. we cannot tolerate it under any circumstances. and i will start with the lady, your commentary on how we can consistently deal with this, please. >> sure. i think as i mentioned earlier, i can't even begin to say how impressed i have been with local community live in in enough states who have done this, who have stood up and said no, this is wrong. and i would agree with you -- >> if i may just intercede for a moment. i want people to stand up and talk about how evil the kkk is. that's what i want -- that's the example. >> i was going to say that's a

nice example for the rest of us. for doing the same thing. one thing i would add to that is protecting those who speak out from backlash. i think is an important component of this. and so there's almost a bandwagoning effect so that more and more people feel free to speak up your butt absolutely, i would say there is an encompassed all of us. >> yes? >> i think one would think about this is your talking about counter narratives, counter notice to hate. counter narratives to extremism, and i think the counter narrative from one corner of our society can be inspiring and helpful to counter narratives to those who want to preach governorates from other segments of society and they should be spoken. and they should be listened to. and my concern along with dr. cragin is that we could be doing more. especially to people who are

economically disempowered or on the site to preach the counter narratives against hatred and fear. thank you. >> i really appreciate your comments. the kkk grew out of a radical reaction christian philosophy used as part of its history. and yet, i would say there is more in between the kkk and the islamist groups who have attacked our country than the kkk has with mainstream christian values. and that's the point, i think, of our conference is that you've got to look not at the etiology that serves as the foundation for the organization, but rather in their propensity for action. whether you're looking at kkk or

some radical islamic group who has attacked us, or non-ideological attacks. look at the anthrax attacks or the columbine shootings, or any of the non-ideological -- >> let me interrupt you. madam chair, would you be so kind to let dr. zogby have a comment on this? >> i will, mr. green. we were indicating the notion of each memory having one more question. maybe you would like to continue your time and have that count. >> i will allow this to be mai tai. dr. zogby, please. >> i remember during the clinton years the dialogue of the national dialogue was an important effort to engage us all as a country in an examination of who we are and how we relate to one another. he also held i think a rather stunning white house event on hate crimes. i was a participant in and i

think we need more and not less of that. i also think if i were to fault the effort in one way, it was that it was too dependent on the president to go from place to place and we didn't begin a national program of encouraging people independently to begin this conversation in their communities, on their campuses, etc. right after 9/11, president bush did a rather stunning thing. when he focused the nation on the american muslim community and said they should not be seen as the enemy, and we have an avalanche of people in hollywood, in various forms of media and politics, this house and senate passed resolutions, people begin to have meetings in the committees talking about. my committee, i will take the measure of our country is that my community, the arab community and the muslim commute as well never felt as protected and redacted even when we are

witnessing hate crimes as we never had before because of the support we were receding from institutions around this country. it all started with the president doing it. and i think we have an opportunity to do that again on many levels today, and not be afraid to encourage a re-examination and he recommitment to what it means to be a american. what it means to be a diverse country of many strands, woven into a fabric that has made us great if we allow that map to define us, and to take those -- and i maintain isolated events because each of them, many of them are different but some of them are criminal activity, convert to islam. some of them who are recruited fighting for engagement, not to attack our country, despite the fact that i think that engagement is long and still should be dealt with. all those things are wrong and we have to look at the. but they cannot define our response. that's what i said not a sledgehammer, but a scalpel.

one of the things to do is to begin this national dialogue not just in this hearing, but among all of our people so that we in fact we commit ourselves to the value stack i'm going to have to take you, doctor. thank you, madam chairman, you have been more than generous. >> thank you and thank you dr. zogby. members were interested in doing this will be able to ask one more brief question, starting with mr. mccaul. >> thank you, madam chairman. mr. green, thank you for that questioning. i think you hit the issue. is hatred. is what we are talking about, and my grandfather lost his job because of the kkk, because he was a catholic. and it was white supremacy, a religious extremist movement. not unlike what we are seeing today in terms of a radical islamic extremist movement. not to categorize all christians as being that way, or all muslims being that way, but we

are talking about a radical form of hatred, a perverted sense of these religions, these two religions, taken to a radical point of. where action, unfortunately, is taken by some in a terrorist event. the kkk portrays terrorism in the united states, in my view. you know, and i think radical islam portrays terrorism, they certainly did on 9/11. and that is -- maybe it's a matter of semantics here but i do think the ideology and the belief system, you can take, you are, out part and parcel from the act itself that i think it does begin with a police system that takes an individual to a point where the hatred is such. dr. zogby, you said it well when you said that night, what he meant was i hate you. that's what he meant.

mr. hassan and fort hood. that's what drove him to kill that they. and so i think the ideology is the belief system is the beginning. of the process. and the radical belief system. and i think the great challenge we have in this country is how, within the constitution, to monitor activities of the radical ideology and radical believes, and to be able to prevent and deter that radical belief and going to next up into an act of violence. so with that, if anybody would like to comment on that. >> that was a brief question? [laughter] >> yes, mr. mr. macleod-ball, briefly, please. >> i believe i disagree with your statement that it starts with a radical belief that i think the radical belief could come in the end. and is the propensity in violence that really is the factor here. and when you exercise your

responsibility to examine these issues, if you exclude other ideologies, if you exclude the kkk from your investigation, you run the risk of missing something that may be critical to understanding the entire process. >> i completely agree with that. >> thank you. mr. carney, a question please? >> how do you define a question, madam chair? [laughter] >> in the two terms i have been here, i've noticed that we often react to fear rather than courage. and i am damn tired of that. i've got to take him that i am very impressed with the panel and what i averted a. and mr. zogby, i really want to associate myself with your comments on what we can do.

and to that end, your discussions of being yemeni american or irish-american or whatever the case may be, how much do these folks see themselves as a soldier via citizen in these wars that they're involved in? >> they do not. and that's the important thing that the majorities of those communities see that ethnicity as part of their heritage, and part of their origin. the land where daddy came from. and that is the nature of exile politics that it is the nature of the kids whose parents came after the hungarian -- 1956 revolution was quashed, and whose parents kept talking about were going to go back, and the kid one generation are saying no, this is home. and that's a process we have to encourage is that since that is your heritage, it's your history. you can be proud of it, but this

has become your new history and this is the america that we become. i therefore think that we don't want to discourage yemeni americans from feeling proud about their heritage and human, but what we want to do is make sure that american side is strengthened and given a sense of purpose so that they identify the way that they expressed their concern about what's happening in the mall you is by voting for a congressman who's going to support their position on those issues or by getting engaged in a political discussion about what can america do to change politics in afghanistan, rather than i am becoming a soldier because i don't really belong here. it's that alienation we have to cheer, and that is the key here. >> dr. weine? >> i think we should remember that these kids, a lot of these people who radicalize and are recruited our kids. they are 17 years old, 18 years old, 19 years old, in high school. they are not rational agents.

you know, making logical decisions with backed by the full weight of a balanced view of the world. and they can't act impulsively, quickly and responsibly to a charismatic person that that makes them very volatile. >> how desensitized are these kids to violence and? >> i don't think -- the ones that i know, they are not violent by nature, most of them. and back, one of them wanted to be a doctor. they see themselves as healers, but they are desensitized to violence in their communities, subject to a lot of community violence. one of the kids who went to somalia was really struck by and wrote on his facebook page the drive-by killing of one of the kids in minneapolis, and said that could happen to me. and i think that changed his

view of the world. to the point i want to make is, you know, it's kind of takes a village idea. teachers, parents, community leaders, not just one person in one conversation, but all these people have to be involved in the counter pole against that one recruiter there because ultimately we have got to convince a 17 year-old acting alone and impulsively to stay on our side and not to go to the other side of. >> thank you. >> thank you, madam chairman. >> thank you. doctor brown's. >> thank you, madam chairman. quick question. i think the only way we can stop terrorism in this country is for the peace and the muslim community, but what we are most focused by now, i think it is for peaceloving muslim all over the world, in this country as else as elsewhere. that's enough. we've had enough, we're going to

put a stop to. and it is true within all committees, whether it is in our communities or the kkk or any other communities. i think the way to stop this is for people to be within that community to say no, and we are going to prevent it ourselves within our own community. do you agree with that, each of you? and if so, how can we promote that more so as a committee and as a government from the u.s. governmental perspective and? jumping. >> yes, i completely agree with that. and it concerns me again to take the somalia example as one indicator of this that a year down the line, those parents of those kids who went away, nobody has reached out to them that they are sitting there with their story.

they haven't told their story. they have a story to go to other community numbers. no one has told them to do that. not social workers, not the police, and they feel victimized, not only by what happened to their kids, but by this lack of response. and then by all the media attention. you i think have to find ways to support parents and community leaders like that, not just to stand up for community values or participate in a community dialogue, but to specifically counter radicalization recruitment. and i think the effort of the bill that was once proposed in general is what's needed, a government entity to address that. so that's what i think you should give. >> doctor, specifically how would you do that though? how would you reach out to the somali families. how would you reach out to any others? not only in this country but worldwide. >> well, we are and i would do

it in the spirit of collaboration. say, you know, the best protection of your community is going to be people in your community is stepping up. but yet we know certain things about, say, how to prevent teenagers from doing other bad kinds of things like drugs, gang involvement or sexually risky behavior. so let's merge the expertise from science and community values, and let's get that worked on in community, on the ground activities to thank, doctor. that was quick, quicker than anybody else. >> thank you, doctor brown. let me conclude with no question, but just an observation first. we have a problem, and the subcommittee is dedicated and has been dedicated over many years on a bipartisan basis to find a solution, to find the

right intervention strategies so that this problem of people becoming terrorists, whatever their motivations are, is hopefully reduced and we present the death of hundreds, thousands of innocent americans. probably on american soil, if possible. we have a problem. the second point i want to make is that security and liberty are not a zero-sum game. i have said this over and over and over again. we either get more of both or less. and i predict that if we don't work together on the right intervention strategies, and there is another major attack or a series of major attacks on u.s. soil, the first casualty is going to be our constitution. i don't want that to happen, and i appreciate the fact that all these panelists and many others we consult the want that to happen either, and therefore, we need to focus on what are the

right set of intervention strategies. third is, we are not limiting our inquiry to the arab-american community or the muslim american community. we never were limiting it. and the comments of numbers of members about a broader inquiry i thought were very viable and the comments of the witnesses about this were very viable. so i think we have built a very good record here. finally, to dr. weine, obviously my favorite witnessed since you liked our bill, that bill was well intended. i don't think any of you disputes that. the goal of setting up a multidisciplinary commission was to give us better advice. it wasn't to tell us what to do. it wasn't to develop a legislative strategy, but it was to give us better advice so we would act based on information, and not just based on a motion. or passion or personal prejudice

that any of us might have. so i continue to feel -- not necessary that that bill has to become law. i know there are strong objections, but working together on a better strategy is imperative. i want to leave that message with all of you, and i see people nodding, so you are in. you are in the tent, and a strategy perhaps based on a refinement of that old bill, perhaps based on a way to go after recruiters specifically, perhaps based on a better understanding of the good community policing and good community strategies, and certainly including the words thank you to those who are trying to help is a way forward. so i want to thank the witnesses for their viable testimony, and the members for very valuable questions. if members in addition to doctor brown have other questions in writing, i hope witnesses will comply. having no further business, the

subcommittee stands adjourned. [inaudible conversations] [inaudible conversations]

>> into new flu vaccine technologies. research directors joined health and human services secretary kathleen sebelius and dr. anthony fauci who leads the national center for allergy and infectious diseases. from the national institute of health in bethesda, maryland, this is about two and a half hours. >> good morning, everyone, and welcome to nih. i am bill hall. i am with the office of public affairs at the department of health and human services. and i want to welcome you here today for this seminar on for the media and the public on new

vaccine, new flu vaccine technologies. we have arranged this session today to offer the media and the public an opportunity to have a little more time to learn about the new technologies that flu vaccine technologies, that our department to a number of our agencies have been working on. as many of you have seen in the news about vaccine, h1n1 vaccine. it has been produced through our tried and true method of using eggs, which has a number of downsides to it, and so we have been working for some time now to develop new technologies, and today's event is a chance to sort of learn about the research that's been going on in both basic and clinical sides, advanced evolved activities that we are working on in order to move this technology along, to

build manufacturing capacity, domestically, and to look at the new regulatory signs that will help us regulate these new products as they come to fruition. this morning, we are webcasting this event. for those of you watching online, welcome. we have an e-mail address that you are welcome to ask questions throughout the morning. you can send us in at any time, and we will pull those up during the q&a sessions. the e-mail address is hhs studio at hhs.gov. so please feel free to send those questions into us. will also at the end of this, after this is over we'll be taking the video of this event and archiving it on the web, along with a transcript of what he said here today. and if we can, we will put up the slides that we have as well if that's possible. so that should be up within a

few days after today's event. so again, welcome. and i would like to get us started today by having sort of an overview welcomed by the director of the national institute of health, dr. francis collins. dr. collins. >> thank you, bill. good morning, everyone. welcome to those of you attending here at nih, and two people joining us by webcast. i am francis collins got the director of the national institutes of health, and is a pleasure for us to host this discussion about vaccine preparedness and new technologies, to put together ideas for the future that many of which are exciting about ways the development of future vaccine for influenza and other infectious agents is actually a very rapidly moving field in the scientific arena, in which you will be hearing about over the course of this mornings presentation. i am happy to be able to host this seminar, just five months after the h1n1 summit that was

held here at nih back in july. at that point, president obama put forward four pillars to a plan that are constantly being revised and reconsidered. those four pillars are surveillance, secondly, community mitigation measures, third, vaccination, our main topic today, and fourth, communication which also an important part of today's activities. we have learned a lot since july about the course of h1n1 over the course of the autumn as it returned to this country, and we have learned how to adapt a plan to conditions and stayed off some of the worst case scenario, although as everyone knows it would also struggled with availability of sufficient doses of the vaccine, because in part, of its slow growth in eggs which is one of the reasons i think many people are interested in hearing about other approaches in the future. i think being here at nih and

its important to point out the very hard work that was done and i am sure you will hear more about that this morning, and other dr. fauci capable leadership, the effort to test the vaccine and to show, in fact, that is highly effective vaccine, and that we know a lot about that based on the clinical trials that were conducted quite rapidly, including on adults and on pregnant women and on our children. so our present position of certainty about vaccine effectiveness is based upon that very rapidly moving and rigorously conducted research. so it's fair to say we have in this particular pandemic that she'd confident that we had a safe and effective vaccine, but we've also learned, if we didn't know it already, that the technologies used to produce that vaccine based on methods that have been around for a long time could certainly use advances for the future, and to take full advantage of the

scientific progress, that's what we would like to talk about today. so this seminar is really focused on how far the vaccine technologies have progress and where they may need to go in the future. you have a variety of expert speakers who will be presenting to you today. bruce gallen, carol hyman, robin robinson, jesse goodman, and especially tony county whose leadership in this whole area over the years has put the united states in a position of international prominence in terms of the technology and the way in which vaccine can both be developed and tested. so i think it's going to be very interesting morning, and again i think those listening on the web will feel free to send in questions through that address that was mentioned a moment ago by bill hall so that there can be a chance for back and forth, including people in the room and people beyond the realm of. finally, i would just like to say thanks to the secretary, secretary sebelius could not be

here this morning but it was clear he played a critical leadership role over the course of these many months of pandemic flu. she made a joke about how she didn't expect to have a pandemic in her welcome wagon, but she has adapted to that, i think, quite brilliantly and certainly would like to give a great deal of credit to her leadership in pushing the agenda forward and making sure that all of the areas that needed attention got that kind of attention. she wanted to be with us today but is unable because of other scheduling challenges, but she could prepare a special message that i hope will appear momentarily, as we queued up a dvd with that message. so without further ado, my boss, secretary kathleen sebelius. >> thank you, frances, and thank all of you for attending the seminar on new vaccine technology. i figure going to be very

pleased you took the time to join us today. the presenters are about to hear from are the leading experts from hhs, nih and the fda. and the importance of the topic couldn't be more timely. the flu vaccine was used to do is extraordinary save. is externally effective that it's the same flu vaccine would have used to immunize 100 million americans annually for decades. by the process we used to make it is cumbersome and outdated. we couldn't have had a better indication of the need for new flu vaccine technology than our expense would be 2009 h1n1 virus best ball. the flu vaccine's active ingredient is grown in chicken eggs. and likely influenced by recent self, and can be temperamental and unpredictable. this year, when we need manufacturers to ramp up production quickly, the editor decided to take its time for even before the first outbreak of h1n1, we have no, we need to

develop new technologies that will provide vaccine with the same level of protection to do with the 21st century ability to meet the demand that it will be several more years before we will be able to wean ourselves away from egg-based vaccine. that we are committed to moving ahead with 21st century vaccine development that ultimately, these efforts will help not just the united states, they will help the world. and when the next pandemic hits, we will be better prepared to mount a speedy, agile response. in the meantime, although we clearly don't have vaccine and the volume we anticipated, we know we have a safe and effective vaccine. and we know that the american people can count on it to provide protection from the h1n1 virus. thanks again for coming. >> thank you, madam secretary. and without further ado, i think we should move into the agenda

for the program. and that involves the first presentation from doctor bruce gellin. >> thank you for posting this here today and thanks to all you for coming and your interest in this topic that i'm going to talk sort of a broader release and some specifics about flu as well there but i wanted to give you a broader vision as well. we are all quite learned what vaccines have accomplished at this as a slide that probably everyone at cdc is required to show it in every session. i happened to bar this one from dr. fauci as you will see several of the slides of dr. fauci him as a. the point here is to contrast

what life was like before vaccines were available and what life is like at a vaccines are available with a market decline in disease but i'm sorry to say i am old enough to remember in my medical training when you would take a history with a parrot and a chuck, you would write down the usual childhood infactions. now we refer to those as vaccine preverbal diseases. so again, how much things have shifted over time. but we're here today to talk about how these advances have come about. another of dr. fauci slides and this link to the jordan report which is in the age periodic snapshot of what's going on in vaccine research and development really features a few components of how we get to the ability to actually have these vaccines, have these impacts. we are covering the technological advances and taking advantage of what technology may be available. numbness or the ones that are directed against specific diseases, but those that can be applied to those diseases and

vaccine. to design vaccines for diseases that are currently among the infections that don't have a vaccine against them, to have to become a vaccine preventable disease, and then had to and understand the immune system and is response into vaccines, both in terms of their safety and effectiveness. of the many slides of dr. fauci have i think this has been the favorite over time that he keeps advancing it to the point is really the convergence of breakthroughs in technology. basic science and applications to the development of vaccines that can have these kind of impacts on the population. so you will see -- you can see some of the many milestones that occurred. odyssey the germ your theory is called a theory that there are many things along the way, and you're going to about some of these later on about some of these specific news outlets that are going to be applied toward new vaccines but you can see the detoxification techies, the availability of tissue culture and now delivery systems give us

a whole new opportunities for developing vaccines. so we are going to focus more odyssey on the rest of the day on influenza. i think when you look at influence of these are among the many key ingredients so we had the egg, the fair and this is a poster from world war ii that was really the burden of illness in world war ii. it's hard to read the basically there's a guy collation of the absenteeism and impact it had on the war effort. so the conclusion of this from the force was that one third of all the men and women who lost these days were making tanks, thurber making bombers, neither were making rifles, there you see the number of days, bombers and rivals that would be made. so again, the impact that it was ahead. so this is just a brief snapshot of some of the history of influenza vaccine and influenza and influenza vaccine. you can see how there's the convergence of various parts and sites that allow things to come together to develop the kinds of

products we already had and the kinds of things we're going to have in the future. in the late 1920 was the first time a virus, and influenza virus was identified from his wine. separately, in nashville, the fertilized egg was a great place to go viruses. started working on other viruses and ultimately as we all know influences found his home there. in the early '30s, flu was isolated from humans. the ferret, it turns out this is as louis pasteur said, was his quote? chance favors a prepared mind because it was in a situation where people in england are working on the distemper vaccine that a lab worker with influenza came in and infected ferrets which was the first identification in tears as an animal model. later on, world war ii and as

you saw before, accelerate the development of a vaccine because the military was very concerned about what the losses were in world war i with the pandemic and wanted to try to protect their troops. later on was the first vaccine, first influenza vaccine was proved for use. and aforesaid '50s there was work. were at that time even apply to influenza, it was clear that the antibody response would be proved. the height of the response was clear. the duration of protection was longer and it was a broader protection as well. that field apparently stopped when there were problems with local side effects with assisted. but again, some were going to about later had its history and some of the basic sciences. and then separately by virus cultivation than from aids, it's ironic that in 1950 -- today indicted for anti-semitism with was the nobel prize lecture about cell cultures, for growing

poliovirus is and all the things that came from the. the point of this is there's a lot of research that has the opportunity to come into vaccines that this is a diagram of the vaccine immunization system. there's a lot more to this and research components. there is the surveillance aspects, subsequently when a vaccine is used, how it is monitored at the interest in that, public perception to vaccines, and whole finances around acting. but just to give you a sense of what we're talking about today on research and develop, license, manufacture, fits into this broader system. i raised that because it is the broader system that is a large part of what i've been working on in developing a national vaccine plan. last year we posted a draft plan that a lot of you had a chance to look into the plan was a sure ticket focused for the nation's efforts to improve disease prevention and enhance vaccine

safety. there are five broad goals in his plan. again, many of them converge will return today. his first goal of developing new and improved vaccines but also the goals that include vaccine safety, communication, education and decision-making, the programmatic aspects and the global aspects of vaccines and immunization. later today the institute of medicine will release a report that we asked them to conduct to give us their views or an extra view about what the priorities should be for our national vaccine plan as we move into the future, and so we'll be hearing more about that as we finalize the plan. i really, i think to take us back to a different point in time, in 1978, lewis thomas had the square which was included in the 1994 plan. and i think if nothing else, we will be looking for a new court on the inside cover of the updated plan. that in 1970, lewis thomas were the real high-technology of medicine is the kind that is so effective it seems to attract

the least public notice that it has come to be taken for granted. things have changed since 1978, and we look forward to hearing more about some of those changes later today. thank you. >> thank you, dr. gellin. and unless there is a specific question at the moment we will have a q&a session after the next few speakers that we will have a bit of time set aside for that. so dr. gellin will be able to address those in. i would like to begin the sort of next session that we will look at basic and clinical research activities that are ongoing here, but that nih and that nih is funding and institutions around the country pics i would like to have that started off with dr. tony fauci, the director of the national institute and infectious diseases there can dr. fauci?

>> thank you very much, bill, and welcome all to the nih for this one i hope will be an interesting seminar and discussion. what i'm going to do over the next few minutes is to give you an overview of the advances that are occurring and that are planned in the technology of influenza vaccine ologies. this first slide which may seem a little bit obligated to those who don't have a habit of looking at structure, this cometic gasket of viruses, but it's very important because you are going to be hearing from several of my colleagues and myself about certain aspects of this particular diagram here that will be relevant to what we call the new platforms of

vaccine technology for h1n1. this is the influenza virus. it is and are in a virus. the rna code for a number of important proteins are the one that is most later i believe not only to this audience but to people in general are the hemagglutinin the, those two designates, for the purpose of today we are dealing with the 2009 h1n1 pandemic influenza designated by a subgroup of other important proteins that could be potential targets for vaccines that i will very briefly mention. the matrix protein, the nuclear capsid, the inputting in the nst. all of these here are potentially important and i'm going to spend a minute or two on one or more of them over the next few mullahs. but i want to make this the background of what you're going to be hearing a lot of over the next hour or two from individuals. having said that, the h and the

n become important when you designate the differences from season to season, what we call seasonal influenza, which as i'm sure most of you all know, results from their he slight changes which we refer to as drifts. mostly in the h and occasionally in the n. these are predictable annual occurrence as every year like clockwork. we have seasonal flu. there is residual immunity in the population, which means the change is so small, that even if people don't get vaccinated and it gives me pain to think about saying people don't get vaccinated, but if people don't get vaccinated, there still is a bit of residual immunity in the population, sometimes substantial, that when it does drift you don't have a public health crisis, which is the reason why some season to season when he don't have the kind of intensity that we are having now when you have a shift, namely, a change that is completely

different from previous years. this is different because it is unpredictable and it is rare. we've only had three of them in the 20th century. importantly, the population for the most part is naïve, because with some exceptions, or few exceptions, they have not seen anything that is closely related to the h or the n of the new pandemic. pandemic. weird assassination come in? there is no doubt in any public health officials on the terri and discussing influenza that vaccination is clearly the most effective method for preventing influenza and its publications. we have at our disposal a conventional influenza vaccine production capability, which as you have heard many of us say, is tried and true. namely, it is a base. it has been used for decades. it's work that it gives a vaccine that is saved and is quite effective and we have a long history of that. however, there are some downsides of that which we have

actually experienced this year of what we're going to know. namely, it is slow that it is in flexible. it requires a large supply of fertile chicken eggs, stringent conditions and a poorly, and we've seen this in spades, it is entirely dependent on the growth characters of the virus that you put into the eggs. we have got hit with that this year with a slow-growing virus. so let me very briefly go through the timetable of what happens to you know in a seasonal flu, put aside trembled for a moment, right around the end of january, and usually the very beginning of february a decision is made as to what viruses will go into the trivalent vaccine that will be used in the united states and worldwide. that occurs their production begins in over a period of several months, usually six to sometimes eight months, you have a variety of processes that go to the production, the villain,

the packaging, the release. and then vaccination you should begins in the pulpit i hope we get to the question very we can talk about the impossibility that came back to bite us this fall when we had a start late in april extent of the end of january, and instead of having vaccination beginning with the flu usually peaking in december, january and february, we got hit with the flu the moment the children went back into school at the end of august, at the beginning of september. so what happened historically that prompted us, interestingly, not eight months ago, or six months ago, but several years ago that we had to bring influenza vaccine knowledge into the 21st 21st century. there was the threat of the influenza pandemic in 1987 that is still smoldering but never materialized and we had anthrax attacks in 2001, so the whole idea of a biological catastrophe and our ability as a government

and as a nation to respond was brought into sharp relief. and then in 2004, some of you may remember the fragility of the egg-based culture became very, very clear to us when a production plant in liverpool out about 50 million doses that we were expecting because of a contamination problem. so the track towards bringing the technology to new platforms begin. and i'm going to spend the rest of my several minutes just talking a little bit about his. i want to make sure people understand the difference between improving production in the search capacity, versus new vaccine platforms. in other words, better way to grow the virus versus a brand-new platform and i was when what i mean in a mullah. also, there's strategies and finally a word or two on universal vaccines. all of these will also be discussed in some detail by my colleagues that i want to give

you the 40000-foot look at that. let's take a look at it with conviction and search capacity. . . bit quicker. the thing that is different is the surge capacity is much more flexible. as you know we are making the transition as you will hear again from others from the abased to sell based. it will be gradual and it will

take a few years but we ultimately will get there. the important thing of want to emphasize during my time is a new vaccine platform that allows for more efficient manufacturing and potentially better efficacy. i have five representative ones here and i am going to spend a few seconds on each to set the stage for the more detailed ones that you are going to be hearing from the colleagues that will follow. let's start off with dna based vaccines. very simple. you take the genes of the particular protein eurostar -- interested in. when you grow the virus and activate it and attenuate it which you are interested in is injecting the h and the n. you do it with the whole virus. you do it in a more precise, christine way by getting the genes, putting them in a plasmid

which is a vehicle to insert genetic material, put it in and injected directly into the host, into the arm of an individual. it goes into the muscle and starts cutting for the protein and presents the hemoglobin on any human cell that is histocompatibility coz it is right in the person's on. it makes a very inefficient way to call upon the system to respond. that is exactly the way we respond to antigen anyway. it gets presented to the immune system in association with cellular elements. these are in various stages of development not quite ready for prime time at all for influenza but it is something you will be hearing from gary and others. the other is a recombinant subunit vaccine. we spoke about that when the press -- you heard about it because it is pretty far

advanced in that. a little bit of a different twist. you take the gene and instead of putting it directly into the person, you put it into what we call a vector. in this case in one example the vector is an insect virus which means it is a virus that in fact insect cells that happens to be a vacuum of virus. it is carrying the gene to the hemagglutinin. you in fact these cells. you heard about caterpillar sells or insect cells. what happens is the protein starts getting spit out. you purify it and then you have instead of the whole virus you have the protein you are injecting which induces a potent immune response. we also have what we call microbial victor vaccine. that means you inject the vector itself with the gene directly

into a person. what do we mean by that? instead of putting the gene into the vector and letting the vector make a lot of proteins you stick a vector like a benign typical safe virus which is a common virus that infects humans, you take the infant when the gene and stick it in and we have a recombinant factor. this very harmless virus now is expressing the proteins that you want to make an immune response again in this case the he malignant. there's also virus by particle. same principle. you take the jeans and you could do the hemagglutinin or the and one, stake in to the appropriate factors as we did before, put it into culture and because you have so many elements of the virus, lucky for us what happens sometimes is these proteins assume what is called the virus

like particle. is an empty virus. doesn't have any genetic material but it has the proteins are arranged the way they are arranged in the virus itself. that is called a virus like particle. then you have synthetic peptides. you could have the peptide. you have amino acids making peptide's which make proteins. they are building blocks. we now have very good capability of synthesizing these peptides to make them exactly how we want them. the peptide component of the hemagglutinin. those are five representative new platforms and i mentioned you will hear more about that from the others who follow me. a very brief word on dose optimization schedules mainly at the men's. i know virtually everyone here -- it is a compound that you

give together with the vaccine protein or the vaccine as a whole during on. what it does is not only boost the immune response to reduce the amount of the antigen needed but gives a more durable response and you know from experience that it widens the breasts of the response so that you have more frost reactivity and a number of new ones are being worked on in a number of sectors. i want to close by mentioning a universal vaccine which in my mind, many of my fellow scientists and public health officials is really the end game answer not only to pandemic flu but seasonal flu. it is something that isn't immediately going to be available to us but i believe strongly that it is doable. let's get back to our original

slide. there are targets for a universal vaccine. it is universal because it doesn't change from a virus to virus. if it shifted seasonal or pandemic the most important target of the protein, this is an example, you will see some beautiful slides of the protein sitting on top of the cell that as a component of it exists as a stem. it is a component that doesn't much change from virus to virus. if we can get this in an immunogenic form which is not easy which is why i say it is not just around the corner, you have the first step toward a universal vaccine. there is a lot of work going on

in that. i will close with this last slide. even though this has been prompted by the need to respond better to threats like pandemic influenza, it should have been clear that everything i am talking about that you hear from my colleagues relates not only from pandemic influenza but something that is highly predictable, seasonal flu. if we get the platform advances that we hope to get from the research that is going on now we will have solved a problem that is unpredictable and eminently predictable. thank you. >> thank you. we will hear from our next two speakers and take a break for q&a from those in the room and on the web. our next speaker will speak about influenza vaccines. dr. gary nabal is director of

the national institute for allergy and if infectious disease. >> thank you. what i would like to do is share with you the perspectives that we have here, i direct a vaccine research center. what we are trying to do is not so much prepare for distribution of vaccine to people in the present tense to protect against this year's flu but what can we do in the coming year so that we don't have to suffer through the same set of circumstances that we did at this time. to give you an introduction to the vaccine research center we are located on campus, to orient you, an overview of nih from an aerial perspective we are on

this end of the on building one. this is the clinical center. between the basic research that we have here and the clinical research and these are our colleagues across the street from us, we have the capacity in the department of health and human services to do the full cycle of product development at least from its earliest stage and research at the vaccine research center, we have a small pilot plant where we can make a vaccine for clinical trials particularly phase 1 through phase 3 clinical trials and test them and look at the immune assessment and have the scientists as well as clinicians who can make this process come full circle and get as to the next generation of vaccines. what i want to share with you in

the talk today are essentially three areas where we are working and where think it is abundantly clear that scientific advances create great opportunities to improve vaccination. to the element of vaccines for previous pandemic viruses no longer in circulation specifically the 1918 flu virus that you are familiar with. this notion of preemptive vaccine, using our knowledge of virus predicting its evolution from what we understand about the constraints on this virus in humans to prepare vaccines in advance of an outbreak so we get started in a different time frame as dr. fauci mentioned as one of the constraints for current vaccine development. finally, the prospects and

progress in flu vaccine, i will go through these recently. we know that clearly there was the great 1918 spanish influenza and one of the problems at the time was we didn't even know the ideologies of the flu when it occurred. any thought of vaccine was out of the question but thanks to some of the work from the intramural scientists it has been possible to reconstruct the 1918 influenza virus. what we have been able to do at the vaccine research center is to take the new technologies, specifically dna vaccines that dr. fauci described to you, going back to the gene from the 1918 jean, if we use this vaccine to immunize in

experimental animals with either the naturally occurring hemagglutinin or one that contains a small mutation that might make it a little less likely to create a problem should anything be combined. with protection against animals in the 1918 lethal strain. you can see the results are quite clear. if you look at the survival of animals that have been challenged with the 1918 virus if they were vaccinated with either of these vaccines we were completely protected but the control animals come to infection in a week. suddenly we get opportunity to control it. you may say why worry about 1918? it is long gone. it is not a completely irrelevant concern. one of the more recent findings

at several laboratories is there is cross reactivity, cross neutralization between this year's 2009 virus and the 1918 virus and immunization with this old hemagglutinin will protect against the 2009 virus. had we known this in advance this is one of the technologies we might have been able to employ to help us in that regard. in terms of predicting the future of flu, our knowledge of the influenza virus has advanced tremendously particularly in our ability to look at the genetic changes that occur in the virus and understand the structure of this virus and how that relates to its ability to infect cells. i am going to take a minute to go through this diagram because it is essential to understand pre-emptive vaccine and in the last part of the talk the

universal flu vaccine. the receptor, beat him a glickman is responsible for its attachment to the cells. you can see in the red, green and gray colors the different components of the human clinton. they are all the same but they come together. at the top of this protein is the respecter binding domain. at the base is the stem and that is the region that undergoes a rearrangement response will for fusion to the target cell. this is the part of a molecule that has to attach to the receptor and if we magnify that protein we see that there is kind of canyon and ridge structure. this is the reason that actually

bonds to the receptor. when we look at the avian influenza we know that the avian influenza that has been smoldering throughout the world has not transmitted to humans because it hasn't adapted to recognize human receptors. but what we can do knowing the genetic changes that occur in this region and the structures here we can actually change these deliberately in the laboratory and we have been able to do this so that experimentally we know how this has to change to adapt to humans. the paper we published in 2007 we actually began to generate vaccine prototypes where we could prepare for the possibility that that might occur and might approach vaccine design in a prospective way that would leave us better prepared for a future outbreak. finally to get to the issue, a very important issue that we are

working very hard on with respect to universal flu vaccine, let me take a couple slides to give you. the year the flu vaccines -- anywhere from 120 to 1 fifty million doses. it results in an expenditure of $2.8 billion and $4 billion every year to generate those vaccines. that is quite an investment of time, effort and expense and the question is can we make a better vaccine? can we enhance the spread and when we talk about a universal vaccine could we make a vaccine that will be used the same way that we use measles, chickenpox, make a vaccine that would be administered during childhood and last a lifetime? we won't get there in one step

but i would like to share some perspectives on how we are hoping to get there and why there is some reason to be optimistic. as dr. fauci mentioned there are a number of different proteins within the influenza virus that are highly conserved. when those proteins are highly conserved it means if we are able to target them they won't change from year to year and might serve as better targets. in our laboratory at the vaccine research center and a number of extramural laboratories, number of different strategies are being used to immunize using chain based vaccination strategies where as dr. fauci mentioned inserts only the genes for these proteins into dna or viral vectors and what we can do is to do a combination of priming and boosting strategies

with these factors to stimulate t-cell responses or antibody responses to these proteins. here is an example published in the paper a couple years ago, we did this kind of vaccination approach, nuclear protein, no viral foods. we then challenged these animals that are highly lethal. it was the challenge strained since the hope was highly conserved. they provide complete protection against legal challenge in these models. this is one model that is being pursued by a number of groups to get us to a universal vaccine. there is another target that tony mentioned in his talk that we are very intrigued by and there's a lot of effort.

this is a structural basis, against the hemagglutinin. on this slide, the flu that i showed you earlier, kind of buried here below. what you see above are these proteins which are actually known antibodies that neutralize influenza. the docking points, these are the antibodies we generate from yearly vaccinations that would actually protect us against a flu infection like the 2009 virus. as you can see on this particular slide, this is a different diagram of the

receptor where i used space filling models so you can see a more compact structure. i have highlighted the amino acids. you can see all these changes in the region where antibodies -- we make antibodies, the virus changes its composition and that is why we have to continually reinvent vaccine and keep up with this tremendous diversity to our immune system. tony mentioned this slide. there are number of laboratories from scripts and harvard medical. and number of others have been around. we recognize that these antibodies at the base of the

receptor structure don't play with the highly variable region. they go on a more conserve and fundamental part of the receptor, part of the structure required for arrangement of the virus to its target cell. what we now know is all of the variation normally occurs in this receptor, there is another portion of the molecule that is a hot spot for these neutralizing antibodies. what i have done is map the contact regions for these neutralizing antibodies. why is this important? had a vaccine like this been available when the 2009 virus came along departmental showing the genetic variation of the 2009 virus among all of the strains that have been

encountered, you can see that that region is highly vulnerable. it can be neutralized by these antibodies to the stem. universal vaccine directed at this target would have worked in 2009. we are pursuing a variety of different approaches to elicit these antibodies involving priming and boosting with dna plasmids as you heard and boosting with the conventional vaccine. in other instancess using priming and boosting vector that i showed you earlier in the top. in summary what i told you today is we have generated experimental vaccine to protect against previous lethal pandemic particularly the 1918 spanish influenza. that could give us a measure of protection against this virus should it be turned or it could give us protection against

related viruses in the 2009 -- in fact has some similarities to the viral hemagglutinin. our understanding of this immunity provides opportunities to develop vaccines preemptively against adaptation of the h 5 and one influenza to humans or evolving forms of the 2009 influenza virus, another area we need to watch carefully. this understanding of structure of genetics and neutralizing antibody interaction are essential to vaccine designed for universal flu and these efforts are moving forward and they are early in their stages with different gene base or a sector approaches to the hemagglutinin, nuclear protein, thanks. >> just a reminder to those

queuing on the web. if there are any questions you would like to send in our e-mail address is h h sstudio@h h s.gov. send as questions and we will take those at the first opportunity we have. our next speaker is dr. carol heilm heilman. she is director of the division of microbiology and infectious diseases at the national institute of infectious diseases. >> good morning. it is a pleasure to be here and give you an idea what is going on in the program with respect to the development of new influenza viruss. i would like to give you an orientation as to what our mission is within a program and briefly we are supposed to be responsible for a lot of basic research that does occur in influenza but this basic

research is guided towards the development of new therapeutic vaccines and diagnostics. to do that we also need a lot of resources to help us guide the development of new ideas and we have an opportunity to do a lot of clinical testing. the major goal of this program is to essentially discover and lower the risk with respect to the ideas behind new vaccines and other product technologies. also to give you a perspective and i am sorry this is difficult to see but the extramural program is 93% of the extramural program devoted towards influenza virus with respect to the amount of money we spend on influenza virus. this is a yearly look at what we spend on influenza. $268,100,000 in fiscal year 2008.

ninety-three% went to the extramural program. the way we divide these funds are shown here. a vast majority of the efforts are focused on the -- just a reminder of what it does take to get to a vaccine. it is important and i know robin will go into this in more detail but in addition to having basic research and the ideas behind what we would like to have in terms of developing new ideas, we have to test these ideas in a lot of animal model systems and a lot of it vitro systems and a lot of safety issues before we can even get to phase i. the niaid concentrates a lot of these efforts and a lot of these areas but that does not mean we have not ventured into these

particular areas. a lot of process development that we have seen at the end point came from basic research and ideas that started out in the beginning. in order to actually execute a lot of these ideas, we have a system in place. this is one example of what we have in space for evaluation units. these units have been in place for a very long time. these units are housed in academic centers and this is the current group that has those awards. they have evolved over many clinical trials. their focus has been on any particular vaccine or pathogen but to be quite honest lot of their efforts have gone towards development of influenza vaccine. we have given you an idea of the types of technology out there. i will not spend time on giving

you an idea what is going on on these two areas because these are vaccines. they are trying to make these ideas better. the attenuated vaccines are tainted, inc. into the back down of an attenuated vaccine whether or not we can get broader in your response. there are activities going on here. gary presented a lot of what is going on and we want to talk more about what we are doing. the way i tried to organize this is if we have at any point in time, fifty or 60 investigators going into the depths, similar to what gary said. i want to give you an idea what is going on in the general idea and give you a few specific examples. in each of the areas i am

presenting there are three areas of emphasis. the groups that are trying to identify the best antigen combination. in the case of dna vaccines gary mentioned efforts going on, there are efforts as gary mentioned about small areas. whether you are talking about things within h as that are common across or looking to separately or in combination put them in with the others. deron lot of efforts to figure out the best combination for the antigen that we would like to do. there is efforts in terms of how to increase the immune response. in this particular dna segment people are modifying and putting in genes that may target or

illicit broader immune responses. they're putting in receptors targeting certain tissue. there is a lot of increasing immune response. with optimizing delivery methods this is going on broadly with all the technologies you are going to be hearing about. but in this case, people that are looking at new deliveries, there are also people that are putting these dna segments into something called bacterial ghosts, essentially just a membrane of the bacteria. the reason they do that is 2fold. you can use salmonella as a ghost, put the guarantee in. the dna because it has salmonella protein will go to your lymph tissue within your

gut and be ingested by the cells. it is a wonderful delivery system to the target you want it to go to. the other thing people are doing that i am talking about, optimizing manufacturing procedures. how can i get this particular segment to grow as rapid as i can get it to grow or to be as effective when it gets into the single. in this case that is the type of manufacturing procedure. how can i get the cell to manufacture that dna sequence rapidly? the next concept, the vaccine, all three areas are going on. most of my focus is going on in optimizing systems. what i mean by that as tony explained, what you simply do overhear is use the technology

to get recombinant protein of whatever sort you would like but one of the things we do know is depending upon how that protein comes out it can be looked at in different ways. people are looking at how to get optimal confirmation. do i want a different type of globular head? what do want this to look like in the end? there's a lot of effort going in on you. exactly what vector you choose to use will help in terms of what your yield is going to look like. this has been mentioned before. one of the most advanced technologies. i want to give you an example of why this technology is where it is right now. and what the potential is in the future. this is an example of the system that has been done in the face

iii trial. the value of this has been you were able to identify from this sequence which jean you want and you immediately put it into in this case a virus that infects insect cells. the value of that once you have gotten it in, early identification, get it into your vector, into your cells and within 72 hours that is all it takes for it to grow. the heels of this, once you have gotten it to grow is 90% of the final product is what you are looking for. you have a very effective vehicle for getting very effective yield. just to give you an idea, this is the equivalent to -- it is a

highly efficient system here. this is like a ghost sell here. this makes the national passage. they don't replicate but you are presenting it to the immune system. the things people are doing over here is trying not only to mimic the passage but improve it. how large they are, this makes a

better virus. some molecular adjutant, some inherent in this particular vector. this is the situation where you have essentially an attenuated virus that doesn't cause problems and you pepper the cell wall with different things you're looking for. the focus of this area of investigation, which ones do you want to use a that gives the optimal delivery system? these are examples of delivery methods being used. the potential virus -- the

vector -- this delivers the immunity to other respiratory package. there's a lot of effort going on here. what are the values of them and what particular protein should be inserted in this to maximize the immune response i am looking for? in this area, this has been an area to remind you where you can sympathize amino acids into whatever peptide you want. people are looking at ways to enhance this particular ability of peptides which haven't been very immunogenic. they're looking at ways to conjugate on to these proteins certain receptors that will go right to the cells i want them

to go through. if i take those same amino acids, they can traffic rights to the tissue i am looking for. there are also people looking at whether i can add pieces of molecular adjutants to this. these are areas of efforts on going. where are we in this whole system? the big xs show you that most of the work in these areas are in basic research or clinical development. for the dna vaccine we have one company that has gone their product into a phase i trial. for virus like particles we have -- this is protein science.

may use either a coronavirus vector, we have not funded merck but i only bring them up because i want to emphasize we're not the -- the other companies that are involved in this, merck has been looking at synthetic peptides. by will end by reminding you that we are at the beginning of these things. much of the work that has been done in protein science, you are seeing an end point. a lot of efforts that have been ongoing for 15 or 20 years, this is not a new idea. 50 or 60 project and not in forced but we have pushed a lot of activity in this particular set of stuff. i will end with this and we can

go on to questions. thank you very much. >> thank you. let's take a pause and see if there are any questions from people we heard from so far. go right ahead. press the button and identify yourself. >> can you rank the five platforms you spoke about. once you start producing vaccines, won't the same process be happening to receptor binding? >> the next to the last slide showed the stage, the subunit

vaccine. sticking into the of viral vector and insert that the personal insect cells. that has gone through trial and interacting with the fda and trying to determine licensure. >> in terms of the stem antibody that is a great question. that part of the virus is fundamentally a functional part of the virus and we think it will be hard to mutates away from the antibody with simple mutations. having said that it wouldn't surprise me if we haven't seen some of that evolution in a

different way over the years. and showed you the picture of the h 3, that stem region is actually very different from the stem region in age one. what happened over the years is viruss have developed subtypes to get away from that pre-existing community. the end game would be to have a cocktail, from switching to new subtypes. and eliminating that particular strain. >> any other questions? i had one that i wanted to -- wasn't quite clear. you said it was the vector based

platform, one potential half of development was the possibility of developing a vaccine that might target multiple respiratory disease besides influenza. can you elaborate on that? >> that is correct. if you are thinking about other viruss like coronavirus these are viruses in young children that cause relative levels of severe morbidity. if you can construct a virus and still want on the surfaces in addition some other info when the virus vaccines, the possibility of your antibody response being better is what the goal is. it is still under investigation. we will see what happens but that is a end bowl. >> any other questions at this point? if you have any questions for

the viewers on line our address is haastudio@hss.com. pas like to have dr. robinson come up, director of the biomedical advanced development authority and and talk to us about eggs, cells and beyond. >> thank you for the opportunity to talk to you this morning. we are not going to talk about buzz light year but the influence of vaccines under where we are moving from the past to present and where we will be ten to 15 years from now. we are the new kids on the

block. this act of 2006 created the biomedical research authority in which we are providing medical countermeasures for chemical biological and nuclear threats and emerging infectious diseases. we have moved from influenza and medical countermeasures will be starting soon. this could be in the form of vaccines and therapeutics and microbial and even ventilators and nonpharmaceutical product. where are we in the continuing of different agencies with the government to provide these products? we are right here. we take a hand off from the nih and the department of defense from early research and development. we have advanced development and acquisition and stockpiling and work with our partners on the

storage and maintenance of that to make sure it is deployed and utilized. the fda has oversight and defense fabulous board. and many of the decisions we have going forward, the public health emergency countermeasure enterprise which is a governing body within the department and u.s. government for countermeasure development. as has been pointed out earlier this is a long continuum for development. this pipeline has seen many products that have to be invented and go through so that you have one or two at the end. where we work with our partners in the department of defense is once products move out of the phase i there is a hand off.

as a dotted line, it does work past the this and we go earlier. we have a fine transition of these parts. in order to have something at the end we have to have many products going forward. i bring that to you because as dr. fauci pointed out earlier, the re-emergence of the avian flu, the katrina hurricane response actually lead to a real need for national strategy for influenza announced in november of 2005. the implementation plan came out in 2006. the ability to have in our country at some point the capacity to produce a large number of vaccines for everyone

and to have pandemic vaccines. we set up and approach in 2005, 2006 for pandemic influenza. for vaccines, three areas. stockpiling and acquisitions, i will concentrate quite a bit on the vaccines, moving forward with the technologies that are right for coming of age to be used in the coming years. with the stockpiling efforts, in an effort that we put quite a bit of emphasis on, how can we build manufacturing infrastructure probe -- egg based supply with retrofitting those facilities and the new still based manufacturing

facilities as we go forward with recombinant based manufacturing facilities. the influence of vaccines provided more robust, scalable vaccine platform being less tolerable, as we saw this year, being able to grow very well. we awarded six contracts since 2005. we took an approach with many candidates going forward that would make it to the market. we had some requirements not only to develop pandemic vaccines that seasonal vaccines with a commitment for domestic manufacture and surge capacity of 1 fifty million doses. that is the commitment they make and the hurdle they have to jump.

those contracts -- where are we now? two of the manufacturers have completed their clinical studies. they are very far along and we expect them to submit their licensing applications in the coming year. the other manufacturers are in early stage development. as we expected, two manufacturers were selected in 2009 because of business reasons, they did not want to go forward show superior products in a debased influenza vaccines. that is where we are. you can see large, two story reactors where you have the virus growing and that is a closed system. it has less vulnerability to microbial contamination and much more flexible. not only can these make influenza vaccines but they could make other vaccines too. as has been pointed out there are other technologies that can

boost the immune response and provide these stimulating molecules to provide these affects so that instead of one dosage you can get four or eight doses in a given amount of vaccine. they can provide protection and enhanced community. we have awarded three contract in 2007 and the cost of $133 million. many of these products -- another type of vaccine and another delivery system for vaccines is transdermal delivery of vaccine where you would put a patch on top of where you administer the vaccine. it would move in and hopefully give a stimulatory effect. those are in phase ii. we awarded three contract for

further development. as we go forward, those are the four companies, two of these manufacturers would have submitted their application with these, had it not been for the 2009 pandemic. we expect in coming years they will submit licensing applications to the fda for the 8 one and one vaccines. the other manufacturers are in early stage development in phase ii clinical trial. we will see where those go. the third area of activity is recombinant based technology for influenza vaccines. this will allow us to be less

dependent on our properties including the ability to grow. you only need the genetic sequence of that particular influenza virus which is known very early and should be inserted into a vector or one of the other technologies and available much sooner. this is an example of one of those vaccines from protein science. we awarded a contract to them in a june for a total of 155 years. they are late stage whether seasonal and have a vaccine they are producing. what is it we can do that has brought them up to this point? this is the industrialization, the scale of development of their process in any late stage clinical development and post licensure clinical development that needs to happen. how we actually get to

commercial scale production is what we will be working with them. they are commitments to demonstrate they can produce fifty million doses with in six months and the initial release of the vaccine could be done within three weeks of the concept. as we go forward we have a solicitation for proposals in september. we receive proposals from a number of companies including these and we will award in early 2010 contracts for advanced development of these products which have been talked about earlier. we have a stockpile, that virus is still smoldering out there. we have protection in that form and we wanted enough for the critical work force. we could actually have 1 twenty-five million doses of

vaccine right now. our vaccine manufacturer building provides x from a farms in different parts of the country to these stockpiled vaccines to building new facilities. this facility in north carolina in 2007 was still there and just recently a couple weeks ago we went to the grand opening of this facility that will be operational to make vaccines in an emergency in 2011. this was part of a five year plan in 2006. we will board more contracts to build more domestic manufacture ease in the u.s.. how did this come to bear? we worked on the clinical

development of these vaccines and a manufacturer to get the clinical development to these candidates and we supported, responsible for having vaccine contracts to produce the raw ingredients to actually have a finish and a contingency plan working with our partners to get that vaccine distributed and oversee the administration of state and local governments. some of these products, the vaccine was licensed. syringes and attenuated vaccines and other products we worked on but also an experimental antiviral drug used under emergency use authorization in

critically ill individuals and has gone to 1,000 individuals and helps reduce the morbidity with this disease. where can you find this? on the web site. okay. >> thank you. any questions at this point? we have someone from online. >> this is probably for parter 11 mort dr. heilman. the question is regarding new platforms -- is anticipated that these will need to be used with the new platform? second part of the question is do purified proteins produced a strong response to the flu

vaccine? >> an edge of an will make something have a powerful response. whether or not alone will require it is a question that will only be answered as we get further into the clinical trial. as you saw from dr. heilman's flow sheet we are at various levels of clinical trials. i would not be surprised, you alluded to it. of the proteins come out of the recombinant system, you will get a pretty good boost. we will be faced with the same decisions you are faced with in the proteins that we get when we do a regular activated vaccine. the answer is conceivably a case by case basis.

>> in terms of the vector approach most of those at the present time do not make use of those. that doesn't mean it couldn't be incorporated into a research plan in the future but they are not reliant on it. tony mentioned it is really an additional tool that allows us to see if we go spare as robin talked about or make it more effective. i don't think it is a requirement. in terms of whether the recombinant proteins are as potent as the existing vaccines, i would say it's early days. in general, they're not as potent. one of the reasons is if you look at the flu virus there are 100 viral