tv Washington This Week CSPAN November 9, 2014 3:12pm-5:01pm EST
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for instance, is that then we are probably going to try and see the senate get into a pattern of moving regular legislation through the committee process, which is almost entirely broken down, and onto the floor with the ability for senators from both democrats and republicans to offer amendments to the legislation that is on the floor with the either being able to thursday night or friday morning advance a bill through to thesee, rather than have set up procedural votes that everyone knows are going to fail and bills failing as a matter of routine that we have seen, particularly in the last couple of years. whether or not that works, it's going to be a tall order. >> the first part of that is the committee process. what will we expect to see here on cspan when we see hearings? >> i think what you will see is
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two different things. when you are looking at hearings, you will see more hearings in the senate that look like what you have been seeing in the house over the last several years. administration officials being called from various departments and agencies to essentially get byed over the coals republican senators who are going to be chairman of these committees for the first time. you are going to see more critical hearings and hearings that are built around topics that are critical of the administration. in terms of legislation, you are probably going to see more markups and more consideration of bills at the committee level and when they come out of the last couple in the of years, bills of come out of committee and then sort of disappeared in a number of cases. what mcconnell is at least
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saying and what he said last coat -- newsnew conference that if a bill comes out on a bipartisan basis, somebody might actually see it on the floor. >> you also mentioned an open amendment process. how likely is it that mitch mcconnell will make good on that promise? >> i think he's going to make good on it at least initially. going to bee is there is so much pent-up demand for consideration of amendments and for votes, and that is largely with republicans but it is true some democrats as well. the question will be getting to the reasonable number of amendments so that bills are actually completed on thursday evenings or friday mornings, mcconnell is talking about keeping the senate in session on fridays, and that is something that very seldom has happened. that will be a challenge because he's going to have a number of his members who will be running
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for president in the next year, and whether or not they are going to want to be in the capitol building at lunchtime on friday when they should he on the plane to des moines is an open question. under democratic majority majority leader harry reid invoked what is called the so-called nuclear option. likely isat and how it that it will be revoked under a republican majority? >> the nuclear option was the use of a parliamentary maneuver to effectively change the senate's rules using the simple majority vote to get rid of the ability of a minority of mostors to filibuster nominations, except those to the supreme court. this is really going to be the first test for the republican majority and the first big decision they have to make. senator mcconnell is playing his cards somewhat close to the rest on this. when on thursday we will see the
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republican conference have its leadership elections, and they are going to talk about this within conference. it's a really tricky question. there are two different ways to look at it right one is the bill has already been run and it should not be on-- -- unrun. there are other republicans who are saying they are trying to restore order to the senate. to establish what senator mcconnell calls regular order, what kind of buy-in does he nee d? certain senators, certain groups? >> i think he's going to need at least a handful. he's not going to have 60 votes within his caucus, but what we are going to see is if you can get those assembled, it has the buy-ni of -- buy-in of six, eight, ten, twelve members of
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the democratic caucus. he was telling me last week there are a number of bills he has worked on with republicans that he hopes might be able to advance. that will be the big test, if you can get at least 60 senators to support a bill, then they should be able to advance. the question will be whether or not to be democrats are willing to offer those votes. >> niels lesniewski with "roll call," thank you. on the next "washington journal ," william galston will discuss his recent op-ed in the "wall street journal." bonnie glaser previous the president koss corporation -- previews the president koss corporation -- persident's cooperation.
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as always, we will take your calls and you can join the conversation on facebook and twitter. "washington journal" is live at 7:00 a.m. eastern on c-span. takes c-span cities tour booktv and american history tv on the road, traveling to u.s. cities to learn about their history and literary life. next week and we partnered with charter communications for a visit to madison, wisconsin. [indiscernible] it is a glorious service. the call comes to every citizen. tois an unending struggle make and keep government representative. probably the most important political figure in wisconsin mostry, and one of the important in the history of the 20th century of united states.
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he was a reforming governor. he defined what progressivism is. he was one of the first to use the term progressive to self identify. he was a united states senator who was a by his peers in the 1950's, one of the five greatest senators in american history. he was an opponent of world war i, stood his ground advocating for free speech. wase all, bob lafalce at about the people. after the civil war, america nation radically from a of small farmers and small producers and small lateacturers and by the 1870's, late 1880's, 1890's, we had concentrations of wealth. we had concern about the influence of money in government.
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we spent the later part of the 1890's giving speeches all over wisconsin. if you wanted a speaker for your club or your group, bob would give the speech. he went to county fairs. he went to every kind of event you can imagine, and he built a reputation for himself. by 1900, he was ready to run for advocating on behalf of the people. he had two issues. one, the direct primary. no more selecting candidates. two, stop the interests. specifically, the railroads. >> watch all of our events from madison next saturday starting at noon eastern on c-span2's booktv. >> now, a discussion on efforts to create an hiv vaccine. speakers include representatives
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from two groups working towards the cause. this is an hour and 40 minutes. i'm steve morrison, senior director at csi. thrilled at the lineup we have an thrilled to be able to do what we hope will be a recurrent series of meetings of session of this kind focused upon technologies and their central importance and the evolution of new opportunities and new tools that can be quite important in a number of different areas of global health. this is a terrific way to kick this effort off. it is really the brainchild of my close friend and colleague, todd summers. thank you, todd, for bringing this together and getting us
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rolling. and i want to thank our colleague who has worked very hard to pull all the pieces together. welcome, and i will turn the floor over to todd and we will get on our way. >> thanks, steve, and welcome to many of the new digs here. we are really happy to be here. many of us in the room have been working on hiv for some time. for some, it is past -- like me, it is past my third decade and we want to move onto something else. we hope for an end to this epidemic. we really wanted to focus on hiv vaccines and give you a sense of
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where we are in the research pipeline, what it is you are likely to see, when you will see it, and what it will look like. and what is the potential impact it will have on the epidemic. we are extremely happy to start this off with dr. tony fauci, who many of you know is head of theniaid and has been a stalwart champion of vaccine research, among many of the other responsibilities he has leading our nation's hiv research agenda. dr. grouchy -- dr. fauci, thank you very much for coming here. i am on the board of avac, so a big conflict of interest there.
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margie mcglynn is here with us. she runs the international aids vaccine initiative. it is one of the product development partnerships that is focused on bringing together multiple sets of actors to accelerate the development of an hiv vaccine. it will be a great opportunity to hear from her and what she sees in her perspective. we will have about 30 minutes for dr. fauci to give us a presentation, plenary talk, and move to mitchell for about 10 minutes, and then margie mcglynn for about 10 minutes as well. and then we'll open it up to the panel for you to engage them in questions and answers. i will moderate that. it is a good chance for you to engage with them on discussions around where we are with hiv research and how it fits in. dr. fauci, over to you.
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thank you again for coming. [applause] >> so i can advance my own slides? there you go. thank you. thank you very much, todd. it's a real pleasure to be here with you today. i will talk about the issue of the role of an hiv vaccine. i want to start off by putting into perspective the concept of why we really do need an hiv vaccine, despite the -- the spectacular successes and really historic successes that we've had in the last several years in the arenas of both treatment and prevention. let's take a look at the background and then i will get into the nitty-gritty about where you are with a vaccine. you are aware of the most recent numbers from unh -- u.n. aid
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that keeps it on a shortlist, less than a handful of pandemic that our so the location has had to face. with a stunning showing 39 million deaths, 35 million people living with hiv, and 1.5 million. we have drugs, we have healthcare that is getting better, i would say, but it is still something that is very difficult to accept. we have 1.1 million people living with hiv, and importantly, about 16% to 18% don't know that they are infected. we've had over 600,000 deaths. the number that keeps bothering me for decades is that there are approximately 50,000 new infections every year, for decades. that is the most unacceptable statistics that after all of our prevention modalities -- and it
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is a good example of the disparity in our society, because 12% of our society is african-american, and 50% of new infections are among african-americans, mostly gay african-american men. again, it is a disease of use, but i don't want to get into that right now, because i want to move on. to why do we say we are doing so well. it is based on decades of extraordinary accomplishments in science. i could spend half an hour on each of these here. the ones that really come to mind are those extraordinary advances in treatment, which started off if you think of the history -- todd was mentioning that he was involved in the very beginning. i began with hiv a week and a half after the wmmr came out on june 5. 5.mwr came out on june i've been doing it ever since. it was a time when we did not know anything, i mean, what the
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virus was to now over the years developing treatments to where we have more than 30 fda approved drugs, which have completely transformed the lives of hiv-infected individuals. we are at the point where we can right now say without exaggeration that if you can put someone on antiretrovirals relatively early in the course of their infection and they stay on their drug, let's say, a 25-year-old hiv-infected man or woman, you could look them in the eye as i do when i see them in my clinic three times a week and tell them that if they stay on their drug, you can project that they will live an additional 50 years. it is one of the most extraordinary accomplishments in biomedical research and translation. now we have implantation in lower middle -- lower and middle income countries through funds
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and philanthropies to the point that when i first went -- not the first time, but when i was sent to africa by president bush to try to scope out the pep for -- pepfar program, they were less than 13% receiving therapy. there are 13.6 million deaths averted globally since 1995. we have a bunch of combination preventions. some are really easy that we knew about even before we knew it was hiv. that is, condom use, needle and syringe exchange. and now we have medically related interventions like circumcision, mother to child transmission, microbial -- microbicides, prophylaxis, and a very important treatment as prevention, which can prevent them more than 95% to transmitted to another individual.
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-- transmit it to another individual. that allows us to talk, starting a couple of years ago at the aids conference here in washington, d.c. and when hillary clinton came to the nah -- nih a few months before. we can talk about a world without aids. i guess, when you say that, given everything we have, one can ask yourself why do we really need a vaccine? i will tell you why. let's take a look at the current status, whether it is essential, and what the pathway is. the current status, the projection in the absence of an hiv vaccine, you can do mathematical models -- and i always worry about mathematical models. i'm in the middle of an ebola mathematical model that is not helping out very much, but that's another story. i'm sure steve will think of another session to discuss that. but the projection is that if you look now, we have about 35%
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decrease since 2005 in deaths. and when you look at the new infections, it's about 38% decrease since 2001. that is pretty good. if you look at the mathematical model, depends on how much you implement what we already have. let's say, we don't have a vaccine and we take all the things that i put on the preventions slide and every thing i told you about treatment. the red to blue to green really means how you increase the implementation of these modalities. if you really put a full-court press on and pep far get funded the way it should and the global fund does what it's supposed to do, you can actually see that implementation. then you can say, is a vaccine essential to the aids pandemic
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. i wrote an article about this in february of this year, of 2014. i will talk a little bit about some of the things that i mentioned in the new zealand journal of medicine article. the reason i believe it is necessary is that if you look at some of the challenges that we face about ending the hiv aids pandemic in the absence of a vaccine, you have to look at the reality that despite all of these great results, there's a thing called the care continuum. i don't want to spend time, because i've spoken to similar audiences about that. we don't do very well and when you look at access to the system, retention in the system, and adherence to therapy. and when you look at the country, we are doing really badly about the number of people who are hiv-infected and the percentage of those who are in the health-care system that stay in the system, get on therapy, stay on therapy, and drop their viral load to the point where they do not infect anybody else. we have a long way to go, even though we are doing very well.
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then there is the social and cultural barrier. i could spend a lot of time on that, but i won't. such as the lag of implementation. one example is circumcision. circumcision now, if you look at the numbers, it started off at about 55% to 65% effective and long-term follow-up, it's about 73% effective. i cannot imagine if i had a vaccine that was 73% effective. we would be celebrating it on the front page of the new york times. and yet, we don't implement it very well. there is also stigma. we all know about that. the legal impediments, homosexuality being illegal in a large number of countries, which is just mind-boggling when you think about that. there are a lot of things that are impeding our ability to get ending the hiv-aids. the other with thing that is apparent to everybody, that is,
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the whole idea of human nature and recidivism. i will show this again, because i've shown it before, because it's a great example of when you are interested in infectious diseases that seem to go away and then do not. malaria is one. the measure of malaria parasite prevalence in zanzibar from 1957 to 1983, there was a program where there was indoor residual spraying that reduced the parasite prevalence from 76% to less than 5%. the officials involved in their great wisdom decided they were done with malaria in zanzibar, so they stopped. then look what happened to the curve. it went right back. one of the things that i'm concerned about is this mathematical model that we always talk about. i'm afraid that even the best of circumstances, if you just take
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the green line that goes down, and i say 2000 with a question mark because i'm afraid to say. when you start with a low level of infection in the numbers look good, i'm afraid we will have a rebound. my conclusion is that the only way to durably control and end the aids epidemic is to have a vaccine. i think we can do an incredible amount without it, but if you really want to nail it, then you need to have a vaccine. let's talk about the effective path of a vaccine. i break it up into three parts -- years of disappointments and unexpected success and the way forward. the years of disappointments i can relate to. cliff lane and i actually did the first vaccine trial in 1987
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with a gp 160 sub unit candidate. thinking that if you vaccinate somebody with an envelope protein they will be resistant to infection. but hiv is smarter than that. the history is truly one of frustrations. first, we started off with the b-cell approach. we were wrong, because the body doesn't like to make neutralizing antibodies against hiv. and as i'm going to show you in a minute, less than 20% or so make it, and they usually do it after one or two years of infection, when it's too late. a very unique microbe and virus.
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no other virus acts this way. ebola is terrible. but you make a good immune response and it's clear. would that were the case with hiv. trials, we did trials -- we did empiric trials and trials with vectors. then the field got a sort of lapsing confidence and said, we can't prevent infection. let's try to at least suppress viral replication. so they switched to a t-cell vaccine, which nobody imagined would prevent infection, but it might suppress viral load. that did not work either. in fact, one of the studies showed that it actually made the individuals more susceptible to
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infection once they were vaccinated. i use the example of why we should not be distributing and ebola vaccine before would prove -- we prove that it actually worse, because we might wind up making people worse. but again, that is another story. ok, unexpected success. you've got to get lucky sometimes. we did an empiric trial of a poxvirus vector with an insert of a bunch of viral components followed by a protein boost, and that is what we now refer to as rv144, or the now famous thailand trial, which showed a 31% efficacy. that is not ready for prime time, but it was a very important study. it was important, because it is least proved the concept that as marginal as it is, you can actually prevent infection with a vaccine. it was an enormous proof of
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concept. what are we going to do with that? it is very interesting, because for those of you who are not involved in following this -- i don't expect anybody to follow it that closely -- but it was an interesting fundamental philosophy of how you approach a vaccine. that is when i get to the last thing, the way forward. think about what we are doing over the next several years as two major buckets. one is the rv144 approach, and the other is a-based vaccine -- structure-based vaccine design, or trying to develop a broadly neutralizing antibody. we found something very interesting with the rv144. rv144 approach, this is a blowup -- if you look at the bottom of the slide, i blew it up. that is the hiv envelope trimer. that is the antigen that you want to use.
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and if you really want to get into controlling antibodies, you've got to prevent -- present the trimer in its stable form to the body so it can see it. but we were not that sophisticated years ago. what we did is we took a monomer of that trimer -- again, trimer means three components. you pull one out and in. we impirically injected it into people. -- empirically injected it into people. and we found out that among those 31% who were infected, they had an immune response against a particular epitope that was in the v1v2 region of the envelope. that means it's one of the varying parts of the envelope. it changes from strain to strain.
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we identified an antibody, and then only by extrapolating backwards that -- did we say that is the site that you really want to make an antibody against. we threw it in and said, ok, that is the immune corollary. now what do you do? you have something that is 31% effective. you say, let's amplify it. and you amplify it by increasing the strength of the response, namely how much antibody you make. you increase the breadth of the response. can it be broadly against multiple strains? and you increase the durability. does it last for a year or two, or maybe three or four? the response of rv144 kept going down as you got further from the vaccination. and you do that by sticking with the products, but now doing multiple boosts, modifying the vectors, and adding attachments. -- agimens.
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you are not changing the concept. you just want to do better than you did it before. and what we're doing now on africa is we are working to find out if we have done anything different between those in thailand and those in africa. in the thailand city, if you vaccinate them with a similar regimen -- if you vaccinate the africans with a similar regimen as the thai, it reacts similarly. which leads us in parallel -- you know, the title of the slide is "alternative strategies and parallel tracks," and that is structure-based vaccine design, namely trying to develop neutral antibodies.
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let me repeat what i said before. the first time we took an envelope, we had no idea what we were looking for in their -- in the immune response. but we injected it and found out what it was and said, let's amplify that immune response. when you look at structure-based vaccine design, it's exactly the opposite. and let me explain. this is the trimer again. you go to a whole bunch of hiv-infected individuals and you find out whether they are making broadly neutralizing antibodies. and if so, to what are they making it against? as opposed to throwing it in and finding out. if you take these individuals, these 20% of individuals who who make broad neutralizing antibodies and you clone those cells, you can identify five parts of the trimer that are actually the targets of neutralizing antibodies.
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now we know what we want to induce. so you are taking that -- and those are the antibodies. those squiggly things. and they have names and numbers. now the antibodies recognize the epitopes. so the challenge now is to take those epitopes on the trimer and present it to the body in a way that makes the antibodies that we know are neutralizing. in other words, we are saying, here is what i want you to make a response to, instead of take this and who knows what you will make a response to. that is called structure-based vaccine design, to get a neutralizing antibody.
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and when you do that, you have to understand what is called b-cell lineage. in other words, can you cope the b cells -- coaxed the b cells to do what you want them to do. why am i throwing that out before you got out because in natural affection -- before you? he cousin natural infection, that is not happen readily. the b cells do not like to make a broadly neutralizing antibody quickly. how do we know that? is 20% of people do it and it takes them two years to do it. we've got to maybe fully and -- fool the immune system. how do you do that? there was a study that was
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reported by a colleague, a fellow named bart haynes, who many years ago was a fellow in my laboratory at nih and he's now at duke. he followed someone who was infected and they knew they were infected really early. so what he did, he followed the evolution of the antibody mutation with the evolution of the virus mutation. if i had a pointer, i could go through that. but look at my talking with my hands italian background and i will tell you. [laughter] the antibodies come in and the virus makes a response. virus mutates and mutates again and the antibody keeps following that mutation to the point where it is such a great antibody that it is now broadly neutralizing. the only trouble is, it's too late for the patient, because they already have so much virus. the neutralizing antibody is not going to do anything. but what it told us is that if
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you selectively present to the b cell a changing, evolving, immunogen, you can actually coax it to make a broadly neutralizing antibody. and that is exactly what the philosophy and the strategy is right now. to mimic, this is natural infection. and on the bottom, to get an immunogen, and that is the trimer i'm showing -- to vaccinate someone over a time frame, maybe to boost or three booths to get a neutralizing antibody. those are the two fundamental approaches that will be taken. one, capitalized on the fauci -- on the rv144 with the results of pure impiricism. and the other is the opposite of that. it is totally structurally-based and planned. we know that t cells are
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important not only in suppressing virus after infection, but this is a complicated slide -- but if you start off in the upper left and it helps to make cytokines and also helps to kill the hiv. in summary, by scaling up the current prevention and treatment modalities, hiv incidences in death, i can tell you, will continue to decrease in the absence of a vaccine and number two, achieving a vaccine is a timely and sustained end to the hiv and aids pandemic. i have just described a clear
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and scientific pathway toward an hiv vaccine. and if we integrate non-vaccine with vaccine prevention modalities, then and only then do i think we can ensure the end of the hiv-aids pandemic. and as i said in the article that was published, the only guarantee of the sustained end and to get where we want to go so that when we put up the last slide it will be a meaningful slide, namely, that we will have a world without aids. thank you. [applause] >> i think if we give laser pointers on the end of your \pointer on the end of your fingers, we will all be in great shape. --
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i think if we give laser \pointer on the end of your fingers, we will all be in great shape. mitchell moran runs avac and one of their jobs is to bring the audience induces discussion -- into the discussion. one of the things we asked mitchell to do was to talk a little bit about how you generate the kind of advocates you need so that dr. fauci and his team have adequate resources, but not getting too far ahead? we keep running on. one of the things mitchell has to do is to figure out how to get people excited enough that they keep the money flowing, but not so excited that they get ahead of our progress. [applause] >> we will see if it's magic. the magic is being introduced by a board member. the harder thing is following dr. fauci.
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we talk about being a translation organization, translating very complex science and competent issues into the science. working in this field, we often see people become compartmentalized. i'm embarrassed to be up here as the advocate for the translator, when i think dr. fauci is an advocate and a translator as much as any of us. we often forget that. if we learn anything in the 30 plus years of this epidemic, is that when these constituencies come together it is true for hiv and it is certainly true for ebola as well. i will try to write in advocates response to all of that. i went back in time. avac for 20 years has an annual report on this and i went back seven years ago when we did a bit of a soundtrack in the research for vaccine. one is the least likely "we are on a road to nowhere" by the talking heads.
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and in fact, if you go back to 2007, there was a sense that we were investing in working hard and making no progress. and perhaps, as we had more and more vaccine candidates out there, it seems sometimes that if you did not know we were going, any road could take you there. and there was a shooting in a lot of different places, but not quite clear where we would take it all. as i reflected back in preparing for today, what i'm struck by is what are marketable exciting time we are in right -- what a remarkably exciting time we are in right now. i guess it all depends on when you start counting come and i would urge you not to start counting too soon. but i think we are in one of the most exciting moments scientifically, and more broadly in terms of the vaccine and how we will get there. last week, 1500 people gathered
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in cape town, south africa for the first ever hiv and prevention conference. i will spend a few minutes talking about why there wasn't easy as him and excitement there. -- was enthusiasm and excitement there. i woke up on monday or tuesday morning to google celebrating john salk's 100th birthday. it just reminded me of how important and powerful vaccines are, and how transformative that is. and what would have been his 100th birthday last week is a reminder of the power of a vaccine and why no disease will be fully eliminated without one. dr. fauci was unfortunately not there, but he did a great visitation via video. i want to point out that all of these topics are catalogued and webcast. it was one of the most
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invigorating meetings we've had in quite some time. but it was in a context that i did want to frame a bit. as many of you may know, in the last several months, we've been engaged globally in this conversation globally about the so-called 90-90-90 targets. and it's not just one target, but multiple. as you know, every aids conference and every report has a new theme, a new slogan. this one is 90-90-90. and importantly, that 90% of all people should be diagnosed, that 90% should be on treatment, and that 90% of those on treatment should be virally suppressed also because we know that if people are virally suppressed, they live longer lives and they also do not transmit the virus. as you saw just before me, there
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is a huge challenging getting that many people tested, that many people treated, and that many people virally suppressed. the target is no less important. and i want to highlight that is critical. in the global community, whether you are talking u.s. epidemic or globally, we should be striving toward that. but i want to highlight that i don't think it is enough. as we talk about a global end to the academic -- the epidemic and whatever timing you are looking at, 99% suppression is fundamental. but only if we complete the entire cycle there. harm reduction, human rights -- this epidemic does not end with biomedicine alone. we know that and we need to act accordingly. this is really where i think there was a lot of excitement in cape town last week, and in the field generally in aids vaccine.
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i will not test you with your eyes. i trust that you know everything that is there. basically, what you see are a range of different approaches that you've heard described already. the reason i put this up here, and the reason i do challenge you to come to terms with it is that as advocates, as policymakers, as anyone working on the epidemic, to know the issues at heart to bear in terms of what is happening and -- to know the issues at heart they in terms of what is happening in the field and we can do. and i want to highlight about rv144 years ago, science is a process as everyone knows and yet we had this tantalizing result five years ago. for many in the community who desperately want an aids vaccine the question is, what happened? five years ago. where is it? but it is a huge challenge to boost that well beyond 31%. what this tries to do is lay out a series of different pathways, both with rv144 approach, but
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also a range of other different candidates. the bottom line is, we don't know which one of these will work. probably some in common nation. -- combination. the challenge is how to articulate that and get people to invest in it. if there were a single pathway forward to a single definitive act that we could invest in and get the result and move on, that would be a relatively easy equation. but it's not that at all. we want to spend a few minutes talking about money. at the end of the day, as exciting as the science is, it takes money. this is work that we've done in the last decade in partnership with others to track investments not only vaccine, but but across all biomedicine are mentioned. something doesn't look quite right in 2013. we saw a tremendous increase over the late 1990's and early 2000. and then it began to plateau and decline in the past couple of week -- couple of years.
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it won't surprise you that the orange bars u.s. federal government assistance, primarily through the nih, but also to the military research program that led rv144 and the u.s. agency for international development. you can see that the u.s. government is a major investor in this endeavor. and last year, about $828 million invested. that is a number that is a fascinating test people. i do these presentations and there are people who say, we invest $828 million and we don't have a vaccine yet? and there are other people who say, that is all we are investing? it all depends on what else you do in this world. one extraordinary analogy. back to the polio experience. you may remember back to the days of franklin delano roosevelt and his attorney collecting dimes in the march of dimes for polio. and we take great pleasure knowing that there were two
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polio vaccines invested in, but at its height as the money was collected, only about 10% was invested in polio vaccine research and development. the other 90% was in public education and in care and support. i would argue as you think about $820 million, is it enough or not if you put that in a global context? money needs to be spent, and in fact, increased to meet the ambitious target of treatment and prevention delivery. we cannot not invest in aids vaccine research. it really is the long-term investment to finally sustain the end of the epidemic. again, to show you the nih at the top, not surprising. and bill and linda gates foundation on that second -- and melinda gates foundation on that second line.
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the decline made very little it's when n.i.h. and gates, when those big numbers stay signature in their investments, do we have a robust pipeline of ideas and activities that get funded. what do we do now? you heard it from the lead scientist. we do need to invest in what is called p5 strategy. this is the partnership to build the thai vaccine result in and southern africa. we have to chase that lead. will we do better than 31%? we don't know, but you cannot not explore that. we also have to look at a range of other ideas on that slide previously that begin to highlight there are other ideas. will they work? we don't know. do the clinical trial. clearly, clinical research needs
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investments. all of the work around the design, around abs.f the abbas, each each antibodies. translate that novel idea into a vaccine candidate into a clinical trial so when you walk the halls of a scientific meeting today, the are beyond excited but how do you capture that into trials are where the still a number of years off? we need to invest in all of ever, delivering what we have today while we continue to develop the tools we need for tomorrow and i think a consistent theme from what you've heard before me and undoubtedly after me. i want to highlight one other piece of information and i keeping hope alive, so to speak, in aids vaccines is so very important. have to be honest and convey both the credible scientific
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have -- better promise, better excitement than we've had in decades in aids have toscience, but we be honest about the time lines. they will take long. and there is no benefit in falsely promising that a vaccine will be licensed anytime soon. we don't actually know. i'm always a believer in under promising and overdelivering. i think that is really important as we think about these timelines. because we have to prepare policymakers, and funders, haul.e long we need to prepare them for both the incredibly challenging but also to be sure that they're there to invest in the fruits of that get it and that we can act on positive results doing after rv144. all this work to deliver what we have today and think about the trials for tomorrow, the one other piece so veryhink is important, is that the clinical trials of tomorrow will undoubtedly be more challenging than they were in the past.
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as hard as the science has been and as frustrating as some of the results have been, the future trials will undoubtedly more complex, because we will be running the next wave of trials in south africa where we're scaling up male circumcision, hopefullye providing prophylaxis,ure where we're providing a microbicide. two different candidates will have the next year. and if they are positive, women will have access to those. i hope when we embarked on this in late 2016 and early 2017, i hope that the incidences are going down. that means the trial may be may take longer. it may cost more money, but it is essential that we do the right thing in designing those trials, providing people they can use,know but recognizing that their contribution in a vaccine trial clearly the ultimate prevention option, that is an aids vaccine.
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thanks very much. [applause] >> thanks, michel. we will now hear from margie mcglynn. she spent 26 years, i believe, at merck. one of her jobs was to lead their efforts on the step trial, and another vaccine products america has led. she's also instrumental in reduce theirca to prices on delivering the into the products world, better than the previous mandela. suing nelson it's a really great opportunity to hear from someone who has been involved in industry and has taken a moment of her life to help us on an aids vaccine. margie, thank you for coming. >> thank you, todd. to mitchell's point, it's very difficult to first follow such an esteemed scientific leader, who's also an advocate, and an esteemed advocate who also knows a lot about the science. they are terrific colleagues to
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work within this field. i think the task at hand calls for the best of all disciplines to step forward. so the organization that i lead -- let's see, i don't have the right slides up here. here we go. the organization i lead is called the international aids vaccine initiative. many of you are familiar with the concept of product development partnerships. and there were anywhere between 13 to 15 depending on how you define the term, of these types of organizations that were started primarily from the mid-1990's through the early 2000's and they were started because of market failures. that there were some diseases especially affecting the poorest countries of the world where there were not enough incentives for commercial organizations to and develop a vaccine. a treatment or diagnostic test.
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hiv isn't necessarily a market failure. i really believe there will be a commercial market for an hiv vaccine. although the road has been difficult and different companies have invested at different times along the road. and i can tell you when you get burned by a significant investment, as certainly merck step trial, it really causes companies to take a step back and say, ok, i want until there's proof of concept. i think that is a good way to think about the role of an organization like iavi. how can we help facilitate the advancement of the science to get us the proof of concept. i will talk more about that in a moment. let me first add a little bit more commentary on some of the modeling work. i'm a little bit bolder than dr. fauci. i put years down on my graph, but a model is only as good as the assumption that goes into it. there's only one thing that we can say about this model is that
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it's wrong but it's demonstrative. there are a few things i would like to point out about this model. let's look at the purple line. that is the una's -- the unaids enhanced investment framework. some of your murmur the publication where unaids put forward a modeling project that answered the question, if we tools thatt in the are available today and we get of these programs everywhere they're needed and we andaggressive enrollment, adherence, target achieved, what achieve? unaids will admit this was aspirational. it was the best we can do with what we've got. it went to 2050 and has been go to 2070. we make it down to half a million new infections a year. that is extremely optimistic, for many of the reasons dr. fauci went through. that's becht we can do without a
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vaccine. add a vaccine. i assumed a launch date of 2027. because i always answer the when will we have a vaccine. i can give you a good sense, we have proof of concept, we should have a vaccine on the market in 10 years. of concept means you have a candidate that has shown the ability to prevent infection or significantly control viral load. and i don't believe we are there yet. as we had a hint of that at the rv144 trial. but once we get that, i think the industry metrics will tell you we can get there in period.10-year know, we we don't unaids and other partners and we looked at scenarios. what if the green line happened? that is, we stay at the current trend and we are funded where we are now, $19 billion a year, and we continue to have it problems with acceptance,
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adherence, of those programs. thehat were to happen, green dashed line would show you you'd have even more significant vaccine. a chances are, we will be somewhere in between. because the can do better than we are doing today and there is very strong funding support and very strong moral support throughout the world. we showed a 50% scale up scenario. to show you what that looks like. on the far right, you can see the cumulative number of new infections that will be averted over this timeframe for those different scenarios. whether it is 16 million or 42 million, that is a lot of lives being saved and the huge burden of illness and the huge burden of cost being avoided. of us should maintain the commitment that we have, the excitement we have, for what a world without aids look like, as dr. fauci said, a vaccine making that quicker but very importantly, sustainably.
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one of the models i would like to show you look at other new prevention technologies. and again, the purple line shows the enhanced investment framework. we then show the next line down, which i think is red. if you were to add on preexposure prophylaxis, that is, you take an uninfected individual who has a relationship with an infected person and you prophylax them with antiretrovirals. you can prevent a significant percentage of infections by doing that. there has been problems with that for reasons i will not go into today, but if you were able to overcome some of the objections to adopting that -- i at the capetown meeting last week, we heard a lot of enthusiasm for approaches to be that -- you could see that additional decline. if you independently took the investment framework and added on treatment as prevention, that
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is, treating early to significantly decrease the likelihood that person will infect a partner, you could then go down to the green line, a little bit under 400,000 new infections a year. thatu independently took enhanced framework and added on the vaccine, that's the purple line. if you do all of those in combination with the approaches that were available when the investment framework was developed in 2011, you can get down to under 50,000 new infections a year and then you can seriously say we will bring about the end of aids and we will have an aids free generation. what does it take to do that? it takes the resolve you've heard so much about already in this program. funding.the sustained and a comment on funding, i was looking at the chart that mitchell showed and thinking back to my days at america. once you start to move through a development cycle and start to get some really promising results, which is where i think we are with a broadly
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neutralizing antibodies, and certainly with the rv144 results, your spending escalates dramatically. it may go up two or three fold. the fact that we are down 15% is worsened by the fact that we really should be increasing exponentially. we have to work hard to make sure that story is heard. and when we are ready to move forward with large-scale trials and manufacturing costs, that the funding is there to support that. the organization that i lead was expertsd because global came together and said we really need an organization that's solely dedicated to the development of an aids vaccine that can help work with all the parties out there and ensure that that happens. not-for-profit organization funded through government. government,he u.s. usaid,icular,
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nationwide. foundation is a large foundation donor and we have other donors, as well. role we play is what i would space.e translational we do not have the research expertise you would see in the such as nationwide or in academia. when those discoveries are there but we have our laboratory capabilities. including biotech companies, contract manufacturers. have product development expertise. we have conducted over 20 phase one trials, primarily in africa and one in india. candidates.accine we have in house individuals who haverom industry joined us that are able to help advance candidates coming from other researchers, help to turn those promising discoveries into
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candidates.ne we also have a clinical trials africa, arimarily in little bit in india. primary funder for that is of. aid who also funds some our product development work, as well. through the network we have been able to make a lot of contributions, first in the epidemiology of h.i.v. as dr. fauci talked about, the broadly neutralizing antibodies. we utilize those centers to help us gather the samples of the hiv-positive patients to contribute to the ultimate vaccine product and have an expansion of those activities. we have nine clinical trial centers in five african but an expansion program to help scientific leadership coming from africa, to help build that infrastructure that majorelp for the next global health threat that emerges and certainly has a lot
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benefits within africa so our real goal is to to to that red star, to get a proof of concept. we're not equipped to bring vaccine to market. individually but as an organization we're not equipped to do that. majorgoing to need a pharma, major vaccine company marketemerging manufacturer if we're talking about delivering the vaccine to the developing world and there beenxamples where that has done without a major company involved, so i do believe that companies will be there. some of them already making ofestments in earlier stages research. sennas point, primarily, fee, j.j., and glaxo. and i believe as we get to that proof of concept that we will partners who will help us with the massive building of manufacturing capacity that will be needed and
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of launchingtaking a vaccine like this in over 100 the world that will need it. so i'm very optimistic about are. we yes, it's been a long winding road but there are other vaccines that have taken longer. there are several vaccines that took 40, 50, 60 years to get to and i'd like to point to 40, 50ber for polio, years, perhaps, and ask the question, what if we had given polio vaccine, imagine what the world would be like today. so let's all move together with not goinge that we're to give up on an h.i.v. vaccine. we're absolutely committed that happen.ng to it's going to happen within our lifetime. tonygoing to happen while fauci is still the director of he's not goingw to retire until he does it. fortunately he's in great health out jogging every day but
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any support you can provide to make sure that resolve continues will be for a good cause that we can be proud of leaving a generation down the road free of the aids virus. thank you. [applause] and thanks to our donors, as well. .an't forget that .> >> hopefully the microphones are on. this is a chance for you to have questions and answers with the panelists. with one to kick off and we'll open it up. we have microphones around the room to take those questions. i ask when you ask a question, if you could give us your name and if you're with an us whichion, tell organization before you ask the question. one of the things that certainly came out of the discussion around polio is the of attention.ss certainly it took some to get
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but now we're seeing dilution of commitment to seeing through the finally, polio virusf the and over the years you've seen spurts of energy. you saw thanks to congressman porter and senator buffers and doubling of the n.i.h. budget and it's almost as if you pay for that later by seeing the lining of the n.i.h. budget and certainly that results in the h.i.v.ning of budget along with the n.i.h. overall budget. do to keep the energy going and get the escalation back that we need to see in financing in terms of political energy? you start?hy don't dr. fauci, you've spent time in canress, maybe you understand what the trick is we haven't pulled yet. i think part of it is
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successessome of the and scientific progress. we do have this challenge where success in 2009. an enormous amount of work has then.ed since it's hard to describe. it's not easy to brief policymakers on the correlates of risk and why that matters for a vaccine but i think we need to be better at articulating the things that have been happening and what to do next. on the polio side, as hard as science is, i don't think we should assume that the delivery is easier. say the delivery will be harder and i think we need to be prepared for that. for the aids vaccine that we're seeing with the other aids options already, the science brings excitement but delivery brings more challenges. the delivery side, artic uth where we are and the specific to expect in the foreseeable future. >> dr. fauci?
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>> when you talk about budget, is a very unusual time. there is no new money for anything. always say get i out there and make argument. you can make all the arguments you want. no new money no matter for anything, literally. so the budget's been flat. it likely, under these circumstances, will stay flat. that doesn't mean you shouldn't try to advocate for important things. h.i.v., important. in could argue that money global fund is in some respects i wouldn't say more important important because we have a scientific challenge with vaccine that is still in the phase as opposed to the implementation phase. -- i would say, not avoid your question, is that we money.can use more i'm always arguing for more money.
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i get in trouble sometimes when but i'm always arguing for money because it will increase the pace of where we're going but it's no guarantee so have now we still scientific challenges so we really need to do the best that we can with the scientific when we getd then to the implementation, we really presso put the full court on the implementation. but the difference with polio is vaccine is a really easy vaccine. sorry. was a really good friend of mine. but it's really easy. you just needed to do it. why is it easy? because 90-plus percent of withe who get infected polio do fine. all you got to do is induce the immune response. implementation as you mentioned is the problem.
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eradicated polio after all these years? much an implementation issue. we're dealing with h.i.v., it's not antific problem, implementation problem. so it is a direct -- we're putting a lot of money in. people say why do you put so much or you haven't put enough. think we need to continue to push hard to make vaccine a very high priority. saying that the factor here is as much science as -- >> it really is. >> and the other challenge, with all the other prevention modalities you talked about is the human part of it, getting them and keep using them. margie, you have to convince donors to continue to support iavi. you've been engaged at merck in trying to convince your board to put money on the table. how do you make the case in the ever changing world of washington, d.c.?
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>> you need data. show modeling slides like what we showed here today, especially when a lot of lay that we have an h.i.v. vaccine and when the announcement came out, it was preexposure and prophylaxis and as treatment and we had to reeducate our audience as to what a vaccine would do differently. you need to talk about what will be, how will it affect total funding. we're starting to model. you look at total treatment cost today for h.i.v. $19 billion about globally. as you start to see the implications of a vaccine, how come down and we showed a little bit of that data in capetown last week. the lines start to cross a little bit after 2050. so donors that are contributing of millions -- talking about national governments who hundreds ofting millions or a few billion to organizations like the global
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fund, which is great, to help h.i.v., well, they have to have a long-term view and canize that if they also invest millions of dollars, that's what we're asking for know, if weike, you had one-20th of what they're fund, youthe global can actually see that total overment line come down time so it's all about data and all about telling the story and them to realize what the implications will be if we are successful. today'smiling because election day, right? you had to worry about focused ons that are quarterly profits. the time line of attention in is probably shorter than a quarter. an fact is that this is argument you need to keep making over and over and over again, so retention of message is probably challenge here. why don't we open it up for questions. but whyots in my head don't woo go to the back of the
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room. dr. bob mauro with the american college of preventive for navalnd center analysis working for the surgeon general of the navy. by theascinated introduction of a new kind of vaccine seemed to be implied by your presentation of the iteratives approach. and i was wondering what does a series look like for the individual that's challenging enough to have a three, four doses to deliver? do you envision a vaccine where there would be multiple boosts and how do we prepare to that social challenge of behavior change? rather people are still poorly trained to taking a vaccine. >> that's a very good question doesn't multiple multiple. really mine in on the science of it, you really want to trigger a b cell that is one that recognizes an epitope
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is actually going to get to the affinity maturation that you mutatethout having to multiple times. in the b cell lineage, i'll try simply forit non-immunologists. affinity, or the more power the antibody has to h.i.v., the more you evolve and mutate the genes the b cell mutate and mutate and mutate until they build up a affinity.ht so we know that the really good mutationalare highly and the reason they are is that infected,en you get just keeps replicating and system,ng your immune it's bad for you, but it ultimately leads to this goodody that's the really one. now how do you do that with a vaccine? the challenge. you have to be able to give the
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immunogen in a form that it you're take, as suggesting, seven boosts to get there. beause if it does, it may scientifically interesting but it's a non-starter for a vaccine to fashion the mune gen in a way that you need maybe one or two to get there. you got to capture the b cell that only requires a couple of iterations. two would be good. three maybe, but when you get to notand seven, i think it's practical so you're right on target with your question. otherve seen that with vaccines, where the require froming, attrition race reducing affects the overall effect. any other responses? questions in the middle? we do kate a couple. dr. ted bailey with john's
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infectiousision of disease. a question for mitchell warren and margaret, as well. dr. fauci pointed out he mapped the scientific pathway and i wanted to build on the analogy polio and ask a little bit about the legal pathway and pathway for carrying that through and the issue i have -- jonas salk's quote that he'd rather patent the sun. we had in the early 1990's, even though we're in a post-do had a world, we're seeing significant barriers. i'm wondering about the terms of the predevelopment partnerships, terms oftions and those so we can ensure that the price of the falcons is such uptake isn't limited and we tolize the promise inherent these vaccines. >> i'll is that right that since
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a critical issue for us. we consider iavi a public good funded by governments, flynn mists, et cetera and consider is mission that a vaccine developed for those who need it the most so what you ask is central to the work we need to have intellectual property on any discoveries dore involved in and we also get involved in licensing technology to biotech companies with a clear access provision and we have march-in rights if they're not able to bring that vaccine to the countries atst affordable prices. we have provisions that we could take that license back, find a developing world manufacturer. it's also quite possible that a theine may get through pipeline that has come out of the work of the various that hasrs involved not been licensed by major
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company and could be especially true if it doesn't developed world potential. at merck, that was our expectation with the step notram, because it did prevent infection, it stimulated immune response to control and a.r.v. already did that and were more easily accessible in the developed world so the approach we were do we find aw manufacturing partner to build the massive that was needed and you would likely find it in a thetry like india with largest vaccine manufacturers in the world and can do it at a much lower cost so we've had with manufacturers in india and if we have the i.p. for that candidate, we would partner with them and through all the various support organizations that exist such as gavi, who is anxiously awaiting an effective h.i.v. vaccine, then include in their program to bring to the
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world's poorest countries. thing i would add in the resource tracking data i and i described $885 million invested annually, you were missing something on the slide in that industries involved from a financial perspective. $30 million is from the private sector. not to say companies are actively engaged in the process. a prime boost vaccine strategy. sanofime is developed by patour is. developed by is novartis. and they are investing time and research and some money but the thes sure is from niaid and gates foundation so when that vaccine showed efficacy, the not only be for novartis -- it is not
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sun and not the original polio vaccine but we would expect given that the lions share of the product development sector,borne by public there should be an equitable, fair price for it. >> you have an arrangement that a product comes out through n.i.h. investment, you have an to engage if the price is out of hand? >> when we get into licensing agreements, we make sure that's part of the licensing agreement. about i add a point recent successes of gavey. they have been able to bring out newer vaccinations rotovirus vaccine. at prices under $5 a dose for hpv vaccine and under $3 per vaccine sotovirus some of the additional modeling work which we're happy to share and we'll put on our website as soon as we finalize
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the slides, but we looked at cost per regimen in that range and including implementation $30 per was about regimen and we looked at whether hit the bars that policymakers would consider very and middleive in low income countries and if we are able to hit that bar, we do hit cost effective regimen and those are the costs that we then model so obviously we need the right licensing agreements company is a for-profit who gets involved but like the place atthat i put in merck and colleagues at other vaccine companies put in place, we had tiered pricing. at merck, it was aano profit pricing strategy and being under $5 for hpv vaccine was because of that. other companies don't use that terminology but the lowest price for lowest income countries is covering your manufacturing costs, i believe. and so if there is an
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arrangement, licensing deal with a manufacturer, you would expect tiereduld set the pricing and in order for gavey to take on that program to bring it into the world's poorest countries, it has to hit that seth berkley who iavs gavey, the founder of iavi, negotiates very hard to prices down as low as possible. >> thank you very much, mccluskey from u.s. aide. i have two questions. aid as a development agency is interested in seeing africa lead the way in the future of h.i.v. vaccinenology. your visionn share and will engage africa in that endeavor. dr. fauci can you mention how
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used inbodies will be potential experiments of passive antibody transfer? >> passive antibody transfer is done as a proof of constont level of breadth of what you would need to induce it. if youal models, passively transfer antibodies, you can not only treat but prevent infection. that means you take antibodies, make ane them and you bunch of the money on clonal infuse them into someone to prevent them from ifting infected or, infected, to treat. it isn't particularly a good approach towards treatment pill ofwe have one three drugs that can do it much better than any antibody can do inbut it's being considered clinical trials now for prevention, namely that if you acting antibody, give it intramuscularly once months, youor four could have pretty good protection.
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the studies ongoing right now whatrying to determine level of antibody do you need to actually have protection, because then you could gauge what you need to induce with your vaccine. and durability. >> is there any discussion around a level of antibody that prevent infection? because i was reading through the lines, some of your slides, i didn't see anything much around preventing infection. controlling infection. >> as far as antibodies go, the control.o prevent, not tels control t cells control, antibodies prevent. >> to answer your question, we have been involved in africa for 11, 12 years now, and we have seen tremendous growth in the intellectual capacity of contributing to the science and really trying to build upon that momentum that's been there ared and principal investigators at each of the sites we're involved in
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are veryrica and these well educated, very well trained professionals, and they don't simply to be a a receptacle coming out of the u.s. or europe and they'll test it in their population. they have a lot of insights and capabilities they can contribute towards identifying what are the components of the vaccine. so some of this work had been smaller scale before. some of the epidemiology work, some of the monitoring of the course of the acute infection, identifying what are the immune components that yield a better and how does that theonse vary depending upon clade of the virus they're exposed to so we have a program going on right now informed by consultation with many of these investigators in africa and have partners that we around the world where we're looking to build forth that, looking to place even more studies in these sites to
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learning, as well as to increase the training, not by building a new training program. we've trained a lot on good goodcal practices, laboratory practices, hundreds of employees throughout africa at our sites as well as other sites have been trained. mitchell's organization has been the g.p.p.,d in participatory practices in clinical trials but looking to take that further. going to set up a post graduate program but some of the universities that have set up can we do that to further evolve the scientific keepr of this talent and them importantly within africa. and the last area i'll mention is also for these investigators to submit proposals that there will be a scientific review board that will pick the most compelling proposals. they've got great ideas on additional scientific experiments that should be done that they can do right within
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their centers so that program is launched this year, as well. >> dr. fauci, you've worked to partnerships with institutions that are in africa asia, trying to build skill sets. gertie is involved in some of this work. what are you doing to build the researchers from the south, critically impacted by the development of the vaccine? fundingrt of our industry, -- strategy, we always of building a sustainable infrastructure so when we start a trial or expand networks to trial uganda, toa or to southeast asia, we always do it with the intent that when we be ablehey're going to to do it themselves so it isn't parachute science. go out. and but we have been doing that for years now. clinical trial network, both vaccine,
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prevention, microbicide, and others, that is totally now, in southeast asia, in southern africa, in and the caribbean. >> one statistic. the capetown meeting where there were five days of intense scientific presentations, someone stood up said, i think it was over 30% of the presenters were from so i think everything that tony talked about and what aivi, all has contributed to building that expertise. mitchell, you've worked to make sure that civil society in fully engageds is and supportive of and holding to account the research going on. how's that going? it's going well. it's hard. this is hard stuff. running clinical trials is not it's not for the faint of heart, whether you're an investigator or in the community to support the research. one of the most exciting parts
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of the meeting last week was in southook place africa, the first time ever of this combined meeting and that was done strategically because the u.s., the infrastructure and leadership coming from south africa is and that shone through quite a lot and the is deeply engaged which isn't surprising because when you look back at the the epidemic, it stands out from a treatment access perspective and we're see the same advocacy support. everyone wants an aids vaccine. the easy part. the challenge is how do we ensure there's a responsiveness in what's happening scientifically on the ground. people not only want an aids vaccine and want the research happening but in the community, circumcision, where is the access. prep?is the access to really it's a question of how do
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you really inspire and develop the trust and research enterprise at large, not just orund aids vaccines microbicides, but how do you build that relationship so that both supports science but has reasonable expectations of what science should be able to deliver. question over here. this kind of touches on what you were saying, mitchell. what do you think will be the for aold for efficacy vaccine that are we going to be looking at the silver bullet or 50% efficacious vaccine that combined with prep or combined gets use circumcision, to ta100% and how do you communicate that effectively in the community that thinks it's bullet?er >> a couple of you touched on the fact that this is combination prevention so when we're doing clinical research
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with all these other eitherntions, individually or together, start to result in a high level of preventive benefit, how do you find a 50% or 60% vaccine, or is it hidden behind other interventions? >> i'd love to see the search a silver bullet stop now. if we're searching for a silver welet in this epidemic, should focus on something else. i don't think that will be one. defeatist but realistic and i think of the signs of efficacy that regulators do but we know from trial, the regulators were clear that the 30% number enough.ood the number often bandied about was 50% but i think we use that the lowest level. and i think the combination plays out in two ways. the future clinical trials will be complicated, we hope they're complicated, by the fact that the other background of
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prevention would reduce the of incidence of new feaxs so a vaccine would have to work doesn't have to be perfect because the number of --ections still to spreevent prevent is lower. thing, other interesting and a presentation last week about a novel trial looking at a combination microbicide vaccine. presented from a couple of monkeys and monkey trials are fascinating and important but we're not here to prevent an infection in monkeys but to stop one in humans. trial,this small monkey a combination of a microbicide with a vaccine in the monkeys much moreto be effective in than either alone as we've assumed that just as with combination treatment being the most combinationeatment, prevention is what we will work towards. whether that is licensed microbicide vaccine combination or the introduction of a 50%
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when rest ofcine the prevention package has risen have to be not perfect to be good enough and i think that is the take-home from high perspective. dr. fauci? >> so 31's not good enough, 95.l never get it's going to be somewhere between the two. thatee with mitchell it's -- i'll take 50. i really would like to see 60. think there's going to be any trouble in proving a becauseis that percent even though we know we have combination prevention, there's of human nature and lack of adherence to that so you have to pick out a highly at-risk population. ethical obligation to offer them things like prep, things like microbicides, et cetera, that at the end of the day human nature will win over and people will get infected and hopefully you'll get enough people in the study
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that you could show that a works. >> i'll be a little controversial coming from my background of introducing other vaccines and looking at the barriers to vaccine adoption. i introduced hpv vaccine and had 100% efficacy, at least thatst the four strains were included for the most common strains out there. within the united states and an insured population you have private insurance or it was covered 18 und under by the vaccine for program, to only get uptake of the three-dose regimen 40% of teenage girls. a lot of barriers, we all know about anti-vaccine groups, it's more of an issue in developed countries but i think we'll see it in some of the developing countries, as well. toeally think that we need strive for 65, 70%. i'd hate to go to market with a that was 50% effective. i think you're going to have all
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sorts of barrier put up, not the least of which is cost effectiveness. we also ran scenarios on that, hitting that about cost effective target that you loweredreach, if you the efficacy, anything below 60%, you lost cost effectiveness. so your policymakers and your payers -- there might be exception. there might be such a high risk population that when you population, maybe 50% is good enough and combined with other approaches. really get global uptake of a vaccine, widespread acceptance of a vaccine, we really have to push the envelope. maybe we come out with something more 50% or 60% but we it to get to the 75% barrier. >> let me tell you a population i had a 50% vaccine, i'd all in a them microsecond. qazu lu district
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of south africa and look at pregnant women between the ages 44%3 and 25, they have a prevalence of h.i.v. infection so i'll take that 50% vaccine it so fast, your eyes will -- >> i'll agree with you on that. and heidi, you have been to qazulu nepal region of south africa. we were there together. who payse questions is for all of this? the global fund went for long ago and not got $12 billion. far has not seen the increases, in fact, there are decreases. do that or do we have to do what margie says which is focus on in the interim while awaiting for the money to go back up, the hot spot areas? find theseo populations where intervention
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makes more sense than trying to do it everywhere at the same time? >> i disagree. i think if we get a vaccine and margie thate with netal,good for qazulu but 50 is not good for everybody who fears they might get infected. that ise get a vaccine 60% effective, i don't think we're going to have a problem in getting that paid for, to be honest with you, because the of preventingness an infection vs. life-long anti-retroviral therapy is huge. you'll get world bank, gates foundation, u.s. government, a lot of groups will pay for that. a lot of things keep me up at night. that doesn't. that's not one of them. >> i agree. we use the term combination prevention and it's a lovely terms inlike many public health, they often get
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mangled and misused. it's not throwing the kitchen sink at everybody all the time. there's talk about hot spots and go where the epidemic is. hopeful andre smarter as a community to figure out where do we need to be with interventions at which time and which place and they're going to be different because see flat lines. that is the new normal. let's hope it doesn't go down from there. we clearly have to be more r&dcient, whether in the the deliveryut in expenditure. how do we take the tools and the sure they're reaching right people at the right time and place, not just throwing things scatter shot which is not therapy.ent prevention sneak preview a for your next talk, mr. fauci,
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how has the re-emerges of hysteria intendant this country, how does that compare with the early h.i.v. in haiti, san francisco, africa? part two, how will you be competing with ebola funding? about flat lining funding levels. and three, are there economies scale in the field for public awareness campaigns for both conditions? >> so i'll take first one. very earlyack to the 1980's, you were having the evolution of what turned out to incredibly historic epidemic, pandemic, and relatively few people paid attention to it. now you have two americans have infected with ebola, both
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of whom directly and deliberately in a self sacrificing way, cared for an ebola patient. are the only two people who have gotten infected in the united states. two. this overwhelming attention and fear to it. nice,would have been retrospectively, if back in the 1980's, when i was saying, hey, got a real problem here, we infectionst more than you could imagine, that we had as much concern back in the 1980's for h.i.v. as we're having for ebola right now. [applause] there's an article in the "new york times" today by larry butan who is semi retired doing reporting on h.i.v. he called it an epidemic of misinformation. when you scroll the papers and get ebola fromu a toilet seat?" if someone has a cut on their
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itds and pick up a plate, does have a little bit of negative deja vu feel to h.i.v. in the early days. information is really powerful so is there an opportunity to the attention that's paid to ebola and actually leverage some oftry to regain the attention on the investments we see need to be made? work here at some csis on the global health security agenda and got a limp andonse from washington weeks later we had ebola and everybody was like why don't we a global health emergency response. is there a leveraging opportunity? >> i try to leverage. throw interesting numbers out. been, now, they say 4951, but it stayed there for a while. but let's say 5,000 people have since theebola beginning. it's probably more. but a month or so ago, it was
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3,000, 4,000. when i try to explain to people the magnitude of the problem. yesterday, 4100 people died of aids. yesterday, 5700 people were infected with aids. one day. compare that to what's going on ebola.ow with and the amount of attention and concern that there is. i'm not downplaying or denigrating at all the concern you have about a very serious disease. is a serious disease. but when you think about the magnitude and how the public that.mmune to every single day, 4100 people of aids, every single day. and you get numb to that and it's not the thing getting people excited so you try to -- you want to really put attention to things that really you couldattention, say, you know, folks, take a
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look at this. we have this ongoing problem. at malaria, take a look at tuberculosis. attention that we're getting with ebola, how the same sustained attention for other great killers. was another part to the question which is sort of the ability to sort of do public information campaigns, economies scale where we're able to in terms of basically capacity building, safe practices in hospitals -- is there something tocould be doing trying leverage what we're doing with information around ebola to help risk?.i.v. it's so different. >> it's a different ball game. geographically, it's important to remember where ebola is and h.i.v. is. affected byuntries ebola are not major endemic h.i.v. communities. struck by, the
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aserian response, at least described, building on pet far aidsth the and gatess in nigeria foundation, allowed nigeria to top of the on epidemic and ebola epidemic in things would have made far more dramatic in terms of numbers and it tells me health systems matter, functioning health systems work. i'm proudly from omaha, nebraska, proud to watch the in omaha. health systems matter and we've underinvested there and i think it will make a big difference when we have an aids vaccine, a health system that can deliver is critical and so the me is don't say we're not going to invest on pet of an ebola outbreak
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single it's probably the batting investment in health system building in the history of global public health so i need to be seen in that regard. >> paul? >> mitchell, you gave voice to comment, the defense against ebola in nigeria could have been incredibly explicit but was largely donor funded. pet far funded labs and things like this. as a point of information, we hear informally from the know,stration, well, you we're not sure -- we have to put money into ebola this coming so stop pestering us about pet far. the vice've even -- president said that in response to a question and answer period in boston, which is rather unfortunate. members of congress are talking a lot right now about an which we supplemental haven't seen for global public health for years and years but
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defense hasnt of freed up $1 billion to go and do important work. this is the lord's work. good that the d.o.d. is clinics and so forth. there's not exactly a shortage funding but nonetheless members of congress are talking about doing emergency supplements that they can put same stamp on and the members doing a year-long grind far.et it's not really a question. it's kind of a washington question. we can continue to say there's momentum around health systems ebola and viruses and that's toortant but we need capture, put a shoulder on that grind stone. >> we're hoping margie's right and we get an h.i.v. vaccine still in office.
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as confident as you are, you see where it's easy to trade one thing off for another and what i hear you to add onthat we need top of what we're already doing, the cost of potentially getting and that vaccine out will mean an increment more in terms of financing so that case made and that's one of the reasons we want to do this session is to help people who have to go back to the hill and explain these things, understand that while it will offer great opportunity, especially in combination with ther things, it will not in short term result in tremendous savings. tofact, we'll have to invest achieve those savings and that's a hard argument to make in this city particularly when it comes to foreign aid. final questions and then we'll close for the >> i want to thank our panelists for coming here. thrilled to have you here is always. thanks for your work on this.
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to get back to the other virus. they've for sharing your views on civil society falls i all of us here have some work to do. we are looking for feedback for future events like this. e-mailsooking for some for great suggestions. thank you all for coming. have a great afternoon, and don't forget to vote. [applause] [captioning performed by national captioning institute] [captions copyright national cable satellite corp. 2014] >> november 18 begins a new open enrollment. . cynthia burrow will speak about that and who ensures the readiness of healthcare.gov will
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