quorum call:

quorum call:

quorum call:

quorum call: mr. pryor: mr. president? the presiding officer: the senator from arkansas. mr. pryor: mr. presidentings, i ask unanimous consent that the senate proceed to a period of

morning business -- the presiding officer: senate is in a quorum call. mr. pryor: mr. president, i would ask that the quorum call be dispensed with. the presiding officer: without objection. mr. pryor: i ask unanimous consent that the senate proceed to a period of morning business with senators permitted to speak for up to ten minutes each. the presiding officer: without objection. mr. pryor: mr. president, i ask unanimous consent that the action of the senate with respect to the discharge of p.n. numbers 265-1279, 1280, and 2896 be vitiated for the information of the senate, these nominations were on the calendar on the privileged nominations list. the presiding officer: without objection. mr. pryor: mr. president, i ask unanimous consent that the senate proceed to the immediate consideration of h.r. 3608, which is at the desk. the presiding officer: the clerk will report. the clerk: h.r. 3608, an act to amend the act of october 19, 1973, and so forth.

the presiding officer: is there ukes t objection to proceo the measure? without objection. mr. pryor: i ask unanimous consent that the bill be read three times and passed, the motions to reconsider be laid on the table, with no intervening action or debate. the presiding officer: without objection. mr. pryor: mr. president, i ask unanimous consent that the senate proceed to the consideration of h.r. 4030. the presiding officer: the clerk will report. the clerk: h.r. 4030, an act to designate the facility of the united states postal service located at 18640 northwest second avenue in miami, florida, and so forth. the presiding officer: is there objection to froaght measure? -- proceeding to the measure? without objection. mr. pryor: i ask unanimous consent that the bill be read a third time and pass and the motion to reconsider be laid on the table, with no intervening action or debate. the presiding officer: is there objection? without objection, so ordered.

mr. pryor: i ask unanimous consent the senate proceed to the consideration of the following bills, en bloc: calendar number 131, s. 684, and calendar number 513, s. 1800. the presiding officer: without objection, the clerk will report the titles of the bill en bloc. the clerk: calendar number ^13 1, s. 684, a bill to amend the mini-cichoni act of 1948 and so forth and for other purposes. calendar number 513, s. 1800, a bill to require the secretary of the interior to submit to congress a report on the efforts of the bureau of reclamation to manage its infrastructure assets. mr. pryor: i ask unanimous consent the committee-reported amendments be considered, that the johnson amendment relative to s. 684 and barrasso amendment

relative to 1800, which are at the desk, be agreed to, that the committee-reported amendments be amended, be agreed to, the bills as amend be read a third time and passed en bloc. the presiding officer: without objection. mr. pryor: i ask unanimous consent the senate proceed to the immediate consideration of calendar number 684, s. res. 595. the presiding officer: the clerk will report. the clerk: calendar number 648, s. res. 595, recognizing noble laureates polish satarski for his efforts to end the financial exploitation of children and to ensure the right of all children to an education. the presiding officer: is there tocts proceeding to the measure? hearing none. mr. pryor: i ask unanimous consent that the committee-reported amendment to

the resolution be agreed to, the resolution as amended be agreed to, the committee-reported amendment to the preamble be agreed to, the preamble, as amended, be agreed to, and the motion to reconsider be laid on the table, with no intervening action or debate. the presiding officer: without objection. mr. pryor: i ask unanimous consent that the judiciary committee be discharged from further consideration of s. res. 226, the senate proceed to its consideration. the presiding officer: the clerk will report. the clerk: senate resolution 226, celebrating the 100th anniversary of the birth of james cleveland jesse owens and so forth. the presiding officer: is there objection to proceeding to the measure? hearing none, without objection. the committee is disarnled and the senate will -- is discharged and the senate will proceed to the measure. mr. pryor: i ask unanimous consent that the resolution be agreed to, the brown amendment to the preamble be agreed torque the preamble as med be agreed to, and the motions to

reconsider be laid on the table, with no intervening action or debate. the presiding officer: without objection. mr. pryor: i ask unanimous consent that the e.p.w. committee be discharged from further consideration of s. res. 564, and the senate proceed to its immediate consideration. the presiding officer: the clerk will report. the clerk: s. res. 564, honoring conservation on the centennial of the passenger pigeon extinction. the presiding officer: is there objection to proceeding to the measure? without objection, the committee is discharged and the senate will proceed to the measure. mr. pryor: i ask unanimous consent the amendment to the resolution that is at the desk be agreed to, the resolution as amended be agreed to, the amendment to the preamble be agreed to, the preamble as amended be agreed to, and the the motions to reconsider be considered made and laid on the table, with no intervening action or debate.

the presiding officer: without objection. mr. pryor: i ask unanimous consent that the senate proceed to h. con. res. 125, which was received from the house and is at the desk. the presiding officer: the clerk will report. the clerk: h. con. res. 125, providing for the sine die adjournment of the second session of the 113th congress. the presiding officer: is there objection to froaght measure? without objection. mr. pryor: mr. president, i know of no further debate on this measure. the presiding officer: all in favor say aye. opposed, no. the ayes appear to have it. the ayes do have it. the measure is adopted. mr. pryor: i ask unanimous consent the motion to reconsider be considered made and laid upon the table. the presiding officer: without objection. mr. pryor: mr. president, i ask unanimous consent that the

appointments at the desk appear separately in the record as if made by the chair. the presiding officer: without objection. mr. pryor: i ask unanimous consent that notwithstanding the upcoming recess or adjournment of the senate, the president of the senate, the president pro tempore of the senate, the majority and minority leaders be authorized to make appointments to commissions, committees, boards, conferences, and interparliamentary conferences authorized by law by concurrent resolution of the two houses or by order of the senate. the presiding officer: without objection. mr. pryor: i ask unanimous consent that during the adjournment or recess of the senate from wednesday, december 17, 2014, through friday, january 2, 2015, senators rockefeller, cardin, levin be authorized to sign duly enrolled bills or joint resolutions. the presiding officer: without objection. mr. pryor: mr. president, i ask unanimous consent that when

the senate completes its business today, it adjourn sine die under the provisions of h. con. res. 125 and when it convenes on tuesday, january 6, 2015, at 12:00 noon pursuant to p.l.13-201, following the prayer and pledge, and following the presentation of the certificates of election and the swearing in of elected members and the required live quorum, the the morning hour be deemed expired, the journal of proceedings be approved to date, and the time for the two leaders be reserved for their use later in the day. the presiding officer: without objection. mr. pryor: mr. president, if there's no further business to come before the senate, i ask that it adjourn under the previous order. the presiding officer: the chair will exercise his prerogative to express its thanks to the floor staff for their work for the senate and for the nation.

under the previous order and pursuant to the provisions of h. con. res. 125rbgs the senate stands adjourned until tuesday, stands adjourned until tuesday,

>> coming up next, we will hear from the former cdc director under president george w. bush. the center for strategic and international study host this two-hour event.

>> we are at a pivotal moment in the crisis in 2004 as it comes to a conclusion and this is a pivotal moment to talk about the efforts that have been underway to bring forward the development of the ebola vaccines and therapeutics to discuss today what lies ahead in 2015. we won't be dealing today too much with diagnostics and i hope that we can talk about in the new year. in the midst of this emergency, exceptional things have begun to happen. on a point early in the fall i would argue that perceptions changed fundamentally and diverse experts working on this began to argue and realize that new technologies, vaccines and some of which were in

development or had been in development for some time, that this would be strategically essential to bringing about a conclusive control to the runaway ebola epidemic that implied that there would have to be an extraordinary effort undertaking on an expedited basis. and that they would be added to the front line of this essential public health intervention and that we would continue to hear about efforts to isolate and ensure the safety and carry contact tracing and energies effective public medications and engagements of communities to build trust and confidence. and this triggered an accelerated globalization across many different institutions and a high sense of institution and that includes the leadership and

ministerial officials and community leaders and regulatory bodies and it included multiple u.s. agencies dedicated to researching and development. to deliver the programs with the department of defense, the regulators and others, multiple industrial players of home johnson & johnson work represented here today. foundations became very important players and that includes paul allen and mark zuckerberg and others. they clearly plan to gather these. ..

unusual speed and the flexibility and cooperation that has been seen across these different decisions. there there was the, i think, pivotal meeting on october 23 which established a club of donors projecting manufacturing capacity. a certain pragmatism and debate about whether it is possible to adhere to the classic randomized controlled trials versus

less rigorous for still very important efforts. a lot of demonstrated regulatory flexibility, a lot of effort to prepare and begin to prepare communities this was driven by a number of factors. the urgency of the threat, the high risk for an action, a certain optimism and determination, and a commitment to operate in good faith. also the degree to which these different institutions began to think and longer terms, to plan and prepare and to think ahead. there obviously was a shared recognition of the security threat and the need for us leadership, private and public in partnership with

other critical institutions. money does not appear -- does appear to be less of an obstacle. that is unusual and favorable position. it does not mean the that sustainable funding is not still an outstanding question. 5.4 building 255.4 billion and emergency funding, terribly important in bringing forward several hundred million in additional resources, accelerating and developing and deploying, delivering technology. i mentioned the eu, the uk, and others. the flip side, they remain considerable levels of uncertainty and obstacles. first and foremost is the epidemic itself and the continued uncertainty.

as it pertains to the knew technologies, their are a few things that are continuing to be at the center of the debate. one is about the science. we will talk about the efforts. related to that is the ethical challenges in terms of what types of field trials will be possible and what sort of access will be possible. or is a lot of discussion around delivery, delivery, run manufacturing stockpiles, cold chains, indemnification. there is a lot around coordination. so many moving parts that we see. the question of how to coordinate those, those, who we will be at the center of this effort. who should carry this responsibility and has risen an certain key moments but

operates with diminished capacities. there is a question around how to build it back to be the relevant and continue to be. thinking ahead strategically we need to be thinking thinking about a second-generation, a second-generation, greater quality in the thermal stability and sustained funding. we want to take care today to take stock of what has happened in these last few very busy months and to look ahead optimistically and realistically as to what may unfold. i am convinced 2015 2015 has considerable promise to be a watershed. so we are going to begin with a sequence of opening remarks starting with doctor felt she.

so please, you have their bios. i have introduced them briefly. i won't go into great depth. please be patient. we will have have about an hour for conversation, perhaps more. we will close at five. we will have a conversation among the group. there will be folks with microphones. we will bundle together comments and questions and come back. back. please identify yourself and keep your interventions to saint. with that, i would like to ask tony to come forward and roll through his presentation. thank you so much.

>> could we get -- is it just the next one? the next slide? okay. we sent to the slides. so -- [laughter] [laughter] i tell you what, we have been through a bunch. okay. you at least have them. that is what i get. >> we received them and loaded them. if there has been some

glitch we will work through momentarily, if you want to offer some opening remarks. >> why don't i start without them. i am going to take ten ten or 12 minutes, and i'm going to outline for you just to set the stage. the seriousness of this epidemic. you all no the history of it. was under the radar screen for a few months until march. in earnest the three borders of sierra leone, guinea, and liberia made for what i have spoken about and written about as the perfect storm of so many reasons why,, in fact, we have an explosive epidemic that is more out of control in the history of this particular virus when it was first discovered in 1976. again, maybe not everyone appreciates that. we have had about 24

outbreaks for a a total of about 2400 people. if you look at the 18,000 infections and seven to 8,000 deaths which is somewhat of a modest undercount, this pandemic in this area or epidemic has really been extraordinary and that it is more than anything that we have seen combined over that time. now, the efforts that have contained these other outbreaks in the past have been a variety of things that are essentially fundamental good infrastructure,, good response, good ability to identify, isolate and protect healthcare workers. workers. this was not easy, but it was relatively easy when one

thinks in terms of the fact that you have very few situations traveling back-and-forth. if back-and-forth. if you look at the original outbreaks that took place in zaire and sudan, the outbreak in the democratic republic of the congo, they were all ultimately controlled. now we have something that we are making progress. if one looks at liberia, the united states has been heavily involved in liberia, the uk, sierra leone, but their have been a variety a variety of agencies involved that have put resources and. okay. here we go.

this is where it started. can i start now? okay. these things happen in may. people were starting to get a little bit concerned. september and october my life changed and turned into an intern in medicine again. you are involved in a very intense situation. here is here is what we are seeing right now with the sierra leone case is essentially overtaking considerably the cases and liberia. i i mentioned the public health responses that were actually involved in keeping these things and the affected countries under control. everything everything really without looking at things like disease specific therapeutics and certainly not a vaccine.

and i mentioned the united states getting involved with the construction, the department of defense playing a major role role when the president called in the department of defense and brought and the ability to do the engineering command and control and the setup of ebola treatment became very important. the cdc did an unprecedented job together with usaid and the number of people they have now deployed. it has been has been an extraordinary effort. however, we are asking the question now, and that where we need interventions in the form of vaccines and therapeutics for the current outbreak, which is entirely possible because until you completely snuff out every case in west africa, as we know, until all the embers

are out there is always the threat of an outbreak. we have seen that and know that it can happen. that is important. the two the two things that i want to throw out for discussion, we need a vaccine to put down this epidemic, and epidemic, and even if we don't get one in time or don't prove it is effective, we will we need it? i say yes for the inevitable outbreaks. why am i telling the audience? is because it we will be very important to know whether the vaccine works because the thing you don't want to do is to deploy a vaccine that might be harmful or that you may assume works and then for the next epidemic you have a problem. that will be the intention i hope we get a chance to discuss about the design of a vaccine trial. having said that, the

vaccine that is already either in phase i getting ready to go to phase ii, there are two of them. getting involved would make it to two and a half or three. the three that you will here about, not about, not that they are any less and quality because we don't really know about quality until you test. they have not yet done in the phase i trial. i want people to understand that. that. i often get asked, prioritization of vaccine, yes or no. getting it into an advanced trial but not necessarily a predictive value of whether or not it we will be better. at a meeting meeting we had just the other day it was

argued strongly for candidates to be an play at the same time. let's focus briefly on the two that are most advanced, and that is the first -- what we are calling the gs k vaccine which is an abnormal three admiral three vector into which was inserted the gene of a glycoprotein. this has gone into phase i trials, but chimpanzee studies have indicated a very favorable protection using this particular candidate. that is good news. also, phase i also, phase i was relatively uneventful. we had individuals. we did it right there. it was uneventful. it. it has been tested in a monovalent form. we did a bivalent in the uk and when we set up to test in africa. this is the new england journal of medicine paper that came out literally a couple a couple of weeks

ago. we are now setting up for testing again of advanced trials using this. the other candidate candidate is the vsv. into which has been inserted the protein gene. phase i trial fully enrolled in collaboration with the department of defense. we are doing it at the nih. others are doing it from the army instituted by the department of defense, united states army now in collaboration also with merck, merck, and you will here more about that from julie. the company that is involved, it involved, it originated in the public health agency of canada. department of defense together involved. the trial

was put on hold. people hold. people get confused about that. there were four individuals. that does not mean it is the end of the vaccine by any means. very common. we saw saw it in a significant proportion of people. you don't even have to give a live virus vaccine. the question is, what is that going to mean? that is why you have phase one trials. the proposed path,, and this has been in close collaboration with the liberian department of health officials, a randomized double-blind placebo-controlled and a trial in sierra leone with at least two and liberia and possibly one or maybe two in sierra leone. we are working with the cdc now.

i want people to really appreciate that none of these have been shown to be effective. i think we we will get the chance to discuss. the distribution and a trial in which not everybody gets a a particular intervention is different. you are getting to an absolutely healthy person compared to a therapeutic when you are giving them to someone who may be drastically help. when you think about the design of trials thus that's the reason the discussion is a bit different. very quickly, you have heard about it. it has been given to seven people. it is an antibody cocktail that has been shown to

protect monkeys. the phase one trial that is ongoing. 4430 would protect monkeys against ebola, also in a phase one trial. developed for other viruses but shown to have activity and has now been used. and so and so an inhibitor which has broad antiviral usage, it protects mice. it has not yet gone into a nonhuman primate. you can argue can argue that these have potential, but remember, despite the fact that they are either given in compassionate use and/or in a phase one trial does not mean that they work. the critical issue issue is to balance the need for

therapeutics with the desperately ill person and the need to show that it actually works. the other is convalescent plasma. first trials first trials kicked off just a couple of days ago in getting an sierra leone and liberia which we will be determining whether the antibodies in a person's plasma will be protected. we protected. we are put together with the people in memory as well as in nebraska adaptive trial designed to take a look at a couple of these therapeutics with the control on being an enhanced care. intensive intravenous replenishment and electrolyte balance. it is different than the situation. i will stop there

and handed over. i was in my actual 12 12 minutes. thank you. >> thank you. [applauding] >> thank you very much. much. sorry for the glitch. >> thank you. as you no, a long tradition of commitment to global health weather on the r&b side of things or the commitment to a malaria vaccine. but also but also the manufacturing and supply of approved vaccines in partnership, part of this endeavor. clinical vaccinations and thriving in the community to participate and help deal with this tragic situation.

the western african countries but on a worldwide basis. in the the next few minutes we we will talk about three things. talk about some key enablers the future looking ideas of how it can be better prepared. we get in. in terms of the status, the first phase one trial has been completed. i think it's very satisfactory. we also have three phase one studies being conducted in

the uk and molly, data which we will be available in the second week of january. i say i say this with precision because our perspective of all these trials, the phase iii trials. we also are planning to start to large phase ii trials in africa, one in africa and one in chile. they would they would also start around the middle of january. two phase iii trials, participate and then potentially participate in the cdc lead trials in

sierra leone. we also have a collaboration and discussion to see how we can not only check the short term but also have a sustained protection over the long-range providing a booster of vaccine by combining the vaccine. so quite the comprehensive effort that should deliver data and information on the effectiveness of this vaccine before the middle of the year. if all goes well. now, during the trial the manufacturer vaccine. over the past four months we have dedicated enormous resources from our organization to make sure that we take a bench level

type process to manufacture the vaccine where we can start producing the vaccine. to relieve the first trial before the end of the year if all goes well and then continue to produce the vaccine in 2015. to potentially participate in large vaccination programs. the main challenges that face us with the production of the vaccine, things like

getting the vaccine out in the conditions required, very challenging to achieve public health or others. also, great partnership with the regulatory agencies to ensure that they have eyes standard, the fastest possible track and making them available for usage. so that's the status of the vaccine. and the enablers, a very important. first, any one of these vaccines that are being developed without the partnership with nih. [inaudible] i think it is really key

that the companies work together. i think the second thing that is important is to think forward about access for the population. what they have to make them available for the vaccine to be provided. and i think the third dimension has been this critical meeting that took place to make sure that all stakeholders come to more or less a common view. it is difficult to have that many countries come to a similar conclusion, key, key stakeholders. many, many countries and donor countries. coordinate our efforts and

help alignment in the right direction. the last.is around liability, indemnification, immunity for the stakeholders involved. and my concern is that when this vaccine is introduced, the large vaccination,, very limited. many, many communicable diseases exist, the number happens all the time. it would happen concurrently with immunization with any vaccine. how will we be able to decipher which of these are ready for the immunization and which are the background of the population, a major

focus that you need to have. could have consequences around liability. very, very pleased about the open enrollment decision. very important to deal with the situation. situation. very important that other countries work to help us materialize. finally, very briefly on the future perspective, in the past four or five years the major bio threat. and every time the community is taken by surprise, resources that are dedicated , whatever it is that they are doing under

emergency situations, either manufacture of vaccine or accelerate like we're doing here dramatically development and supply of a vaccine. we think that we should have a more proactive approach to this. we should have an infrastructure that can prepare various technologies for immunization and vaccination to be highly accelerated when the need arise. from discovering vaccine against a number of pathogens. ..

company is 100% committed to make vaccines available and to work with all the stakeholders, all the companies. our intent is absolutely not one of return on investment but our social responsibility. and hopefully we will be able to tackle this and future outbreaks. >> thank you very much.

i think you are in the boundaries. johan. >> first of all thank you very much. i'm very pleased to be here today to give you an update on the ebola vaccine. before i do that i really would like to echo what he said. it's very clear that this devastating disease i really see a lot of sympathy and working together because all stakeholders and i'm pleased to see that indeed there are no borders between companies. we really want to join efforts to make this fight successful and without all the stakeholders joining efforts certainly we would not have been able to be where we are today. johnson & johnson as you know is

a global health care company and since the start of the crisis we suddenly realized that it's part of our corporate responsibility and in line with the mission of our global public health organization we really wanted to leverage all capabilities of know how we have internally to fight this disease. today i will focus on the vaccine but also we have heavy investments in the area of the developing a treatment and also in terms of diagnostics we know that today and going forward in the trials is order to have bedside diagnostics that allow you within minutes to know the patient you are confronted with carries the ebola virus are not so these are areas we are very active in. beyond that one we also are very active in our efforts and have

collaborations with several ngos such as project hope in the cece foundation and partners in health. when we look to the vaccine and it was briefly mentioned before we have been working on this and thanks to the partnership with our sponsorship from nih we have been working with several generations of vaccines and we actually just before the summer came to a vaccination schedule that was shown to be 100% protective blend the virus was used in different climates. what you see is actually there are three vaccination regimens that turned out to be 100% protective. one involves platforms that we have fully in house which is at now 26 and 35. the other was 26 boosted with nba or vice versa with 26. as you can see below all of the

animals were vaccinated and survival of the animals which were vaccinated. in view of emergency we decided at the moment we really wanted to accelerate the development. the development was focused on multivalent vaccine but we knew very clearly that if we would focus on single valent vaccines on the ebola strain that it would go fast. in addition to in addition by buyer sells focusing on one of vaccines and seeking a -- that could produce everyone we felt felt we could shorten the timeline significantly and that is indeed what we have achieved. what we actually have is the vaccination schedule itself composed of two doses. there's a prime given with an additive factor in the boost given with the valent nba. we are convinced that we have optimal protection in

combination with a prime doses and a booster dose. one of the advantages of the forms that were used as both of these platforms have already been used extensively in the clinic with commercial products. there are more than 7000 subjects vaccinated today. we have a satisfied safety profile -- profile and add no factors have been shown to be well tolerated in the different programs we have like hiv tuberculosis and malaria. we actually selected a dose and we selected a dose based known to give good immunogenicity. we will have to wait for the immunogenicity's once we come up with the specific insert. one advantage we see in this is that the work we have invested in these platforms over the past

years have helped us to optimize the manufacturing process. just to give you an example by a scale of two times 10 meters we have at least 150,000 doses that we now have for five consecutive round so we are a substantial amount of vaccine in the freezer that can be used by march of next year. production of nba is ongoing as we speak in the folders -- first results from denmark we are confident we will be able to release 500,000 doses by early march of next year. an important aspect also is that formulation work has been conducted by these vaccines in the past and the data for using this platform with the inserts we have seen the product is stable and add no platform for up to two years and for nbaf to

one year. it means logistically we will allow in a frozen labor locally could be using the classical distribution channels for the vaccines to increase. this is just a schematic scheme on how it looks. the important factor is -- one of the reasons is indeed you will avoid immunity but certainly there is much more complex immune system behind this that brings the benefit of the boost. where we are today is that we actually in the coincidence is is that it's december 23 next week and we are actually in discussions with oxford and we really want to have the first patients does in the early days of january. everything is aligned to make this happen and we will

accelerate to weed out the does and should become available sometime by mid-february such that in the timeframe we can participate in a trial that would allow us to -- with regard to production plans are to produce at least a million doses for next year but a recent evaluation if need be we could go up to next year up to 5 million doses and the year after that magnitude of 15 to 20 million doses. that is actually what i want to say. again i would like to stress as most of us have indicated we are convinced that we should go beyond the borders of the companies here. we should work together with all stakeholders to be successful in this fight. i also hope that when i see how this partnership of stakeholders works and how it has helped us

to compress timelines from years and two months i hope it teaches us a lesson going forward that we can do this in other areas also. thank you. >> thank you. [applause] julie gerberding. >> thank you and thank you so much for posting this and to my co-panelists for their contributions and their partnerships as we try to work through this. i thought what i would do is maybe try to put a little more context around some of the things we are talking about as we open this up for conversation at the end of our discussion. one of the things that i reflect on is that this is a predictable surprise. this is a disease that emanated from contact with probably bats that harbored the virus and that virus spilled over into other

than a million species. sometimes it spills over directly into people but we have known about this ecosystem for a long time. we didn't know that it had reached the west coast of africa in quite the way it did but it's there now and there's no reason to believe that we are not going to see this again. so we have to be fully prepared for the possibility that even if we are able to quench the particular outbreak we are experiencing that this is not the last time we are going to be dealing with ebola. it don't mean to sound like a pessimist but i think it's very important to have that longer-term perspective on what lies ahead of us with respect to diseases and this one in particular. i think we also need to really think about the issue of plausibility. from everything i've heard and everything you have seen in the preclinical and early clinical studies that are going on creating a vaccine for this

pathogen is biologically plausible and that gives me a great deal of optimism that even if the 1.0 vaccines we are working on today don't prove to be the best vaccine are the ultimate vaccine we need to keep going because it is possible to develop a safe and effective vaccine that can prevent infection either pre-or post-exposure and that's something we need to stay the course tenaciously stick to install for it. with respect to the vaccine that merck is partnering with, these are early days. this is the vsb virus is a virus that is designed so there are active cycles of replication of the vaccine vector when it's in the human host and that has the advantage perhaps of prompting a robust immune system past. we have to watch carefully for side effects. the arthralgia as they were reported from whence they say were particularly worrisome but that is why we two days one and

phase two study so we are alert to things that could signal reacted should the city were something that would be a harbinger of a more serious issue down the road. i think we also anticipate the creation of a solution to this is going to have to be pragmat pragmatic. lives are at stake today while we are sitting here having this scientific conversation and we can't move at the pace we are used to moving out. i don't know if i can speak for my colleagues and the other manufacturing pharmaceutical companies but this is an incredible disruptor of business as usual because we have to be pragmatic. we can't take our time. we can't have lots of conference calls and meetings and do all the stakeholder engagement and on and on and on. we can do things in series. we have to do them in parallel so we have to be willing to work faster to move more people and

mobilize more people to come to the table inside the company let alone what's going on with incredible partnerships we are experiencing outside the company. i think you said it really well about the disturbance of other important pharmaceutical work that would otherwise be going on. the poll of this vaccine incites the pashtun people certainly in the vaccine business but across the entire enterprise that merck. we are passionate about this. we know it's the right thing to do. we know we have something to contribute. we know we can do alone and people are leaning into the opportunity to be a part of this process. but at the same time we didn't budget for this. we didn't structure our company for this. this came along as a sudden requirement and we had to step up to the plate and do our share. it comes than an opportunity cost. that is something that we feel we have concerns about.

it doesn't change our commitment that is something we have to factor into it and something we need to plan better for going forward into the future. this challenge that we are facing is also about unprecedented partnerships but i think in this world where we are always talking about public-private partnerships and it's kind of a buzzword there are some very special partnerships that are going on here. one of them is a partnership between people who are traditionally competitors but there is a much more robust set of partnerships happening between people who may share a broad agenda that duart used to working for each other. the transnational government partnerships even in the u.s. government, the incredible partnership of the bard at the leadership with the nih and cdc,

with golf e.. how wonderful is it that got the has made a commitment to make sure that this vaccine will be available to the people who need it the most by creating a macroinvestment commitment to bring it forward. i think the beauty of that to me is the fact that underlying this kind of glaring public health requirement is to trust that has been developed in the past several years as we work together on on other problems. so we have developed some understanding of how each other works in some appreciation for who has a stake in white and are willing to build on that trust and connect these partnerships even when there is enormous uncertainty about where this is going to land and where we will ultimately end up. the last thing i wanted to talk about was poignancy. the fact is this is about 18,000 people who had ebola, about 35%

who are no longer with us but it's also about the whole milieu in which they lived and shared their lives and their families and their memories and their loved ones. people who have suffered deeply from this tragic outbreak and the poignancy of being where we are today in the context of a predictable surprise at not being able to work faster to contain the outbreak and make their lives more secure and reduce the incredible human suffering that surrounds us, not just for the directly affected people but for all the people in the communities who don't have health services and whose lives have been so disrupted and these economies that have been so disrupted and potentially whose democracies are going to be so disrupted that the other poignancy to me and because i don't work for the government anymore i can say this. sorry, tony.

the poignancy of having been here and done this before. we do not have to keep reinventing the wheel. how many sars outbreaks do we need to have? how many mrsa. how many public disease outbreaks on a global scale do we have to experience before we recognize we can't have an ectopic response. we have to have a sustained commitment and we have to stick with it whatever their participating problem was goes away. to to me innocence that feels my poignancy and i share with you your final remarks about we need to lean into the future here, create new avenues new tools and partnerships to be able to sustain this effort over the long run because i don't want to have to sit on a panel like this again as much as i've enjoyed it. >> thank you so much julie. it was very eloquent. >> thanks very much and i appreciate being invited to join

his panel today. doctors without borders has been responding to this outbreak simply started raising the alarm. we are looking forward to more resources in terms of teams and infrastructure. we realized this often we do in emergencies where responding to we simply don't have the tools so we have taken a pragmatic approach to deal with this outbreak in a way that are health care workers and people have died in this as well as affected communities can get the best outcomes. just quickly to talk about some of the things msf is doing vis-à-vis trials. we are going to be launching two of the trials before christmas this year for some of the drugs that tony had put on his slides. we also are going to run a third trial by using convalescent plasma. our criteria is based on whatever safety net the cwa had

as well as simply having a supply available and that certainly has excluded the use of some of the antibodies and zmapp. one thing that i've been especially involved in a sum of the safeguarding of access issues that we consider very important both in terms of the immediate term and ensuring that we can use these drugs for emergency or compassionate use for other patients outside of the trial. we don't want to have differential outcomes for patients that are within the trial were simply we are certainly concerned about the medium-term access issues that we can continue to ensure that there is a supply available to the patients if the outbreak and he continues his julie is noting and certainly we are very concerned about the long-term access issues in terms of registration of these products in terms of adequate supply in terms of the affordability of the products and the management of intellectual property. this is especially important because as julie was noting this is something unfortunately

that's going to keep coming back and we are not sure is an organization of the future all these responders will be there in the communities and we will need access to these products in the future. we need to take steps now to ensure we can safeguard long-term access. in terms of vaccines or leon alongside others we very much were thinking about the importance of vaccinations to turn the tide of the ebola outbreak and had to engage in pragmatic efficacy to pull out all the stops of accelerating the trials and in terms of accelerating the production recognizing both for the companies this would entail certain risks be taken in the short term in the medium-term. we certainly try to take a pragmatic approach to that and we really do welcome the commitments that have been made at coffee although we do have some short-term concerns in terms of the lets a structure that has been put forward. one is certainly around potentially the price of the

vaccines which has not been specified in the strategy that has been put forward. it's been left to be very vague and to the extent we think these vaccine should be available close to marginal cost is something we hope can be achieved. related to that we would like to avoid overpayments for these vaccines. there's a lot of contributions the companies are making and a lot of contributions that governments are making to help to pay for these vaccines and we certainly support direct compensation for the investments companies are making insofar we can make sure the vaccines are available at its marginal cost. we should also remember their incentives that are being introduced to potentially reward companies for development of these vaccines including the very important sum of money not to encourage companies to develop vaccines against specific diseases. congress has amended legislation to include ebola. these are important senses that we need to be sure in terms of

its well coordinated as we have been discussing pay the last issue is about equitable distribution. we see we are moving towards industrial scale production for a lot of these vaccines within a short or medium term there will be some problems in terms of providing adequate supply into the extent we discover these vaccines are safe and effective we want to make sure they are prioritized for the affected communities and we know there will be interest in terms of securing supply for developed countries but there are issues in terms of how to manage the distribution between different communities and we hope the w.h.o. was able to take a central role. as an organization we are considering developing a clinical trial in guinea with the government of norway and other partners that we hope we can get off the ground by next march. moving now into issues around second-generation products which we think is important certainly in terms of vaccines. would like to see a future vaccine to be more thermal stable.

this is a challenge for many of the products the companies on the stage are currently selling to us and we are often unable to deliver in remote settings because we simply cannot move them out of the cold chain to control the temperature chain. in terms of drugs we do think they show promise and there's a lot of interest to use these drugs. we are concerned over potentially the use of biological samples from infected populations. it's potentially a concern that has arisen for us internally so we simply want to ensure that if materials are being used from affected countries at various concerts concerns around access are triggered in terms of managing the supply and of course we want to ensure their supportability and they are available in a sufficient supply for the affected countries. and perhaps demand on some remarks and just to note also the u.s. has expanded the tax

drug credit to include these monoclonal antibodies and doesn't safeguarding of the access issues so demanding they are affordable and are available in sufficient supply is also a concern we have with the voucher and all of the funding being provided. seems like none of that is has been tied to access which matters because in the long-term we are going to be responsible for acquiring those products in using them in the fields where patients. justin and in terms of some additional thoughts. in responding to this outbreak in terms of the drugs and vaccines one is certainly about the challenge we continue to to have been insisting and the importance of access with it the short or medium term or long term and funding the governments are providing links to these access issues are clinical trial partners are not as from iraq these issues because it's not

the course to think about these issues in clinical trials are not normal to be engaged in clinical trials. this in front -- is front and center for us as an organization delivering treatments in the long run. the second thing is around transparency especially funding. there's a lot of money being put towards this and that's important to move from the famine to feast but we think we need to understand better how the funding is being spent and what conditions are attached to it and how it works together and certainly that's important for the u.s. government which is offering so much money from different sources towards the response for which there is often not an organization. the last issue i would notice the system of research and development that i work for an entity called the axis campaign and organization launched in 1999 because we are concerned that our system of research and development does not ensure that drugs and vaccines are affordable that they are suited

to the conditions and that is what this outbreak represents us. simply we are faced with the same situation we had 15 years ago. the systemic failure is something we own is a global community and it's something which we have still not responded to. when you look at the vaccine which mark has now licensed and developed by the canadian government many years ago it was licensed to a small manufacturer for 200,000 dollars for which nothing was done for a long period of time until this current outbreak. that is a failure. when i hear comments unfortunately saying this is an opportunity cost were not expected as business as usual that confirms our concern. ebola is a public health problem and needs to be front and center. we need to have new incentives to prioritize these diseases. they should not be seen as opportunity cost. they need to be seen front and center as part of our global response in our system of innovation and that is what is

required to have changes in the future. this is an emergency but so are the things. so is basic antibody persist in a range of 17 neglected diseases and maladies merit our attention that there are new ways of thinking and new ways of research and development and it's only if we can find new ways to develop drugs and vaccines are we going to prevent being on these panels in the future because we will continue to face challenges and ed has an operational organization meant to contain the respondent put it that -- as they have in this outbreak. c thank you very much. [applause] is really striking how much soul-searching and introspection this crisis has stirred and how much effort at innovation and changing business practices and modes of operation how much all of you have been stretched in this. not to do things that are outside the normal pattern.

there are three issues i would like to quickly touch on and then open it up to the audience. one is the question of how these trials can be best carried forward. there is a debate going on now. there would be in an ideal situation and obvious preference for the classic randomized trial approach, double-blind trial and that will be attempted in many settings as we go forward. there is uncertainty though. we know the risk environment is complicated. we know the operational environment is concave. we know the exhibits by communities is very fundamental, and being able to move forward with trials. so it seems to me that as we are entering 2015 and multiple expanded trials that this unresolved debate around how do

you operate with the greatest adherence to principles of safety and efficacy while being pragmatic, adaptive to a highly challenging and highly urgent environment? how is that likely to play through? it's an honest and open set of challenges for words i don't know there don't know there's an immediate and clear answer but it would be useful to hear from all of you how you anticipate navigating the environment and moving forward. tony do you want to say a few words about that? >> first of all when you are dealing with trials there is the balance as i said to my opening remarks of trying to get a product that potentially is going to be beneficial to get to people as quickly as you can while making sure it is beneficial and that's really the fundamental rationale for randomized controlled placebo at double-blind trial. ..

everybody will ultimately get the vaccine. if it works, that that is good. the other trial, the randomized trial