We are also very concerned about the longterm issues of the registration of these products, in terms of the affordability of these products. This is especially important because this is unfortunately something that is going to keep coming back. We are not sure our organization in the future will be able to respond. Need access to these products in the future. We need to take steps now to ensure that we can safeguard the longterm access. In terms of the vaccines, we very much worth thinking about t and the important of importance of vaccination protection. The stops pull a all in terms of really accelerating the trials and in terms of accelerating the production and recognizing that both for the companies and the donors and that this would entail certain risks in the short term and the medium term. We certainly take a very pragmatic approach to that. Approach of the structure that has been put forth. One is certainly around the price of the vaccines, which has not been specified actually in the strategy that has been put forth. It has been very vague. We think these vaccines should be available close to a marginal cost. Related to that, we would like to avoid overpayments for these vaccines. There are a lot of contributions that these companies are making, and there are contributions that governments are making to help pay for these vaccines, and we certainly support direct compensations that these companies are making. Order to make sure that these vaccines are available at a marginal costs. Cost. And we want to make sure that it is a small amount of money, and congress has just amended legislation in regards to ebola, so we need to make sure how this funding is well coordinated, as we have been discussing. We areainly see that moving towards an industrial scale production, but in the short and immediate term, there will be some problems as far as providing adequate soprano adequate supplies. We want to make sure that they are prioritized for the affected communities, and we want to make sure that there is enough supplies for all companies whotries, and we hope the is able to take a central role. At our organization, we are hoping to develop a clinical we hope we can get off the ground by next march. Moving out to issues around secondgeneration products which we think are very important, including vaccines, we would like to see a future vaccine be more stable. Sf, ins a challenge for m that we are not able to deliver them in very remote settings. We cannot move them out of a controlled temperature chain. We hope that we will be able to overcome these issues. We think that these vaccines show a lot of promise, and we are concerned over the potential biological samples in a population, and in order to beelop these products would a concern, so we sibley want to in sure that materials are being used from affected countries are being managed. Ensurese, we want to that these products are available again in sufficient untries. In these com remarks, weon some also heard there was the expansion of the orphan tax drug credit. It pays for 50 of the trial cost, but it does not safeguard any of the issues of that were concerned upon, so demanding that there would be affordable drugs, they should be available in sufficient supply, these are also concerns that we have and with all of the funding that has been happening, and it seems that it is not being tied into this global access. We are going to be responsible for acquiring these products and using them in the field for our patients. Just to end in terms of some additional thoughts. Certainly in responding to this outbreak in terms of drugs and vaccines. One is certainly about the challenges that we continue to the an really relying on importance of access. Whether it is in the short term or the mediumterm, we need to have access, and we have access issues. To think the course about these drugs in Clinical Trials, but this is front and center for us. We are trying to deliver treatment for the longterm, so there are certainly a lot of challenges there to normalize these more in Clinical Trials and in the future. Another concern is around transparency and money pain for resources. We think that we need to understand better how this funding is being used and how it all works together. Certainly important for the u. S. Government, which is offering money from all isferent sources, and there not a lot of clarity for us as an organization. Lastly, there is the issue of failure in research and development. Wasrk for an entity that launched in 1999 because we were concerned about research and development does not ensure that the development of drugs and vaccines are affordable. Is what this outbreak represents to us. We are faced with the same situation that we had 15 years ago. That systemic failure is something that we are all responsible for in a global community. It is something that we have not responded to. When you look at how the vaccine has been a licensed by the canadian government many years ago, it was license to a Small Manufacturer to which nothing was done for a long. Of time until this current outbreak. That is a failure. Unfortunately, this is an informsity cost, that can our concern. They should not be seen as opportunity cost. They should be seen is front and center to read that is really what is required to have the heanges in te. This is an emergency, but so are other things. So is basic antibiotic resistance. So is the range of 17 other neglected diseases. They all demand our attention. But they require new ways of thinking and new ways of research and development. And it is only if we are able to develop new kinds of drugs and vaccines that we will be able to be on these panels in the future , because we will be facing these challenges in the future. Thank you very much. [applause] it is really striking how much soulsearching and introspection this crisis has stirred and how much effort and innovation and changing business operationand most of how all of you have stretched in this. To do think there outside the normal pattern. There are three issues that i would like to quickly touch on and then open 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, doubleblind 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 complicated. We know the acceptance by the communities is very difficult in being able to move forward with trials. So it seems to me as we are entering 2015 with expanded multiple trials, that this unresolved debate around how you operate with greatest adherence to the principles of safety and efficacy while being pragmatic and adaptive to a highly challenging and highly virgin environment, how is that likely to play through . Ofis an honest and open set challenges with that i do not know if there is any immediate answer. It is very clear from all of you how you anticipate navigating the environment and moving forward. Tony, do you want to say a few words . So, first of all, when youre dealing with trials, there is a balance of trying to get a product that potentially is going to be beneficial to the people as quickly as you can will making sure that it is beneficial and not harmful. That is really the fundamental rationale for the placebo doubleblind trials. I think that it can only be done inh complete by in buyy by the people involved, which is why we are in our fourth visit to liberia with the meetings regarding whether decisions in the medical community should be made, and to do randomized control trials, fully being aware that the advantage of doing a placebocontrolled trial where not every Single Person gets the product is that from the standpoint of proving efficacy or not, it is really of doingrefire way that. You can have other trials. You can have cluster randomization. Those are actually ok. H lessey are muc stringent than a doubleblind amount of data. The benefit of these kinds of trials is that everyone can eventually get the vaccine, so if that works, that is good. But with a randomized trial, you can probably get the answer about efficacy more quickly. When she get the efficacy, you are going to distribute that vaccine that everybody and anybody who might benefit from it. So there is a balance about ultimately if it works, everyone is going to get it. That is the framework. Then we look at the advantages and be disadvantages. If foreign fact you are distributing the vaccine before you know it works, the advantages are if it works, you get it to people quickly. The disadvantages is are the if it proves that it does not work, we are going to be sitting on the panel with the inevitable next outbreak and will not know if we have a vaccine that works. That is the problem. Randomizedith the controlled placebo trial is that some people are not getting it right away. There is this absolute understandable desire that if going to be beneficial, and going to get it that quickly as possible, is important. I will just finished with this. I have just been to another seminar that we had here about the issue of the difference that you canpy make readily available, for which i was the champion of during the hivaids. , first as a vaccine that you dont know works. Hivaidess period, verus and vaccines that you dont know works. They have heard of this, we had that lookedr hiv really good in an animal model, and hast taste for one, it lookedphase one, it safe, it even passed phase twoa. The last four days 16,000 people have died from aids. Argument for you have that data in each of the trial, give it to everybody who needs it because it is a terrible and catastrophic pandemic. The only trouble is within the randomized control, the doubleblind trial, we found there was a 41 increase of risk of getting hiv infected if you were vaccinated with the vaccine. It had nothing to do with behavioral changes. It had to do with the vaccine. So that is one of the reasons that if you are given something giving something to someone who is an otherwise normal person, there is a great risk that you must seriously balance. I dont know what the right answer is. Able to consider the pros and the cons, and that consideration has to be with the people and the country were going to be involved with the vaccine. And if they dont want to, they should not get it. They should get whatever trial they feel is appropriate for them. We are balancing out the andncy and the leadership that is all to be determined. A mix of tools and approaches. I am very supportive of you, and i would like to add two dimensions to it. Between 12000 and 18,000 children every hour. We need to be very cognizant of the proportionality. The very important point regarding a bull is regarding , we dont have a vaccine to m as everybody. Izeunites immunzi everybody. This is not a situation where we save peopleially who participate in the trial, and i think the ethical question is keeping people away from the that could be expanded to the overall population. For me, it is one of the reasons there is nothing else that we can do in providing these vaccines to a smaller proportion of the population. Having an agreement is absolutely paramount. It is the reason why we are not favoring anyone and people are working to two put one forward. I do have a concern when we look at library a, will we see the next was introduced a month ago, and we have seen events now, therefore, we would not know that we may be wrong. We should have a very balanced, very open, but also scientifically sound discussion regarding this. This hits really hard, and i just wanted to jump in here for a second because i completely agree with tony. Par the separate ticipatory is very important. We need to have a conversation with all of the people involved, and have a cultural context on the situation. The only thing that worries me is that even if we knew the vaccine works, will people take it . See is a problem that we with vaccines that have been around for as long as they have been. The polio vaccine has been around, and when a disease is as frightening as ebola, it is going to be very difficult to help a population have trust and confidence in a product. Thehe more participatory processes, it can be helpful to actually be at the front line were people need it. I fully concur. By the be as excepted entire population, not only by the medical communities, but by the entire population . Be occasions anyway the social start thinking around how to involve a certain population and to work importantues is very to make these trials successful. One thing that i would like to go to that is on how we later on demonstrating for later vaccines whether we can go to when theses again, vaccines become even more controversy or. Should we start looking into these discussions that we sunni to have . Msf, out of all the organizations here, is the one that is deepest on the ground and has the most extended contacts and knowledge to read you are being pulled in divergent directions in terms of these issues of ethics and trials and community relationships. How do you see this . It is what the others are say, it is about Committee Case and and the acceptance. We are built on that basis. That is just part of the dna of the organization. We have not finished the trial design for the vaccine. We decided not to do randomized trials. We made that very early on in the decisionmaking process. We looked at the historic trends in some of these communities, in terms of what is the outcome of mortality rates, and there is an understanding of the shortcomings, but also as a medical provider, there is a need for us to be engaged. We felt that we sibley could not simplyged that we could not be engaged. Steve, again, the point that you made is an excellent point. I think the people need to when someonetween is sick versus a vaccine, there tono kind of trial you need do what is acceptable and what you feel is the best, so there isbetween us on that. That has the issues surfaced in this. Is coordination. How to make sense, how to travel , how to make efforts, getting i would likeine, more toosh a little bit just say a few words. There is a microphone right here. How does this help put in place mechanisms that build confidence around the coordinated efforts looking forward . Are you excited about that . Thank you, steve, and the you are a terrific group of people who are really in the middle of all of this right now. It is great to be here. Ofgive everyone a little bit background, in september, our executive committee and our board asked the secretary to basically look at ways to have a role in the Ebola Outbreak and the crisis. Essentially, over the last two months, there has been a tremendous amount of work that has been done over this. All of the people on the panel and pretty much every stakeholder that is involved in came to a point at the board last thursday when the board discussed the idea what the role would be. The decision was a couple of things. The first was that everybody that was related would have a funding envelope to up to 300,000 to a vaccine that was be deemed safe and effective by the who. There is also a 90 million envelope for two purposes. One is for the rollout of the vaccine once it becomes available, and the other piece is around the recovery of the m ationzation immuniz systems. Especially these countries, there has been a huge reduction of immunization. A lot of these countries are going to have to rebuild, and we are going to be part of that solution for them. I think it is very important for people to understand, i think some people here know that we are just weeks away from our second replenishment. The number we are looking for is seven and a half billion dollars, so the numbers we are talking about ebola are in addition to what we are looking for as far as replenishment. I think it is important to know that that funding is active and not part of the regular critical immune eyes asian immunizatio n work. The work is already started to really get ourselves in place. To be ready when a vaccine comes about. Four work streams have been created. They will roll out for potential outbreaks and recovery of the system. We are really working to ensure that these pieces are all set. When a vaccine becomes available, we are prepared to roll it out. Piece goes,recovery as i said, i think countries are still in the process of figuring out what they need to do, and we are putting ourselves together, so when countries are ready to start rebuilding, we will really be there to support it. Far as we are, we have seen in the last two months that it shows the Important Role that we have around m as asian immunization. Does going back to what everybody said, this is all about partnership. People play a certain role in the vaccine process, but in order to ensure that it is really getting in control and to the people that need it we rely on our partners on the ground, along with all the other people. Thank you very much. There seems to be a pretty strong consensus among the speakers that future Business Needs to be done on a different basis and that part of this introspection process is looking ahead with that in mind. Could we get a little more particular, a little more concrete as to what would you see as essential changes in practices and inquired coordinating mechanisms and in planning and creating incentives. Julie . One thing i would think we would all agree on is that companies crave predictability. So we like to have the confidence that if we start something, we can move it to completion. We like to have the confidence, for example, we have a government partnership, and that the partnership is good for the duration of what ever it is we are trying to do. Whether it is the next sequestration or the next challenging circumstance within anybodys government. That is kind of the concept, if we are going to make an investment in our partnership, that the partnership can hold. I think we have really good examples were that happens. Have been able to come through on commitments, and i am not a resizing not criticizing anyone in any way. I think we would all benefit from a public that is more informed and more reliably informed about why these kinds of investments are important. About a pledging conference were people need to tomit and governments need commit, and donors need to commit, and in order for that to happen, the public really have to understand and understand why it is important to vaccinate. What is the benefit that not only the children or the adolescents are benefiting from immunization, but what is the benefit to the people who dont have Affordable Access . What is the advantage to the rest of us . I think it is important that we not be shy from the fact that vaccines and vaccination is a Public Health good. And the problem with sharing a good has become very global. Awaye only one traveler from a threat in our own neighborhood if we dont do a good job asserting Affordable Access to all of these communities. I think in terms of how we vaccines, iline think