I think that a sound effect was appropriate for the tension that might existtwe if there is the outbreak in the the need to learn what works to address that outbreak for one that is the merging and the need for learning it is quite acute. With that humanitarian need is so great . So are the leaders of the team recently published to implement Clinical Trials so i will turn over the podium the cochair of the team and is currently a professor at university and also managing als a very exciting institution to do research on dangerous diseases. He is working hard to try to bring that to fruition. David peters will be talking for a few minutes and then there will be a Panel Discussion from the humanitarian group that has saved more ebola lives than in the other group in those that supported the United States efforts to control the ebola epidemic as director of emergency the office said u. S. Foreign disaster assistance. My thanks as well for those who are watching remotely we are very grateful for your input for the National Academy of medicine to let get the issue of Clinical Researchs an e with those issues at the start of the outbreak. So actually there was very little known how to manage c the patience of ebola. There were no therapeutics or vaccines to human current Clinical Trials. So that is the genesis of where this committee began and i will tell you about that. Will were hoping todays to hear from you and your thoughts. Questi i dont think we need to go into those technical aspects but how do you integrate research of the epidemic response . Rigo clearly this has to happen. How you create that overall governance and structure with this type of issue and the criteria . I thought it was worthwhile how do you develop new drugs and vaccines . Except that issue of safety is not as significant so first you need the science to figure out the target for the viewer responds immune response for that pathogen and now you have to findo fund t that hour and d and that is the of Stream Research fromh, public money. The process that is done in this country in particular but determined ultimately whether these things work in humans and often they have applied where you have to show safety and efficacy in part because in response to a single drug or vaccineording depending on the species it works with to animals that it is safe for humans. So to get the Regulatory Approval to start phase one which is a small study looking for safety. If you can show that it is safe you can move on to a larger study with a Larger Population as well as the indication to perform as expected that it willte produce the immune response. And if that goes well so those phase three trials are larger scale as we begin to look at the efficacy of data. Most of the candidates thatnd enter into the process that is through phase three sow one of the questions that might be asked why is it different than other things in the past . So high mortality no proven treatment experimental human infection models are not possible. Even those of developing vaccines. So an outbreak is the only opportunity for human trial. Ria. With highly safe vaccine. And to shorten the clinical course. Not yet but it is not difficult to conduct trials as their large numbers of patients in generally summer not people. So why d you need research . To figure out how to care for the patience looking at the korean with two sides and those to we are inseparable that is part ofhe the model to be a health care professional. To invest that investigational drug back seat and efficacy because those the new models in general do not reliably predict a response. W to show that is working in its base and to ruth have a future outbreak and the fed has people who are said to have to be able to retrievee them effectively with fis standard of Clinical Care with survival and reduction. So this part of a dancing general knowledge isnt what the fda says and conditions dont know how or well if there are several of them in and what part of a treatment will work . You need that information to manufacture and distribute to and rapid the as possible expand access they say Clinical Research is not necessarily for the person involved in the Clinical Trial but it is potentially available to individuals that are suffering from the disease if they show that to be beneficial so withoutt Research Done during the outbreak definitively and because of that the National Academy was asked to assessmy the trial and recommend improvements sponsors with three parts to hhs the academy created from usa and europe with three public workshops, six closed Committee Meetings and Conference Calls and incredibly expensive internal and external review process basically in that context, is thought that patient zero as day to yearold became ill towards the end of december 2013 by the middle love jerry that some of january they were recognized as an unusual and of medical officer notified the ministry of health and sent the team but only because that was a part of that without breaks in the past the diarrhea was bloody they did not identify that an until that is to be Something Different doing something and the response was immediate and they said the society tragic fever and the diagnosis was made in march. Class to lunch at the point of the outbreak that was important because at thathat po Point Crossing borders and to those contiguous countries. And they quickly recognize it was different from anything they have done with ebola and they kept sayingth this is different. And with that contained outbreak could be you easily controlled but did not agree. And as a moderate event to be supported by the Regional Office with that Global Recognition that it needs and not until o august that publest level of concern then it was declared by debbie rate to zero. And then it started to kickto kk in and then with the possibility of Clinical Trials and now six months have gone by and that has never been seen before inha the Ebola Outbreak. So ultimately 28,000 infected there was no vaccines or treatments and then to think about Clinical Trials then they came out of though woodworking you talk about eliminating there were still potential candidates. This is a time line so those three lines were the three target countries your is when the International Concern was raided by who with the outbreak is sluggish and several months i later those trials that were done were all initiated with major implications and here are the results. None were conclusive that this works. But one of the trials suggests efficacy but it will not be sufficient for the Regulatory Agency that this is okay. The initial indication that they were not to intervene to mortality and not at that point. No evidence. Although it was publicized last december when it defective. The problem with that conclusion is the most appropriate Statistical Analysis the effective rate was 65 but to be around that estimate it could be coincidental. D be not so it looked promising but they still need to go through the necessary Clinical Research. The next outbreak will not likely be as big as this one that we have to be prepared. Poi so the of Clinical Trials of september or october to get that improved and or logistics if the rate to which this happened was remarkable. Enough. Net is a key lesson. The conditions on the ground were really a chaotic and because of that if you fixeded on those people who were at risk for dying, they were sitting right in front of you why do we get involved . Pa under those ambient conditions to havede investigators there there is a whole set of issues on the study in how to organize it. They really did not recognize ebola although that the virus was in west africa. It ended is how the messaging works into engaged the community in the process some of these experimental therapies were from west africa. They seem to do pretty well. Mortality was pretty low with a magic surround searle that was given but not to the africans. With say lack of trust in with a civil conflict. Es were in to be poorly coordinatedetit to get into west trial that is the most with dad that was controlled. So that search is necessary that is to be integrated into epidemic response. How do y so that is the challenge now. So to do randomized trials that analysis of the report is clear in did is proven to do those randomized trialsprep and to participate in this research will be useful at all it will be rigorous with useful information. So planning and organizing with International Coordination and collaboration in the of process is before the next epidemic happens. You cannot do the Research Without it soco excluding them makes that separate there was little capacity that we dont want to separate the research a first World Research agency to build a beautiful study ward in a decrepit hospital where the level of Clinical Care is awful but it has to be the response. And need to be linked together. So moving toward this process with the engagement and coordination and that is critical heidi get that off the old leadership . And his team is doing a clinical intervention. And a broader picture of what was going on. And now a share of the department of Global Health is great expertise will try to raise some of those t questions to create that collaboration. Thanks for inviting me. Invin i am happy to be here. Im happy to follow up on those points with of governance and leadership aspect. With the i h. R. Is a regulation the wingback to the 1850s. In it is about setting those conditions for those epidemic diseases. And the difficulty is notve working very well. But it does happen from time to time. And not just the inability to have a side 196 countries have the capacity in and of those west african countries are in the position. But still there is a long way to go. So it does have cleared governance structure so i can call and other experts using of the emergency communities. So hopefully it will be further revised in terms ofa making it work better. City but lack of enforcement and in fact, never has there been a mandate so research has not been a part of this but it needs to be part of as epidemic response in ways to bridge those practices. How to redo this Going Forward . So with say work in progress have we do with that governments gap . Has a social construct so the issue around Health Research is that these are broad multi stakeholder networksks with those capabilities andin mandates so we need to have that governance model so we need to learn how to do that. E thin sold to highlight those takeovers those National Governments with ministries of a and often they are critical but yet not talking to each other. Obviously who has a major role. And with those most prominent with those humanitarian ngos and those other groups with dating to Research Shows pharmaceuticals and diagnostic companies they are all critical stakeholders so what we did in the report with a set of functions and principles that are around inclusivee prinl autonomous organizations so with that epidemic and planning period, but between a major crisis we need to be better prepared to bring across these stakeholders with these occasional sets an io to involve those full sets with the Community Representatives and how do you prioritize the research that needs to be done . And to identify those standard types of research. All the things that slowdown the research and the key players without rapidti response workgroup when the outbreak is with people whogi have expertise specifically with those viruses you need to bring it in those to doth that regulatory work so we propose to that to have that roster so these are the two kinds of functions that we think need to be set up as a coalition so looking at what is happening in with that agenda and the coalition and a ban of them are perfect fits the we really like the approach with the full set of stakeholders. And then to move toward Something Like that. We have and to bring in the full set of stakeholders with those capabilities. What are the key issues . So we have thought about the things. We need to have clarity to recognize and those ideologies and that each address these issues. And to have that david kaygo att so that entrenched opposition and with day favoritism with the who in the same room with these types of patterns. Bed the example i gave it is very hard for who to partner in particular but they also have difficultyil itll think it is entrenched opposition but i did think that is a barrier. With ebola you really need to have the engagement. Absolutely Community Engagement. In those processes that is legitimate it is say book of Justin Parker so now i do have questions better on the table now that things over neglected or should be addressed that includes welcome our who but this main thing to bring together Collaborative Research to save peoples lives andt there is some agreement. But what is that Research Agenda and scope . And what pathogens to include . Epidemiological so these kinds of issues and accountability and you should benefit and it should be made explicit as we develop government. L even t so to this kwh ago is claiming they have the of vested interest but ofma course, everybody does with certain ideologies and organizations for what it is evidence, the with the previous guidelines with a vested interest of that ideology and power is critical if we can implementgo that it means we can determine what gets done and recognize the agencies are a twoway accountability. Alth. And with a working principles yes with that global coordination mechanism there is a blueprint that a group of scientist at their behest that there are 39 passenger and pathogens but there are differences of buy you prior ties and there are other principles but there is a number of things of those stakeholders and how you get them to the table but cdc china this the biggest and held them for structure sold similarly to have bad infrastructure capacity to be very clumsy so a big issue hat you properly balance these . So with that delivered a of process, right now there is a default type of approach that governance is just like the International Health regulations. So high to avoid a conflict of interest so the other notion is really need to have a distributed approache ofe of those areas we dont arouly know how to do that the both of them will have issues so now even if you have the mandate to manage the research function but basically it is the full cycle out of you do research and development or other epidemic related research with that analysis thank communication and with intellectual Property Rights and access to a product as low as those that the mountain that translation with apple set of Research Functions and you want to have leadership in the idea is you should not do those things that are in conflict with those printers haitian efforts obviously that should have been done ahead of time and also it commissioned research and they were subject to ethical review. Analyzing the results so that is the trial they were devolved and involved in so i think the question and moving forward is how do you create this . This is a list of all those leadership functions the save list over here and what we should be asking is we have that capability and the right balance of accountability if you are funding and commissioning and for those who gets that to regulate that so this is Going Forward with the systematic approach in terms of capabilities so the red ones i have highlighted that are in conflict and played all of those roles. So how can we do better . Going back to the reports and we need to engage in coordination mechanism to develop those mechanisms of the Network Structure in those processes to move forward. And with that certain analysis and with that working group that you would have available with a Rapid Response for the next outbreak there is a lot we can do we are hoping their reports and the further discussion will help us move forward to be better prepared to respond to the next major threat of emerging infectious disease. Thanks very much. [applause] [inaudible conversations] were now entering that more interactive face. If youre watching the live t stream version you should use the hawks in now so now alaska ever to invited panelist to comment and this is been mentioned several times during the talk and i want to hear your reaction we share the fact we both had service in west africa so we were neighbors in that sense into developed countries and also a leading part of the Research Effort so i am wondering if you can respond . So those red squares talking about those potential conflicts that manifest during the Ebola Outbreak having who doing essentially everything. A ag for having us here today we are happy to be part of the discussion so that caveat very much speaking from my personal experience in the field of humanitarian madison so we have that internal capacity of that operati