Thanks to all of you for coming to the center for global job today for this discussion of tension the tension between i think that sound effect is appropriate when i say the tension. For the tension that might exist between the need to deliver humanitarian care when thereseh an outbreak as serious as the recent Ebola Outbreak, and the need to actually learn, learn what works to address thatre outbreak, especially in the case where the outbreak is of a disease which is emerging, for which at therapeutic does not exist and even a vaccine doesott not exist. Anin those cases the need forhe learning is really quite acute ear but how can that need for learning the accommodated when the humanitarian needs is son nd great . So our speakers today who will be addressing that point are the leaders of a team at the National Academy of science who produced a report just recently published on the topic of inflicting Clinical Trials during epidemics. Im going to turn over the podium now to the cochair ofpodn that team who is doctor gerald keusch, currently professor at a Boston University and is also managing a very important and exciting institution that is resulted been created their where one can do research on emerging and dangerous diseases. This is an institution which we desperately need in the United States and is working hard to try to bring that to fruition. He and his copresenter david peters will be talking for about 15 minutes each and then will have a Panel Discussion during which we going to welcome doctor carrie teicher, the you maintain group that actually did most of, did more health care and save more ebola lights and any other single group during the Ebola Outbreak and also Jeremy Konyndyk who was you with us at cgd and who supported the United States effort to control the ebola epidemic from his position as director of our emergency, what is it, the office of u. S. Foreign Disaster Assistance at usaid during that time. So now ill turn it over to gerry. Jerry. Thanks, mead. And my thanks as well to everybody for participating and for those of you are watching remotely. We are really grateful for your input. Im representing, and with davie as well, representing a committee that was formed at the National Academy of medicine too look at the issue of doing Clinical Research when there is an epidemic, and there were a multiplicity of issues that were present at the start of the outbreak. And so critically as mead said, especially for ebola, there was actually very little that was dont buy how to manage a patient with ebola. Just plain clinical support. And there were no therapeutics or vaccines that had gone through human Clinical Trials and shown to be both effective and safe to use. So thats sort of the genesis of where this committee began. Ill tell you a little bit about that. What david and i are hoping to do today is to hear from you, to get some of your thoughts, and particularly around two other questions. I dont think we need to delve t into the technical aspects of statistics and study design, but how do you in fact, integrate research into an epidemic response . I think we are past the time when we would say does that need to happen . P i think we now know clearly that has to happen. The question is how. And then secondly, how do you create the overall governance and Leadership Structure thatgon can address this kind of an issue, and what might be the criteria . So i thought it was worthwhile to back up just a little bit to some fundamentals of how to develop new drugs and vaccines . And the same thing could be said for diagnostic tests, except the issue of human safety is not really as significant as it is for drugs and vaccines. So first you need the site. You need to figure out whats a target for a drug, whats a target for an immune response and a host, whats a molecule and a pathogen that would beberp useful for the same thing was applied to diagnostics. And now you have to find that r d. Fund. A lot of that is funded of this upstream basic research is funded i public money. The Development Process is something thats done by industry, and particularly in this country. But you need to determine ultimately whether these things work in humans. We start with animals, and thedm fda has often applied a too animal rule where you need to show both safety and efficacy in two different species. And thats in part because response to say a single drug or a single vaccine may differ according to what species you are in. And showing your work into animals doesnt say works in humans or that is actually safe in humans. When you have several data from animal studies, you can get Regulatory Approval to start a phase one trial in humans, which is a small study, usually a dosing study, looking for safety primarily. These are not people who are at risk of the infection or might need treatment. If you can show that it is safe in a smaller study you can move onto a larger study which looks at both safety and a Larger Population as well as an indication that these perform as you expected, that a vaccine will produce an immune response that you think will be protective. And then ultimately if all of that goes well and something is licensed and introduced, as three trials are larger scale and we really begin to look at the efficacy and get much more safety data. Safety and most of the candidates that enter into the process fall off for one reason or another before you get to phase three and even the result of the phase three. So one of the questions that might be asked is, why is research during ebola different than other things that weve done in the past . Cholera, dengue. First thing is high mortality, no proven treatment, and experimental human infection models are not possible. You can do that with cholera because we can treat you if you develop the disease, and thats been done. Human models of cholera to develop vaccines. For this kind of an infection like ebola, and outbreak is the only opportunity for human trial. Op measles, as we know, has a highly safe and highly effective vaccine. H cholera we know how to treat, and antibiotics can eliminate the organism and short of the clinical course and is now ready a cheap and effective vaccine. Not yet bernanke, but its not for dengue but is nott difficult to conduct trials during baking a large embers the patient all the time and dengue is typically not a lethal and disease. So a bowl and diseases like it stand out as different. Out is. Why do you need to do research during an Ebola Outbreak . The first of Clinical Data to learn how to best care for infected patients. Im a physician. I look at what we do is appoint with two sides. One side is taking care of people. The other side is learning how to do a better than those to me are inseparable. Constant learning is part of the model of being in the health care profession. Drug vaccine for safety and advocacy in humans because animal models in general do not reliably predict the human response. So you actually have to go to the human trials to show that it works and its safe. If you had good vaccines you would be able to use them to enhance the Public Health approach and use it to prevent future outbreak and when it fails to prevent an outbreak and you have people that are sick, you need to be able to treat them and treat them effectively and the addition of drugs to the higher standard of Clinical Care in maybe a significant improvement in survival and reduction and consequences. So this part of advancing medical knowledge in general and patient care and this is what the fda says about Clinical Trials and why they are needed, clinicians dont know if and how well new approach will work on people, if there are several, which of them are better, are there subpopulations in which one or another the treatment will work and whats the context, whats the setting. You need that kind of information before you can approve and license something and manufacture it and distribute and use it. And to rapidly as possible approaches. We say that Clinical Research is not necessarily for the person thats involved in that clinical trial, its certainly for the future. It is potentially available to individuals who are themselves suffering from the disease if the progress can be made and shown to be beneficial. So sum up Clinical Research that was done during outbreak, wewe learned very little definitively and because of that, the National Academies were asked to assess the trials and recommend improvements during future emergencies, sponsors with three parts of the department of health and Human Services from the assistant secretary for preparedness and response, fda and infectious disease, thehe academy created 16member from the u. S. To europe and africa, we had three public workshops. We had sixclosed committeeor meetings, very comprehensive literature, review, conferenceli calls, email exchange and incredibly external and internal review process before the report was issued. Basically the context of the outbreak was actually its thought that patient zero was a 2yearold in ginny, in rural ginny who became ill in December December 2013 by the middle of january the trail of cases frome that child to to relatives and some of the Health Care Providers resulting in similar kind of death was recognized aso unusual. Unusual something and the medical officer out in the boonies in ginny notified the administry of health and they came to the conclusion that it was coolor. That shouldnt have been on their mid because the stool is bloody. They did not identify it and it wasnt until the latter party, we are worried this may be Something Different and they asked nsf which was doing work in the country to come and take a look, nsfs response was immediate and strong and they said, this looks like a fever, sent it to france and diagnosis was made in the middle of march. Last two months from the point at which an outbreak was identified and that was really important because at that point already it had crossed the borders into continuous countries. Mff now came in and built an enterprise to take care of patients and they quickly recognized that this was out off control, it was different from anything they had ever done with ebola and they kept saying, thim is different, this is different. At least influenced by past experience with ebola which is smaller contained outbreaks that are relatively easily controlled. It did not recognize, did not agree with nsf. They declared this as a moderate event in their language it is level two which can be supported by the Country Office andice an regional supervision, it didnt get the Global Recognition that it need and it wasnt until august that the highest level of concerns, Public Health emergency of International Concern was declared by who, nol the International Response started again and only then was the possibility of doing Clinical Trials and now six months had gone by and the thousand effective people which had never been seen before in Ebola Outbreak. So ultimately there were over28,000 infected, over 11,000 died. At the beginning no approved vaccines or treatments and then in august or september of 2014 when you started thinking about Clinical Trials, things start today come out of the woodwork, 20 potential candidates that could have been studied. This is the timeline of the outbreak in terms of cases, and so the three lines here are the three country, target countries, here is the middle of march, ebola is declared, here is when this International Concern was raised by w. H. O. And now the response and outbreak start to kick in. Its sluggish and its several months later before the outbreak start to come down. The trials that were done, this is a their therapeutic trial and there were a few cases and that had major implications for the results that we were gaining and here are the results, there were five therapeutic trials none conclusive that would work and safe. One of the trials suggest efficacy but not going to be sufficient for convincing a Regulatory Agency that this isia okay and [inaudible] so the initial indication was that the therapeutics were not contribute to go contributing to more mortality, but not at that point. No evidence, not from the nature of the data. From the vaccine trial, one candidate had a protective effect although it got publicized last december as 100 effective. The problem with that conclusioh from our point of view is the most appropriate statistical analysis, 60 efficacy but the confidence around that estimate span zero. So it could be coincidental and looks like its effective. It looks like it could be not effective. One promising therapeutic and one vaccine but they still need to go through Clinical Research which in ebola will be the next outbreak. Next outbreak is unlikely to be as big as this one which means that we really have to be prepared to move in as quicklyan as possible. So the Clinical Trials that were implemented here sort in january, you go from say, september, october when they start to think about doing something, getting it approved, getting logistics, it was remarkable, unprecedented andra not fast enough. And so thats the key lesson. Is that we have to be event more effective and efficient andgot faster. The conditions on the ground and carrie may talk about this were really chaotic and because of that, if you focused on the people that were sick and dying and their families who were at risk, that was sitting right in front of you as something of importance, why are we going to get involved in trying to do research, particularly because you had to deal with patients and protective equipment under ambient conditions that made it very difficult to provide health care and let alone having investigators there collecting the data. Theres no consensus on what the study or how to organize it. Very limited experience with ebola. They didnt really have recognized ebola, although it turns out from the virus was, in fact, in west africa. It may have been impuring and unrecognized and unrecognized is unknown. There were real big mistakes in how the messaging was done, there was a failure to engageen community and process and some of the experimental therapies were used to expatriots that were from africa. T they seemed to do pretty well, mortality was very low andpr suddenly there was this magic medicine, magic certify uim serum that was given to foreigners and not africans. And Research Groups themselves were poorly coordinated and competitive to get their product into a trial. It was no mechanism to triage which are the most important things to do and how to do it and that was particularly true with the cases dwindled. Search is necessary and best way to ensure that it can be done under these kinds of circumstances is integrate it into epidemic response. We think these can be organizedo to work together, the question is how do you do that. Thats the challenge now. Questions were raised about the ethics of doing randomized trials, the analysis of the report is clear. It is both ethical and it proves to be feasible to the randomized trial, what you need to do is prepare the community to engagement to be able to participate. And if the research is going to be useful at all, it has to be scientific rigorous and designed in a way that would produce useful information. This kind of plans and organizing begins an outbreak occurs right now and requires international and National Coordination and collaboration and across everything, local Community Participation in the process is actually essential, not only during the epidemic but before the next one happened. [inaudible] happens. You cant do the research about it, but it also the community as a part of the effort, so excluding them makes to delete a separate increase adverse conditions trying to do it. The various capacity to do Clinical Research, but the key message to the key part of our message was pseudowant to separate the Research Establishment and agency going into liberia and building a beautiful award in a decrepit hospital where the level of Clinical Care is awful. It has to be across the spec to a Public Health and respond in the Clinical Research. These need to be linked together. Investment is needed now to start moving towards this kind of prepared processes and engage in coordination among the research and Development Agencies to cover the whole broad agenda is critical and how do you get the optimal leadership to do this . It may be different with Clinical Research then if youre trying to do a rapid clinical intervention. So that is the setup of my remarks for this broader picture of what was going on, what it means and why its necessary. Now if not quite apparent. David is that hopkins and is the chair of the department of International Health really has great expertise on these issues. Hes going to raise some of the questions about how we go forward, how we create the collaboration and leadership. Thanks for inviting me. Im very happy to be here. The point on the governance and leadership aspects of leadership. The ihr, this is a legacy that we have the legal regulations go back to the 1860s and revised from time to time of International Protection in response to epidemics for purposes of Public Health and trade in the difficulty they have not working very well. Its funny when there is no major outbreaks are the problem is that happens from time to time. What we saw and the failure of the ihr was basically not just the inability to have a surveillance in rapid response, but really the whole preparation side of things. Who was passed with preparing countries. Countries are obligated by legal agreement. 196 companies have signed up to have the capacity. They were supposed to be in places in 2012 and not the west african countries are in that position could liberia is the first one to do an assessment in 2017 and still has a long way to go. Currently, this is a problem with capabilities. At does have clear governance structure is led by who. Its really government to government you can call another expert and organizations using the roster of expert and Emergency Review Committee who last revised in 2005 after the start of the epidemic. It will be further revised in the area where we put a lot of emphasis in terms of making it work there. It doesnt work in large part not just because of capacity nationally, but lots of enforcement for public accountability and in fact never has there been a mandate and govern it structures. And what we see is this growing consensus that it needs to be part of the epidemic response and we need to find ways to bridge practice into the effort of epidemics. How do we do this Going Forward . This is really what i want to talk about in terms of this work in progress really. How do we fill the governance gap with leadership putting research into epidemics. Obviously a social construct highlighted in terms of need the institutions and the epidemic responses that these are really broad Multistakeholder Networks that have very different interests capabilities in mandate in very different asymmetric levels of power. We really need to have a governance model that recognizes and addresses these types of concerns. We need to learn how to do that. One thing the report said is highlight a broad set of stakeholders involved in the response. National governments, but many different agencies. Not just tall foreign affairs, but the Regulatory Agency in research and Public Health agencies are critical enough of not talking to each other and why you might have different designs and move on in terms of research. Obviously, who has a major role in humanitarian organizations certainly at the frontlines have played a Critical Role in the most prominent but others as well over 70 different humanitarian ngos were involved in the outbreak anonymously other groups related to research, professional associations and industry. Pharmaceutical and diagnostic and Civil Society. All of these are critical stakeholders. So what we did in the report was proposed that type of government structure for basically a set of functions and print a to be adhered to. The principles are not inclusive autonomous and independent organizations and the college during the interepidemic planning. So its an epidemic going on. Between major crises, we need to be better prepared. What is needed is really bringing together all of these types of stakeholders and not just the government to government occasional sets of select an involvement that because im typically that involving the full sets including the Community Representatives dealing with industry academia organizations. The purpose of this group is really to do things like how you prioritize the research that needs to be done, doing the research is being able to identify research designs, being able to identify standard agreements, all the things that slow down research when you have to respond quickly and identify the key players who can be there and be called upon for this next group in particular, the rapid response, and our three w. The idea is when an outbreak is emerging, but you have people who have expertise in those viruses. You need that kind of expertise. You need to bring in those who can do the regulatory work, the design and we propose that you need to have this kind of Group Brought on a need to have the operating procedures that had. These are the two kinds of functions and sets of organizations that need to be set up with coalition and we look at, what the Global Health security doesnt want the Organization Called coalition for epidemic preparedness and innovation does. There were huge problems with all of them in terms of capacity. We like the approach and the full set of stakeholders around International Coalition stakeholders. We dont have the perfect model right now. We have to move toward something that brings in the full set of stakeholders. We have to think of the key issues in terms of establishing the governance arrangement. What weve done to think about a working group in one of the things involved. And recognize their differences and commonalities of stakeholders. Look at the ideologies, power and accountability in how you set up governing that addresses these issues. One of the things about Global Health architecture as you have really unruly characters have a go at it with that bit of naivete or sort of this entrenched opposition to certain groups were sort of a favoritism. Certain academics or select. These kinds of patterns we need to get over. Its very hard for who to work with industry in particular. Its difficult for them to do that. They also have difficulty and how you bring in Civil Society organizations. I dont think its entrenched opposition. I think its lack of understanding of how to do it very well. One of the big lessons of the Ebola Outbreak is you really need Civil Society is a huge part of the outbreak response. That is a whole talk in itself. Not just principles of processes. Inclusiveness, authority and accountability. These are not new concepts and theres a really good book by Justin Parker these are things we should look at. Things that are going to be addressed. They seem that way, but they are things neglected or should be addressed. Right now a group of interested parties brought together there is bringing together collaborative Coordinator Research during crises. So that is great. There is some agreement around availability. What is the research agenda, which the passage includes Antimicrobial Resistance . Does it include Epidemiologic Research that you need during an outbreak . These issues around Capacity Building, when accountability is you and the sharing of an asset of who should benefit from this. This is all made explicit as we develop government similarly, the issue of interest ideology power. There are still even to this day who claiming the urbanization of vested interests. Maybe there are enough commercial interests, but they certainly are dependent on governance and foundations. Certain ideologies and organizations have their own beliefs about what is evident, intellectual property, but there is also a commitment to previous guidelines and things you have done whether its clinical guidelines or programs with a vested interest in these things in ideologies. The issue of powers critical. Whos going to pay for what goes on in whos going to implement it . That may ultimately determine whats done. Recognizing different agencies. This is a serious area of inquiry that is not to systematically address for this issue in many issues in Global Health. Working principles, yes, the group has put together global coordination mechanism with some good work in terms of some of these mechanisms. A group of scientists how to prioritize. This is not the only list. There is a list that has anything 39 pathogens that have potential to do this. There is a huge overlap, but if the differences in terms of how you poorer thais a political issue as well. Other principles theyve got in terms of using evidence and accountability, but a number of things arent there was stakeholders beyond government and Scientific Community and how do you get them to the table. Who gets to choose whos involved or not its edc china is going to be the biggest investor of Public Health infrastructure and if you dont have it at the table, you have to wonder if youre really having a Global Governance framework. Usaid has roles in terms of infrastructure Capacity Building universities in Civil Society are very clumsy in terms of how this is being done. One university is involved. So a big issue about how you have the conflict of interest and how do you properly balance. Related to the deliberative process, there is a default type of approach to governance for research should be under Single Agency by who just like the National Health regulation. So while the functions you need we will talk about that. The second is how do you avoid conflicts of interest in research because thats a big deal in research. The other notion is governance arrangements really needs to have a distributive approach because of the wide set of leadership in different areas and the need to balance accountability. We dont really know how to do that or we have to get her way around it. Others will have issues around these questions of legitimacy. Even if you have the mandate, theres a question of do you have the capabilities . This is a set of Research Functions from the report but basically the full cycle of Research Functions from how you do research and Development Prioritization of the presiding officer the senate will come to order. The clerk will read a communication to the senate. The clerk washington, d. C. , august 15, 2017. To the senate under the provisions of rule 1, paragraph 3, of the standing rules of the senate, i hereby appoint the honorable john neely kennedy, a senator from the state of louisiana, to perform the duties of the chair. Signed orrin g. Hatch, president pro tempore. The presiding officer under the previous order, the Senate Stands adjourned until 10 00 a. M. On friday, august 18, 10 00 a. M. On friday, august 18, we are now in this watching the live stream version of this should know that you can submit questions via twitter and you should use i am now going to ask panelists and jeremy to comment, we will start with carrie. It has been mentioned several times during the talk and in particular i want to hear your reactions. You and i share the factories serve in the peace corps. So we were neighbors and not then. I know your experience in developing countries and crisis situations and gives you a unique insight here. Im wondering if you can respond. One particular thing im hoping youll speak to a little bit is this red squares that david presented the became apparent, manifest during the Ebola OutbreakCommittee Organization structure. Great. Thank you for having us here today. We always are happy to be part of the discussion, especially when it comes to the experience weve had. Also the caveat im speaking from the experience and very much speaking my personal experience as a medical epidemiologist, in the field in which they work. We internally has the capacity to conduct Operational Research epidemiology and humanitarian contacts and ways had this experience for three decades. There is the capacity to do this, but at the very base of the, we are humanitarian Aid Organization, so we thank and applaud the idea of continuing research. We also have care and treatment has to be there as well and that is not for us to kind of start. We think you can have a Clinical Research agenda around therapeutic vaccine diagnostics and we applaud that effort, but also around Public Health and Clinical Care because delivering the care be a select and data physically by writing or trying to treat a patient on the ground needs to be looked into as well. Building on that, wed also like to state which was stated earlier come in the next epidemic is now. There is a lot about the scale that we saw in the ebola 2014, 2015 the. Today, but in 2017. Last year in nigeria and again this year there was ebola, so for us as a medical humanitarian Aid Organization would like to point out an on the ground the reality the next epidemic is here. Also reflect being is the scope of the 2014, 2015 epidemic was unique and we should be cautious or at least recognize extrapolating that experience and all events for which to engage in which is a little bit in terms of the need for flexibility. We also know for a earlier presentation we definitely had the who that is well known, but we would also like to reaffirm the legitimacy of who and include a blueprint is a step in the right. It reaffirms the rule and value in this process and the need to continue to fund them. Circulating back again, we are a medical humanitarian Aid Organization. If hypothesis testing in center field, we ensure its better. We are not sure why they are having most questions in that context makes sense. That gives us our example more recently of the nonthermal stabilized vaccine in which it has to be kept hidden, which even putting aside the very large regulatory issues about what we were able to use, we couldnt use it this past year, even if we were able to from a regulatory standpoint because you cant get something [inaudible] nonthermal stabilized vaccines where you work. It needs to be appropriate as well. We look at the report not only the key messages we think should be amplified. We would like to have flexibility. Phase three trials are difficult to forecast. We think about it in terms of vaccine trials in different protocols in the known data with the photo call in the report might have been more constraining than liberating for fast track of that time. However, protocols and ethical guidelines for Clinical Trials and from this experience its very clear he cant do that during the epidemic. I next accessibility we need to ensure the technology be at vaccine therapeutics are affordable, appropriate and available here. Its kind of our key while moving forward. Evolving effective communities as well as to when you think about the role of both national and local government as well as local communities, not only been part of the discussion and defining research priorities. The argument the epidemiological shift happened because of changes in behavior cracked this is and was largely driven by the community is something we should ignore. I wrote the number down here. There are 1400 staff working in our Ebola Treatment Centers and a bowler response. Over 4300 staff our staff are part of the community and we are part of the community. Whereas it has really been close to home and are involved in the conversation. You really spoke to the key issues they are. Lets go to jeremy now. Jeremy had the responsibility of directing a large part of the United States response to the ebola epidemic and position at the usaid and as i understand it was responsible for a large portion of all the financing of the external response and also the support and i would say jeremy also attempted to orchestrate and coordinate a lot of the american response is then perhaps even some of the coordination between the u. S. A. Chance and those people who are working france and other countries. Trying to deal with how to have the humanitarian support. The need to do research at the same time the humanitarian services were supported. Hopefully you can speak to how hard that was for you and if it had been available in 2013. Banks, mead theater when the office for foreign investor into the out rake in partnership with cdc i am not a doctor. Im not a scientist. I have the humanitarian field operation. I also now serve on the Oversight Panel that who established after the Ebola Outbreak to supervise the implementation of their postebola reform and management of some of those new structures. I also see that from that vantage point. This is an extremely important issue because we are very fortunate in an odd way that we have the tools at the outset of the outbreak we needed to contain, but it was a very close call. We came close to seeing the outbreak even more completely out of control to where its hard to imagine how it ever could have been contained without doing dramatically more damage than it did. So we didnt in the end need these Research Projects that did emerge to contain the outbreak, but we could have been its easy to imagine and i think we have to expect that sometime in the next 50 years we will see him out rake in the world cup and may be much sooner than now for the tools available to us at the outset will not contain it and we will need to realtime medical innovation to deploy in order to defeat the pathogen. This is a very important and very pertinent issue. One of the big challenges in any Emergency Response certainly in some future academic responses in the report is interesting to see the points of convergence around what this report identifies a new Realtime Research effort. We are seeing overall Response Rate lurch. Everyone, the researchers, operators, they are all jockeying and this seems day. Everyones got a finite end with. If you need to report talking about the importance of figuring out the legal and ethical parameters with the host government and host authorities. They are also charged with a million other things. This radar screen is going to have to jockey for states. This was a real issue because nih wanted to send and Research Teams and usaid have missed rons team on the ground. Just one very basic example of how this would play out, to manage all of these different visitors and it could be difficult for the ambassador was sometimes a little bit skeptical of why we need another u. S. Initiative showing up to do something they will do medical research and how important is that. These are some of the realities that this kind of a report is important and highlighting to an investor. They give clearance to the nih teams to do research. One problem we had at the outset of the Ebola Outbreak was the Public Health specialists, medical specialists and humanitarian specialists really didnt have much of a common language or a common operating platform. Inherent to the nature of the organization, the u. S. Government didnt have that in more broadly, most of the humanitarian field did not have that. That is one of the important aspects of what they are proposing here was this idea that begins to establish the touch points, the connective tissue between the emergency op raters and Public Health specialists and scientists so that when it is go time, their relationships that need to be placed are in place. And theres things that will be mapped closer together. There were problems in the early days of the response with just massive confusion about what the disease was and how to you protect yourself and what do you do, getting clear and consistent messaging and trusted authority thats transmitting messages its very important. Interesting differences across theth countries in the level of communityun awareness and the level of the types of Community Behavior you saw and some of that has to do how effective the government was and we saw interestingly much better take on some of the key messages and we saw and that had to do in part with the populations trust of the governments and the populations trust of which avenues were being engaged. So dropping another element and that needs to be handled. Dropping like a research element. You want to really just hammer on these core messages, how you prevent this from spreading in your community, how do you protect yourself, part of the part of the core messaging is if you are the only way to protect yourself, the only way to protect you and your community, the best way the get people to be isolated. And you know talking about the treatment and research is unknown in that, right. We are going to treat some of you, how do you map the explanation of rcp process into that, into that Core Community mobilization . I think its essentially pretty delicate. Would you say its impossible . I dont know ifha its impossible. Its proven to be possible, there yout. Go. Again, my point is it needs to be mastered because if done separately its going to break also struck in the report by patient data and the difficulties of patient data and that was aul huge problem for us in outburst and response. The data was terrible, people could be counted, one time in the case when they were first identified in the community, they could be counted a second time when they were admitted to the clinic and a third time they were transferred too another clinic or a third time when they were if they passed away. You could have one case because of, initially impossible to track people consistently across different sensors and avenues. That made the numbers very difficult. The response like this that moves so quickly and fluidly, you need to have good realtime information so that you knowl hw to orient respond resources appropriately. We didnt have that. You need that as well, youre projecting out what this disease might do based on what its doing now. Its interesting how it manifests in this issue. The challenge is how do you get a good Data Management in lowtech, complicated logistics and unreliable power services. I think theres some theres fascinating work thats been done with biometrics and other humanitarian contacts, using biometric for refugees, arrivals, for example, selfcontained way that may have some applicability here. Whether or not thats a solution, this is an area that we need progress because it was such a handicap in the early dais of the response and it wasnt until hon went out and took a few, volunteered him a few military personnel to do data entry and he and those soldiers and several lie brotherrian countersparse scrubbed the data and thats when we got accurate picture of what this outbreak actually looks like. In response to these, thats comments. I think we are in general agreements to the pointsts that arere made. The issue for us now as i said, lets go from words and thinking to taking some action. The time is now. There are outbreaks and epidemics going on. This is the time where you can actually have these kinds of conversations. Yeah, i dont have much to add except that we are in agreement in basic principle and what theut next steps are and i think you highlighted also the importance of what is the Research Agendas and its really downstream access but some of the other epidemic related research that needs to be done thats kept behind. I think its an opportune time to address the issues. I want to emphasize on something that jeremy said that resinates with me with long experience with hiv aids response. One of the Biggest Challenges in managing hiv aids response which is, of course, on a different time frame, years and decades rather than weeks like o ebola, one of the biggest problems the same patient gets counted multiple times and gets missed when they change from one treatment to g another. When they are recognized hiv positive, we dont have as good information as we would like with respect to patients are successfully making it through the entire treatment cascade and so this issue of a patient identifier strikes me as a common theme with this. Im wondering if carrie and jerry would agree that as part of the technical fix that can be prepared now as we prepare for the next epidemic that strengthening patient identifier system in country is a fundamental step in order to prepare for the next outbreak. So, jerry, how do you feel about that . Thats basic Public Health and health system. I think its absolutely essential. Carrie, how do you feel about it . I think the answer for us is, yes, except i think that a little bit on the biometrics identification as aon humanitarn aide organization we kind of step away a little bit and by a little bit i mean a lot. Do you agree that it would help with your humanitarian tracking of patients but youre word about some of the ethical implications . Exactly. Ethical implications could be effectively addressed then you would feel more comfortable in. Exactly. Mitigate that end of it. Which is why you need engagement of community and community leaders. Yeah, absolutely. Okay, im not sure exactly how much time we have, but lets start to take questions from audience and roxanne if you have questions on twitter, please let us know. The lady in the front. Im an anthropologist promote today practitioner. I did my agree in department of International Johns hopkins before it went the social awareness revolution and became the school and im excited to hear the importance of communities, social awareness, et cetera, et cetera, theres one more that i did not hear mention by anyone in this fascinating and very thoughtful presentation and that is they role of the anthropologists and i would say the anthropologists are the capital a because that would be a key role in the area of prevention, a key role in the area of stakeholder investment, a key role in mediation between the actors and between the researchers and the community to make the research possible. So i would hope to see at some point that the anthropologists welcomes a key player in this process. Okay, lets collect two more questions and then turn it over to the panel. Twoo more questions. Can we get two more questions . If not the the anthropology question will bequ featured. Im curious myself. We have one more . Okay, yeah. S the decline and the proper acting at some of the and Age Department six of that. Do you think there will be an appetite for this kind of work you are proposing . Good question. Please introduce yourself. I used to be with the world make and im interested in these fields. I used to sit on several bodies of research coalitions, Global Research coalitions and thats what you proposed for this very ambitious program. You may be could you may become it on some of the Lessons Learned from this kind of research coalitions, its not for the first time, right . I would be interested. Y skepticism . You can hear the tone of my voice, right . The role of anthropologist i would be curious. Ouno none of you nor did i mention that word. The funding possibility Going Forward and some skepticism about davids very, very ambitious plans for international collaboration. The anthropologist i think as a Critical Role to play. During critica the outbreak theo anthropologist platform proved to be very useful and as aar leading part of what, part ofngg the Community Engagement. I would say having that standing anthropology platform and its t not just anthropologist. Theres sociologist involved ina the whole social science aspecta as part of it. It. I would say thats one of the ques questions in terms of thehe broader what is the research t agenda because there are huge questions on thehe applied research that it plays as wellat as the actual programming. Its s its not just recoup a research. Its actually an important part of the Community Engagement approaches. Rapid anthropological approaches to assessment engagements arege over critical to response and thats what liberia did early on. I would say its also important inou imp terms of their some gre working on the anthropologyac accountability space as well. Nd some of that research and particularly in terms of looking at some accountability, mappinga and accountability ecosystems that would help us as we move m forward as well as organizational and individual se its crossing disciplines. The t some of the same types of methods and tools would be useful both at the global levela for the global mechanism as wela as the practice and research around the response. Just quickly to auk. Qui he was formerly my boss. Why dont we take that sure. I want to make one point i thina you wanted to chime in as well. N as you can imagine to these kini of Clinical Trials on therapeutics and vaccines, theex expertise was coming from outside of west africa and its highlevel researcheves organizations. It was interesting that at thehe beginning they really hadntnt heard about social mobilizationn and Community Engagement and why you really needed to make thosec connections. That egan once that started to happen, things began to move. E a, i and, in fact, we said in the course of the presentation that, in fact, randomized control trials could be done, but onlynl when the community was engagedhe and understood what the rationaleale was. This connection is as intimate as could be, and has to be done better. Would you say that a key requirement is the community understand the depth of the mic immigrants in medical community that what reallyou works . Theres lots of therapeutic misconceptions. No, im not saying theot s community itself had misconceptions. Im saying that icoity would td that for the community toonpt endorse the concept of an rcdouv they would have to be convinced that theres no cure. Ur currently there is no cure and o if they understand that, that you are trying, the best people in the world dont know how to t fix this, that might be sort ofr the first step. You want to talk about the messaging . Go ahead. I think thats rather important. I think it would be difficult to assume that because what wesw found was a lot of the earlyinad messaging that did not work with round ebola kills and there is no. Rig right. Develop alop snsense of hopele, and that undermined both the response and the research. I would say its really, reallyd understanding some of the constraints of that is thehe approach. That was when the issues thas led families to hide the patients which led to more transmission. That was a very telling moment we had at one of our open meet meetings in monrovia, and one of the senior clerics in liberia who got engaged in this sort ofn late in the fall of 2014 whend m they discovered Community Engagement, social mobilization. So he said that, in addressing his congregation and talking about safe burial, verytrit traditional religion, handson, the touching, all of the thingse that exposed people, he said you know, when christ talked about the length on the fancy did essentially mean skin to skin. A you can lay on hands at a safena distance. And suddenly the acceptance of the safer burial practices turned around, and its both kinds of insights and messages d that need to be there for the we very beginning. When the call for what is quote interepidemic period, its the time to get that conversation going. Some of the lead researchers in this field said wed never hearr about social mobilization, do mo concept to us. Ake hows the time to make that connection happen. Its fair to say ive never heard accountability system ot those two words pronounced together before today. Ay. Gary . I didnt mention, but msf contacted a lot of operation ono applied research during themic,h epidemic both from beginning when we heard deafening silencef from our colleagues and national of international across the board of not therapeutic you but when were in the field and when others joined us, including most certainly with anthropologistsol who helped deliver some of ouraf Key Committee messaging and ther Core Research in which enabled us to get patientse to treatmen. I think the role and importance of anthropology isis really what you recognize now out of this. Ants. In time you were social mobilization, communityia engagement, you are talkinga about a role for exactly that function in the reinforcement and the importance of that and i know that amongst the reforms that w. H. O. Is now carrying outi theres also building more of that capability into the w. H. O. W Emergency Response section. Just quickly on the funding. Di it remains to be seen yet whatlh will actually happen. There have been cuts that have n been proposed by the white houst that are incredibly irresponsible and would be incrediblypo damaging. Im not a u. S. Government employee so i can say that. Though i mean really deeply irresponsible. What is encouraging is those cuts have not gotten a lot offtr attraction in congress and, of course, congress that willhbudg ultimately write the budget. So i think there is some recenta will help to hold out that some of the more damaging things that been proposed will not make it to the congressional it appropriations t process. Ap its hard to have a level ofe confidence in congress taste onc past pe erformance, but i think there had been some strong signals, in fact, when the president s budget proposed redn reducing nih this fiscal year, hir the remainder of this fiscat year by a billion dollars, congress increased it by2 billio 2 billion. That increase in 2 billion isstp the set point if theres a a fontinuing resolution for nextn yearr , the budget is now 2 billion more than it was a a little while ago. So one of the things that we are trying to do as a committee, we are getting d ionto politics, bi raising issues and in constituencies and in the public to respond to an challenge u. S. Government policies that are being proposed and sometimes implement it. Ai we need to raise the alarm. We need to get the Larger Community in agreement that our health is tied to help the people elsewhere, and that Global Health is relevant to us. And thats part of what were trying to do in disseminating the issues around this reportthe and activities the National Academies can do. Its n its not an implementing organization. Its not going to be in the field with you and in takingitn caotre of g patients, but it hae some substance, and trying toeta get that out there and this slice of the response agenda is part and parcel of what were tt trying to get. And the cost benefit on thate spending is so incredibly compelling. He goes if you look again at ebola, by having a slow response that didnt have much in the way of therapeutic tools or vaccinec tools ready, the u. S. Government had to t spend 5 billion to prepare for and respond to both, prepare on the homefront andefro respond in west africa to this crisis. Th that is an awful lot of money. T and that is a very small amount of money compared to what it would be, what the nation would have to stand in the case of aea truly deadly pandemic thatly w probably will emerge at somee so point. So this sort of researchompaso spending pales in comparison to what we would have to spin and a crisis scenario and helps to avert those crisis. You said in the report said singly, pay or pay a lot more later. The pay a lot more later is nots just the treasurers money but its death and morbidity and economic consequences that have huge implications. I wanted to respond to aukss point as well about the researcu consortium or coalition. I dont see this as a researchrh co consortia. This is something thatsnser different. This is about an integration ofo response and research, and thatp is a different set of players. S to we havent done this before, nol at the global level. And so what makes aat m a collaboration, network work . Sam is the same set of principles around how do you add value and looking at commonality of goals and a kind of things we talked about in terms of recognizing different interests and matching accountabilities. Once you start losing that you lose the legitimacy can you lose the trust, you lose the abilityl to add value. I think thats what were trying to be more explicit about what other things he really have toet take care of, understand andde going with your eyes open rather than just saying you know, it ta will take care of itself, ornita that unit industry do somethingw then we will combat on the other side with government. We really need a new type of approach and i think we go into it with our eyes open and looking for that, looking for the data around how do we add value your. Let me on this last point, you know, with w. H. O. Monadic system, with the Single Institution responsible for thee entire chain of functions identified so clearly, we atsno least know who screwed up. Right . Now, with respect to therespt to proposal is your accountability ecosystem may not allow us to even know that. No so im wondering, i guess it would allow us to know that ifti the accountability part really works, right . Rks. It looks to me as if whate psi theyre proposing is a more inclusive system, one which involves multiple entities in aa more peertopeer network sort of arrangement, but in peertopeer networks in Information Technology to ourorn accountability systems that olde each peer accountable. Im wondering what you have in mind, how actually would you have a Network System withisaacq accountability, right . I think its a question ofli balancing and making it explicit. I dontthem think that the probp with having a single hierarchy h is that we havent invested dont have the capabilities to have both the capacity and too both th deal with the complex because there are conflicts that you dow not want the funder, the commission being the one telling you what the results are. Huy and doing the ethical clearancee its just not, you get confusede messages and you get the wrongu messages. Outside. And you get suspicion. Exactly so you lose that trust. Im not talking about sort of tn just the loose market with noo restrictions on it. There needs to be realco accountabilities for whos actually going to invest inro developing the new product. St whos going to assure against the financial loss, fin howan ds make sure do you track what to y happens to the profits, who theh actually gets access to the new vaccines and drugs. Can you can use to a lot ofen transparency. It doesnt happen on its own so i think you do needit dwn and tf you have those set of functionst i would do it around it a responsibility for functions. You can still have w. H. O. And should still have w. H. O. Leading the International Call to armsll and the response and activating the network in terms of the epidemic response. I think thatt thats clear and w have a new invested enough in making thatug work. But i think just by the way, in the International Health regulations or is a responsiblel for National Governments to do a lot and theygo a failed terribl. So its not like there is ever s single responsibility its just that we needed a more creative e and inclusive in terms of how we bring us together. And what we apply and actually bouncing independence. What we have lacked. By putting it all in one bowl,bg the same agent is the soccer r player, the referee, the person in the stands and the commissioner and the ball. And the ball. Bal its a boring game and iting ga. Doesnt work very well in terms of its how much is the ball . So i think unfortunately its time to wraps up. I want to thank all of our participants, all four of you for coming in. C we are glad to be able to helpp th in the dissemination of this im important National Academies report, and we hope that actually pandemic preparedness is going to be a continuing priority for the international ealth community and for this administration here in washington, d. C. We think this report is, points out some of the reasons why wehe need to prepare now, not wait for the next ebola epidemic, and also gives us some pathways, directions in which we can movec and we need to do that fast. Do so thanks to all of you