 And now without further ado, I'm going to hand it over to a very close friend and mentor, Elias Serhouni, who's going to lead a discussion with the current director of the NIH, Francis Collins and former FDA commissioner, Peggy Hamburg. And before I hand it over to Elias, I'll introduce you. Elias is one of the most multi-dimensional leaders that exists in our industry, having assumed top leadership positions in academia, government and industry. Elias was the executive vice dean at Johns Hopkins. I said that correctly. Elias, you have funny stories about that pronunciation I know. Elias was the director of the NIH under George Bush and Elias was an R&D head at Sanofi Pharmaceuticals for almost a decade. And Elias, if you read through all of your, the Wikipedia sites and all of the online sites, your CV, there's one thing that doesn't show up and that's the mentorship and the teaching that you provided to so many of us. And I was the great beneficiary of your mentorship for several years. And I say that for two reasons. One is to thank you for everything that you did for me and for the many individuals for whom you mentored. And secondly, I'll harken back to the first fireside chat that we have between Albert Borla and Stelius Papadopoulos, in which Albert acknowledged Stelius as one of his mentors and mentioned that Stelius cooks dinner for him all the time. So I'll leave that up in the air, what I'm getting at. Without further ado, Elias, I'll hand it over to you. Well, thank you, Andy, for your kind introduction. Actually, I'm getting better and better at cooking since I have more. And my wife doesn't want to cook anymore as much as she did before. So next time I'll treat you all with my own cooking. But let me first thank Peggy and Francis for agreeing to share your experience and views here at the US India Chamber of Commerce Forum. The session will essentially be about lessons you learn during this pandemic, the challenges remaining ahead and the recommendations for the future that you would espouse to be better prepared and avoid the high tribute will all pay to COVID-19 both from the US point of view as well as the international point of view and more recently the India point of view. And so I would like to start with Peggy, if you allow me. Peggy, you've been a public health leader. You've been, as you know, as I remember leading public health in New York, in Washington and also you've been the commissioner of the FDA. I know you've been involved to a great extent during the response. But my question is this, is that the regulatory systems of the world have been challenged by this pandemic, not just for vaccines, but for diagnostics, for therapeutics. And as you observe the approach of the FDA and other regulatory agencies, what did you learn? What struck you as either very different, uniquely creative or things that need improvement during the pandemic response? Peggy. Well, thank you, Elias. And let me add my thanks to you for your leadership and mentorship over many years as well. You've been an extraordinary role model for so many. I think that there were lessons learned and also understandings that were very solidly confirmed as we dealt with the unfolding COVID pandemic and as we continue to struggle to find our way through this. Certainly one of the crucial lessons learned is the importance of partnership and transcending boundaries, whether it's boundaries of discipline or sectors or of countries. And the fact that we have to work together to really think through from start to finish, how best to frame R&D efforts and regulatory oversight in an urgent and pressing crisis of this kind. I think obviously the vaccine development issues have become a much remarked upon scientific accomplishment and it really does reflect the fact that we, at the very beginning, had the players at the table, both the companies, government scientists and funders and regulators thinking about what were the critical questions that had to be asked and answered and how could we be more flexible in our approach to doing studies and developing the necessary data to maintain regulatory decision-making that was rigorous and scientifically based but was as streamlined as possible. And the way that the studies, the clinical trials and the preclinical work were kind of telescoped to really create maximal efficiency and also, of course, the way financial risks were taken in terms of beginning to invest in manufacturing in a very significant way and scale up before we knew for sure which vaccines were gonna actually make it over the finish line. Of course, we continue to face the grand challenge of how do we actually make remarkably safe and effective vaccines available to all who need it around the world and India is such an important partner in all of these efforts. But I think that clearly, we learned important lessons that we could be more nimble, we could be more responsive to critical unmet public health and medical care needs and that we could work together in important ways. For me, it reaffirms the lesson that we live in a globalized world. Some may like it, some may not, but it is simply the truth and that we need to think about and implement stronger governance models. And certainly in the regulatory area, it's something that Elias and I actually worked on together at an earlier time, trying to think about how to bring regulatory authorities together in new ways to really align and harmonize regulatory oversight, both the standards and approaches, but also the regulatory activities including things like inspections that don't need to be done by multiple different regulatory agencies with slightly different standards and approaches. So I was delighted to see that a new governance model that I had worked on as a commissioner, ICMRA, was actually put into practice during COVID in ways that I think did make a real difference. So happy to talk about all of this more, but I will stop now. Can you comment on the global supply chain for vaccines and its regulation? Because I understand that this is actually a difficult issue in terms of national policies, exports, controls, quality. Is there anything there that we as a world, India for example, is a great producer of vaccines, but vaccine nationalism in terms of global supply, command and control, what would be your advice on that? Well, the complexity of global supply chains for routine medical products is challenging. And then you get into a crisis like this one and it gets even more complex. The fact that components or the products themselves of drugs and vaccines and diagnostics and other medical products that are used in one country are coming from different countries around the world and are moving through a complex supply chain that involves many different players and partners and is subject to different rules and regulations in different countries. So we need very much to streamline that for routine needs, but in a crisis it becomes more complicated because countries do implement certain kinds of emergency laws that limit export of certain items to other countries and may also sometimes limit imports from other countries. And that can be so disruptive. And again, to the supplies and components that are needed for medical countermeasures in a crisis, but also can have impacts on routinely needed important medical products. So we've seen this really as a huge barrier to some aspects of our international collaborations to try to make vaccines more available where certain countries, including my own, the United States have been making sure, understandably that we have enough things like even the glass vials and rubber stoppers needed for packaging vaccines to address our own national needs, but that does create gaps and shortages in other places and it includes assays and reagents and other important components of vaccines and their manufacture. And so I think we do need to step back as a global community, a scientific enterprise and a regulatory community, look across the needs of industry and the role of government and really try to learn from this experience so that we can be better prepared for the next time. Thank you, Peggy. There will be actually follow-on questions from some of our panelists. Let me go to Francis. Francis, science has delivered this year and a major reason for it than your role and the role of NIH under your strong leadership, which has been central to the public-private approaches that have been taken. Could you share with us all your experience over this year and the most important lessons you drew from that experience and obviously, from your point of view, we were doing better thanks to vaccines, but we're not out of the tunnel yet. We have multiple issues that are in front of us, not beast of which is what Peggy was talking about, manufacturing vaccines. So what do you see as lessons and major challenges ahead of us nationally and internationally? Francis? Well, thanks, Elias. It's nice to be part of this and let me add my thanks to you for mentoring me when I stepped into the role that you once had as NIH director and you shared a lot of good points that kept me from making more mistakes than I otherwise would have. I didn't expect, however, that almost 12 years later, I would still be holding this particular position, but it's a great privilege to be able to do so. It's certainly been an incredibly intense year and a half since COVID-19 appeared on the scene and devastated our planet with all of the consequences that this coronavirus has created. Actually, for the first time in a year and a half, taking a little bit of a break, I'm at a beach house in North Carolina with my daughter and three grandkids who are hopefully not going to disrupt the proceedings here. We'll see whether that happens or not, but it's nice to have a chance to converse a little bit about the lessons we've learned and there are a lot of them. One lesson that I think we shouldn't lose track of is that the investments that have been made over the course of decades in basic science were really critical to get us to the point where we could in the space of just a day or two after the sequence of SARS-CoV-2 was posted on the internet, design an mRNA-based vaccine, which turned out to be remarkably successful. Building also on the hard work that had been done prior to that about how one might optimize the pre-fusion form of the spike protein so that it would be maximally immunogenic work that was done at our vaccine research center by Barney Graham and Kizmiki Acorbit and others over the course of several years. Because I think some people thought, oh, well, you just suddenly thought up this idea of mRNA and then that changed everything. And of course, instead, that's based upon decades of work done all over the place to make that possible. So that's a lesson we must not forget that as we see the necessity for quickly approaching an outbreak, we also have to have a foundation of really solid science upon which we can build. I guess for me, what I was able to see early on as we began to try to figure out how to respond with vaccines and therapeutics and diagnostics is that there was ever a time to get all of the talent around the same table, public and private and regulatory agencies and everything else, this was it. And out of that came the formation of something called ACTIV, which stands for Accelerating COVID-19 Therapeutic Interventions and Vaccines. An effort that now involves 20 pharmaceutical companies, multiple NIH institutes, the FDA in a very important fundamental way to be sure that we are understanding each other exactly. CDC, the Veterans Administration, the European Medicines Agency, and all of this managed very effectively by the foundation for NIH, which brought to the table the kind of program management that was necessary for this very complicated organization to be able to go forward. And people dropped everything. It was amazing to see about a hundred people engaged in the four different components of ACTIV, pretty much 24-7 doing everything we could to identify ways to move forward, defining master protocols for vaccines and therapeutics so that we would all have the same understanding about what power was needed, what kind of end points were gonna be followed, how do you prioritize therapeutics to get into clinical trials? How do you pull clinical trial networks together to maximize their ability to quickly mount a randomized trial that was gonna give you a definitive answer? I think we saw that there was really a need for that. In the early days of COVID-19, I think this is true across the world, but it certainly was true in the U.S. There was a lot of scrambling around and setting up clinical trials that were actually not that well-designed. They were underpowered. Perhaps they weren't particularly thoughtful in terms of the end points. We would not have been able to get many answers if that was all we had going. We had to regularize this and make sure that we were putting together trials that were sufficiently large in scale to be able to get answers. All of that had to come together. And I can't say enough about the remarkable way that all of the sectors just decided that this was okay and let's not worry about who's gonna get the credit. Let's just do it. And ACTIV continues to this day to have about 30 working group meetings a week with this ongoing effort, because we're not done. So that was a really important lesson that how we can pull this together. I think it helped that we had had other public-private partnerships building up to this and particularly think of the accelerating medicines partnership in the U.S. where the people involved at high levels in the government science agencies and in the companies, we already knew each other. We knew each other well enough to call each other up and say, hey, we gotta do this and to have the trust that it was gonna work and that people would live up to their commitments and that milestones could be set and they would be absolutely rigorously adhered to. So that was a pretty important lesson. In terms of where we got to, obviously to have two vaccines in the U.S. approved for emergency use in 11 months, the Pfizer and the Moderna vaccines was pretty amazing record compared to what had ever been done before. And again, a testimony to the remarkable efforts that were made to make that. So particularly important part of that and a lesson we must not lose is how important it was that the recruitment of participants in those trials was diverse that if you're going to have a vaccine that you want people to take advantage of, you wanna be able to say, yeah, in the trial, people like you were included. And for us, that took an additional push forward to be able to do that kind of outreach, setting up community engagement efforts to be able to enlist lots of other participants from the African-American, Latino and Native American communities, which ultimately was pretty successful, although it was a bit of a heavy lift right at the beginning. We must not forget how we did that and we need to apply that in other trial situations as well. In terms of where we are now and what we need to do next, I mean, Elias, you and I've talked a little bit about this. We certainly need to learn the lessons from this with mRNA vaccines having turned out to be as safe and effective as has been the case. We are in a position, I think, to basically look at the list of the 20 most likely pathogens for the next outbreaks and go ahead and get started on designing those vaccines, maybe carry them all the way to a phase one trial to see if you can get a decent antibody response and then have those in the freezer and ready to go if that next pandemic does appear. So 11 months was great, but maybe we could do it even faster if we planned ahead. And the other thing, which we really have to work hard on and which the US government has just announced about a week ago, a $3.2 billion investment is antivirals. We tried really hard to find things that could be repurposed for COVID-19, an awful lot of the clinical trials that were run over the course of the last year, took things that maybe we're gonna have some promise and almost all of them failed. Well, we did get a hit from remdesivir, although it was modest in its contribution and certainly dexamethasone coming out of the recovery trial in the UK turned out to be a really important advance for the sickest patients. But we don't yet have an oral agent that could be quickly administered to somebody who just got a positive test. And that's what we really need and that's what now, again, with a lot of effort in a pharmaceutical effort that Andy could talk about, called Intrepid and with the US now making this commitment to put another $3 billion into this to have hopefully in the course of the next year or two, not just one, but more than one, a safe and effective oral antivirals that targets one of the vulnerabilities of a coronavirus and there are plenty of them particularly the proteases that deserve that. And that's a hard problem and it's the sort of thing we couldn't get done in that first year but we should not give up now. We still have lots and lots of needs for those kinds of therapeutics and we will be pushing forward. I didn't mean to skip over the monoclonal antibodies because that's also been a big step forward and to have monoclonals very quickly developed and tested which do show benefit for outpatients has been really valuable. Although I think we were disappointed to discover that monoclonals at least for the most part have not been helpful for hospitalized patients. That by the time you get that far along in the illness they don't seem to add much to therapeutics. You've got to give them early and of course that's a little challenging logistically because that's an infusion to somebody who's infected with a contagious agent that you need to do as an outpatient and that has challenged our medical care system to figure out how to do that. And ultimately we'd like to have something much simpler like that oral pill that we're all now working on. I could go on and on about all of this but I think I'll stop, Elias, and see what questions people have for us. Terrific. Could you comment on the emergence of the variants and the Delta variant in particular and what you're thinking about or how to address this challenge? Yeah. Well, obviously we're all watching this with great interest and some anxiety in terms of what these variants mean for the effectiveness of the vaccines which are incredibly effective, 94, 95% efficacy against the original virus. And with the variants that have appeared so far, Alpha, Beta, Gamma, Delta, we're looking pretty good and Delta is probably the one of the greatest concern now as it has absolutely decimated the country of India and now has rapidly spread through the UK or it is now by far the majority of the isolates. And in the US this has gotten up to 10% rather quickly and is predicted to become the dominant viral strain by August. I mean, it is interesting if you look at the shape of those curves, previously we thought that B117 which we now call Alpha was a very rapid spreader. Well, this Delta is spreading even more quickly in the space of a few weeks. And of course it is alarming because it is more contagious, estimated about 60% more contagious and also potentially more dangerous, at least a Scottish study suggesting twice the risk of hospitalization if you get infected with Delta and that includes young people. The good news is that the mRNA vaccines are still effective after two doses, about 88% efficacy. By the way, one dose, not so much, only about 33%. People really gotta get that second dose in there. I don't know the data about the J&J vaccine for the Delta variant, I think that's still in the works. But I guess what I'm worried about is what's the next one? And I think we all have to be really watching this closely. The one called Lambda coming out of South America, C37, which I don't know the data yet, but it's also spreading quite rapidly. It must be one of those pretty contagious items. It's got a seven amino acid deletion in the spike protein, which really makes me worry about what it looks like to the immune system. So we just have to watch these closely and we have to be prepared, if necessary, to deliver boosters that are designed against something that the current vaccines don't cover effectively enough and that's already been put into a trial basis by developing boosters against B1351, South African variant. And it does look as if that's something you can do fairly quickly and safely with the mRNA platform. I kind of hope we don't have to, because that's a big deal and it's gonna be a huge challenge once again to do the manufacturing and the distribution, but we gotta be ready for it. And considering that this virus is still spreading so rapidly across the world, there's lots and lots of opportunities for additional mutations. If you want a textbook on viral genome evolution, it's happening right in front of us every day in a way that's actually kind of alarming, but we gotta stay ahead of it. Elias, can I just jump in for one second to build on what Francis was saying and just quickly underscore three critical lessons from the variant experience, things we need to be acting on now and building better for the future as well. One is genomic surveillance. We need to integrate that into how we think about biosurveillance so that we can really understand from the get-go trends in variants that are to be expected, but have real impact on disease control and on our lives. Secondly, we have to really recommit to the international vaccine delivery issues. Every country remains vulnerable when, as Francis noted, we're allowing transmission to be running rampant in other places in the world that can really foster the development and spread of new variants. And then thirdly, it really speaks to the fact that we have to think about these new opportunities in science that we have with the mRNA vaccines, but other emerging technologies as well. We can develop and sort of pre-study and pre-approve certain kinds of platforms that then can be quickly used in a sort of a plug-in play way as new variants emerge and as we see the need to rapidly develop new vaccines or other modalities to address emerging new variants and new threats. Thank you. Thank you. I would like to point out to everyone that indeed you probably are the longest serving director of the NIH. I think Jim Shannon may have been 12, 13 years, but no matter what, this year counts for three years. Because... Oh, so you are the longest serving. The other thing I'd like to tell the audience is you are a genius at acronyms. And I learned that from you. You were a mentor to me. So when I heard the acronym ACTIV and what it meant, it said that absolute signature of Francis Collins. And you're always... But acronyms, one time we were doing this proposed study called AGES, American Gene and Environment Study. And I thought it was a struggle genius to put AGES in the study, or the book of life, which you have used. So I think you're willing to communicate to the general public in ways that really connect both the momentum and the substance of something is unique that all of us are learning from. Anyway... And his ability to sometimes do it in song. We can't forget that. And write poems about it. I mean, you know, Francis can only... He can not only just play music, but he can write poems. So anyway, enough kudos. Questions from the panelists who have really signed up to ask you questions. And the first is going to be by Professor Sinhar Sanjeev. Sanjeev is a professor of medicine at the All India Institute of Medical Sciences. Sanjeev, can we have Sanjeev please? Thank you very much, Professor Ilyas, for giving this opportunity. Very nice discussion by Professor Colin and Peggy. Thank you very much. My question is the COVID pandemic has demonstrated that WHO's lack of authority regarding enforcing pandemic control measures internationally. Should the WHO be invested with more executive powers in the interest of ensuring global health? And number two, would the empowerment of the WHO go act more decisively in the interest of global health influence upon the sovereignty of the countries for the COVID pandemic? Thank you. Thank you for that question. Yeah, that's a very important question. What is WHO's role and what has it been? What should it be? For Francis, you've been, I know that WHO is funded by NIH in many ways and help by NIH. Could you comment? I mean, there's been defunded WHO. WHO really has not been given a lot of credit for managing this. What is your thought, Peggy, from your point of view, what should WHO do differently? Yeah, well, I'll start. Yeah, it's been a difficult period, of course, in terms of our relationship with WHO, with the previous administration, basically wanting to withdraw from that organization. I will tell you that we continued scientifically to interact almost daily with WHO in the course of COVID-19 because of all the shared interests. And we have people in Geneva who continued to be a part of that partnership. WHO now, I'm glad to say, we are back very much in the connected state and it's wonderful having Sumia Swaminathan there as the chief scientist, somebody that I've known for quite a long time. WHO has a tough job to do, of course, because they have so many masters that they have to try to satisfy and makes it very difficult to move things along in any kind of rapid fashion at a time of a pandemic where you really want to try to be as rapid as possible. But they do provide a connectivity for all of the international efforts that are happening at a time like this, which is greatly valuable. I just think it's very difficult for them to be the driver of big changes in policy because they have too many people who don't quite agree about how that should be done. So that while their hands in some ways end up being tied, they're absolutely critical and we depend on them a lot for that kind of interaction. And just to follow up on Francis's comments, I mean, I think it is absolutely the case that WHO is a critical point of information and coordination for countries around the world. It surely is not perfect and we can all identify areas where we wish they had been stronger, swifter or more focused during the response to COVID. But I think that they are uniquely important, uniquely situated and we need to support them and we need to help them strengthen and extend their work. They are the only unifying health agency of its kind in the world. They provide really critical normative standards and guidance and information for countries rich and poor including also a mechanism to help countries that have much less well-established systems for drug review, medical product review, et cetera, get information and ultimately access to critical products. And they really in times between a crisis can and should play a critical role in defining critical competencies that countries need for pandemic threat preparedness and response and helping to ensure that that set of capabilities is actually built up and sustained over time. But they do answer to many different masters, as Francis said. They also are dramatic in terms of, are dramatically underfunded and the way that historically they've received funding, I think has exacerbated some of the problems because they get funding for very specific areas of work sometimes which may not actually reflect what is their core mission, what are their critical and unique functions. And I think that as a community of nations, we really should help to make sure that the core functions of WHO are identified and supported so they can play that role and then add on extra programs that are sort of a special interest to different countries or different groups. But we really do need to recognize that WHO warts and all plays a critical role and it's our job to help WHO do a better job going forward. But Peggy, on a very specific point, that I heard from many different countries, especially low income countries, is that many of the governments really expected and waited for WHO approval to acquire the vaccines. But the WHO approvals have been delayed and not very swift, if you will. So people who wanted to buy Chinese vaccines said, no, there's gonna kill us for Russian vaccines and FDA did not approve the AstraZeneca, I mean, EMA bit, which is a subject near and dear to you and I, the harmonization issue. Yes. Well, it's what you would recommend for the future to make sure that countries are a level playing field in terms of approval of vaccines. Yes, I think that this is gonna take some time and some thoughtful work. WHO is not a regulatory agency, yet it can convene regulatory authorities to work together in important ways. Now that we have a new global governance framework through ICMRA, the International Coalition of Medicine Regulatory Authorities, I think we need to strengthen that activity and then we have to get those two entities to really seamlessly work together because I don't think that WHO should pretend to be a regulatory agency, should take that on, they don't have the depth and breadth of experience with respect to the science and R&D and they don't have the kind of legal authorities that they would need to be able to serve the world in that way, but working closely with regulatory authorities around the world and an international governance mechanism for regulatory authorities. I think we could really make systems much clearer, make information more accessible and really help countries to better use information coming through that network for their own regulatory decision-making without having to create additional new mechanisms to satisfy the needs and concerns of their own country. So I think it's a really important area of work. I hope that you and I, LAS and others will have a chance to continue to work on this issue as we come out of COVID and look towards the future. Thank you. The next question is from Stan Ella, who is Chairman and Managing Director of Barrelt Biotech. Questions related to vaccines? Krishna. Thank you. Thank you, Professor Deroni. It's really honored to video connect to Francis Collins and Margaret Amber. Thank you, honored. And I think I'm also a distinguished panelist. My question is very simple. Would establishing a manufacturing facility dedicated for pandemic, is that a right decision for many countries? Well, I'll jump in first on this one. I think that what we really need to think about is how to make manufacturing and scale up more efficient, how to make it work on a routine basis in a more distributed way where we have more capacity in different parts of the world. And we need to think about what are the elements that make it possible to scale up even further in a crisis. I think the idea of dedicated manufacturing for pandemics can have an appeal but can be dangerous because if you're not using a manufacturing facility and keeping it warm so to speak on a day-to-day basis, I think you're gonna find major problems when you go to use it in a crisis. And the truth is that we still have vaccine needs for a lot of unmet public health and medical care needs. And we really can and should ensure more vaccine availability through manufacturing and distribution to address a range of preventable diseases of childhood as well as an increasing set of adult immunizations as well. So I think that if we scale up capacity, we'll use those vaccines, we'll be able to keep the manufacturing facilities in good use with trained people and quality manufacturing capabilities, but also be able to gear up. And I think we need to be thinking not just about how to introduce advanced manufacturing approaches to some of our vaccine manufacturing and really modernizing these processes, but also with new vaccines, some of the manufacturing requirements are gonna be, I think, easier to stand up to maintain and will be less cumbersome in terms of what it requires. So at least that's my hope that we can apply new technologies and new systems as well as making broadened commitments to making manufacturing capabilities available in places around the world. Yeah, I totally agree with Peggy's perspective here. The idea that you're going to set up manufacturing and just sort of have it on hold waiting for pandemic needs probably isn't gonna be a successful approach. You've gotta have a facility that has actively trained individuals that has all the materials in place to be able to make this happen quickly. But there's plenty of need for that kind of manufacturing capacity and it is really a problem that right now it is not distributed across the world the way you would ideally wanna see. I've been engaged in multiple conversations about how we might do something about enhancing vaccine manufacturing capacity in Africa and there are places that I think are potentially ready to try to take that on like Senegal and South Africa, for instance, but we should not actually underestimate the complexities in doing so. And certainly for a quick turnaround to try to produce more vaccines for COVID-19, I don't think it's realistic that you're gonna go from a standing start to be able to do that in less than a couple of years, but we should be doing it anyway for the next pandemic and for all the other vaccine needs that are gonna be ongoing for childhood illnesses and other things. But it's not just about the technology, it's not just about buildings, a lot of it's gonna be about training and that's gonna, I think, call upon the existing manufacturing capacity to not only expand its capability which they're being asked to do but also being willing to do that kind of outreach, to do the training for new facilities as they begin to step up. But yeah, that's gotta be a big lesson from this experience that vaccine manufacturing has been way too limited geographically and if we really care about the health of the world, we gotta fix that. Thank you, very helpful. The next question is actually from Robert K. Leif. Rob is the head of clinical policy and strategy at Verily and Google Health. As you know, he was a former commissioner of the FDA but I think his claim to fame is to have created the best clinical research institute in the world at Duke and changed the old trials from academia to industry to government. So Rob, your question. Thanks, Alice. This is a rare opportunity. I wish we had five hours to ask questions but I know we're short of time so I'm gonna fire out a two-sided question that is in the jurisdiction between FDA and NIH and that I think all countries need to be thinking about with regard to vaccines and other issues. The first is diagnostic testing and I think I certainly learned a lot at FDA about the issues in diagnostic testing that are not going so well. It is the foundation of precision medicine but of course you need to be able to make a diagnosis to treat during a pandemic. And then the second is the global suspicion about vaccines, which is a huge issue in the US right now and I'd particularly be interested in Francis' view on this because somewhat unexpectedly to a lot of people the residual vaccine hesitancy people turn out to be conservative white men and from areas like where I'm from. And I'm sure every culture has its own groups of people who are hesitant. So those are two big issues that sort of reside between NIH and FDA. I wonder what your thoughts are about them. Well, I'll start and try not to take too much time because I wanna hear what Peggy will say too. With diagnostics, I agree that this was perhaps underappreciated as a critical part of dealing with a pandemic. I think we've come a long way in the last year and a half on that after a very rough start. One of the things that NIH got engaged in in a way that we never really had before was to become kind of a venture capital organization to try to create platform opportunities for new diagnostic technologies to detect the presence of virus in a nasal swab or a saliva sample. And with that encouragement from the Congress we basically have now funded the development of no less than 32 new platforms for doing this kind of technology including many that are point of care and quite a few that are now home-based testing which of course if we'd had at the beginning of the outbreak that would have been really helpful. It's coming along a little later than you would like for this. And I think that is something going forward that we can build on because we learned a lot about ways to do this either using nucleic acid or viral antigen assays that we hadn't really invested in in quite the same way before. And we ought to be prepared to utilize those lessons also going forward. As far as the global suspicion it is incredibly frustrating that we have now vaccines that are safe and effective and yet there are about 90 million people in the United States who have yet to roll up their sleeves to get the first dose. Many of them skeptical suspicious and much of that driven not by scientific information but by misinformation, by political posturing, by things that you would not have thought such an advanced technological society would be so tripped up by in which many of us, bless him, Tony Fauci especially have been out there trying to counteract and basically getting demonized as a result. It is a sad tale, I'm sorry to say that kind of reflects the way in which at the present time there's so much polarization in our country and not uniquely in our country. And here it is in this instance, not just causing headaches but causing loss of life. I mean, people are dying because of misinformation about COVID-19 that otherwise could have saved them. And that's a terribly sad thing to be able to say. And despite efforts for lots of people and lots of different venues, we not apparently made very many inroads into the most resistant part of the community that simply is not interested in something that they've decided is not for them. So yeah, Rob, I'm really frustrated about this and it's also this terribly ironic situation where the rest of the world is desperate to get access to vaccines. And now here we in the US have done all this manufacturing, we've got all these copies and people don't want them. So what's wrong with this picture? We have really turned everything upside down. Peggy. Okay, well, I'll try to be quick because I know we're up against time. First on the diagnostics question, this has been an area of great focus and concern in the pandemic preparedness area and biological threats, literally for decades. Back in 2003, actually, I co-chaired a National Academy of Sciences study and report with the late great Dr. Joshua Letterberg called microbial threats to health in the 21st century. And we did in that report call out the need for new better diagnostics as one of the most critical elements of preparedness for a full range of biological threats both naturally occurring and deliberately caused. And we expected action to happen very swiftly to really organize activities. And sadly, there were cycles of crisis and complacency, little progress was made in the pandemic preparedness domain with respect to diagnostics. From the perspective of working at FDA diagnostics have been a challenge in terms of the legal regulatory framework and how to really harness what are opportunities in science and technology today to develop a whole range of new diagnostic technologies. Many of those are going forward, but have been caught in the crosshairs, I think, of the legal regulatory framework and the willingness to invest, but also reimbursement. It was sad not too long ago when we had very dramatic advances in precision medicine that could make huge difference in disease, but the diagnostics to enable the alignment of the new therapeutics with the underlying disease weren't being reimbursed. And so this precision medicine wasn't being adequately utilized. We're making progress in those domains, but it's a question of really, again, recommitting to work in this area. And with COVID-19, we saw in those early days, the floundering around getting diagnostics and not just any old diagnostic, but multiple diagnostics for different purposes. What you need for public health surveillance is different than what you need for medical diagnosis. So I think it's an area where we have to do better as we come out of this in terms of creating strategies for diagnostic development and their application in medical practice, whether for routine use or in a crisis. Vaccine hesitancy, it's a problem around the world. It's multi-determined. The anti-vaxxers had a huge impact pre-COVID and then were able to reinforce their misinformation and negative messaging, praying on vulnerable people. Of course, that then got overlaid with concerns about the adequacy of the science and was the vaccine being developed with political interference and pressure and was it really safe and effective because of that? And then of course, the fact that there are social and cultural issues that affect people's willingness to trust vaccines and their youth and political ideologies that are now undermining uptake in many countries, including the United States. So we have to make sure we have the right messages about vaccines, why they matter for individuals, families, communities, and our overall national and international security. But we also have to have the right messengers and for different communities and target populations, those messengers are different. We have to be very mindful of that as we proceed with our vaccine programs. It's interesting sometimes I was just put an anecdote up in the vials of vaccines that are distributed around the world. Sometimes the world's sterile is written on the vial and that has been misinterpreted as sterilization of women and you have this rumor going around that the vaccine is to prevent actually, I mean, it's a contraceptive essentially or actually no, but pretending to stop, you know. You know, I think we are out of time. This was a fascinating panel. I want to thank you both. I want to apologize to Dr. Ship-Sarin, who had the last question. And I think, fortunately, because of fine limits, I won't be able to let him ask his question. You can see the amount of interest that these issues have raised. You've absolutely led the world in terms of your leadership, your differences in terms of active responses and the acronym that you use, which really activates everybody. And Peggy, your experience in policy and global common regulatory responses needed in the future. So with that, I'd like to thank all of you and all the participants for this great panel. Thank you very much. Thank you. Thank you. Thanks a lot, everybody. Thank you very much. Thank you, Peggy. Thank you, Peggy. Thank you, Thomas Collin. Thank you, Dr. Krishna. Thank you, Karan. Thank you, Karan. Thank you so much. And can you put the poll slide, please, quickly? That's an exciting question for this panel. What is the most crucial step to building resilience against the next pandemic? The poll starts now. We have 60 seconds. Please cast your poll. Welcome back, everybody, and thank you very much to Elias, Peggy, and Fran for a really terrific fireside. Three incredible leaders who have all served or continue to serve as civil servants and their role in helping to drive science and policy on a global scale is greatly appreciated by all of us. So we can now bring up the results of the most recent poll. And the question was, what is the most crucial step to building resilience against the next pandemic? And you can see the results here. And we have a favorite, an overwhelming favorite, where over 50% of you believe that the answer is B, establish infrastructure for more efficient research, collaboration, and data sharing. So thank you very much.