 Good morning everyone. I want to thank you all for joining us today for NCSSM's COVID-19 Symposium. I'm so excited about this event and the amazing scientists and leaders we have with us will share their insights and work related to helping battle the terrible COVID-19 pandemic that has so impacted everyone across the world for the past year. I want to first begin by thanking our guest speakers for joining us this morning. Dr. Collins, Dr. Corbett, Dr. Fisher, Dr. Gay, Dr. Olick, Dr. Tropeshia, Dr. Thorpe and Secretary Sanders. I'm sure that many of you in the audience probably recognize this, but I want to make sure to point it out that these scientists that you're going to hear from today are truly the all-star team of scientists in our country and in the world. We're extremely fortunate to have this opportunity today and truly honored at NCSSM to be hosting this event and to have all of our guests with us. Thank you all so much for your time this morning. I also want to recognize Dr. Amy Scheck and Mr. Bob Gottwals for their leadership and work in conceiving and planning this symposium. Before we started, several of our guests were talking about, well, how, wow, how did you put together this lineup? And it was Amy and Bob, so thank you both for making today possible. Today's event is such a timely and amazing opportunity for our school community and the broader community to be engaged in learning more about the battle with COVID-19. So Bob and Amy, again, thank you for making this possible. And I also want to thank Lee Welper and Donald McIntyre for planning and the technical work behind today's webinar, and also to thank our faculty who will be leading some fascinating workshops this afternoon. For many of us here at NCSSM, particularly all the members of the class of 2021, you might recognize that it was exactly one year ago today, March 13th, when we had to close campus and send all of you home and switch to virtual learning for the rest of the academic year. At that point, we were just beginning to understand in a very personal way the impact the pandemic would have on all of us in the world. I noted that I know at that point, I certainly did not fully comprehend the magnitude of the impact the pandemic would have on our community and every single person in our country and across the globe. At this point, the impact is certainly much clearer for all of us. And as devastating as it has been, it could have been so much worse if not for the work of the truly amazing scientists we have with us here today, and many other scientists in our country and around the world. From scientists and healthcare professionals at the NIH, the CDC, those universities like UNC Chapel Hill and Duke, and organizations like RTI and in our state and local health departments. We have received guidance on how we could keep ourselves safe and those around us and how we could safely operate our school with students on campus this academic year. We've maintained less than a 0.2% positivity rate in our testing on campus so far this year, because we've received great guidance, and everyone in our school community has done a fantastic job of making the sacrifices necessary to follow it. And now we can begin to see the light at the end of the tunnel with the rollout of multiple vaccines. It is absolutely amazing that scientists, some of those with us today have been able to develop, run trials and deploy multiple vaccines in less than 12 months. Unheard of. And again, absolutely amazing and something for which we can all be truly thankful. In this year of so many challenges, many of which have been significantly exacerbated by those that have refused to listen to and follow the science and the guidance of scientists. What I think we can and should all recognize is that has it has been the unwavering commitment of scientists to solve this most challenging of problems and the willingness for so many like those in our school community. In spite of all the noise and misinformation that has abounded this year to do the right thing and follow the science. That's what has us looking forward to the next 12 months being much brighter than the past 12. I again want to thank our very distinguished guest speakers. Dr check and Mr got walls and our faculty for making today's symposium possible and for everyone joining us for today's event. At this time, I'd like to introduce Dr Holden Thorpe. Dr Thorpe is the editor in chief of the science family of publications position he began in 2019. Prior to his current role, he served as the provost at Washington University from 2013 to 2019. And where is the Rita Levy Montalachini Distinguished University professor and holds appointments in both chemistry and medicine. Dr Thorpe joined Washington University after spending three decades at the University of North Carolina Chapel Hill where they served as the 10th Chancellor and from 2008 to 2013. He's a North Carolina native, and he started at UNC as an undergraduate student and earned his bachelor in science degree in chemistry in 1986. He ordered a doctorate in chemistry in 1989 at the California Institute of Technology and completed postdoctoral work at Yale University. He's also an entrepreneur and an inventor with at least 18 patents. And he's a fellow of the National Academy of inventors and American Association of the advancement of science. I had the privilege of working with Holden when he was the Chancellor at UNC and very much appreciated his leadership and the opportunity to learn from him. And Holden it's great to see you, even if it's virtually today. And thank you so much for being with us. Thank you Chancellor, and it's great to be with you all. Congratulations to Amy and Bob for the extraordinary panel that they have pulled together here I just get to be the emcee. As Todd said I have one of the greatest jobs in science which is that I'm the editor in chief of the science family of journals. And as Todd said the people that are assembled here. Dr Corbett Dr Collins Dr gay all these folks, they're the ones who saved humanity I'm just a guy who makes sure that the papers get reviewed, but it's an honor to do that and I've gotten to see a lot of amazing science over the last year. That's for sure and not just in this area. I think the fact that all these folks are here is a testament to the power of the state of North Carolina and how much people love it but especially the affection and admiration that everyone has for the North Carolina School of science and math. Todd does such a great job of leading you all, and you're all very fortunate to be able to learn at such a special place from such special people. I was admitted to the first class of science and math and I made a dumb decision not to go but it was the very first one so the people who went in that first class were great pioneers and. Wow everything that has happened since then is just extraordinary so congratulations to Todd and all of you. The first task is to introduce Francis Collins, who is the director of the NIH. He was on MSNBC on his earlier zoom call today so you're getting someone who was just on another important interview and if you've been watching the news lately you've seen a lot of him on 60 minutes and on Axios and just about every cable news channel talking about the pandemic, but Dr Collins has had an extraordinary scientific career doing many, many different important things. And I just want to put in a plug because yesterday we posted an editorial in science magazine that he wrote for us that probably includes some things that you're going to be hearing about in today's talk. Francis Collins became the NIH director in 2009. He was the only NIH director to serve two presidents when he stayed on in the Trump administration, and then just recently became the only NIH director to serve three presidents. When Joe Biden made the very good decision that was a great comfort to us all to keep Francis on at the NIH and he graciously agreed to continue to lead us. Dr Collins was a leader of the human genome project. He got his medical degree at the University of North Carolina. He is a grandparent of a North Carolina science and math student. He is a member of the National Academy of Medicine, the National Academy of Sciences. He won the Presidential Medal of Freedom and the Presidential Medal of Science and he also won something I know he's very proud of, which is the Templeton Prize in recognition of his extraordinary ability to connect science and community, something that is sorely needed in science communication in today's world. So it is an absolute honor to introduce someone who is a mentor and leader and cheerleader for us all and an extraordinary scientist. Please give a warm North Carolina School of Science and Math. Welcome to Dr. Francis Collins. Well, my goodness, Holton, that was incredibly gracious and wonderful to see you, albeit virtually, and let me add my voice of admiration to Amy Scheck and Bob Gottwals for having put together a truly amazing symposium for today. And I'm just honored to be part of it and to start us off by talking about some of the science of vaccines, which I think is going to be a main focus of what we're going to be discussing this morning. Yes, I am the grandfather of Sellers Hill, who is the class of 20, who is taking a gap year right now because of COVID-19, not being a terribly good plan for starting your college education, but we'll begin at Harvard in September. And he certainly would speak about the wonderful gifts he was given as a student at NCSSM in terms of starting him on a path that is going to be really interesting. And sorry that he is not with us today because he's off in Hawaii building a garden for somebody. Go figure. So I'm going to share my screen so I can actually show you some visuals as well as talk to you about this whole issue of vaccine development. And hopefully, somebody will tell me that you can actually see this in the title being how we built a better vaccine curiosity persistence and partnerships. I don't want to talk about this from the perspective of the NIH director but you will hear from other folks who have been deeply engaged in this in the course of the morning. So hopefully you'll get a whole sense of just what an amazing team effort this has been to do something really unprecedented. So in January, where in Science Magazine, yes, hold it, we started to learn that there's something really serious going on scientifically in China, this event in Wuhan. And then in January 9 for the first time, we learned that Chinese scientists were declaring that whatever this pathogen was, it seemed to be a coronavirus. This caused a lot of ripples of concern since SARS and MERS had preceded this and are also coronaviruses. So where was I the NIH director at this time. Well, I was right at the North Carolina School of Science and math, because I visited you all there on that Friday, and had a wonderful time visiting with some of the lab experiments that were going on with some crickets and also giving a talk and getting to know a lot of the students. Again, in being introduced to many of them by my grandson, and I came away with an incredible sense of what an amazing place this is and what talented amazing visionary students occupy the place. And so kind of a moment because that very day, the sequence of the particular virus that was causing this outbreak was posted on the internet by Eddie Holmes, who's an evolutionary virologist in Sydney, Australia. And so as I was meeting with your students, I was also getting information that caused me to want to stop and look closely to see what is this virus. And then we began down a pathway of what do we do about it. And as you will learn, especially later from Kizmiki Acorbit, who's a significant part of this whole effort at the vaccine research center at NIH on that day, January 10th, the design of the Moderna vaccine that is now in many arms, including mine, got underway. There was no time to waste. NIH does have this remarkable opportunity, responsibility to be the leading source of biomedical research support in the world, both doing fundamental basic science and applying that to extend healthy life and reduce the illness and disability. The NIH's largest diseases led by none other than Tony Fauci, the director of that institute is a big part of what we do as the NIH director I have 27 institutes and centers that report to me, all led by amazing scientists, and all trying to do everything they can with taxpayers funding to try to make discoveries that are going to extend life and reduce illness. For COVID-19, there were three areas that we knew immediately we would need to charge into diagnostics therapeutics and vaccines. For the diagnostic part, we set up a program called RADX rapid acceleration of diagnostics, which if there was time I could tell you about because there's some amazing technologies that we have been developed that are now leading to about 2 million tests a day, most of them point of care, which is really making a difference in our ability to figure out how to manage this. For vaccines and therapeutics, I had a personal hand and putting together a partnership called active, you can see what that stands for, which now involves 20 pharmaceutical companies, multiple government agencies, including NIH, FDA, CDC, and brings everybody around the same table to design master protocols to figure out the priorities and to be sure our clinical trial networks are set up in a fashion that they can quick test both treatments and vaccines. Let's talk about vaccines today because I don't have that much time but I could go on all morning if you gave me the chance. It has been an amazing ride and amazing people have come alongside and dropped everything as we all have been doing for the last year to try to make these advances happen in record time because people are dying and we had to recognize that there was no time to waste. So let's talk about the vaccines and of course we have to then talk about the virus and we particularly have to talk about the spike protein that sits on the surface because that's what your immune system reacts with and recognizes if you happen to get infected with this terrible virus. So if you were going to try to design a vaccine that would protect you against that you would want to prime your immune system with the ability to raise antibodies against that spike protein without getting you actually infected could you actually do that well exactly that's what all of the vaccines currently do is to provide an opportunity for your immune system to see the spike protein make any bodies against it and be ready if the real virus comes along. That's how this works. And this is maybe a little overly simplified cartoon for the students at NCSSM who know a lot about immunology but just for the heck of it. Just think of your body as basically a biotechnology factory that is capable of responding to a whole lot of outside threats, like those viruses that I have diagrammed in green yellow and purple. So if such a virus comes along your immune system that gadget you see down there takes account of what's there and makes an antibody that Y shaped protein that's specific for that particular insult. And of course, once you have had those exposures, your immune system keeps a file cabinet that remembers what it has seen before, then is ready if called upon to produce those antibodies very quickly doesn't have to go back to square one it's got this information ready in its blueprint file to make those antibodies again. That's the idea of a vaccine is that you basically prime the immune system by giving it a chance to make those antibodies that it can call upon if they're needed. If a virus comes along that you really need protection against and to do so in a matter of hours or a few days as opposed to maybe a week or more which could be all the difference in terms of whether you're going to fight off that virus or it's going to get the upper hand. The vaccines that are currently being studied and great intensity and supported with the operation work speed effort in the United States are six, but they have three different so called platforms. Each platform has two different companies that are developing and testing those vaccines with help from the NIH and other organizations to do the trials and you're going to hear a lot about the trials from Dr gay a little later this morning. Two of them are based upon mRNA I'm going to say a bit more about those in a minute that's Moderna and the biotech Pfizer vaccines. Two of them are based on using an adenovirus vector which is DNA and that's Astra Zeneca and Janssen, and two of them are actually purifying the spike protein and adding to it an adjuvant to rev up the immune response, and that's no the backs and Santa Fe GSK of these that you see here all five of them have now gone through phase three trials and three of them have received FDA emergency use authorization that being Moderna, Pfizer and Janssen Astra Zeneca and Novavax are already being in other countries as well but are within the next month or two of having their phase three trial evaluated in the US so watch for those we could easily have five approved vaccines in the United States by May 1. We shall see how those go but already now with the doses we have from Moderna, Pfizer and Janssen, we're in a circumstance for the president to be able to say everybody who wants a vaccine should be able to get one by June. Let's see how the messenger RNA approach works. Basically the idea is, as you all know, a messenger RNA codes for protein, instead of injecting the spike protein itself, which is what Novavax and Santa Fe are doing, inject the messenger RNA that codes for that into the muscle cells, and basically the cells of this messenger RNA, I know what to do with that. It goes to the ribosome, it makes spike protein, and that's what you wanted to do now notice, there is no intact virus here it's just a spike protein there is no risk of this making you sick from the actual COVID-19 infection. It just makes the spike protein that your immune system can then respond to generating antibodies, and then you are protected. This is just the first time that a messenger RNA vaccine has been carried all the way through to phase three trials and FDA approval, even though this has been around for a while as an idea. What happened? And it happened with remarkable speed. Here you see December 11, December 19, that would be 11 months after that sequence of the virus was put forward. And not only that we got a good result, we got a result which Tony Fauci and I had to agree was better than we almost dared to hope for. Tony and I were looking at the way in which the trial was playing out, maybe in August or September, we would have conversations about well, what do you hope is going to be the efficacy? Well, maybe 70%, maybe 75%, nope, much better, 95%, 94%, phenomenally effective and also totally safe in terms of the risks to people who were enrolled in these trials. Dr. Gay will tell you more about that. That's 30,000 people from Moderna, 44,000 for Pfizer. This is a huge amount of data. So look at this, time to develop a vaccine for previous infectious diseases stretching out over years and years, and for COVID-19 11 months. Absolutely astounding record. Now people will say, wait a minute, did you cut corners here? Should we trust this term? It sounds like maybe you're getting sloppy, no. Everything about this was done in the most rigorous fashion. What we did, and Dr. Gay will tell you more about that as having been part of it, was to figure out how to get rid of the down times in between phases one, two and three. And also how to make sure that we were planning for manufacturing of doses even before if we knew if the vaccine was going to work because you didn't want to have a long gap there once you had something that looked successful. And this had never been done in this fashion before. And again, huge credit to all those folks who rolled up their sleeves to take part in this. So how did this messenger RNA approach end up working? And what were the tricks here? I want everybody listening to realize this was not a flash in the pan on January 10th of 2020 where somebody suddenly said, Well, you know, we've never tried mRNA. Let's try that. No, that's not how it works. The basic science that was necessary to be able to get this to work stretches back. Well, you could say it stretches back to the discovery of messenger RNA in the 1950s and 60s. But it certainly stretches back 25 years to think we could use messenger. How do you inject this into a cell and get it to be used for productive purpose? That was not a trivial thing to be able to do. And this is written about in, again, science magazine, Hattip there at the Holden, about how exactly we got to where we are. After all, in the 1990s, we were thinking about gene based therapies, messenger RNA as a possible vector didn't seem that promising. Low levels of proteins degrades quickly. And most importantly, seemed to trigger an immune response that actually could be harmful because messenger RNA was seen injected into the body as something abnormal and foreign. Well, 2005 very important paper here from Kathleen Careco and Drew Weissman and their colleagues and certainly people are talking about this might be a candidate someday for a Nobel Prize, even though at the time it hardly got noticed. And that was basically figuring out how you could modify messenger RNA to overcome these limitations by doing nucleoside modifications basically changing the chemistry a bit. So you still coded for the same protein, but you didn't have the chemical structures that caused the immune system through its toll like receptors to get upset about this. And that then opened the door to the possibility of using this as a source for vaccines. That was of course 15 years ago. On top of that, there had to be a really clear path forward to figure out how would you design the precise sequence of that messenger RNA to make a protein that would be appropriate for a vaccine that's not trivial a lot of structural biology necessary to make that happen. And again, here we are in 2020 for the spike protein of the virus that causes COVID-19 being put forward in a fashion that taught Barney Graham and Jason McClellan and Kismickia Corbett notice the co author here. How best to design that messenger RNA so that it's a little different than what the virus itself has as far as the precise sequence, but you fix it into the pre fusion confirmation, which is more immunogenic. That was a big deal. That was a recognition that was adopted by all of the vaccine makers since then without which we probably wouldn't be talking about 95% efficacy. So, again, this has been a remarkable story and one should also think about this as not just COVID-19 specific having succeeded with an mRNA vaccine for this agents. We are in a good position now going forward with other agents of pathogenic nature to be able to do the same thing and to do the same thing as quickly as possible. What you need to make this particular vaccine or to get started is to know the sequence of the genome of the pathogen. You don't have to have the virus in the lab, which is sometimes a long drawn out process. You just need to know the sequence. That's pretty breathtaking. And what's been accomplished in those 11 months to get to approval is absolutely beyond what I think most people would have thought possible. And this is a story about scientific ingenuity and determination motivation that's going to be told for many decades. So let's celebrate the vaccination here in the middle. Here's a photo of the new president of the United States, Joe Biden in the laboratory at NIH, the vaccine Research Center, being educated about how this all came to pass by none other than Maria Corbett, the doc who's going to talk to you shortly about her role in this. And over on the left there you might see Dr. Fauci if you haven't seen enough of him already because he's everywhere, including on the late show with Stephen Colbert last night. Tony is just this amazingly dedicated and articulate spokesperson as also being of course probably the best known infectious disease expert in the world and it has been an absolute pleasure to work with him on all of this. Lots of other pictures here of people getting vaccinated in the upper right, you might see the Vice President of the United States, Kamala Harris, she's at NIH, she's doing an elbow bump all right there with Dr. Barney Graham of the vaccine Research Center who working with Kizmikia, I would say are the main reasons how this messenger RNA approach ended up being successful so that's kind of a nice picture as well. And as of yesterday, how this is the data from eight o'clock last night, we hit a milestone, 101 million doses have now been administered not just distributed but administered gone into arms. Many of those first doses, about 30 and people have gotten two doses. And interestingly, people over 65 at highest risk 61% of Americans have received at least one dose. And I know this got off to a rocky start and there were lots of issues about distribution administration but boy we seem to be hitting our stride now. With two and sometimes more than two million doses a day, and the way in which the manufacturing has geared up so that there's going to be sufficient doses, pretty much for everybody who wants one. We are on a very good path in the United States now to achieve this kind of immunization by this summer for people who are looking for that and of course we hope that will be everybody. I mean, while worrying about the hesitancy that some people still feel about this which is something we also have to address. So I've told you a bit about things that relate to coronavirus, particularly the vaccine efforts, little plug here for my own director's blog, which I post every Tuesday and every Thursday stuff about what's going on at NIH and for the last year. I would say 90% of it has been about COVID because that's what people want to hear. If you're not already getting that, or if you're not one of my Twitter followers at NIH director. Please feel free to join up because I'm always trying to put information in front of everybody about what's new in the scientific investigation of this virus and what we can do about it. So that's a positive story but before I finish let's actually look at the state of the pandemic across the world and realize that yes, we still have a long way to go and we have a lot to be grieving about in terms of what has happened over the last 14 months. This is the Johns Hopkins site which I think many people look at regularly I look at it every morning to see where we are over here on the left global cases 119 million. And for the United States 29 million so we have about 20% of the cases, even though we have only 5% of the population that tells you we haven't handled this very well. More seriously global deaths 2.6 million people have lost their lives and more than half a million of those in the US also telling you that we haven't handled this in an optimal way when you consider the frequency with which we have been hit hard by this. We have a lot of work to do and it is truly tragic that over the course of these 14 months, there have been missed opportunities, oftentimes because politics got mixed together with public health. And that really is not the kind of thing that is going to serve us well going forward. We are now in a much better place with the vaccines getting put out there with cases having come down, but they haven't come down that far we still 50 to 60,000 people a day, getting diagnosed with coven 19 over 1000 deaths and day, and we worry about the variance that are beginning to emerge in various places including the US that may be more contagious. There's ever a time to double down on those public health measures, wearing the mask, six foot distances don't congregate indoors. It is now and it is really unfortunate that some political leaders don't seem to get it in that regard that we really have to work together in order to get us through this and have a reasonable reasonable good chance by the summer of being able to be in a better place. The NIH has a website if you want to know more about what we're doing communities fighting coven, please feel free to use that for all kinds of information about what we're doing with testing with treatments with our strategic response. But I want to finish just with this slide about what hope is all about because people want to have hope we've all been through an incredibly difficult time. Hope is not a strategy all by itself hope in every sphere as Peter Levi has written is a privilege that attaches to action, no action, no hope. That button that I wear on my lapel is a shape like a guitar pick for reasons that might relate to the fact that I'm a guitar player but it's supposed to remind everybody and myself as well that while we are the National Institutes of Health, we're also the National Institutes of Hope, and that ought to be the thing that we try to move forward by the actions that we are taking. And for me it has been an incredible privilege I'll be at a totally exhausting one to be able to serve as the NIH director in the course of the worst pandemic that the world has seen in 103 years, and I can now see a path forward that is going to get us past this, but we're all going to have to work together to make it so. Students, if you needed evidence that science is the best solution we're going to have to an awful lot of challenges, whether it's climate change, or whether it's COVID-19, here's your evidence. And so I'm really delighted that there are young, talented visionary creative folks that are going to come and join us and if you want to think about a career in life science let me tell you it's going to be an amazing few years as we take everything that we're learning about how life works and how disease happens and take it to that next level, and you can be part of that team and we hope you will be. And with that, I will say very much screen and see if there are some questions. I'm hoping there's somebody still there. Yeah, it's me. I missed my cue there. I, the questions are going to come from the students and they're already prepared. Thanks Francis for an extraordinary talk. And all you have done to get us these vaccines with your colleagues. And we're now going to hand it over to Gracie for the first question. Good morning Dr Collins I'm Gracie and my question is, how did the NIH, along with leading scientists coordinate a national effort to produce a vaccine in record time. Well thanks Gracie for the question. I hinted a little bit about the partnerships that we developed, and one of them this thing called active was a big part of putting together a master protocol for vaccines. And then we had to basically line up all the clinical trial networks that could actually enroll participants, and you'll hear more about that from Dr gay. But maybe the most important thing I should say is we have to give thanks every day to the volunteers who agreed to sign up for these trials. And they didn't know whether the vaccine was going to work they didn't even know if they were getting the vaccine or a placebo. And they agreed to be part of this incredibly important journey in order to give the information that we all now benefit from in terms of finding out what works and what doesn't. So that was our most important partner I guess, but it did take an enormous coming together around the same table not worrying about who is going to get the credit to bring the best science from every sector together, and to do it at record speed. One of those things that I think we have never quite tried to do at this scale or in this timetable and it worked because of the dedication and the smarts of the people involved. Thank you. Fantastic and now our next student question is from Morgan. Hi Dr Collins, my name is Morgan. My question is, as coven 19 is affecting the entire world. How has international collaboration assisted in fighting the virus. Morgan that's a great question. You saw that map of the world from the Johns Hopkins site, and while we focus, most of our efforts on the US as a US agent of research we are deeply concerned about the entire rest of the world. As a research director. I've had the opportunity to work with the leaders of all of the other countries that have major investments in medical research. We're having another meeting next week of that group. And that group represents about 95% of the dollars that are spent publicly on on medical research. We've tried in every way possible to coordinate, figure out who is running a clinical trial on which particular therapeutic, for instance, we particularly work closely with United Kingdom in that regard. But with vaccines, obviously we do want to be sure that successful vaccines are made accessible to everybody. It's going to be critical for this pandemic to come to an end. It is both an altruistic motivation but you could also say it's selfish if this virus is still spreading around the world, we're not going to be able to say that the US is out of the woods. So we have worked and able to do so more easily now with the covax effort, which is the way in which vaccines are to be distributed, especially to low and middle income countries. We're not going to be sure in every way that we've enhanced the manufacturing capacity. We are thrilled to see that the Johnson and Johnson vaccine is a single dose, which means it's going to be easier to distribute in difficult circumstances and it also doesn't require freezer capabilities beyond a simple refrigerator. That's going to be a big help to the future. Likewise with the AstraZeneca, although we have less data about that so far in the US. Let's be clear. Global is not the opposite of domestic and domestic is not the opposite of global. We are all intertwined as citizens of this planet. And if we forget that when it comes to a medical question, then we are not doing our job. So thank you for raising that. Thank you. Thank you, Morgan. And our next question is from. There we go, Nick. Dr. Collins, thank you for your remarks. I would be curious to know what your view were on what the most important next steps for the scientific community would be in terms of enhancing and restoring trust in the work of scientists and other experts. Thanks for the question. And it's really important that we figure out how to do this. It is deeply troubling when you look in the United States at attitudes towards accepting the vaccine that we still have, depending on which group you're talking about, anywhere from 20% to even 40 or 50% of people saying, I'm not sure I want this because I'm not sure I trust the science behind it. I think we have a history here that we have to acknowledge for African Americans, the history of Tuskegee is still very much on the minds of people know that that was a circumstance where medical researchers in an absolutely unethical way, took advantage of individuals to study a disease that was curable and didn't tell people that they could have been cured. And that lingers for a long time. So we have work to do to try to explain ourselves and that this instance of COVID-19 and other things that we're doing now in science would definitely not go down that kind of unethical road. There would be no way in the current climate that we could allow somebody to do so. But that takes time. And I think one of the things we need to do, Nick, is to have voices coming towards the skeptics that are actually people that resemble them in terms of life experiences, maybe even in terms of race and ethnicity, because, you know, for me, this, you know, old white guy from the government to say trust science. Maybe that doesn't necessarily cause those people who are skeptical to say, oh, yeah, I can, I can believe it now because Colin said it. We need to have more of those voices that come from many different directions that have credibility in their communities to try to convey the facts. But I have to say, if I'm really troubled about the aspect of this over the course of the last year, it does seem that we're in a crisis in our country in terms of people's ability to distinguish between things that are actually true objective facts versus opinions that people may hold very strongly but turn out not to be true or worse yet conspiracy theories which social media has provided an amazing platform for distribution. So that would be a lesson I hope we can look at soberly in a case where I'm sorry to say I think the lack of adherence to objective truth has cost tens of thousands of lives. This is not just an uncomfortable situation. This is a dangerous situation. And how do we figure a way to come back as a nation to be a nation where truth is our standard is our touchstone. It's how we make decisions. Scientists are in a position to be able to be the holders of those truths, although we all know that science also can be wrong and has to revise itself when new data comes along. So we all have a role and it's not just a few of us. It's all of us. So all of you students at NCSSM, whatever you end up doing, you're going to find yourself in a position of needing to be a purveyor of facts even when they're inconvenient. And I encourage you to do that with all the energy and courage that you've got. Amen to that. We got two questions left here. So next is Tyler. Good morning, Dr. Collins. My name is Tyler and I was wondering how we can execute a proper lockdown without causing loss of jobs, homelessness and a taken economy. And on a second note, if it's too late, just order another one after America's mostly opened up. Tyler, great question. These are all great questions. You know, I really have not liked that lockdown term. It gets used a lot. It's sort of as if it's either all the way on or all the way off. And lockdown means everybody goes in their house closes the door, businesses are all totally closed. I think we have learned along the way that there's a more nuanced way to do this to prevent the terrible economic trauma that has happened in so many places in our country and people are still suffering from. And I think what we need to do is say look at the data. Clearly, putting a mask mandate in place makes total sense, but that doesn't mean you're locking down that means you're basically trying to reduce or eliminate the spread of the virus from asymptomatic people which this is the big deal about SARS-CoV-2 that that's thrown us into a much more difficult place that you have people walking around who have no symptoms who can be super spreaders. And that's why the masks are so critical. So yes, let's not lock down but let's be sure people are wearing the masks and certainly let's pay attention to the other dangerous places where spread happens which is often indoors where there's not enough ventilation and especially if people are tempted to get close together and take their masks off. Well, think bars for instance. So doing these things in a graded thoughtful science-based way where you can dial up or dial down the restrictions based on what's happening in the community makes a lot of sense. A absolute hard-edge lockdown has not necessarily made a lot of sense and has actually turned a lot of people off. Is it too late? You know, I hope we don't have to do this, but I do worry this B117 variant from the UK is now 30% of the isolates in the US. It is more contagious, like 50 to 70%. It might even be more serious and cause more serious illness. If we are in a circumstance where a fourth surge could still happen, we got to watch closely and that's why this would be the worst time to prematurely start opening things up. But we don't have to lock down to be smart. Let's try to find that balance. Great. So last question from Sria. Hi Dr. Collins. My name is Sria Mantena. Thank you so much for taking the time to kind of share your knowledge and enthusiasm with us. I was wondering what is one thing about the current crisis that worries you the most and what is one thing that gives you the most hope? What a great final question. Well, I just alluded to the thing that worries me the most. It's these variants. The B1351 that particularly has taken over South Africa, which is now in the US, the B117 from the UK. And now we have our own homegrown variants in California and in New York that are worrying us. This virus is able to follow amazing path of evolutionary selective advantage as it travels through lots of people. The best way to stop those is to have fewer infections because the virus isn't going to evolve unless it has a person to evolve in. So that's what worries me. What gives me hope is looking at that trajectory of vaccinations over 100 million doses in arms as of today and seeing the path forward that that can get us to in this country and in the world to be able to say we have conquered this. I think we can do that. But as the president said in his speech on Thursday night, that's not just because public health people are doing that's because all of us need to get engaged. We're just wearing your mask. That means if you get offered a vaccine, take it. Don't wait for the next one or wait for somebody else to try it out first. We can do this and that gives me hope. And yes, hope is attached to action. We're all about action and I know you are all too. With that, thank you all so much for the chance to speak to you as part of this remarkable symposium, and you've got lots of other great speakers waiting in the queue to tell you about their expertise which is going to be amazing. Many thanks. Thank you Francis and one of the things that gives us hope is that you're in the role that you're in doing all the things you were doing and hey thanks for all the shout outs to our journal. We're proud of all those papers and we really appreciate Dr Corbett and Dr Graham sending us the spike protein on February the 10th. Thank you Francis I know you probably got to go beyond some other major cable channel in the next few minutes so we appreciate you joining us. Thank you. The next section is a tremendous panel. That will be introduced by our next speaker, but before I introduce her I just want to explain how this is going to work we're going to use the q amp a function of the of zoom. So you can submit your questions be sure that your name is on the questions. So that Secretary Sanders who will be moderating the panel can read out who you are and if your question is selected, it'll be presented to the panel. We'll be doing a zoom panel with the zoom q amp a and most of you have probably done that many times now in the last year so I think that's probably self explanatory. Now it's my honor to introduce the Secretary of Commerce of the state of North Carolina Michelle Baker Sanders. Secretary Sanders got her BS in biochemistry at the first university where I have my first faculty job North Carolina State. She got her master's in health administration at Pfeiffer College. She has been an executive at many important biotech and pharmaceutical companies in North Carolina, especially at Biogen, where she had a very important role in the manufacturing there that employs so many scientists in the research triangle region. She has been an important advocate for equity and prosperity and the Cooper administration she was the Secretary of Administration, and then she became the Secretary of Commerce on February 12 so she's been the Secretary of Commerce for 31 days, but she still has time to come do this for all of us Secretary Sanders. Thank you very much and I'll turn it over to you for the panel. Thank you holden very much. I am so glad to be here today. I'm here with this panel of experts that we have come in before us, and with the others on the program who are sharing so much of the intellect and insights surrounding coven 19 and the vaccine nations and, and everything that impacts us and also everything of the toast, and I'm looking forward to hearing from the panel members on vaccine development and distribution mask efficacy and other learnings from this past year of the pandemic. I'm sure that you would share with me and saying that there's been so many emotions during this difficult time for all of us, but I have to say when I saw on television, the truck leaving the Pfizer facility, which meant that there was product coming from the market. I was so full of emotion. I was full of hope. I had pride, and I was just so thankful because I was just pleased that the life science industry. All the scientists and researchers had come through for society and for the world. And so that's just the way that it goes, I believe in our sector of science there's so much. So much that science offers to problem solving and to all the tough problems that we are all faced with and will be faced with. I want to applaud all of you who have the interest and who are pursuing the studies and really hope that you will continue to do so for it for sure the world needs you and needs more people like you and the esteem panel that we have today. I'm also very glad to recognize that we have fully vaccinated more than 1.1 million people in North Carolina. And in fact, the Kaiser Family Foundation ranked North Carolina as the first in the nation for vaccinated the largest share of it 65 and older population. That's, you know, no small job or task at hand. And so we're pleased to be here in this state as residents and be a part of that. And Bloomberg has recognized North Carolina as one of the best performing states in the country and distributing vaccines evenly among black and white residents. We have to do in part, because we have excelled at collecting demographic data of those receiving vaccine. We have racial data for 99.6% of the people who have gotten a shot in our state. North Carolina is committed to a fast and equitable rollout and distribution of all available vaccines. And having good data on the race and ethnicity of those vaccinated in our state means that we can work to make sure that the population receiving vaccine mirrors the diverse population of our state. And so you can visit North Carolina Department of Health and Human Services website at your spot your shot dot mp.gov to check on when you'll have a spot to get your shot. And so it is a real pleasure and privilege to be a part of state government and serve in the state in this in this way. I like to call on each of our panelists now to briefly introduce themselves before we dive into today's questions. So I'm going to start with Dr. Corbett. And Dr. Corbett, if you will, just give us a brief introduction of yourself and share with those joining us today. Dr. Corbett. Hi, everyone. I, I'm Kizmiki Corbett and I am a bona fide Hillsborough, North Carolina native. I graduated from Orange High School. And during that time I actually worked at the University of North Carolina Chapel Hill. I was in high school and then also I went back to UNC for graduate school so Carolina blue is the color of my blood, I like to say. I now work at the National Institutes of Health and the NIA ID at the vaccine research center, where I am a research fellow so that is the part of your career where you're still figuring out your life that's how I like to term it but it's after your PhD and before you go on to do more independent research. And so I work under Dr. Barney Graham, and I do coronavirus research and have done coronavirus research for the last six years there. And a lot of our research as Dr. Collins explained has really been proven to be very fruitful in this time of the 19 pandemic and so we've been fortunate enough to be able to deploy some of the science that we, we had figured out in the last six years towards vaccine development in the very rapid speed. And yeah, it's nice. It's really nice to be here I also almost went to North Carolina School of Science and Math when I was in high school. Similar to Dr. Thorpe, I didn't understand what the, the gravity of admission into the, into the school men and so, nevertheless, I'm still here today and I'm a scientist and I'm very happy to be with you all. Thank you Dr. Corba and we are so proud of of you and I'm really proud of those deep roots that you have here in North Carolina. I just wanted to ask Professor Fisher, please introduce yourself to please. Thank you, Michelle. I'm Martin Fisher, I'm associate research professor in the Department of Chemistry and Physics at Duke University, so darker shade of blue. I'm here also direct the advanced land imaging photography facility. What I usually do in during my day is develop methods that use ultra short laser pulses to image the structure and chemical composition of very complex materials, such as skin or solar cell materials or even even historical paintings. I did a little bit something different during the lockdown. I was asked for help by a colleague by a medical doctor from the Duke clinic that who needed to help with testing some masks that he wanted to distribute to the community. In response, we developed a very easy and low cost method to test the ability of mask to block droplets that are admitted during speaking. We demonstrated this technique, and in a few household masks, very common masks, and we noticed a surprisingly large range in the performance of these of these masks. So by doing these tests and developing this technique, we, we have, I think, helped improve the overall quality of masks we have helped a large number of people and labs to set up their own rig to test these masks. Thank you. Thank you very much. And I would also like to welcome Dr. Tropshaw. Dr. Tropshaw as you will introduce yourself to our members here. Thank you. Good morning. I'm Alex Tropshaw. I'm a native of St. Petersburg and Moscow in Russia. I've been at UNC since 1989, overlapping a good portion of my time with Dr. Thorpe when he was at UNC. I'm a computational scientist. My interests have been in the area of computer-assisted drug discovery and later in data science and application and informatics in most general sense to make sense of biomedical data. In the past year, I would say it's been two main areas and directions and research. One is computer-assisted drug design against SARS-CoV-2. And second, capturing and making sense of incredible amount of research that's been going on in different directions as it relates to coronavirus. If you mind PubMed, as of today, there are more than 112,000 papers that have been published since people learned about coronavirus. Many impactful research papers have been published in science, thanks to Poland for promoting this research. And so there's an enormous amount of information that relates to understanding the disease and disease progression and the future of the disease and the future of pandemic research and anti-pandemic research. And there is a lot of interest in development, perhaps a little bit overshadowed by the success of vaccine into drug discovery, low molecule-weight molecule, drug discovery that still is an incredibly important area of research. Patients, as you know, are managed if they happen to get sick by traditional medications. So that area still needs to continue and be supportive. Thank you. Thank you very much. So as you can see, indeed, we have an esteemed panel with us here today. And I'm going to start and move right into the discussion. And I'm going to start with Dr. Corbett. Dr. Corbett, you're from a small North Carolina town, as I am too. And you've talked about how surreal it's been to be leading the cutting edge work of rapidly developing a COVID-19 vaccine. Can you talk to us about the equation of speed and safety in the vaccine development process? I'm sorry, you said the what of the speed and safety. Can you talk to us about the equation of speed and safety in the vaccine development process? How those two have been working hand to hand. You know, sometimes I think that when we hear about the speed of forward error, sometimes people think, oh, is it really safe or is it not safe? Talk to us about that. Right. And you know, I think Dr. Collins touched on this quite a bit. You know, their vaccine development has been said via the media to take upwards of 10 years. And that actually is generally true. But there are several factors that come into play in that and that one of those large factors is the preclinical side of things. So that is before the vaccine actually gets into any one human ever. There is a large body of preclinical studies most of the time in animals to tell us whether or not the vaccine might be safe or illicit and illicit immune responses in people. And so that amount of data, that package of data that is necessary, we had a full package of data around MERS and our mRNA vaccine for MERS, which is another coronavirus that could have actually been submitted to an FDA for a phase one clinical trial even prior to this pandemic. And we were able to use a similar set of studies to move really quickly into a phase one clinical trial in the case of this current SARS-CoV-2 pandemic. And as far as safety is concerned, aside from all of the preclinical testing that happened prior, there are checkpoints at each of the stages of clinical trial that tell experts at the FDA and otherwise whether or not a vaccine is safe. And as those checkpoints are made, then you can go to your next phase of the clinical trial. So as Dr. Collins was saying, there was really this large effort to cut out the time wasted here where we would wait and you would get full results from the clinical trial. And then you analyze them and then the company decides whether they want to fund it and all these other things. There was resources poured into this and there was really strategic thought around how can we cut out those times that are wasted so that we can move really quickly in the case of this being a very dire circumstance. None of the steps were skipped. Actually, it's my understanding that actually some of the steps actually are compounded here and there's extra precautions taken given these circumstances. And so that's kind of how it worked out from a timing and safety perspective. Thank you so much, Dr. Corbett. And I'm going to go back a moment because I was being too anxious and hasty and forgot one of our expert panelists to get an introduction for her. Dr. Oleg, I apologize to you for moving too quickly. And would you please introduce yourself and then we'll go back to our discussion. Thank you, Secretary Sanders. I'm like you. I'm excited to hear from the scientists. I'll say I am not a COVID researcher. I am a knowledge broker or a force multiplier. I am the Vice President of University collaborations at RTI International. I support the research and implementation work of colleagues and partners at RTI. And RTI as many of you know is a nonprofit mission-driven research institute located here in the Research Triangle Park area of North Carolina. And Dr. Corbett, I'm actually joining you from Orange County, not that far from where we're used to live. Dr. Corbett has been a leader in science and research for more than 60 years. And during the coronavirus pandemic, we have worked at local, state, national and Morgan's question I think is important, global levels on a range of issues from predicting the scale of the pandemic to monitoring and potential vaccine outcomes to helping teachers in the new environment to COVID-19 emergency preparedness messaging for people with disabilities and extreme low literacy, as well as slowing the spread of COVID-19 in the Philippines. So the work of my colleagues and the researchers at RTI informs policymakers, the medical community and practitioners. And notably my esteemed colleague Dr. Doris Rouse is a member of the NIH group that Francis Collins referenced who work on public-private partnering to address COVID-19 and future pandemics. So thank you. Thank you so much and we're glad to have you here. Back to our discussion and Dr. Corbett, thank you so much for really highlighting how speed and safety has worked together and can work together. And the one thing that we never compromise right is the safety piece of it for the sake of anything because that is so important and vitally important when it comes to a patient safety standpoint. So thank you very much for that. Now on to a second question. I'm going to turn to Dr. Shropshire for this and Dr. Shropshire, a recent article in the magazine Science, discuss findings from viral epitope profiling of COVID-19 patients. Tell us about the implications of that research. It's a great, really great and highly visible paper. It's been cited nearly 70 times and was only published in November. So that indicates the impact that it has. It really addresses a critical question that has been asked but not necessarily answered and that is, can we forecast the severity of the disease? We know the origin of the disease. We know the virus that causes the disease. But it really touches on the issue of personalized medicine and personalized approach to figuring out which people are going to get infected. How the history, the history of viral diseases that they had, demographic and other factors, how those collectively determine whether the person is going to get the disease and if so, what the severity of the disease is going to be. And so it's really looking at an interesting way of making a test that could forecast what's going to happen with individuals. It's the beginning. It's really a multifactorial situation when it's hard to make an assertive statement, but it's beginning to look into methods and tests and protocols that can forecast the degree of the disease. And that really is critical in terms of selecting people who should be vaccinated more or less frequently, perhaps looking at the differences to vaccine reaction. So that's overall the impact of this type of research. Thank you very much, Dr. Shropshaw that was insightful and helpful to us to really understand those implications. Professor Fisher, your article in science on measuring mask efficacy, got a lot of attention from the media and general public. You have mentioned that in some cases, your data was misinterpreted. What do you want folks to take away from your research? And what are your next steps in studying mask efficacy? Thank you. Awesome question. It was indeed an interesting story. So since this work was published in Science Advances, actually, there were about 500 news reports related to this work. Most news reports got the gist of it. Some really did not. I saw some headlines that read certain face coverings, increased a transmission of coronavirus, worst and going maskless. That is not at all what this work was about. This was really a developmental effort for a measurement technique to measure mask efficacy, not with systematic mask tests. So now, while it's true that measured one mask in particular that produced a lot of small little droplets. This was so more droplets than the control without the mask. We were very clear that this result is not generalizable to all masks. So in summary, basically, not all gators are bad. And this is what the gator gate got started from this. So it depends so much on how you wear a mask and what material the mask is. If you do a single layer, a double layer, it's really hard to generalize. So the key message is that every mask is a little different, so be careful what you wear, use some common sense. So what's the other question was what's next. So we are not the Duke face mask certification facility right we are in the business of testing masks. What we do help people with is setting up their own rig to test these weeks. We've helped research labs manufacturers you help clinics, even a major airline museums, all want to set up their own mass testing rig. And this is going to be very important, not only for testing the mask but also show that the mask actually does something it's it's easy to see the changes. When you put on a mask or something you don't put on a mask. Okay, great, you know, Dr Fisher also I guess you know one thing that I think many of us if not all have noticed sometimes the mask that are worn and I know you're not the certification by there. I'll type below the nose. And, and so, you know, give us your thoughts on that and your feedback on it I think we all know but you wouldn't hurt to hear that from an expert like you. Sure, it's an awesome observation and I've seen many mass squares that have a mass dangling off the ear right a mask that you dangle off your ear is really not doing anything. There's there's a there's a trade off when you wear a mask right you can do you can wear a mask that is really tight fitting that's an N95 that is super tight super good and performance. That's one extreme. It doesn't have to be a perfect mask to help right you also need to be aware of that you need to wear the mask. You actually need to wear the mask. Right so if you if you wore an N95 mask, and you can only stand that for 10 minutes then you take it off and put it aside then you run around without mask. That's not helping anyone. So you got to wear you got to wear something that you actually are willing to stick with if you go out and after five minutes you toss it in the trash that's not good that that's not a good mask. So, the other question that I actually see in the Q&A already is, well, what about the people that that don't want to wear a mask and then they don't believe that that it's not valuable. Well, it's hard to believe to convince people that that have their mindset, but haven't have an open mind just because somebody else on Twitter says, Oh yeah, I'm asking useless don't believe that do your own research look look at look at the facts. There's, there's lots of research out there that that shows masks, even if it's a, even if it's a cotton mask that is not perfect but that it maybe prevents 90% of a mission that really goes a long way. There's lots of demonstrations out there that shows that masks are efficient that's why medical folks wear a mask that they don't wear a mask just to look pretty right that it actually helps. That's true. And thank you so much for that. You know, Dr. Oleg, one of the challenges with this virus is doing the needed social distancing that takes such a toll on us, you know, psychologically. And I would like to turn to you that as how can we use positive psychology to help us through this phase of of containing the virus. What are your thoughts on that Dr. Oleg. Thank you, Secretary Sanders. Well, you know, according to UNC Chapel Hill, a scientist Dr. Barbara Fredrickson, what is needed now is not social distancing, but physical distancing and social solidarity. So the best advice is to increase our positive heartfelt connections with others, especially people beyond our inner circles. And we know that connecting to community brings out the best in all of us. And over time it makes us kinder more humble and brings us a greater sense of unity. So during these challenging times, it's more important than ever that people stay connected and help each other. I think really what we need are more innovation. We need more innovation around new approaches to socializing in safer ways, ideally outdoors during the COVID pandemic. And I think that is something we all can benefit from hearing and doing during these difficult times and post pandemic as well. Right. Just to be able to move safely and and engage ourselves and engage in a safe way. So thank you so much with that. Dr. Schropzer, I'm going to ask you a question. And around how we can better prepare you think for the next pandemic. And then I'm going to go to each of the panelists and panelists I'll ask you to just maybe we have a speed round where you can give us a key takeaway for folks today. And so first, Dr. Schropzer, how can we better prepare for the next pandemic, which we hope will not happen, but we're going to be in that reality do them here because we know things do happen. So how can we better prepare. Let me share my screen, if I may, can you see my screen. So this is this is a study that that we have conducted sort of in this regard with a little bit of history and a little bit of projection. The curve here shows research response to COVID-19 measured in the number of publications as of as of about mid 2020. As I mentioned this paper is learning from history do not flatten the curve of anti viral research. And what we have done here is to look at research response to pandemics historically that hit the world at different times in the last 20 years. So this is really, we talk a lot about a spike in different context. In all cases it was a spike like research to pandemics the pandemics hit. People get interested the pandemics goes down. So does the research interest in in pandemic. So what we really advocated for and I think that's my answer to this question is we should never stop anti viral research and just in contrast. This is what's been happening with HIV research since the beginning of the problem. It was a huge amount of attention. We are developing medications and treatments against HIV and it's been steady research interest funding and steady development of medications against it. And so really what we need to do is to understand the sources of the pandemic to understand similarity in diseases caused by previous viruses. And understand the general causes and sort of preparedness in terms of drug discovery, vaccine discovery research, but do this on a stable ongoing basis and really focus our effort on understanding how we can continue to develop rapidly a broad spectrum and they were all drugs and broad spectrum. Vaccines. So that would be my answer to this. Thank you, Dr. Schropzer. So panelists as we wrap up this portion of our panel and move into q&a. I'd like to ask each of you. Take away a key takeaway for the folks here today. And Dr. Corbett I'm going to start with you and I'm going to get a little more specific on this question if you don't mind. You know, the field of science and stem is in I believe desperate need of being more inclusive and diversifying the talent and the pipeline that we have specifically with reference to COVID-19. We know that COVID-19 has disproportionately impacted people of color with this virus. And so, you know, that's no surprise to me and hopefully is not a surprise to many people. So I'd like to ask you as an African American and female in the face of science and research and and the landscape there. I like to ask you about what is your key takeaway for other young women and other people of color who would like to get into this space but may have some hesitancy for whatever the reason. I think what you have demonstrated and shown is what's possible for all people. And not only that, but you have also had to overcome probably some some challenges and barriers that are unique to you and who you are. And so I'd like to ask you what is your key takeaway for the students and others on the phone about what's possible, how to manage and navigate that. And once again, helping them to realize the significant contributions that they can make as you have made as a North Carolinian as a black female in this space. You know, so I get that question quite a bit. My answer remains the same in that I think that one of the key takeaways for me. And I hope also for everyone is that just staying true to yourself is important. And that's really what diversity means in a workplace is that everyone can come to that place and be exactly who they are, but still be productive. And so I notice my hair has changed in the last week because they just decided that I was done with wearing straight hair because I, I made kind of an unconscious decision to wear straight hair because I have my media appearances over the last year. And then I decided that I was just going to continue to just be me at this point, and that I prove myself maybe already too much. And so that's the first thing. And being me was the reason why I actually was so dedicated to continuing to work on Mars, which is the coronavirus that was circulating in 2014. The BRC was planning to just discontinue their vaccine program for Mars because it didn't really have a clear cut way to be a product because Mars was taking a downturn. The outbreak was clearly not going to turn into a pandemic of any substantial proportion. And so, you know, I was, I come from a family of people who have diabetes. My mom might honestly, at this point, probably me at some point, but I mean, I'm joking, but just genetically, it's something that is, and if I was going to be as anxious, I was going to do something that even in the slightest place helped my family. And I chose vaccine development because of how interested in is especially from a virology standpoint. But then there was a paper that came out that Mars was had the worst outcomes and people who had diabetes and then someone followed that up with the receptor and on the lungs and people have diabetes or more abundant. And I was like, okay, well, then if I'm going to work in this place, then I have the ability to work on basically anything that I can. You could think Dr. Collins for that, like, you know, and I actually kind of have that unique ability. And I might as well work on something that at least closely helps my family. And that was me kind of just bring myself to the table. And I think that that's it. That's really the entire point. Sure, they're going to be countless barriers and you could literally save the world and still have them placed in front of you on a day to day But, um, I mean, I'm Christian so I don't, I don't think there's anything that God can do through you. Right. So that's how I kind of look at it. Thank you. And amen to that. And so I think you're so right. It takes all of us and it has taken all of us all the differences that we bring to move beyond and move to the point that we've gotten. And one thing that coven 19 has really shown all of us is that we are so interconnected. And we have so many similarities. We have differences, but yet we have so many similarities and the contributions that we all bring to problem solving is for innovation is that it's best and problem solving is that it's best. So thank you, Dr. Corbett. Dr. Oleg, would you leave us with your key takeaway. Thank you. Thank you. I think for me, what's really struck me is, you know, the example of Dr. Collins and bringing together government and industry to develop and evaluate new vaccines and therapeutics, and just how much we need public private partnerships for these challenges. And I'm really proud that RTI has been investing and will invest in jump starting collaboration through the forethought. This is a five million dollar research collaboration challenge that invites bold visionary proposals, because this is these types of challenges at this scale takes partnership on, on a scale that we really haven't seen before. So the, the vitality and the essential nature of public private partnerships has been my biggest takeaway. Thank you. So true. Would you share with us. That's the easy question. So the key takeaway, I guess, what goes for a selection of masks goes for pretty much everything. Learn to hone and apply your your common sense. It's easy to get swept away in news and social media wave and on a certain topic, but you really have to learn how to how to evaluate information critically and then of course act accordingly. There's there's so much information out there don't don't be content with what you're fed by any sort of feed or whatever it is. Do your homework in a sense that go out there and actually be curious, see how things work go to other sources and, and make sure you, you know what you're what you're broadcasting if you do this on social media and, and yeah, look around be curious. Do your work. Yes, be curious and do your work. Yes, that's a shopster shop for share with us your key takeaway. Um, I guess the ability. So I mentioned how enormous the information stream has been and I think other panelists talked about, especially Martin, how difficult it is sometimes to figure out what's right what's wrong. His paper he mentioned was misquoted. And I think it's just the time to be, I don't know, perhaps more introvert in processing information in comparing different information resources, I'm an informatic sciences, scientists, and making sense of information, making sense of data, separating signal from noise. That really what, what is it all about for kids and for grown kids called adults is how to really learn how to be objective how to be data driven, how to be model derived from data driven, and how really how to, for me, the main message is trust but verify. Trust but verify everything that you hear everything that you read about and, you know, again be data driven and study tools as a data scientist study tools that help you understand and make sense of data. Thank you very much. I would like to thank all the panelists during this discussion we're going to move into our q amp a section, and we already have questions coming in. So, I will begin the q amp a the first question is from having long, who is a student journalist and student at North Carolina school and science and math and the question is, how can journalism and news majors contribute to helping out in the effort. And that's all like I'm going to turn to you and ask you if you can offer this student some advice about how news majors and journalism can contribute to the coven 19 effort. Thank you Secretary Sanders and thank you for that excellent question. As you may have seen in my bio I'm trained as a academically as a historian. I think it's really important that everybody sees that they have a role to play and tackling some of these challenges. And I think what we just heard from from from Dr throat show about separating signal from the noise and the importance of being able to critically communicate information and sources and interrogate sources is something that is bread and butter to historians as well as to journalists. So I think going into media or maybe I'll try to recruit you to our Center for Communication Science at RTI. We need students and young people with background in science based fact reporting in our agencies in our research institutes and in our universities and in our media. So, you definitely have a role to play. Thank you. Dr structure. How effective are the drugs that have been created to combat coven 19 in parallel to vaccine that have been produced. Right so that's that's an interesting question. So, as you know, in December, that was not initially developed for COVID-19. There are no drugs specifically developed to treat this disease and approved developed and approved. There are clinical trials of the Pfizer drug that they're ongoing, which also was initially created against another version of SARS SARS one. So, we're really talking about how to use current medications to manage this disease. And we're talking about how to, you know, back to Francis top, one of the most incredible observations that he made is how previous science had expedited the vaccine from so far the fastest 10 years to less than one year. That's the challenge for common drug discovery and and I continue to maintain that drug discovery. Small molecule large molecule drug discovery should not be overshadowed by ability to develop vaccines for various reasons. They're not effective. Similarly, to all people. They're not 100% effective. And, you know, we need to continue to develop those treatments. So the challenges are how to develop broad spectrum direct antiviral. Compens learning from previous antiviral research and maintaining this research and how to develop host directed therapies that can in a long term protect humans from diseases caused by the viruses. And that's a little bit different question. And that's a huge broad area. I think we talk about it forever as the out to organize and speed up drug discovery but that's sort of looking into the future. That's my answer this question. Thank you very much. Another question as a student. I'm curious what kind of skills are needed in the area of disease and medicine. What are the most opportune fields of study. What kind of education will the future scientists and researchers pursue Dr. Corbett would you mind answering that question for us please. So I, I might not be the best person to answer that question because despite the fact that I have a PhD in microbiology and immunology, I have explored all corners of all subjects in any way that I can. I was, I was that person and I kind of rounded out by majoring in biology and have a double major in sociology, mostly because of influence of professors, and not necessarily with the end goal in mind because it is, it is my feeling that the best are the people who can think critically and anyone who can think critically about anything whether it be history or I don't know English lit probably could end up at the end of the day being a very productive scientists. There are basic levels of biology and all these other things that you have to understand, but the key is to learn how to think critically, first, and then to focus your energy on what will be your niche, and that is the or immunology or whatever and what have you. And so, you know, the general pipeline which I am also writing an article, a commentary right now that is called dismantling the pipeline because I think it is just something that has to happen in order for us to really pick up the most talent along the way, but nevertheless, I, if you're thinking about the traditional pipeline, most people go about doing things by majoring in a science and undergrad, and then getting a terminal degree also related to health so whether it be public health or an MD or a biology based PhD that's that's generally how people go about it, although I am. I'm again probably not the best person to ask because I'm trying to revolutionize that in some many ways but yeah. Thank you Dr Corbett I can't wait to hear more about dismantling the pipeline that sounds very. Take away throw it out. Thank you. The next question that we have the state given all the knowledge and experiences we have gained from dealing with COVID-19 pandemic. How prepared would we be from a societal and scientific standpoint. to deal with such an event in the future. And so, Dr Fisher professor Fisher I'm going to ask you if you would give us your response on that one. I'm probably the least qualified for all the panelists here to answer this question. This is I'm just going to echo what what Francis Collins said this morning, mixing politics and public health is an exceptionally bad idea. Right this is this is really changing the mindset of people. When I see folks that that refuse to remastered refuse to get vaccines. Well, how do you change the mind of these people. It's it's partly it's what you're being told right it's it's political question for which I don't have the answer to. So, I probably passed this question on to whoever wants to chime in because that's a question that there is no easy answer from my side. Dr Shropshire or Corbett or Dr Oleg, or, or we're going to go with you, Professor Fisher and, of course, all these questions can be discussed forever and probably many different perspectives. So I hope everyone is just enjoying and appreciating the responses that that we have in this limited time. Okay. So I have another question and Professor Fisher I'm going to go back to you on this one. As a high school teacher in Western North Carolina, many of my students do not believe in the efficacy of math. They are reluctant to wear them properly and are very vocal about their perceived uselessness. What is a good way to convince them that the mask are essential to combat in this virus, if they're unwilling to believe in research. If I only knew the answer to that. So I, I've seen Twitter feeds with videos of somebody vaping and having a surgical mask and stuff going out left and right. Sure, if you if you, it looks very impressive right it looks looks like the mask doesn't do anything, but I can, I can show you other videos that show exactly the opposite I mean, the fact that when you, when you speak that there's stuff coming out of the mask actually stops these particles. It might not be as as flashy you might not get as much attention. But it is, it is science based video science based facts and how do you make people believe in science. I'm working on that every day right it's a it's a matter of getting the message out and trying to combat these these fake science posts or videos, but it's it's not about. I'm going to answer. We have time for maybe a few more questions and this one is panelists please Dr structure I'm thinking I'm going to turn this one to you but if there's someone else that feels more comfortable answering. And the panelists have talked about how past research about coronaviruses and messenger RNA was useful to expedite the vaccine production process. What parts of that were directly applicable to cove it. And what were the main new things they had to be discovered. So, how in a similar way can we use current knowledge to apply to future pandemic, which I think we discussed that some earlier in preparation for future pandemic. So, Dr shop sir or Dr Corbett. I really think that's for Dr Corbett, because I think that she had actually talked about him just a nurse so I think that's. Yeah, I can answer the first one and then I'll have you repeat or maybe we define the second question but the first question is the thing. So, in science what happens is knowledge continues to build on each other. Right, so I, people are like, Oh, you have a 95% vacations vaccine. You can go and just all things happen after that but then comes a million and five questions like what happened to the 5% of people who didn't get it protected, and those kinds of things and so that's what's been happening for the last x 20 years or so with mRNA and for sure for the last six years in regards to how we have been understanding Mars, we basically have been asking question as I have a question. So we got to the point where we understood that the spike protein which is that protein that Dr Collins pointed to on his on his slides can be delivered by the messenger RNA. That was the point where we knew exactly what pre clinical or animal doses we could, we would test to prove its utility towards a human. We got to that point, and we knew exactly how to design that protein. We knew that and everything else that was to come after that is what was the discoveries for the COVID that were COVID specific. So, you know, we followed a similar model, but all of the clinical aspects of the of the vaccine relevance to what was was new. We had no idea whether it would work. We actually didn't know what doses to use in the clinic. I, but that's why there's this large dose range in the phase one clinical trial. And so those kinds of things, and then the second question I don't think I understood. It was basically how in a similar way can we use the current knowledge to apply to your pandemic. Oh, all types of ways. So there are about there were actually there are exactly 24 of viral families that can infect a human or have the potential to infect the human that is coronavirus is influenza, etc. So, all of these viral family are just hanging out in nature somewhere, potentially poise to jump into humans and cause this level of destruction. And if we could do the same exercise for each viral family, then the same way that we did it for coronaviruses, we could. We would obviously spend billions of dollars, but if we could drive a vaccine product into a phase one clinical trial and get phase one clinical trial data for each of the viral families by a mRNA vaccine candidate. I think that we would be in good shape around pandemic preparedness and full. So that approach is called the prototype packaging approach. And what that means is that you pick one of the cousins in the family. So one of the viruses in the viral family, and you make a vaccine for it. And you prove that vaccine might work for another vaccine virus in that family. And so I think that that has so much utility aside from the fact not only that but manager RNA has utility for because of its rapid manufacturability and reliable manufacturability to be able to deliver multiple things. So antibody therapies that are kind of hanging on the back burner at this point, but they could actually you could deliver antibodies the messenger RNA and use messenger RNA more prophylactically so before someone was to get sick. So those are the kinds of utilities for for messenger RNA, I know, you know, been reached out by several startup companies that are taking their own various approaches to give me so that there are dozens of companies that are popping up and everyone is really interested in their own approach messenger RNA so I'm excited about the future of the technology in full and how it's going to drive forward other technologies as well. Thank you very much. We're going to have this last question and then close out. I'm going to cap you on this one I know RTI international has a sense of experience and addresses and public health threats and lots of data and research there. This is with reference to rapid testing technology. And basically, do you anticipate that there will continue to be innovation in rapid testing technology. Now that vaccines are becoming more widely available. What are your thoughts. Do you think we're going to continue to see innovations in this space. You know, I'm thinking about back to what Dr Francis Collins spoke with us about earlier about the kind of the threefold the diagnostics of therapeutics and the vaccines and, you know, we need inclusive innovation in all of those in all of those realms. So I would like to think I would like to think the answer is yes and with with all of us working together. I think they'll continue to be innovations in that space. Thank you very much. And I'd like to thank all the panelists for your participation and insights that you share thank everyone who participated in and asking questions. And so I want to say that this is an exciting time in science with the rapid development and deployment of three safe and effective vaccines. Last week, North Carolina received 80,000 doses of Johnson and Johnson one shot vaccine. The third vaccine means that North Carolina can get more people vaccinated sooner. It means keeping people out of the hospital and preventing death from the pandemic. And so we are excited about the progress and going forward. And we continue to put our efforts forced to reach everyone, especially those models to analyze and underserved communities. Governor Cooper is continuing to advocate for more vaccines in the state. But as we wait for that to meet the demand we have those three Ws that remain our best tools to protect ourselves, our loved ones, and our neighbors. So I ask everyone to please continue to wear a mask, wait six feet apart and wash your hands frequently. And as our Secretary of Human and Health Services in North Carolina, Dr Mandy Cohen often says, whatever your reasons, get behind the mask. So thank you all so much. I'd like to thank the School of Math and Science for this opportunity and I'm going to turn it back over to Mr. Holden thoughts. Thank you, Secretary Sanders. And thanks to the extraordinary panel. Dr. Corbett, Dr. Tropshaw, Dr. Fisher and Dr. Olick, it's great to see all of you. And Secretary, thank you for your leadership and getting so many people vaccinated in North Carolina and so many other things. Now we're going to have a another terrific talk from another wonderful leader in science in North Carolina and around the world. Before I introduce her though I just want to remind everyone that there are outstanding workshops after this, that everyone should stay on for and lots of other exciting things to do with your colleagues as it relates to COVID and everything we've been talking about. But now it's my privilege to introduce Dr. Cindy Gay, who is an associate professor of medicine at the University of North Carolina. She is part of a team at UNC that is one of the great jewels in medical science in the world that works on infectious diseases. They have been leaders in HIV, where they developed many of the protocols that are used to manage HIV through clinical trials that they did around the world and especially at a very special place that I've had the privilege to visit in Malawi, where many of the most important HIV studies were done. You're going to get to hear from Dr. Gay about how she got to where she is and how she does this kind of clinical research around the world. She got her undergraduate degree at Duke University. She got her MPH and her MD at the University of North Carolina. As I said, she's on the faculty there in medicine. She is the medical director of the HIV Cure Center, which is another great topic. If you want to have another symposium, she could tell us a lot about HIV latency and how we might actually progress to a cure for HIV and not just managing it with medicine the way we do now. Like many researchers, she pivoted to COVID and has been a PI on the Moderna trial, and she is a PI and the co-chair on the trial for the Novavax vaccine, which just announced the last couple of days outstanding data from the United Kingdom and is moving towards completing a trial in the United States as Francis Collins just said. So with that, it's my pleasure to introduce my former colleague and great leader, Dr. Cindy Gay. Great. Thanks so much. I'm going to go ahead and share my screen so you can let me know if that's great. Am I good? Hopefully. I am just incredibly honored to be here today. I hope you all recognize what a truly remarkable esteemed group of people you've heard from today. I just feel, you know, incredibly honored that I was asked. Today, I've titled the talk at risk the challenge of COVID-19 vaccine trials, in part because my journey with all this started probably the end of the spring in 2020. And the word risk just kept coming up in so many ways, both in clinical care and in these vaccine trials. Hopefully, by the end, I'm going to have you thinking that risk is not always a bad thing, that it can be a great motivator. Before I launch on all of that, I want to talk or describe what a clinical trial is, because I'm going to talk about that a lot, and that's kind of what I'm going to frame on. Part when I'm going to tell you over the next few minutes is a little bit of a story of how it is that I came to be asked and I'm talking to you today. And a lot of that includes just my experience. I also want to frame this more of a story versus sort of what I typically do, which is going to kind of go through boring data and numbers and etc. To help you think about what a career in clinical trials might actually look like, what could it be? Part because of where you are and part maybe to inspire you because we need people with energy and passion and critical thinkers as other people have said. So what is a clinical trial? A clinical trial is a research study in which one or more human participants are assigned to one or more interventions to evaluate their effects. For the rest of the talk, I'm really going to be focusing on vaccines, but this could be either a drug, which is what I think most people are used to. It could also be a clinical trial of a device. Can it even be a clinical trial of something that tries to change behavior? Really, you're just trying to answer a question of does something work. So I'm going to sort of back up to a real big picture. This is a slide that Barney Grant and I shared with me and I've kind of mucked around with a little bit. The title of the slide seems a little daunting, the deadliest pandemics in history, but I really just want to make a couple of points and hopefully have a somewhat positive take on all of it. What you see are by size, the largest is the virus that had the highest deaths associated with the pandemic and going over time. And I want to make a couple of, hone in a couple. Smallpox is a really interesting pandemic for a lot of reasons. One, it was the second deadliest pandemic in our history. The other is that was the first infection, if you will, to have a vaccine developed for it. It also is incredibly notable because it is the only disease that we have wiped out from the planet. And that's largely due to having a vaccine for it. So I want to sort of put a exclamation point on the end of that statement about what vaccines can do, how effective they can be and how they can really benefit us. Another pandemic which is highlighted in the blue rectangle is the HIV pandemic, which up until a year ago I had spent my entire career focusing on. It has been a very deadly pandemic, in part because it's ongoing. It doesn't sort of have a pandemic that lasted a year or two, doesn't sort of run its course, it sort of hangs out in the body. And so we have a lot of people still living with HIV, a lot of people are still getting it. But the thing that I kind of really want to make the biggest point on is on this version of the slide, where all of the pandemics and outbreaks that you see highlighted in red, these have all occurred during my lifetime. I think we all sort of follow into this mindset that pandemics are something quite extraordinarily that why is this happening, this shouldn't be happening. And in fact, if you look at the slide over our sort of whole history, they do recur, and they're going to happen again. So we remain at risk for that, because these viruses and bacteria, they evolve as we evolve. And our lives are changing due to globalization and travel and climate change. And so these are going to change with us. However, I would say, if you look at the ones that have sort of occurred most recently, they do tend to cause less death. So I think we are learning things. The big challenge is learning or what can we learn from these pandemics. Can we allow technology that Dr. Collins and others have talked about, and motivation, which means people allow us to respond better. What else do we learn about these pandemics, in my own opinion, I think, in particular, the most recent HIV and the COVID pandemic, they uncover some ugly truths about inequities and who bears the burden of these. And respond to those in between the pandemics so that they don't have the same disproportionate fact. So flashing back to the year 2000, which is before you were born, I was in my second year of residency, I was already kind of knew that I was going to do infectious diseases and at that time were really the dark days of the HIV pandemic. And we had only recently a few years before figured out how what really effective treatment was going to be like, but it wasn't available to everybody in the United States and it certainly wasn't effective, or sorry, available to other people and other more resource poor settings. So I took an elective during my residency and I went to Botswana, which was the wealthiest country in Africa. They at that time did not have any treatment for HIV. And I spent some time in a hospital there, working with the other healthcare providers, and it was, you know, sort of to use the quote, very eye-opening and was really me seeing what this was like, that the hospitals were overrun with extraordinarily sick people. They were dying every day. The healthcare workers were exhausted. They were demoralized because they didn't have anything to offer. And there was a sense of hopelessness. Sounds sort of familiar, doesn't it? So it was really sort of understanding in a much more tangible way what the risk of not doing anything about that was. And at that time there were people saying it couldn't be done. We couldn't roll out HIV treatment into such rural sort of places with lack of infrastructure, but there were a lot of people said, yeah, we can. And we decided, and I decided at that time that I really couldn't look back and HIV was going to be my thing. It was very similar, like their big problem, big risk. A lot of people need health and making a career decision based on that. After Residency, I spent some time and worked with Doctors Without Borders, and this was when I landed in a tiny town in Uganda. They didn't even have a streetlight. There were 20 people have been started on treatment. And one of the things I started to understand then was that although we think of Doctors Without Borders as a humanitarian organization, they were trying to collect data. They were smart enough and had a database. And I spent a lot of hours ending data into that. And the idea was that they were going to have to show that this worked. That's research. If you're going to do a program or roll something out, you need to show that it's going to be effective. You need to be able to show that data to other people. So that was a big moment for me. I love seeing patients. I have a clinic. I see patients in the hospital. There are so many times where you realize, oh gosh, if only we had that. Or wouldn't it be great if we had treatment? Or how can we get treatment out to people faster? And the way that you do that is through research. It's by making big advances that eventually would trickle down to the individual people that are in front of you. So dark days of the HIV pandemic, how do people respond? It wasn't me at the time, but some really smart people figured out that if you wanted to answer questions and specifically about what works, you could do it a lot faster if you have a lot of different sites doing it at the same time. I mean, if we were only doing a study at UNC, it might take a long time to get hundreds of patients enrolled on a study so we could eventually have the answer. We didn't have time for that. So a lot of people got together and decided, well, we'd have one study, but you'd enroll it across multiple sites. What you see on this map are now where some of the AIDS clinical trial sites are that started back then, still going on today, and are largely responsible for the fact that we have effective treatment now that allows people to pretty much live a normal life. An offshoot of that was there was also an HIV vaccine trials network that was focusing just on trying to get an HIV vaccine like we are now for COVID. And there was a whole other network that was focusing on how do we prevent HIV. And then for another network that also focuses on other vaccines because they cause a lot of death and morbidity from flu from diarrheal diseases that primarily affect children and resource for countries. And what happened back early in the COVID pandemic, we were all figuring out, well, how am I going to do remote learning, how am I going to do remote learning for my kids. Some very dedicated people decided we needed to bring all of those networks together and they formed something called the COVID-19 prevention network. Why this relates to me is at a certain point in my career, I had great mentors who sort of said, you know, here you should work on this, this trial and with the AIDS clinical trials group and I did that. At the time I became a site PI for several studies through the AIDS clinical trials group, the vaccine trials and the HIV prevention trials, such that when we realized we're going to be able to have some vaccines that we could roll out and do these phase three studies. I had already worked with this group, I knew these people they knew me, and they sort of offered me this opportunity to be a co-chair on the Novivax vaccine trial. And I would say there was risk with that, both with being the site PI for Moderna, it meant long hours, it meant weekends, it meant less time with my family. But I felt like the risk was worth it. It also meant coming in and, you know, seeing people on a regular basis that were at risk for COVID, or they were diagnosed with it and we needed to bring them back in and get them tested. The Novivax, I would say from a career perspective, it was risky because a lot of people were going to be watching what I did and these vaccine trials are under a microscope. So it was like, well, it's a risky thing. But at the end of the day, I felt like it was my opportunity to help out. It was a service role, essentially, that I could provide in helping us all get to a better place. Dr. Thorpe sort of mentioned earlier, my other role has been working with the sort of on HIV cure for the last 10 years, and that was kind of also a risk, but I'm going to throw it out to sort of help you think about making choices going forward. About 10 years ago, I was sort of pivoting from doing work and internationally because for family reasons mostly. And some of my colleagues came to me said, hey, why don't you help be sort of the person who oversees clinical trials that we're doing related to HIV cure. And this is mostly working with scientists who are in the lab coming up with these new ideas. I've learned a tremendous amount from them. But at the time I was like, you know, I only understand what you're saying about half of the time. I don't know that I can actually really do this, but they believed in me and they said you can you can learn this. So my role with this group is in taking when they have something that's new and promising. My role is to help design a study and then conducted implement and sort of translate what what's happening in labs and with these basic scientists into clinical trials and people. So this also sort of prepared me for this role within of the vaccine trials, because I had experience with phase one and phase two studies in this work. So let's talk about that. There's been a lot in the news about phase one phase two phase three with this coming vaccine trial. So let's break it down a little bit so you understand it. Dr Corbett talked about sort of the pre pre clinical work, which would be the trials that are the work you would do in a lab and also in animals. And once that looks good at safe and for example you have an idea what sort of dose you want to do it would go into a phase one trial. So this is when you're actually trying your new vaccine or an adaptive vaccine in people, your primary concern is showing that it's safe and you may look at varying doses. So oftentimes you're starting with lower doses and you really think you might want so that you can show it's safe to safe and kind of incrementally increase the dose to sort of get where you want to be. If you if the if that's found to be safe and looks good, you could then move into the phase two trial. This is also looking at safety and more people who are sort of a few hundred. And you're usually also going to see if the vaccine is doing what you wanted to do which is eliciting these antibody responses that you heard about, and you can even measure the levels. So if you get safe, it's well tolerated and the vaccine looks like it's doing what we wanted to do, then you can move into a phase three study. This is sort of the hallmark and the kind of study you would have to do to get something licensed improved by the FDA so that it could be prescribed or even something you could buy over the counter. These are usually called they're usually placebo controlled, which means some of the people in the vaccine are getting the actual in the study are getting vaccine, and some people are getting a placebo. So you can see if there's a difference between those two arms, and usually they're blinded meaning they don't know which one they got and the people doing the study don't know either so everybody's treated the same. For these studies you often need thousands of people and for these vaccine trials we did had 10,000 people trying to get an answer as quickly as we could, and in general you want people to be at risk for the thing so we wanted people to be at some risk for COVID and how that was defined was kind of varied a little bit but and also changed over time with these studies. So, the question I get the most often was were the steps missed or why are these vaccines available so quickly with some concerns about trust. So I like this figure because I sort of breaks it down in the easiest way possible. On the top bar is sort of what you see is the typical process and it's color coded by those phases that I talked about with the farthest on the left, almost black, being the pre clinical and animals and in the lab. The do blue would be the phase one, the UNC blue phase two, the lightest blue phase three, and then that muddy brown color would be the manufacturing that you would do after you found your vaccine was effective and safe. And then the yellow sort of distributing it. So if you go to the bar below that that sort of tip sort of what happened with these COVID vaccine trials. The big picture is all of those colors are still there right. They've been condensed and as Dr. Corbett said a lot of it was because we took out a lot of the steps that usually have to happen because we're not in such a hurry. The two biggest reasons why things happen faster were technology and resources and what falls into resources would be funding and people and by people, I mean a lot of people with the expertise and experience to know how to do that and already know how and are doing clinical trials and how to make it go a little bit faster. So what you can see and also the phase one to there was some overlapping meaning in the phase one study when we had enough safety data on the people in that study to so that it was safe and tolerated we could go ahead and begin to start the phase two. Same thing with the phase two phase three, a little overlapping. And as you can also see the manufacturing started at the beginning of the phase two studies so at risk, meaning we didn't know what the vaccines were going to be effective but we needed to be prepared to make them if they were. So a lot of this was happening at risk we use that word a lot. And these COVID vaccine trials, meaning at risk because we didn't know exactly when they were going to start because they're going to start as soon as the vaccine was ready, etc. So on this slide you see all the human clinical trials with COVID vaccine COVID vaccines in the United States. And I wrote about this opportunity because, as I mentioned back in the sort of March I was just trying to help my colleagues figure out how we were going to take care of patients with COVID in the hospital. And I was asked to be a PI or site PI for the Moderna study is we were selected for a site. So my role for that was to oversee the conduct of the study at UNC, and it has some challenges and I'm going to talk about that. And then it was asked to be the, as I mentioned a co-chair for the Nova back study. So what's similar about all of these vaccines and Dr Collins and others talked about this. They're all similar in the sense that they're all trying to list at a vaccine response to the same target that spike protein and I'm going to quickly review that they're different in the technology in the way that it was done and they're, which Dr Collins also went over, but they're all targeting the same protein. So let's quickly go over that because I think you got a pretty good idea before. So here on the left is the SARS-CoV-2 virus. And we've already talked about the spike protein that sits on the outside. And again in a review what's critical about this protein is that the SARS-CoV-2 virus has to use this protein to bind to something called an ACE2 receptor on our cells. And it's that binding that allows the virus to get inside our cells. As mentioned earlier, all viruses have to get inside our cells to use our own cell machinery to make more virus. That's what causes infection. So if you only present the spike protein, one, you can't cause infection, none of the vaccines can do that, but this is critical to having antibodies to this spike protein, right, because it can't do its thing if we block this. So here's kind of an idea. Don't be too amazed with my graphics. But the idea is you give someone just that spike protein, your body makes these antibodies that bind and recognize it. And then after the vaccination, you have these antibodies in your blood and in your tissue. And when exposed to the SARS-CoV-2 virus, they're there and they also, as Dr. Collins mentioned, sort of stimulate a process to quickly make more. And as you can see, this sort of physically interrupts the ability of that spike protein to bind to the receptor so you can't get in, can't cause infection or causes less severe infection. That's the idea. So what's the big picture? Instead of going through all of the sort of data from the three vaccines that are now approved for by emergency youth authorization, I wanted to do a big picture because I think it makes it simpler. And I want you to be able to think about this and also talk to your friends and families and encourage people to get a vaccine. So on the left is sort of a cartoon about, but in essence, sort of a kind of figure we would use in these studies where you have the number of COVID cases going up vertically. And then what you want to see is that there's a big difference in the number of people that get COVID between those who got the placebo, right, not the vaccine and those who got the vaccine. And the joke is always trying to get data that's good enough that you don't need to do statistics. That's appealing to me because I'm not very good at statistics. The big picture is that thus far, all of these vaccines prevent severe disease and they prevent COVID-19 death. It would be great if they also prevent sort of mild disease, but that's not really what we care about. We want to be able to prevent people from getting severe disease, having to be in the hospital, and we of course want to prevent people from dying. So all of the data is very encouraging. We do have to worry about the variants with some people I've mentioned, but I'm not going to get into that. It's too complicated. I don't have enough time. And thus far, there are no safety concerns at all. The symptoms and some of the side effects we see with these vaccines are really typical of all vaccines, including those that are licensed. And here, just to show you, it's not, it's sort of a joke, but not a joke because here that I've just shown up is a figure from that was published on the Pfizer vaccine, showing you the number of cases in blue and the people in that study who got the placebo compared to those who got the actual vaccine, which is kind of a steady flat line in red. Pretty amazing. And I would agree with Dr. Collins that these efficacy of these vaccines is far greater than I think anything that certainly myself or my colleagues were hoping for. So I mentioned earlier that what do pandemics teach us? And as I mentioned, I think sometimes they make us look at some ugly truths that we were kind of ignoring. And these are some figures from North Carolina, but similar things can be shown across all the other states about how certain groups bore a disproportionate burden of COVID-19 illness and death. In addition, those over the age of 65 were also found to be at higher risk for disease and severe disease and death. And I think it raises the point that, in essence, we sort of knew some of these inequities were there, but we weren't doing anything about them. This came into play when we were just making decisions about how we were going to do these studies at UNC, and there were certainly many other investigators who were thinking about this across the United States and other places where they're doing these studies. We decided that we had a moral and an ethical obligation to make the participation in these studies reflect how it was affecting the people in our community. So we put a priority and made a commitment to first trying to enroll people at risk so they could potentially benefit from being on the study, but also to have it reflect black and African Americans in our community and her spanics. And that required some additional work. For the reasons mentioned, there's a lot of mistrust with some of these communities for good reason. We haven't always reached out to them to be in research studies. We haven't always done a good job with that. And we had not a lot of time to do it because of pace that we were being asking to roll on the studies. So what did we do. I'm just going to focus on these two at UNC just to give you a flavor but understand that across more than a hundred sites for each of these studies they were enrolling. Overall, all of the vaccine studies that I showed on the first table enrolled somewhere between 30 to 40,000 participants in very short amount of time. So in the Moderna study at UNC as you can see we've rolled 174 participants in about two months. We had about two months to prepare for that we would normally have somewhere between six to eight months. We're very proud of our team and you can see sort of the breakdown of the demographics that we were able to enroll on the study here at UNC. I think we did a tremendous job and we're quite proud of that I would say for the Novavax study which again this IPI and a co chair, we enrolled 271 participants and about six weeks. It's kind of hard to imagine really what that looks like but for each enrollment takes about two to two and a half hours because you have to go over something called informed consent with people. It's about a 20 page document explaining to them what's what what they're going to be asked to do what the risks are that it's voluntary etc. And we really make sure people understand what it is that they're signing up for. So, if you can envision it's also COVID. We don't have all of the staff here coming into the office and into the clinics to help us do the study a lot of them they're remote. We don't have all the space we would normally want because of COVID restrictions. And even within that space we have we have some places we can't bring people who might have COVID because of all the concerns about transmission. So, since about June, our, our, our challenge and getting these trials off the ground was a lot about problem solving a lot about my team who are could win any survival contest about how to do research. It was almost daily we were having to try to figure out how to get around COVID restrictions, how to reach out to these communities how to do it in a respectful way and try to establish some trust. And the other challenge we have was about the time we were starting to roll on Novavax, the Moderna study or the Moderna vaccine had gotten emergency use authorization. So we were unbinding people and bringing them back into get vaccinated. So we were juggling those two things at the same time. But both were equally important to us because we wanted everybody who had really been brave and a hero for us to sign up for the Moderna study to come in and get vaccinated as soon as we possibly could. So it was just kind of crazy. So, I'm going to talk in the last few minutes and I hope I'm not going over too long but how do we do that in ways that were new. So again, talking about problem solving. Back in June we realized we're going to have this problem with space like how could we even bring in all these people to enroll them on a study and do it safely for them and protect our staff. So we found some retail space and leased and actually put down a three year lease for this space because we knew we just needed it. We have no idea where we're going to have enough studies to really make it financially feasible for the next three years. So why did we do it, we did it at risk because we just needed to realize that it was just such a that we just had to get these vaccines we you know we had to show whether they were effective or not. Another thing we did sort of getting back to our commitment to reaching out to communities that were being hard hit was we decided we would try to take the vaccine study to people and these communities. So also thinking about the idea of trust we have some colleagues who've been doing work for many years and siler city it's about 45 minutes from here, it's about 50% Hispanic and also has a large proportion of black and African Americans. And they have been working there they had trust with these, this community and these, these people. So, the Kobe PN provided us this crazy like rock band looking van that is fitted on the inside with a small area for pharmacy where we could prep the vaccines. A place where we could process blood samples that we're collecting, and even like little clinic rooms. So we took that van to siler city and we set up outside the free clinic where they're providing free health care and try to sort of build on that trust and bring the vaccine study to a place that we knew was being hard hit. There are a lot of manufacturing plants and siler city that we knew had very high rates of coded. What else did I find myself. Oh, and to get back. This whole idea about reaching out and some things that we did for these vaccine studies that were really new was the Kobe PN created a website one that provided information education, also at sort of a level that that most people can understand and breaking some of this down, but they also created this Kobe PN registry that wasn't specific to any site, but people were interested and in either a vaccine or even a sort of therapeutic trial of COVID. They could go and input their information. And one of the things that was really helpful to my site and many others is that would ask you some questions, sort of what might be your risk for actually acquiring Kobe. It would also ask for some demographics and so it helped us be able to sort of prioritize those who were at the most risk and would thus potentially benefit from being on the study and also be able to prioritize these groups that I talked about that were being disproportionately impacted in our own committee. And then just sort of another off the wall thing that we realized we had very little time and that we needed to one have a way to reach out to Spanish speaking individuals, and how we were going to do that so I worked with a company that helped. This is what they do they create small videos around educational public health things, and they created specific videos and English and Spanish to talk about what is a research trial what is that. What is that about, and then specifically about the COVID vaccines. And we played this in the, in the places in Silo city sort of routinely. So they could break it down in a way that's like visually appealing and more interesting than just me dragging on about it. And that's just kind of another picture of what the video sort of looked like. And the last thing I think that this is my last slide the last thing we did it goes back to a point that Dr cons made is that part of my role I felt was at some point less about a rolling on the trials and more about trying to provide confidence and trust in these vaccines and how the studies were being done. I'm an introvert by nature but I accepted every request for an interview with the news on the trials and because I felt like it was the right thing to do. But understanding that my message is different. I'm a white physician and I'm working with the studies. So we asked some really great people who enrolled in our study to talk about why they would do that. And we sort of sought out for people who would look like those we wanted to think about being in research or understand why we were reaching out to them. And you see a lot of them on the slide. But the one exception is a white guy down in the bottom left corner who's Ralph Barrack who is sort of internationally an international expert on SARS-CoV-2. My personal here is Pastor Nichols here he enrolled on the study without us really even knowing who he was or what he did. And then he decided to take a video and show it to his congregation about why he was doing it and why it was something for predominantly black people in his community and then invited us on a waste Facebook webinar to talk to his congregation others about it. So a lot of kind of crazy stuff I know it was a little all over the place but that's kind of what it's been like for the last eight months. So I want to thank you for your attention and being asked to present with all these wonderful people. And I can't help but get on my soap box for one more sentence to say please get vaccinated when you can both for you and your community. Thanks so much. Fantastic. Thank you Cindy, for a great tour of what you've been doing and the challenges and the inspiration that you are able to bring to so many people about how we can confront these things. So we've got another round of student questions and we're going to start with Hannah. Hello Dr. Gay. My name is Hannah Gever-Michael and my question is what were some of the unexpected challenges of clinical research? Yeah, I think I hit a few of those. You know, I would say one of our challenges was we realized we were going to be asked to enroll more participants more quickly than we normally would. So we were hiring staff as fast as we could because we knew we were going to need more help. And that was hard because back in the spring and the summer there was only a core group of us that were actually coming into the office. So we were learning how to communicate with each other. I would tell you I mentioned I'm an introvert but I learned to ask a lot of favors. I learned to ask a lot of favors of people on high. I didn't really care anymore if I was bugging them or being a nuisance. But, you know, the reason you do that is because, you know, the need was so great. You know, we just problem solved all the time. I mentioned the space that we needed to find a space that would be more convenient but also safer for people so they would feel okay coming into clinic because people were even nervous about that about coming out of their house to sort of a clinic space, you know, and back in with the Moderna study in particular but also when things got really bad in January. So we had to create a space where people would feel comfortable to come. And also, yeah, I would say it was a challenge to even make our staff feel safe. We had to we had to do a lot with that. There was the challenge of the pressure. We were asked to really enroll people as quickly as possible. So there was a balance. There was some of me talking to myself about how to balance the pressure what they were asking us to do but, you know, keeping my staff happy enough that they were going to continue to show up and not be, you know, burned out. So there were, you know, a lot of frequent check ins to make sure that we were doing everything as fast as we could but in the right way across all of those particular issues. Does that answer it well enough. Yes, thank you so much. Yeah, of course, great question. Thank you, Hannah. Great question. And now Divya. Hello, Dr. Game. My name is Divya. So since people of color are at a greater risk of having underlying health conditions, how did Moderna address racial disparities in the clinical trials regarding the effectiveness and presented symptoms given the development of the vaccine. Yeah, that's a great question. And this was really, I think a journey for me and many others about how we were going to make sure I'm going to, I'm going to if it's okay with you I'm going to answer it in an even bigger way that's not just applicable to Moderna. I would say the one thing that was also unique about these studies was that it was such a collaboration of different groups overseeing them, meaning there was the covp in which I mentioned because that was sort of my role was to support those sites, but the NIH, and by the NIH, I mean, like the best of the best from the NIH, there's a group called BARDA that sort of oversees research and the government a little bit. But in all of these groups are kind of overseeing it and it was the input of all of the sort of leadership across those groups that understood that making participation in these studies was going to be important. It was, again, you know, an oral, not oral, a moral and ethical sort of reason to do it, but I think they also really thought early on that it was going to be important that when we had the results of the studies that people were going to need to see that people like them were in the studies that we were going to need to have this participation. We also knew that these these trials are going to be under the microscope like nothing else with clinical trials, and then again people needed to see that people were thinking about them with that way we're thinking about who is being impacted. Because at the end of the day, it doesn't really do us a service to have a vaccine that people don't want to get. And if they don't see that people like them were included it they'll wonder like, well, is it going to work for us or why didn't they include us when we're being so impacted. So I would say the, I might get in trouble this, I think the pharmaceutical companies were thinking less about it, because that's sort of less their traditional mission. And it was, in my opinion, a great service that the way these trials rolled out was with all this collaboration of people. One of the reasons why they brought the covp insights and is that we because we've done so much work with HIV clinical trials, we had this history of reaching out to some of these communities. HIV is traditionally impacted more African Americans also Hispanic, also the LGTBQ community so we had a history we have groups we have people who focus on engaging those. And so I think it was the understanding that we kind of knew how to do that, that it's not just kind of like, oh yeah we're going to take that box that's you know, because somebody says we have to that we're really passionate about it that we feel it's the right thing to do. So I think all, all of that was one a record recognition that it was important, and then one a commitment you've got to have people who are willing to do sometimes the hard work to make it happen. Terrific. Thank you, Divya. And now, Akshara. Dr. Gay, my name is Akshara Pimogam and I'm actually stepping in to ask Shrieker compel us question, which is, how do Moderna and other companies that have produced vaccines plan on being involved in communicating the complex science of a vaccine safety and efficacy to the general public to ensure that people feel safe receiving it. Yeah, that's a little harder for me to answer because I don't I don't work for the companies I would say I sit on lots of calls with them. I think, in my own opinion, it's really sort of less are that we need their responsibility for that less and the sense that there are so many groups that find it their mission to look at vaccines making recommendations on who gets them and really kind of break down the science and the results from these studies in ways that are applicable and understandable. Sort of as I mentioned all those groups before the COVID PN and others they're doing this on a regular basis breaking down what's being published and putting it into a context and trying to make it available widely to sort of give you an example I think at every layer of provision of care and and including from like primary care positions to even you and sees. So an example that you would see myself and many of my colleagues have been asked to do several town halls the first it was to even address this issue with health care workers, you know, some were saying they didn't want to get vaccinated so we had to try to address some of the misinformation and mistrust, just within our sort of own setting of employees, since then I've also been asked to do lots of have lots of input on what would be sort of communicated more widely to UNC patients across the state of North Carolina. So, in my own opinion, I think it's the pharmaceutical companies or the companies are making vaccines is kind of their role to have the data be clear and presented to the rest of us. And then it's really kind of I think more our role to break it down, provide, provide it to our patients to our clinics to our state and ways that are understandable, and also make it easy. So I totally agree with Dr Collins about the issue of misinformation and trying to both ourselves in amongst our friends or colleagues, etc. be married, very mindful of where we're getting our information from. I think you and see other academics, the CDC, the Kobe P and all of us it's all of our responsibility to make this information understandable to make it easy to find. And I now talk to every single one of my patients about COVID vaccines when I see them. Great. Thank you, Akshah. And now, Gracie. Hi, I'm Gracie and I was wondering what was the process like in terms of developing the vaccine. Again, there would be somebody else who can answer this question better but what I've again sat on so many calls that I'll answer it to the best that I can. I think it was a lot like it was for us in the sense that as Dr Corbin mentioned once they had the sequence of the virus so they knew physically how to make it. And it was all hands on deck at these companies, meaning six, seven days a week into the evenings. And essentially I think for them like us, all other research was basically put on hold, we really couldn't bring in up clinics anymore but I think they put everything else on hold or at least deprioritized it to focus on that. I want to tell you that we all have now standing calls on Saturdays and Sundays. My staff would work until, you know, five and then they go home and get on the phone and I know that all the people involved with the leadership roles and these studies are doing that and I know through my role of Novavax that they're just working out all the time. So I think it was, you know, they knew how to make these vaccines, they had, they've been doing it for other viruses, and they just took that and pivoted it and like us started hiring new staff to be able to do more and less time, just, you know, as fast as they could. Thank you, Gracie. And now our last question my Ghana. Hello, Dr. gay. My name is Megan at 20. And my question is how has collaboration among members of the scientific community changed as a result of the pandemic. Yeah, that's a great question. I mean, this, this was unprecedented to have this many groups focused in overseeing these vaccine trials. So some of these standing calls I mentioned they'll have over 100 people sitting on them and that's just one call and then you'll have another call the different 100 people. I think, you know, our challenges. Eventually, when we look back on this what worked and didn't work. I think what worked for the vaccine trials was this incredible commitment across these different groups of resources and people and time. And so I would envision, I think that if we, you know, have to deal with another pandemic anytime soon something similar like that would sort of be the model. I think there are things that we definitely were learned we could have done better in a pandemic and other people have touched on that a little bit. I think we've also learned ways to reach out to these communities that haven't really participated in research as much. I think. What I think is that won't fade off that won't taper off that will can continue to do that for other reasons outside of even just COVID vaccine trials. So I hope that that will continue. But I think that in, you know, a global tragedy global pandemic people would come together as they did in this way with the right experts and the rights expertise the right sort of passion the right goal. And I think in a few years, if not already will see that the success of these vaccine trials is going to be like a considered one of the greatest medical, you know, sort of successes or events or whatever you want to call it of our decade, if not more than that. Thanks. I'm going to thank you. And that what a great place to end. Cindy, thank you for tremendous talk and for all you're doing to promote health equity and vaccine access and bringing these extraordinary advances in science to so many people. That brings us to the end of this extraordinary session. What an amazing lineup of speakers, we had congratulations to Todd and Amy and Bob for bringing together this extraordinary and inspirational group. Thanks to the students for their remarkable questions. A year ago, when this all started I remember saying at the first few meetings of our team at science well let's cover this now but you know, people aren't going to stay interested in this for very long. I was wrong about that. And I take a lot of hope from that because people are really interested in now, verology and immunology and health equity and biostatistics and lots of things that people hadn't thought about before. And the enlightenment that that is bringing to the world and especially through the people we heard from today is a reason to be hopeful about the future. The workshops start at one o'clock. So everybody come back for that. And in the meantime, take a break and have your lunch, and to everyone involved. Chancellor Roberts, Amy Bob, the speakers, the students. Thank you all for inspiring me today, Chancellor. Amazing school you've got my friend, and thank you for the great job you do taking care of it. And thank you so much and thanks again to all of our guests just what an amazing event and great unbelievable opportunity for us to have, you know, folks like yourself and all of our panelists with us today so thank you so much for your time and good to see hope to see in person one of these days. Yes, sir. Getting closer.