 And with that said, it's a great privilege to introduce the first panel and I'll hand it over in just a second to Bill Chen who's going to moderate the panel and what better topic to start on than COVID-19. So Bill, I'll hand it over to you. Thank you very much, Andy. Thank you very much for that introduction and Karun for your words as well. In addition to welcoming everyone in across the world, I want to particularly welcome those in North America and hope that you have your requisite hand as we begin the 14th Biopharma and Healthcare Summit with a panel on COVID-19. Most of you are alienizable in the matters of the pandemic by now, but you probably might not know everything. In fact, it seems that we learn something new about the virus every day as the world struggles with the elis and its deadly reach. Today we have assembled a panel of world-class leaders, an incredible group really to help us understand further the challenges and opportunities engendered by COVID-19. The panelists we have today are Dr. Barry Bloom, Professor and former Dean Harvard T.H. Chan School of Account. Dr. Richard Hatchett, the CEO of the Coalition for Epidemic Preparedness, Innovations, or CEPI. Kiran Mazmdar Shah, who is the Executive Chairperson of BioCon. Dr. Rajiv Venkaya, the President of Global Vaccine Business Unit at Takeda. And finally, Dr. George Yankopoulos, who's the Co-Founder, President and CSO of Regeneron. So I'm going to start off and the way we're going to do this is we're going to start off with a couple of questions. I will ask the panelists and then we're going to come back to some of these points a little bit later. And I'm sure we'll have questions from the audience as well. So I'm going to start off with Barry. Barry, what is the current status of COVID-19 testing and vaccines? I know this seems like a very simple question, but try to do this succinctly. I appreciate it. Thank you. Thank you very much, Bill. It's an honor to be on this panel. With respect to testing, the standard of testing is highly sensitive and specific. It uses PCR and it has big problems in this country and everywhere in the world. It's limited availability. It is expensive. It can't distinguish RNA from dead or currently infectious viruses. It doesn't enable frequent testing. It's difficult to test because it has to go to central testing facilities. And the delays in getting answers are slowing down the ability to stop the transmission by the time the results comes in. Transmission has already occurred. Exciting thing is there are new technologies being developed, sensitive technologies to measure, antigens using antibody tests, crisper possible tests, tests for antibodies to the virus. These are relatively cheap. They can be repeated. They can be used in schools and businesses in principle. They of course have lower sensitivity, but that may be an advantage to detect the highest transmitters. And there is a major fund to accelerate diagnostics that was late to start, but they bring them into practice. In vaccines, as you heard from Dr. Plumb, since 19, 2009, after H1N1, we understood it needs a revolutionary approach to making vaccines to new threats. And that has led to the development of platforms rather than one-off vaccines developed for each new pathogen. My understanding is there are 26 vaccines currently worldwide in clinical trials. Mine in or about to enter phase three in multiple countries. I would point out that all of those are two-shot vaccines, which makes it difficult in many countries to get people to come back for a second shot. When will we have a vaccine? The question I get asked all the time. The answer is, of course, is one there shown to be safe, efficacious, and available. But there are issues. The first is there is tremendous pressure to win the race, which is unfortunate for each country to be able to claim that they won the first test of a vaccine and got the first approvals. That is not helping confidence in vaccines in the general public. The second issue is, will they protect against only disease at which is their tremendous achievement? Or will they also prevent infection and interrupt transmission? And thus far, none of the vaccines, at least from animal studies, suggest that they are able to completely sterilize and provide sterilizing immunity. There are issues that are being discussed. One, allocation priority with limited available. Who will get the vaccines? And in the U.S., it is likely the priority will be protecting against death and disease, which means healthcare workers aging high-risk populations and probably in the short term sacrificing the effect on those populations of younger people, students that congregate and cause transmission. What is exciting is that the new platform have produced vaccines that have high probability of being efficacious. In the U.S., if it is over 50% protection with minimal adverse effects, they can be considered probably some of them by the end of the year. And second, unprecedented, is the companies have decided to produce large amounts of vaccines at risk without knowing that they are safe and work, but to be prepared if they are safe to be able to make them available at a speed that we have never seen in the world. So I'll stop there and thank you for the opportunity. Thank you, Barry. Next, I'd like to ask Richard. And we know that, you know, this pandemic is going to face us in a number of phases and maybe with us for a long time. So how can we best control this current acute phase of the pandemic? Thanks, Bill. Just to build on what Barry described, I think our core hypothesis is the acute phase of the pandemic is being driven by the disruption and the fear that is a consequence of the severe illness and death that the pandemic is causing. And if we can use the tools that we have available to us to reduce the severe illness, the death, the disruption of healthcare, that's how we can best bring about the end of the acute phase and allow for the restoration of more normal patterns of being, more normal patterns of commerce and trade and travel. There are no magic bullets, obviously. I think we all know that. I think we also know that whatever the solution, it's going to have to be global. You cannot end the pandemic in a single country. You cannot end the pandemic in a group of countries unless we bring the pandemic under control globally, everywhere. We will continue to see the disruption. We will continue to see the economic damage, the dislocation. And so the challenges that we really are going to need to use the resources that we have, the diagnostics, the therapeutics, oxygen, PPE, ultimately a vaccine, which will be scarce. The vaccine will be scarce. That's the one thing that we know in 2021. If we are fortunate enough to have vaccines is we will not have enough to meet global demand. But we will have to use these tools in conjunction with the individual measures, the social distancing, the personal hygiene, the self-protection to achieve this goal of bringing the severe illness and death under control. We've been working at CEPI. We've been working as part of something called the Access to COVID-19 Tools or ACT accelerator, which is a global effort led by WHO. But with the partnership of CEPI, GAVI, Welcome Trust, Find, the Global Fund, many other organizations to essentially provide these tools globally. Within the ACT accelerator, we've been working closely with GAVI and with WHO under an initiative called COVAX, which is the initiative focused on the delivery of vaccines. And I'm very pleased to say that the COVAX, as a concept many people will have heard about it recently, it is open for business. We've had 78 self-financing countries announce or not announce, but indicate that they do intend to participate. And we have another 92 countries that will receive access to vaccine through an advanced market commitment that we have established. So that's 170 countries that will work together to share these scarce resources, to make sure that they are distributed, to make sure that they are prioritized as Barry suggested, to those who are most vulnerable to healthcare workers to the elderly with the goal of bringing this acute phase of the pandemic to an end by the end of next year. Thank you, Richard. I think we'll come back to that very important point of how do we actually distribute all the care that we are currently developing to all the people in the world? So my next question goes to Kiran. We'll talk a lot about the speed, the speed on which we test, the speed in which we can get protective vaccines, either active or passive. So one way to do this more rapidly would be able to take medicines that are already out there, repurpose them in order to help with various conditions. So my question to you is, how do we repurpose medicines to meet specific needs and patients in this pandemic? And then I have maybe a quick follow-up to that, Kiran. Thank you, Bill. It's great to be on this panel. Let me answer your question in a couple of ways. One is to say that, look, this panic and anxiety that this pandemic has brought on to the world at large has seen what you just described as warp speed regulatory approvals. And I think this has actually made it possible to look at regulatory science in a very different way than what we used to in the past. So if we can do that for vaccines, I think repurposing drugs should be a lot easier. As you know, regulatory science really fixes on safety first. And I think approved drugs have actually established safety in a very, very confirmed way. So I think that is a big, big starting point, which then allows you to really focus on the proof of concept on whether it is efficacious in addressing some aspect of the COVID disease. And I do believe that having abbreviated trials to look at an existing drug on the hypothesis of why it should work ought to give you an accelerated approval for emergency use as it's being described these days. And I think by looking at real-world evidence thereafter, I think you ought to be able to get a lot of validation of a repurposed drug. I think that's the way you ought to look at a repurposed drug in a crisis like this. I just want to also add another dimension to accelerated regulatory processes by saying that since vaccines have actually brought a new perspective to regulatory science where they know that a lot of sequential processes are now being looked at as parallel processing, I think why are we not now looking at actually doing that for drugs as well? At the end of the day, getting a drug or a vaccine from the lab to the market in the shortest but safest possible time is very important. There is a lot of concern around the vaccine. I think trust is going to be very important in terms of approving a vaccine and getting people to use it because I think focusing on speed to market is not going to build that trust. I think we must follow science, we must follow regulatory science. It's about safety, it's about efficacy, and it's about the durability of response. And I think a lot of people are going to be very concerned when they see the vaccines out in the market to know whether there is any uncertainty or risks that they are going to be exposed to. Because remember vaccines are being delivered to healthy people, drugs which are really used to actually treat illnesses. So I think we should put that into perspective, but at the same time, this is a unique opportunity for us to accelerate the regulatory processes across the board because I for one believe it takes far too long to get either drugs or vaccines to the market. So I'll end there, Bill. Thank you very much, Kiran. I think this whole question of how do you balance regulatory approvals and its speed with acquiring all the information that's necessary to make sure the medicines or vaccines are both safe and effective. We'll come back to that in just a little bit, but your discussion leads me to the next question, which is increasingly relevant as we get closer and closer to the development and availability of a number of vaccines. In fact, the CDC in the United States just recently really asked the states to be prepared to start distribution of vaccines by the end of October. So the question is, how do we address the issue of trust that Kiran raises? How do we address the possible COVID vaccine hesitancy? How do we develop and assure confidence in the planned COVID-19 vaccines? Rajiv? Thanks, Bill. And thank you to Karun and others, Andy, for having me here today. I'm delighted to be on this panel. And I think this topic of the public's confidence and trust in vaccines is crucially important not only to uptake of COVID-19 vaccines, but also confidence in vaccines in general. I think we can distinguish between any hesitancy we see around COVID-19 vaccines and some of the historic hesitancy that some have had about the rest of the vaccines that have become available. And I would say that the group that has concerns now or questions is much, much larger than the population that had questions about vaccines previously. And perhaps the number one driver of concern is the speed with which we are developing these vaccines. As Kiran has mentioned, we are going from a standard timeline of 10 to 15 years down to one to one and a half years to bring these vaccines to the people that need them. And so many people are understandably saying, wait a minute, how is it that you reduced the time to reach people by 90% to approve these vaccines without compromising somewhere? And so that's one important set of reasonable questions that need to be answered. But I don't think we can ignore some other elements that are raising questions in people's minds, specifically around political influences on decision-making at what previously have been independent objective agencies like the FDA and even at CDC. There has been a lot of attention to emergency use authorizations that have been granted to hydroxychloroquine and more recently convalescent plasma. And so in light of recent discussions about a COVID-19 vaccine becoming available by the end of October, just prior to the election, as you can imagine, there are questions about whether there will be political influences on decision-making. The final factor driving hesitancy here, well, the final that I'll mention, there are many others, is the influence of social media. There is no question that if you have an issue or a conspiracy theory that social media has essentially acted like pouring gasoline or petrol onto a spark. And we've seen these kinds of ideas that are not founded at all in science taking off like wildfire and getting traction in the mainstream of the population in ways that we've never seen in the past. So what can we do about this? The first is to be very transparent. And when I say be transparent, I mean companies as they're generating data on their vaccine candidates. The peer review process needs to be respected. Agencies need to be transparent in their decision-making. That is the most important thing we can do to increase trust in the process and trust that safety and efficacy thresholds have been reached before vaccines are made available. We do need to make the data available to external independent experts. This peer review process has to be very open so people know what very knowledgeable independent people think about the safety and efficacy of vaccines that are going to be approved. And then we have to be honest about what we will and will not know at the time these vaccines are licensed. We'll know a lot about the safety and efficacy profile because we will have taken these vaccines into very large clinical trials. The similar size to what we typically use in phase three or four vaccines, what we won't know is about the durability of protection and we won't know fully about the long-term safety profile. Any risks that we see in the long-term safety are likely to be quite small, any events quite rare, but it will be important to explain that we don't have all the information but that we will be updating our safety assessments on a continuous basis over time. The last thing I'll say is that the industry has come out with very strong statements supporting transparent rigorous scientific approaches to assessments of safety and efficacy free of political influence. Bio the trade association released a letter, an open letter to the industry in the FDA yesterday and late last week the International Federation of Pharmaceutical Manufacturer Associations did something similar and that statement is up on their website. Thank you very much Rajiv. Next we'll go to George. We've talked a lot about the progress that has been made, the incredible speed in which a lot of the new therapies are being developed and being tested and that itself presents as a problem, but as all of you do the Ebola crisis which was only five years, five, six years ago and I think many of us were thinking then we should be prepared for the next infection, the next pandemic. It was not a matter of whether but when. So in the spirit of you know this crisis being a learning event as well, George you could have answered any of all these questions but I'm going to ask you how do we ensure that there is international national preparedness and you've talked about that the emphasis there is an emphasis on on databases to help with future pandemics. Yeah, thanks Bill and I appreciate the opportunity to participate in this wonderful summit. I also appreciated the optimism voiced by Andy Plump in his intro. I do think that we can underestimate the challenges and the needs to be better prepared and by way of background I think that I have to start by just saying why we thought that we were at Regeneron uniquely suited to help during this pandemic and it was due to the preparedness that we had put in place over our 30 years in investing and inventing world-needing technologies that have delivered more important first-in-class biologics to the world in the last 10 years than any other company because of this long-term investment and in particular how these investments had already paid off in terms of our track record as you already referred to in terms of our rapid response against infectious diseases including Ebola and in our understanding of how to do rapid and effective drug development. So this topic of repurposed drugs came up and I think we have to be very very careful about rushing things forward. I mean a lot of us know the hydroxychloroquine story and others but we have to be very careful. In our case we followed up on multiple small academic studies from China and Italy and other places claiming that the two approved IL-6 receptive blockers, Tosalism app from Roche Genentech and SuruliMap from our company and from our Sanofi partners were potential miracle drugs for the cytokine storm driving COVID-19 disease. But we thought that you needed to get real data. You couldn't rely on these small studies and mechanism of action and theories and so forth. So we felt it was so important that we had to get right in and do a large definitive phase three study and we found that essentially all the results from these small studies were entirely misleading. We did not find any enormous benefit. Similarly months after we completed our large phase three study Roche Genentech entirely confirmed our conclusions. Okay so these the results of these large phase three stories really raised questions about how to repurpose drugs even how to develop vaccine and the value of small academic trials to test things and to test repurposing. For us much more hopeful is our specifically targeted anti-COVID approach that's based on making an antibiotic cocktail specifically designed against this virus using our rapid response technologies. We used it was this technology that we used to develop our Ebola antibiotic cocktail which was found to save lives and people already infected in a trial major trial run by the World Health Organization and it's on track to be the first Ebola treatment not in a vaccine an actual treatment which will be approved hopefully next month and we used the same approaches to develop our antibody cocktail for COVID-19 which is now in multiple large trials to try to really see whether it can be as effective in COVID-19 as it is as as the approach was for Ebola. So getting back to the question about how we can be prepared as I said you know optimism how we've been doing I mean that all sounds great but I think we are very far from where we need to be as an ecosystem and as an industry in terms of lessons learned national preparedness this pandemic should serve as the as a major wake-up call and not just for infectious pandemics but for the burden of all diseases we have to understand this constant political rhetoric about the cost of health care the need for free universal health care that the real threat and the issue we should be focusing on and talking above all else is disease burden no society or economy can support the degree of future disease that is coming our way. Estimates are because the aging of the population the lack of effective treatments by the year 2050 there will be 10 to 20 million Americans with Alzheimer's disease with no treatment that is astonishing the associated economic burden would be astronomical forget universal health care this would cripple our economy to a greater degree than COVID has okay but layer on top of that the obesity epidemic with projections that up to 25 percent of the US population could be afflicted with type 2 diabetes and that most cancers still don't have cures and that heart disease is still the number one killer in the United States and not to mention the potential of seeing these sorts of infectious disease pandemics with increasing frequency we have to recognize the threat to our overall society and economy of this amount of untreatable disease burden we have to recognize and we have to decide what we want to do about it and as a society what we should be investing in and my perspective is that any rational thinking would lead to the conclusion that disease is an existential threat to our world okay in line with that of climate change and that the only solution is is not a little bit more orders of magnitude more long-term investment in the ecosystem that brings us cures starting with and the NIH and academic environments but we need massive increases industry right now is not delivering at the level that we need to be because we need massive increases in society in the incentives and the drives to have private sector make more investment in the long term to develop new technologies and approaches so that when we face new threats such as Ebola or or now COVID-19 and the evidence shows that the companies that are leading the way whether it's let's say Moderna and others with vaccine or us and others with antibody treatments these are the companies that historically invested enormous amounts of effort and resources in developing new technologies that's what we have to focus on as a society enormous overall increases in investments in new technologies from the academic center all the way through industry because without these we will have no new medicines to address this huge upcoming disease burden I'm sorry you know to counter the optimism that Andy Plump offered but all the major diseases we've had very little progress it could destroy our society our economy in an entire way of life it's a true existential threat we really have to recognize this just like we recognize climate change the degree of investment has to go up orders of magnitude the notion that 30 billion dollars is the budget of the NIH and we've now cost ourselves tens of trillions in terms of impact on just the U.S. economy okay just shows how ridiculous our thinking has been to date about the amount of investment that we make in this sector and the amount of of incentives that we have to drive more investment large think I think we're gonna we're gonna have to move on thank you very much for for those ad admonitions for sure but in that vein before we take a couple of questions there is then the issue of how do you promote global collaborative efforts and so one one issue that comes comes up is once vaccines are available how do you assure that they're distributed and access provided in an equitable way is there a way of of achieving vaccine equity for for instance so I wonder Barry could you just start us off and and then I'm going to ask the panelists to raise the hands if you'd like to make a quick comment and then we'll um we'll entertain questions we'll have to make the comments quick though Barry thanks for the question I would hope Richard would in because the concerns from the beginning are almost all the vaccines being developed are from high and high middle income countries how will they be affordable how will they be distributed equitably to developing countries and thanks to the thinking of sepi leadership of who there are plans as you heard from Richard to bring countries together to say we have to be able to share at least for the people at highest risk and the healthcare providers in every society um some level of access to the new vaccines being developed vaccine nationalism is self-defeating if in essence we are always subject to reinfection from those individuals in countries that don't have them I would point out that's impossible to do if the United States as continuing to withdraw its funds and participation in the world health organization which is really the only force that can bring all 170 some countries together to deal equitably with vaccines uh Richard yes thanks thanks Barry and thanks and thanks Bill I I just want to underscore I mean I I I think this issue of equitable access globally particularly to vaccines which I do believe will be the ultimate exit strategy from the pandemic is it's absolutely critical and it is what inspired our our vision of creating the covax facility the arguments for sharing vaccines globally and and for treating vaccine as a as a scarce and critical resource that needs to be distributed in a prioritized way with the goal of ending the pandemic is you know there's an there's an argument from equity from from a humanitarian perspective but there's also an argument from efficiency and this is a case where the arguments for global distribution the arguments on the basis of equity align also very closely with the arguments for efficiency we cannot end the pandemic as I said you know in one country at a time and what happened in 2009 during the last pandemic I mean I think we should remind everybody this is the second pandemic of the 21st century it won't be the last but in the last pandemic 10 or 15 countries bought up the global supply of vaccine and it was only very late that there was an effort to distribute that vaccine globally and ultimately too little vaccine was distributed too late you know for too many people and we are now dealing with a threat that is an existential threat certainly to our economies if not to the global population and if we don't use the tools that we have in a very directed targeted and and focused and prioritized way to end the pandemic the pandemic will be perpetuated and more people will die and more economic damage will be done thank you rich I think we're going to go on to a number of questions that have come in one is from Professor Ganguly Professor thank you for the chain and thank you for allowing me to ask this question for this august speakers my question is that beta seron when it was there was not available globally one of the countries banned its export to all the multiple sclerosis patients so it is not necessary that the vaccines will be available globally even though this alliance has been formed my question is that when you some countries with a very short data I will not name any country with a very short data without phase 3 have gone to population and some more countries where vaccine is not a race it's a matter of public trust some countries are planning to do away with phase three to go into the population what will be the minimum standards like without knowing whether it will cause gullion barrier or it will cause disease and disease enhancement what will and what will be the efficacy 50 percent 40 percent 30 percent there are consequences for that what will be acceptable and if a country puts its population to danger or endanger its population can it be punished in our current new UN charters thank you professor I'm going to ask both Kiran and Rajiv to perhaps respond maybe Kiran first if that's possible Kiran you unmute yourself yeah so I think like you know we just discussed a while ago I think it's extremely important to ensure that it is you know the data is peer reviewed and that we are absolutely clear about the data we are sharing with the public at large I think we have to be very transparent we have to be very honest about the risks and uncertainties that we are going to expose populations to so building trust is going to be very important and I think there is going to be an opportunity to basically get you know countries to work out their own vaccination strategies in their own countries and it is going to be a question of choice as to whether people are going to when they are going to vaccinate do they want to wait for more data or are they going to vaccinate themselves as soon as the vaccine is available and I think you've already heard both Barry and Richard talk about the importance of making sure that these vaccines are not denied to any part of the world because of their lack of affluence I think that is an absolute concern that everybody is focused on and I think that's why we have GAVI and COVAX and other such you know initiatives to make sure that we do provide access to these vaccines as and when they're ruled out so I would say that I mean you can't I mean as for as for that last question of Professor Ganguly is about can you you know take you know stringent measures against companies if vaccines do provide or do generate serious adverse events I don't think that is going to be possible I just think like any drug any product we need to be honest and transparent about data okay Rajiv maybe a quick comment and then I still want to get one more question in we only have a minute and a half so Rajiv very quickly I'll say that there may be special circumstances high-risk groups that that would deserve to have or would benefit from having early access to a vaccine or a large phase 3 trial is completed these would be very selective unique circumstances and it would be something like an emergency use construct to guide that but for use of vaccines the general population for the general public most people would feel that you absolutely must have a large phase 3 clinical trial that would allow you to confirm efficacy but more importantly identify low probability or low incidence safety events that will inevitably be missed in early trials every country has its own national regulatory authority every country has the authority to make its own decisions but from a ethical and in practice standpoint that those are the standards that the world has established and and I think need to be kept you know we had one one other question unfortunately we are running out of time so I'm going to have to to end this wonderful panel and say the following we are obviously in the midst of an unbelievable perturbation in the history of humankind I'm gratified to see so many great scientific and business minds come together to meet this seemingly impossible challenge so let's let's keep it going on behalf of our summit I wish to thank our panelists so much for their insight and thoughts today and may everybody stays well and safe you'll note that at the end of this panel there will be questions posed for a poll and you have a chance to all the audience members to to respond and then the the response tally will be provided by by our emcee Andy thank you so much and let's have a great rest of of the summit bye bye