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Milken Institute Global Conference 2020
October 19, 2020, Online, USA
Milken Institute Global Conference 2020
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A Conversation with US Department of Health and Human Services Secretary Alex Azar
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About the talk

Topic: Finances

Guest

Alex Azar

Secretary, US Department of Health and Human Services

Moderator

Meg Tirrell

Biotech and Pharma Reporter, CNBC

About speakers

Alex Azar
Secretary at US Department of Health and Human Services
Meg Tirrell
Senior Health & Science Reporter at CNBC

Meg Tirrell is CNBC’s senior health and science reporter. Since joining CNBC in April 2014, Tirrell has covered the development of new medicines for Alzheimer’s, cancer and rare diseases, and tracked public health emergencies from Ebola to Zika to the COVID-19 pandemic. Her reporting has also chronicled the massive set of trials seeking to hold the drug industry accountable for the opioid epidemic, market failures that have led to life-threatening drug shortages, and the ongoing fight over the cost of medicines. Prior to joining CNBC, Tirrell covered the biotechnology industry for Bloomberg News, where she also contributed to Bloomberg Television and Bloomberg Businessweek.

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Oh, hi everybody. I'm makes her out here with health. Secretary Alex, Azar Mister secretary. Thanks so much for being with us for this conversation with you. Thanks for having me and really glad to be with an event with Milken Institute, the mic and the work he does. And the great work of The Institute, really are a valuable partner stuff. Especially we've been going through. Cobra. And let's talk about where we are, of course, with covid-19 into the colder months, or at 55 thousand cases, on average per day and

Rising heading into what a lot of people are calling sort of 1/3. Third. What do you see when you look forward to the fall and winter? What do those months? Do you think look like for the pandemic in the US are on about a 14% the 7-Day rolling average increase in cases with seen it. Primarily in the midwest Upper Midwest the plane upper Plains areas, but it also just really across States. We've got a large number of jurisdictions with increasing cases. And then when you have increasing cases

are going to take recent hospitalization, so we're seeing that also. And I we we believe that a lot of this is driven by some of the phenomenon that frankly, we saw back in June comes out of Memorial Day holidays, which is in the Southeast and Southwest, we saw basically a virgin Southern version of winter with his butt. With a lot of heat, people go indoors and air condition settings. You had, you lose the natural social distancing, a call from out of the thing that we are concerned about, of course, is in the northern climates right now, especially as it gets colder,

we lose some of that natural social distancing to come from, being in the backyard, being an outdoor dining. People move indoors, they moved indoor Gathering and so you did just like you do with blue season, you lose some of that natural protection from natural social distancing and we seen a great deal of community spread from a local Gallery. So just people having friends and neighbors and family members over and not practicing the precautions. You know, washing your hands, watch your distance and we're in your face will cover it. When you can't watch your distance because you

think of your home to say, if you think the people, you know, you're safe. We try to remind people that you can get disease from people that you're related to, as well as the people your friends list, as well, as for neighbors, and you can transmit to them and it's in Europe right now. It's the same mitigation fatigue. I think lady to lot of folks dropping their guard, and we're just asking people to, please recommit to some of these basic public health. And without these steps will see continued, increases the case,

every holiday coming up. What do you tell? People when cases are rising like this about what to do? Yeah, I'd say first and foremost, follow the advice of your state and local authorities in from the Gathering. Second. Follow CDC guidance and we're going to keep putting out information and guidance around what to do, but just use common sense. Thanksgiving Christmas. Gatherings again, your immediate household members. Of course, you already exposed to your closing to

each other. In terms of the Texas disease, you want to assess the circumstances in your community, in terms of how, how much is disease spreading your in your community. You have individuals coming to do any festivities that are from an area that has hired disease. Spread and just some of those basic again washing and watching the distance. Even at home, even the family gathering, washing your distance setting things up, in a way that set you up for success and wearing face, coverings of it when your cat social distance. And so just being very careful, especially being mindful of you

have vulnerable people in your household or The households of those that are going to be joining you, it's just it's I hate to say it because people have really sacrificed a lot over the last many months. And so I know that there is a a desire to reconnect socially, but we have to just, we've got to carry forward being careful with each other right now, even if we honor of the holiday season has been going in the wrong direction, obviously, and you're this guidance, you've been saying other health officials have been saying

he do distance wear masks your hands when you can does it require some other action. When did it's obviously not working, people have Pandemic fatigue mitigation, but whatever you want to call it. Do we need more of a national directive. To try to change the trajectory here? Like I actually, I don't, I don't believe so, but I actually think that would be counterproductive because again, it's precisely because of the the fatigue issue. I don't think things like National mandates and a proven useful because people are going to come by or not comply based on whether they have bought into the need

for the intervention. We see this in Europe. So, Western Europe has some of the strongest force of law Community, mitigation measures that have hats and yet, they're experiencing cases per million that are vastly higher than the United States across Europe and the US rate of infection right now. Frances. Well over us UK as well over a stained well, over us. And many of them have very strict controls. People in open, democracies will behave as they will. And it's more

important to try to educate get there by in. And get people understand that these simple measures washing your hands, washing your distance where on your face covering when you can't watch the distance. These are your ticket actually to freedom and re-engage. I tried to describe this people to resist Master, not as restricted to think of them as empowering schools. It's your way to go back to school. It's the way to stay at University. If you're there, if your way to be going to church or synagogue, it's your way to be reconnected

with Healthcare getting screenings and elected Health procedures. It's your way to be rain, gauges and political Civic community life, and be reconnected with friends. So, I think of this is, how is this is a paring tool as opposed to control an acting Aponte. What is such an important Public Health message? And you just mentioned people's willingness to do these kinds of things really comes down to their amount of buying into the need for them. And you talked to us about the messaging from the government. And why not have CC be out front on this.

I mean, I've been a help reporter for a decade and every Health Emergency ice-covered. It has been the CDC out there almost everyday multiple times a week. Doing press briefings being the, the key messenger really from the government and public health. Why are they not the key messenger here? What will make a CDC, has a vital and important role in does provide, of course, guidance out there that has CiCi's guidance. But if you got, if you mentioned the distinguished career covering help the best, but never one like this. This is an unprecedented Ken, domik, you know, really probably.

And I'm pressing him for almost a hundred for a year. And and so it's a man to hold your patience. And so those happen across the u.s. Government, not just one agency, Give an example. So the CDC obviously, is the world's Premier epidemiological organization organization on which the other day actually, takes the name of European CDC, if they, they use that brand. Even it's so important up there. Also, even just within my own Department. There are many other perspectives that have to be brought to bear with a pandemic

of this magnitude. For instance the Substance Abuse and Mental Health Services Agency. Bring the bear important, mental health, behavioral health considerations. In addition, to those that are purely about infectious disease spread. This is such a large, National Emergency. All of those perspectives have to come to the forest very different. Even from an H1 N1 situation or even from the Ebola outbreak where you might have the CDC. Is the only spokesperson of the only entity talking about this is genuinely impacting the entirety of our economy, all of our Lives,

more than just about a virus or does he But if you're just saying, you know, if we all implemented these Public Health measures we would get through this faster and we would be able to get back to more normal life as the one that has the public health agency. That's telling us how to get through the fastest speed a messenger. Well, they talk about it. We talked about it. You know, we were all out there. I was going to meet the press this weekend. Dr. Fauci. As you might have, noticed is on TV, right? He's on TV all the time. The red Fields out there. On Doctor Burke store is for goes

around the country, dealing with a lot of our regional operations. So we're out there were providing direct access to our leaving, top docs for the media for the public. So that's what we've been trying to do. Really from day one here view. I heard you on Meet the Press yesterday, telling Chuck Todd. That's not the the national plan to return immunity. Before we have a vaccine has a lot of epidemiology and public health, experts fear. What they wanted to hear from you in this conversation. And many of them said, we want to know what the national plan

is. Can you tell us what is a national plan for getting us out of this pandemic for trying to Disease before we have a vaccine in the bit of time, sequence, of course, initially or course refused to give Jester that the beginning was too. And I said this publicly was to delay and flatten the curve as it. Would we knew that even with all of our containment measures that it would come here to the United States. Because there's no way I said except beginning of February, can't hermetically seal off the United States. Will you take these aggressive containment measures the ones? The

president took the unprecedented control and travel, that would delay and flatten the curve. And from the spread here in the United States to maximize the odds that we can remain within the health system capacity here in the United States. So that, that was the core initial objective. And we use that time to build up our personal protective equipment flies. Develop our health system capacity, build up our ability to flex and expand their ICU beds and over that sun. What are we done with our house? Will have 30 60, 90 day, PPE supplies. We don't have. Read Therapeutics from dust of your

steroid convalescent plasma that we can use to treat people with dramatically. Alter. The profile of our bill is from the mortality profile of the successor of those people. People 870 tube of one from about a 30% chance of totality just from being infected in April. So now below 10% and if not even more than that today. So we we've made math. Incredible progress. They're on increasing our capacity to deal with the crisis and improving our health system capacity. Improving our ability to reducing mortality bringing Therapeutics and investing in and driving the

Next Generation therapeutic, monoclonal antibodies and back pain, but I'm sure we'll talk about the operation warp speed. And then driving to that day right now. What are we doing? Would do spaces reduce, hospitalizations reduce mortality. That's the key until we can get them on their bodies. With the corset feed into the reduce hospitalizations and Bruce mortality and vaccines, which will reduce actual case spread to the point that we would hope to get to eventual National herd. Immunity from vaccination, programs and

Coronavirus. Vaccines, you know, we're getting very close to what we've been told. At least from Pfizer could be there first efficacy data and just a few weeks moderna is modeling November potentially for their. Tell us. When will it be that? You think we will have a vaccine of the first roll out for the the first people and then when will be that everybody who wants Messi vs. Omega says, you know, we don't have any control over win a vaccine trial will read out a very different than a

therapeutic trial, say, where you might have the disease burden by The Rolling, people in the trial and you'll get an outcome really within days. Because you can see the clinical endpoints audit. These are some of the largest vaccine clinical trials, ever orchestrated, 30,000 people products in these clinical trials, minimum. And as you know, the way they work, you put 15,000 people on vaccine, 15,000 on Placebo. You have a crease Us by statistical, endpoints that will determine when you reach neffex. The Point weather for 90% effective vaccine, 75%, or 50% effective. That's why is

that the DSM be today's date in safety, monitoring board. And then what has to happen is you basically have to as they call it. A crew of s meaning you need enough people to get covid-19 clinical trial that you then take a look at the ends of the SMB text. Look at the data and determine have we gotten 90% of the people who have covid-19 level of statistical. Significance. Are they in Placebo versus 10% Below in active arm? And then that could be a data readout point from the demonstrating say, 90% efficacy. And of course, you have no

control over when you look through those event, Pfizer. CEO has said publicly, that he might see the data readouts. As soon as late October. We don't know if that will happen. But obviously we were all hoping that will feed out as soon as possible and be able to demonstrate but there are no fathers were both as safe and effective, vaccines will be driven by the side of the science on that. What we ought to be talking about is not whether it's next week. 3 weeks from now 3 days from now, but just what a writable at historic achievement it is

that we are literally talking about the possibility of a company like fives or filing for an emergency use authorization by the end of November, literally 10 months after the entry of this virus to the United States. This is historically. It is an amazing achievement. For the president for operation, warp speed for our biopharmaceutical industry in the United States that we even have this in Rain. Remember back in January, when the questions are vaccine. First came up when people talked about 12 to 18 months

for a vaccine. They said that would be the most optimistic scenario. I think dr. Fauci when I was with him up at and I agree with the president even said to reporters, everything would have to hit exactly right to be in the 12 days in months time frame. And now God willing baby. It's even in the 10-month time frame. But again, this is timeline on production and vaccine. When would every America have access. So, under operation, warp speed, we're producing millions of vaccines as we speak. All six of the candidates that we've invested with, or, or contracted

with. We are manufacturing at commercial scale. Right now. We believe will have enough vaccine by the end of December to vaccinate the most vulnerable populations in the United States, by the end of January, enough to vaccinate all of our seniors, health, care workers, and First Responders, by the end of March to early April, we believe you would have enough vaccine produced to vaccinate anybody in the United States who wanted to get back to me. And do everything really has been going great. So far. It's kind of been amazing to watch, but we have seen a clinical trial hold for astrazeneca's

product in the United States. It has restarted in countries around the world. What can you tell us about what's going on there? And it was the FDA be more prudent and perhaps other Regulators are Well, I'd say with regard to not just the easy clinical trial hole, but the J&J dancing slippers call, hold or say the Eli, Lilly monoclonal, antibody impatient clinical trial, hold. That the American people should feel very reassured, actually. Buy these developments that this shows were putting patient safety at the center. It shows were playing this by the book. It shows that FDA is in the

driver seat, making the calls on this that are biopharmaceutical industry acting the way that a cycle and independent also, and that we've got many independent checks. And so would have seen the other UK restarted, quite some time ago. The FDA has been working with AstraZeneca to get out of the cfda with Bill. Allows it to make its own independence of terminations regarding any potential connection between any serious adverse event and the vaccine whether any changes or modifications to Protocols are required. As we said, those are going to be called 4 ft 8 in We're

scientists investigate. That's how they're proceeding. And I'm not going to either publicly or privately, judge them for taking a different, or more, conservative approach than the UK, and other countries has done there. I know that there are another attempt is to to look out for patient, safety, and make sure that when we do get back, seen their public trust and confidence. And does the final Authority on whether vaccine makes it to the market here in the United States. Rest with those career signs. It's at the FDA. Yes, I made it very clear that these will be

determinations, the approval of the vaccine or therapeutic to go to be determined by the career leadership of the sensors, at FDA along with, of course, doctor on. Operation warp speed, you know, either of course, it's the one that's giving the fastest timeline moderna. It is right on his heels. Really Pfizer did not participate at least in terms of funding from operation warp speed and the US government for the development of its vaccine saying that they thought they could go faster. If they did it by themselves and how do you kind of look at that? I

don't think anybody doubts what operation warp speed has achieved but the fact that a large company did it essentially on its own as fast or faster than operation works. Well, you better remember Pfizer was very much earlier in the process here with the messenger RNA vaccine candidate. So it's not like they at least brought they were also very early on in that in the MRNA platforms by the Speedy development timeline as well as manufacturing. And so we are happy to work with the manufacturer's instructions to deliver results. And if,

as as we've done with Pfizer, we have a a free stuff defied, commitment to purchase and that's the way to incentivize and get Speedy production as well as to work with them on how we can get we how we can facilitate development online. That's the perfectly good approach but with others if it's more for us being very much LinkedIn and assuming more of the Financial Risk. As you go we're happy to do that and have done that. Also a company like five or one of the about the largest farm. Google company on Earth. They may not need our working capital in order

to be able to run their clinical trials and dearest the process as much as possible. And then we we were able to be there with the purchase agreement at the end of that process so that they know they've got a market. Well, as you are drinking the Finish Line on getting the information about whether these vaccines work, you're also preparing for the distribution of them, which will be an unprecedented challenges in itself. Was issue that I've heard might be coming up, is the availability of needles, not just for covid-19 vaccines, but some of us an idea that this,

how's the stock piling of needles? For vaccines affected, the flu shot Market? I'm not heard any concern in that regard actually begged. I'll certainly look into that to make sure but I know we're going full speed ahead with the flu vaccination campaign. In fact, we work with the flu manufacturers to get extra. I think about funny million more than originally planned vaccine to make sure we have plenty of. We try to really encourage people to protect themselves by getting the flu vaccine. This is every year, but this year

in particular. And so, I haven't heard of any concerns about that about that issue. We have course of negotiated supplies of needles for purposes of operation for feedback Nation program. I don't know why that would necessarily get on the way such as you think about timelines of when you're doing flu vaccination campaign and your operation, warp speed of covid-19 program. We really getting into those types of numbers later in the winter season of fight when he won, but I've not heard that much. Well, as soon as our plans were due on Friday for states in terms of their

distribution. Have you seen them? And how prepared are we here? What kind of pickups could be potentially run into. So, we've now received plans, from all 64 of the jurisdiction States territories in the Fourth of July. We work with some cities as independent Public Health Department. So we've received all 64 of them. Are reviewing them now working with them, but we got your back meeting. For instance, General Perna. The leader of operation, warp speed in the CDC. Seeing the fact I have worked with the New York team under dr. Howard, Zucker on New, York's planning for vaccine and a robust

discussions Roebuck planning there. And so that's all move forward. That was, that was done. They cover phone decided not to spend any of those processes with his team, but his team about the reactive response. I got. Was that the that they're planning is moved very far ahead and we're doing that in in all of our states and jurisdictions helping them. Think about how do you get Saxena out effectively, as we Pace it out. It comes off reduction lines as an does FDA authorizes to The seat Friday, we

announced a CVS and Walgreens where they're going to use their capacities and be available to help acne in our senior. The nursing homes that will be really important for Swift distribution of the vaccine for those who are most often. You know, we've heard from Stacy that they more funding to be able to implement this rollout. Is that in the works? Will they get more funding to ensure that they can do this? So they've actually there, they do not have a need for additional funding. For the rollout of the vaccine program. They actually have received funding for this.

They have plenty of resources to, to, to manage the vaccine distribution program. And so that's, that's why I've heard through the media only but not directly from space about this concern, because they actually work through with them where the funding sources are and that there's plenty of funding available to do to meet all of their needs. Okay, let's talk about the therapeutic antibody drugs. Of course, they apply for emergency use authorization, regeneron and Eli, Lilly both. This would be potentially, for a sliver of a

patient because we've only seen results in people. Who've been recently diagnosed with covid-19 or not. Those think that they're in the hospital tells about how you actually getting used if and when they reach the market, so I want to be careful, of course because the conference to cover those two companies, The Book of Revelation by want to be careful to not get into much detail. The nature of the regulatory proceedings as we have, let me if I could step back and just talk about how we see, monoclonal antibodies

fitting in, it's very similar forces. We see convalescent plasma, which I think the, I think that as we move forward, The promise of these antibodies therapies are going to be highest when we get to the patient for earlier in the disease progression. Of course, you're going to be able to actually jump, start the patient's immune system by this antibody infusion weather, monoclonal antibody cocktail a convalescent plasma through polyclonal. The sooner, you're able to get there when you have lower viral load. Once you get to accept the viral replication, you're going to

be more dealing with system management. Then you are with the ability for the antibodies actually, beat back, the viral replication on viral load. And so we have to work on how we get these products, whether there are monoclonal antibodies convalescent plasma that people as early as possible as clinically indicated by FDA in the disease progression. There is limited Supply right now. I mean, regeneron has said, it has fifty thousand doses available of its treatment if it gets cleared for Market, how will you prioritize who gets the leg

actually? Thanks for the work that we've done through operation. Warp speed, we work. We we of course the funded research and development of the vagina, Ron cocktail back in February contracted with them in the spring for manufacturing and commitments of up to 300,000 of courses of treatment. Depending on the size of size of the dosing for support and outpatient setting up the more prolific capacity. And then we also work using our authorities to assist regeneron, actually, work with Genentech, Roshan manufacturing. So it was all of that

as well as the worth of Eli. Lilly with M gentlest production. We believe we're looking at the well, over a million Force has a therapy between now and the end of the year. So we actually believe Or any clinical indications, that would be supported by emergencies authorization, we have, but that we've got very significant about the supply coming. Thanks for the early planning work and work. We did with these manufacturer of year, was the first drug proven to have a benefit is breeding season for covid-19. But the World Health Organization solidarity trial is just

question. I hung from that benefit really is. Well, I haven't studied the w. H, o a solidarity results. I actually just received correspondence from the sea of Gilead today that I haven't been able to go through a detail because I'm working on a lot of operation. Warp speed activities today, but presenting a fairly serious a challenge to some of the reporting around that trial will look at that. But we certainly feel very strongly about the quality of the authorization process here in terms of rum dust of beer. And it's used to know, we, we

were able to secure ninety percent of the world Supply, run dust of beer through the end of September to the point. That now, we have a surplus in the United States was unable to make sure the market is satisfied. Now able to go through commercial channels here and the first of the initial clinical trial information suggested as much as one-third reduction in hospital stays coming from a proper administration of rimmed up a beer and we'll have to see if we get ongoing data on. An ongoing clinical trial data, whether that's bruised to prove to be the case, but we feel very

strongly about the sport for the DUI. Original further questions for you on testing and I've got about thirty seconds to ask you. But you're one of the questions that came up from about testing is should we have more rapid test. Is there a place for trying to get those seen into the home setting for folks to try to stop this pandemic? How do you look at that regulatory perspective, but we have these really simple Hospital cheap, we can take frequently. So, where are you at the point? Where half of our half of our testing in the United States is

his point is point of care. And so, that's a remarkable achievement. Think about that, 20 Care Rapid, testing 10 months and never happened before that. You see this kind of Diagnostic in a vacation and we're seeing more Innovation almost every week on testing and adding to our capacity at some point. I certainly hope we get to the point that you can a self-administered and self-evaluation testing, but you have to get up the April, get up the a validation we have crossed for that Meg. Right now with our testing that our individual self swab even remotely from home on a video

monitor with it with a clinician supervising the self the swabbing to make sure it's inaccurate sampling and then we may get to the point. Where was some of the stuff FDA is willing to act Lee authorized self, admit actual self evaluation Administration and evaluation through a video Mater, Telehealth type of protein. Or just straight patient adjudication of those results, but the diagnostic to generate the data and that they will have to find the test that leads to Quality Diagnostics results. All right. The

blinking clock is telling me. We're at a time and that's your secretary. Thanks for being with us.

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