Business as Usual: Operation Warp Speed

So good afternoon, everyone. I know all of you are entering the room right now. And I'm Audrey Russo, President, CEO of the Pittsburgh Technology Council. And I think today marks 125 interviews that we've done since the beginning of COVID. So I want to thank you all for being here with us today. And Jonathan kersting is with us. As usual. He is the Vice President of all things media and marketing. He's going to be managing the chat and making sure that we have an opportunity for people to exchange questions. So we're very thrilled about our guests today. But before I jump right in with our guests, I just want to give a shout out to Huntington bank, who's been with us all along this journey during COVID as well as the work we've done on tech, five radio, they are very active in the business community, and it provided a lot of support for those people who were looking For and needed government assistance during the onset of COVID. So we're thrilled to have them as our partners. And I also want to extend appreciation to at&t. They have been joining us through much of our public policy and government relations work and they have been very active right at the onset and making sure that we are eradicating the digital divide, which we saw, you know, immensely in terms of the bifurcation of the community, particularly as kids return to school, with school being at home. So they've been tremendous partners. So I mentioned that this is 100 and 25th session of business as usual, we launched this at the beginning of the pandemic. I only thought we would do this for two weeks. Little did I know that here we are approaching six months and we are continuing to be pretty much booked with guests and people who are just at the forefront of making sure that the lives of those of us that are you know, working in tech and working across the community We're providing you with relevant information. And today is another great example of that. So we're pretty thrilled. So we've muted your microphone. And we also have a chat. So ask questions in there, Jonathan will keep his eye on that to make sure that we have a chance to do that. So we have, we have today, Paul Mango. He is no stranger to the Pittsburgh business community, and nor to the membership of the Pittsburgh Technology Council. So I'm going to welcome to the program Paul and I mentioned that you are more than familiar with Pittsburgh. Today you are serving as Deputy Chief of Staff policy at the US Department of Health and Human Services, and are in a very important position relative to the current pandemic. But before we talk about operation warp speed, how about we just take a minute for you to describe your background and the journey that you've been on professionally, having arrived at HHS, and then we can talk about your current role. So welcome. Thank you.

Well, thanks, Audrey. It's great to always interact with folks in Pittsburgh. I haven't been there nearly as much the last since the beginning of the year as I would have hoped. I still my wife is back there. Many of you probably know my wife, Dawn Rucker, she has a different last name, but she's very active in Pittsburgh technology and has made a lot of contributions there. But so I got to Pittsburgh in 1988. came there with McKinsey and Company. I'd never been to the city before. So it was a pleasant surprise. And like anyone else at McKinsey, we thought we'd stay a couple years and move on. But now it's been 32 years or so. And we'd love it. I just by way of background, grew up in upstate New York, went off to the West Point to the military academy. Dawn's also a graduate of the military academy. That's where we met spent five years in the service here in the US in the 82nd Airborne Division and over Germany for a couple of years, so we lived overseas and then I went straight to Harvard Business School. And then I joined McKinsey. I left McKinsey for a couple years and great scientists in Pittsburgh at the Institute for transfusion medicine, which has a close research relationship with the University of Pittsburgh. And then went back to McKinsey and we built a big healthcare practice. I spent the bulk of my career there. I in 2017, I call it my mid my midlife crisis, I actually became a candidate for governor in the Commonwealth of Pennsylvania. My wife, it could have been worse than that. And but I had a great time as candidate but shortly after, I lost the primary secretary, a czar called because I'd known him obviously we both in healthcare for a very long time. I'd known him since 2006. And he said, Hey, really sorry about the primary but why don't you come on down and help us out we need a lot of help down here. So I started out in the summer 2018 as the Chief of Staff of the Center for Medicare and Medicaid Services. And then 14 months ago, July of 2019. He asked me to come up and serve in the current role as Deputy Chief of Staff for policy. Little did each of us know that, you know, on the day we returned from our Christmas break on January 3, Bob Redfield at the CDC called and said, You know, I think there's something going on in China. And that was, like I said, that was January 3, and this is whatever, September 17th. And I don't know where the last nine months went. I did spend about, I don't know, 12 or 13 weeks straight. Every day over at FEMA, FEMA was the lead agency for a while on this. So we were closely coordinating. And I tell my wife, it's the longest time that since 1979, that I didn't see her so so It was literally like, close to 14 weeks. And then I know Today's topic is very much about operation warp speed. When that came about in the springtime, the Secretary asked me to be kind of the prime his primary liaison to that effort, which is a joint venture between HHS and Department of Defense. So that's what we've been doing. For the last operation warp speeds have been about been around since about the middle of May. And it is moving, as I've said to many folks, externally, it is moving at warp speed. So I'm very happy to talk about it today. So that's, what about me and I should mention, I always put this last for some reason, but I do have five daughters, also, of whom are Steelers fans, and one of whom is left in western Pennsylvania, but they all love it as well.

That's great. Thank you so much. Yes. So we're gonna we're gonna dive into the cement. You know, many of us in our numbers have been closely following operation work speed. But for those who haven't, here's what is said on the website. So tell me if this is correct. It's work speed o Ws aims to deliver 300 million doses of a safe effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics and diagnostics collectively known as countermeasures. So the question is hearing this and hearing this goal and knowing that we've never approved a vaccine faster than four years, and usually the approval process is probably seven years. At least one journalist described this as an arguably the most ambitious scientific endeavor undertaken in recent American history. So barring the moonshot program, which we're big fans of, I tend to agree with that. So in terms of the stated goals, element of safe vaccine ramping up manufacturing 300 million doses and preparing for distribution. How are we doing? How are we doing that? Yeah, it's give us a status.

Yeah. So, and I always preface these comments by saying when it comes to science, nothing is certain. So things could change tomorrow, things could change next week. But barring that things are going extremely well. And a little bit about how operation warp speed came together. As you mentioned, Audrey, it is think about it. There's three vertical aspects to it. There's vaccines or therapeutics, there's diagnostics, but there's also three horizontal aspects to it. From an organizational standpoint, it's a matrix and those three are research and development is one manufacturing is two. And the third one is distribution and administration. And there's been a lot in the news in the last 24 hours about distribution and administration because yesterday we released our strategy and our plan and our playbook for the states. distribution and administration. Early on, what we did was attract literally the most successful vaccine developer in the world. His name is Monsef slouchy, spent a lot of his career with GlaxoSmithKline. I believe he has successfully brought 14 vaccines to market including shingrix. So any of us who are over 50 I'll make a plug to go get your shingles vaccine at about 99% effective one of the successful vaccines ever SAF develop that. So just to put it in perspective, we were able to attract literally the best vaccine developer in the world. He has a counterpart carload dignitaries, Tiffani who's been 35 years in manufacturing in the industry. And we have some of the best. This as well, obviously, Tony Fauci is deeply involved Francis Collins. From the NIH, we have a guy named Matt Hepburn, who came from DARPA and d o d, who was a vaccine kind of an immunologist, type of guy. And we have the D o d itself. So Gus prerna, four star General, ran the Defense Logistics Agency effectively is now full time assigned to operation works. We so we pulled all that together, we set criteria for success. And we launched it started with about 114 vaccine candidates. That was whittled down to about a dozen or so maybe a little bit more than a dozen. And then we have invested in six vaccines across three different technology platforms, the the messenger RNA platform, which is relatively new, the viral vector platforms, which had been around a while, and then the protein subunit platform, so six of them and it's very intentional, that we did that. It's a portfolio strategy that places There's a lot of bats, so to speak with some of the best companies in the world. As you've probably read, Pfizer is one of them Johnson and Johnson is one of them. AstraZeneca is one Novavax, as I said, GSK Santa fi is one and then a relatively new company named Madonna. And three of those are in three of those vaccines as of today are in phase three clinical trials with a temporary halt on the AstraZeneca. One because they had a problem with a patient in the UK, be expected to more of those will be in phase three trials within the next four weeks, and then one will come after that. But just to put this into perspective,

it's already operation warp speed is already setting a number of records. So from the time of the identification of the virus to the first phase one trial starting was 43 days. From the time of the identification of the virus to the time the first phase three trial started, was somewhere between six six and seven months. So there's a lot being done, where everything needs to be done in sequence. Now it's being done in parallel. So we are actually funding and supporting the advanced trials. But we're setting all those up before the companies are even done with phase one trials so they can move literally on the day after they get approval, they can move into the next phase. We are already what's called manufacturing at risk. There are millions of doses of vaccines already manufactured today as we speak. We have no idea whether the vaccines are going to be safe and effective yet, but the intent is and you probably read about it yesterday that upon FDA approval for let's say an emergency use authorization within 24 hours, people will be getting vaccinated all over the country. So we that that's never been done before. And you can think about it as most pharmaceutical companies would not take that risk. They would not take the risk of manufacturing investing billions of dollar in manufacturing before they knew they had a good product, we can do that. And that's kind of the beauty of operation warp speed is that the return on the investment to the United States as a society is so much greater than that return on investment would be to any pharmaceutical company of having a safe and effective vaccine, that it was a very good investment for us. So Secretary minuchin would say, in March and April, everyday the economy were shut down cost us $40 billion in GDP. If you say the federal government takes in about 20% of GDP in terms of taxes, you can you can do the math, that's a billion dollars a day. And a patient warp speed will cost us somewhere between three and four days of the economy being shut down in terms of tax revenue. So if we can cut off a year or 18 months or two years from what would have happened, it's an enormous return on investment, not even to mention, the number of lives it'll save. But just from an economic standpoint, I think we could say that we are being Great stewards of the taxpayers dollars in a way that the individual companies could not assume that risk. So, where are we right now with this? As I mentioned, these phase three trials are being evaluated by a completely independent body known as data and safety monitoring boards. For those of you who are researchers, you probably understand that we do not have any access to what is happening in terms of case accrual. In terms of enrollment, it's going very well Pfizer has already exceeded its 30,000 initial 30,000 you have Madonna which is getting very close to that number. So that's another record which is having enrolled close to 60,000 persons and phase three clinical trials and remember, really, it was effectively August 1 before these trials open. So we're saying within six weeks, we have 60,000 persons in base clinical trials, that doesn't really matter when you talk to him on staff, what matters is how many cases are being generated out of those. And we did the best we could we get daily data on hospitalizations due to COVID. And we get daily data on testing results for COVID. And in the last couple of weeks, we're doing about 750,000 COVID tests a day. So we can see by county where those are coming in which ones are positive. So we did the game, the name of the game is to set up the clinical trial sites in places that have the largest outbreaks and while the President and Dr. Burks and everyone else and we're all hoping we have fewer and fewer cases, if you're a researcher in a phase three clinical trial, the thing you want is more cases, more of an outbreak because you have to prove that the vaccine works and the only way you do that is you have 15,000 who have a placebo 15,000 grab the vaccine and watch how many of each of those categories. I'm sorry, you those categories actually leads to infection. And that's where we are right now. But we have no insight into when we're going to get that date those data, because it's all run by a completely independent non government body called the data and safety monitoring board. A feel there are good data. And let's say they are effective, they will send those data to the company, the sponsoring company of the trial. That company will then decide whether they think it's good enough to send to the FDA for emergency use authorization. So that's kind of where we are right now. And I think when you hear the President speak about this, he is accurate. It is possible that this could happen in October. It is more likely because we we statistically Look at all these things it is factually more likely that that'll happen in November or December.

It is highly unlikely it would happen anytime after that meaning We are with all our probability analyses. We know it's going to be sometime in October, November or December. So we feel really good about that. So I'll just pause with that. Hopefully. That's great.

That's, that's great. That sets the table. We have so many questions. I want Jonathan to pick a few out just to ask them. And so we can get engaged when people are passionate, as you know.

Absolutely. First and foremost, just the one that just popped up right now. And people want to get involved with this. They want to be helpful on how can they get in touch with Operation warp speed. There's many of us here who can help with the effort to make sure in pharmaceutical glasses available but can't get through. Is there a way for people to get through?

Yeah, and just just Dean is in my office of Justin, could you get the website for there is a website, a single website for enrollment in clinical trials and we haven't talked too much about therapeutics, but there are a number of tremendously exciting therapeutics. In fact, I think University of Pittsburgh yesterday man or mentioned or announced or The day before about one of their antibodies, which is early, but also exciting, but there's a whole bevy of therapeutics that we have going through clinical trials with the NIH as well. But to answer the question directly, the one area where we feel we're not doing as well as we would like to do is minority recruiting into clinical trials for vaccine. So particularly African Americans, we want 10% minimum in our aisles and we're running, you know, seven or 8%. I know that sounds like a small difference, but we don't want the FDA to hold up the trial because we were unsuccessful at getting enough African Americans in there, as you know, they have been disproportionately affected by COVID, mainly due to mean we've done some analysis of sickle cell is something that really complicates this disease, obviously, a number of underlying conditions and so forth. So That is an area that if anyone could help they're rolling. And we don't just need young, healthy African Americans. Unfortunately, what we need in the trial is older African Americans with underlying conditions.

With that hasn't technology or supplies or something like that? Would that be a way they can help as well, too? I'm sorry, say again, if any of our members have technologies or supplies that might be useful to the operation, can they be you

that we feel pretty good about? We have, for better for worse exercise a lot of defense production act authorities. We are flying equipment in from all over the world that would take six weeks on a ship and we're getting it in 24 hours through very air transport. We've procured over a billion needles syringes, because these vaccines, we don't know which one is going to be a winner or which ones are going to be winners and some of them have different gauge needles, different size.

syringes we've procured by

We actually feel from industrial response us, you know, industrial base respond. We are in very, very good shape. And we've established 25 manufacturing facilities to include fill and finish all over the country in a very short period of time, so that we feel we feel good about it is minority recruiting where we feel less less good.

So, before we go into interest, another question, I want to ask you something that Dr. Fauci talked about the importance of the widespread adoption of the vaccine wanted to clear the regulatory process and well educated and well informed people have serious worries about that speed. So we've talked a little bit about that. Can you talk Can you react to that and then we'll jump to some questions.

Yeah, I think the couple things one is, again, I'm getting this from Dr. slouchy, but a typical vaccine clinical trial might have have 8000 or 10,000 persons in it, we have six of them going that will have 30,000, minimum of 30,001 of our candidates is going to actually have 60,000 in it. So this is unprecedented in terms of the number of persons who will be in clinical trials. So that gives us some comfort number. Number two is, as I said it is neither the president nor the secretary nor Dr. Lowery has any influence on what the data and safety monitoring board does. They make a completely independent decision on data. They have statisticians, they have experts, scientists and so forth. So they will not make a recommendation or release the data unless they think it is either really good or really bad. They could say, shut this down. They could say shut this trial down right now. There's no sense in giving it to anyone else. That's obviously we don't we hope they don't say that. So I think that should give some some people some comfort, then, you know, I mean, I've been been here a couple years I have the highest regard for our colleagues at the FDA and the ones who are running the Center for Biologics, which would Peter marks in particular, who is going to wind up his team is going to wind up saying yes or no on these things. He's a career official has been there a long time was extraordinarily high integrity. And he won't be bullied, I can guarantee that so I, I would, I would take the vaccine as soon as it came out. And we have a pretty and we'll have a pretty aggressive campaign communications campaign that we're gonna ramp up. I mean, we've already been doing it, but we ramp it up more to give people comfort. The only caveat is that we have no reason you haven't seen kind of general PSA announcements and those types of things is we do not yet know how effective these vaccines will be in certain segments of the population. It is entirely possible that a vaccine could come back and say it's no good in persons over 70 bucks. It's great if you're 25 to 60. So we don't want to get everyone so anxious and lathered up about Oh, I'm going to get my vaccine only to learn that that particular candidate is not good in a certain population.

Okay, good. So Jonathan, you want to grab another question out there,

please. Yeah, some great ones here. So from Michael Nilo says, we're still currently struggling with infrastructure for proper testing and distribution of PvE. Are there any aspects of operation warp speed that are aimed to overcome that?

Yeah, so let me address because I oversee the Strategic National Stockpile as well. That's one of my rules.

Let me talk about PP First,

there is a very well defined process that should go like this. You Pennsylvania has, you know, representative from FEMA, okay. Every day we're tracking requests through states, through states that can to FEMA, where there are shortages of pp. And when we get those requests, we look at our data. You know, we get we get a lot of requests for things that don't make sense. We had a governor asked us for 40,000, ventilators, for only 80,000, ventilators in the entire United States perspective, that Governor wound up using 1200. Just perspective as well. So we verify the request and say is there an outbreak there is this is, like I said, we get every hospital is every COVID hospitalization reported to us every day. And if we see that's an area that's requesting stuff, and there's some sense of a patience that COVID patients that need it, we ship it through FEMA and you get it within 24 hours. What the purpose of the federal government is not to do is to restock the shelves of hospitals who have no COVID patients and should be buying their own pp. So that's what that's not the purpose of The Strategic National Stockpile. We save it for emergency situations. In terms of testing, we're perplexed by this because the productive capacity of us testing industry today for COVID is 3 million tests a day. And we're consuming about 750,000. So there's, and we know that there's different technologies that take different reagents and so forth. But we are a little bit perplexed as to why anyone would say they're having trouble. We have heard spot shortages of certain reagents. We've heard spot shortages of certain swabs. We've, we continue to have a lot of swabs in our own stockpile that are ready to be shipped. It depends on I guess what technology testing platforms the individual hospital has, in this case or testing laboratory but I if anyone has any specifics, I'll be happy to pass it on to Dr. Grr who works right down the hallway and get him to to leave Look at it. One thing I'll say about testing is we are in a massive kind of transformation away from laboratory based tests to point of care tests. And today, what's going on in the country a little bit over 50% of what's being manufactured is point of care tests. They're quicker, cheaper, and almost equally reliable, you know, 98%, sensitivity 98% specificity. So if if it's, I would just encourage you, whatever members are looking for laboratory testing capacity to think about point of care as a as the new newer technologies that they might want to switch to.

So, Jonathan, maybe one more question and then I have a wrap up. I know people are asking amazing,

some really, really great. Let me pull something up here. So this is a little bit of a long one, but very interesting here from Sam Brower. So operation warp speed has focused heavily on vaccine development, but diseases such as aids and hepatitis C had been managed with antivirals, not vaccines. Furthermore, SARS has mechanisms which would aid the immune system, which makes it vaccine more of a challenge than diseases such as smallpox. Why is not more being done on the dedicated anti viral front? Yeah.

Well, there's let me just speak a little bit more broadly, there are scores of trials going on right now, for therapeutics. They're not all antivirals. Like I said, some of them are antibodies. Some of them are just coagulation. I mean, a lot of these patients are dying of blood clots. So there's a Mrs. Collins at the NIH launched a massive kind of heparin related study that there's studies going on on convalescent plasma remdesivir, antiviral, there's still a lot of studies undergoing we've shipped, probably, gosh, in the last five months, I'm just guessing a million doses of remdesivir to us hospital. So there's a lot of that going on, I'm just guessing 15 to 20, minimum, different therapies being evaluated in general. And there's a lot of enthusiasm for them for whatever reason, they're not getting the same attention, then scenes are getting but big, multi billion dollar investments in clinical trials. And actually the same thing, as I mentioned, with vaccines, which is preparing products before the before the trial is even over.

So we're coming, I want to be very sensitive to your time, and there are some great questions and we'll archive them. I don't know if we'll ever will, if we'll be able to get the responses back to the individuals but there, there's lots of questions. I mean, how can a couple of things looking at this, this is a global crisis, right? And how does the United States gonna work to ensure that the vaccine can be distributed equitably? So Every corner of the planet.

Yeah. So a couple of things just to set the record straight one is the only thing we've done is obtain licensing agreements. Many of these candidates have manufacturing agreements all over the world. We are not preventing that at all. We're not hoarding the intellectual property. We got licensing agreements to engage in manufacturing for us citizens. If all goes well, by June, July timeframe, will about 2.2 billion doses, hopefully successful vaccine. So we are already going through the process with the National Security Council and the State Department as to how we can if you will export those. We're not going to do that prior to us having confidence that we can take care of all Americans. It's it's your taxpayer dollars at work here. But we feel very comfortable that by late spring, mid to late spring, we will be able to export product all over the world. And we're gonna start with lower income countries, because most of the Western developed countries have manufacturing contracts or, or even if they're not manufacturing, they have contracts for end product delivery for many of these companies, so we're very cognizant of that we think it's vitally important. And by the way, there's self interest in that. Because, Guess how this virus got into the United States. So we just don't have the whole world vaccinated and not have to worry about this. Again, and you know, from a global economic standpoint, and so forth, we want to we want to do that. So that's that planning is underway and think about it as middle to late spring. We are keeping our fingers crossed, but we hope to be exporting a lot of product.

So how can our members and people are on this call? How can we support operation workspace?

Well, I think it's great that we're exposing the group to you know, the facts, so to speak. I think the talk about it as a As you mentioned as a scientific achievement that is nearly unparalleled rather than a political event, because it's not, I think, to continue to promote the fact that there are tremendous safety gates that these vaccines have to go through before they will be in widespread use. I mean, now, almost 60,000 Americans already have been injected with them. By the way, zero incidents zero safety incidents does about that right away. We don't know the effectiveness yet. But we do know it looks like they are pretty darn safe. Knock on wood there and then I think with the minority recruiting, so I think providing greetings Hey vaccines, the minority recruiting unfortunately, Western Pennsylvania is not in a big outbreak situation. So having African Americans from Western Pennsylvania will not really help us much on the trials but you know, elsewhere they will if your companies extend out to different parts of the country I think those two or three things would be very valuable and very much appreciated.

Listen, we have extended our time, I know that your time is precious. We can't thank you enough for sharing with us getting an inside view in terms of what's happening. It matters. Your work matters to each and every one of us, and I can't thank you. There are a lot of, you know, questions that are out there. We'll share that with your team. If there's a way for them to get answered, we will we will make that happen. Thank you, everyone for joining us. I think this is helpful. It gives us as Eileen has just said, This puts into context, better than sound bites that we hear on all the different pieces of news and social media these days. And that's really important and that's what we try to do through the work here at the Tech Council, and thank you for carrying the flag for Southwestern Pennsylvania. Absolutely. A lot of great work someone rents referenced the work she's done with Girls of Steel, you know that. And I know there's numerous other things she's been involved in. So we will share the webpage with everyone so that they can get involved and they can be cheerleaders for this work. And we will stay connected with you, Paul, thank you so much for your work. Thank you, Jonathan. Thank you, Brian Kennedy for making sure that this this event happened today. And thanks to Huntington bank and at&t for for being our partners over the long haul. So great if they fall.

Okay, great. Best regards everyone in southwestern PA. Thanks. Okay. Bye.

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