Perna serve this Community General the armys material for nearly four years leading 190,000 military, civilian and contractor employees with a mission to provide logistics, sustainment, maintenance for globally deployed army. General perna is a career logistician to estimate complex supply distribution and Maintenance Operations in multiple combat tours with on the joint force and serve as at the national supporting department of defense supply and Distribution Efforts so as this with the back and its easier when he was selected for this critically important position. General perna graduated from the Valley Forge Military Academy and has a masters degree in logistics from the Florida Institute of technology. General perna will provide introductory comments and then befuddled by dr. Hepburn, ahead of Vaccine Development. Following dr. Hepburn general perna will come back specifically to talk about Vaccine Distribution and then we will move into a questionandanswer period that ed and i asking questions and then after that we will turn to your audience questions and thats what makes it so important that you in your questions, so we can get to your questions. Thats our plan and general perna i now turn the floor over to you. Thank you for that very gracious welcome. Its a real honor for myself and dr. Matt hepburn to be here and talk to the Heritage Foundation group. First and foremost, its just an honor to colead of this task force with as you said a mission to develop, manufacture and deliver safe and effective vaccine to the American People. First and foremost though, i just want to highlight this is a whole of america approach. In that light i would be remiss if i did not introduce to the conversation here my other colead. Because without him, without all that he brings to the table, without his leadership and direction, we would not be successful. That individual is dr. Moncef slaoui. Truly a coleader with me. He serves as a chief science adviser, and every day i learned from him, and i am outlaw at what he brings at all when he brings to the task force here. His efforts, tireless and demonstrated by the progress we made public when you make a difference for us. In my opinion, deserves the most credit for our success. With that i say though this as a whole of america approach, and we will exceed because of the unparalleled expertise of health and Human Services scientists and logisticians, department of defense planning and logistics capability as well as american industry ingenuity and innovation from the academia. Its this collective effort that will really ensure we are successful in our endstate, and im proud to be a part of it. I would like you to think of it this way. The worlds best scientists and doctors working beside the worlds best military with the support of american industry and academia, that is operation warp speed. And we really proud to be working together as a collective team to drive towards a solution of safe and effective vaccine for the American People. And i am very confident that we are going to be successful to this end. And today we would like to talk to you a little bit about our approach and where we are at in this Herculean Task that weve been working on for the last four to five months, and we are really just at the brink of finally seeing the fruits of our labor. So more to follow from the but i took it back over to you, generals for. Tom spoehr. Great. General perna, thanks much. Ed, wider to take it from you . If i could introduce dr. Hepburn. He has an undergraduate degree at his medical degree from Duke University and a 23 a 23 year r in the United States army, and in that career he has had extensive experience in developing vaccines and therapeutic solutions, particularly against current future potential biologic threats, including serving as director of medical preparedness on the White House National security staff from 20102013. Also serving as Clinical Research director for the u. S. Army medical Research Institute for Infectious Diseases from 20072009. So he comes to his current position as the Vaccine Development lead for operation warp speed with quite a depth of experience in this area. Dr. Hepburn, thank you so much for being with us. It is just a privilege to be here and certainly looking forward to answering the questions, and we will get there soon. I want to limit my comments actually to the probably the most important question, at least the question i i receive most often, whether its at my daughter texting me from college or all of these different Public Meetings that weve had and communications over the last six months or so. And the simple question is how can you achieve the impossible . How can you take a Vaccine Development process that typically can take five years, eight years, ten years and truncate that into the timelines of operation warp speed . I want to basically put my answer into four categories and hopefully i can convince you that, number one, we made incredible progress so far, but that we can meet the ambitious challenge of operation warp speed. So theres four categories of how we do it. The first is in terms of Vaccine Technology. Its very helpful to point out that the efforts that have gone on for decades in terms of developing vaccines, we stand on the shoulders of giants, of the people that worked on polio, measles, the smallpox eradication campaign, all of that that we learned in terms of how to develop vaccines. Theres been massive progress even before we started operation warp speed in terms of how you can accelerate Vaccine Development. Theres been investments. This is a key point that this site and Technology Investment payoff, sort of does. These are investments that have been made by health and Human Services come with the National Institutes of health and very proud of duty investments especially at darpa but elsewhere. Investments, how can we make vaccines at record time . [inaudible question] on weight, especially the process . These investments were used for ebola, in the ebola vaccine developer processes and not feel like they are really paying off. Thats how we are in phase three Clinical Trials now. Because of decisions, because of those investments and those technologies that were started in the spring that are now really paying off, both for their ability to be developed quickly and prove that the work in animal models, but also that they can be manufactured at a very large scale. The second point is in terms of manufacturing. Weve talked about this a lot but i want to highlight not just one point but two. What highlight is instead of doing the typical parallel process of Vaccine Product Development we do a Clinical Trial in the need to cite to manufacture on a larger scale, and another clinic Clinical Trial in the larger scale, tht we run this processes in parallel, and will make investments where large amounts of vaccines are being made much sooner. It is possible that some of those vaccines if they turn out not to work that we will not use those doses, but by those investments were able to have millions of doses available much sooner than we ever would. But i think the second part that doesnt highlighted as much is really the dod of bringing together the best of the department of defense and health and Human Services. By bringing as we talked about in the introduction, the supply and logistics expertise of a globally deployed force, and applying that to the critical supply chain issued a potentially critical shortages in vaccine manufacturing, critical equipment being delivered months earlier than it otherwise would. That is massively accelerated our vaccine manufacturing timelines. The 13 space of Clinical Trials, and i want to put stuff on this a little bit because i think everybody hopefully has been tracking both the astrazeneca and the other Clinical Trials been given the green light. They are to proceed from the fda. Both of those products have been on a safety pause and that safety pause has now been withdrawn but also emphasizes very much the prioritization that with safe and effective vaccine, that we are following the highest ethical standards to ensure that these vaccines are safe, and that those Clinical Trials are conducted to the highest regulatory medical standards as well. So the vaccines are back on track. These are not small Clinical Trials come again in it typical Product Development you may see a vaccine trial of lets say 5000 volunteers or maybe 8000 80 volunteers. Our standard has been 30,000 volunteers in our Clinical Trials. Thats because we want to gather as much Safety Information as we possibly can, and we also want to know if they work. With the more people you enroll, the sooner youre going to be able to evaluate the effectiveness. What we have done so far, and to think again most of you have probably tracked this, that moderna has not completed their phase three Clinical Trial in terms of 30,000 30,000 patientr 30,000 volunteers in all. Pfizer is still in building but they are about 40,000 volunteers now. What that shows you, for me, i dont know if this message is appreciated, but i but i want o emphasize, is that that shows me that over 60,000 americans have decided to say, i will volunteer. I do know if im going to receive the vaccine or i may receive a placebo, but im going to do my part in fighting this pandemic. I think we feel extraordinary appreciation for the volunteers. But today as i mentioned the astrazeneca trials are going to need another many thousand volunteers for each one. So were hoping we can send the message to the participants in this meeting as important in volunteering for vaccine Clinical Trials, and to encourage, and courage of those. Very proud of that spirit of volunteerism that we see in america. We also always emphasize the word volunteer means it is a personal choice and no one of you and makes the choice individually. But we think this thing you and many others are great opportunities to strongly encourage people to look into the opportunity. Let me give you one more specific example. Were having multiple sites in our Va Medical Centers that will be enrolling. And for our nation veterans this is another way that they can continue to serve in this way fighting the pandemic as a volunteer. My final point among those four on how we can achieve the impossible is through teamwork. I think this session is called fighting the pandemic. Were fighting the virus and the way we fight the virus is really getting the best from all of us. What we have seen is extraordinary integration and cooperation between our department of defense and her health and Human Services. Its the best that are covered has to offer. But when general perna mentioned the whole of nation, all of us fighting this together, the public, the public sector, the private sector, the Foundation Come everybody altogether finding that virus, i i seen se of the best teamwork ive ever been a part of as part of operation warp speed and it is the essential for the ingredient on how we achieve the impossible fourth ingredient. Thank you. Dr. Hepburn, thank you so much for that. I am not going to invite general perna to come back to make some very specific remarks regarding Vaccine Distributional over to you, sir. Thank you, sir. What a powerful update my dr. Hepburn. I great teammate that ive just been really blessed to work with over the last five months. Matt, thank you. I would like to touch on, quickly hit where dr. Hepburn talked about manufacturing. I know its not lost anybody listening to this conversation, but in order to really take the risk in manufacturing, we had to do a lot of things parallel. He described i thought incredibly well the risks that we took it that we proceed with six vaccines while simultaneously implementing the manufacturing capacity that is required to meet our mission. So just simply said, right, we had to make sure that we had the right capacity to manufacture the vaccine, which we didnt have five months ago. What we have done is weve added, actually added brickandmortar come in the city. In other words, we have built facilities from the ground up to produce a vaccine. We have garnered all the materials required to produce the six vaccines. Not only to execute trial, trials, but also to bring it up to scale in full manufacturing for eventual distribution to the American People. And then we had to accumulate the right equipment from all the manufacturing that we put together. And then the last stage of that was making sure with the right workforce that was trained and ready to produce and actually manufacture and go finish the vaccine. So really a remarkable task on its own in an effort what we did is we did implement the federal production act authorities with ows through the sector of Human Services and secretary of defense. Today weve implemented 12 with industry and we are working eight more. And it is, this effort that has allowed us to prioritize, contracts can prioritize material, authorize control of skiers and critical material and then drive industry to expand production and supply resources, which i think will be at the end of the day really critical to our overall success. We received nothing that absolute support in this light, whether it was permission from hired to do so or the execution by our Industry Partners to do daytoday business. Really remarkable effort collectively by the again whole of america highlighted particularly this part by industry. So lets assume that we will have vaccine available where sites will drive the safety and efficacy of vaccine as dr. Hepburn spoke about. Lets assume that with quantities of vaccine available to go upon fda approval. What is next, right . It goes without saying, the distribution of the vaccine across all of america to include territories and major cities, large metropolitan areas, and its just a Herculean Task all on its own. What do we do . We thought through the process, there were many courses of action, but at the end of the i made the decision that we were going to utilize the commercial industry that was most capable of implementing this task, right . There were three Large Companies all capable, all three of them are playing a role in Vaccine Distribution as well as therapeutic distribution but the primary industry partner for distribution will be the casting. Wellversed on how to do this. At the end of the day i chose it because they know how to do it. They have experience doing it. At the end of it we want to transition to them down the road for routine efforts and then third and most importantly is that the states are very culpable with dealing with the commercial industry as we do all sorts of vaccines and therapeutics throughout the year accordingly. And so in fact, i just dr. Slaoui and i were just visiting with mckesson yesterday in tennessee, memphis, tennessee, and we get to see firsthand a brandnew distribution warehouse thats included that can go down to minus 80 a 20 and then have facilities really distribute across america. Mckesson will partner with fedex and with ups for distribution not only america but around the world as well as local farmer, walmart, cvs, walgreens, programmers, et cetera to ensure that distribution can reach everybody. For tenets of the Distribution Strategy that he gave the team as we are working, planning is first and foremost we need to understand, when you do visibility and control of all vaccines. We need to know where every bottle was, whether was in the factory or it was on a truck or it had been distributed down to at administration site. We must have 100 accountability of all vaccines every day. Second, we must be able to track the uptake of vaccine to persons out in america. Two reasons for this. First and foremost, because five of the sixer two does vaccines. Vaccines. We need to make sure that people are registered to the vaccine that they were administered, and that there is failsafe checks and balances to make sure when they come back 20 21 or 28 days later that they get the right vaccine for their second dose. The second point was we want to manage the flow of vaccines to the American People. Initially, we are going to have tens of millions of doses available come december. That come january, february, march it will quickly and exponentially increase hundreds and millions of doses. So we will be essential that we maintain the right flow of vaccine to the American People. Third, we must make sure that we have traceability of the vaccine and that we know where the vaccine is going at all times. It will be a hot commodity, of course, and we needed to get to places where it will be distributed based on state priorities and requirements in accordance with the state and effectiveness of the vaccine. A