Good morning, everybody. If we can go ahead and take your seats, well get started in a moment. Good morning, im the chief medical advisor of the bipartisan Politics Center and i want to welcome all of you to todays event entitled budgeting for biodefense are we prepared. Our mission is to actively seek to combine the best ideas from both Political Parties to promote health, security, and opportunity for all americans. We drive principled and politically viable policy solutions through the power of analysis, negotiation, and advocacy. Yesterday, former senators tom daschle and judd greg released a b. P. C. Report outlining options for policymakers to optimize funding that supports the procurement of medical countermeasures needed in the event of a chemical, biological, radiological or nuclear event. Today well hear about the findings from this report and hear from experts from congress, the executive branch and industry. Without further ado, id like to vite b. B. C. Cofounder and former Senate Majority leader tom daschle to the podium. Were fortunate for his leadership. Senator. Senator daschle thank you very much. Thank you to all of you for coming on this valentines day. We can only describe it as an unconventional way to begin a day like this. But as some of you may know, the issue of biodefense is one thats intensely personal for me. A little over 16 years ago, my Senate Office received a letter containing anthrax. 28 people were exposed. The entire harp Senate Office building was closed for nearly 100 days. It was a frightening time. The good news is is everyone who was exposed was kept healthy thanks in large measure to dr. Greg martin, the n. I. H. , and lots of cipr. One of my Lasting Impressions was the strong, bipartisan support and resolve of my senate colleagues. Republicans gai temporary office space to democrats. Democrats lent staff and equipment to republicans. It was extraordinarily gratifying. Biodefense is not republican or democratic. Nor is it something that the public or private sectors can ever do alone. And thats why im so pleased to be here today to have part for thed on this project with senator judd greg. Senator greg was unable to be in washington this morning but were very, very grateful for his continued leadership and his dedication to this issue. Unfortunately, in the past 16 years, the danger from chemical, biological, radiolg call or Nuclear Threats has only grown. Many states named by the state department as sponsors of terrorism are believed either to possess or be actively pursuing biological weapons. Including north korea. There are new concerns that it may be easier than we had feared for terrorists to recreate the smallpoxvirus. And we need only to look at the devastating flu season to realize how unprepared we are for a true pandemic, whether natural or manmade. Unfortunately, i believe its not a question of if, the u. S. Will face another biological threat. But when. The good news is, we are more prepared than we were 16 years ago. In 2004, senator greg sponsored the bioshield act which established a Publicprivate Partnership that has taken significant strides to making our country safer. It created a government market guarantee by providing a 10year appropriation, permitting the secretary of health and Human Services to obligate funds to develop and purchase medical countermeasures for stockpiling by the government this program was essential because theres no typical commercial market for these products today. By any measure, project bioshield has been a success. Since its creation, the program has facilitated the procurement of 27 medical countermeasures against threats like smallpox and anthrax and chemical events. Six of these products have received f. D. A. Approval. But we still have a long way to go. Critical to project bioshields early success was the fact that the original funding mechanism was a 10year appropriation this provided the private sector with a critical degree of certainty and allowed them to make awards that supported a Late State Development activity as well as procurement. Unfortunately, when project bioshelled was reauthorized in the act of 2013, the program reverted to a year over year appropriation this led to a funding shortfall, smaller awards, and much greater uncertainty. Many would say the program has suffered as a result. This year, congress will extend the project bioshield as part of popa. Authorization of were delight to have had senator byrd here with us today who is leading the effort in the senate alongside senator casey. For that reason, senator gregg and i thought it would be timely to take a fresh look at project bioshield and the programs funding. When we spoke with stake holders there was universal agreement that the original 10year appropriation was a critical part of the programs success. Developing medical countermeasures is a costly and risky endeavor. This multiyear appropriation gave private sector partners the certainty needed to make those investments. As jut lined in our paper, returning to a multiyear appropriation mechanism would require action by authorizers, appropriators and the budget committees. Most importantly, restoring this structure would provide the certainty needed to show that project bioshield will continue to support the innovation that will protect our nation for another decade. Im delighted that the administration has recently come out in support of restoring the original funding mechanism as part of the administrations request for fiscal year 2018 taking into account the new resources made available by last weeks budget deal, the administration has proposed an additional 4. 99 billion for project bioshield. These funds would be used to move from an annual appropriation process back to a 10year advanced appropriation. I want to commend the administration for their leadership on this issue, which is so essential to our countrys safety. I have now had the relatively unique experience of working on biodefense issues from a number of different perfect is, including as a member of the bipartisan Blue Ribbon Study Panel on biodefense. One thing that has always stood out for me is the broad consensus around these issues. Everyone recognizes theres a threat. Everyone recognizes that more needs to be done. But the issues the issue is one of priorities. Biodefense is relatively unique in that it spans both health and defense. Meaning it is an issue with many supporters but very, very few champions. Some mistake venly belief if and when another biological threat arises, our government will find the resources to address it, but addressing the threat after its already emerged will not only be far more costly than preparing in advance, but potentially come at a great price of human life. As we all know, the federal budget continues to be under enormous pressure. The biothreats are too real and too potentially devastating not to be a national priority. For that reason, i am extremely pleased to be able to introduce someone who has been that true champion for many, many years. Senator richard burr was first elected to the house of representatives in 1994 where he served for five terms. He is currently serving North Carolina in his third time in the u. S. Senate. Hes a vocal advocate for veterans and men and women serving in the military. Hes also been the champion on the issue of biodefense. And i mean the champion. He sponsored the original pandemic and all hazards act as well as the 2013 reauthorization and under his leadership the senate has begun consideration of the 2018 reauthorization. Were grateful he could take time out of a very, very busy schedule today and we look forward to his perspective on whats to come. Elcome senator byrd. Thank you very much and i jump on the opportunity to talk for 15 or 20 minutes without mentioning russia. It seems to be allconsuming but it also demonstrates the things we think are in our Rearview Mirror all of a sudden reappear right in front of us. Senator burr thats how we have to put in perspective the need for an investment in the right leadership in biodefense. We have new adversaries every day that enter the game. They look for the fastest, cheapest, most effective way too produce a threat. Im going to also remind you that a lot of that comes naturally. As i walked over here, though and listened to your description of accomplishment, it proves to me what you can do on the hill if youve got good staff. But i also reflected back to 16 years ago. And ask myself how many Staff Members on the hill today were here then . Probably less than 20 of the staff. So it made me understand that reauthorization is not an Automatic Process for the Staff Members that are serving many members of the house and senate. That they likely were under 18 years old on 9 11, they dont remember the debate that happened here relative to bioshield. They probably were just coming out of college when the first reauthorization happened. And now they are seasoned staff on the hill having not participated in any debate. I think its plopet for me to spend a second telling you why we created bioshield, what our frame of mind was and what led us to go to popa. I liken this to a story i heard about a young lady a graduate of the university of North Carolinachapel hill. She had a lifes ambition to be a schoolteacher. On chapel hill you graduate on a sunday. She went across the stage on sunday, got that diploma. She was from eastern North Carolina. When she got that diploma she went home and started interviewing for a schoolteachers job. Third superintendent she stopped and saw for a job as a third grade teacher and she spent all summer, she couldnt wait for that hot august day, she had her seating chart ready, ready to fill every childs first name she shoe the she knew the most important thing was filling in the names. She got halfway around the room, she said, whats your first name. He said damnit. Nd she said, whats your name . Damnit jones. She said does your her pick you up in the afternoon . He said, yes, maam. I said, come see me id like to see your mother. The teacher knocked on the car window, the poor woman rolled the window down. She said, i meant to come talk to you. He was the ninth child, it was the only thing that came to mind. About three months later, superintendent is out in schools. He happened to be visiting that school , he remembered this young schoolteacher he had hired and he wanned to go into her classroom and see how the kids were doing. She decided she was going to have a spelling bee. She had a talented group of third graders. She started calling out words and they were raising their hand theyd gone nine for nine, the superintendent visibly impressed. She thought now is the time to quit. She turned to go back to the black board. There was damnit with his hand up. She said young man, whats what do you want . He said id like to spell chrysanthemum. She said, damnit you cant spell that, the superintendent said why dont you let him try . We had a need in the federal government, a need in america to produce medical countermeasures for threats we saw. We looked at big pharma and there was no movement. But we had a lot of innovators, a lot of small companies, saying hey, why dont you let us try . Let us spend some time telling you what the difficulties are we identified this phrase, the valley of death. That point an innovator get to where theyve got promising data , they know where they want to go but they dont have the funding to make it through the clinical side of it. We looked at popa and realized we could structure, for lack of a better word, a public v. C. Company. Venture capital fund that funded that valley of death. That inknow viteors had a understanding of the technologies, their technology was certified as potentially meeting the need we had, and we gave them the runway to get there and i think it gave us the predictable pathway of an accelerated process of trials an hopefully approval. A has had ba trmbings 34 successful m. C. M. s through the system. Weve done that even with the limitations that were put on bioshield from a standpoint of our ability to acquire those particular things at the end of the process. Nobody is happier than i am, tom, that the administration has come around and basically said were going to fund 5 billion over the next 10 years. But ive got to share with all of you, it doesnt happen just with money. It takes two additional things. It takes leadership and it takes commitment. I think for the first time in a long time weve got the leadership in place at all levels. We will always have a problem in the executive branch, i dont care who makes it up, as making sure that medical countermeasures raise to a level that requires a financial commitment. So im glad that maybe we wont have to revisit that for a 1year period if we get the advanced fuvending. But i cant tell you how much commitment and leadership all the way down the pipeline are to the success of the program. Its the ks ability to bring people in and assure them that were a partner. And i cant stress this enough. This does not look like the historical f. D. A. Model. Theres an f. D. A. Component to it. But up until the time you go through that and i would tell you that even through the f. D. A. Process, it is a part for theship between the Public Sector and private sector. And the American People are the beneficiaries of it. I dont think youll have any company say we became rich participating in this program. What we hope and what we see through the creation of barta and this pathway is that weve companies whotive have new technological platforms they may be producing a product that goes for a particular threat that we have on our matrix but they also created a platform that could potentially treat six different types of cancer. Could begin to address certain things that we havent had an alternative to today. Im not sure the f. D. A. Would publicly say it but some of the folks in the pipeline at barta in development have actually been called in to the game where we had no countermeasure for a particular type of disease that hit and they asked them to produce it to save kids lives. Thats happened just about every year for the past five. We wouldnt have that ability if it wasnt for bioshield and it wouldnt for popa and the creation of barta. And now i think weve got in place the overall leadership we need to grow this in to something that becomes much more permanent from a standpoint of its impact and its mark on i think government and the private sector. Our goal when we started with this was to foster innovation in the private sector through arity of need, financial partnership, and that accelerated pathway. Clarity is a requirement by people like me to go out and hold administrations accountable, hold agencies accountable, to work with agencies on correcting leadership problems which is a function that congress likes to get involved in way too much but in this particular case i think is way too important. The opportunity to make this permanent, to embed it in statute, and thats the challenging thing. Is how much of what we have been provided now with this leadership from the white house can we put in statute in a way that we dont have to worry every 16 years whether the brain trust of the United States congress, you that are staffers, remember or were even here when we had the debate. But that you can look at the successes of what we did and say, what we should do is continue programs that are successful because they provide value, they provide certainty. I think this is particularly important right now. Because i would suggest to you in my day job of chairman of the Intelligence Committee that were getting ready to go through a decade of disruption. Disruption that for many in this room is not going to be foreign because you grew up using the device in your pocket and tom and i grew up at a time where we called somebody and asked them to do something for us. It will come natural for many of you but it will happen at an accelerated pace that none of us understand today. Our ability to adjust and adapt and to take advantage of it is ur ability to forget the historicalprocedural markers in place that have driven American Society for so long and accept the fact that if we dont allow innovators to innovate in this country at the pace that they can anywhere else in the world, a predictable thing will happen. They will leave here. So it is absolutely crucial whether were talking about the Health Care Space and biodefense or whether were talking about the department of defense or whether were talking about any other area of our economy. Weve got to make sure that the architecture that weve got in place is not one where the limiting factor to success is government itself. Weve got to position government and all agencies of government to be a partner in the success of where innovators and technology allow us to go. And i would telling you as a part of health care, as political as it can be, and we had one of those debates earlier this year, my belief that in two years from now that debate is irrelevant. Because if we do this right, whether he have overcome everything that was an obstacle to finding a common ground. Because there will flonger be a separation between rural and urban delivery of health care. Because most of it will be generated right here. Thats whats possible. But i would tell you our success with at the signing, reauthorizing, funding the effort, driving innovation, is also important to making sure that what we can do with this fact reality. So, if i have any takeaway from what i talk about, talked about, its that this is much igger in my book than just a biodefense issue. This is about creating the framework for how over the next 10 to 20 years the United Private tners with innovators to produce things that benefit society, our economy, our people. So, toms i thank you and tom, i thank you and judd greg for the leadership on this. It takes a lot to have a partnership with trent lott. I understand that. Hopefully he doesnt sing to you like he used to sing to us. Leaders ly respect at leave the institution i serve in and stay here to continue to do good for the American People. And i think judd gregg and tom daschle are two of those individuals that i hold in tremendous regard. I admitted to him bf i came up, i spent most of my day trying to figure out how i come back here when i leave. I will get over, that im sure. But for the time that i am here , im committed to making sure that we put together the internal partnership in congress to make sure we maximize the policies that effect the American People with a Publicprivate Partnership that everybody looks back on and says, this is one of those success stories. That we will highlight. With that, can i take some questions . Id be happy to take questions or dance around them. Or shove them to tom. Yes, maam. Questioner first of all, thank you for your years of commitment and service and leadership on this. You talk about the critical importance of partnering with the industry, with the innovators, on the science side. Do you see a model thats more based on coinvestment, innovators on the financial side, the invests that are are coinvesting, along with the significant government commitments that are being made in bioshield . Mr. Burr my answer would be, i wouldnt leave anything off the table. Because i think part of governments responsibility to the taxpayers is to leverage federal money where we can leverage it. I think it was impossible for us to go from the typical injection of cash that we saw 14 years ago to a partnership on the financial side that is possible today and we see examples of it beginning to emerge. And some of thats even coming out of federal investments in n. I. H. Bart is a great example. I think were going to look at ways to do that in the future barda is a great example. I think were going to look at ways to do that in the future. The ability is there to structure deals that way. I think we do have the leadership that can begin to do that. I just want to stress that this is a period where we have to keep our foot on the gas. We cannot throttle back, weve got to have it all the way to the floor board. Innovator market, big pharma, small pharma, bio, whatever it is, needs to know that were going to be successful. I can understand that theres some that may not want to play in the space because of the limited markets. That tom talked about. But my belief is were headed into a period of time where it will be the Technology Platforms that are created, producing medical countermeasures, where nobody knows where else that platform may have a marketbased application. So, were about Building Technology and platforms in the future. And it may be that were the everyone tus to have that platform launched and theres some of them in the pipeline right now. Where theres great hope that were going to be able to produce other medical solutions off of that same platform. Its exciting. Its way above my pay grade, though. Its a free shot at me. Take it. Yes, maam. Questioner [inaudible] you mentioned other medical solutions that could come up and i was wondering what your thoughts are on expanding the Biodefense Program to include nonstrategic threats. M speaking specifically of antimicrobial resistant or natural outbreaks like the avian flu, those kinds of things. Mr. Barr mr. Burr trying to get me in a fight this morning, arent you . Listen, the great thing is, weve been able to enhance the scope of where barda could be over time because it was the best option that we had to explore expansion of needs. And some of that was in the antibiotic area. What i dont want to do is i dont want to get it so broad that were in competition with research in the federal government. And i think that the next phase, rather than massive expansion of jurisdiction, would be federal partnerships which flu is a great example of where that has been an ongoing federal partnership between barda where appropriate and n. I. H. I think if you look at an example that was called in but not planned, was ebola. Where it encompassed more than just n. I. H. And barda, they were all at the table trying to figure out how to bring what they needed to the table in a very expedited fashion. We learned more from that on the hospital and response side than probably we did anywhere else. But i would just take you back to ebola and remind you that ebola was one of the targeted Infectious Diseases. And at some point somebody made a decision. Lets shelf what weve got. Lets not run this through until the end. Because we have other things that are more important. When you have a targeted list of things, you cant shelf things. You cant prioritize them. Because most of that list, we dont know when its going to happen. And as we begin to look at intentional threats, i become more and more concerned with what i see every day because of the actions of those that i am most concerned with as adversaries and what potentially they can do. It was described to me this week that a biology major with a c as a grade can take whats Available Online today and be a tremendous risk to the United States and to the world. And thats an accurate statement. Yes, maam. Questioner [inaudible] waiting for the next thank you for the next few weeks. What do you see as our greatest bottle neck in moving whats been some Great Innovation and into early development, into readiness . Mr. Burr i stated larks mar alexander was nice enough to let me chair both the hearings. Were at least targeting in april to mark up the bill. I said at the beginning of the first markup, the only thing that stands in the way of us and reauthorization is a deep desire by members of the committee or members of congress to take a simple, bipartisan reauthorization and understand that were opening up an act and that they see this as a train leaving the station and they want to put all sorts of other policy things in it. If that happens, in todays atmosphere, it makes it extremely tough to get across the goal line. Because not only are we trying senate process, we have to game out a house process. So the question is, who goes first . What do you do . Do you put certain things in here, you might know that its the intentions of the administration, theyve noted it, to move the management of a stockpile back to h. H. S. I think thats a good thing. Thats how i originally envisioned it. Had we had somewhere to put it back then other than c. D. C. , we might have put it somewhere differently. But it makes a tremendous amount of sense to take those individuals who most understand the pipeline, most understand the process that these countermeasures went through, to be in charge because the lead time for a majority of the replacement units that we need in the National Stockpile is somewhere between 12 and 18 months. And if im relying on somebody that wasnt part of that process, they may assume that when 10 million doses expire, that this is like calling the drug store and getting a reload. This takes a tremendous amount of planning and i think that, as we have seen over the life of the stockpile, weve got a unique partnership with d. O. D. Relative to anthrax vaccines. Where we dont do two separate acquisitions or at least i dont think we are now. Theyre pulling out of the stockpile so we dont have expiration problems on things that we keep for the American People. And let me just say, anthrax is a great example because weve ne from weve gone from basic development, was it eggbased originally . Now were in cellbased. The same transition were making on fluns influence. Im not sure we flu. Im not sure we could have done that had we not had d. O. D. Out there pounding on the process saying this has to happen. I think our innovators were in competition with the researchers at d. O. D. In thk case. So in this particular case. So everywhere you look in the process, theres a success story, theres a reason that having it structured the way that it is has been beneficial. I want to thank you for the opportunity to be here. Ill leave with you the words of george bush sr. The old guy, 41. When he stood on the west steps of the United States capitol on the day he was inaugurated and he said this. Were not the sum of our possessions. Theyre not the measure of our lives. And our hearts in our hearts, we know what matters. We hope to cannot hope to leave our children a bigger car or bank account. We must give them a sense what have it means to be a loyal friend, a love parent, a citizen who leaves his home, his neighborhood and his town better than he found it. I truly believe that what were doing with the reauthorization of pahpa, with the creation of bioshield, with the commitment to continue these, it isnt benefiting us, it isnt benefiting a company. Its benefiting the American People longterm because it gives us options that would not exist if it wasnt for these programs and an unbelievably talented group of people. Thank you very much. [applause] i want to thank senator burr for his leadership and those inspiring and insightful comments. Now well transition to a Panel Discussion before we get to your im sure terrific questions in a few minutes. Youve already met and heard from senator daschle. I think you have the bios for each of our panelists in front of you. But just very briefly, to senator daschles left is paul chaplain, the president and c. E. O. Of the very in order nordic. Thank you for joining us today. To his left we have the director of barda. Thank you for joining us. And to his left we have the Senior Vice President and at the bipartisan policy certainty and probably a master of the congressional budget bill. Thank you for being here. Senator daschle, maybe if we could start with you. In your opening comments you reiterated that experts have tell us that its not a matter of if, but when an event or an attack or a threat will be something that well face. For those out there who are still skeptical, if you want to underscore how this ranks as a Public Policy issue for you in terms of National Importance and how real is the threat and what are the stakes . Thats such a great question to start the discussion. I mentioned in my opening comments that in my case the anthrax attack affected 28 people. But there are examples not that far back that had unfathomable stakes for the world. One only has to mention the spanish flu outbreak in 1918. With the loss of somewhere between 20 million and 50 million people, over 600,000 in the United States. 1 3 of the worlds population affected by that experience alone. The spanish flu. You could take another example, the smallpox problems that we faced throughout history. Where over 30 of those affected would die, lost their lives as a result of exposure. Detectability wasnt even necessarily something one could do for a week or two. And you can only imagine what kind of consequences that would have in todays world. With transportation and with commuting and with shipping and all the things that happened. The demands that would be required to contain that kind of an outbreak in todays world is phenomenal. The coordination, the preparation required is just amazing. But you dont even have to go that far back. You can look at zika and ebola and look at the gaps that we had in responding to those outbreaks in recent times. , so i think it would be a huge mistake for us to be complacent, to underestimate the threat, to think that in some way this is not going to occur. It is going to happen and the remarkable thing to me is that when it comes to biodefense, we spend about the equivalent of a half of an Aircraft Carrier every year defending against a threat that has, in the last 100 years, the last century, caused more deaths than all the wars that the world has experienced. In a century. And so were not makering the commitment necessary making the commitment necessary. I think senator burr said it so powerfully today. The notion that weve got to commit, weve got to have the leadership, weve got to have the funding, we have to make this a higher priority. That ought to be the message of the day. Thank you, senator. , one of can ask you the responses has been the creation of barda and now its been over a decade, bardas been in its existence. Seen tremendous progress in our preparedness efforts. As you look back over the last 10 years, what are some of the Lessons Learned, you think, from bardas work and effort to date . First of all, thank you for inviting me to be part of this panel. As a distinguished panel, very rare opportunity i get to sit here with senator daschle and senator burr. Two people who really understand what were trying to do to protect our country. In new ways and ways that we never thought possible before the creation of barda and the wisdom and knowledge that went into the original creation and passage of i think two of the most important pieces of legislation that provided protection to america and the American People. The creation of project bioshield and pahpa and reauthorization of pahpa, wisdom i think that we are still learning the true value. But its immeasurable success. Because what we didnt know before the creation of barda is that it could be done. Theres a lot of doubt, theres a lot of languish of medical countermeasures from Industry Partners and academic partners and small and large farm suit cap kls pharmaceutical companies to try to address the threats that we facesed a faced as a nation. Coming off the heels of the anthrax attacks and other attacks in our country, we knew the value of trying to create a new model to address these threats. So it was a really hard thing that had never been done before. The creation of an entity within the government, with the goal to form unique Publicprivate Partnerships to address this valuey of death. So we would have medical countermeasures available when we need them, to address these threats upon our country and our people. So i think one of the most important lessons is that it can be done. We did it. We have a model. We recognize the need. Its beyond the need for just money. It is a recognition of the need for the partnerships, a recognition of the need for the special Technical Expertise want government. And its recognition of the need for the commitment, not only to the American People, that we will be there when its needed, but a commitment to Industry Partners, to work with government, to set aside very lucrative, very profitable products and development to work with the u. S. Government in a space where they didnt have a guaranteed marketplace. A space where their commitment to protecting our country and the people in our country was as great as ours, as government representatives. So our Lessons Learned are many. One of the next Lessons Learned that, once we learned we could make it, we could do it, weve been successful. Weve developed medical countermeasures. Now we have to recognize that tale of success. The need to continue the progress thats been made. The need to sustain the enterprise of not only making and developing new medical countermeasures for the evergrowing list of threats that we face as a country, but also sustaining those companies and those manufacturing sites and those stockpiles so we have those medical countermeasures where we need them and where we need them at the right time. I think thats important to look back but also looking forward at the critical need for continuation of this program. Thanks. You mentioned the word partnership. A couple of times. I think thats probably the theme of today. We heard it from senator burr as well. Publicprivate partnerships. Even more important than sort of biodefense. Paul, youre here today as sort of on the private side of this publicprivate sector partnership. Love to get your thoughts on how it feels to be on the private side and what has worked, what have been the challenges from your perspective. Yes, so, thank you for inviting me to the panel. Im the c. E. O. And i guess many people believe we have been one of the Great Success stories in the privatepublic partnership, working with barda. And i would say what has worked really well is that the last decade or so i worked with some really talented, smart and dedicated people and Vaccine Development is really tough. Its long, its expensive. Its typically 1 billion. Somewhere between 15 to 20 years to get a vaccine from the bench to approval. Just last week, last phase three critical trial for our safest smallpox vaccine, which proved that its not only safer but more efficacious than the vaccine thats already stockpiled. So what has worked extremely well is that working with barda and other agencies of the u. S. Government, we have been successful in taking a safer vaccine all the way through and to demonstrate that we can bring better products forward that will help protect the u. S. Population. So thats whats worked really well. Its been a long journey. And i am very proud to play a very small part in the success that barda has had. But to senator burrs point at the beginning, our safest smallpox vaccine is also a vaccine platform. So weve spent a lot of time coinvesting in that and we have programs trying to combat cancer and other Infectious Diseases and together with our partner we were also at the forefront of the response to ebola. But with that comes the challenge. , so as a c. E. O. Of a private company, i am questionable, i am answerable to my investors, who are coinvesting in this journey. To my customers, which includes the u. S. Government. But also patients and the public at large. Im nding on who [inaudible] depends on whos important. In reality its who pays the bills. For investors, they need to see a c. E. O. Add value, create value, grow the company, and, to put it crudely, make the money. So im often faced with the question, why are you investing in biodefense when you could be investing in other cancer vaccines, which many people have a closer relationship to . And basically its hard to answer. Because without a proven marketplace, there are questions, why do you continue to invest in this space . Albeit that weve been one of the most Successful Companies in this space. And to try and put that in the context, we have been awarded two large contracts by barda over the last decade. The first was actually, i believe, the first contract from bioshield was in 2007. Which is 500 million to develop a safer smallpox vaccine and produce and deliver 20 million doses. The market, the Investment Community loved that. It was 500 million as a block award. I could explain the value. I could explain how the revenues would be coming through over the coming years. That contract was highly successful, as i just said, brought a better product through to the marketplace. And last year we were awarded another contract of a similar value. 500 million. But because barda is now funded annually, that was only split in between a base contract of 100 million, and Everything Else was future options. The market hates it. My share price hardly moved. The Investment Community is asking why you have gone from 1 billion contract to 100 Million Contract . Options are seen as risk, options are seen as no value driver. It prevents me from arguing that there is a marketplace out there for c. E. O. s and Companies Like mine to develop countermeasures. Having said that, im arguing strongly for it. But multiyear funding for barda will go an awful long way in creating or recreating that marketplace and that guaranteed market and also allow barda and the u. S. Government to basically explain more of what their future strategy is for the next 10 years or so. Which will create that market, will keep Companies Like mine in the space, and will attract more companies to the space. Thank you. In the paper released yesterday by senators daschle and greg, youll find in the back, there are various options that are laid out for congress to optimize the medical countermeasure enterprise. Im wondering if you can provide paul talked about juxtaposing the experience with advanced appropriations essentially. With an experience with sort of annual appropriations. From a government side, when you compare and contrast these two funding mechanisms, what are the strengths and the weaknesses . What have been your experiences and bardas experiences with the advanced appropriation versus the annual appropriation . I think its a really good question. And its very timely as well. As paul mentioned, weve had the luxury, you might say, of experiencing it both ways. So we can compare and contrast these areas. I think it all goes back to what i said before and what senator daschle and senator burr also mentioned. Project bioshield is a commitment to have an established marketplace for the companies who will put other profitable things aside and encur additional risk to work with the u. S. Government, to make medical countermeasures to keep our country and the people in our country safe. That commitment is a commitment to the American People that. Commitment is a commitment to industry. Those are really, really hard commitments. And so how you fulfill those commitments varies in different models. I think models have been proposed in the paper as billion as well. When we establish the first contracts with project bioshield, and we had the multiyear advanced appropriation funding, we were age to meet with companies and able to meet with companies and identify a full path forward to development, all the Late Stage Development steps required in developing complicated biological medical countermeasures. And that marketplace commitment at the end. If you achieve these mile stones, and when you get that product approved by the f. D. A. , and it goes into our strategic National Stockpile, we already have a contract in place, we already have the commitment of funds to procure it. That is the marketplace that industry likes. Thats the industry perspective and thats the commitment for that marketplace. Take it back to barda and our model of working with companies to develop the medical countermeasure is another important approach that we dont lose in the conversation. Remember, its about more than just money. Its about the Technical Skills and ability to work unencumbered in a comprehensive way from start to finish in developing a very complicated medical countermeasure. If these were easy to make, we wouldnt need to be here. , so everything we develop in medical countermeasure, each step from the start depends on the next step, the previous step. And its a complicated process and lease some setbacks and then we move forward again with the science and technical information. If we have to fragment that approach into unnatural ways of developing a medical countermeasure, based on fragmented funding and unpredicted funning for the next steps, then it delays that process. It increases the risk it. Sometimes drives technical decisions that are not in the best interest of accelerating the development and availability of that medical countermeasure. So, from a technical stand point, its very critical that we have all the funding needed for the end to End Development of that medical countermeasure. So we can accelerate its availability. Were not doing basic research here. Were not trying to discover the next signaling pathway that he is going to help some other process along the way thats going to change the world 50 years out. We are trying to accelerate the development of medical countermeasures that are going to save lives when were exposed to these threats and these threats are growing every single day. So we need that couldnt nuent. We need that continuity. We need that flexibility to move forward and backwards and forward again in developing this. And we need that marketplace commitment. So we have companies, large and small, willing to dance with us in that complicated process. So i believe the approach we had with the advanced appropriation gave us the framework and the space to be successful and that is why we were successful in developing 34 medical countermeasure f. D. A. Approvals in 10 years. When we changed the annual appropriation, it introduced so much more risk. So much more fragmentation. So much more complication in working with Industry Partners. So many people walked away from the table, negotiations, Industry Partners, large and small. Because it was too riss chemist and so risky. And so its critical to consider these options. But most important to recognize the real value of what what were doing, the expediency at which we need to do it and the flexibility that that advanced appropriation gives us to be successful. Thanks. So, bill, publicprivate sector partnership, what were hearing from the Public Sector side, as well as the private sector side is there may be advantaged, there are advantaged from multiyear funding mechanism. In this fiscal climate, times have changed since twure. Congressional procedures have changed 2004. Congressional procedures have changed. Can you help walk us through it . Congress wanted to take this route, how would it be zphon how could it be done . Thank you. Thank you for letting me participate with the real experts up here. Let me just say at the outset, though, i was one of those staffers that was here in the hart building. The day of the anthrax. I can tell you it was a very scary time that we went through at the staff level. During that time. Let me also just say that, yes, absolutely. Things the fiscal situation has changed dramatically. Back in 2004, when project bioshield was passed, at that time the Congressional Budget Office had estimated that there would be a declining deficit for the next 10 years. In fact, they were suggesting that we would have a 1. 3 trillion surplus over that 10year period. So, its not surprising, if you take that into consideration, that congress would come along and say, well, then theres no problem with advanced appropriations of 5ds. 6 billion with a surplus of that reaching that range. As it turned out wherks a down turn, major down turn, in the economy, major recession. And so we didnt end up with a surplus over that 10year period. But literally a deficit of nearly 6 trillion over that entire period. So about the time of reauthorization came up, we were in a situation where we were looking not at surpluses but at deficits and i think thats what turned it from being a forward funded, advanced funding to an annual appropriation. And more importantly at that time, 2011 we passed legislation called the budget control act of 2011 that set caps on discretionary spending. And so the appropriators, lots of demands, lots of issues, besides just bioshield and the federal government, and the question for them was then should we advance and take money out in the future from that which we have a fixed cap Going Forward . And that made it difficult. And i think thats why we ended up, for that time period, having the annual appropriation Going Forward, creating the problems that you have outlined. So i think its a much different situation. I will say this is a good its a good turn. If i understand exactly what the president s proposing here for 2018. If we actually are now going to appropriate, advanced appropriate 5 trillion or 5ds billion over the next 10 years, 5 billion over the next 10 years, and were going back to where we were originally. To do that, though, senator burr made it very clear. The first thing you have to do, from being an old budget ear up here, is you have to pass the authorization bill. And in that authorization bill make sure you, when youre passing it up here, that youre passing it with the authorization for advanced appropriations. And then second of all, assuming that Congress Gets around to passing a budget resolution this year, we put which may or may not happen, but if they were, there were a number of provisions that were put thats in those budget resolutions, rules that govern consideration of legislation here in the senate and the house that limit the amount of advanced appropriation. In fact, put a total on the amount of advanced appropriation and youre going to have to change those that somehow. Ts unfair, im not picking on the organization that has advanced appropriations, there are some accounts that have a corporation for broadcasting, public broadcasting has an advanced appropriation written into law. Its a little unfair it seems to me to barda that they have it and you dont have it. So we have to go in and we have to change that list, those programs that can qualify for advanced appropriations. If you do all that, then i guess weve just gone through changing the caps, which will help make it possible to do this. But those caps are the only adjustment that Congress Reached here last couple of weeks ago, its only for two years. The caps come back into place and in fact theyre lower. So i would argue that if youre going to really have good advanced appropriations of this amount, you ought to also look at changing those caps in the next two years and making them consistent with what Congress Just made a decision on, to adjust them here in a couple weeks ago. Thanks. This sort of multistep process that bills outlined, is nicely outlined in the paper that senator daschle and greg released yesterday. I want to open it up to audience q a. I do want to provide rick one opportunity, of course, monday the president s budget was released for fiscal year 2019. If there are any takeaways that you have for the audience and any other final panelist comments. Then i want to open it up for a few minutes. Im absolutely grateful for the continued support that barda and pappa are receiving to complete this mission. The language weve seen from the administration is very supportive. Of what were doing. And putting the language in and the administration as they write the policy for the advanced appropriation i think is critical for our success. And i encourage congress, as they take up the pen and write the policy for the bills, as they work on the caps, etc. , that they continue that important momentum. We have done a lot, its also important to recognize that the Threat Landscape is continually changing and evolving. Theres so much work that needs to be done to fully address the threats we faced as a nation. Not only from individual terrorists but as we think of state nations that are also increasing the threats to our country. So theres a lot of work that needs to be done and now is the time to put the panel all the way down pedal all the way down. Keep the momentum, keep the energy. Make sure that we are operationalizing our Rapid Response capabilities using the platform technologies and innovation in all areas and also not forgetting flu as one of the most important threats that we face as a country, as a world, a global population. And the important work we must still do to address pandemic influence butals to make the influenza but also to make the influence of vaccines every single year more effective for the population. So, again, thank you for all the support, Bipartisan Policy Group as well, senator daschle. I know senator burr and everything that everyones doing to keep this on the forefront of your mind as we go pahpa and reapprove all the critical components. Thank you. Thank you. Lets open it up to audience question and answer. Here are microphones questioner thank you. Thank you to the panel. A question on pandemic influenza. So as many of us are aware, pandemic influenza has its own budget line. It doesnt fall under project bioshield. And so i was wondering what you uld say to how we maintain sustainable, consistent funding for pandemic influenza that creates the kind of market and the kind of pathway that bioshield is set to do for ther kinds of threats. Rick, do you want to start us off . Near and dear to my heart. Ive spent 20 years of my life trying to address influenza and the threat pandemic influenza faces. Every year were reminded, the interrelatedness of pandemic influenza and seasonal influenza. And influenza is a killer. Its a killer virus. We see it every single year. When we try to address pandemic influenza, at the same time we are addressing improving seasonal influenza. Many times our preparation and planning and research and development for influenza gets compartmentalized into pandemic response. And what we can do without pandemic vaccines, some unique approach, some unique thing. I think its very critically important that we address influenza as a threat that it is. And make sure that we have bolstered our domestic capabilities to respond and create more effective vaccines to support diagnosics for early indications so people know when theyre infected sooner, so they can get treatments sooner. So the drugs are more effective. And its a way of empourg the patient, the end user even, to be a First Responder as the pandemic virus begins sweeping across the tpwhrobe. We have to build these tools tpwhrobe. We have to build these tools globe. We have to build these tools in vaccine response and early indication and treatment and create and treat influenza and pandemic influenza as the virus threat that it is. Thank you. Any other comments, responses to that question . Thank you. Other questions . Yes, please. Questioner hi. Kind of similar to the last question. But as you mentioned the threats are not necessarily under project bioshield. Is there any opportunity to crosswalk some of the, as we say in local Public Health, the issues that we see in the day to day practical basis that would lend itself to the need for that Publicprivate Partnership and incorporation of medical countermeasures . For example, the hepatitis outbreak that were seeing in california. And the impact that it has with respect to being able to deliver countermeasures to the community in a way thats practical and that can help mitigate what we call domestic issues, that may lend mastery of how we are able to respond to the extraordinary . Thank you for that question. Anyone want to tackle that . I think that gets to senator burrs point. Theres going to be a debate not only in this room but in congress in terms of how broadly do you open up pahpa and what goes in there and does influenza go in there . Do other Public Health threat goes there . And i suspect that there will be quite a bit of conversation about how broad to make the jurisdiction of pahpa and project bioshield. But i dont know if there are comments that any panelists want to make. Ill make a comment on that. I think thats a really important question. Not to negate all the various Public Health threats and all the eamericanning infect shuzz diseases around Infectious Diseases around the world and models to approach how the world prepares for those in response to those threats. At the same time, i think its critically important to understand the purpose of the creation of project bioshield and pahpa and to prepare our country for these bioterrorist threats, these threats to our american way of life that are determined to be significant threats. Biodepartment, homeland security, tense community. Weve been successful intelligence community. Weve been successful in addressing many of those threats through preparedness because weve had that focus to the strategy and the mission. Not saying that those other threats arent as important in cases but its critical we do not expand the model for preparing for these significant threats through our homeland security. I think opportunities to take parts of the model and maybe replicate it in other areas. But i think barda and barda and project bioshield and pahpa should really focus on those threats. Remember, theyre eslosking, theyre changing, theyre evolving, theyre changing, theyre spreading and mutating and being mutated. In ways faster than we can even imagine right now. So we want to stay disciplined to our strategy, to protecting our country from these threats. Its important that we keep a focus. Its important that we keep the constant flow of funding for those threats and not dilute that effort. Other questions . While were waiting, senator daschle or others, comments or reflections on what weve learned or heard this morning . Well, i would just, first of all, commend our my fellow panelists for their leadership. Senator burr made quite a point this morning of talking about the components to success. And he mentioned three. He said it was critical that we have leadership. That we have commitment. And that we have adequate funding. I think there is a real possibility that this year were going to have those three components. All you have to do is listen to dr. Rick bright to know we have the leadership and bob isnt here today but he also is that kind of leader. So we have leaders that i think can make this happen up and down, within the system. And i am just extraordinarily grateful for that commitment and that leadership. I think secondly, given the budget, the president has now offered, and given, as bill so eloquently again described the budget process, we still have a lot of hurdles to go through with regard to making that budget a reality. But we have the potential for funding this year. And i think the bottom line is it takes a commitment. I think the commitment is clear from those here on the panel that we all have a commitment here that is so critical. I dont i hope none of us in the room think of ourselves as spectators in this sprose. Process. We all have to demonstrate engaged commitment. So im hopeful that we can leave today with a renewed sense of that commitment and that realization that its going take all of us to keep the pressure on, to make in the kind of priority it deserves to be. And if we do that, i predict at the end of this year were going to look back with some real satisfaction. Thank you. Any final thoughts or comments . I just want to the last gentlemans question. I just noticed that you should realize there is something called a Public Health Emergency Fund thats in the federal budget. Its been funded in the past by transfers and i think maybe some transfers out of barda. But the president s budget does increase that funding here for 2018. And so some of the issues that you were talking about outside of barda i think could be focused on in that particular fund as opposed to putting all the burden on barda. Any final questions from the audience . With that, i want to really thank our panelists for their tremendous insights and thank senator daschle and greg for authoring the report. Senator greg couldnt be with us today. Senator daschle said. But were very thankful for their leadership. This is such an Important National security and Public Health issue. As youve heard. Really takes a commitment from the executive branch, congress, as well as the private sector, and industry to really make this happen. So we look forward to tracking and monitoring this issue and thank you again for your leadership and your attention to this issue. Thanks, everyone. [applause] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] [captions Copyright National cable satellite corp. 2018] tonts, testimony from steve mnuchin. He spoke earlier today in front of the Senate Finance committee and well show you that tonight at 10 00 p. M. Eastern on cspan. Cspans washington journal live every day with news and policy issues that impact you. Coming up thursday morning, Virgin Islands Democratic Delegate stacey plaskett, a member of the oversight and government reform committee, discusses the committees recent decision to investigate white house vetting systems and the in the aftermath of the rob porter story. And then Pennsylvania Republican congressman Ryan Costello talks about the future of health care and republican efforts to reform the Affordable Care act. Be sure to watch cspans washington journal live at 7 00 eastern thursday morning. Join the discussion. This weekend, the cspan cities tour takes you to lynchburg, virginia. Located along the james river, its home to both Liberty University and Thomas Jeffersons retreat. Popular forest. With the help of our Comcast Cable partners, well explore lynchburgs rich literary life and history. On saturday at 5 00 p. M. Eastern, on book tv, well visit the anne spencer thousand hear about how this poet brought the harlem renaissance to lynchburg. Anne spencer was a poet, an american poet, mostly associated with the harlem enaissance period. Its how harlem comes to lynchburg. Unfortunately theres a whole group of people who are associated with that period of time, like anne spencer, that people dont know about. Then on sunday at 2 00 p. M. Eastern, on American History tv, an interview with Liberty University president jerry fall well jr. About the origins of the university. Its impact on lynchburg. And the role evangelicals play in politics. In spite of trumps background, theyre really pleasantly surprised with how hes come around on issues that are important to evangelicals. And how hes really been the best president for those issues and really for, i think, for i think going to end up being one of the greatest president s weve ever had. Then a conversation with johnson, whose grandfather hosted a tennis camp in lynchburg for young africanamerican athletes, including Althea Gibson and arthur ashe. This created this interest in my grandfather and his ability, i mean, phenomenal physician, but somehow he managed to be a student of the tennis game and transfered that learning into a program that would for decades provide players and opportunities for africanamericans to integrate the sport. Watch the cspan cities tour saturday, beginning at 5 00 p. M. Eastern. On book tv on cspan2, and sunday at 2 00 p. M. On American History tv on cspan3. Working with our cable affiliates, as we explore america. Today, first lady melania trump, visited the childrens inn at the National Institutes of health where she ex changed valentines cards with the children. The facility, located just outside the Nations Capital in bethesda, maryland, is a private nonprofit residence for children who are receiving