Transcripts For CSPAN3 Biodefense Preparedness 20180216

Special interests. Watch American History tv every weekend on cspan3. On wednesday, Senate Intelligence chair for congress reauthorize the pan dem and i can all hazards preparedness act at the bipartisan policy center. Following his remarks a panel of experts on bio defense discussed the process for developing drugs and vaccines to protect against a chemical, radiological, biological, or nuclear attack. This is an hour and 10 minutes. Morning, everybody. If we can please go ahead and take your seats, well get started in a moment. Good morning. I want to welcome all of you to todays event entitled budgeting for bio defense are we prepared . For those new to bbc 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 gregg released a bbc report outlining options for policymakers to optimize funding that supports the present curement 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. So without further ado id like to invite bbc cofounder and former u. S. Senate majority leader tom daschle to the podium to share some opening remarks. Senator daschle has been a critical champion for Public Health Emergency Preparedness and were grateful for his leadership. Senator . Thank you very much. Thanks 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 bio defense is one that is intensely personal for me. A little over 16 years ago, my Senate Office received a letter containing anthrax. 28 people were exposed. The entire hart Senate Office building was closed for nearly 100 days. It was a frightening time. The good news is that everyone who was exposed was kept healthy, thanks in large measure to dr. Greg martin, the nih, and lots of cipro. Oops one of my Lasting Impressions was the strong bipartisan support and resolve of my senate colleagues. Republicans gave temporary office space to democrats. Democrats lent staff and equipment to republicans. It was extraordinarily gratifying. Bio defense is not republican or democratic, nor is it something that the public or private sectors can ever do alone. Thats why im so pleased to be here today to have partnered on this project with senator judd gregg. Senator gregg was unable to be in washington this morning but were very, very grateful for his continued leadership and dedication to this issue. Unfortunately in the past 16 years, the danger from chemical and biological, radiological, or Nuclear Threats has only grown. Many states named by the state department as sponsors of terrorism are believed its tore both or to be actively pursuing biological bep weapons, including north korea. There are new concerns that it may be easier than we had feared for terrorists to recreate the smallpox virus. And we need only to look at the curt devastating flu season to realize how unprepared we are for a true pandemic. Whether natural or manmade. Unfortunately, i believe it is not a question of if the u. S. Will face another biological threat, but when. The good news is that were more prepared than we were 16 years ago. In 2004, senator gregg sponsored the project bio shield act which established a Publicprivate Partnership thats taken significant strides to making our company safer. Project bio shield 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 there is no typical commercial market for these products today. By any measure, project bio shield 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 fda approval. But we still have a long way to go. Critical to project bio shields 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 barta to make awards that supported a state Late Development activity as well as procurement. Unfortunately when project bio shield was reauthorized in the pandemic and all hazards preparation reauthorization act of 2013, the program reverted to a year over yearappropriation. 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 bio shield as part of the reauthorization of pappa. Were delighted, and i mean this sincerely, to have senator burr here with us today, who is leading the effort in the senate alongside senator casey. For that reason we thought it would be timely to take a fresh look at bio shield and the projects funding. When we spoke with stakeholders 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, and this multiyear appropriation gave private sector partners the certainty needed to make those investments. As outlined 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 ensure the project bio shield 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 bio shield. 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 bio defense issues from a number of different perspectives, including as a member of the bipartisan Blue Ribbon Study Panel on bio defense. 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 issue is one of priorities. Bio defense is relatively unique in that it spans both health and defense, meaning that it is an issue that has many supporters but very, very few champions. Some mistakenly believe that if and when another biological threat arises our government will find the resources to address it. But addressing the threat after it has 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 bio threats are too real and too potentially devastating not to be a national priority. And 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 term in the u. S. Senate. He is a vocal advocate for veterans and our men and women currently of serving in the military. Hes also been the champion on the issue of bio defense. And i mean the champion. He sponsored the original pan dem and i can all hazards preparation reauthorization act, as well as the 2013 reauthorization. And under his leadership, the senate has begun consideration of the 2018 reauthorization. Were grateful that he could take time out of a very, very busy schedule today, and we certainly look forward to his perspective on whats to come. Welcome with me senator burr. Tom, thank you very much. I jump on any invitation right now to go for 15 or 20 minutes and not mention russia. [ laughter ] it seems to be allconsuming. But it also demonstrates the things that we think are in the rearview mirror, all of a sudden reappear right in front of us. And thats how we have to put in perspective the need for an investment in the right leadership in bio defense. We have new adversaries every day that enter the game. And they look for the fastest, cheapest, most effective way to produce a threat. I might also remind you that a lot of that comes naturally. As i walked over here, though, and listened to your description of accomplishments, it proves to you what you can do on the hill if youve got good staff. But i also reflected back to 16 years ago. And asked 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 the senate. That they likely were under 18 years old on 9 11. They dont remember the debate that happened here relative to bio shield. They probably would just coming out of college when the first reauthorization happened. And now theyre a seasoned staffer on the hill having not participated in any of the debate. So i think its appropriate for me to spend just a second sort of telling you why we created bio shield, what our frame of mind was, and what led us to go to pappa. I liken this to a story i heard about a young lady who was a graduate of the university of North Carolina, chapel hill. You graduate on a sunday. She went across the stage on a sunday and got that diploma. She was from eastern North Carolina. When she got that diploma, she immediately 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 so she could go in, she had her seating chart ready, she was ready to fill in every childs first name. She knew the most important thing was as fast as she could to learn their names. She started around the room and she was filling in the chart, and she got halfway around. This little boy stood and up she said, whats your first name . And he said, dammit. And she was a little bit thrown back, whats your full name . He said, dammit jones. She graduated from university of North Carolina, chapel hill. She says, does your mother pick you up in the afternoon . Yes, maam. After school, come see me, id like to see your mother. Sure enough, he came up and they went and the teacher knocked on the car window and this poor woman rolled the window down and she said, im sorry, i meant to come talk to you, she was my ninth child, it was the only thing that came to mind. She knew she was going to have to deal with this all year long. Three months later, superintendents visiting schools. He happened to be visiting that school, he remembered this young schoolteacher hed hired. He wanted to go into her classroom and see how the kids were doing. She decided she was going to have a smelling bee. She had a talented group of third graders. She started calling out name words. They were raising their hand. Superintendent visibly impressed. She thought, now is the time to quit. She turned to go back to the blackboard, sure enough, there was dammit with his hand up. She looked at him, what do you want . He said, id like to spell chrysanthemum. She said, dammit, you cant spell chrysanthemum. The superintendent said, why the hell dont you let him try . Thats where we were. We had a need in the federal government. We had a need in america to produce medical countermeasures for threats that we saw. We looked at big pharma, and there was no movement. But we had a lot of innovators, a lot of Small Companies that were saying, hey, why the hell dont you let us try . Let us spend time with you telling you what the difficulties are, the pathway. Make the pathway clear for us. We identified in turn this phrase, the valley of death. That point an innovator gets to where theyve got promising data, they know where they want to go, but they dont have the funding to make it through that clinical side of it. So we looked at pappa and realized that we could structure, for lack of a better word, a public vc company. Venture capital fund that funded that valley of death. So that innovators had a understanding of the technology s, their tech tholg was certified as potentially meeting the need that we had, and we gave them the runway to get there. And i think pappa gave us the predictable pathway of an accelerated process of trials and hopefully approval. Well, today barta has had 34 successful ncms through the system. And weve done that even with the limitations that were put on bio shield from a standpoint of our ability to acquire those particular things at the end of the process. Nobodys happier than i am that the administrations come around and basically said were going to fund 5 billion over the next 10 years. But i 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, at 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 10year period if we can get the advance funding. But i cant tell you how much commitment and leadership, all the way down the pipeline, are to the success of the program. It is the folks at barta, trick bright and his 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 fda model. Theres an fda component to it. But up to the time you go through that, and even through the fda process, it is a partnership between the Public Sector and the private sector. And the American People are the beneficiaries of it. I dont think you will have any company say, we became rich participating in this program. What we hoped and what weve seen through the creation of barta and this pathway is that weve got new Innovative Companies who are creating technological platforms. That yeah, they may be treating they may be producing a product that goes for a particular threat that we have on our matrix, but theyve 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 fda would publicly say it but some of the folks in the pipeline at barta in development have actually been called into 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 bio shield and it wasnt for pappa and it wasnt for the creation of barta. And now i think weve got in place the overall leadership that we need to grow this into something that becomes much more permanent from a standpoint of its impact and it mark on i think government and the private sector. Our goal when we started was to foster innovation in the private sector with clarity of need, financial partnership, and that accelerated pathway. Commitment is always going to be something that is a requirement by people like me to go out and hold administrations accountable, to hold agencies accountable, to work with agencies on correcting leadership problems, which is a function 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 weve 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 say what we should do is continue programs that were 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 a 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 none of us understand today. Our ability to adjust and adapt and to take advantage of it is our ability to forget the historical procedural markers that are in place that had 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 in bio defense, whether were talking about department of defense, 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 tell you that from a standpoint of health care, as political and partisan as it can be, and we had one of those debates i think earlier this ye year, my belief that in two years from now that date is eba irrelevant. If we do this right, we will have overcome everything that was an obstacle to finding a common ground. Because there will no longer be a separation between rule in 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 designing, reauthorizing pappa, funding the effort, driving innovation, is also important to making sure that what we can do with this device is, in fact, reality. So if i have any takeaway from what i talk about, talked about, its that this is much bigger in my book than just a bio defense issue. This is about creating the framework for how over the next 10 to 20 years the United States partners with private innovators to produce things that benefit the society, our economy, our people. So tom, i thank you, and judd gregg, for the leadership on this. It takes a strong person to have a partnership with trent lott. I understand that. Hopefully he doesnt sing do you like he used to sing to us. But i really respect leaders that lead the institution i serve in and stay here and 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 before i came up, i spend most of my day trying to figure out how the hell i never come back here when i leave. I will get over that, im sure. But for the time that i am here, im committed to make sure that we put together the internal partnership in congress to make sure we maximize the policies that affect the American People with a publicprivate public 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 . Senator burr, 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 investors that are coinvesting along with the significant government commitments that are being made in bio shield . My answer would be, i wouldnt leave anything off the table. Because i think part of governments responsibility to taxpayers is to leverage federal money where we can leverage it. I think it was impossible for us to go from the typical vc 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 ih. Bartas a great example. So i think were going to look at ways to do that in the future. Thats really going to be more an internal process. I think that the way things are written, the ability is there to structure deals that way. And 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 floorboard. Because the innovator market, whether big pharma, small pharma, bio, whatever it is, needs to know were going to be successful. I can understand that theres some that may not want to play in this 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 impetus to have that platform launch 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, id take it. Yes, maam . You just mentioned other medical solutions. Thank you. You just mentioned other medical solutions that could come up. And i was wondering what your thoughts are on expanding the Bio Defense Program to include nonstrategic threats, speaking specifically of Antimicrobial Resistance or natural outbreaks like h7n9, ivian fle i avian f kinds of things. Listen, the great thing is weve been able to enhance the scope of where barta 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 other areas of research in the federal government. And i think that the next phase, rather than massive expansion of jurisdiction, would be federal partnerships which influenzas a great example of where that has been an ongoing federal partnership between barta where appropriate, and tony fallchi and nih. I think if you look at an example that was called in but not planned was ebola, where it encompassed more than just nih and barta, 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 to the end. Because weve got other things that are more important. When youve got 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. 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 boyology 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 . Waiting for the next few weeks what do you see as our greatest bottleneck in moving whats been some Great Innovation and an Early Development into readiness . I stated Lamar Alexander was nice enough to let me chair both the hearings where at least notionally targeting sometime in april to mark up the bill. And i said at the winning of b 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 to manage a senate process, we have to game out a health process. So the question is, who goes first . What do you do . Do you put certain things in here you might know its the intentions of the administration, theyve noted it, to move the management of the stockpile back to hhs. I think thats a good thing. Thats how i originally envisioned it, had we had somewhere to put it back then, other than cdc. 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 drugstore 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 gone from basic development was it eggbased originally . Now were in cellbased . The same transition were making on influenza. Im not sure we could have done that if we hadnt had d. O. D. Out there pounding on the process, saying this has got to happen. And i think our innovators were actually in competition with the researchers at d. O. D. 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 you with the words of george bush senior, 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. In our hearts we know what matters. We cannot hope only to leave our children a bigger car or bank account, we must hope to give them a sense of what it means to be a loyal friend, a loving 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 pappa, with the creation of bio shield, 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. I want to thank senator burr for his leadership and those inspiring and insightful comments. Now well transition to 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 chap lip, president and ceo of vary nordic. To his left, dr. Rick bright, director of barta at health and Human Services. To his left we have bill hoagland, Senior Vice President at the bipartisan policy center, probably a master of the congressional budgets. Senator daschle, if we could start with you and your opening comments. You reiterated that experts 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. Onethird 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 died, lost their lives, as a result of exposure. Detect ability wasnt even necessarily something one could do for a week or two. 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 happen. 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, 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 bio defense, we spend about the equivalent of 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 making the commitment necessary. And i think senator burr said it so powerfully tonight, or 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 daschle. Rick, if i can ask you, that threat so eloquently articulated by senator daschle, one of the responses has been the creation of barta. Now its been over a decade, bartas been in existence, barta seeing tremendous progress in our preparedness efforts. As you look back over the last 10 years, what are some of the Lessons Learned, do you think, from bartas work and effort to date . Well, first of all, thank you for inviting me to be part of this panel. Its 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, in ways that we never thought possible before the creation of barta. The wisdom and knowledge that went into the original creation and passage of i think two of the most important pieces of legislation that provide protection to america and the American People. The creation of project bio shield and pappa and reauthorization of pappa is wisdom we are still learning the true view. But its immeasurable success. Because what we didnt know before the creation of barta is that it could be done. Theres a lot of doubt, theres a lot of language of medical countermeasures from Industry Partners and academic partners and small and Large Pharmaceutical Companies to try to help address the threats that we faced as a nation. Coming off of the heels of the anthrax attacks and other attacks on 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 a goal to form unique Publicprivate Partnerships to address this valley 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 as 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 within the 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 candidates in 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 we learn, once we knew we can make this, once we knew we can 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. 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 can have those medical countermeasures where we need them and when 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, rick. You mentioned the word partnership a couple of times. I think thats probably the theme today. We heard from it senator burr as well. Publicprivate partnerships even more important than bio defense. Paul, youre here today sort of on the private side of this publicprivate sector partnership. And id 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. O. Of venordic and i guess many people believe we have been one of the great Success Stories in the privatepublic Partnership Working with barta. I would say what has worked really well is that of the last decade or so, ive worked with some really talented, smart, dedicated people. Drug development or Vaccine Development is really tough. Its long, its expensive, its typically a billion dollars, 15 to 20 years, to get a vaccine from the bench to approval. Just last week, last phase 3 Clinical Trial read out for a safer smallpox vaccine, which proved its not only safer but is more ev case than the vaccine thats already stockpiled. So what has worked extremely well is that working with barta 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 im very proud to play a very small part in the success that barta has had. But to senator burrs point at the beginning, our safest smallpox vaccine is also a vaccine platform. Weve spent a lot of time coinvesting in that. We have programs trying to combat cancer and other Infectious Diseases and together with our partner jansen at the forefront of the response to ebola. With that comes the challenge. So as a ceo 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. And depending who im sitting in front of depends whos more important. But in reality, its who pays the bills. So for investors, they need to see a ceo add value, create value, grow the company, and to put it crudely, make them money. So im often faced with a question, why are you investing in bio defense 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 weve been one of the most Successful Companies in this space. And to try and pit that into context, we have been awarded two large contracts by barta over the last decade. The first was actually, i believe, the first contract under bio shield, in 2007, which is 500 million to develop a safer smallpox vaccine and produce and deliver 20 million doses. The markets, the Investment Community, loved that award. 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, its brought a better product through to the marketplace. Last year we were awarded another contract of a similar value, 500 million. Because barta 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, if youve gone from a billiondollar contract to a 100 Million Contract . Options are seen as risk. Options are seen as novalue driver. It prevents me from arguing that there is a marketplace out there for ceos and Companies Like line to develop countermeasures. Having said that, im arguing strongly for it. But multiyear funding for barta will go an awful long way in creating or recreating that marketplace and that guaranteed market. And also allow barta and the u. S. Government to basically explain more of what their future strategy is for the next ten years or so, which will create that market, will keep Companies Like mine in the space, and will attract more companies to the space. In the paper released yesterday by senators daschle and greg, youll find in the back there are various options laid out for congress to optimize for the medical countermeasure enterprise. Rick, im wondering if you can provide the government perspective. Paul talked about juxtaposing experience with advance appropriations, essentially, with an experience with sort of annual appropriations. From the government side, when you compare and contrast these two funding mechanisms, what are the strengths and the weaknesses . What would have been your experiences and bartas 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 bio shield is a commitment to have an established marketplace for the companies who will put other profitable things aside, incur additional risks, to work with 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 the models have been proposed in the paper as well. When we establish the first contracts with project bio shield and we had the multiyear advance appropriation funding, we were able to meet with companies and identify a full path forward to development, all the latestage development steps required in developing complicated biological medical countermeasur countermeasures, and that marketplace commitment at the end. If you achieve these milestones, and when you get that product approved by the fda 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. That is the industry perspective and thats the commitment for that marketplace. Taking it back into barta, in our model of working with companies who develop a medical countermeasure is another important approach 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 and the previous step and its a complicated process and theres 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 funding for the next steps, then it delays that process. It increases the risk. It sometimes drives technical decisions that are not in the best interests of accelerating the development and availability of that medical countermeasure. So from a technical standpoint, its very critical that we have all the funding needed for the end to enddevelopment of that medical countermeasure so we can accelerate its availability. Were not doing basic research here. Were not trying to discover the next signalling pathway thats 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 and 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 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 advance appropriation, gave us the framework and the space to be successful. And that is why we were successful in developing 34 medical countermeasure fda approvals in 10 years. When we changed to 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 in negotiations. Industry partners large and small. Because it was too risky. And so its critical to consider these options. But most important to recognize the real value of what were doing, the expediency at which we need to do it, the flexibility that that advanced appropriation gives us to be successful. Thanks, rick. So bill, publicprivate sector partnership, what were hearing from the Public Sector side as well as the private sector side is there may be advantages, there are advantages, from multiyear funding mechanism. In this fiscal climate, times have changed since 2004. Congressional procedures have changed. Can you help walk us through if congress wanted to take this route, how would it be done . How could it be done . Thank you. And thank you for letting me participate with the real experts up here. Let me just say at the outset, i was one of those staffers that was here in the hart building, senator dominicis office was in the area senator daschles office was during the anthrax incident. It was a very scary time. Let me say, yes, absolutely things the fiscal situation has changed dramatically. Back in 2004 when project bio shield was passed, at that time the Congressional Budget Office had estimated that there would be a declining deficit for the next ten 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 5. 6 billion with a surplus reefing that range. As it turned out, we had a major downturn in the economy, major recession. 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 deficits. I think thats what turned it from being a forwardfunded, advanced funding, to annual appropriation. 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 bio shield 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 . 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, rick. So i think it was a much different situation then. I will say this is a good its a good turn if i understand what the president s proposing for 2018, if we actually are now going to appropriate, advance appropriate, 5 billion over the next 10 years and were going back then 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 budgeteer up here, you have to pass the authorization bill. And in that authorization bill, make sure when youre passing it, 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 in thats in those budget resolution rules that govern consideration of legislation here in the senate and the house that limit the amount of advanced appropriation, in effect, put a total on the amount of aadvanced and youre going to have to change those, change that somehow. Its unfair, and im not picking on the organization that has advanced appropriations. There are some counts that have a corporation for broadcasting, public broadcasting has an advanced appropriation written into law. Its a little unfair, it seems to me, to barta, that they have it and you dont have it. We have to go in, we have to change that list of those programs that can qualify for advanced appropriations. If do all that, then i guess we have just gone through changing the caps, which will help make it possible to do this. Those caps are only the adjustment that Congress Reached here last couple of weeks ago, its only for two years. And the caps come back into place, in fact, theyre lower. So i would argue 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 make them consistent with what congress has just made a decision on to adjust them here a couple of weeks ago. Great, thanks. This multistep process that bills outlined is fiesly outlined in the paper that senator daschle and gregg released yesterday. I want did open it up to audience q a. I do want to provide rick one opportunity. Monday the president s budget was released for fiscal year 19. Rick, if there are any takeaways that you have for the audience and any other final panelist comments, then i do want to open it up for a few minutes. Im absolutely grateful for the continued support that part that are relieving to be able to accomplish this important mission. The language weve seen from the administration is very suppo supportive were doing. And putting the language in and the administration as they write the policy for advanced appropriation i think is critical for our success. I encourage congress as they take up the pen and write the policy for the bills as they work on the caps, et cetera, that they continue that important momentum. You know, we have done a lot but its also important to recognize that Threat Landscape is continually changing and evolving. There is so much work that needs to be done to fully address the threats we face as a nation not only from individual terrorists buts as we think of upstate nations and 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 pedal all the way down. Keep the mom momentum, keep the energy, sustain what we built and address that tail of success and make sure were operationalizing our Rapid Response capabilities using the platform technologies and innovation in all areas and also not forgetting influenza as one of the most important threats we face as a country, world, global population and the important work that we must still do to address pandemic influenza and make the influenza vaccines we use every year more effective for the population. So again, thank you for all the support, the Bipartisan Policy Group as well and senator daschle and i know senator berr and everything that everyone is doing to keep this on the forefront of your mind as we go forward to reapprove popra and all the critical components. Thank you. Great. Thank you. Lets open it up to audience question and answer and there are microphones coming to you. Yes . Thank you. Thank you to the panel, senator daschle, dr. Chaplin, dr. Bright. A question on pandemic influenza. As many of us are aware, pandemic influenza has the only budget line. It doesnt fall under project bioshield. So im wondering what you would say to how we maintain sustainable, consistent funding for pandemic influenza that creates the market and pathway that bioshield is set to do for other kinds of threats. Rick, do you want to start us off . Near and dear to my heart. I spent 20 years of my life trying to address influenza and the threat that a 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. And so when we try to address pandemic influenza, at the same time were addressing improving seasonal influenza. And 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 if that is some unique approach or diagnosics, if there is some unique thing i think is very critically important we address influenza as a threat that it is and make sure 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. Its a way of empowering the patient, the end user even to be a First Responder as the pandemic virus begins sweeping across the globe. So we have to build these tools not only in vaccine response but also in 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 . Hi. Kind of similar to the last question, built as you mentioned that the threats are not necessarily under project bioshield, is there any opportunity the cross walk, some of the as we say in local Public Health the issues that we see on a day to day practical basis that would lend itself to the need for that Public Private partnership and cooperation of Counter Measures. For example, the hepatitis outbreak that were seeing in california and the impact that it has with respect to being able to deliver Counter Measures to the community in a way that is practical and that can help mitigate what we call domestic issues that may lend mastery of how were able to respond to the extraordinary . Thank you for that question. That gets to the senators point he is making earlier. There is going to be a debate in this room but in congress in terms of how broadly do you open up pop eye and go in there and does influenza go in there and do other Public Health threats go there . I suspect theyll be quite a bit of conversation about how broad to make the jurisdiction of popa and project bioshield. I dont know if there are any 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 merging Infectious Diseases around the world and the critical need to try to find novel ways, novel models to approach how the world prepares for those in response to those threats. At the same time, i think critically important to understand the purpose and the creation and project bioshield and popa and to prepare our country for these bioterrorist threats, these threats to our american way of life, theyre determined to be significant threats by our intelligence community. Weve been successful in addressing many of the threats through counter preparedness because we had that focus to discipline to the strategy and to the mission. Im not saying the threats are not as important. But its critical we do not expand the model for preparing for these significant threats to our home land security. I think its opportunities to take parts of the model and maybe replicate it in other areas. But i think barta and project bioshield and popa should focus on the threats. Remember, theyre evolving and changing and spreading and theyre mutating and theyre being mutated faster in ways faster than we can even imagine right now. And so we want to say discipline to our strategy, to protecting our country from the threats. Its important that we keep a focus. Its important that we keep the constant 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 my fellow panelists for leadership. And the senator made quite a point this morning of talking about the components to success. He mentioned three. He said it was critical we have leadership and that we have commitment and that we have adequate funding. Well, 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. Dr. Bob cadlic is also that kind of leader. So we have leaders that i think can make this happen up and down within the system and im 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 he will consequently 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, but we all have a commitment here that is so critical. I hope none much us in the room think of ourselves as spectators in this process. We all have to demonstrate engaged commitment. And so im hopeful we can leave today with a renewed sense of that commitment and that realization that its going to take all of us to keep the pressure on, to make this the kind of priority it deserves to be and if we do that, i predict that the end of this year well look back with real satisfaction. Thank you t paul or bill or rick . Any final thoughts or comments . I just want to the last gentlemans question, i noticed you should realize there is a Public Health emergency funneled in the federal budget. It has been funded in the past by transfers. I think maybe transfers out of barta too. But the president s budget does increase that funding for 2018. So some of the issues that you were talking about outside of barta i think should be focused on in that particular funneled as opposed to putting all the burden on barta. Okay. 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 bipartisan policy report. Senator greg couldnt be with us today. Were very thankful for their leadership. This is such an Important National security and Public Health issue as you heard. It really takes a commitment from the executive branch, o, congress and the private sector. We look forward to tracking and monitoring this issue. Thank you again for your leadership and your attention to this issue. Thank you, everybody. 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 lynchbergs rich literary life and history. On saturday at 5 00 p. M. Eastern on book tv, well visit the ann Spencer House to hear about how this poet brought the harlem republican sons to lynchberg. Ann spencer was a poet, an american poet, mostly associated with the harlem renaissance period. How she becomes part of the harlem renaissance is how harlem comes to lynchburg. Unfortunately, there is a whole group of people who are associated with that period of time like ann spencer that people dont know about. Then on sunday at 2 00 pm eastern on American History tv, an interview with Liberty University president Jerry Fallwell jr. , about the origins of the universities, its impact on lynchburg and the role he van evangelicals play in politics. Its important how they have come around to issues that are important to evangelicals and how hes been the best president for those issues and really for, i think, for i think hes going to end up being one of the greatest president s weve ever had. Then a conversation with Lance Johnson whose grand father hosted a tennis camp in lynchburg for young africanamerican athletes including Althea Gibson and arthur ashe. That created this cavalcade of interest and my grandfather and his ability, phenomenal musician, but he managed to be a student of the tennis game and transform that learning into a program that would for decades provide players and opportunities for africanamericans to intergrate the sport. Watch the cspan cities tour saturday beginning at 5 00 p. M. Eastern an 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. Now a discussion on President Trump and his conflicts on his investments in russia. They spoke about russias attempts to influence american democracy after the Panel Discussion. This is about an hour and five minutes