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 HealthEmergency 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