Goal 3: Ensure Biodefense Preparedness Enterprise to Reduce the Impacts of Bioincidents

Biodefense Summit Transcript

​Panel Moderator: Dr. Rick Bright, Deputy Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advances Research and Development Authority, U.S. Department of Health and Human Services

Panelists: Dr. Paula Olsiewski, Pro​gram Director of the Alfred P. Sloan Foundation; Dr. Laura Evans, Director fo Critical Care at Bellevue Hospital, New York City; and Dr. Steven Higgs, Director of the Bio Security Research Institute at Kansas University.

​>> CICELY WATERS: We’ll continue our meeting this afternoon with our next panel, which will focus on goal number three of the strategic plan. Goal three focuses on ensuring bio defense preparedness enterprise to reduce the impacts of bio incidents. The moderator for panel three is Dr. Rick Bright who serves as DEPUTY ASSISTANT SECRETARY within the Office of The Assistant Sec. for Preparedness and Response. Dr. Bright is also the director of the Biomedical Advanced Research and Development Authority or BARDA, within ASPR within HHS. Dr. Bright?

[Applause]

>> RICK BRIGHT: Well, good afternoon everyone. I'm glad to see   people made it back from lunch and I thought we should start with a little exercise of some sort, to wake you up.

[Laughter]

>> RICK BRIGHT: A good laugh will get your juices flowing. Goal one we heard a lot about this morning and I really first before I get into that I want to thank Dr. Kadlec and ASPR of the leadership in putting this summit together and driving us through this strategy and I really want to thank Teresa Lawrence for her leadership and her role in putting all this together and coordinating everything across government to make sure this is an effective strategy. A lot of work has gone into this. And a lot of good discussion from you all this morning, from the panelists and the audience too. So I hope we continue that for goal three. I do want to remind us, goal one was about risk assessment and awareness. Goal two was about prevention. Goal three is a little dose of reality. We do know something will happen. How prepared are we? And how can we then continue to collaborate, to close the gaps of preparedness, to reduce the consequence of that bio threat? And goal three is a very broad goal. As you will notice, there's a lot of things in goal three. It encompasses a wide range of activities. It encompasses a wide range of stakeholders, of industries, challenges. Public roles. Private roles. International roles, federal roles, local, state, tribal territory roles, community roles, coalition roles and completely reaching into the homes of everyone in our country to make sure that we understand preparedness and that we are prepared for these events that we know will happen. There are many cracks in that sidewalk for us to fall into. There has been a lot of progress made in each of these areas, each of these nine areas that I will repeat for you in a minute, but each of these nine areas a lot of progress has been made and I would argue a lot of that progress has probably been made within each of those nine goals or subgoals. And there are probably still a lot of silos that surround those goals and subgoals. And what I would argue we need to do as we think forward to more effective preparedness strategy for a national bio defense strategy is find ways to bridge those silos, break down those silos and make sure we are focusing on an end to end approach, of collaboration, of transparency to ensure that we are prepared for these threats that will come. Now, because so much progress has been made another unique aspect of goal three is, we have to sustain that progress. We have to sustain what we have built we also must be wise of living in the 21st century. So we have to drive innovation to make sure that our preparedness is also modern as the threats we face today are modern. And in breaking down those silos again I believe is one of the biggest hurdles that we still have before us. I want to read for you again the goals and the subgoals in goal number three. We must ensure a vibrant and innovative science and technology base. We must ensure a strong public and veterinary health infrastructure. We must develop and exercise prevention, response and recovery plans and capabilities. We must develop and exercise and update our risk communication plans. And we have to enhance preparedness to save lives through radical countermeasures. We have to enhance preparedness to limit the spread of disease through community mitigation measures as nonpharmaceutical interventions are as much a critical component of preparedness as medical countermeasures. We have the enhance preparedness to support decontamination. We have to strengthen preparedness to operate and collaborate across the United States and yes, across the globe. To make sure we are prepared for the threats and bio incidents that we will experience. So I am very confident today that we have established a distinguished panel that needs very little introduction, a panel that represents perspectives from a variety of these various areas of impact for goal number three. We will have Dr. Paula Olsiewski from, who is a program director of the Alfred P Sloan foundation. She will be followed by Dr. Laura Evans, Director of Critical Care at Bellevue Hospital, New York City, then Dr. Steven Higgs, the Director of the Bio Security Research Institute at Kansas State University. Go Kansas. I'm from Kansas.

[Laughter]

​>>RICK BRIGHT: That didn't have anything to do with the panel selection, but yes. Then Dr. Tom Inglesby, who we all know quite well in this area and the director for the John Hopkins Center for Health Security. So without further ado, I would like to invite our first panelist, Dr. Paula Olsiewski to the stage and she will give us her perspective. Thank you, Paula.

[Applause]

​>> PAULA OLSIEWSKI: Well I have to start with a disclaimer. This talk is my own and does not necessarily reflect the views of the Alfred P Sloan foundation or anyone else I could possibly work for. I want to start by congratulating the team, everyone who has been involved in developing the national bio defense strategy. This is a very important achievement and I was really inspired. I have been inspired by all the presentations and so on. I want to thank the organizers for inviting me to participate. I spent 11 years from 2000 to 2011 directing the Sloan foundation's program to reduce the threat of bioterrorism and at the Sloan foundation we basically try to be early, catalytic, then at some point we declare victory and pull out. I continue to advise and consult in bio security because I think it's such an important issue that it's worthy of my time. I want to then, but in acknowledging the Sloan foundation program, I want to thank all of the bio security bioterrorism, whatever category grantee you are, because the people did really important work, continue to do important work and many of them are here today. There were a couple comments in the previous sessions, where people may not realize that the Sloan foundation sponsored the think committee report. The Sloan foundation has sponsored a lot of work on do-it-yourself bio, Sim bio, and I encourage people who had questions in those areas to go to our website, Sloan.org under completed programs and there's a lot of very good information there that is still current. So as Dr. Bright mentioned, there's a lot to cover in preparedness. There are six pages in the strategy. It's a very small type. So I'm going to make very brief remarks on two areas that I think are really important. Citizen preparedness and decontamination. Okay how do I get my next slide here? Thank you. All right, so citizen preparedness. Citizens need to be prepared for bioterrorism as well as all other types of disasters. So the Sloan foundation started their program in 2000. In 2001 we had the anthrax attacks and September 11. And we were very concerned that people didn't have good guidance. So at that time there was no Department of Homeland Security. So we worked with the office of Homeland Security and the Ad Council, which eventually developed ready.gov. I just pulled this screen shot down. Recently it continues to be a vibrant place for information for all types of disasters. If you go to their page on bioterrorism there's good information and links to fact sheets by the Academies, by CDC. That's all good. All right, but I live in New York City. I take the subway. I have a five-month-old grandson. And measles is on the rise. And it's very troubling to me. So I'm going to make a few very personal preparedness comments. So, the guidance says to people who go to this guidance, which millions of people have for bioterrorism or bio threat, get information, go to some official sources of news, TV, radio, the Internet. You might need medication. You might need a vaccination. This is really good information. This was really good when it was developed a while ago. As I mentioned we have a problem with measles in New York City. It's very personal to me. And in the particular communities, people are refusing vaccinations. So I want to refer you to a threat to preparedness. There is an article published by Dr. Barney Olsiewski, no relation of mine, but in the American Journal of Public Health that talks about Russian trolls and the spread of disinformation on vaccines. So despite all of the good work that we have made a lot of progress on citizen preparedness, we have good information, this is a very different, this is a 21st century threat that we have to take into account when we are preparing our citizens because if something big happens or even something, I think measles is big is happening, we need them to take the vaccines, we need them to take the medicines. So that's all I will say on citizen preparedness. So let's talk a little bit about my next slide, decontamination and waste management. You saw from Dr. Kadlec’s slides in our offensive program demonstrated that aerosolized agents could quickly spread over wide areas. In this day and age we have to be very practical about any sort of cleanup and waste management strategy that we have. Certain communities such as hospitals are very regulated about what they can do. Other places may not be as regulated. But we have to use the readily available materials and methods, and when I started working in this area, one of the things I learned is my second point. And that is, waste management influences decontamination. If you are going to use water, where does it go? If you are going to put stuff into a barrel and then burn it, who is going to burn it. A lot of the waste management companies are privately held. And they can say I don't want to take that Ebola waste. So let's move to my third bullet, Ebola waste. Ebola came to our soil in 2014. How many cases did we have? 11? That hardly sounds catastrophic. However, where did the New York City waste go? All right. New Jersey would not take it. It had to go to Texas. All right, so that is just from a very small number of cases that we already have a waste, we had good procedures for decontamination, but we couldn't manage it. A previous speaker this morning was talking about bird flu and the flocks, the 30 million chickens that had to die in Iowa. Various agencies came together and were able to deal with that decontamination and waste management but those are relatively small animals. So let's move on to some current topics. The New York Times, one of my favorite papers despite a variety of things, had a big article on candida aureus. It sounds bad. I don't want to get a fungal disease. Okay, it seems like you only get it if you are immune compromised, but I focused on the section since I care about decontamination and waste, was that one of the hospitals followed their procedures for decontamination and then tested what grew up. Candida aureus. So are we using, did they have a problem? Was their decontamination done incorrectly? Or should we be developing our decontamination and waste management methods around fungi. I'm going to close my marks about African swine fever. I've been following that. It seems like already 1 million pigs in China have been done in. There was a report I read today that 200 million can die. That's a lot of carcasses. Now, we've heard from speakers today about all the good things that the US is doing to prevent these diseases from coming into our country. But if we have large carcasses on very large-scale to euthanize and do the waste management, we are not prepared for that. So on that note, I think you all.

[Applause]

>> RICK BRIGHT: Thank you, Paula. Our next panelist will be Dr. Laura Evans, director of critical care from Bellevue Hospital, New York City. Someone on the front lines of the Ebola outbreak in 2014 and still living it today. Thank you.

>> LAURA EVANS: Thanks. Hey. Good afternoon everybody and I want to thank Dr. Bright and thanks to ASPR for the opportunity to be here and talk briefly with you. So as you heard from the introduction obviously I'm representing the perspective of the healthcare delivery system in this, and goal three is exceptionally broad as we already heard. So I think I'm going to focus on sort of four brief topics here. Excuse me. So we heard a little bit about well maybe I don't have slides. Anyway I will wing it. We heard a little bit about we are focusing on prevention here. We heard a little bit about measles in New York City. So measles is a circumstance where we have a highly effective vaccine. So we know if people get vaccinated it ensures a very high level of population protection for this. But nonetheless we have a very large outbreak of measles in New York City. So I think you don't have to look very much past the current headlines to recognize that even with effective medical countermeasures, even with vaccination, we still have significant risks in our system with that. So that begs the question then, what does this look like for the healthcare delivery system and how do we prepare the front lines of the healthcare delivery system to do this? So back in 2014 and 2016 some of you may remember that CDC really promoted this concept of identify, isolate and inform. Thank you for the slides. Appreciate it. With that, so CDC really promoted this concept of identify, isolate and inform. Which is a wonderful kind of rubric for if you are approaching a new patient as a healthcare worker. I want to put some caveats on that as well. We heard from Gov. Ridge this morning that we have 330 million Americans probably many of whom are not aware of the bio defense strategy or even the bio defense threats that are out there. We have over 5000 emergency departments in the US. Let alone the thousands of healthcare workers who work in the different emergency departments. It doesn't count urgent care clinics or other sites where people may present for care. We are not going to turn all those healthcare workers into infectious disease experts. So what do we need to do to build a system where those people have the technologies that they need, the information readily available at their fingertips to make it easy to detect these patients when they present for care. Because we are not going to have a million healthcare worker-strong network of subject matter experts. We need to basically build tools that help clinicians to do the right thing at the bedside in a time sensitive fashion. And it needs to accommodate existing workflows for busy healthcare workers at the front lines, who are very occupied with recognizing other time sensitive health conditions like acute myocardial infarction, acute stroke, sepsis. All of this comes as one type of commuting priority along with many other competing priorities that a triage nurse in the emergency department may be faced with. So we need to integrate these types of tools with solid, high-quality information feeding them. They need to be integrated into our electronic health records so that with a minimum number of clicks it doesn't slow down throughput through the emergency department or through the primary care clinic where a person is being evaluated but nonetheless gets clinicians at the front line the information they need to protect the other patients in that environment, mitigate the risk of spread, protect themselves and their colleagues as well. One of the other sub bullets of the strategy involves testing our preparedness. And I think this is a really critical concept. That the healthcare industry needs to get behind. And I think we need to recognize that it doesn't necessarily need to be a complex, full-scale, multiagency, multi-day drill to provide us very valuable learning and very valuable tools for improvement for our preparedness process. So in New York City, through both our hospital system, as well as the Department of Health and through NETEC, the National Ebola training and education center, which I have the privilege to be involved with, which is funded by ASPR and CDC, we have really promoted this concept of doing things as simple as mystery patient drills. So you get, it can be done from start to finish in 60 minutes. You train somebody to  act as a simulated patient, you have them present for care, you insure some basics screening  questions are asked and you basically time how long it takes for that healthcare worker to say that this person may have some risk for a highly communicable disease, put them in isolation and notify the appropriate people within their system. And we think we are going to get a lot of mitigation of impact by doing relatively simple steps like this. But to do this well across those 5000 and more sites is indeed I think a heavy heavy lift. And lastly, I want to touch briefly on personal protective equipment. So this is a photo from one of our recent NETEC trainings in New York City with this, and you can see the wide variety of PPE the people have used in their healthcare systems with that. I want to comment that none of this is easy to use. Most of this was not designed for the purpose in which we are using it now and I would advocate, I know we are going to talk some more about these research agenda pieces but I think there was an urgent research agenda piece here as well to emphasize that we as healthcare workers need the tools at the bedside that can be simple, easy to use, keep us safe, keep our other patients safe as well. So with that I will close and I will just say thank you again so much for letting me be here and I look forward to the rest of the discussion.

[Applause]

>> RICK BRIGHT: Thank you, Laura. Our next panelist will be Dr. Stephen Higgs, Director of the Bio Security Research Institute, Kansas State University.

[Applause]

>> STEPHEN HIGGS: Thank you so much. It's a great honor to be here today. So I'm the director of Kansas State University's Bio Security Research Institute. It's a unique facility, that it's biosafety level III and biosafety level III Ag. It's research, education and training, which is critical for our preparedness. We've been working on numerous biological agents, including select agents over the years, since 2009. The goal is to increase knowledge, understanding, and develop tools that will help us to prepare to reduce the impact of these pathogens if they are ever introduced intentionally or naturally into our country. There is actually a handout down here that describes the pathogens we work with. It might not be coffee-table sort of material but it's there if you want it. I'm going to talk about threats to agriculture, including zoonotic vectorborne and non-vectorborne diseases. The need for the BRI was realized by Kansas State before the 2011 and 2001 bioterrorism attacks and before the subsequent anthrax attacks. In terms of filling gaps, the BRI in the presence of Kansas State University, including especially the college of veterinary medicine were influential on the Department of Homeland Security's decision to build the national Bio Agro defense facility NBADF for short in Manhattan Kansas. NBADF fills the gap. It addresses one of the gaps in goal three for the strategy. It provides new and much-needed biosafety level IV, the first in the US to work specifically with livestock in the US and to work with those livestock diseases. As we heard, the national bio defense strategy was built on previous documents. And that includes HSPD nine defense of the United States agriculture and food. BRI focuses very much on that particular component. We are working actually on four NBADF priority pathogens, foreign priority pathogens already, African swine flu, classical swine fever and important vectorborne zoonotic diseases, Japanese encephalitis and Rift Valley fever virus. Our researchers have actually been filling the gap. They have published over 60 peer reviewed publications just on these four diseases since 2013. Based on past experience it seems likely that new biological agents introduced to the US with a high impact on human health would likely be vectorborne, perhaps, probably a virus and almost certainly zoonotic. I was having this thought this morning, which I didn't write down, that I realized that I moved to the US eight years before West Nile virus was introduced into the US. We don't know how it was introduced, but the impact of that has been remarkable. I realize that my 18-year-old son has grown up in an America where that virus is endemic. It's probably infected two and half million people and kills people and causes neurological disease every single year. Things change fast. So, I think awareness underpins preparedness. I didn't realize that slide wasn't up. That is the BRI in case you are interested. Here are some other gaps. So as an example of preparedness, the BRI is doing the research on African swine fever and classical swine fever. Collaboration is critical. And our researchers work with the USDA ARS staff to look at Rift Valley fever for example infectivity for deer. We've also been doing Japanese encephalitis studies, looking at US swine and mosquitoes, some of the first studies for over 40 years. To look at our vulnerabilities. We are even a looking ahead. We've done some work on an emerging European virus, a virus in Europe called [indiscernible]. Awareness in terms of looking ahead includes work of the Kansas intelligence Fusion Center. They are unique amongst fusion centers in that they have a bio threat team that meets regularly to look at potential threats in order to prepare us better. They have experts on foodborne pathogens, animal pathogens and plants as well. Plants are very important. I have to emphasize that. We heard questions about that. It is important to understand the role of wildlife on mosquito vectors and other vectors in these things because that knowledge allows us to consider potential control strategies, vaccination strategies and so forth. We are actively working on diagnostics surveillance tools and vaccines. To do this. That's an important part of preparedness. We have heard about African swine fever. Jim Roth mentioned it and others have mentioned it. If that gets into the United States and we are vulnerable, it could devastate very very important swine industry, FMD could infect that, and of course our cattle industry as well. This isn't about putting food on the table. This is about not being able to put food on the table. And that will affect us all. To meet the goals, we also need a trained workforce. We are very lucky that we have had homeland security and USDA funding at the BRI to train staff to work specifically at that all-important NBADF facility. The college of vet med and the tier 1 veterinary diagnostic lab that is part of the national animal health laboratory network is also part of that preparedness. We also have a national bio security Center at K State, which is preparing for mitigation strategies. They do rehearsals, they train people, they work with FEMA and homeland security. It was noted by the blue ribbon study panel on bio defense that we lack leadership funding and strategic planning. It's great to see some of these gaps being filled and addressed and taken seriously at last. We are certainly very privileged that we have our president, retired Gen. Richard Myers who is chairman of the joint chiefs of staff 2001-2005. He understands the importance of defense. He understands that bio threats are real and helps us to support that. It is something we do every day. Finally, I really do echo Governor Ridge’s sentiment that we need to translate the strategy into action. It will need function. This is not a plea for function. It's just a reality that this type of research education and training is very expensive to do. And we must have response and recovery plans like we are going to hear about. I think we must do everything within our power to avoid the necessity of implementing these. We have to get ahead of these and not get to the stage where we are responding and controlling these pathogens. And without, I will thank you.

[Applause]

>> RICK BRIGHT: Thank you, Stephen. I must admit that wasn't what I expect of a typical Kansas accent. I thought maybe I'd just been away from home for too long. Our final panelist most of you know. Dr. Tom Inglesby, director of Johns Hopkins Ctr. for Health Security. Tom, thank you. Welcome.

[Applause]

>> TOM INGLESBY: Okay thanks. Okay, I just want to start by thanking Rick and Lisa and Andy from NAS for inviting me to be part of this and for Teresa and her team at HHS who has been working so hard on this strategy. Publishing this strategy last fall was really important and a big step and has been years in the making and I want to commend all the people across government who have been working on it. I see people from DOD and others have also been working on this. For this to succeed in the years ahead it's now going to needed to be connected to budget and to timelines and two assignments and implementation plans so I think this is a really important step, this gathering towards that end. There are so many preparedness priorities and so little time, so it's not easy to choose. I would normally speak about public health preparedness priorities or include that on the list like surveillance and outbreak containment. But given that I see that those things are partially being covered over the course of the day as well as medical preparedness, but science communications I'm going to focus instead on four priority and budget goals that I think are important in the strategy and that I think maybe aren't particularly well attended to at the current steady state. The first is driving the US bio S and T base. The second is the development and manufacture of medical countermeasures. I will say more about that. A lot of it is going well but there are a couple things maybe we could amp up, international preparedness and finally ensuring continuity of operations. I will just say a few comments about each one of those. First, driving the US bio S and T base. There is astounding innovation going on in the life sciences community in the United States biotech. It's not just technologies, but it is new products, new code, new recipes, new systems all being generated by US life sciences and government and industry and universities and small bio techs. It's amazing, but we can't take it for granted that it will stay like this. We need to study and understand how other countries are driving their own bio economies because they are. We need to know how most successful biotech companies could be acquired and moved to other parts of the world relatively easily if we don't pay attention. And bio is not only important for medicines and vaccines and diagnostics, which we are talking about today, but it's also going to be crucial for the economy writ large. Especially as we start to get a handle on bioengineering and all that it can do in terms of transforming industrial processes. So, we need to treat bio S and T, the bio S and T base more like we treat the defense industry or Silicon Valley then we might treat for example the textile industry, which was entirely off shored, and has become in many ways a commodity. Bio is not a commodity. It's a national resource. It's of national security importance. So together we need to focus on how to drive the US biotech S and T economy. Second, development and manufacture of medical countermeasures. With Rick here we don't really need to say much about BARDA and its expertise and leadership, it is BARDA, NIH, FDA, CDC, industry partners, all working toward developing medical countermeasures making incredible progress throughout the years. This model doesn't exist in other countries. I don't think we should take it for granted either. At times it has been under resourced and it can be under resourced again and we need to accelerate the development of medicines and vaccines. As much progress as we have made, we still need to go faster and broader. So that's going to need support, political support and technical support over the years. One particular area that's worth mentioning that I think has received comparatively little attention or less attention, which is surge manufacturing. How do we manufacture high levels of products that exist for crises? How do we do this we can't stockpile everything we have. A key example for the moment is Ebola vaccine in DRC. Things are not going particularly well in that response. We have a vaccine that works but we don't have an enormous amount of it. So that should be a tractable problem. It's a very hard problem but it's potentially a tractable problem and I would urge the US government to try to make as much progress as we can on that. Third priority, contributing to international preparedness. The US should continue to fund and support the global health security agenda. The US helped launch it, it has paid enormous dividends already, it helps countries help themselves. It's aimed at keeping disease from spreading in the world and we by participating have much more visibility in country for what's happening there early in outbreaks. We have more data, we have more warnings. It's the right thing to do and we should definitely proceed. We also need to be able to respond internationally. And DRC has shown us the limits of being able to respond in dangerous places in the world and we need to keep thinking about and driving forward and how we will respond to outbreaks and dangerous conditions in the world and the ways that we are able to respond to dangerous environments in the DOD and for humanitarian action. We don't have that ability in terms of response to outbreaks. We also need strong White House leadership around these issues and response. There is a bill that's called the Connolly Chapman and Global Health Security Act, which was just released, which I fully support, and we need stronger efforts to be able to send clinical teams and epi-teams to places in the world where it's quite difficult. And my last priority here is ensuring continuity of operations. Potential biological threats range from small to grave. On the smaller end, we have potential ricin in an envelope or anthrax in relatively small places. Or on the other end of the spectrum we have very large potentially contagious potentially uncontrollable pandemics. This is all part of the bio defense suite of problems. So, new pandemics with highly lethal avian influenza deliberately created pathogens engineered to be able to spread widely in the population. Those are still part of the same spectrum. And on the higher end of the spectrum if those threats appear, they could cause national or even global catastrophe. So, the US government, the local governments, communities, businesses, we need to have plans in place to be able to withstand the high end of these events, to withstand and persevere in the high-end and the face of high-end events. So we need continuity of operations systems in place for those events, plans and exercises should test a failure. We shouldn't reassure ourselves when things get too big. And we need to include in the continuity of government for things that are on the very high end of the epidemic spectrum. So in conclusion I will just say there is an enormous amount of good work to be done. We've heard a lot about this morning and look forward to talking about this with all of you. Thanks so much.

[Applause]

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