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Goal 1: Enabling Risk Awareness to Inform Decision Making across the Biodefense Enterprise

Biodefense Summit Transcript

​Panel Moderator: Dr. Cindy Bruckner-Lea, Senior Scientist and Manager, Pacific Northwest National Laboratory

Panelists: Noreen Hynes, Associate Professor of Medicine and Public Health at John Hopkins; Sandy Wedgeworth, Director of Public Health Emergency Management, Long Beach Department of Health and Human Services; and Henry Willis, Associate Director of Homeland Security Operational Analysis Center at RAND Corporation.

​>> CICELY WATERS: Thank you, Governor Ridge. The remainder of today's summit will be structured in the form of panels. We'll have five panels devoted to the five priorities of the Natio​nal Biodefense Strategy. Our first panel will cover goal one, and the session will focus on risk awareness and informed strategic decision making. Our moderator for this session is Dr. Cindy Bruckner Lea, senior scientist and manager at the Pacific Northwest National Laboratory in Richland, Washington. Dr. Bruckner Lea?


>> CINDY BRUCKNER-LEA: Well, I'm very excited to be here to moderate the first panel, um, related to the national biodefense strategy, and this, um, panel is about goal one, which is enabling risk awareness, um, decision making across the biodefense enterprise, as summarized in the strategy, um, the United States will build risk awareness at the strategic level through analyses and research efforts to characterize deliberate, accidental and natural biological risks, and at the international, at the operational level, through surveillance and detection activities, to detect and identify biological threats and anticipate biological incidences, and, um, for this panel, we have, um, we have three panelists here, which I'm really excited to hear about their comments first, um, and they are Noreen Hynes, Associate Professor of Medicine and Public Health at the Johns Hopkins University, Sandy Wedgeworth, Director of Public Health Emergency Management, Long Beach Department of Health and Human Services in Long Beach, California, and Henry Willis, Associate Director of Homeland Security Operational Analysis center at RAND Corporation.

Um, so, this goal, um, indicates that the U.S. will build risk awareness in two areas. Um, the first is at the strategic level, it includes actions to ensure the decision making is informed by intelligence, forecasting and risk assessment, and the second is to ensure that domestic and international bio surveillance information systems are coordinated and capable of timely bio incident prevention, detection, assessment, response, and recovery. Now, through all of the, um, actions needed to address this goal, it's important to note and to remind, I just want to remind you all about the scope of the biological threats that are covered in the national biodefense strategy. Um, they include threats that impact, as we've heard from our great, inspirational talks so far, impacts to humans, animals, plants, and the environment, um, as well as biological events that are naturally occurring, accidental, and intentional, and in addition, the threats that we see could be, um, known, things we've seen before, or unknown, things we hadn't seen before, so when you look at all of those combinations, it's a huge landscape and extreme challenge that really is going to require harnessing, um, all of government, as well as, um, all of the capabilities outside government. Um, and, so, another key consideration I want to emphasize, especially for this, um, goal, and actually, many of the others also, is, um, the time.

So, risk awareness through detection can occur before release or event occurs, at the time or early stages of a release, or after the release, and, so, of course, to minimize impacts, we want to move that detection as early as possible, and those impacts, and we've heard this mentioned earlier today as well, can include impacts to health, um, travel, trade, and the economy, so this is so far reaching. Um, and the strategy also recognizes that many of the capabilities that address the risk awareness goal, as well as the others, are outside of the federal government, um, so, for one little example I want to mention is for the initial detection of a disease surveillance, um, often involves a person, a farmer, a rancher, or an animal owner seeking healthcare, um, or reporting a concern, and this step can be limited by several factors, including lacking access to healthcare or failing to recognize that a person, animal or plant is ill and the ability to diagnose that illness. Um, and, so, that means, when you think about it, every single person is part of the biodefense enterprise, and so that's why it's so important today that we're getting input from outside of government, from the whole biodefense enterprise, and we want to continue to do this over time.​

Um, and, so, um, I mention this to provide an example of how capabilities outside of government are important from the perspective of bio event detection, which is one part of the risk awareness goal, and, so, now, I'd like to, I think there's another slide that reiterates the questions, so the panel discussion questions, um, they're also in the agenda that you have, I'll mention these first so that you can be thinking about them as our panelists provide their comments, and then after the panelists, um, provide their comments, I'll open this up to individuals here in person to provide additional comments or questions to the panelists, and also, if we have time, folks that are on the webcast today to get input, and as we heard earlier, if you're not able to provide your input today, there is a, um, website, um,, that is open for input until May 1st, and so, and, actually, really, it will be an ongoing dialogue beyond that as well, but initial input. So, um, so the questions that, um, to be thinking about throughout this panel are what are the most significant gaps or challenges either at the national level or within your business sector related to the implementation of goal one of the strategy, which is risk awareness, what are the highest priority actions addressing goal one of the strategy that would best advance biodefense, um, what new initiatives are planned by your sector that would contribute to filling gaps in risk awareness and informed decision making as it applies to national biodefense, and then, also, what proposed initiatives would be most effective in enhancing risk awareness and informed biodefense related decision making by leaders. So, now, I would like to move to invite the first panelist up to provide, um, her comments, and I'm pleased to welcome Noreen Hynes, Associate Professor of Medicine and Public Health from Johns Hopkins.


>> NOREEN HYNES: Good morning, everyone. It's very nice to see, um, many of you who I haven't seen in awhile, since I, myself, left government, so, you know, there are some of us who will be talking up here who, once upon a time, did sit in government. so, thanks so much for inviting me, um, Dr. Kadlec and your group. I appreciate very much being here, and what I'd like to do today, you saw all those questions, and hopefully, my fellow panelists plan to be covering many of them as well, but what I would like to do is to take a little term from our, um, our British friends across the sea, I'd like to mine the gaps in two particular places. One, to look at risk assessment that is talked about here, and then, also, risk posed by research. As one of my co panelists, Professor Willis, um, will certainly be able to attest, this risk assessment that we talk about, um, that's very important is really just one of three parts of the critical risk analysis paradigm that also, that informs risk management, that is the decision making and the policy making, but very importantly, the risk communication. Many people would say that risk assessment, that is the models that are created to tell you how much threat, um, exists when looking at a particular, in this case, microbial threat, um, is key, but others will tell you that the most important of the three in the triad is risk communication, how well do you tell all stakeholders, um, at all levels about what you're doing and what the outcomes are, what the threat is, and how you hope to respond.

So, I think that it's important to realize that within the risk assessment piece of this, there are some very important gaps. There are four parts that have to inform it; risk characterization, um, exposure assessment, dose response, particularly for microbial risk assessments, and risk characterization. Often, we have to rely on very imprecise data. You know, Geico, garbage in, garbage out. So, this is, I think, a very important area that we will need to address. So, um, informing data, or data gaps becomes very important for a better outcome. Importantly, risk assessment does bound itself with uncertainties, and then, of course, this has to be communicated by both, um, the risk managers and the risk communicators, but importantly, all risk assessments also provide, um, with a list of where the knowledge gaps are, that it can inform future research, and, so, that becomes very, very important. Along, but importantly as well is the fact that the time and resources to fill the gaps become important, and the intelligence communities, um, can often help us with understanding where we should prioritize them, but ideally, addressing these research gaps needs to be a collaboration amongst government, um, industry, and academia, and, unfortunately, you know, it takes money to do this, and one has to assume that government will play a very big role in helping to fund these efforts, but within the context of also filling the gap and using more, um, recent developments, I would call on the concept of precision medicine.

This particular concept now is being applied to look at the genetic influences, lifestyle influences, and environmental influences that, um, might be important for structuring a treatment plan or prevention plan. Right now, precision medicine tends to be used in cancer and chronic diseases, such as multiple sclerosis, but I would suggest that precision medicine may be very, very important for doing research in, um, for microbes and, um, pathogens, to tell us how the same and different individual hosts respond to exposure to, um, particular pathogens. Again, this may be very important for informing that exposure component, as well as dose response component of risk assessments. And then, moving on to the second risk, um, that I spoke of, and that is this gap in biosecurity that arises in research laboratories, that, um, the important thing about this second gap, we tend to talk about two pieces, um, to the, um, to threats posed by, um, research. One is in, um, bio safety, and the other in biosecurity. We tend to have a pretty good handle or an improving good handle on biosecurity. We make sure people who are going to work in labs have to have training, re training, um, we do, um, loop cause analyses when there's a big faux pas and try to fix it.

On the biosecurity side, we do things like saying you can't, what you have to do to work with select agents, etc., but what is missing from this piece, including in my own institution, is a codified manner in which we create, for bench scientists at all levels, laboratory experiment based ethics, in which you bring into, um, into the fold the concepts of, um, of dirk, gamma function research, and synthetic biology. The place to, um, what happens now in the university setting, this is left to the, um, principal investigator, to work with their, with her or his mentee. Often, the other people who work in the laboratory are not privy to these discussions, nor is it a repeat type of training. I would submit that all life science education, beginning at the most fundamental level, long before you hit the university, should be a place where this laboratory experiment ethics begins and is continued throughout the career of a life scientist, during all of their education and continuing in their career. One of the things that we don't know now is how big the gap is, how bad the training is or how good it is. I can tell you at my institution, there is only one course, um, that graduate students can take in the School of Public Health, and this has to do with this type of policy, dealing with, um, dual use research of concern, gamma function, and synthetic biology, but it is not required by laboratory scientists. So, I think that's a very good place for us to begin to fill this gap, is to find out how big that gap is and then address it. So, thanks so much.


>> CINDY BRUCKNER-LEA: Thank you, Noreen. Um, our next panelist is Sandy Wedgeworth, Director of Public Health Emergency Management, Long Beach Department of Health and Human Services, all the way from Long Beach, California.


>> SANDY WEDGEWORTH: Thank you very much. Um, good morning, everyone. I'm really, um, very grateful for this opportunity to be here with you today to, um, share the local perspective. Um, when it comes to biodefense, communities are where our battle will be won or lost, regardless of breakthrough, medical countermeasures, progressive policies, increased fundings, lessons learned, or recognition of best practices. None will matter without diligent and thoughtful execution at the local level. Having first hand experience implementing and operationalizing such solutions at the ground level, I would be remiss if I did not take this opportunity to advocate for broader inclusion of local experts into similar meetings. Developing a biodefense strategy is commendable. I urge the professionals in this room and the policymakers on the hill to pursue truth in what success should look like. The truth manifests at the ground level and may manifest in various ways from jurisdiction to jurisdiction, which makes the inclusion of local officials, from development to execution and program evaluation, the linchpin of genuine success. Furthermore, aggregate indicators of achievement today and tomorrow will likely evolve as progress is made and could look quite different down the road. My hope is that those charged with implementing this strategy will take full advantage of the operational expertise, experience, and legacy knowledge present within our local public servants to inform and reshape the strategy as necessary.

At the local level, we have seen the gaps that widen and additional fractures develop when federal partners withdraw from spending time with us and pull the shade over transparency. When pursuing new technologies, they end up protecting the public. We in local government are the power and defenders that will be brought to bear the burdens of the sick and dying. We have and will continue to have first hand knowledge of death and long suffering when we are not successful in completing the mission. We also hold more than simply a vested interest in the economic impacts and recovery from consequences of biological incidents. We live in the communities we serve, as do our children and our loved ones. I implore our federal colleagues to include us in the design, execution, deployment, and institutionalization of any capability that we are charged with responding to. The stakes are higher for no one but us, and accordingly, in assistance to achieve demonstratable success is greater in no other group. To this end, our federal partners cannot afford to withdraw from us. It is my sincere hope that my presence here today will spark re engagement and facilitate restoration of the strong relationship that led us to, that will lead us to a better prepared state of readiness than we currently have today.

So, um, my last comment is, earlier, um, Secretary Azar spoke about the importance of collaboration, and I know that, um, 20 years working in government, a lot of times, we get, um, caught up, it's all the different priorities, and we have a tendency to just kind of check off boxes, and, so, I hope my being here today as a local is not, um, does not end up in, um, someone just checking off a box, that, well, we collaborated with the locals, because we had that gal from Long Beach show up at the meeting, um, I hope this really is just the beginning of, um, improved relations and continued relations with, between the locals and the feds, um, because we definitely, at the local level, want to work, um, with all of you. So, thank you.


>> CINDY BRUCKNER-LEA: Thank you, Sandy. Um, our final panelist now is, um, Henry Willis, who is Associate Director of Homeland Security Operational Analysis Center at RAND.


>> HENRY WILLIS: Thank you. Good morning, everyone. When I think about, um, risk awareness, um, I particularly thought about the strategic aspect of risk awareness, as a number of you who have many of the technical, much more technical expertise on the bio surveillance aspects, and I'll give a few comments on the first two of the questions, starting with what are the gaps, and to think about gaps, I start with the recognition that risk is a function of three interdependent factors, that is the threat of an event occurring, the vulnerability of our society should that event occur, and the consequences that will propagate out, and in each of those factors, each of those factors highlights some information gaps, as we heard from our first speaker. When we think about threat, for example, we all know there's many advances in the biological sciences that are, cause us to think about what are the new emerging threats because of the technologies and knowledge that exist, but we also have to think more broadly into the economic systems that are evolving globally around the world because of those advances, so we need to understand, because of those advances globally, what is the state of bio safety and bio risk management in countries that are pursuing those economic, new economic activities, because the diseases that we're focusing on with this bio security strategy will not pay attention to borders.

The second factor, vulnerability, raises the significance of interdependencies that exist between, across society and infrastructure. Some of those interdependencies are well understood, that is, for example, if a disease outbreak happens, um, people may be sick and not show up to work, and that'll affect economic activity, or the things we do, such as implement school closures or travel restrictions will have downstream consequences that'll affect the economy, but we also have to thing about how natural and physical world could, through these interdependencies, affect public health preparedness. So, for example, um, experts know, but maybe not everyone was aware that when Hurricane Maria hit, that affected the supply chains for things like saline and pharmaceuticals, and you could have interdependencies that propagate back into the public health preparedness infrastructure, and we need to better understand and be able to better characterize those interdependencies that affect vulnerability. And this leads right into consequences. When I think about consequences, I pose the question, how well positioned are we to react to bio security threats? In other words, in what ways are our communities resilient? And how can they be made more resilient? Um, Senator Lieberman and Secretary Ridge, in an op ed yesterday, posed one example of this aspect of resilience when they talked about the measles epidemic. They pointed out that our state of bio preparedness has, or public health preparedness has maybe created vulnerabilities for the measles epidemic, but also, as cities like New York have to direct resources towards measles, they may not be as prepared for bio threats, and, so, these kind of connections can lead to affecting our resilience.

So, let me transition now to what we can do about it. The second question is what are some of the highest priority actions, and I'll highlight two, and in doing that, bring up the International Risk Governance Council's governance framework for risk analysis. As you see here, there's a risk management sphere and a risk assessment sphere, with communication central to it all. I'll start with the risk assessment side. Um, the nation has, over the last decade, developed advanced risk assessment tools, for example, a bio terrorism risk assessment, and a series of hierarchical models that can be used to help communicate and inform policymakers about what the threats are. It's probably time to revisit these, particularly the Bitra, with some of the advances I talked about in the threat gaps, and that's something that can be done and can be revisited. The second aspect I'll highlight is focusing on communication, in particular how communication with the public is a key enabler of resilience. We have strong guidance and good knowledge on how to communicate with the public issued by CDC and most local public health departments have people who are well trained on how to communicate, but the response is going to take more than that, it's going to spill out into emergency management, the private sector, and we need to smooth over those seams so that we deliver a common message to the public when events happen, and I'll highlight one advance in the field of risk communication, and that is inoculation messaging. We know that just like a vaccine, if you inoculate someone, you can reduce the consequences of those outbreaks, should it happen. The same is true with risk communication. You can, in advance, tell people what we expect to happen, how we'd respond, and help them, help the public better react and, um, and respond in the event, thus improving community resilience. With those comments, I think we'll kick off into the discussion session of the session.