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Goal 3: Discussion Questions and Answers

Biodefense Summit Transcript

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

>> RICK BRIGHT: Thank you very much. I don't think anyone could argue and say we could not have chosen a better panel to talk about this topic or to touch upon this broad topic. So thank you all for your perspectives and touching upon many of the broad array of challenges and preparing for these threats. There are additional comments I'm sure in the room. I would like to hear from the audience now. And we're going to put some questions up on the board for you to guide, to guide your questions or comments and add to the discussion this afternoon. Thank you.

>> KRISTI POTTLE: Thank you. Kristi Pottle. I just have a question from a clinician’s perspective where we are talking about empowering the medical community to recognize when we have epidemics or pandemics coming along. And that is putting extra workload on those, all those individuals as people. At the same time, the medical profession is cognitively overwhelming our medical professionals with EPIC and other healthcare administrative things that are totally crushing them in their everyday work life and it's taking their cognitive function away from patient care. So when we talk here, we want to add additional knowledge and awareness and currency to these medical professionals that are just struggling to hang on with the job they are trained in, how is the federal government going to respond to remove some of the administrative challenges that are preventing the healthcare professionals from doing what they want to do and to be aware of these emerging threats  particular to their patients.

>> RICK BRIGHT: Great question.

>> LAURA EVANS: I don't work for the government, but [indiscernible]

>> LAURA EVANS: ... So I definitely can't answer from that perspective, but I think your point is well made in that clinicians at the frontline of our healthcare system are faced with many many competing priorities at the same time and so I think we have a systems-based obligation to try to recognize that and try to build systems that are efficient workflows that work for the end-user. And so we really need clinician input into the systems to make sure that it functions in a way that works for nurses, care techs, physicians, PAs, whomever at the site of care, and that it works efficiently, incorporates workflow considerations, and there is a commitment to iterative improvement of that system. It shouldn't be a said it and forget it and come back to it 10 years from them. It should evolve and change in response to feedback.

>> FEMALE SPEAKER: From the online watchers, Saskia Popescu at George Mason University had a similar question about priorities for frontline facilities and in particular what you would anticipate the focus of frontline healthcare facilities being for bio preparedness in the new strategy?

>> LAURA EVANS: Somebody else want to talk? I think, again, you know I think the obligation of frontline facilities or the need of it is just that people with an infection are not likely to necessarily know or read or investigate that a certain institution is a referral center for highly communicable diseases. They are going to seek care at a place that is convenient for them or for a place that they know or are connected to in some way. So I think all of our sites of providing healthcare need a basic level of preparedness in terms of being able to do this concept of identify, isolate and inform, recognizing that we are going to have depths of subject matter expertise necessarily. But then I think the rest of the system needs to have readily accessible access to experts, to specialty care. And so it needs a sort of regional concept of delivery of care, where everybody can do identify, isolate, inform, and then you have access to world experts in Ebola or in pandemic flu or in addition to just basically being able to take care of the initial piece of care.

>> TOM INGLESBY: I could just add one comment, which is that, or I've got one of these, that the system that was built, the healthcare system that was built in response to Ebola cases, including yours, Laura, I think was fairly incredible. It's not perfect, but I think compared to anywhere else in the world, it's top of the class. But unless we continue to fund that and support that, that system will go away. So that has not been regularized in the budget as far as I understand. Still kind of, I don't want to say this, Laura wouldn't say this, but I think it's begging for its life. So, and that's the top of the big pile. And if you go down below that, we don't have a lot of resources for infections control for highly infectious diseases. So I think we need to do more to support efforts like Laura's and others. Chris's and other systems that are working on this.

>> RICK BRIGHT: Phil, it looks like you are out there for industry.

>> PHIL GOMEZ: Thanks. Phil Gomez from SIGA technologies. Tom, you illustrated the importance of having international engagement in this activity and it made me reflect on the fact that Rick, you have had 44 licensures of products at BARDA that have made us all a lot more secure but unfortunately most of those products are only here in the US. Most of the activities are here in the US and as an industry person having been out there, there isn't a BARDA really anywhere else but here in the US. How do we help make sure our allies and the folks around the world have access to some of those products, so that we have a more resilient and sustainable enterprise being able to develop those kind…?

>> TOM INGLESBY: I don't think that's an easy problem. I think companies have been talking with governments for a long time to gauge their interests and I think other governments have been, there are some but there are fewer governments that are interested in stockpiling products. So that may change. That does change when there are threats in the world that wake people up and I think there has been some uptake here and there for various products, but I think a lot of other countries might see the US as a potential resource in a crisis, and I think it's just important for the US government to be frank with other countries and say, we have to do burden sharing. If we've got a product that we've developed here and we are stockpiling, we have limited doses, it's a little bit like how we share defense responsibilities. People need to share responsibilities around defending themselves against outbreaks. It's not an easy answer though.

>> RICK BRIGHT: And Phil, I can add, moderator privilege.

>> TOM INGLESBY: You should know. Yeah.

>> RICK BRIGHT: But BARDA I think was an experimental model initially. It was a unique model set up to bridge government and industry to pull technologies through that valley of death into the FDA approval licensure so they would be available in the SNS or when we needed them. And to the 12 years because of the industry partnership and leadership to government industry we have had success in getting drugs and vaccines, diagnostics approved and cleared. And we are now getting surprisingly high number of calls from other countries to try to replicate that model. So there are countries that, Japan for example is standing up a group, AMED, that I spent a lot of time with, allies to educate them on the BARDA model and how it was established, the resources behind it is not an easy thing to stand up and it's not an easy thing to sustain. And many countries we talk to about replicating the BARDA model don't really always have a full appreciation for the cost involved in sustainment of that model. In many countries we talked to about a strategic national stockpile and the concept of a stockpile in other countries in the world don't have an appreciation of the true cost of building that stockpile, sustaining that stockpile and keeping the enterprise around those medical countermeasures alive and sustained. So it's been an educational process with other countries. There are some who are dipping their toe in the water. We're spending a lot of time educating them as well. There are some who would like to do it who just haven't been able to find the resources and the money, the technical expertise to do so as well. So, for the time being there's level of recognition is a great novel. But we are hoping through our training and international collaborations that we will be able to find additional countries that replicate that model as well. Robert?

>> ROBERT: Thanks. So on the topic of the frontline decentralized overwhelmed healthcare worker network, both domestically and foreign, you are directly managing Ebola patients I suspect you know Michael Callahan. He is at DARPA and subsequently through that crisis he had some souped up near point-of-care devices, let's say, and was able to come up with clusters of symptoms that were fairly productive as diagnostics at a time when, in that interim period where things are a little gray about what the diagnosis might be beyond fever. So his thesis was that if we had advanced near point-of-care diagnostics and had the interface between that and machine learning where we have unbiased detection of symptom clusters whether or not they make medical sense, that could be really useful for signal detection. Is that, is that, do you pragmatically is that a way out of the woods? Or is that naïvely optimistic that we are going to get there?

>> LAURA EVANS: I think it is a great concept. Right? So the basic premise is I think that clinicians at the front lines are smart, talented people who want to do the right thing and if we build the tools that help them to do so faster, more accurately, those are great assets. But there are also issues of scalability around that. So if we are talking about real level preparedness we have to be prepared at your real critical access hospitals as well as the academic health centers in major US cities. So the question is then I think it is a great step forward and then it becomes I guess is a truly useful, and can it be scaled to sites across the US and sites across the world.

>> ROBERT:  not saying, we don't have to get all the way to point-of-care intermediate diagnostics, but it seems to me that one thing, if I was God and I could say, BARDA, you are enabled to do this one thing, near point-of-care, affordable, rapid diagnostic device that is tied into an informatics network that applies machine learning to look for these symptom clusters would have huge value for risk detection, threat detection, globally, not just domestically. So I leave you with that wish.

>> RICK BRIGHT: Okay thank you, Robert. This side of the room? I don't know how much more time we have left. Someone can time check in the front. All right, five minutes.

>> TENER VEENEMA: Okay. I will try to be quick, Tener Veenema from Johns Hopkins University and I want to thank the panel for their wonderful presentations and again, once again highlighting the importance of workforce development and workforce preparedness for bio security and certainly I think all of us as educators recognize that schools of medicine and schools of public health and schools of nursing really need the help of the accrediting organizations and the licensing organizations to allow us to devote the time and the curriculum to help prepare our workforce. But going back to some other comments that have been made in response to the panel, this question of, how are we going to optimize the healthcare system and the public health care system and the interaction of those two systems to optimize this bio defense strategy, I think still kind of remains unanswered. And certainly that's going to require very high level, complex capabilities from operations and logistics to really make this work, and no matter how well we educate our healthcare workforce, unless we really address this issue of how systems optimization, we are still going to be putting very well educated prepared well-meaning healthcare workers in a system that is so burdened it's going to collapse when these events occur. So I just think about other types of industries that use systems engineering and very proactively and aggressively look at how can we streamline or reengineer our healthcare systems and from that goes the question how do we make our healthcare executives and chief executive officers of these large healthcare systems and rural hospitals recognize that investing in preparedness and investing in systems reengineering and looking at the use of point-of-care diagnostics and handheld gene sequencers and AI as it can be used to facilitate medical decision-making is really worth the investment.

>> RICK BRIGHT: If it's okay with you, we will take that one for the record. And get you back on that. And we are going to hear a few more comments in the limited time we have left and of course I encourage you all to submit your comments and questions through the website as well.

>> STEPHANIE GRACIE: My name is Stephanie Gracie and I'm a practicing pediatrician representing the American Academy of Pediatrics and I'm also a medical epidemiologist and used to work at CDC for six years and not surprisingly my comments are on children. We know they are more vulnerable and they may have more severe illness, they may have higher fatality rates. So it's really important that we are able to respond effectively to them. So I have two comments specifically in regard to medical countermeasures. So, the first is that just because we have a medical countermeasure in the stockpile doesn't mean that it's authorized for use in children. And what that means is if you give it to me and I gave it to a child, I now take on the liability for anything that happens to that child as a result of the medical countermeasure. So I would just urge kind of this committee as they think about implementing this a strategy to make sure that all the medical countermeasures we currently have, plus any additional ones that are created, that those regulatory mechanisms are in place so that we can actually use them in children. I don't think the public would be very happy if we are like, yep, you can have it, but your child can't. The second piece of that is recognizing that pediatricians and family care providers are going to be our allies when it comes to distributing the medical countermeasures. If you think that people and parents are resistant to the measles vaccine, which we have decades of knowledge about, if you try to give them an anthrax vaccine, they are going to have a lot of questions. Recognizing that there probably going to turn around and reach out to their pediatrician to get information on that, that the pediatrician is probably going to have no clue what to tell them. So just recognizing that that's going to be a very important part of kind of risk communication is reaching out to those pediatricians.

>> RICK BRIGHT: Thank you, very important comments. Thank you. Two more comments and then we will close.

>> JENNY BLAIR: Thanks. Jenny Blair from PATH. And Tom, I wanted to get to your point. You talk about the importance of investing in development and manufacturing and medical countermeasures and we saw that as a theme throughout the bio defense strategy, specifically the prioritization of R&D for new tools and the coordination across governments. So a quick question, we can take it for the record if there's not time, but what policy shifts would we expect to see and would you have recommendations for to actually be able to implement that part of the strategy?

>> TOM INGLESBY: Yeah, that's a really big question. And I don't have all the answers. I definitely don't have all the answers to that question. But it's clear that other countries have government programs that invest directly in some critical companies. And that they are supportive of some kinds of S and T infrastructure that I think in the US what we have typically, we have approached many problems with we don't do industrial policy because we are, that's capitalism. But there are times when things are important enough that you need to think about whether that is the highest principle, or whether there are certain investments whether there are tax breaks or direct investments or grants or something else where the government has an abiding interest in the success for the good of the people of that particular industry. So I think it is not one magic policy, but a series of things that are directed at creating vibrancy and sustainability in the industry. That's a great question though.

>> RICK BRIGHT: Last comment.

>> JOE FERKO: Hi, Dr. Joe Ferko, EMS innovations and also involved as both a physician and entrepreneur. I just want to go over three very quick points that we did between 2014 and 2016 with the Ebola scare. In particular, one was the state of Alabama. Do we have anybody from the department of Alabama, Department of Health? Alabama instituted 3200 PICs unit, patient isolation containment units, and actually moved the containment to the field. And what was interesting is that based on US funding, then followed South Korea and Germany, that put thousands of these into their systems where they would isolate as quickly identify, isolate, transport. And this was very very helpful to them in terms of minimizing the amount of training that was necessary, localizing the PPE that was utilized and what they did was decontaminate the unit before it entered the hospital. So once it was in the hospital and the patient was isolated within the PIC system, the patient was transported throughout the hospital to whatever it has to until the patient gets into negative or positive pressure dependent on what it was being useful, whether it was chemical, biological or in some cases even burns where they wanted to   isolate the patient from the outside and positive pressure. So just a different alternative to what we typically do. They immediately isolated and had great results with it.

>> RICK BRIGHT: Great, thank you very much. I'd like to thank our distinguished panel for your comments, perspectives and everyone in the audience that commented as well and I encourage you to follow that website email address to submit your additional written comments or questions into the organiz​ation and we will make sure that those are considered and incorporated in our final action plan. Thank you for your time.