This article is part of an ongoing collaboration between the Colorado School of Public Health, the Denver Museum of Nature & Science, and the Institute for Science & Policy. Click here to watch the full recording of this session and find all of our previous COVID-19 webinars and recaps here.
Much of my career has been tied to tracking novel diseases and outbreaks. I came out of the Naval Research Lab after earning my Ph.D. at UC Davis and actually started during the earliest days of one of the first HIV outbreaks, working on artificial blood technology. Eventually, my path led me to the Defense Advanced Research Projects Agency (DARPA).
Perhaps unfortunately, some of that experience covers the offensive use of biological pathogens. In the 1980s, the Soviets had built their response to the Reagan administration’s Star Wars Strategic Defense Initiative. They had no missile defense, so they were active in a very large program with 30,000 people dedicated to weaponizing pathogens, looking at loading missile heads with anthrax. That really spurred our own significant investment in preparing for pandemics. But many of the things that we would do in preparation for an adversarial use of weapons are the same we would do when nature is the threat. The Soviet Union was working on pathogens, not only for humans but to take down the agricultural sector. (There's a great Pulitzer Prize-winning book titled “The Dead Hand,” by David E. Hoffman, which chronicles how that biological weapons program was eventually dealt with.) We often talk about a war on disease ─ the war on cancer, for example. We adopt jargon from a wartime approach to fighting disease and that’s very much the case now with COVID-19.
After getting my business degree, I founded a number of private companies to develop biomedical products (including freeze dried blood platelets) as well as a diagnostic company that focused on outbreaks of rare diseases such as chronic wasting disease and mad cow disease. I returned to government service during the Obama administration and ran the country's biological defense and chemical defense programs for the Department of Defense and then Homeland Security before coming to Colorado State University in 2013.
We've seen an increasing pathogen presence and threat in recent years, both from adversarial intent accidents and of course, Mother Nature. This teaches us many things. First, these problems are not unique to humans. We look at this under what’s known as the One Health framework, the idea that we cannot solve these problems simply by dealing with the human aspects of disease. The interconnectedness of animals, humans, the environment, climate issues around water and air quality, the distribution of rural and urban assets ─ all of these things contribute to how emerging threats increase in frequency and severity. Outbreaks occur as a result of disruptions and we're understanding more and more about that. That’s part of what the holistic One Health approach considers.
We’re continuing to study how these diseases jump from animals into humans. Camels were a reservoir for Middle Eastern Respiratory Syndrome (MERS), the bat and the pangolin are thought to be the origins of COVID-19, and there are also reports in the literature of the domestic cat being a reservoir capable of transmitting viruses from cat to cat. And so this leads us to the question of what causes viruses to jump from animals to human hosts. What is it about the host and pathogen dynamics that enables that jump, or conversely, enables a host’s resistance? These are really important questions and really important investments countries are making.
I want to talk a bit about this diagnostic testing, as that’s a big component of what we're doing across the state and certainly at CSU right now. Diagnostic testing and bio-surveillance are our first line of defense. They are our first opportunity to detect that there's a new emerging virus in the area or a flare up of chronic diseases that we see regularly. We've created two Clinical Laboratory Improvement Amendments (CLIA) certified testing sites, because all of us are focused on testing in some sense or another, whether it's RT-PCR, serology, or even wastewater testing, which is now starting to show up across the state as a means of early detection.
Most of the surveillance efforts in the state are still focused on screening workers for symptoms, and that's a really important piece. We know fever and cough are early symptoms. We also know about the loss of taste and smell. But we also know that this virus can be transmitted from person to person even before somebody becomes symptomatic. And so it's really important to be able to screen for those who aren't showing symptoms, but may be able to transmit it. We waking up to the importance of testing the asymptomatic population.
Bio-surveillance in senior care facilities is particularly important. This is the highest channel of mortality in the state, with our most significantly underserved population in terms of liabilities. We know the aging community has a greater incidence of underlying health conditions and it can lead to higher incidences of morbidity. The majority of deaths in Colorado are associated with skilled nursing facilities. We started a pilot program with the state in February testing asymptomatic workers. About 13% of workers who didn't show symptoms were positive for COVID-19 on average, with some spikes as high as 20%. As a result, we were able to remove those people from the workforce population quickly and thus increase the health of nurses and residents in those facilities. You may have seen in the last week or so that Governor Polis announced expansion of this screening. We hope that the program can be extended to other workforces too, like the agricultural sector.
As we know, the effectiveness of masks, gowns, plastic shields, and other PPE is a really critical aspect of protecting workers, particularly in healthcare. We were well prepared to support the state with testing to ensure that any procured masks met the required standards set by the National Institute of Occupational Safety. The state and manufacturers can send us masks and we can certify their filtration properties, both new designs as well as existing commercial ones. And we've also established decontamination methods for PPE. We now have thermal and chemical techniques that can essentially regenerate N95 masks for multiple uses, which extends our supply considerably.
Once you know an emerging or chronic disease is coming your way, you need to be able to produce countermeasures in an agile fashion. We are in a very unique situation here at CSU because we have four vaccine candidates in development. Solavax™ is our most mature product and it represents a really interesting near term opportunity to produce a vaccine based on an existing manufacturing platform. It's a reduction technology used to remove pathogens from blood and has been approved for use in parts of Europe, Asia, and Africa. That same device can use light and either vitamin B2 or riboflavin to create an antigen to inactivate the virus so that it can no longer replicate.
Because Solavax™ already has a manufacturing platform and because it's already used in blood transfusion commercially, it is on a very fast track for regulatory purposes. We just received funding from NIH to take this all the way through human clinical trials, which is about a $30 million effort. So we'll be moving very quickly. And this is a very exciting opportunity for us and for the state and for the region to very rapidly produce a vaccine.
There are three other vaccine candidates that are also in play, being supported by internally now and waiting for NIH funds. To end a SARS-like pandemic in the U.S., we need to be looking not only at human channels, but stopping the animal channels as well. We’re well prepared for this effort thanks to our BioMarc facility here in Fort Collins, on the west side of our campus. It's an FDA-approved manufacturing facility (it won the Colorado manufacturing award in 2019) with 50,000 square feet of biosafety level three manufacturing space. So we're very uniquely situated in Colorado and in the region to produce a commercial vaccine.
We’re still in the middle of this pandemic and it's hard to think about the after-action reports and next steps right now when we're all still mostly in our houses waiting for society to reopen. But this is a very important aspect of investing in our future. And so I'd like to come back to this issue of agile and resilient technologies that allow you to essentially find an emerging disease like COVID before it happens. We often refer to a study we did on defending the homeland against biological threats in 2001, and it was entitled “Looking for a Zebra in a Herd of Horses” because that's essentially what you're doing. You can't be testing for singular pathogens all the time, you have to test against syndromes. Syndromic screening is our future because we’re going to need to screen against a whole series of pathogens at once. That's called multiplexing, and we have it available now. For example, we began investing in a small company called Idaho Technologies about 20 years ago; today, a small desktop unit can test 21 to 35 pathogens in one test, including COVID-19. That kind of broad and rapid screening will help us move quickly to prevent the same kind of pandemic we see today.
We also need to look at our data sharing, integration, and analytics. Artificial intelligence and machine language are buzzwords today, but they're really about predictive analytics. Colorado is very uniquely situated with strong health information exchanges on the human side. Going back to considering this under the One Health framework, it’s about linking human data to animal healthcare data and environmental healthcare data. That’s really critical in communicating around a threat that is emerging. We're getting better at making those kinds of predictions.
Are there ways to shortcut normal regulatory hurdles?
Yes, one component of our response is the FDA’s Emergency Use Authorization. As we know, the FDA’s primary role is the safety of products for human use. They operate in a very regimented way and it's a long process. For drugs, it can take 10 to 12 years for approval. For vaccines, it's even harder. So there are safety considerations and efficacy considerations. However, during emergencies, acceleration of the regulatory process can occur. The EUA allows them to change the rules to move faster.
Let me give you an example. For a diagnostic test that's approved by the FDA, normally you would have to test that against a lot of clinical samples. Let's say you had a product for the first SARS disease. You would have to have a number of samples to test against. But in the current COVID-19 outbreak, you don't even have those samples yet because it’s a new disease and things are happening quickly. So under the EUA, the FDA would allow you to spike that requirement. That allows products to come to market more quickly.
What are some of the risks of fast tracking COVID-19 therapeutics?
This has certainly been a tremendous case of science having to meet implementation. In other cases, we're often moving products in areas with diseases or pathogens that we know a lot about: dengue, the flu, malaria. But here, we have a pathogen and a virus that we are still learning a lot about. So what does that mean? It means we have publications that are not peer reviewed in the same way, with people reviewing them who don't have the experience with the virus that they would normally have. And so as we’ve seen with hydroxychloroquine, you have a lot of so-called peer reviewed data getting out and then being called into question as time goes on, either because of the data sources or they were quick to publish before they had a chance to really understand all of the data.
With regard to PPE, how effective are homemade cloth masks compared to N95 masks or other designs that have been rigorously tested in the lab?
The N95 is so-named because it’s preventing 95 or more percent of viral particles from transiting across that mask. And as you go down into cloth masks, of course, that percentage drops precipitously. So they do offer some minimal protection in terms of projecting particles if you're coughing or sneezing. We’re still learning about this. When I was with the Department of Homeland Security, we were of course worried about plumes of large pathogens; when somebody exhales in a room, where does it go and how long does it take to get there? That involves some very interesting physics and it's pretty hard to predict. Cloth masks do reduce projection from an individual so in that case, they are providing some good protection as we go out into public and maintain our social distancing.
There's has been some talk about developing a global program based in genomics to try to intercept pandemics. Could you talk a little bit more about what that is and how that would potentially work?
The Defense Department has had a global epidemic epidemiological surveillance system program (GEISS) for a while, because they have thousands of men and women wearing our uniform in tropical parts of the world who are exposed to outbreaks all the time. So there has been a significant investment in global surveillance of disease and in our health national security programs that have been fortified by other programs like USAID. Those surveillance systems build up our health capacity around the world. We will very likely see a stronger investment in programs like BioWatch, which samples air in major US cities for pathogens of concern. But it must be inculcated into our state and regional systems, and we just have not had those systems linked together in any kind of integrated way.
There is a program called PREDICT, out of USAID, which has essentially been going around the world sequencing all the new emerging pathogens they can find. And pre-COVID-19, there was a moonshot proposal made in Washington to sequence all the nasty viruses that we know about. That's about a $4 billion price tag. Some proponents claim that that will provide the foundation from which to predict when we see something new on the horizon.
You are also the chair of CO-LABS, a Colorado-based research consortium. Could you talk about the state’s research ecosystem and how we compare to our regional neighbors?
The Front Range has an unusually high number of national labs contributing about $4 billion of economic development to the state. More importantly, that’s a real intellectual and translatable asset that will play a very important role for our region and in building resilience capacity for future outbreaks. The ecosystem that we have in Colorado really positions us quite well to consider something like a new national lab for outbreak research and response. The integration of the public and private sector will be a really important building blocks for us.
Compared to the western region, Colorado is well positioned because of the health of our economy pre-pandemic. I think we're going to return to a position of prominence. We've been leading a coalition on agricultural outbreaks and that’s been getting a lot of momentum. For example, before COVID-19, there was an African swine fever outbreak where half the pigs in China were lost. So these outbreaks are unfortunately not just happening in the human channel.
What are some of your recommendations for us to be more resilient and more prepared in the future?
Having spent 25 years both investing and executing R&D to prevent outbreaks has taught me that we can have all of the things we need on the shelf, but if we don't know how to implement them, we don't know how to work across sectors to build that resilience. We won't be successful. It’s really just as much about the social and cultural underpinnings. This is really going to give us a window of opportunity to transform our thinking. We have the technology, we have the diagnostics, we have the therapeutics, and we just didn't implement them in time. We need to do better. We can't have a one bug, one pill approach. We need to invest in host response so humans are better prepared for the next pathogen. We need to build syndromic surveillance so that we're not looking for one bug, but instead we've got multiplex opportunities to look for it. We need the FDA to lean into approving drugs and countermeasures that have multiple indications and we need things that are used for multiple threats. I think it will take a social and cultural understanding of the importance of doing this to prevent the kind of results we've seen in the last three months.
How can move faster and more effectively going forward?
One issue to address might be stockpiling. Pandemics should not be treated like hurricanes, where you see one coming at you and you stockpile a bunch of things and then you deploy them and then you stockpile again. That’s not really not a sustainable model. We have to make it so that we're investing in these things continually, that it's built into the very fabric of our society. The agility will come naturally; we'll always have strategies that allow us to move quicker. But we need market capitalization and social structures to understand and act on that. It used to be that we’d only expect to see this level of threat once every hundred years. What we've learned in the last 20 years is that the frequency of these threats is increasing. And we need to take that seriously and start to invest in in a very serious way.
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