Can Biotech Be Harnessed?

Hello. I’m Richard Haass, the president of the Council on Foreign Relations, and this is Nine Questions for the World, a special limited edition podcast series. 

In each episode, you’ll be hearing me in conversation with some of the best thinkers of our time, as we ask fundamental questions about the century to come.  

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Today’s episode features a conversation that took place on September 29th 2021. I sat down with Michelle McMurry Heath, she’s President & CEO at The Biotechnology Innovation Organization. Like any technology, biotech has its ups and downs alike, it all depends on who is in control of the research, the purpose, and the safeguards. We talked about the risks and rewards of  biotechnology, and its potential applications in food production, climate change, energy production, and medicine. Given all that’s going on and promises to go on with covid, it’s hard to imagine a more relevant topic. Enjoy the conversation. 

Richard HAASS: Michelle, thank you for giving us your time and your perspective.

Michelle MCMURRY-HEATH: Of course. It's a pleasure to join you.

HAASS: So let's start out with some basics. Let's talk a little bit about what we mean, actually, by biotechnology. What is the definition? And then once we are clear about that, let's take a step back and just give people a sense of what this field is and where it is and what's going on. So, just paint the canvas, if you will.

MCMURRY-HEATH: You know I was reflecting on the definitions we tend to use, which is, biotechnology exploits the functions and abilities of DNA, but it's also broader than that. It uses any building block of living organisms to create new solutions. And we see solutions not just in healthcare, but also in agriculture and the environment. So the applications are almost endless and bio tries to capture that breadth of expertise.

HAASS: And right now let's get a sense of the dimensions of that. So we speak about biotech. What does it touch? What does it reach? What are we including here?

MCMURRY-HEATH: Well, I ran across a very interesting statistic recently, which is that in the auto industry today, there's roughly 800 million Americans working in the auto industry, but there's 1.8 million Americans working in biotechnology. So we have really grown at a rate where we touch almost every facet of life in the U.S. but also life around the globe and the rate of increase of knowledge and the breakthroughs that are coming are just coming so fast. And it just keeps accelerating so we have the ability to deliver so much more than we've ever delivered to date.

HAASS: So when people like me here, biotechnology in the benign sense and later on, we'll get to the potentially or actually maligned. But let's talk about the benign. We think of it obviously in terms of healthcare. But when I talk to people in preparation for this one, I read around, what's interesting to me is it's got to do with way more than that. It deals with food production, agriculture, climate change potentially. Give a sense of the reach of this field.

MCMURRY-HEATH: It's so broad. So for example, we have companies like Lonza Tech that are developing biofuels that they hope will replace current jet fuel, if you can imagine. I know there's lots of angst around air travel these days and not just due to COVID, but before that, due to the impact on the environment, if we could create a homegrown jet fuel, imagine the democratization of air travel that we could really see going forward without impacting the environment. There's also the ability to develop bio-based plastics. There's ways to change the way we manufacture, not just what we do in biotechnology, but across many manufacturing platforms. And there's the ability to address hunger. We are seeing some amazing examples of using the latest in biotechnology to deliver more nutritious, cheaper, more plentiful foods to neighborhoods around the globe. One of our companies, Benson Hill, they use CRISPR, which is a very specific gene editing technology, to be able to produce micro crops that perhaps can grow even better than expected in hydroponic settings. Hydroponic settings are basically indoor settings where you pipe in light and water and you create plants that can grow. Now imagine that that technology is applied to every empty strip mall in the U.S. and that you're able to engineer fruits and vegetables that taste better, are more nutritious, and more protein and are cheap to grow in local neighborhoods all over the U.S. and all over the globe. We would be able to boost the nutritional input of so many of our citizens. There's so much to do and that's just on the broader environmental side.

HAASS: Just to follow up on one thing. So that would suggest to me that. I actually know this. I'm almost embarrassed to say this, from golf, where there are certain golf courses now, which are growing kinds of grass which use less water. So I assume in a world of higher temperatures, water shortages, common droughts, biotechnology then gives us something of a response for agriculture.

MCMURRY-HEATH: Yes. Unfortunately, most people have heard about biotechnology and agriculture through some of the very earliest attempts and those really got the moniker of GMOs. Genetically modified organisms.  So, what we're seeing today is so different. So for example, it started with rice and corn crops that had certain resistance to pestilence or better response to pesticides. But now we're able to so specifically rewrite the specific genes that we are doing this with a much more delicate touch and the applications are so much cheaper and easier to use. And so the benefits are also so much greater. So getting people to take a second look at what 20 years ago was a GMO and what today is something almost completely unrelated, but is based on the technology around DNA to deliver benefits.

HAASS: One last question on the technology then I want to get into some immediate issues dealing with COVID. When people like me hear things anything with the word bio, we think of high school science, we think of test tubes and laboratories. What's the intersection between your world and things like artificial intelligence or potentially quantum computing? To what extent is the revolution in biotechnology very much part and parcel of the revolution in artificial intelligence and computing?

MCMURRY-HEATH: They're very much related and the advances we've seen in information technology has really helped us screen compounds much more quickly to pinpoint where we need to go in identifying genes and where in a gene we need to make a change. There's so much intersection of those two disciplines that it's almost hard to put a boundary around them, but it's also just exciting to see. And I think while information technology in the last decade has really transformed the way we live and we attribute a lot of our progress to it, I think the next several decades are going to be the biotechnology decades where it's not your grandfather's test tube anymore. It's really the ability for small groups of entrepreneurs to make major breakthroughs in health, agriculture, and the environment, and then deliver them at scale around the globe.

HAASS: Let's talk about the immediate situation. When this crisis began and now we're looking at somewhere between 18 months and two years ago, the COVID-19 crisis, people were talking about vaccines, even at that point, Dr. Anthony Fauci was talking about the normal production or development cycle of a vaccine, and it was close to a decade. And obviously it has been telescoped to less than a 10th of that with the so-called mRNA vaccines, which raises all sorts of questions. One is, why were we able to do it so quickly? Did the science move quickly, or was the science in large part already there?

MCMURRY-HEATH: Much of the science was already there. And it was there because of 20 years of consistent investment in mRNA technology, waiting for that moment when it was really well understood and able to be applied in lots of different settings. So that was a happy coincidence that the intersection of the rise and understanding of mRNA coincided with COVID. But the other half of the coin is that we responded to the vaccines in a way that we don't typically respond to other new medical breakthroughs, which was, the public sector really said, "We are going to partner with you. We're going to partner with you in making sure you're manufacturing in a way that our regulators want to see. We're going to help you with your clinical trials. We're going to be in close communication and coordination between you and regulators. And we are going to make those regulatory decisions as fast as humanly possible." And that also telescoped the time in quite an incredible way and it's an important lesson because it says that with investment and with focus, the public sector can do a lot to accelerate innovation much more than we're doing on a normal day to day basis.

HAASS: You're alluding to the so-called, I think it was called the Operation Warp Speed, and basically the idea was that the previous administration made some investments and took some risks in front loading investments and vaccines before they actually knew they would be effective?

MCMURRY-HEATH: Well, that's part of it. Even with public funding of science, public funding of the success of science turns out to be a very small percentage of the investment that's needed to carry a medical product, for example, across the finish line and deliver it to patients. So while that was a happy situation to have their cooperation there, it was really the private sector that was going to drive those solutions into real products. Where they really made a difference was on the regulatory pieces, the clinical trial pieces, the manufacturing and distribution pieces. All of those were critical and they really accelerated the research.

HAASS: Just as an aside for a second, more traditional vaccines, like the Johnson & Johnson vaccine, are those essentially increasingly obsolete? We've seen the end of that vaccine era and mRNA like genetically oriented vaccines that instruct cells what to do or don't do and the like. Have we arrived at this new era of vaccination?

MCMURRY-HEATH: Well, I don't think it's isolated just to vaccines. mRNA technology, for example, has so many possible applications. So as we learn more about selling gene therapy, as we learn more about targeting specific genes to make changes, a lot of our modern medicine will seem obsolete in just a few short years, but that's what's so exciting about biotechnology because you can say that no matter where you're sitting, if we were having this conversation in 1970, I'd be telling you the same thing. And it would be true because our scientific understanding in biology since the early seventies has just increased exponentially and that's what comes from sustained investment and the commitment and passion of great scientists.

HAASS: Just to roll back history differently, if COVID-19 had broken out, not roughly two years ago, but 20 years ago, where would we have been? Would it have been five or 10 years of almost medieval-like situation of massive lockdowns? Would we have basically been forced to fight it with very few tools?

MCMURRY-HEATH: I hate to even guess. It would have been excruciatingly painful. We would not have been able to accelerate the timeline to the amount that you saw in this instance. The fastest vaccine production prior to COVID was six years. Six years to get through the development process as well the regulatory process. But we did see an incredible telescoping and I really hazard to guess as to what would have resulted without it.

HAASS: One area that seems not to have gone well, and still isn't going well, is the global effort. And there's an enormous gap between, how would I put it, global supply and global demand. In this country we have the ironic, tragic, frustrating, choose your adjective, where in many cases supply exceeds demand and what we're trying to do is stimulate demand, but we still have a quarter of our population that isn't there. Around the rest of the world the demand is there. The supply isn’t. Why is that? And to what extent are the companies, the Pfizer's, the Moderna's, the J&J, to what extent are they responsible?

MCMURRY-HEATH: Well, let me start with why it is not. So it is not because of barriers to intellectual property. Moderna has made it clear that since early in the pandemic, they announced that they were going to let anyone have access to their proprietary secrets, which is almost unbelievable. But I've spoken to many members of their board and that was their public commitment early in the pandemic and they've kept to it. What's happened is that a few well-intentioned, but misguided policies have just exacerbated something that was going to be difficult to do from the start. The invocation of the Defense Production Act has really turned global production of vaccines on its head. The restriction of manufacturing of the supplies and most people don't realize it takes almost 200 ingredients or objects to create an mRNA vaccine. We manufacture so many of that raw material that goes into producing those vaccines, not just for the U.S. but for around the world and the Defense Production Act restricted the exportation of those raw materials. So for example, of the 300 manufacturing partnerships that are leading vaccine manufacturers already have today in countries around the world, we saw plants ready to manufacture in India that couldn't get the raw materials to actually produce COVID vaccine doses. You add on top of that, that the Defense Production Act mandated that our vaccine manufacturers fulfilled their U.S. orders before they exported any doses. And that meant that many middle income countries, and I'm thinking of several in South America who took the extra step to put in their orders early and be prepared for the vaccines when they came online and to then wait. And they found themselves having to double back and trying to get the Chinese vaccine, so that they'd have something in time. So there was good intentions, I believe, behind that move, but it was a devastating policy move. And we have to look, going forward, not only in how we break down the vaccine nationalism that has exacerbated the shortage, but also how we move manufacturing capacity around the globe so that we're not waiting on either raw materials or U.S. manufacturing to make it happen. That's going to be critically important. But despite all of that, the global vaccine manufacturers are now projected to produce 12 billion doses of COVID vaccine by the end of the year, which is incredible given that we've never, as a globe, produced more than 2 billion doses in any year of a vaccine. So this is an incredible increase in capacity and I think the companies should really be applauded for everything they've done to make that happen.

HAASS: Often in the pharmaceutical business and the rest, one always hears there's a tension between the companies are spending decades doing research and development, massive investment on their part, they produce a successful drug, demand grows for the drug, and the question is, how does one price it? How does one determine what's a fair return on investment? How does one come up with adequate availability and distribution? To what extent is that a factor here?

MCMURRY-HEATH: Well, it's very important to consider. So at the start of the pandemic, bio started tracking all over research and development projects targeted at COVID. And as of, maybe about a month ago, that was over 1,000. So just imagine this and companies all over the world, over a thousand research and development projects, each trying to make a product that would stop or fight COVID. That includes over 200 vaccine efforts. So that's an amazing amount of input. You take vaccines alone, 200 try to make the vaccine. Today, we probably use five of them globally. The rest of all of that investment is sunk cost. It's just gone. Now, some of the learnings and outcomes of those studies will be helpful in future vaccines. Some of the delivery research is going to be critically important, but a lot of that scientific research is just not going to be used. So we have to pay attention to not just paying for what comes out at the end, but also making sure that we can attract the investment so that we can have those 200 shots on goal, because I will tell you, anyone who tried to predict which vaccines were going to be first across the finish line, or which were going to work best, was probably wrong in their predictions. You cannot predict ahead of time who the winners will be in a biotech race. You have to invest broadly and use every different scientific idea and approach to try to get to the financial end. So there's a lot of angst around it, but that is really what's at play.

HAASS: Let me circle back though because you mentioned before the unintended consequences of the Defense Production Act. Are there other aspects either of domestic public policy or international policy, either what exists or what doesn't exist that would really help here in terms of amping up production availability, affordability, distribution? Either what needs to be removed or what needs to be added to the mix nationally and internationally that would really help?

MCMURRY-HEATH: Well, there's a lot of efforts that have gone on and gone into addressing those issues, but they're not actually living up to expectations. So we're partnering and working very closely with COVAX, which was meant to be a global bank of COVID vaccines that would be distributed to countries at a price scale scaled to their ability to pay. So middle income countries would pay a reduced price. Low-income countries would get their vaccine doses for free, but it depended on Western countries and other countries developing COVID vaccine actually prioritizing donating those doses and that just hasn't come to fruition. So while the international effort and the public-private partnership was built, it's not had the opportunity to really work at scale the way we all hoped it would be and those have been political decisions, not scientific decisions and not even corporate decisions. So there's a lot more to do there. And that's just in affordability. Now, when it comes to manufacturing and access, there's a lot that we need to do.

MCMURRY-HEATH: We need to have manufacturing capacity for particularly the raw materials distributed around the globe and at the same time we're facing pressure from the U.S. government to repatriate manufacturing facilities for critical drugs. So we have to strike this balance and we have to make sure that we're allowing our companies to spread their science around the globe.

HAASS: So in the expectation that one day there'll be a COVID-23 or a COVID-28 or some other infectious disease that spreads, should one of the things we be doing is creating what you might call production hubs around the world so if and when these diseases break out, we don't essentially run into the same set of problems?

MCMURRY-HEATH: It would be wise. We’ll never know or be able to predict where we're going to need it. We have to make sure that we're detecting much better than we are today, detecting new outbreaks, and that detection technology needs to be spread around the globe, but we also need to be ready, willing and able to produce. Now one of the most heartbreaking misunderstandings in the TRIPS wavier debate around waiving IP is that if we waive IP, countries around the globe would simply be able to produce COVID vaccines overnight. And actually as a former FDA regulator, I will tell you, it will take them two to three years with all of the intellectual property and all of the trade secrets to be able to produce a single dose. So even with the TRIPS Waiver enacted, we would not produce a single vaccine dose that would change the course of the pandemic.

HAASS: So that suggests that the answer at least for the next couple of years is less licensing, if you will, than simply going out there and creating more of the raw materials and then wherever you create them, either if you create them here and make them available for exporting or you put together the vaccines elsewhere. Let me ask a question more broadly about competitiveness. When you think about the vaccines and you got Russian vaccines, Chinese vaccines, English, British whatever, obviously the American companies, are you seeing real trends in competitiveness this time with Moderna and Pfizer at the center of things, J&J, AstraZeneca and this Chinese Sinovac less so, in terms of availability and effectiveness, are you though worried when you look at the trends about American competitiveness, or are you feeling pretty comfortable?

MCMURRY-HEATH: I'm very concerned, particularly with what's happening on Capitol Hill over the last few weeks, because we're actually debating dismantling our ecosystem that has been so successful, the most successful biotech ecosystem in the world. There's a reason why our vaccines were the best and some of the first. It's because of the long sustained investment, not just of the public sector, but of investors at the capital markets in the promise of biotechnology. So that is really important for us to recognize. The other thing we have to be worried about-

HAASS: Also, if I could interrupt for a second. What is being contemplated that would threaten, if you will, what you described as this development ecosystem? What is being contemplated that could interfere with it?

MCMURRY-HEATH: Yes, of course. I should specify. I'm so steeped in it. I focus on it too closely. So the reconciliation package that's being debated right now on Capitol Hill contains many laudable components, particularly in the climate change area. It has some proponents that we've been fighting for for a long time, but some of the drug pricing proposals that have been suggested would have other unintended consequences on the attractiveness of the biotech sector for private investments. You cannot produce a single drug without private sector investment. I know there's a lot of folks bandying around that ARPA-H, Biden's initiative to build a governmental biotech organization might be able to do so over the period of a decade. But we have not seen that kind of effort work before. It's been tried at the National Institutes Of Health under Jim Katz or the National Center For Accelerating Translational Science and that is now a decade old and has yet to produce a single drug. So we are dependent on a full ecosystem, not just to produce the science, but also to filter out the truly promising innovations and make sure that they really rise to the top. And that to date, only efficiently being done by private capital markets. My colleague in BioCanada likes to say that we are like a coral reef and you can't just take out the plankton or some of the fish and get a healthy coral reef. You need the entire ecosystem, but you can't just remove all of the attractiveness from the capital markets and strike a blow to big pharma without wiping out the small biotechs that are employing people across the country and making sure that they're producing great science that goes around the world. And while China is not hampered at all by many of those same hindrances, they are so pro innovation from a very top down deliberate strategy that is really being quite effective. They have grown in their ability to produce successful medicines and drugs over the last decade. And they will only continue to do so. In China, they have one whole province that is the innovation zone province. And that means that you can test early medical devices and medical products in that province to get the clinical data needed, to get full regulatory approval. That's a national strategy to accelerate research that we'd never be able to implement here in the U.S. and maybe we don't need to, but we also don't need to unilaterally disarm either.

HAASS: So what you're describing is almost the difference between China's more top-down approach and we've historically had more of a bottom up and you're concerned, and the industry is concerned, that we're introducing policies that would discourage it and I expect people will want to ask more about that. Two things in terms of competitiveness, you didn't mention, which are less immediate, but longer term. One is immigration. One is the quality of public education. Are we producing or importing and retaining the talent we need or do we have a problem there as well?

MCMURRY-HEATH: No. The number of times I hear in a week that talent is the scarcest resource in producing new innovations is almost countless. That is definitely our scarcest resource. And I think that's happened for several reasons. One, because we're not importing all the talent we need and drawing that talent to be in the U.S. and we've only become less attractive over the last five to 10 years than we were even before, but we also have to get better to attracting talent into biotechnology. Now, my hope now is with the power evident from the COVID vaccine effort, that we will attract more young people into studying biotechnology. Now they will have to have the educational system that fosters that interest and prepares them to really act upon it and we don't have that today, but it's critically important because of all of the things that science can unlock. In bio we like to talk about just science or science that can produce that justice. And I feel adamantly that science is our most powerful tool to reduce inequality and deliver justice around the globe. But it's going to take investing in science, making sure that our scientific workforces are diverse and that they're paying attention to diverse issues and it's going to take equitably, distributing the benefits of that science or the end products to everyone who needs them. That is going to level the playing field more than almost any public policy could, but we need to not shy away from it.

HAASS: Thank you for that. Let me raise one last set of issues which are negative issues, and which is here, my background is obviously foreign policy and when issues like biotechnology come up, it's usually questions of people thinking about germ warfare. More recently, it's been bio-terrorism. And I would think if someone were a young, aspiring terrorist in any number of countries around the world, and he or she would be watching the news and looking at what has been the economic and social and political effects, dislocations, costs, use whatever you want of COVID-19, they would say we've been wasting our time hijacking airplanes, or even flying into buildings. We can reach, if you will, threaten the lives or livelihood of millions. So how worried should we be about that the next year of terrorism really becomes bio, that one of the unintended consequences of COVID is it's, in some ways, perhaps led some people down that path who might not have otherwise taken it. How real is that? Is that sci-fi or is that all too real?

MCMURRY-HEATH: Well, in terms of the possibility, it is all too real, and that possibility does keep me up at night. We've seen that it's possible. We've seen that investing in gain-of-function studies can lead to pathogens that can be quite deadly. The one thing I think will temper it is that starting a biological fire is a fire you can't control. COVID has shown no respect for borders or for different ethnicities. And so it's mutual assured destruction which we used to discuss in the nuclear sense, is also what would be delivered from biological terrorism.

HAASS: I might interrupt for a second. That might, to some extent, inhibited government. It might not inhibit a territory-less terrorist organization. And the fact that it might be somewhat indiscriminate, that might actually make it even more tempting because they're not worried about, mutually assured destruction is based upon the ability to retaliate, that you can attribute where a threat or an action is coming from. Could this though, in a funny sort of way, lend itself to a very different type of threat?

MCMURRY-HEATH: Well, actually I can understand the framing in the nuclear sense that mutual assured destruction is around retaliation, but actually biological warfare is self retaliation. You don't need a state actor to have retaliation in an outdoor bio terrorist attack. If you actually create a biological pathogen that can create the kind of damage that a terrorist would seek, it would be so dramatic that you can't stop it from having the backlash on yourself. So people who are not thinking through all of the steps might try it, and we have to be prepared. We have to have better action methods and modalities distributed around the globe, but I stand here warning any terrorist, if you unleash a biological pathogen, you will also fall prey to that same pathogen.

HAASS: You may well be right, but in my experience that is not necessarily a calculation or consideration that deters certain people who have made that career choice. You mentioned gain-of-function research. I might ask you to spend 30 seconds explaining it because obviously it's become a controversial subject, thanks to Senator Rand Paul and Dr. Fauci and their multiple exchanges on the subject, but it raises another issue, which is not terrorism, but the question of monitoring, supervising research and accidental leaks for all we know COVID-19 came out of a lab in Wuhan. The Chinese are not helping us, to say the least, get to the bottom of it. But to what extent do we have a real problem with these, you mentioned there's 200 vaccines or whatever being developed around the world, whatever. I would think the chances of some of the research having consequences that were truly unintended is not negligible. How much of a problem do we have in the business you're in? That you represent all these companies and all these countries, that as benign as the effort might be intended to be, we simply have too many people playing with a different generation, I would say, too much dynamite. And what can we do about it?

MCMURRY-HEATH: I think we do have to be a lot more intentional. I've been in the public sector. I've, of course, was in academia when I was going through my training and have been in the private sector. And I will say the private sector does the best job of keeping people focused on the outcome that you're trying to get a specific product that you're trying to cure a certain disease or create a certain crop. And that focuses the scientific efforts on things that are actually useful in getting to that goal. We've got a lot of science for science sake in both our public sector and our academic sectors. And I think it's good for us to ask, is that the best use of even our raw material efforts? So of course we need academic partnerships. Of course we need public sector interest in investment and science, but maybe we need to start thinking about whether or not the balance has tipped too far and we need to be much more accountable for what comes out of the research. The reason I actually left academia for science policy was because I was always bothered by the fact that I would get calls in my graduate immunology lab from people who had read about a latest scientific advance in a newspaper, usually from an academic source. And they would call and say, "Can you give me that technology because it can cure my child?" But that technology was really just a discovery for discovery's sake. And while that serves some purposes, we also have to think about being more accountable for how we spend our scientific time and more judicious with it. Initiatives like the TRIPS Waiver would be giving away some of the most competitively valued research, mRNA technology to any entity that wanted it in a way that you could not control around borders or falling into the wrong hands. But we have to be responsible and intentional, but I think it's possible for us to be good stewards of the science.

HAASS: I guess I'm slightly skeptical and only because with nuclear weapons, usually there's a scale of production. Even the Irans and North Koreas, we had warnings. We chose in some cases not to act on them. My concern about this is it may not necessarily be in a bathtub in a basement, but the scale could be such easier to hide. We learned that in some ways in Iraq, at certain points. A lot of scientists might have certain capabilities that either well-intentioned or anything, but well-intentioned individuals and groups, it seems to me have a potential to cause real damage. And again, the lack of the ability of governments to police the world here, that even if tomorrow we all said this type of research on, you mentioned CRISPR before or gain-of-function research is, the downsides are too great. It's too risky. My guess is it would be very hard to implement such a ban simply because this is a world of distributed capability, which leads me to think that we're going to be dealing with both naturally, but also unnaturally occurring challenges from biotechnology for some time to come.

MCMURRY-HEATH: Well, I won't disagree. I will not stand here and say, we should not have some sleepless nights over the potential of misuse biotechnology. That is of course possible. And we have to be on guard and set at all times, but we also have to strike the balance that I mentioned that one in a hundred chance of success from most biotechnology efforts, those hundred efforts have to come from very diverse and geopolitically, politically, geographically, ethnically diverse scientists, all trying to answer a question that is what's going to get us to cures for patients for example, much faster.

HAASS: That is why the word dilemma was invented. Dr. Michelle McMurry-Heath, I want to thank you for all you've done in the course of your career. I want to thank you in advance for all you're going to do. And I want to thank you for giving us your time and the benefit of all your experience and knowledge. 

Thank you for joining us. I hope you enjoyed the conversation.

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