In this episode, we interview Dr. Larisa Rudenko, a research affiliate at the Program on Emerging Technologies at MIT and a co-founder of BioPolicy Solutions LLC. We talk to Dr. Rudenko about her career developing regulatory guidance for genetically engineered organisms for the FDA, public perception of genetically engineered products, and tips for engineering biology trainees interested in science policy careers.
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Episode transcripts are the unedited output from Whisper and likely contain errors.
Hello and welcome back to EVRC and Translation. We're a group of graduate students and postdocs working to bring you conversations with members of the engineering biology community. I'm Andrew Hunt, a graduate student in the Jewett Lab at Northwestern University. And I'm Katherine Brink, a graduate student in the Tabor Lab at Rice University. This episode, our guest is Dr. Larisa Rudenko. Dr. Rudenko is a research affiliate at the Program of Emerging Technologies at MIT and a co-founder of Biopolicy Solutions, LLC. Prior to these roles, Dr. Rudenko worked for over 15 years at the Food and Drug Administration during which she oversaw the world's first approval of food from a genetically modified animal. As Dr. Rudenko describes herself in her Twitter bio, she is an MIT research affiliate, recovering regulator, policy wonk, public speaker, creative derisker, and problem solver for emerging biotechnology, as well as a mother of cats. Welcome to our show. We're excited to have you with us today. Thank you very much for the invitation. I appreciate it. To get us started off, in just a few words, how would you describe your areas of expertise? Well, in addition to being the mother of cats, as I said in my Twitter handle, I guess the way I would describe myself is someone who was trained in molecular biology, did not find a lot of joy at the bench. I did my graduate work with the late Dr. Richard Setlow, who was a physicist by training and actually discovered the earliest examples of DNA damage from ultraviolet radiation and some of the early enzymes that repaired that damage. But Dick was a member of the National Academy of Sciences, and I was working with him when he was at the Brookhaven National Laboratory. That's where I did my graduate research on the role of oncogenes in DNA damage and repair. And he knew and I knew that I was much more interested in using science than actually kind of doing science. And that was fine with him because not everybody's destined to work at the bench. And I was someone who was not getting a lot of joy out of working at the bench. So when he would go down to Academy meetings, he would occasionally bring me with him and tell me to go sit in the corner, be quiet and learn something. And one of the things that I really learned was how one approaches the entire issue of risk assessment and safety assessments. And I was actually fascinated in how one does that. It just became really interesting to me to see how policymakers sort of took this bench knowledge and tried to turn it into something that resembled a science-based and reasonably cogent way to deal with public health issues. And I was very interested in those. So I gave a talk at Brookhaven probably my last year, and I did a seven-year PhD, because I switched topics in the middle. And the person who heard me give a talk said, when you're ready to get a job, let me know. So I completed my PhD with Dick, and then I did a very abbreviated postdoc-y type thing at the medical department at Brookhaven, where I looked at cytogenetic damage with the late Dr. Michael Bender, who was the cytogeneticist evaluating the blood of the early astronauts. So the fellow who came up to me and talked to me while I was giving a talk worked for consultancy in Washington, D.C. And I thought, oh, great. Well, that's where the policymakers are, so maybe I should go do that. And I went and interviewed, and they made me an offer. I thought it was for a tremendous amount of money because I had been on a graduate students' stipend. And in point of fact, it was hardly enough to live on in D.C., which even back then was expensive. But it was great. There were a bunch of really, really smart people. One of the founders of the company used to be the chief science advisor at FDA under Joseph Califano. Again, I was there for about, I don't know, 10 days or so. And this gentleman, the founder of the company came up to me and says, Rudenko, you know how to spell DNA. I've got a tomato for you. And it turns out that the people we had feared that company had a very large practice in food safety and other issues dealing with FDA. And it turns out that Calgene, one of the early plant biotech companies, had come to Envira and wanted to know what FDA needed in order to make some judgment about the safety of these tomatoes. So I was like, well, I don't know what people usually do. I don't know how to do this. And the answer was people don't usually know how to do this. You've got to make it up. You're going to be the first one. Do it. So that was fun. I mean, I was just barely out of graduate school. And so it was a matter of trying to identify hazards. What would you worry about in a tomato that had a piece of missense DNA included in it and basically was not producing a piece of RNA that would have allowed the tomato to soften as it ripened? And it had an antibiotic resistance gene. And so maybe that would be something that might be risky. So I stayed there for about nine or 10 years. And then this founder of the company with whom I was working, who threw the tomato at me early in my career, and I and one other fellow decided to leave and start a company on our own. And the company that we started was a consultancy that was associated with a baby VC. And the baby VC was started by five extremely successful men in the Washington political arena. And when you get five alpha males in a room who are used to being the boss, it's difficult to find compromise. So that VC lasted for about two and a half years. But during that two and a half years, I learned an enormous amount about what's involved in a startup. How do you get a startup? How do you find the startup? How do you have virtual staff before you actually get to hire a bunch of people? And what the downsides of having the founder being a successful CEO at the end of the as the company grows are. So I found that absolutely fascinating. And I thought the business aspects of it were really interesting. And the interpersonal relationships and the types of personalities that are involved in startups and in funding are really, really interesting. And I never thought I'd do that with a PhD in cellular and molecular pharmacology. So we did that for a while. And while we were working on these startups, also doing a little bit of consulting and I was working with someone who was an attorney who was interested in how one applied existing broadly written statutory authority to emerging technologies, in particular animal biotechnology. So he and I wrote a couple of papers. We wrote a primer for the Pew Initiative on Food and Biotechnology about the sort of spaghetti approach that the U.S. government has to regulating the products of new emerging technologies. Because in the U.S. we regulate products and not processes. We don't regulate technologies. We regulate their applications. Whereas in Europe for biotechnologies, they regulate by technology and not by the specific topic application. Although at the end of the day, it's a specific thing that gets regulated. Anyway, so I did that for a while. And then I was approached by the Food and Drug Administration, the Center for Veterinary Medicine, to come help them develop a science-based approach to regulating animal clones and genetically engineered animals and the food derived there from. So it took me a while to sort of come around. I mean, the VC had broken up. I had continued consulting on my own. I formed a partnership with a woman who I'd worked with before and we were doing really well. And then the agency was very persuasive and sort of said, you know, you're the right person to do this. You know, your country needs you was the trump card that they played. And so I went and I told my partner it was going to be two years max. Well, 14 years later, I finally accomplished what I set out to accomplish, which was to have a science-based approach to the regulation of animal clones and the safety, whether or not there was any additional risk from the food from animal clones or their sexually derived offspring. And built a group, developed a science-based approach to the regulation of genetically engineered animals or what are now known as animals with intentionally altered genomes because that's how we get the genome editing in there. And had a nice group that we were working with and we approved a drug that came from a genetically engineered chicken, another drug that came from another genetically engineered animal. And then finally, we were able to get an approval for the aqua advantage salmon, which was genetically engineered to have a growth hormone that was on constitutively rather than seasonally. And I had not been hired on the usual hiring program that FDA, that the government has. I was hired under a different part of the employment law that basically lets you get hired, let's scientific or technical experts get hired in without going through the usual civil service queue. And so they could lift the salary cap, but they don't give you tenure. And that was fine with me because I hadn't even intended to stay for 15 years, nevermind a lifetime. So they were very kind to me and they gave me basically a transitional sabbatical out of the agency. And I went to MIT where there's this program on emerging technologies and got exposed to a whole nother set of really interesting ways of looking at things. Basically the entire science, technology and society field. I sat in on a pile of courses at the business school at MIT and just sat in on a bunch of courses and learned a whole lot and felt like I was just learning a new life. And I really appreciated that opportunity. I will always be grateful to the agency and the government for giving me that opportunity. So I was a visiting scholar there for almost two years. And then we converted that to a research affiliate position because I was no longer being paid by the government. I could now consult. And so the same person with whom I had a consulting company before, and I got together again 20 years later, and we have this consultancy that's called Biopolicy Solutions. And we work in really emerging. It's a very boutique firm. We only work in emerging biotechnology products such as cell-cultured meat, proteins that are made by alternative methods either by with microbes, with prokaryotic microbes or eukaryotic microbes, and possibly looking at some cell-free synthesis as well. So that's where I am. And that's how I got there. Well, you've been a lot of places in the policy world. So it's really cool to hear about all that. So thank you for sharing. I'm curious if you could share a little bit about what about going into policy really motivated you? What was interesting to you there? And why did you want to do that? Well, I think part of it was opting out of the traditional academic route for PhDs. As I said, I did not get any joy at the bench. And I looked at a lot of my colleagues who were doing postdoc after postdoc after postdoc and not getting jobs. And then to be perfectly honest with you, it was not easy for women at that point. And kind of the best that you could hope to be is maybe to get an associate professorship, but tenure was very, very difficult for women. And I just didn't want to be fighting to do something all the time. I wanted to actually do something. And I was interested in public policy because, as I said, I attended some open meetings of the National Academies of Sciences and actually saw the sausage being made and thought it was really interesting. You pull together a bunch of real experts in a room, and you listen to the kinds of things they think are important and when they disagree, how they disagree, and how they resolve those differences. And to me, that was all for the public good. And for me, that was really, really important because I wanted to do something that would lead to a public good. I didn't think I was going to find the cure for cancer. So maybe I could use what I knew to help mold some public policy. That's how I got into it. Speaking of the public that you were just talking about and doing what's best for them, we found some data from Pew, which conducted a research study in 2014 that found that there was a greater divide between scientists and the public on GMO food safety than on any other issue, including requiring childhood vaccines, human evolution, and anthropogenic climate change. So keeping those statistics in mind, we wanted to know where you got pushback on your regulatory work, which you alluded to before, and how you dealt with that kind of pushback. And also as sort of a secondary question, what can we as scientists do to help close the gap on this issue? That's sort of the million dollar question, isn't it? It's often a behavioral question. Humans are very tribal people. I think we've seen more and more of that lately. And we all identify with the tribe of graduate students who are trying to get post-docs. We identify with a tribe of bench-scientists, people who are trained in scientific method and know how to ask questions and get answers that are meaningful and know how to deal with uncertainty. Then there are the tribe of people who are soccer moms or are barbecue dads or whatever other sort of societal stereotype that you want to use that are not really very well-educated in scientific method and take their cues from people they know and trust or sources that they know and trust. Those sources aren't always correct. And one of the things that I learned very early on is that not everyone comes to the table in good faith. So one of the questions you have to ask yourself is why is group X so vehemently opposed to this? Or why is group Y so vehemently pro this? And I just had an interaction with a person who on a personal level I like very much and I very much respect her honesty. But she believes that no industry, any industry at all, is good. That they have a profit motive and the profit motive drives everything and that's all you can get. And that all public interest groups are good because they're really interested. I mean it's an exaggeration. And I have to tell you that some of the most ethical people I have ever met work in biotech startups or companies because they really are trying to do something. And frankly we all have to make salaries and the only way you can have a salary in a startup is or in any company is if you have a product and it makes a profit so you can pay for what you're doing. And that's the nuts and bolts of it. And so I've met some real chameels in business too but I've met some very, very honest people. On the other hand, I have been physically accosted by members of green organizations and have gotten death threats from members of green organizations. So I don't believe that anybody is all good. Any group is all good or all that. And one of the things that I find most frustrating in this whole science, technology and society field is why do we have to separate science and society? Why are we trifurcating or bifurcating scientists and everybody else? I mean I'm trained as a scientist. I go to the grocery store. I want to eat safe food. I'm trained as a scientist. I don't want to pass diseases on to people. So I think to get back to your question, why are there these problems? And I think it's because we sort of operate in different spheres and we don't overlap enough in a meaningful kind of way that we can actually talk to each other in a way that leads to understanding instead of hardening of positions. And I think social media does a lot to exacerbate that because you end up in your own echo chamber. So the policy issue of whether or not we should approve genetically engineered organisms or GMOs or whatever you wanted to call them at the US government level was relatively easy to do because the law simply stated that you had to make a science-based decision and you did not take ethical, economic, moral, public opinion into account. That basically the people who wrote the laws believed that the market would take care of that and that we did not have to take the opinions of this group or that group into account. We just needed to determine that food was safe to eat, that animal drugs or human drugs were safe and effective, and that biologics were safe, effective, and pure. And then you could decide whether or not you wanted to use those things or not. Then the question comes to, well, without a label on food from genetically engineered organisms, how do you know that you're eating one or not? How do you make that choice? And the answer for the agency at the time when I was there was, well, the organic standard strictly prohibits the use of biotechnology writ large. So if you really don't want to eat a genetically engineered something or another, eat organic food. These are important. These are really important questions. There are no easy answers. I think the fact that the Federal Food Drug and Cosmetic Act was written to simply look at safety turned out to be an expedient way to get around that issue without ever anticipating that issue. I think it was written back in the thirties. So I don't know. I don't know how we're going to resolve all of that. Yeah. Sort of following up on that, what do you think some of the potential biggest hurdles are regulating emerging biotechnologies over the next decade? Is it things like we just talked about? Is it really most of the biggest challenges managing public opinion? Or are there other technical challenges like maybe dealing with biocontainment or something else that are also going to be really big hurdles that we're going to run into? Interestingly, let me go back to the first part of your question, which was sort of public opinion. I don't remember what the verb form you used about that was managing public opinion, I think you said. Very early in my career when I was looking at flavor, savor, tomato, I had a meeting with somebody from the FDA, high up in policy at the FDA and young, naive, you ask stupid questions, but you learn from them. I was talking about the agency having a more active role in providing information about this technology and these products. Then this gentleman looked at me very seriously and said, Larissa, it is not the job of the US government to run public relations for individual companies. So the point of that was don't ask somebody to sing if all they're allowed to do is dance. You know, it's not the government's job to promote one technology or one product over another. I mean, it's just making a transparent decision about these are the questions we ask. This is what the producer came back with us for answers. This is how we evaluated that. And this is the decision we came up with. Now, I think an important thing to understand is peer-reviewed publications are how scientists communicate with other scientists. Raw data are how sponsors of applications communicate with regulatory agencies. So, you know, you can't just hand something over to somebody, no, we didn't, it didn't look like there were any problems here. Now you have to hand in the individual data and then the agency reruns the stats the way that they ought to be run. Have either of you had many courses in public policy as part of your graduate degree? I chose to take an elective related to science policy, but we didn't have any required public policy classes. And I haven't, I'm fascinated by it. How about bioethics? We definitely had a ethics in science course. It was more towards the whole engineering grad school. So I don't think we talked specifically in the context of bioethics. Yeah, similarly for us, we did have a bioethics class, but it was more geared toward the NIH guidelines and doing responsible conduct of research. Well, there are, there are all kinds of really interesting questions out there, like, should we be doing gain of function research on emerging or endemic viruses? What are the trade offs there? How do you balance biosecurity against the public good? You know, these are kind of philosophical questions, but they get answered often with very technical data and information. And there is a real need for people to become involved in this. And I see basically a gap in the age distribution of people who are involved in this field. You know, I think most people tend to get involved in the social policy kinds of aspects of science later in their careers. But, you know, I think there's a real place for grad students and postdocs to actually start learning about this kind of stuff. And, you know, it's sort of the intersection of social sciences and biological sciences. I would encourage anybody who wants to get involved in this to go talk to people who are doing it and find out how they got there and, you know, what the upsides and the downsides are. So maybe as a taste for our listeners, who I think are primarily graduate students and postdocs, could you give us some insight into how the sausage is made? So how do you actually do a risk assessment on one of these types of products? What factors do you consider and how do you weigh them? Okay, I think it's very important to make a distinction between a risk assessment and a safety assessment. If we want to think about this in terms of physical spaces, if you want to define these concepts in terms of space that they occupy, you know, risk is one minus safety, or safety is one minus risk, you know, there's this safe sphere. Think of it as the distribution of electrons around a nucleus. You know, there's an area where you know something is safe. You know it's safe because there are no data demonstrating that at this particular dose you will get an adverse outcome. The farther away you get from that, the looser the distribution is, the more uncertainty there is, right? So I used to like to say that regulators only use data to identify uncertainty and it's uncertainty that we regulate and not actual data themselves because, you know, what's completely safe is pretty obvious but, you know, there's always uncertainty and I think that's one of the problems we have dealing with the public is that uncertainty is we, as a scientist, I could never say this is safe because I know it's the dose that makes the poison. I always bristle when somebody says toxic chemical. What the hell does that mean? Everything is toxic at some dose, you know, but, you know, we have now inculcated into our DNA, which I really hate that phrase because at best it's epigenetic, it's not actually genetic. The concept of some things are bad and some things are good, you know, some chemicals are bad and some chemicals are good and I actually did an interview, this is a confession. I did an interview with Molly Wood and Kai Rizdal on one of their programs and we were talking about cultured meat and Molly asked me a question about, well, you know, what about processing? What about all these chemicals they put into things and like an absolute idiot, I said. Well, Molly, you know, life is chemicals. Everything we do is made up of chemicals. So, you know, you can put the chemicals into the manufacturing process or you can dose it with chemicals afterwards. Those chemicals could be soy sauce or butter or whatever. You know, you're still exposing yourself to chemicals and I did not get the question she was asking. You know, I came back as a smarmy scientist and did exactly the wrong thing. So, there's a lesson in this, you know, you will make mistakes even when you don't want to make them and you think you know better. I should have said, well, you know, what particularly, I should have answered it with a question, you know, what are you particularly worried about in terms of chemicals? I mean, what do you mean by processing and, you know, can we parse this out a little bit? It would have been an opportunity to actually have a conversation instead of being a smarmy little smug science nerd. But how is the sausage made? Risk assessments try to identify the space in which there is a probability of an adverse outcome. So, risk traditionally is defined as the probability of an adverse outcome provided that exposure has occurred. All right. Hazard is what a lot of people colloquially substitute for risk. A hazard is an intrinsic property of a substance or an activity that at the appropriate set of conditions may result in a harm. So, the analogy I like to use is ice on a sidewalk is a hazard. It's not a risk to me unless I actually step on it and break my leg. Right? I can mitigate that hazard in so many ways. I can sprinkle salt or sand on the ice so I get more traction. I can cross the street and limit my exposure to zero because I will never be exposed to that piece of ice. You know, I could take a torch and melt the ice and my exposure to ice would be zero because it would be water. So, I like that analogy of the difference between a hazard. Ice is slippery. It is an inherent characteristic of the substance. But it doesn't pose a risk unless somebody encounters it in a way that could result in a harm occurring. Safety assessment is sort of that turned inside out. You know, how may I encounter ice and yet not hurt myself? Right? Well, I could wear shoes with cleats on them. I could walk on the other side of the street. So, they're the same kinds of things, but you ask the question in a different kind of way. Now, some people will say that if you look at everything as a risk, you're going to take a much more negative approach to things than if you look at it from a safety perspective. And that's a matter of interpretation and where you're coming from. But I think the thing that's really important is that the federal food, drug, and cosmetic data, for example, is written with safety in mind and not necessarily with risk. Other laws are written with risks in mind. You know, what are the risks associated with exposure to these pesticides? And so, they may do a risk assessment as opposed to doing a policy assessment. The other thing to bring us back to regulating products versus processes, there are a number of geopolitical units like the EU or Singapore or Japan. And I'm not calling anybody out in particular right now, but rather than saying country, I just said geopolitical unit who insist on doing a risk assessment on a technology. So, what are the risks of gene drives? What are the risks of nanotechnology? And to me, that is not a useful question, because unless you know exactly what form the nanotech is in or exactly what form your gene drive is, is it attenuated? Is it global? Do you have a mitigating system there? Is it a daisy chain kind of gene drive? I mean, those are all the things that go into doing a risk assessment on a particular kind of gene drive. But to say, what are the risks of nanotechnology? Well, everybody's going to go to the science fiction story where nanorobots come in and, I don't know, make your nerve connections wither or something. We do a lot of regulation by science fiction because it's something that people grasp easily. It doesn't require a lot of scientific method. It only requires the story. And once you have that idea in your mind, it's hard to get it out unless you've already been trained not to take that story seriously. So, my favorite line from a movie is The Martian, where Matt Damon is stuck on the surface of Mars and he wants to grow tomatoes or he has to figure out how to grow food. And he says, we're going to science the hell out of this, right? Science being used as a verb, or maybe he said the heck, I don't remember. But it was kind of an interesting line in that science was being used positively there. Whereas in Jurassic Park, science is always, we're always running to catch up with it and life will always find a way. You will always have, even if you use lysine minus strains of whatever, somebody's going to develop a resistance to it. And that is actually the case with all pesticides, with any metabolic poison. You're eventually going to select for a population that is resistant to that poison. And you can see this playing out in any number of fields. So, that's how you make the sausage. You identify what your hazards are, and then you identify the conditions under which that hazard will not pose a risk. So, that's the risk assessment, safety assessment, sausage making. How that gets turned into policy is a whole other story. I am not sure that we'll have time for how that gets turned into policy. You've touched on this a couple times, but I'm curious what maybe you could restate and also add on to the advice you've already given. What would you tell an early career scientist who is interested in getting into regulatory policy? How would you want them to go about that? And what advice would you give to them? To have realistic expectations. Every time I hired, I had a great staff at FDA, and they've all gone off to really fantastic jobs, and I'm really proud of them. And I hired them all as early career scientists. And after they'd been there for six months, we would have a little check-in. And I'd say, well, you've been here for a while. What is it that you would like to do? And the answer inevitably was policy. I want to do policy. And okay, you actually have to crawl before you run. And so, you were hired to be a reviewer, and a reviewer is somebody at the agency who actually reviews data to help make decisions. So, if you're in a new field, every time you review data, you're making policy, because there is no precedent to lean on. So, that didn't satisfy anybody. They wanted to go sit in the commissioner's office and make policy. And I was sort of like, well, depending on the commissioner, I worked under four commissioners. And some of them were really good about bringing people at my level in, and I was considered middle, very middle, not very high, and would ask us questions and would listen to what we had to say. And others just didn't want to hear it. They just wanted to hear from the lawyers or whatever. So, how one actually gets... If you really want to get into policy, I would say try one of the... Find a fellowship, like the AAAS fellowship, or some other fellowship that actually gets you there. Maybe do a postdoc with somebody who's trained as a biological scientist, but is doing social science research. And there's a lot of statistical analysis and mathematics that goes into that as well. So, you won't be swimming upstream the whole way, but you have to learn how to approach topics from a different perspective. And I think our educational systems in the hard scientists don't prepare people for how one's research will be accepted or how one's research can be received by the public. Sometimes people say, I don't care what you're doing. That has no relevance to me. That's all rocket science or brain surgery or something. But some people are very suspicious of science because they feel that scientists will plow ahead to do research just because they can and not because they should. And there's a very fine school at Harvard, the Kennedy School of Government. It's a master's program. But there are some people there in the science, technology and society field who have really grown this discipline up. You can agree with them or not agree with the approach that they're taking, but maybe you could talk to people in programs like that. There are some programs around. Often they're in law departments or in social science departments where you really begin to look at how hard information gets turned into soft policy. But you basically don't do it in the department of biophysics. LESLIE KENDRICK Well, that's certainly some great advice that I hope to take to heart as well. One last question before we wrap up. Is there anything in particular that you would like to plug? LESLIE KENDRICK I would like to plug the idea that you should always be open to new ways of looking at things. My grandfather used to say that a day that you didn't learn anything new, didn't learn something new, was a wasted day. And so I take that to heart. And if it's like 930 and I don't feel like I've learned something new, I kind of, I don't know, go look in a dictionary and find a word. And that's just the way I think about things. What did I learn today? How can I be a better person? How can I do my job better? How can I do things if I haven't learned anything new? And for me, that period between working for the, I mean, going to work for the agency was just this mind-blowing experience. I learned so much there. And then leaving the agency and going to academics late in my career was another mind-blowing experience because I never thought that people thought about things like this. I mean, they, unfortunately, I had some friends who were bioethicists and I learned a lot from conversations with them. But I had never really thought about the work that I was doing in those terms because, you know, I was pretty convinced that I was doing the right thing for the right reasons. I guess the one thing I would plug is keep your mind open, look in the mirror, recognize who you are and where you are, and don't stop asking questions. Well, that is a wonderful plug and I think a wonderful philosophy. So thank you so much. It's been a blast to have you on the podcast. Really learned a lot talking to you. So thanks so much for coming on. Thank you for the invitation. And I wish both of you great luck in your careers and to really find joy in what you're doing. Thank you so much. Thank you. This has been another episode of EBRC in Translation, a production of the Engineering Biology Research Consortium Student and Postdoc Association. For more information about EBRC, visit our website at ebrc.org. If you are interested in becoming a member of the EBRC Student and Postdoc Association, you can find our membership application on our website. A big thank you to the entire EBRC SPA podcast team, Catherine Brink, Fatima Anam, Andrew Hunt, Adam Silverman, and Kevin Reed. Thanks also to EBRC for their support and to you, our listeners, for tuning in. We look forward to sharing another episode with you soon.