Paul Radspinner: Founder and CEO of Flugen

Paul Radspinner, founder and CEO of Flugen, shares his thoughts with BioBoss host John Simboli about leadership in biopharma and how Flugen is working to develop a more effective vaccine in the fight against influenza and respiratory disease.

Transcript

John Simboli: 0:00

Today I'm speaking with Paul Radspinner, founder and CEO of FluGen, headquartered in Madison, Wisconsin. Welcome to BioBoss, Paul.

Paul Radspinner: 0:09

Thanks, John. Looking forward to having an interesting discussion today.

John Simboli: 0:13

Paul, what led to your role as founder and CEO at FluGen?

Paul Radspinner: 0:17

I, John have a really typical path, I think to get there. It started out with a BA in history from a small liberal arts school. I then went to work at an auto factory for five years, got my MBA at nights and started then working for a larger pharma company, Eli Lilly and Company. And that's really where I got connected to, the industry. I always had a capacity for science, interest in science. And obviously, I'm being facetious about this being the typical path. I think you've probably interviewed enough people that there is no typical path to get to the to the top here, running a company, other than maybe the drive and the interest to do something really, really important and really different. You know, once I had the chance to get with a big company and see the impact, you could have getting things done in this field, I was I was hooked, then the standard observations of big companies are really great at doing some things, but other things are very challenging. And for entrepreneurs, they're impossible. And I ran into that stage. And even though I had just a great time at Eli Lilly and learned an incredible amount about the business, I knew I needed to do something a little more hands-on and closer to the front lines.

John Simboli: 1:29

When you recognized that opportunity, from the research had been done the University of Wisconsin, was it clear that that was something that was going to be very intriguing to you? Was it a group of 100 things that you had sifted through?

Paul Radspinner: 1:45

It's really an interesting story. Because after I left Lilly I ended up going to a group called WARF, in Madison, Wisconsin, you may be familiar with it. It's the Wisconsin Alumni Research Foundation. It's a unique institution in that it was created in the 1920s and they took the idea of licensing technology from a university, really created it, and then built up a pretty significant war chest by taking the revenues from that and reinvesting those into the university for all kinds of research and new ideas. So I had a chance to go work there for a while. And what that allowed me to do is to really understand a completely different aspect of the business, where before I was working with large pharma and all that that entails. At WARF, what I was dealing with was actually much closer to the origin of the technology. When it's coming right out of the lab, and some of it is just extremely early stage technology, I was lucky enough to work with Hector DeLuca, who is famous for his work in vitamin D, putting the active form, discovering the active form, and then using that for many therapeutics that have been used in the market. While I was there, I worked for, I left WARF and worked with him at his startup for a couple of years to then get the hands-on work, and then decided it was time I wanted to run my own show. And your question is a great one. Because as I started to think about that, was it identifying, you know, the killer app or the killer technology? And I stepped back and said to myself, why am I going to be so much better at identifying that than these brilliant scientists that that the university has. So what I did instead is, I'm a firm believer in that great people have great ideas. And those great ideas can be managed into profitable enterprises and opportunities that can help human health, obviously. And so I actually interviewed, narrowed it down to four of the top inventors at University Wisconsin that I had contacted and had interactions with over the years. And really, what I chose was Dr. Yoshi Kawaoka, who's a famous virologist who focuses on everything from Ebola, but primarily flu. And he's now a full-time professor at University of Tokyo and at UW Madison, so the only person I know that has 200% of his time he's working. But his work that he had done was so novel and so interesting that I realized that I was betting on the man as much as I was betting on the technology at the time. It was, I think, fortuitous, because in the end, what we took was a great idea of his. And that was the idea of M2SR, we'll probably talk about that. But this idea of deleting a gene and creating a single replication vaccine. And we were able to take that and then improve on his amazing discovery, because his discovery actually didn't work very well when it came to a practical application. And then when I brought in a team that had more of the industry experience they were able to do that. And it's just a great, great collaboration

John Simboli: 5:07

When that opportunity arose and you reviewed Dr. Kawaoka's research and you'd met with him and you were moving forward with the idea of of creating FluGen, did it, at least for a moment, your mind, you know, I think I'll take this to a large pharma company, because you know, they had the infrastructure in place. I won't have to build it from scratch. Or did you say no, that's just not the way this is going to` work out?

Paul Radspinner: 5:33

No, for two reasons, I think. One is, that's not what I wanted to do, you know, so that was my selfish reason for doing that. But more importantly, there was a change that was going on in kind of technology licensing and so forth back then. And when I first started working on business development, technology, licensing at WARF, and even at Lilly, it wasn't unusual for a company to buy something very early stage, license it in, do a lot of the development in collaboration with the professor and then forward. During the period this was going on, that was happening less and less. What they were looking for at companies was technology that had been developed. You know, some of the platforms that we've seen, mRNA, for example, obviously, are exceptions, but still, they were looking for things that were much further long. And that's difficult in the university environment, as you know, to find. I think the idea of taking, and in particular vaccine—vaccines at that time were a tough area to work in. I've had friends that say it was a backwater. And that we had flu vaccines that were coming down to $1 a dose, if you can imagine that. And not that it's all about profit. But the reality is that big pharma wasn't looking at vaccines as a way to license technology and enter into the the business. So there were kind of two forces coming together at once, kind of this move away from early stage technology at the big pharma companies, and then also, the fact that vaccines just weren't that exciting. Nonetheless, I decided I could try to take on both of those problems and see if we could do something about it.

John Simboli: 7:12

That step from identifying the team and, and finding a very interesting technology, that gets things going. That next step of saying, I'm going to be the leader, I'm going to create this thing, I'm going to be the founder and the CEO. That's not a step easily taken. How did you find yourself saying this is the time to do this?

Paul Radspinner: 7:34

Yeah, that's, that's a good question. Because, you know, I've questioned my sanity at times for making that decision. You know, it's, I'd like to say it was a well thought out process that had gone on for years, I think underlying, I knew that, at heart, I was an entrepreneur, and that I wanted to use my skills, and I think my ability to lead people and teams and take something from start to finish, and make that happen. And having said that, I think after having gone through and watched others do the same thing, realizing I thought I could do some things differently and, to me, I thought better, that would result in different results. That was what kind of sent me down that path. I think as I look back now, I always wanted to run my own show and knew it underneath and that going through those other processes were actually really beneficial for me, and I'm glad I did that. But it's almost like this was destiny. It was it was somewhere I was going to end up no matter whether it was going to be running a pizza restaurant, or if it was going to be running a biotech company. I'm glad I chose this route.

John Simboli: 8:50

Let me ask you about the early stage aspect of it. You said a moment ago that you realize this is probably something that I was destined to do or something that was in the cards for me. So going way back to when you were eight or nine or 10. And you were trying to figure out, as a kid, what you wanted to be when you grew up, I don't know how many of us can remember those those self-image questions, most of them probably had to do with what we thought our parents wanted us to do when we grew up. Anyway. can you remember what yours was? Does that have anything to do with what you're doing?

Paul Radspinner: 9:19

Yeah, so it's a really interesting story. So there's two components to it. My grandmother, whose father and brother were doctors, said that I had the worst handwriting she'd ever seen, and that I was destined to become a doctor because of it. And so actually, that was imprinted in my mind very early on. So I thought I was going to become a doctor. And in all seriousness, and that was serious. But what was more important was that I started delivering papers. This is a lost art, unfortunately, for kids these days, but I started delivering papers when I was, I believe, nine or 10 and would walk with a bag of papers around. You know, the the classic scene from a Norman Rockwell painting with the bag around your neck and the papers in there and throwing them up on the porch. And you know, the funny part is a lot of people don't realize that at nine years old, you're also a collections agent. So not only did you deliver papers, but every Saturday you would walk and knock on the door and wake up very sleepy and not necessarily happy customers, and you would tell them they owe you money. I actually really enjoyed that. You know, so that probably said a lot more about where I was going to end up than my grandmother's recommendations.

John Simboli: 10:37

I've noticed over the last couple of years, in particular, talking with founders and CEOs that they are sometimes observed during the work day by their kids or their spouse. And sometimes the question I have heard back, is them relating, Is that all you do, mom? Is that all you do, Dad? You just talk? Because the kids or the spouse has the image in the lab. So I guess the question is, what does a biopharma CEO do with his time?

Paul Radspinner: 11:04

I think that the pandemic has not really changed what we do so much, but where we do it, how we do it. And for a CEO, you know, so much of what I do, and I think I delineate here, because we're a small, semi-virtual biotech company. And so that's so different than, obviously, even a company, that's, you know, I'd say, over 100 employees would be one that's very different. If I was in that situation right now, I would feel obligated to be on site on a regular basis, maybe not every day, but I would feel obligated to be there. Because there is an element of seeing each other, the visualization that really makes a big difference. With our company, which is, you know, less than 20 people, we are in a situation where we can jump on a Team's call and talk to each other. And we really know each other, individually. And I just had a comment made to me yesterday, by my head of Clinical. I said, how are the troops doing? And she said, You know, Paul, I have to tell you, I think they're doing better without the parents at home, you know, meaning me and the CSO and the head of clinical, because we're working from home primarily because it's where we can do. And what it's allowed is for our team, and I'm diverging here a little bit, but it's allowed for our team to actually not only be able to do their work in the lab, but it's given them more office space to spread out into for confidential discussions, for concentration time to write on publications, that kind of thing. So coming back to what I do, you know, really what I'm doing is making sure that I'm giving that team all the resources they need to be able to get done what we need to get done to move this vaccine and this platform forward to where we want to go. So that's first and foremost. And then, because we don't have the luxury of staff underneath me that covers business development, I am the Business Development Executive. And on top of that, there's this little thing called capital that is required to keep the doors open, which is probably where I spend the vast majority of my time because it's no secret to you and to your listeners that we're in one of the most difficult times for the biotech industry in history, certainly since the last crash around the I think the genomic revolution that kind of coincided with the dot bomb crash around 2000. So capital is at a premium right now, valuations are down. And so you have a lot of time spending, trying to keep your board calm, and understanding that these are turbulent waters that we're going through and that this too shall pass. But you've got to keep the capital coming in one way or the other. So that's what I do on a daily basis. I probably have to answer way too many emails. I would get rid of email if I could, tomorrow. But yeah, so if, if my kids were young enough to come in and see me they would say exactly what you just said, you know, what the heck are you doing, Dad, you look like you play on the computer all day.

John Simboli: 14:11

Within the social realm and you meet someone, perhaps through your family that doesn't know you well enough to know what your working life is like. And they ask the usual question, what do you do for a living? How do you answer that?

Paul Radspinner: 14:26

It's been very interesting with the pandemic because I let them know that we're working. But what I'm a CEO I run I founded and run a small biotech company, a vaccine company that's working on a universal flu vaccine, and also a potential COVID Flu combination vaccine. And then all of a sudden, I think they have this image of, you know, Guru, that's getting, you know,$1.5 billion from the government. You know, obviously I didn't make the cut with moderna and Pfizer. Read. And then they think also, you know, so winter vaccine gonna be in the market hopefully tomorrow because look, look at what what these guys did with mRNA. They were there in a year in a year, year and a half, right? So that must be how easy it is to do a vaccine, you just pop it in there. And so it is, you know, I always have to step back because often, you have to assume most people don't understand even the remotest components of the science, certainly before the pandemic, the idea of vaccines and, and the idea of, you know, kind of even something like antigenic drift, the idea that the that the average person I run into actually has a sense of what the heck that is between alpha and Omicron. And all this kind of stuff has changed things. But we also now have you know, I jokingly said, when I was talking recently, to some folks publicly here in Wisconsin, I said, you know, I just want to thank everybody because I no longer have to look for virologists to hire because everybody's a virologist now. And so I can just hire anybody, and you guys will be able to help me out because everybody seems to know all the answers. So just to ask him we're

John Simboli: 16:13

very familiar with neurologists coming on TV now. It's it's interesting, I was thinking about that it's

Paul Radspinner: 16:17

science is one of those things, right, that, that it's so great to have people more knowledgeable about the science I'm so and even though they've been some some down downsides to it, I still think we're far better off having people engaged, and trying their best to learn about the science and follow along than we are, you know, trying to just pretend that we're all up on high and we know all the answers. If you want the public to trust what we do, and you want them to trust that we're doing it for them, and for the right reasons and not just to make money, then you have to try to bring them along. And by not doing that you create some of the more negative situations I think that we've seen along the last couple of

John Simboli: 17:04

years, what have you learned about your management approach as being a founder and a CEO that works for you that defines who you are, that lets you interact well, with the people who are your colleagues,

Paul Radspinner: 17:15

You know, a couple of things as I think about it, one is don't pretend to know what you don't. I'm always amazed at the people I've run into in my business who—there's, you know, a fairly clear divide between those who have a substantial science background and those who don't, and how they approach things. And not that either can't dabble in the other area. But I think there is a tendency, on the part of my group, who are business people who may not be trained in science, to think they understand things a lot more than they do. And if you ever want to become humbled, you simply meet with your co-founder and your CSO, and you ask them to have a, you know, a detailed discussion about the inner workings of the flu genome and protein expression and, you think you understand that at a very simple cartoon level, and then maybe you're deeper than that. And then they talk for about three minutes, and you know, you're lost. The other side is I've seen a lot of it, and friends that I've talked to about this, who are, you know, Ph.D. trained and have a lot of experience at the bench and so forth, who think well, you know, if I can do you know, gene expression? Or if I can, you know, clone a gene, how hard can business be for God's sakes, you know. And I've, I've heard that from people. So, you know, I think it's having that humility, that's an important part, to my style and letting, for example, my senior scientists teach me because they love to teach. So you ask them in-depth questions that you want to understand. And you let them teach you and they love it. They absolutely love it. And they feel important, as they are important. And they get to share what they're up to, they get to share their work, what they're doing to develop. And so that kind of bonding with my team has made a huge difference. The other piece is we went to a, when the pandemic, again, I keep coming back, but it taught us a lot. We went to kind of a two shift work process where we had half of our team working kind of six to three and the other half working, you know, kind of a little bit of a handoff. But the idea was if if one group got infected, then they would have to be quarantined, then the other group could come in and pick up and we'd have a seamless process going on there, at least for the short term. Well, once we got over all of the quarantining and the different kinds of issues, we ended up just having them all, as I said before, work, you know, on their own in the facility. And we never once doubted that, for a second. My view on that is look, we hire really bright, really sharp people who are absolutely committed to what they do. And if you don't, then you're not hiring well. And if you're just figuring that out, when a pandemic shows up, then you're not on top of what's going on in your facility. And I've always thought that, while there's absolutely people that have to be in the office are in the lab, because you can't do lab work at home, by requiring people to be in an office, at a desk, for X amount of time a week, conveys a certain lack of trust in your people. And I think it's kind of one of the most damaging things that you can do to that relationship between you and your employees. Now, if an employee gives you a reason to feel otherwise, then, you know, then you address that in the way that you have to address it. But I'm absolutely convinced that this new approach to kind of the workplace being all over the country anymore is the future. And it's important for a company like ours, because we're in Madison, Wisconsin, got great talent here, everything's exploding in Madison right now with the different companies that are that are growing. But if I need really strong regulatory support, for example, that's not a particular area of strength in the Madison area. So if I can have somebody from Washington area working for me, that's fantastic. And, you know, we'll have them come in and meet the team once in a while. But I think we've all gotten so used to to Zoom and Teams and everything else that meeting on screen is ialmost as good, not quite as good, but almost as good as being there.

John Simboli: 22:07

When people say who is FluGen, how do you like to answer that?

Paul Radspinner: 22:10

We're a small biotech small vaccine company, trying to do something that has been attempted for the last 70 years, unsuccessfully, and that is to make a highly effective influenza vaccine. That is our lead charge, we're also developing the M2SR vector as a platform. But that's simply what I say. And you get a lot of nodding heads. I think most people understand the flu vaccine, you know, they understand this idea of, ah, the vaccine doesn't match the drifted strain and whatever. So then it's not very effective. And that's why you don't get a flu shot or whatever. So, I think, pretty simple to be able to explain that.

John Simboli: 22:55

When people misunderstand the FluGen story, what do they tend to get wrong? And and how do you get them back on track?

Paul Radspinner: 23:01

So that's an interesting question, because one of the challenges for influenza vaccines right now is that you are injecting a dead virus into your arm to protect against a live virus that enters your nose or your mouth and infects you. And people wonder why we don't have highly effective vaccines. Now, do they reduce, you know, similar to what we've seen with COVID, do they reduce death and hospitalization? Most likely they do. So that's a good thing. But the reason that we see efficacy rates, for example, this year, the efficacy rate, I think they looked at it halfway through the season, it was at 16%. And it may come out to be less than that, in the end, because of, again, a mismatch of the strains is, you know, they look at that and just say, well, you know, why? But the misunderstanding, I'll get to that, is that there's only been one vaccine in the history of flu vaccines that really made a significant dent in efficacy. And there was a vaccine called FluMist. And FluMist, I don't if you remember this, John, but it is an intranasal vaccine, at the site of infection. And when they delivered that to children, anywhere from two to six years old, the efficacy rate went from what we see now with regular vaccines of 50%, on a good day, to 85 to 92%. Went through the roof. And so that story was a great one. The problem was because of its mechanism, it didn't work very well in adults, and definitely didn't work well in older adults, which is a high risk population. So the thing that people don't understand is, that we're approaching from an intranasal delivery standpoint and they start to pigeonhole us in that we're FluMist 2, you're the next FluMist. Well, FluMist worked very effectively in kids, as I said, but it's picked up some baggage along the way. And we're just a completely different approach than FluMist. But because of the intranasal delivery, that's, that's how they think about it. So I think that's the one place where you kind of get off the wrong path there.

John Simboli: 25:17

When you go into that next level of the discussion, when you get past the, we're not FluMist 2, because we just happen to share the way it's delivered. But the foundation of a therapeutic is very different. When you get to that point, what do you, how do you differentiate the approach, the scientific approach, the mechanism of action? How do you explain that how it's different from what came before?

Paul Radspinner: 25:42

Yeah, it's actually it's fairly simple. So FluMist was created with work from the University of Michigan, I think back in the 70s, maybe even the late 60s. But it's a Live attenuated vaccine. So it's a virus that actually replicates slowly, but it replicates and so it sheds, and it acts as if you're infected with flu, but just a calmer version of the flu. It's also cold adapted, so that it will only replicate in your nose and nasal pharynx area, it will not go into your lungs. Because you don't want flu to grow in your lungs. That's a very bad thing. And so we think that mechanism is why FluMist struggled to work in adults and older adults, because you couldn't raise the dose. They tried to raise the dose with FluMist, from 10 to the seventh, to 10 to the eighth. And if I'm getting too technical, tell me here, but what happened was people just got really sick because they were being infected with more of a replicating flu virus. And you can imagine that would cause illness. So what our vaccine does, it's completely different, is we're not temperature regulated, and we replicate a single time, our vaccine can go into the cells, it replicates, all of the viral proteins are expressed, and then it stops, it doesn't infect anymore. And so what that allows for is a much higher dose of our vaccine than other live viral vaccines for flu. And that. in turn, we've seen a completely different immunological response. And, we think, different efficacy response, as well.

John Simboli: 27:31

Does it ever happen that after you explain what you just explained, which sounds straightforward, about the single replication, does that ever happen that someone says, I don't know, if that were so clear, and so simple, why didn't somebody else invent it before?

Unknown: 27:44

Oh, my God, yeah. Yeah, it's either why didn't they invent it? Or why hasn't somebody bought your company?

Paul Radspinner: 27:50

It is a description of an elegant Right? I mean, you know, that's it. And it's because there's great ideas all over the place. So the reality is, I do get that question. This is such a, I mean, how many times have you found yourself saying, you know, I don't do it with Twitter, because I still don't understand why it's so popular. But you think of something like PayPal? I mean, how, what, just what an obvious cause? I mean, it's just obvious, right? And so this Musk guy and this Peter Thiel guy, I mean, they really weren't that smart, right? I mean, I could have invented that. Well, obviously, they saw something and they took advantage of it. I'd say this isn't really, you know, the idea of a single replication vaccine is actually not a unique idea. We're not the only ones pursuing something like this, I think the more important thing is, you have to know which part of the viral genome can you delete, and still get into the cell, uncode all your proteins and stimulate the immune system, and then not come out the other side and replicate again. And then also the possibility of recombination, right? So you have to have something that can't pick up that piece it lost from, let's say, you were to be co-infected with a live flu virus. What if you pick that up, and all of a sudden, you become something, you know, a Franken-virus or something like that. And I mean, we've looked at all that. And I think that's the elegance of what we determined that's allowed this to happen. Because so many of the components of the flu virus are critical to the immunological response. What Dr. Kawaoka discovered was that the M2 piece is really more involved in viral entry into the cell and viral exit. And so then what we ended up perfecting was trimming down how much of that gene you take out, so that it still can enter the cell but not get out. And ultimately, the way we do this, and again, if this becomes too complicated, I can try to simplify but what we do is we take that gene out of the virus, and then we add the protein back when we manufacture it. So we have a cell line that adds the protein back so that allows it to go into the cell, but not get out process.

Unknown: 30:09

Yeah, he worked on, you know a number of other ones where he took the PB one PB two different genes in the flu genome and tried to do similar thing that just found out, you know, you just you would lose so much of the immunological effect if you hit some of the other ones that it didn't help out. And so that ties in also to what we're doing right now, which is on the platform side, what we're doing is actually inserting the spike protein. So we're taking portions of the flu genome, and we're adding the spike protein into it and using it as a vector. And we're also we've done that with RSV, as well. And the idea is that you'll Express not only the flu proteins, but you'll express the COVID proteins as well. And you're going to be delivering at the site of infection. So we hope I mean, that's further behind that our flu program, but what we hope to see is that you would have a combination vaccine to protect against flu. And our vaccine has shown that it can protect against the drift that we see from year to year, and that it would also protect against COVID. And we would hope provide a better, longer lasting response, because it's being delivered at the site of infection certainly would provide mucosal immunity, which which the current vaccines don't do.

John Simboli: 31:28

It was a broad enough idea for me to think about the possibility of a universal flu vaccine, then we think about universal flu vaccine, it could be a COVID related vaccine, I guess we're combination vaccines which is used. That's that's, that's a big project that's touches a lot of plants.

Paul Radspinner: 31:49

And, you know, to be fair, Maderna is doing the same thing, as is Novavax, but what they are doing is they're putting the two components together in a vaccine to achieve flu and COVID, where we're using the flu virus to actually express the COVID protein, and then get the immunity that way. And and I think the big advantage, frankly, John, is not just that it would be the combination, but it would also be that you're delivering it at the site of infection. We keep talking about mucosal immunity, you've probably seen in the news recently, that's been a big discussion that the idea of delivering a COVID vaccine intranasally, and it may be that you need to do both. It may be that the ideal would be to have both an injection in the arm and then an intranasal delivery, and then you would be able to get both robust antibody response and mucosal response and T cell response that would be able to provide a really broad protection against the vaccine. And we'll see, maybe that'll be the case.

John Simboli: 33:00

How does the pipeline express your vision for the company?

Paul Radspinner: 33:03

You know, it's interesting, because, you've been around long enough, John, you've seen this, right? So you walk in the door to you know, VC X, Y, or Z and the first time you go out, you end up in a situation where they say, you know, we don't want platforms, because we, you know, we hedge on our own portfolio. So I don't want you to spend a bunch of money chasing for different diseases. And so then you go down, you just say, Okay, well, let me change my presentation. Okay. So you go down to the next guy, and he says, Well, you don't have a platform, you're a one trick pony, what if that dies? You know, this seems to ebb and flow in our business over and over and over again. And it gets to the point where you just think, you know, what's the right answer? And I don't think there is a right answer. So, you know, from my perspective, originally, our company started out with my vision was to try to hit three different areas, but two, in particular, one was the flu vaccine. What's always driven us is a more effective flu vaccine. We also had a cell line that we were using, because at the time, there were no cell-based flu vaccines, they were all made in eggs, as you probably know, and just a cumbersome process. It has all kinds of limitations. If you have, you know, for example, a an avian influenza that jumps over to humans, well, what happens if all the eggs are gone? Or what if it can't grow in an egg? Because it's a you know, and so, so we were working that and that changed pretty rapidly right around the time we started, and a number of companies came out with cell lines. You know, Novartis and then ultimately, Seqirus, went to a cell-based flu vaccine, all those things, and so we had to pivot in terms of what we could do. And my chief scientific officer Pamuk Bilsel, is just absolutely brilliant. And she came in and she talked to me about one of her dreams, which was always using flu as a vector. And I said, well, that's interesting. Tell me more about that. And it had been research that was done back in the 60s, but nobody had ever really pursued it as a viable commercial option. So we started to do some just really basic science on it. And then, you know, go into the preclinical studies. And the initial results didn't get us where we wanted to go. But we saw enough positive signs that we figured that you know, that we would keep rolling with it. Well, then the pandemic hit. And so the biggest challenge for us at that time was capital conservation and all the the challenges of our workforce not being able to work full speed all the time. So we had to shelve that, which, in hindsight, you wish, that would have been the absolute perfect time to really invest in this process, but we couldn't do both at the same time. And so, once again, that capital constraint dragon raises its head. But since then, we've gotten back on track, and we're developing it, so they're still preclinical candidates. But what we've been able to show clinically with our flu vaccine, when you think about it, it's not going to be a big jump to take epitopes from a COVID, or the spike protein, or the RSV, for example, and to go to that next stage. So we're not going to face, we've got, you know, safety numbers, well over 500 subjects now and so forth. So, you know, it's one of those things where I think that platform wasn't part of my original vision for the company. But as we grew, realized that we could create value, a lot more value, by putting that all together. And to the point now, where, I think, as we see some results of a study we're doing, you know, if that's positive for, I think, either or both COVID and RSV, that could just dramatically change how potential partners look at us at that point in time.

John Simboli: 37:09

How would you describe a good partner for FluGen?

Paul Radspinner: 37:13

From an academic standpoint, we'd look for people who are working on cutting-edge research. One that comes to mind is a Akiko Iwasaki, she's at Yale, and just down the street from you. And she actually just wrote a guest essay in the New York Times about intranasal delivery in COVID, and how important that would be. And so, you know, I frankly, on the academic side, I leave most of that to my chief scientific officer, because she has her fingers on the pulse of everything, knows these people, and I trust her, you know, she's my right hand woman, so, yeah, she's the one that would hold on to that. On the business side, it's a little different. Because in the vaccine business, it's a pretty small group, ultimately, of people that are involved, even though it's big business, you know. I know all the key people at all the key companies that we would potentially partner with. And so it's one of those things where I feel like we have great relationships, and it's really more technology, and results-based than it is anything else, which is always the case in this business, right. And it's always, when you were talking about what's it like to be a CEO and some of those things, one of the things that jumps out to me is that I can improve my product if I'm a widget maker, or if I'm making Teslas or whatever I'm making. I can bring a design team in and we can do that. But biology is biology and even though you can tweak it here and there, the reality is, we sit and we put our product into subjects who trust us to do clinical studies and then we get results. And we all sit by the the magic machine, the computer machine, and wait for the results to come out. And they're either great, bad, or indifferent. And our world has changed immediately. And it's just so different, I think than than most other businesses that people deal with or that lead in those situations. So you may deal with the people the same way. But the outcomes you can't, you just can't fix and change things the way you can and in other sectors. So I've just always found that both humbling and inspiring, as well, because it's exciting. It's exciting. It's quite a roller coaster. I had somebody say to me once that being a biotech CEO is like being a manic depressive, without lithium, that the highs are much higher, the lows are much lower and the the space in between is much shorter.

John Simboli: 39:53

What aspects of what's going on in our industry are really the most intriguing to you at this point?

Paul Radspinner: 39:58

I think a lot about vaccines because if you if you go back, and you look at the the effectiveness of preventing death and disease in this world, nothing's more cost effective or has been more successful than vaccines. The idea that we have eliminated one of the biggest scourges in the history of mankind, with smallpox with vaccines, that we are within 100 people a year of eliminating polio. It's nothing short of a miracle. It really is. And so now, here we are, we have this challenge that we face with a pandemic. And we've, I think, responded, amazingly. I think the industry just did a great job. But we're seeing a pressure on the environment that is probably going to, most of the experts say, is probably going to drive more disease, more animal-hosted disease into human populations as time progresses. And so how are we looking at that? And what are we doing? What are the leaders doing to try to not only find vaccines to solve the problems at hand, but try to prevent some of those problems from happening. I have the the fortune to be a co-chair on of Bio's committees for vaccines, it's the bio-terrorism vaccine group. And what we do is work on, you know, all the different kinds of advocacy with the US Government and the state governments on making sure we have things like a smallpox stockpile available, so that we can end up, you know, treating or preventing things like smallpox if there were some kind of an event. But just recently, we have monkey pox. Most people may not know this, but that smallpox stockpile actually works to solve monkey pox, there's actually a vaccine out there for smallpox that can solve monkey pox. So, you know, so those kinds of things, and that kind of forward thinking and and making sure that we have policy, that kind of aligns with those things I've just been talking about is really interesting to me. I find it absolutely fascinating. We've had some tremendous leaders on the Hill that have really understood this and they're retiring from the Senate. You know, I just hope that we're going to have more people down the road that have that kind of vision and understand the importance of this kind of thing. But that's our job. We need to sell them on why it's important for them to pay attention to us and fund programs that can that can get us down that path.

John Simboli: 42:53

Paul, thanks for speaking with me today.

Paul Radspinner: 42:55

I really enjoyed it. John, this is this is great. I'm glad you're providing this. I've just clicked on my podcasts, so I'm now subscribed to you. And I'm going to go back and hear all your old shows and learn from them. Thanks again for providing this.