Episode 143: Why Animal Health Is the Next Frontier for Biotech Innovation

Let's talk about the elephant, or chicken, in the room. Today, we're exploring the future of animal health. You're listening to Bio from the Bayou, empowering biotech leaders with the tools, assets, and expertise to improve healthcare outcomes. Each episode provides insights and information to expand your network, advance your product line, and help your company thrive.

Serving the entire Gulf South, but recorded in the heart of New Orleans. Welcome back to Bio from the Bayou. I'm your host, Dr. Elaine Hamm, the executive in residence at Tulane School of Medicine, and today's guest is Dr.

Patrick Ehrlman. He is the global head of biological development and animal health for Beringer-Ingelheim. Welcome to the show. Hi, Elaine.

Thank you so much for having me. It's a great pleasure to be on the show. I've listened to it a couple of times, and it's great to be on. All two times.

Amazing. I mean, that's pretty better than me. No, I'm just kidding. I listen to it all the time.

I make my husband listen to it, whether he likes it or not. It's awesome to see, well, I get to see you because I'm on Zoom with you, obviously, but it's been a little bit since we've seen each other. We have worked together over the many years. We've worked on a project together at Beringer Ingelheim.

You have been, I guess I'm going to say that you've been a fan of Tulane because you've actually come to Tulane a couple of times. That is true, but I have to say I'm currently here in Athens, Georgia, so go dogs. I have to bring in some of the local spirit. Wow, out of the gate, out of the gate, just going ahead and just setting up a rivalry.

All right, that's fair enough. Well, when we first worked together, you were on the human side, and now you are on the animal health side. But before we get into the subject of animal health, why don't you give us your origin story here, how you got into this wacky business that we're all entrenched in now? I'm originally from Germany, even though we met in the States.

I grew up in Stuttgart, the city of cars. But then I studied biochemistry, virology, did a PhD in molecular oncology, and then a very science-y postdoc that I can talk hours about, but it's not for today. And then I switched to the dark side because my publications just were not good enough. I ended up in a small startup in Ilsebruch in Austria, working on oncologic viruses.

Very fascinating topic. and we brought the startup into the clinics. We were quite successful, so successful that Böhringer Ingelheim actually bought the startup. We got the exit.

I stayed on with the Böhringer team, transferred my knowledge, transferred the product. In a very successful stint of, let's say, seven and a half years, we had four stars of clinical trials and human pharma with oncolytic viruses and oncolytic cancer vaccines. some of those are still running and I hope to maybe have a product someday. It's exciting as well.

Then COVID came, worked on a COVID vaccine like everybody else, vector-based vaccine. And after that, I said, okay, my deed is done more or less in Europe. I actually reached out to a very dear friend of mine that you know as well, who's currently leading the BI Venture Fund. And he brought me to the U.

S. where I led a research team that was working with interesting projects that are not your everyday big pharma projects. And that's where we met. We had a very interesting project that ran for three and a half years, as long as our project ran.

And then as it is in big companies, strategies change. I had to also change. I looked around. What jobs could I do in the world that interests me?

And I have to tell you, I'm not a real big pharma guy. For me, it's a little bit boring because if you're in a big pharma company, they're really great in specializing. In a big pharma company, you have every specialist that you can think of. But it also means that you look at the really tiny slice of the whole thing, and I'm more of a broad picture guy.

I liked it in the startup where you can do a lot of things. I liked in Research Beyond Borders where we worked together, where it was more holistic. When my former boss called, said, oh, I'm now in animal health. you want to join me?

And he said, it's a handful. I said, okay, I'm going to do it. I moved back. I actually moved to the company headquarters in Ingelheim, Germany.

That's why it's called Berger Ingelheim. I work now for the animal health arm of Berger and really developing all our biologics. And this is a lot, as always, in animal health. We have vaccines mostly.

We also have antibodies. We have the odd stem cell. We have proteins. We have bacteria.

We have viruses. And of course, we have a host of hosts. So we do everything from chicken to sheep to cattle to cats to dogs, whatever you have. I'm super happy here and happy to talk a little bit about it.

Animal health is such a fascinating area. I mean, one, I have three dogs myself. The amount of money I am willing to spend on these creatures and what I would be willing to do knows no bounds. I mean, my old dachshund has gotten acupuncture for his back before I've gotten acupuncture for my back.

And the amount of supplements and vaccines and medications and biologics, I mean, all of these things. I mean, the amount that people are willing to spend and the insurance industry hasn't quite tainted the animal health industry. I mean, there is animal insurance, but it's quite different from, you know, our human and American system in particular. So I think it's such a fascinating topic across the board, not only the types of different animals, as you said, the host of hosts that you get to work with and learning about, you know, chickens and do they have innate immunity, all the way to how do you give a vaccine And then you get to dive into the various sort of different modalities and disease types And then the intersection of human health and animal health because that obviously very intertwined as we think about endemics pandemics et cetera So I think there also a lot of misconceptions too, because when I was in the tech transfer world, I think there was sort of this idea that, well, if your drug doesn't work in humans, let's just take it into animal health and see what goes there.

And there's some, maybe there's some truth to that or not, but I'd love to get your thoughts now that you've gone across, of course, human pharma, startups, and now animal health. What are the biggest commonalities, differences, and surprises that you've run across? You hit one point there. It's a lot of out of the pocket for animal health.

And that's maybe one of the major differences that, especially if you're in human pharma, if you're with novel products, and this shows in the money that you can make. You will not be as successful with an animal drug that you will be with a successful human drug. Sure. Nevertheless, it is important, but for me, it's even a bit more, let's say, down to earth.

The money that we make is money that somebody spends because he wants to spend it. I do like this sometimes, but that is one of the big differential. There's a lot of commonalities, actually. So we go to the same regulations and regulators.

So our drugs are FDA regulated. They are UGMP regulated. And there's also building scrutiny and the safety behind those drugs, sometimes even more so. What people don't know is that animal health products in the U.

S., there's two regulatory agencies. The FDA for everything that's a pharmaceutical. And then you have the USDA for everything that has something to do with the immune system.

Vaccines actually are not regulated by the FDA, but for animals are regulated by the USDA. That's really interesting because these two agencies have almost contrary ideas about the development. FDA, much like in human pharma, is really all about safety. They want to make sure that your drug is safe and it helps.

USDA has a very different focus point. USDA's main focus is safety of the food supply. For them, it's much more important what is in your drug and could it bring any harm to the U.S.

And that changes how things are looked at, what materials you use, where you produce, with whom you collaborate. That's maybe the biggest differences. And then other than that, the many different animals that we are dealing with. I mean, we always say in human research, we don't care so much about experiments in mice because a mouse is not a man.

Sure. But a mouse is not a cat and a cat is not a dog and a dog is not a swine. Turns out. It's this multitude of hosts that we are dealing with.

All slightly different diseases, different immune systems, different prerequisites. And then you have these two arms in animal health that is pets, dogs, cats, horses, where you have owners that really are interested in the well-being, in the longevity. and then you have, of course, livestock animals. It's all about the business.

We touched on this earlier. There might be vaccine hesitancy everywhere, but there's no vaccine hesitancy in livestock animals because the farmers know, if I don't vaccinate my pigs, if I don't vaccinate my cattle, I will make less money with them. That's that. And that also means that here, there's a huge price pressure.

Yeah, especially as you think about livestock having to vaccinate pigs and whole herds of cattle. You can't have really expensive or arterous ways to inject them with either. So obviously market research has to occur both in human and animal health. How have you found it different as it relates to animal health?

I imagine there's things that, I mean, obviously payers are a little bit different. And does Beringer have a consumer products division with animal health or is it strictly more? We also have consumer products. Okay, yeah.

Talk to me a little bit about, as you know, someone brings to you, I'm just going to throw this out there, a hearing drug for dogs. Because yes, I have literally barked up this tree myself, having a deaf dog. And it's challenging. And you have to start with the market of like, yeah, dogs are deaf.

That happens. This disease impacts chickens, whatever it is. But how do you think about the market versus, you know, as we think about human markets? I think it's a little bit different because what you see is that your dogs can't talk to you.

We have two customers. The dog as a customer, but we also have the owner of the dog as a customer. So there might be something that helps your dog, but if you don't see it as an owner, you don't want to spend money on it. And the vet, I'm sure, too.

Same thing. and there's also a lack of testing. Yeah, I'm going to say, like taking the hearing loss as an example, it's not like vets just constantly run a really strategic battery of hearing tests. It's usually just squeaky toys and seeing if the dog pays attention or not, which, you know, quick and dirty.

Exactly, and that makes it a little more difficult. So for us, it's important. Does the dog see it? Does the owner see it?

And then that for us plays an important role. And then the data density, generally, data is much less available for animals than it is for humans. You might think, oh, it's easier to get the data. It might be easier, but why would you do it?

And we underestimate the amount of data that we have in human disease. We do not at all have this in animals. And that makes, also, I mean, talking about new technologies, AI is great but it really catered to humans and human diseases because that just where all the data is That something that we are looking into is like how can we generate more animal data More data on dogs, data on cats to then use some more step into the modern world and use AI machine learning approaches to new drug candidates.

That's interesting. I guess when you think about animal data, you're talking about cats and dogs and fish and chicken and pigs. We have lots of data on mice, not human primates. Maybe a very specific type of dog, maybe some swine, but probably, and even if we did have that data, it doesn't mean that it's queryable.

I mean, we have our IND packages, but it doesn't mean that we shared all of our data that we acquired in pigs or dogs, etc. So, interesting. I hadn't thought about that. No, no, it's something that for me was actually really interesting because I thought the same thing.

It's like, it's animals, it's so easy to get data. So in principle, yes, but nobody spends the money to actually do it. Because if you spend the money, you do it for your human samples rather than for animals. Also, talk to me about timelines.

Because, you know, of course, one of the biggest challenges in human drug development is that timeline of discovery all the way through the clinical trials. You know, depending on the indication, it can take quite some time. What your endpoint, it can take a lot of times. Talk to me a little bit about the animal health piece of it.

I would say that it is not necessarily faster. But what is faster is that you're much faster in the relevant target species. Meaning that already very early on, you can do proof of concept field trials with dogs or cats that are diseased. Much, much earlier than you would do in humans, where oftentimes a phase one is with healthy individuals.

And only when you get to a phase two, you would actually know if your drug works in humans or not. We can kind of front load this with quite some good safety data and efficacy data. And so we know that we are at this proof of concept point. When we get it to the market, it will work.

So that is, it's not necessarily faster, but it's the risk. Maybe that's the model. Are there standards? I mean, as you're presenting, obviously we have our IND that we file with the FDA.

I mean, what is the process? Okay, so you have some initial data, you know that it works, and it's fairly safe in a small, you know, in of your target animal. Can you walk us through the next steps? Because we have a very prescribed sort of in phase one, and depending on your indication, it's this many patients.

How does that work for animal health? Again, to be a bit careful because it's not, animal health is not animal health. It depends on, is it a USDA regulated vaccine? Is it an antibody for a dog?

It's slightly different. how we would go about it. So normally we have a classical research phase, quite similar, then we would do for human drug. But then instead of going in mice, we would directly go into target animals.

For a vaccine, very easy. For pigs to go into pigs. For disease in dogs, you would already at a very early time point try to do a field trial with diseased dogs. Get some proof of concept data and that is more easy to get.

We have to ask the authorities for approval to do the study that is clear. I would say compared to human pharma, it's a little bit easier. We do a normal classical CMC development because we want to get it right. And then we just do basically one trial.

We do one pivotal clinical trial in a diseased animal if it's for disease or in a large cohort of swine under field conditions if it's, for example, for a swine vaccine. And then normally what we do is safety studies and those are regulated. So for the USDA, There's no GLP, GCP, but for FDA and for EU, there are studies in GLP, GCP. And then you can get your market approval.

So it's rather easy. A good thing is there's both in Europe and in the US, there's accelerated approvals for unmet needs and for transboundary diseases or infectious diseases that are not endemic. Having gone through this from a startup lens yourself, what are you looking for and what should startups be thinking about as they approach you? I have to start with an anecdote.

Because, I mean, when we were working on the oncolytic virus, we also actually planned studies in dogs with cancer. And we said, we can develop it for humans and in parallel for dogs. It's great. it's great until you tell your investors that you want to spend some money to treat dogs.

And then your investors tell you, drop it right now. We don't make any money with dogs. We make money with humans. And that's a little bit of part of the problem.

It's true, especially in oncology. There is a small market for animals, but you will make nowhere near the money with animals than you will do if you get something that works in humans. That is a little bit the difficulty that we face. So the startup scene is much smaller for animal health, I have to say.

So what I would look for, and when we look for partnering opportunities, it's really real-world data. I'm not interested in mice. I'm interested in the actual species. And also, let's say an animal health mindset, does the interpreter know what it means to develop for animals from a price perspective, from a regulatory perspective, because it has nuances, yeah?

And that can kill your project. So what about technology transfer offices? Because right now, I mean, that makes a lot of sense that there's probably not a ton of animal health startup companies out there. But when you see it from the university side, I've worked for the number of universities over the years, and we've had cases where we've had technologies that were specific for animal health, whether it was a skunk odor neutralizer, which yes, I've worked on.

And I realized that Europe doesn really have skunks And that was something that I had to figure out from a market research perspective But what is something that a tech transfer office needs to present to you I mean they may not know all the ins and outs of how it works in animal health, but they do have a researcher that, hey, they developed a really cool thing for chicken viruses, let's just say. So what should they present to you on that? I think there's lots of room for improvement from both sides.

It's also for us. I have to say we need to work much closer together with universities. And we do this on a couple of fronts, but we have the ones that we know, that we trust, that we work with. We not nearly have a system like in human pharma where we reach out to a lot of different universities.

We go to kind of the classical meetings. Our BD&L colleagues go to the bioconferences of the world and they look at things. So I think make clear that you develop for animals. Try to look who's, and it's easier actually because there's not so many big players in the animal health world.

It's just a handful. Get into contact, see who's biting and try to co-develop. One of the things that, I mean, if you have lots of different animals, lots of different diseases, it also tells you that we are most likely not the expert everywhere. So we rely much more on academia to help us.

because there's more experts out there rather than in human pharma. I know my colleagues in human pharma, in their disease areas, they're absolute experts. And there's hardly any KOL that can beat them, but it's not the same for a fine one because it's such a diverse area. You know, and that just made me realize, like, I imagine that, and maybe this is just a hypothesis of, you know, we think about the Midwest and the Gulf South region of these flyover states.

But I can't imagine that Boston and Harvard has a ton as it relates to like pigs and chickens. I mean, we have so much greater access and a lot more ag-related universities that focus on animal health or have vet programs and have access to the large amount of space that is definitely required for the large animals. Is that something that you've seen? Yes, absolutely.

And that's, I mean, you see it reflected. So while, of course, you know that the human farmer arm of Beringer has the headquarters in the East Coast, close to Boston for animal health. We have our sites right here in the heartland. I'm in Athens, in Georgia.

Before that, I was in St. Joseph, Missouri, where we have also production and development facility. And we have a nice research facility in Ames, Iowa. So we are where our customers are.

Yeah, all this time I didn't realize that you were just located over in Georgia. I was thinking that you've been in Germany this whole time and it turns out not so much. Yeah, I'm here quite often. I have a great team over here, very dedicated, very hardworking.

I love it. Well, as we wrap up, are there certain areas of interest that you, or market trends that you're noticing in animal health that you could share with us? I think it's really important for us is vaccines. And they are important.

They stay important. One thing that we didn't touch on, which of course is also very important, is AMR. Absolutely. Yeah.

And I mean, you can look at the chicken you eat today, it probably says no antibiotics ever. Yeah. And of course, it's only possible because these chicken are vaccinated. And we need to do the same with swine.

We need to do the same with cattle because that's where most of the resistance are coming from, actually, for overuse of antibiotics in agriculture. And it's not easy to develop vaccines for bacterial diseases. Here, technology is needed. We talk about maybe mRNA technology when it gets a bit cheaper, of course, a price problem.

But also novel adjuvant technology. I think we made strides during COVID. We made strides with the cancer vaccines in our understanding in humans how the immune system works. And if you can translate some of it to animals, that would really help the industries.

And then things we can do easier in animals than in humans is more the in-situ technology. So in-situ, let's say CAR-T cells in dogs, it's less risky. We can do in-situ vaccinations and things like that. But this is really, I think this is a whole space that we say, oh, you would never try this in humans.

Yeah, CAR-T and dogs, not on my bingo card, but it makes a lot of sense. It's a lot less risky. And especially if you get it cheaper, if you do in CTO, generation of contraception. Oh, that's fascinating.

Yeah, no, and AMR, antimicrobial resistance, is such a Venn diagram of animal health and human health. It's very overlapping in that particular space. And we saw what happened when you use a lot of antibiotics and throw it into your cattle or throw it into your feed and how it can impact human health. And we're seeing that impact today.

And great point. Vaccines are the way that you prevent antimicrobial resistance. It's never getting sick in the first place. I'll get off that soapbox.

Well, thank you so much for chatting with us today. It's super interesting, this area of animal health, and I don't think we talk about it quite enough. I really appreciate you taking the time, and always a pleasure to see you. And yeah, as we always do, we'll be sure to have Patrick's contact information and informational links posted on our show notes.

Thanks for joining us, Patrick. Thanks for having me. It was a pleasure. Thanks for joining us for Bio from the Bayou, and we hope you'll join us again.

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