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While calls for the reduction and elimination of drug testing on animals have increased in recent years, the solution may well revolutionize the entire drug discovery and development process. Doctor Eric Merle is the chief business innovation officer at GenoSkin. Eric, welcome to the program.
Dr. Eric Merle:Well, thanks, Moira.
Dr. Moira Gunn:You know, we've grown so used to first to test your drug in animals. And and, and and we pick animals that are close to humans wherever the drug is going to be used or needed, such as human insulin is very close to pig insulin. But, it never occurred to me that we could be working on a drug for humans and we couldn't find an animal to test it in.
Dr. Eric Merle:Yeah. There there are plenty of diseases, in which an animal model just can't, be found. Whether the disease is rare or common, actually being able to reproduce a disease in an animal takes a lot of work. That's how our company was started. When we realized, actually, our founder and CEO, Pascal Des Garg, when he was in San Diego doing a postdoc, he, found that a skin disease that was, dramatic on, human babies, was unable to be reproduced in animal models.
Dr. Eric Merle:There were no animal models that could reproduce that disease, and yet he would try he was trying to find a solution to that disease. So he looked at the problem a different way. Is there a way to not just reproduce something, but can you leverage what already exists? Can you take something that might not be as needed or no longer needed and use it to generate data on it. And he realized that there was plenty of human skin that was just thrown away post surgeries.
Dr. Eric Merle:And, that's how he started the company. He went to a local hospital and, got the authorizations to be able to use that tissue and, afterwards was able to maintain that tissue alive, maintain its properties, and study the disease in that tissue.
Dr. Moira Gunn:How long can you keep such tissue alive?
Dr. Eric Merle:So depending on the technologies, and technologies can always improve. We today have, the ability to maintain it, viable, functional for 10 days.
Dr. Moira Gunn:So you get in there, you get the skin, and you start working on it with your drug. What are the advantages of working with skin?
Dr. Eric Merle:Well, the advantages of working with skin is, 1, it's available. It's something that is commonly available, albeit it needs a lot of, ethical review board authorizations. You can't just work on human tissues just like that. You have to get the the approval of the patient. You have to get the approval of the ethic review boards.
Dr. Eric Merle:And, then key to to using that tissue is maintaining its properties, and that was really the the the the key driver to the technologies that we've developed. So maintaining the immunocompetency of the tissue, the ability to find the immune cells within the tissue, to understand how there is the crosstalk, the function, the, understanding the molecular signature of the tissue, so that when you introduce a drug, depending on the the route of administration, whether you're gonna do it topically, such as a cream, or you're gonna inject it, or you're going to provide it to the tissue, as if it were an injection in a human being, you can look at what happens in the tissue. And because you have such a large amount of that functional organ, you can compare different conditions, something that you can't do in a clinical trial.
Dr. Moira Gunn:I keep thinking about how in clinical trials, you give one person or set of people one dose, and then another set of people another dose, and another set of people still another dose. And you say, well, what dose should we have looking at all these different people? Can you give multiple doses to the same scan?
Dr. Eric Merle:You can. Because actually it is separated in small units. We make small units that are about an inch in size, and, that will allow you to look at these different conditions. In in a typical surgery, we can do roughly 50 of those for 1 individual. So you can think of looking at multiple conditions and doing replicates so that from a scientific perspective, you're also, very sound.
Dr. Eric Merle:And, then look at how those minute sometime changes can have very large changes on the body.
Dr. Moira Gunn:You know, we have another aspect that we see in clinical trials is that we wanna look at different ages. We wanna look at different ethnicities and sometimes even different medical conditions. Are those able to be distinguished here as well?
Dr. Eric Merle:Yes. In the majority of cases, yes. The the diversity, and the heterogeneity of the population that is gonna be the patient population that we find, among our our our neighbors and, and and family members. They all have different age groups or all different ethnic backgrounds. You have, males, females.
Dr. Eric Merle:And and and so all that has to be represented when you do a clinical trial. And the FDA just recently actually stated that, when, one particular drug was, brought to their attention and was tested on only one particular group. They requested that it be tested on something more representative of the overall population. Luckily, those surgeries are so common that they replicate the human diversity. So we can have men, women.
Dr. Eric Merle:We can have different age groups. We can have different backgrounds. And, so that that is a great opportunity to to have this type of diversity, in in a clinical trial.
Dr. Moira Gunn:So much of what you're saying to me sounds not only like research, it sounds like an ongoing, ever expanding research base. How do you work with drug companies?
Dr. Eric Merle:You just mentioned it. We are a research partner. So we come in to answer questions. We work with various pharmaceutical companies, biotech companies, academia, to answer pointed questions. What will happen?
Dr. Eric Merle:What's inside that black box? Because often in a clinical trial, you'll see the end result. You may not see all the different steps, all of the different pathways, and understanding that, understanding the biomarkers of what will be the effect of a particular drug in a full human being is key to accelerating, the speed at which we can develop drugs.
Dr. Moira Gunn:So even if you have a good matching animal, you really wanna see what it's gonna do in humans before you get to live human testing.
Dr. Eric Merle:Even the best research animal is just an animal.
Dr. Moira Gunn:Just before the COVID pandemic hit, the Environmental Protection Agency of the US, that's the EPA, declared that starting in 2035, there would be no more testing in mammals for the research it funded, the the EPA funded. And they awarded 1,000,000 of dollars to to search out alternatives. The Veterans Administration, the Veterans Affairs declared no more testing in dogs and cats after 2025. Even the Department of Agriculture, they've already banned research using cats. I mean, the trend is clear.
Dr. Moira Gunn:The goal is for animal testing to be retired. It seems to me that Geno Skin is fits right in with those trends.
Dr. Eric Merle:Absolutely. It's a, a desire of the greater public. It's a request of the regulatory bodies. And, it is a need of the pharma and biotech industry, to do better, to, have better solutions. The attrition rate, the failure rate 90%.
Dr. Eric Merle:So we can improve that, and by obtaining or having the ability to obtain human data before you do any testing in human not only makes it less risky, but it will improve, the number of drugs that will be developed. It will improve our understanding of those pathways, our understanding of how we can solve, a little baby's uncurable disease.
Dr. Moira Gunn:Now many people don't realize it, but it's, on average, 12 to 15 years from the lab bench to an approved product. As you say, 90%, like 1 out of 9 succeeds somewhere in there, 1 out of 10. What in that process can accelerate, and what do we have to live with? What how could it be shrunk, if you will, versus, well, some of this just takes time?
Dr. Eric Merle:It takes time. Recruiting patients even in the clinical trial takes an enormous amount of time. Reproducing that diversity, finding patients that are of different age groups, finding patients that are different different ethnic backgrounds, that takes time. The sheer, ability to find patients that are willing to test a drug that's unknown, That takes a lot of time. And the the preclinical aspect that's currently being done essentially on animals and also on cell cultures, that may be human cell cultures, but they are cell cultures.
Dr. Eric Merle:So they don't reproduce the 3 d environment, which is our organ. There's not the metabolism, that you have in a normal human organ. So that period of time that's in the preclinical stage, that usually takes on average today in in drug development about 5 to 7 years, that can be shortened, because the data that we can obtain can be human data already. So you can really compress that 5 to 7 years. And you were mentioning 9 drugs.
Dr. Eric Merle:Well, can we think that maybe it won't be 1 out of 9? Maybe it'll be 3 out of 9? I would, maybe be shocking and say, why can't it be 9 out of 9? Why can't we be certain that a drug will work in a human and that the question isn't whether it works or not, but how well does it work? And then our efforts are on developing the better drugs.
Dr. Moira Gunn:Well, I have to say, Eric, going back to the idea that you are research partners with these drug companies, It's almost like every relationship. And within that relationship, every project you have pushes that frontier forward.
Dr. Eric Merle:It does. It's exciting every day. So, we have projects with partners that are, short projects, take a couple months. We have projects that are now year long projects where we are part of the drug development. The industry is changing, and, we are very fortunate to be part of it.
Dr. Moira Gunn:Well, I've been waiting till the end to finally ask you this question. Where do you get the skin?
Dr. Eric Merle:There are plenty of surgical procedures, today that skin is, can be sourced from. And, there are a lot of patients that undergo surgeries such as tummy tucks that want to get rid of that skin. And when you tell them that they have the ability to participate in research as an alternative to animal testing, but also an alternative to some human testing, a way of accelerating drug development, most people will say, you know what? Instead of throwing it away, please use it.
Dr. Moira Gunn:That's amazing. I do want a tummy tuck, and I can actually do good at the same time.
Dr. Eric Merle:You can.
Dr. Moira Gunn:You can. Eric, this was just terrific. I hope you come back and see us again.
Dr. Eric Merle:It will be a pleasure. Thank you very much, Moira.
Dr. Moira Gunn:Doctor Eric Merle is the chief business innovation officer at GenoSkin. More information is available on the web atgenoskin.com. That's GenoSkin, genoskin.com.