Dr. Khanna: Comparative oncology 2.0 describes an approach to further incentivize these types of transactions that have already occurred. How do we get more human health companies to realize that they can generate revenues from an early transaction that comes before potentially a full human approval? It doesn't have to, but it could come earlier than a full human approval. And that's attractive to them because they know that ahead of them has a 9% chance of failure to approve a human drug. And this allows them to create some revenues from the research they've done to get a drug to the point that we're talking about in this example.
Dr. Venable: Welcome to the Veterinary Cancer Pioneers Podcast, the show where we delve into the groundbreaking work of veterinary professionals who are dedicated to advancing the field of veterinary oncology. I'm your host, Dr. Rachel Venable, and I'm thrilled to embark on this journey with you.
Hello, and welcome to the Veterinary Cancer Pioneers Podcast. I'm your host, Dr. Rachel Venable, and I am so excited today to welcome Dr. Chand Khanna back to our podcast. He was on previously, and today we're going to talk a bit more about comparative oncology. And so Dr. Khanna, just to briefly go over his bio. He's done so many things, but he is the founder and board chair of Ethos Discovery. He's also a veterinarian and a diplomate in veterinary oncology. He has a PhD and did a postdoctoral fellowship in pediatric oncology at NCI. He's published over a hundred different publications, and edited a textbook. He's done so many things. Honestly, Dr. Khanna, what do you think in oncology you haven't done?
Dr. Khanna: I mean, I don't do a lot of surgery. I love surgery. And back in the day, I aspired to be a surgeon and throat did my own procedures and biopsies. But I've never done an amputation. I've never done any good surgical oncology, something I'd love to have been able to do. I see some of the cool things that surgical oncologists do now in the minimally invasive environment. That's definitely something I wish I had the skills to do. It's very cool.
Dr. Venable: Nice. Well, I think that's fair if you haven't done a lot of surgery. I feel like a lot of medical oncologists were not necessarily into surgery. I know for me, I thought I would really like surgery. I always like to watch it. But then when I started doing it as a veterinary student, I was like, no, this is too tedious and too long for me. I can't. This is just not going to work for me. But I agree. The minimally invasive stuff is really interesting and exciting what all they're able to do.
Dr. Khanna: Yeah, it's awesome. And I come from an era of medical oncologists where we did our own procedures and so lymph node resections and splenectomies and biopsies. It was sort of what you did.
Dr. Venable: And I love doing it. And I just never got enough time to do it. Nice. Now, I'm impressed you did your own splenectomy. I mean, I biopsyed some lymph but not, I've definitely never done a splenectomy by myself for sure.
Dr. Khanna: Yeah, slenectomy and, you know, biopsies and full lymph nodes, biopsy, all the biopsies, I'd love to do that stuff. And, you know, I had a great practice environment where, you know, case would come in, do staging, do the workup, do the biopsy. And I didn't have to sort of plan my day around other people's time. And so I really enjoyed that part of clinical practice.
Dr. Venable: Yeah. Well, and there's something to be said. It is hard to coordinate when you use a lot of other services. It's nice, but I've definitely ran into that where you're trying to coordinate like with imaging or biopsies, all that. It can get tough. But to switch gears, so I know we want to talk today a little bit more about comparative oncology. And I wonder if you could go ahead. I know probably a lot of people that listen to this podcast know about comparative oncology, but if you can just kind of tell us a little bit more about how it plays a role and just sort of the broader field of cancer research.
Dr. Khanna: Yeah, so from my perspective, it's a field that people in my era, we got to sort of stand on the shoulders of giants and they open the field and we're able to refine it. And the refinement from my perspective is the ability to answer questions in the development of an oncology drug destined for human use that can't be answered within conventional preclinical models, mostly the mouse, and can't be answered within human clinical trials. And so those questions go unanswered in most human oncology drug development efforts. And the consequence, in my opinion, is that the failure rate for oncology approvals is so low. You know, most more than 90% fail. And I believe that part of that failure is many of those questions go unanswered.
And so comparative oncology allows you to ask questions and answer questions that can't be answered in those other ways. And that knowledge can be applied towards a more successful drug development effort. And so that's really how I describe comparative oncology. I think the field has sort of succeeded from a number of perspectives. You know, there are comparative oncology programs within biopharmaceutical companies on the human side. There's the National Cancer Institute's endorsement of comparative oncology. Its program that currently is directed by Amy LeBlanc and was a program that I was able to launch when I was at the NCI, so I think those are the things that say that we're on the right track. I think we see now more and more non -veterinarians, non-veterinary oncologists, proposing comparative oncology trials is a solution to their problem. So it's no longer crazy veterinarians standing on a chair trying to get people's attention. It's been endorsed by others and used by others now more and more. And I'd say that for the most part, it remains an academic endeavor, something that's pursued from an academic research perspective. And I think one of the elements of the future of comparative oncology is to view it in the realm of commercial opportunity.
Dr. Venable: Yeah, I think that's interesting. I do want to hit a little bit of that between the academic and commercial, because I agree with you. I think we've always historically thought of something in academia, a lot of times because they have the manpower and the time. But something that I've noticed, I'd be curious your thoughts as well. I feel like the vet schools, they're not as busy as they were, right? There's so much more competition. There's many more private practices. And just by virtue of how they work, most of these private practices are able to see a lot more cases. I think from a commercial standpoint, it would be really interesting if we could do more clinical trials in private practice because there's just so much more to pull from. But there does seem to be this, I don't know, tug and pull a little bit between private practice. And so what are your thoughts really about that, you know, academia versus more of a private practice model?
Dr. Khanna: Yeah. And I'm not sure that I would describe it as a private practice model, but more as a self-funded commercial model. So to step back, I don't know how many years ago, but several years ago at a World Small Animal Veterinary Association meeting, Joelle Fenger and I hosted a meeting in Toronto, Canada, at a World Small Animal Veterinary Association meeting. And the topic was comparative oncology 2.0. And the idea was, whereas historically, Somebody would say, yes, this sounds like a good idea. I'm going to write a grant and get funded by a national funding body to do a study in comparative oncology. And I'll answer the question and I'll use that knowledge to help inform a drug development effort.
That's the sort of the model for the most common approach to comparative oncology, which is, in essence, in an academic endeavor. The alternative which we discussed in Toronto, and Joelle and Will led the discussion was, could we imagine a self-funded model that emerged from the growth of the animal health veterinary medical industry, whereas veterinary medicine proved itself to be recession proof and pandemic proof as a business. Animal health drug companies, biotech companies are growing, and really the growth of animal health biotech created the vision and the opportunity for a commercial transaction to occur between an animal health.
So a human health company develops a drug, licenses the drug for animal health use to an animal health biotech company. That animal health biotech company launches an animal health approval plan and approves the drug for animal health use, pays a licensing fee to the human health company. And the result of that is then dollars that can fund things by that animal health company, including its approval, but including additional studies to learn more about the drug and how it should be used, which fall under the comparative oncology agenda that I described earlier. So that transaction creates revenue to do comparative oncology studies that doesn't require an academic grant or academic approach by itself.
It doesn't mean that academic individuals couldn't be involved in this commercial transaction as people that make introduction so that that commercial transaction occurs. And it's been done. You know, we have verdinexor, courtesy of Cheryl London and Karyopharm and Anivive, and the development of selinexor continues on the human side. And really, that is a tangible example of what we're talking about. But that required the input and the knowledge and personality of Cheryl London. And, you know, she is a force of nature that we all know in our field.but there's only so much that she can do. So the question is, can we incentivize these transactions between two independent entities, an animal health biotech company and the human health biotech company to do more of this so that some of the research on the drug in the animal community isn't solely focused on an approval, but answer some of these comparative oncology questions so that knowledge goes back to the human health company and becomes part of the transaction. That's sort of the alternative view of this.
Dr. Venable: Okay. Let me make sure I'm getting this right. So you're saying instead of the traditional, you know, having to write and apply for a big grant so that you can get money to do studies, you're saying, is there a way that we could work with these commercial biotech companies where essentially like you work together to come up with the study? They provide some of that initial funding. You do the study, but it doesn't just stop with, okay, yes, this drug works in animals, now we're going to take it completely over to people. You're saying, do it in a way where there would be continuous. How would you be able to do it in a way where there'd be continuous research, like where it wouldn't just go straight over to people?
Dr. Khanna: So Comparative Oncology 2.0 describes an approach to further incentivize these types of transactions that already occurred. And I share the most mature of those examples. And there are others. So in that example, Karyopharm, the human company entered a transaction with Anivive, the Animal Health Company. Then transaction gave Animal Health Anivive the opportunity to approve verdenexor in animal health, while Karyopharm received dollars and the freedom to continue to develop selinexor for lymphoma in humans. So those two things occurred and a further incentive would involve dollars from Anivive to Karyopharm and not only to receive the license, but an additional agreement to do, let's say, a PKPD study in dogs that would help Anivive understand how best to use verdinexor. But the results would help Karyopharm in this example, to know more about how they should apply that knowledge to their human development efforts. So those transactions create dollars for both companies to execute on research and go beyond the simple transaction that is licensed. And you develop a veterinary drug, and I'll stay on the human health side to continue that effort. And so the things that don't exist to amplify that opportunity for those two groups, and all we're going to do is incentivize more of this in comparative oncology 2.0. We're not going to enter the commercial transactions ourselves necessarily. I mean, people could if they chose to, but there's not a requisite for this to work.
So one is we don't have the knowledge of the veterinary market itself, what is the veterinary oncology market, what is its size, both in terms of volume and price point. And with that knowledge, the transactions could be richer for both groups and you could do more with those dollars. And that's something that we've failed to execute on after the meeting in Toronto that I described. People have touched on that Craig Clifford and Phil Bergman have been working on that with me and others. And we've not so far been able to figure that out and figure out the partners to do that effectively. But that continues to be something we talk about and seek to solve. One of the things that was successful is to align the human FDA approval process with the veterinary FDA approval process.
Dr. Venable: So like right now, generally speaking, the way it works, you know, on the veterinary side, you know, because I've heard these studies can cost a lot of money. And so it's hard for these companies sometimes. So are you saying like there's a way now where we can get more of this PK data and things in dogs to also help with people? Because it seems like we don't often get that data in dogs. We maybe get how well the product works or how safe, but we don't get like the PK data and things. So how are you proposing? Like I hear what you're saying. It would be a way so that both we could get more information and more dollars for the human version of a product and the dog version. How do we end up doing that if it's not from grants?
Dr. Khanna: So it's from the commercial transaction between the animal health company and the human health company. So right now, the transaction is limited to licensed the rights for the use of a drug developed by a human company in animals. And that license results in the animal health company and prioritizing the steps associated with the approval of the drug through the veterinary side of FDA. And that's appropriate and reasonable. But if we knew more and could do more, then that transaction could also involve the animal health company doing studies that further the knowledge of the drug in the animal health arena and agreeing to do some studies that inform the human health agenda. And so that transaction is more involved, has more gates in it, and is richer than the initial transaction that I described. So that's how that both groups would learn more by studying the drug in animals with cancer and would agree in a transaction that would make it worthwhile for both groups.
So speaking of the FDA currently to approve of any drug, sort of there are three classical steps. One is you have to prove that the drug is safe and that safe and that's done in beagle dogs. And safe is different than tolerable. So tolerable means we can give it to pet dogs with cancer. Safe has a very different definition. It's defined by regulatory guidelines and statutes and it's executed in beagle dogs in a research colony setting. That is going to need to continue to occur. We're not going to replace, we're not going to add safety as an endpoint by that strict definition to a veterinary oncology population. That can't happen because you have to sacrifice the dogs and do histology of all, every organ in the body, and have a pathologist read it out. And that's what safety is. We're not going to do that. So that's going to continue to need to be a beagle dog study done by the animal health company. So that continues.
Item two on the list is efficacy. And that's a pivotal field study, which proves that drug works in veterinary oncology. That's going to continue to need to happen without any major changes. Not knowing that the drug works in humans doesn't change the need to know the drug works in dogs under a regulatory process. But there is a piece under manufacturing, so CMC being how you make the drug, how you fill the vial, and how you label the vial. So surely, if we give the drug the same way in dogs as we give it in humans, let's say by IV injection, for example, if you can show the FDA on the human side that you can make the drug sterilely and consistently with the correct potency and you can fill a vial and everything is good. That should be relevant for the veterinary side, but until recently that wasn't the case. So after approving that manufacturing process for a human drug, when you brought it over to the veterinary side, you'd have to repeat the process for the veterinary FDA, even though it was exactly the same use case. So we were able to work with members at the FDA who were interested by this comparative oncology 2.0 agenda, and they agreed through public disclosure of frequently asked questions that there's a reason to align the veterinary and the human manufacturing approval in a drug. So if there's a human approval and a veterinary use that's going to be identical, The frequently asked questions answer two questions. The first is if there is a human approval for manufacturing, then the veterinary FDA will rubber stamp the approval for manufacturing for animals. So that saves a step for the animal health company in their approval process. And by saving that step, that makes it that transaction more valuable, a richer transaction. So more dollars flow and can be used for doing these additional studies in comparative oncology if both groups agree. And the second piece that was agreed to by the veterinary FDA was that when the veterinary FDA approves the human manufacturing package, nothing in the veterinary approval process could damage that existing human approval. So those are the two questions that were answered publicly on the FDA website under Frequently Asked Questions. And that second piece made the human companies happy that when they entered this transaction, they weren't going to have somebody else find a problem in their existing approval and sacrifice that manufacturing approval. So that's basically what's been done to make these transactions more richer so that there's more dollars to do more studies. Some of those studies could be comparative oncology studies that lend knowledge back to the human side to better develop their human drug. So that's the essence of it. There's a manuscript, and you can provide the listeners the citation. And the citation is so Joelle Fenger and William Eward, who are the first authors on that paper. And that's basically what was described in that paper.
Dr. Venable: Kind of blows my mind a little bit to think that if they've already a company has already shown that they can manufacture a product, well, like FDA approves it, that they would have to do that again for to prove it in animals. That kind of blows my mind that that was a step. But I have a I can imagine that was a very expensive step, and probably why a lot of people maybe didn't bring it back over on the veterinary side, that's really interesting. I think most people, like myself had no idea that that hurdle was in place.
Dr. Khanna: Yeah, no, it was. And because it was incredulous to you to imagine that you'd have to go through that, that's the one that we sort of asked, why is that the case? And when we asked that question of the FDA on the veterinary side, they agreed that in the spirit of creating an opportunity to do more comparative oncology and do it within these commercial bodies, that there was a reason for them to create this alignment. And they did so, they didn't do so by creating a guidance statement, which describes this to be the process. And that would be the highest level of evidence from the FDA. So that does not exist. But they've made a public statement on this idea that I've described in these two questions. So that's that's an important step. It's not going to answer everybody's interests. They're still going to explore this. So I say wait a minute. There's not a guidance on this topic. And that's true. And somebody who's listening is going to pick up the baton and make that happen. Because I'm I'm going to step away from that and give that to somebody else to get done. But it's an important step. And the very FDA stepped up and did what they needed to do to make this happen. And the very FDA were motivated by this opportunity and saw this as a small gift that they could create, with alignment between them and the human FDA to get it done.
And there are going to be situations where that alignment can't happen. So, for example, if the drug is going to be given I.V. in the human and subcu in the dog, that's different enough that it'll need to go through another CMC approval. And there are probably other nuances where that will happen again. But for the most part, a CMC approval now has value in the transaction beyond the license to use the drug in animal health. And that is the knowledge that I hope this podcast brings attention to. So people in the biotech community see that there's more that can be done in these transactions than simply licensing for the use of the drug in animals.
And somebody who's listening is going to pick up the baton and make that happen because I'm going to step away from that and give that to somebody else to get done. But it's an important step and the veterinary FDA stepped up and did what they needed to do to make this happen. And the veterinary FDA were motivated by this opportunity and saw this as a small give that they could create with alignment between them and the human FDA to get it done.
Dr. Venable: Yeah, no, I think that sounds huge. I mean, it sounds like it's two separate companies that would have like a, even though it could be, let's say, a similar version of the same drug, but the human version and the animal version, how do we get these two companies to talk or how do you find companies to put together?
Dr. Khanna: That's a really important question. So out of this Toronto meeting, figuring out the market in veterinary oncology would make more of these transactions happen. That's number one. Creating this alignment between the FDAs was number two and we could checkbox that one. And number three was exactly what you're saying, which is how do we get more human health companies to realize that there's revenues that they can generate from a early action that comes before potentially a full human approval. It doesn't have to, but it could come earlier than a full human approval. And that's attractive to them because they know that ahead of them has a 9% chance of failure to approve a human drug. And this allows them to create some revenues from the research they've done to get a drug to the point that we're talking about in this example.
Dr. Khanna: So we need to bring these two groups closer together. And we've imagined that that would be done within meetings. And so bio BIO is a a meeting that is a biopharma meeting and hosting a session on this topic of synergies between animal health and human health would be a way to do that. There are other meetings that are similar that sort of where this would happen hasn't happened yet, but something that we can still do. As a follow up from this meeting from Toronto from many years ago. And as you can see, this takes a long time taking us all this time to get one checkbox out of the three done. But there are two more to still get done. What is the battery market and how do we bring these groups closer together so they can be introduced and make good decisions in their own best interest? And we're not trying to sort of get into their business themselves. We just want to make them aware that there's a mechanism for them to do good things for their own interests by working across species. And that's the essence of comparative oncology 2.0.
Dr. Venable: Yeah, I think there are a lot of companies out there, a lot of biopharma that just they think of mice. They don't think of dogs. They, you know, and I think you're right, just trying to get this message out to more of those companies, that this is something we're really trying to help everybody, you know, helping so we have more, you know, more drugs, more things we can use to treat for our pets, but then also hopefully helping the right drugs get through on the human side. Now, I know also it's really expensive to do these trials. So like for, you know, new startups or, you know, things that aren't like these big biotech companies to start, how do you see trying to help them with funding or do you think this mechanism might help those guys at all? Or is that going to be just a totally separate like grants and things like that?
Dr. Khanna: I think that'll fall to the more traditional approaches. And, you historically, there was a person in a human biotech company, biopharmac company, who was personally motivated by the idea that they could help pets. And that's often what resulted in these relationships building. But that was it. It was somebody's personal love of animals that did it. We all have that as veterinary oncologist. But you had to find that person in the human company to make that happen. Sometimes it was someone who had a scientific curiosity and a scientific sophistication to know that these dogs can answer some questions. But now what we're talking about, that there's people who can make money by having these transactions occur. And that specifically is more animal health companies buying the rights to drugs held by human companies for development of a veterinary oncology drug, but for the conduct of a study that will generate data that goes back to the human side. So that's the extension of these transactions that we're talking about.
Dr. Venable: Interesting. And I know you said it's been taking a while to get some of this message and you know, some of these different steps done. What do you think, you know, are people getting a little bit discouraged because it's taking a while? What are your thoughts or?
Dr. Khanna: So I'd say that people probably have never heard of comparative oncology 2.0. So They weren't waiting, so they've not been frustrated. You know, the people at that Toronto meeting, I think, all knew that this was going to take a long time because on the step that we succeeded on, we had to convince the veterinary FDA that there is a reason to look at things definitely, and that took time. But nobody got frustrated because the process moved forward. It moved very slowly, but it moved forward and now is done from the standpoint of the frequently asked questions. The next step is a guidance, and I don't know if that's necessary or achievable. But that's again not something that we're going to or I'm going to champion. Further, if it's needed, somebody else can step up.
Dr. Venable: Well, you certainly have done a lot. So I feel like that's fair. Are you you can pass the buck there. And you know, earlier you were talking about trials and making sure they're asking the right questions. How do you make sure involved with clinical trials. So whether you know, I think you can think of this as whether you're the researcher or involved with the research or even if you're the person who's reading the paper afterwards, like, how do you decide, like, are we asking the right questions? Are we answering the right questions?
Dr. Khanna: Yeah. So I think that you have to know what are the important questions is where you start. And they may be different. So for my use of a drug in pet animals, I may have a different agenda than somebody who's trying to learn something on how to use that drug in humans, who may have a different agenda than somebody else, another veterinary oncologist who wants to use the same drug, you know, so we all may have different agendas, but we should have the awareness to talk about the priorities of these questions.
And once we've identified the questions that need to be answered, you prioritize them. And once we prioritize them, then we build them into the study so that they can be answered. And that's probably what's not done most effectively. And that's where veterinary oncologists are still really needed is to help in the comparative oncology agenda understand what questions are important and can be answered in a dog with cancer in a comparative oncology study. That's not knowledge that many other people have. It's knowledge that veterinary oncologists have and that's really where we need them to stand up and lead these now multidisciplinary teams to do this work. It's the essence of the work we've been trained to do, but these people have to stand up and say these are the important questions and these are the important questions that we can answer in a dog that has cancer and convince the team that that's how the resources should be appropriately allocated.
Dr. Venable: So I think that's our problem in veterinary oncology. You know, if you are a veterinary oncologist and you want to get more involved with comparative oncology, how do you recommend going about that? Sometimes I think it's just trying to connect with the right people. What do you recommend if you want to help with some of this stuff? How do you meet these companies or how do you get involved?
Dr. Khanna: So I think it depends on when you develop that awareness and interest. And for me, it was very helpful to be abundantly trained by getting a PhD and then doing a postdoc at the NIH. That was all necessary for me to be able to do this. It would be very hard for me to do what I've done without those, that training. And it's not to say that that training taught me to do things that was necessarily different or new, but they gave me the credentials to have people listen to what I was saying. And so I think it would be hard if you wanted to do that stuff, to jump in and do that without that training. And I understand that there's a lot of time and a lot of years without a good salary that people have to decide to put in.
If that's not feasible or not desirable for any reason, I think these meetings are important. So VCS is a great meeting and people should go to that. But AACR is a great meeting and going to AACR as a start and then getting a little bit of an extrovert in you out so that you go to the posters and you start talking to people at posters. I think that's the easy next step. And when you talk at posters, it's usually one-on-one with the other person, and you can say, well, this is really cool, this is really cool, but have you thought of this? If you can articulate, have you thought of answering this question in a dog with cancer, then that person is going to be excited, and now you have a network that you can build and move on from. So I think not only going to those other meetings, but going to poster sessions. So I'm specifically saying, go to AACR, go to the plenary sessions where you sit down and you absorb a lot of great knowledge, but go to the poster session so you can interact and speak with people in a one-on-one setting. I think that'd be a valuable thing, especially for people who are interested in building a network and haven't done so already.
Dr. Venable: Yeah. And can you just tell us for the audience? What is ACR stand for? What conference is that?
Dr. Khanna: So, sorry, AACR. So American Association of Cancer Research. So AACR is more research-based. ASCO is American Society of Clinical Oncology, much more clinical. Those posters are going to have MD physicians in front of the posters. ACR is going to have PhD scientists in front of posters. So you've got to decide where you're more comfortable stepping in and chatting and both would be good meetings. There are smaller meetings by discipline. A great meeting that I learn a lot from is called CTOS. That's the Connective Tissue Oncology Society, and it's a small meeting, and for those people who remember when VCS was one room for one agenda for a couple of days, CTOS is that, all around connective tissue tumors, so sarcomas. These happen to be the cancers we see a lot of as veterinary oncologists, and they happen to be the rare tumors for MD physicians, so they're very excited to have venri oncologists at their meetings because we know about sarcoma and not a lot of them unless they really decide to get into sarcom and know about sarcoma. So that'd be a good place for someone who's interested in sarcoma to go and present, go and speak and sort of chat at a poster session.
Dr. Venable: Yeah, I think that's great. I hadn't really thought about the poster session, but you're right. If you go there, you're more of the one-on-one. If you're just sitting in a big lecture, you know, that's harder to make an impact. So that's a really great advice. I like those different conferences you mentioned too. And then of course, your PhD. I think you're right. I think sometimes education, it just opens the door so people will listen to you. Right? I mean, I think there's a lot of truth to that. Certainly in the pharmaceutical industry and things where I think more and more people are getting the awareness that, you know, especially dogs can be a good model for cancer. But I find there's still a lot of groups that think just it's a mouse and then you go straight to people. So yeah, know.
Dr. Khanna: So for sure that's the case, but it's, it's changing and there's more people who are becoming aware. And I think there's a risk associated with that as well. So as more people do comparative oncology,
there'll be more people with less experience doing comparative oncology. And there'll be more comparative oncology trials that don't ask the right questions. And the result of that is there'll be future disappointments in comparative oncology. So trials that don't recruit as quickly as they should have or could have. They weren't appropriately incentivized for owners. And that'll disappoint the people who were getting interested in comparative oncology. So there is a risk ahead. That risk ahead should remind us all to be excessively diligent and careful as we continue to raise the banner for comparative oncology.
Dr. Venable: That's That's true. It is something you want to get people excited. You want to get that momentum, but it's something kind of keeping that, keeping realistic expectations, it sounds like, too.
Dr. Khanna: No, absolutely. That's exactly right. So people who are convinced who are not veterinary oncologists to do this have heard this story. So quick accrual, answer scientific questions and bring back the knowledge. And then if you open the study and the accrual is poor because the study wasn't sufficiently incentivized or the design wasn't what it should have been, then that group is all of a sudden, you know, this was not as much as I thought it was and I'm disappointed. And that happens in every field. You know, there's a peak of expectations and everyone's really excited. And for me, that's when the NCI opened the Comparative Oncology program. And then there's a following disappointment that comes from people having heightened expectations and people not being as careful about how to deliver on those heightened expectations.
Dr. Venable: Yeah, true. And what do you think? I feel like in veterinary, we're kind of seeing this, I don't believe they see in people so much, but companies where they're starting to sell a product, but, you know, they're marketing it to consumers or vet clinics, but we don't really have all the data yet, whether it's a diagnostic or I think therapeutic. You have to have more, you know, USDA or that kind of thing. But what are your thoughts on that? Because it is quite expensive to do a lot of these trials and things. Where do you think there's sort of this happy medium or some kind of an approach with those? Because we don't want bad players in, right? We don't want our pet owners or ourselves getting bad products, but then you need new technology. So what's your advice as far as maybe just for vets or just sort of that incoming market in general.
Dr. Khanna: So I think for the incoming market, you know, part of the allure in diagnostics for the incoming market is that for companion animal diagnostics, there's not a regulatory process that defines when they can commercialize a product. And that is distinct for therapeutics in veterinary medicine. There is that regulatory process needed for it. So as you said, therapeutics come to us with more mature data. And if I was to sort of express my enthusiasm for those people coming to their markets with novel diagnostics, they should, but they should recognize that the absence of a regulatory hurdle shouldn't mean faster and cheaper. It should mean there's a different standard because my expectation is that our standards in veterinary oncology are going to be higher or as high as a regulatory standard. So if those newcomers come in and say, we need to prove this diagnostic works, then prove it and don't assume that you don't need to prove it because there's not a regulatory standard. And because you know it's coming, because you know you're going to have to deliver that level of evidence to the market and not to the regulator, then you fundraise appropriately and you plan your time appropriately and you do this study just like you should. The problem is that people believe that that hurdle doesn't exist because it's not a regulatory hurdle. So they don't fundraise for it. They don't prepare for it. And if they could replace the idea that it doesn't exist with a realization that the hurdle is just a different hurdle, it's a market hurdle, not a regulatory hurdle, then I think we'd all be good.
Dr. Venable: Yeah, I like that. And I think, too, as vets, we just have to continue to be diligent, whether it's oncology or dermatology or whatever it may be of just, you know, when are we seeing a good product? Is there any data? And if anything, explaining that to pet owners, because sometimes I find pet owners find these products before we do. And so just really looking through it and saying, okay, do we think this is a good idea? What are the limitations here? You know, do we know anything?
Dr. Khanna: And that's even more our responsibility when, in the example of these diagnostics, there's not a regulatory body involved in that good steward process. We become the only good stewards. And so we have to do that. And so it becomes very important. But I think it's answered by those innovators just being prepared for what lays ahead. And there is a need for evidence. It's just not a regulatory body that needs the evidence. It's the market that needs the evidence. And they get to decide what level of evidence the market should have to sell their product. But I know that things that don't work don't make money. And I believe that things that do work have a better chance of making community. So that responsibility can be planned for.
Dr. Venable: Totally agree. And I think this has been a really interesting conversation, kind of getting a little bit more into the weeds, a little bit more in depth about comparative oncology and, you know, what are the hurdles and how we can try to get more of these companies to talk and hopefully get some more of these animal health groups combining with human health or, you know, some of those companies just so we can, I feel like move the needle forward. That's always the goal. I feel like in oncology, whether it's pets or people, how can we move the needle forward this disease? And I think this is all really exciting. And I'm glad that we have that kind of, to me, seems like a crazy hurdle with the FDA. But I'm glad that that's gone. I'm sure it was quite the wall. And yeah, just talking more about these new products and sort of just keeping realistic expectations. So I think this has really been a great conversation. And then whenever we wrap up, I always like to ask, you know, who is someone else that you think would be a good fit on this podcast?
Dr. Khanna: Yeah, well, thank you. Thank you for the opportunity. I know we dig into the weeds and it's sort of like glassy eye for some people when you get bored and you're hearing about CMC and this and that. But it's important stuff. So I really appreciate your interest and the opportunity to get other people interested. And I would say, to answer your last question, Joelle Fenger, is sort of a leading this comparative oncology 2.0 agenda as well and would have an interesting and important perspective because she's got the energy and time to continue this effort longer than I do. And I'm officially on this podcast passing the baton to her. So if you want to know more, she's going to carry it.
Dr. Venable: I love it. We will definitely reach out to her. So thank you so much. And Again, Dr. Khanna, thank you so much for being on this podcast. We really appreciate it.
Dr. Khanna: Thank you very much. I enjoyed it. Well, that's it for this episode of the Veterinary Cancer Pioneers podcast.
Dr. Venable: Well, that's it for this episode of the Veterinary Cancer Pioneers podcast. If you enjoyed this episode and gained valuable insight, we would be so grateful if you could share our podcast with your friends and colleagues. And it would be even more wonderful if you want to give us a five-star rating, positive review, or any kind of feedback on Apple Podcasts or wherever you listen. The Veterinary Cancer Pioneers Podcast is presented to you by ImpriMed.
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