Success at multimodal, multi-indication, deep-pipelined Incyte—where commercial operations are as familiar as pre-discovery activity is—begins at the earliest opportunity to achieve research and discovery efficiencies. The company’s a bit larger than those we typically cover on the Business of Biotech, and that’s okay! Sometimes, the smartest approach to creating your own masterpiece is to study the masters On this episode of the podcast, we sit down with Incyte’s Group Vice President and head of its Inflammation and AutoImmunity Group, Jim Lee, M.D., Ph.D. for a dissection of the company’s approach to the comprehensive and efficient R&D that leads to repeated clinical and commercial success.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
Success at multimodal, multi-indication, deep-pipelined Incyte—where commercial operations are as familiar as pre-discovery activity is—begins at the earliest opportunity to achieve research and discovery efficiencies. The company’s a bit larger than those we typically cover on the Business of Biotech, and that’s okay! Sometimes, the smartest approach to creating your own masterpiece is to study the masters On this episode of the podcast, we sit down with Incyte’s Group Vice President and head of its Inflammation and AutoImmunity Group, Jim Lee, M.D., Ph.D. for a dissection of the company’s approach to the comprehensive and efficient R&D that leads to repeated clinical and commercial success.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
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Matt Pillar:Wide-ranging success is no stranger to the pharma company Incyte. The company boasts eight approvals, all but one in its oncology, inflammation, blood disorder and GVHD portfolios. The most recent commercial win for the company has come from its most recent major endeavor into the dermatology space. That effort has been fueled in large part by the addition of Dr Jim Lee, group VP and Head of Inflammation and Auto Immunity at the company since 2018. Right about the time it dove headlong into the dermatology space. I'm Matt Pillar. This is the business of biotech and on today's episode we're sitting down with Dr Lee for an inside look at managing R&D and pipeline progress in a large, multimodal, multi-indication company. Dr Lee, welcome to the show.
Jim Lee, M.D., Ph.D.:Thank you, it's nice to be here.
Matt Pillar:It's really nice to have you, I appreciate you coming on and, as I mentioned, insight is decidedly a multimodal company, having successfully developed and commercialized both large and small molecule therapies in those multiple indications that I mentioned, and I want to get a sense from your perspective how this multimodal kind of broad indication environment impacts the research function at a company, at a larger company, larger than we typically cover, frankly, on the business of biotech company like Incyte. So I guess I'd start at the highest level. What's strategic at Insight about this multimodal approach? Why not just focus on biologics or just small molecules, or maybe just focus on oncology or a specific indication?
Jim Lee, M.D., Ph.D.:That's a great question and it really comes down to our DNA at Insight and that's keeping the patient out in front and center.
Jim Lee, M.D., Ph.D.:But we're trying to figure out how we can develop a drug for patients but utilizing our science. We have a great group of biologists, of chemists, and so we're agnostic to the modality. Whether it's a small molecule or a biologic, we first look at the diseases we incorporate and come up with a list of potential targets that can help these patients and then we try to figure out a way to develop a drug for these patients. And sometimes it's a small molecule that you apply onto your skin. Other times it would be a biologic that you inject in yourself. So it's really we seem to be taking a multimodal approach and it's really because we utilize the best science to try to figure out or try to develop and get drugs approved for patients. That's really how we think, that's our approach that we take and as a result, it doesn't look like we take or look at develop multiple types of drugs biologics, small molecules but it's just the opposite we look at the patient and then we figure out what the best approach should be.
Matt Pillar:Yeah, yeah, I mean it's a logical approach, one that can certainly create not complications but complexity. I guess when you take a patient first approach and then you pursue the modality or the target or the indication that makes best sense, and you do that in an iterative fashion, in multiple places with multiple patient groups, you end up with the necessity of a lot of intellectual property, a lot of expertise in different areas. I'm thinking at it from a very simplistic point of view and I'm curious how that impacts the research function. I mean, I want to get a sense for how the research function gets structured at Insight. As a result of that, we'll choose the best, most efficient path to patient centricity.
Jim Lee, M.D., Ph.D.:That's another great question, and is it clear.
Matt Pillar:I mean you understand where I'm going with that question.
Jim Lee, M.D., Ph.D.:I hear you because you're right. It's as you try to develop multiple options for patients. That does increase the complexity of the things that we do because of all of the drugs, all of the various pathways that need to be considered. So it does create complexity, and the way we address that complexity is to structure ourselves by function. So within the R&D function, we're basically broken up into clinical development research, which include biology and the chemistry, and then we also have our chemistry. Manufacturer controls is what we call the CMC group, and so that's how we're broken up by function.
Jim Lee, M.D., Ph.D.:But in terms of the project work itself, that's really done via a matrix environment. We have representatives from all the different functions clinical, regulatory, et cetera that contribute and make sure that we have considered all of the critical things when you develop drugs, and obviously those change depending on the stage of the drug. But so, in terms of how we're structured, we have the functions and then, in terms of the processes that we use, we use a matrix, team-based approach to develop drugs. We think that's the most efficient, at least for us. Obviously, other companies take slightly different approaches, but for insight, that's been successful and we continue to use that approach.
Matt Pillar:So there's not like an oncology R&D department and a dermatology R&D department.
Jim Lee, M.D., Ph.D.:No. So we do have therapeutic area focuses in the clinical development group, but for the most part that's really the only area where we have separate groups, just because of the specialized nature of the different diseases that we study. So obviously oncology, hematology, those are all very specialized areas and so for the clinical development stage we do have those different therapeutic areas. This one of the therapeutic areas that I head up the inflammation and autoimmunity group but all the other groups really are broken up by function chemistry. We don't have a separate inflammation autoimmunity chemistry group. The chemistry team works on different projects and if it happens to be an inflammation autoimmunity group that's great, but they don't belong into that sort of separate, distinct function. It's really only the clinical group that is broken up by therapeutic area.
Matt Pillar:Does that create a very specific, I guess, sort of persona, Like, let's say that you're looking at adding some research scientists? Does that approach dictate sort of the approach that the company takes in terms of the specific research scientists that it pursues? I guess? Does that have an impact on the type of talent that you're looking for to join the R&D departments?
Jim Lee, M.D., Ph.D.:Absolutely, and so when you're in a therapeutic area, you get experience. That's the type of person that we want to bring on board from the outside to join our team. We do bring in people who are less experienced and obviously they get training, they have exposure to the therapeutic area, but when we look outside for external candidates, we definitely want experience in the therapeutic area of interest. In my case, when I hire I look for people with experience in the dermatology space.
Matt Pillar:Yeah, which you have plenty of. I'm sure you can recognize that experience in a hurry, given you're we'll get into that in a little bit, some of your experience in the dermatology space. But I'm curious also about the research strategy there. I guess the molecular discovery slash, acquisition slash, partnership strategy. There are a million ways to build a pipeline. You can turn to academia and acquire novel molecules that are newly discovered. You can buy novel molecules that are at any point in there and their design, development or even clinical stages. You can rely solely on internal discovery and come to market with your own thing. What's the modus operandi at insight?
Jim Lee, M.D., Ph.D.:As you mentioned, there are many different approaches to build out your pipeline and then to continue to grow your pipeline In. Our main focus is we have such good scientists biologists, chemists that the core, most of our projects, most of our molecules are developed internally. They're identified internally and then we work on them and many of those projects get into the clinic, into human studies. But we also recognize that not everything you work on is going to be successful. We are doing research and so we're doing experiments and we don't know what the results of those experiments are going to look like.
Jim Lee, M.D., Ph.D.:We understand there's always going to be an attrition rate internally for our projects. We have to also supplement our internal research with potential business development, licensing or acquisitions, collaborations, as you say, with academic sites to look for, understand potentially new targets for the diseases of interest. We pretty much take all of the things that you just said. We do consider that. But our main core of what we do is really internal developing molecules, getting them to the clinic and developing on ourselves. But we also recognize that you would be foolish not to look at the external environment for potential partnerships.
Matt Pillar:You briefly mentioned failure and I'm curious about this.
Matt Pillar:Failure being sort of the I don't want to say the norm, but the common denominator in early drug research and discovery.
Matt Pillar:Failure is an interesting thing in this space because it's not always black and white.
Matt Pillar:There are varying degrees of potential for therapeutics at the discovery stage and decisions have to be made from a business perspective about is this close enough to failure, to shelve it, to can it, or is this maybe close enough to showing signs of potential success, to maybe put it on a back burner and revisit it, or maybe put some secondary resources on it while we pursue more promising options? It's a very broad gray area and when you have that and when you have individuals, humans, human beings who are invested in their daily lives in a specific project, you have inevitably emotional and professional connections to those projects that sometimes get shuffled, sometimes get canned, sometimes get shelved. So it makes me curious, in an environment like the one at Insight, where there's a lot of activity going on and a lot of different modalities and a lot of different indications, what sort of competition internal and healthy I don't mean this in a negative way but what sort of healthy competition may or may not exist at Insight for the resources to move a project forward.
Jim Lee, M.D., Ph.D.:I think you mentioned it that we are very emotionally invested into the projects that we're working on. The reason for that is we learn about the disease state, about the patients and the suffering, the unmet needs as we progress the project. It's natural to invest some emotion into that. That does complicate decision making and it's a good thing that it complicates decision making, because we always want to keep the patient front and center. But, as you say, when there's some data, we run a study and perhaps the study is not what we expected, what we'd hoped for. That leads to decision making in terms of prioritization Do you continue, do you invest more resources, or do you then terminate or hold the project and deploy those resources into another important area? Those are questions that we all struggle with.
Jim Lee, M.D., Ph.D.:Throughout my 25 year career at various companies, it's an ongoing challenge to make that decision.
Jim Lee, M.D., Ph.D.:But ultimately you go back to data and you really try to make a data-driven decision, looking at the data objectively and really setting aside the emotion, the biases, even though it can be very painful for many individuals knowing that you're walking away from a disease.
Jim Lee, M.D., Ph.D.:But if you take the data and look at it objectively, if it's not going to really help the patients. I think that has to be part of decision making. If the data isn't good enough where it's going to help the patients, then you have to make the decision that obviously you should stop that program and deploy and focus on another disease, another program that can help either the same set of patients or perhaps a different disease condition. So that's how we think about it. In terms of that creating any internal competition, it really doesn't, because as long as the organization is really focused on patients, I think everyone can agree, and does agree, that we've made the right decision, and then any potential competition among resources or for resources within the organization, they really never materialize. And so I think that's one of the things that INSIGHT does so well is we're on it together, we're one team, and when we do make a decision, yes, certain individuals, certain project team members will be disappointed, but we get over that, we move on and then we focus on trying to help other patients.
Matt Pillar:Yeah, sort of the old saying and God we trust, all others bring data, All others must bring data right. I want to try to get a sense for you know, obviously without physically being there and seeing the quote unquote operation, I want to ask you to try to help give us an illustration of what the R&D function at INSIGHT looks like. So maybe share some stats, if you can around, like people and facilities and just what it looks like there, like what it takes to keep this big multimodal multiplication engine on its toes.
Jim Lee, M.D., Ph.D.:So we have approximately 2,400 employees spread across three continents countries, so Europe, north America and Japan. A little over 1,000 of those 2,400 patients are scientists and work in the R&D space. Our main R&D hub is here in Wilmington, delaware, where we have two laboratory buildings and many of us, even though we're in the research space, many of us don't work or work in the laboratory buildings, and so it's very resource heavy and intensive company. We spend probably 44, 47% of our revenue. We actually reinvest that into R&D, so we're one of those companies that you know we put a lot of resources into developing these drugs, and so it's a very large part of the inside culture, it's a large part of the organization, and so it's if you work in the R&D space like I do it's a great place to be.
Matt Pillar:Just a quick follow up on that. I'm curious. You know you can, to the extent that you're able or willing to share. When you came on in 2018, as I said, you came on as the head of inflammation and autoimmunity at the company your appearance on the scene kind of coincided with an added focus on dermatology. When a new program comes into view at InSight, is it immediately given the same access to no-transcript?
Jim Lee, M.D., Ph.D.:It's. Eventually it does get there. You know, it's like any research project earlier on there's healthy skepticism, as there should be, in terms of the potential for that project, and as you generate data and the data looks very promising, then obviously the company has invested a lot more resources into the dermatology space as well as other immunology projects. And so, just to give you an example, when I joined the company five years ago, I think, in my group there are five of us and within the larger inflammation audit in me space, within the various functions, there are total 50 people working on these projects and right now I think we have over 300 people. So it's been a steady growth and at various milestones, when we've looked at the data and the data was very good We've obviously Insight has obviously invested a lot more resources into this space because of the opportunity to help patients.
Matt Pillar:Yeah, just to wrap up sort of this section on sort of the I guess illustration or description of the R&D function at Insight. If you were looking at, you know, I guess, if you could go back in time and give Jim Lee you know, dr Jim Lee and his more formative early years of R&D management, specific to management like managing the departments, managing the people, if you could give yourself some advice going into this, this endeavor, what would it be? And I'm sure there you know we could probably go very long on this, but maybe give us some of your best nuggets.
Jim Lee, M.D., Ph.D.:Yeah, I think, knowing what I know now, what would I tell my earlier self?
Jim Lee, M.D., Ph.D.:I think it's just can always stay on top of the science, stay on top of the research, not only in what you're working on but others are working on, because you just don't know when that next opportunity will come up or present itself, and whether it's an internal discovery or another company approaching you, having the broad breadth as well as expertise in our space.
Jim Lee, M.D., Ph.D.:It's immunology that's going to serve you well and it's really about following the science, understanding all of the scientific pathways, the pathogenesis of the very diseases, because, you know, science is a slow process. I mean, if you think about it, Jack inhibitors were discovered probably 30 some years ago, and only about five or six years ago was it really observed that it could help a disease called vitiligo, and so it took a long time, 25 years, before someone connected the Jack stat pathway to actually working in a disease, a condition like vitiligo. So that's the advice I would give my younger self is always stay on top of the science, always continue to read and look both internally and externally at new pathways that can help patients. Yeah, very good.
Matt Pillar:Like I said, I want to get into a bit of the story about how you came on the scene at Insight and in order to do that, we need to sort of take a retrospective of Dr Jim Lee's career. So your previous three posts were on the derm space, as we mentioned, you were CMO at Graceway Pharmaceuticals, vp and head of clinical medical dermatology at Stiefel Stiefel, stiefel, stiefel, stiefel, stiefel you need to brush up on my German. I think that's German, that's great and you were chief medical officer at Dermavant Sciences. So, as I said, it's really no coincidence that you would join Insight at this juncture, just prior to its establishment of Insight dermatology. So tell us the story, I guess, of that move to Insight, the company's subsequent focus on dermatology and where the Dermatology is and where this head of inflammation and autoimmunity role at the company kind of intersects with the dermatology effort.
Jim Lee, M.D., Ph.D.:No, I always say it's better to be lucky than good and opportunities arise, and if it's a good time for you to consider these new opportunities, then you really should consider yourself very lucky. And then that was the case. When Insight approached me five years ago a little over five years ago actually they had an opening for the head of the inflammation autoimmunity group, and so when I looked into the opportunity and learned more about Insight, I saw that it really matched up with what I was looking for, and that is a company that's patient focused, that has excellent science and have good molecules to work on. And so those are the main reasons why I joined Insight, and it's been a great five years. I'm actually very, I feel very fortunate to have this opportunity to develop drugs. We've gotten two approvals with Ruxalbit Cream. We're advancing other drugs Hopefully we can get approved in the next few years and so it's actually for me, it matched up perfectly with what I was looking for.
Jim Lee, M.D., Ph.D.:And to your early question, how did that line up, or what did my previous experience do? Well, when you work in the field, I'm not a dermatologist. I actually was going to be an academic ophthalmologist. That's how I started my training after my MBPHD and realized that I probably to focus in on research I probably should have should get out of a surgical subspecialty, and so I finished up in internal medicine and happened to start working at 3M on asthma studies of all things, worked on asthma studies for a couple of years and then was able to start working on a topical product called Aldera, which got three approvals basal cell carcinoma, actinic heritosis and genital towards.
Jim Lee, M.D., Ph.D.:And that was my foray over 22, 23 years ago into the dermatology space. And, as I've been, I've just been very fortunate to have been able to work on at companies that focus in dermatology, but also on some great products as well, and all of that sort of helped me really look at this insight opportunity and say, wow, this is a great opportunity, it's a great company with great molecules, and so, again, it just was just my good fortune to have this opportunity come up when it did.
Matt Pillar:Yeah, it makes me curious. You mentioned a couple of times there in your response the great molecules, right, and when you're, you know, when you're a scientist and you have the opportunity to work on great molecules, it's obviously intriguing. But it makes me curious about, like, when you were in that sort of recruiting stage and getting a look at the company and you know, rationalizing the move in your own head, how deep behind the curtain does a company like Insight allow a recruit in a role like yours to analyze what it's working on, right? Like I mean, obviously you're going to be very deeply ingrained from day one, but at the same time you know they're not going to have a parade of potential people walking through their labs analyzing the R&D function, right, I mean, there's some secret sauce there. It just makes me curious, like how far do you press that when you're looking at a new opportunity and how much do they let you in?
Jim Lee, M.D., Ph.D.:Yeah. So you know they didn't let me do a deep dive, obviously, and they didn't need to, because they had presented enough data externally out in the public domain. I could do my own diligence, you know, reading up on the data that they had generated, that they had presented, as well as in the space they were competing in, and so that's what I did. So you know, anyone who is considering a move should really do a deep diligence about the company that they're considering, and when I did that, when I learned more about Insight, it was clear that they had some very good molecules and good products that had a lot of potential, and that's what excited me about the opportunity and really swayed me to come over and join the team.
Matt Pillar:Previous to the three roles that I just mentioned in the Derm Space, you were director of immunology at SENTACOR, which is obviously focused on antibodies. I think their biggest claim to fame today is in FLEXIMAB. That makes me curious how your sort of straddle of the large and small molecule research worlds influenced influences your personal drug discovery approach or your philosophy.
Jim Lee, M.D., Ph.D.:Yeah, it had a significant impact on how I think about treatment paradigms, treatment options for patients.
Jim Lee, M.D., Ph.D.:It was my first exposure to the biologic space and I was able to work on used to KAMIMAB, which eventually became Stellarra, and, ironically, we had a molecule in the freezer that eventually has become Tremfaya.
Jim Lee, M.D., Ph.D.:That was approved many, many years later, and so it was a great experience, a great company. Obviously, they were part of Janssen and J&G at the time, and so getting that exposure to the biologics was very helpful in terms of how I had luck at things, because since I left and subsequent jobs and positions, I've always looked at biologics and clearly since then the use of biologics has grown dramatically. They've really helped a ton of patients and so you really do have to look at biologics and small molecules as potential treatment options of solutions for patients, and so, yes, it had a major impact on how I look at things. It also helped me in terms of the differences in approach, regulatory approach for submissions and the data and the differences in the presentation and the testing, et cetera and things like that. So it was a great experience, experience that I'm very grateful for, and it definitely impacted how I look at things and my approach subsequently.
Matt Pillar:Yeah. So given this patient-centric worldview, modality agnostic, I guess perspective when you survey the biotech landscape and when I say biotech I'm talking about new and emerging biopharma companies, preclinical companies, early stage clinical companies we're seeing a trend. We're seeing a lot of companies that are decidedly specific. We're seeing a lot of platform companies coming about, where perhaps it's a platform that's purpose-built and dedicated to a single modality. A lot of companies that are focused on very specific indications. What do you make of that? Does that bode well? Do you feel like perhaps that platform spinning off products in a specific place approach is maybe a little bit myopic? I mean, what's your general take on it?
Jim Lee, M.D., Ph.D.:I think it's very useful to have platforms and technologies that scientists are able to test and clinicians are able to develop, and I think, if it ultimately leads to better drugs, safer drugs, I think it's a great thing.
Jim Lee, M.D., Ph.D.:But I think, as I think your last point alluded to, sometimes people can just latch onto the platform itself, forgetting about the science, forgetting about the pathway and the disease, and that I don't think is a very useful or helpful approach, and the reason for that is you're not developing a platform, you're really developing a treatment, and so the platform, if it can lead to a better treatment, that is a great thing, but it's not a one size fits all or never should be looked at as a one size fits all, a solution or approach we really do.
Jim Lee, M.D., Ph.D.:I mean, this is science we're doing right. Human body is very complex, and so to think that one thing is going to be the cure all for everything is probably not likely going to happen, and so it's a great tool. It's a great addition to the armatarium in terms of addressing and trying to solve solutions or solve problems, and I think, if you're presenting it as sort of the next best thing since sliced bed, it's probably an overreach, but I think it's an important advancement and an additional tool that we have access to to get patients better drugs.
Matt Pillar:Yeah, I want to jump back real quick to some of the commentary you're making about your former, your academic years. Right, when you're you know your move is like lateral moves, like ophthalmology, dermatology right, you kind of covered a lot of ground there. But when you were, you know, when you were considering back, when you were considering practicing, when you were considering, you know you were perhaps staying in an academic and ophthalmological research. What, when you decided to make the move to industry? Obviously you did that for for some specific reasons, there's opportunity, you know, opportunity to reach more patients, etc. But at the same time that's a it's a considerable move. I mean, it's a different, it's a different world, there are different expectations. I guess the question I'm getting at is like what were, what were the primary motivations and what were the primary anxieties? You know perhaps that that you pondered before you made that move.
Jim Lee, M.D., Ph.D.:No, it's a fair question. You know, I really hadn't thought about a career in the pharmaceutical industry or clinical research space. You know, when you, when you train in medicine and when you're doing research, you don't get exposed to that side, or at least I didn't back back in the 90s. And so during my training you do this first time I get exposed to clinical research and it intrigued me because basically, you're asking a scientific question but you're you're testing it in human subjects, which is very complex and challenging environment, to, to, to run experiments, and so, and as I learned more, I became very intrigued. And then I learned more and realized that area was a great space to apply sort of the scientific knowledge, the information, into into human diseases. And that's when I really became interested in a career. And so once I learned more, once I learned about what you get to do and ultimately developing drugs and taking care of you know it's great clinicians you can take care of lots of patients, but in a way, when you develop a new drug, you can take care of thousands of patients. Right, you can help thousands of individuals. So so all of those things sort of led me to to make the jump into into pharmaceutical research and, in terms of apprehension, I didn't really have any apprehension because it was a research oriented job, which is what I wanted, but it still had that connection to the patients which I also wanted to maintain.
Jim Lee, M.D., Ph.D.:And so I you know, I look back at it I really didn't know what was involved. But to your previous question, what would I tell myself? I say this is a great field, you know, knowing what I want to do, what I was interested in doing. Back then I would tell myself this is the perfect role, this perfect opportunity to the based on on what my interests were at the time.
Jim Lee, M.D., Ph.D.:And so, you know, look back on it, I just feel very fortunate to have had this opportunity to work in this space and also very fortunate to have different, you know exposures, different companies to work at, because that that in itself also I think we haven't touched upon that but every company is different and I've had many different experiences and so I've been able to see how companies, different companies, approach things, how they do things, and that that also has helped me in my current role in terms of, you know, managing processes, managing people, and so all of the above, it's it's been a great experience, great learning and I continue to learn. I learned from from everyone around here, and that's what I love to do. I love to continue to learn. I love asking questions. I'm still very curious about pathways and about why things happen, and so this has been, this has been a great career move for me, and I'm very happy that I did it.
Matt Pillar:Yeah, very good, you mentioned, you know, the, the desire to impact patients and the fact that you can still do that when you're, when you're working in pharmaceutical research and perhaps on a broader scale, right, and I think things, things are going right. At the same time, you know, when you enter an R&D lab at a mid cap or larger pharmaceutical company, as a research scientist perhaps, or even as someone who's leading those research scientists, it can be difficult to maintain that, that connection to the patient-centric kind of mission driven mentality. So so how do you maintain that? And how do you, how do you maintain that for your troops, right? Like, how do you? You know it?
Matt Pillar:I guess it's one thing If you're, if you're in the, in the, in the working in the clinical department, and you're making direct connections with physicians and practitioners who are who are participating in your trial, and patients even that are participating in your trials. But when you're in an R&D lab, is it, is it challenging to kind of like, go in every day and maintain that like, hey, what we're doing is drawing a connect, a direct line, connecting a direct line between this important work and the patient community.
Jim Lee, M.D., Ph.D.:That's a great point and it is a lot more challenging.
Jim Lee, M.D., Ph.D.:So if you're you're working in a basic research lab and it is it is because you don't have the sort of the frequent exposure, you don't have the frequent interactions with people who take care of patients.
Jim Lee, M.D., Ph.D.:And so what we try to do internally is to, to, you know, always remind people why we're doing this right, and that's the patients. And so just that reminder in itself can have have a good impact and remind folks who are in the trenches, so to speak, in terms of the research, why we're doing this and why we continue to work hard and dedicate ourselves to our work. And then we also, you know, try to get people to scientific meetings. Sometimes those meetings will include presentations on clinical topics, and so, you know, we can try to connect our employees in that way to the closer to the patient. That way, and then inside, also for our approved indications, we do bring in patients who actually asked to speak to the scientists who worked on the products, so they can thank all of the scientists for their, for their past work and continued work on behalf of patients. And so, so you know, we take a multi-prong approach to to try to help connect everyone within the company to that patient.
Matt Pillar:Yeah, I want to get back to the sort of the strategy at insight a little bit and get some understanding around you. I mean, I feel like inflammation is a good place to be because it's got so much and it's inherently connected with so many disease states, so many that, frankly, insight has a legacy, and I mean oncology, for instance, you know, and the understanding of inflammation's role as you know, a product of, or causal love, so many different disease states, it's a great place to be. I mean, I think, generally speaking, but I'm curious about how you know the strategy insight dovetails or intertwines or recognizes common threads of connection between inflammation and oncology and dermatology and even you know perhaps some of the other indications that the company has found success in.
Jim Lee, M.D., Ph.D.:You know, you absolutely nailed it there are common threats between cancer and inflammation, and so we've known that for a while. We actually have leveraged our expertise in both of those areas. And so, just to give you an example, chronic inflammation contributes to some of the many of the myeloprolipid neoplasms, the disorders that ruxalatinib is approved for, the oral version of ruxalatinib approved for, but it also contributes to many of the symptoms, the skin inflammation the topical ruxalatinib is improved for. So there's a lot of overlap in terms of the basic mechanisms that drive or contribute to many diseases that happen to be both inflammatory disorders as well as cancers. And so we you know the field has known that We've, I think we've become leaders in that space and been able to leverage expertise in those pathways, those basic science pathways in the therapeutic areas of both oncology and inflammation, autoimmunity. So, yeah, absolutely, there's lots of connections there, and so we have experts who can tell us and work in different projects that encompass both the autoimmunity space but also the cancer space.
Matt Pillar:Yeah, so they're not working in silos or vacuum, so to speak. There's a lot of interplay. Interplay there, yeah, so you mentioned the first US approval in the Insight Dermatology lineup. Was it topical Jack inhibitor approved for the treatment of eczema and vitiligo? What's next in the dermatology lineup? What are you guys, to the extent that you can share right, like, what are you guys working on now?
Jim Lee, M.D., Ph.D.:Yeah, and we continue to work on Ruxalinda cream or opselura. There are additional indications that we're evaluating. We're also we've just shared with the external community our results in atopic dermatitis in patients 2 to 11. So we're approved for 12 and above in atopic dermatitis and we've just completed, or in the process of completing a study in the younger kids, and so we continue to work broadening the age range as well as looking at other inflammatory skin disorders. For Ruxalinda cream, we have an oral Jack 1 specific molecule that we have two ongoing phase 3 programs. We've just shared the top line results of a phase 2 program in Parago nodularis, a different inflammatory disorder of the skin, and so we continue to invest in dermatology as well as looking at other inflammatory disorders. So those are the main things that we're doing that are going to come up in the next few years for our therapeutic area, and obviously we're continuing to look at other targets, other diseases that we can evaluate so that we can bring better medicines to patients that need them.
Matt Pillar:Yeah, do you have a forecast or any forward looking statements on the role of biologics and dermatology perhaps and I ask that question sort of selfishly because the show is primarily focused on biopharma, like we cover large molecule therapies. We have a lot of vaccine and antibody manufacturers on the show. I'm just curious what role biologics might play. Again, to the extent that you can share, I don't expect you to go too deep into the R&D lab, but is there a place?
Jim Lee, M.D., Ph.D.:Yeah, absolutely, and we're very excited that we're able to acquire a monoclonal antibody directed against the IL-15 receptor beta. So it's an anti-CD-122 monoclonal antibody. We just got into the clinic this year and hope to continue to progress it and we believe by targeting IL-15 at the receptor it can knock down tissue resident memory cells, so CD8 positive tissue memory cells, resident memory cells, and so that's an exciting target for us and at least from a therapeutic area perspective, our first four are way into biologics. Obviously, insight has been working on a number of different biologics. We have a couple one approved, and so it's nothing new to INSIGHT. But for our therapeutic area it's our first biologic and we're hoping obviously to bring additional biologics forward and obviously that depends on the disease and the targets, because we want to make sure that we get the targets right for the specific disease. But it's an area of opportunity, an area of growth for us, and so we're excited to have that and excited to continue to work in that space.
Matt Pillar:Yeah, very good, I warned you that I was going to ask you a question that's decidedly out of your realm. If I had the chief commercial officer of INSIGHT on the show, I'm sure that we could have a lengthy discussion about the value of the celebrity of Mandy Moore as a spokesperson for INSIGHT. And I had to ask the question because I'm just going to go ahead and say it at the risk of ah, my wife already knows. I mean, mandy Moore is my celebrity crush. But not too long ago INSIGHT landed Mandy Moore as a spokesperson for some of its eczema therapeutics. Does that impact either? Like, does the momentum behind a sort of a celebrity I don't want to call it an endorsement. Maybe it's an endorsement, it's a partnership. Does that trickle down into the R&D department at all? Does it create any momentum for you guys?
Jim Lee, M.D., Ph.D.:I think we're excited to see INSIGHT, the ability to INSIGHT, to partner with someone as famous as Mandy Moore. Obviously, the primary goal is to increase awareness to patients who have eczema, let them know that they're not alone, and to obviously get them thinking about seeing a dermatologist if their disease is not adequately treated, and so I think it's great for patients From that perspective. It obviously trickles down to R&D, because even though we're in R&D, we really do care about the patient. So to see that brings us happiness. But from a direct effect on R&D, no, it doesn't have a direct effect.
Jim Lee, M.D., Ph.D.:But ultimately, I think we have 45% of our revenue we reinvest in R&D, so indirectly it potentially could, but I think it ultimately goes back to the patients and just the increasing awareness to patients that there are more than just the old topical corpus steroids and calcium and heparz other topicals available to them. And it's amazing there's 20 to 25 million Americans who have AD only about five or five and a half to actually go seek treatment. So there's just a lack of awareness out there, and even among patients who seek treatment, many of them are really not satisfied with their treatment and so it's really important we assume that everyone's seeing their doctor, that everyone's seeing their dermatology, and that's just not the case. And I think having someone, as you say, of maybe more stature, to help educate and bring that awareness is a great thing and just from an R&D perspective, I think it helps us because we know that hopefully the drug that we got to work on is helping as many patients as possible.
Matt Pillar:Yeah, that was a very good answer to a question I wasn't even sure I should ask because it was just sort of an ooshiny thing that I thought, oh, I got to ask him about Mandy Moore. But you gave a very good response to my left field question. Dr Lee, what milestones are next for you If you look at your immediate horizon in the R&D department there and the work that you're doing? What's next on your plate?
Jim Lee, M.D., Ph.D.:Yeah, so it's continuing to develop the drugs that we're working on. I think I mentioned earlier we're not done with Ruxaline Lymph Cream. We're working on the oral jack one. We have this new monoclonal antibody. We continue to look for additional assets that could help patients, and so that's really.
Jim Lee, M.D., Ph.D.:The next step is just continuing to do what we've been doing, always focusing on developing drugs for patients, and sometimes it sounds hackneyed, it's overused a lot, but it is really what drives us. What drives me is we want to help as many patients as possible, knowing that we're not going to be able to help everyone, but if we can help as many people as possible, then that would give us the people in R&D. That's what gives us job satisfaction Because, as you said, a lot of us we're sort of working the lab, not really well connected, but when we find out and we get to work on a drug that ultimately helps somebody, it's very rewarding. It just makes you feel like you've really helped society and helped people out, and that's for many of us that's a very important part of our lives.
Matt Pillar:Yeah, yeah, I imagine. Yeah. Well, I appreciate it. Dr Lee, I know we're short on time here so I'm going to let you get on with your day, but I do really appreciate the opportunity to get to know you a little bit and for the peek behind the curtain of the R&D ops there at Insight very insightful, for lack of a better word, and very much appreciated.
Jim Lee, M.D., Ph.D.:Thank you very much, enjoyed our conversation.
Matt Pillar:So did I. So that was Incyte's Dr Jim Lee. I'm Matt Pillar and this is the business of Biotech. We're produced by Life Science Connect's Bioprocess Online, which offers a trove of pure generated content for biotech leaders at bioprocessonlinecom. If you like listening in on conversations with biotech leaders like Dr Lee, subscribe to the business of Biotech podcast and sign up for our newsletter at bioprocessonline. com/bob. Also, be sure to leave us a review, Let us know how we're doing and, as always, thanks for listening.