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This is the Leap Together podcast, where we highlight top leaders driving breakthroughs in clinical research and life sciences.
Most importantly, I think it's what we do for our patients and what the patients actually unknowingly give back to us. I think I still remember one of my patients, as we were talking about, you know, how the disease really impacted him and what it means to like navigate around living with it and the hardships. He said something that really stuck. He said that I started living with the disease and not dying from it and that helped change his approach to how he was living with it. And that really was something that impacted me.
Dr. Kulkarni:It's really what these patients have to say to us and the impact they have helping me continuing to try to improve outcomes for them. And what keeps me in this field really is the strength of the patients that I meet. So I'm thankful for my mentors, my family, and the patients that I've had the privilege of helping and working with.
Zach:Hi. Zach Gobst here. I'm the host of the Leap Together podcast where I speak with leaders in clinical trials to explore how medical breakthroughs come to life. This episode is brought to you by Leapcure, the equitable leader in patient engagement and recruitment for clinical trials. Leapcure is equitable and empathetic process, accelerates research while empowering patient advocacy.
Zach:Hundreds of studies and millions of patients across more than 50 countries have used Leapcure to contribute a participation average of 62%. Visit leapcure.com to learn more. I'm really excited about today's guest, doctor Teja Kulkarni. She's a trailblazing pulmonologist and the director of interstitial lung disease at University of Alabama at Birmingham, where she's leading groundbreaking clinical trials and translational research to improve care for patients living with pulmonary fibrosis. She also holds national leadership roles in pulmonary societies and multicenter initiatives helping shape the future of ILD care and elevating standards across the field.
Zach:And what I love about doctor Kulkarni is how powerful she connects science, education, compassion, whether she's driving protocol innovation, mentoring colleagues, or building more equitable access to care. Her work is deeply rooted in real world impact for patients' communities. We've seen it up close for maybe four years now and just excited to have you on the show. So, yeah, doctor Kulkarni, thanks so much for being on the show.
Dr. Kulkarni:Thank you for this opportunity, and I'm excited to be here today.
Zach:Yeah. So let's start at the beginning. What inspired you originally to pursue pulmonology and and ILD? Where did that come from?
Dr. Kulkarni:That's you know, it feels like I'm back in an interview for fellowship. But, really, my interest in pulmonology in general started, early during medical school where cliche, my mother had asthma, and so I've been reading more about it. I thought it was really interesting and then led me into projects looking at the impact of occupations, especially construction workers on lung disease. You know, that followed a master's in, environmental and occupational health. And from there on, like, you know, really, I built on my interest in pulmonary diseases in general, but it was really when I started my fellowship that I was first drawn into pulmonary fibrosis.
Dr. Kulkarni:That's where I really, got the most exposure. It was really through the influence of inspiring mentors that doctor Thanical, doctor D'Andrade, doctor Will Clark, who had been working on the in the space and seeing their deep commitment to patients living with pulmonary fibrosis, especially in an era when for idiopathic pulmonary fibrosis we really did not have any treatment options. And, you know, seeing their compassion and their passion to advance care, doing research in a space that really we did not know a lot about, was really, you know, what drew me into this field. But then as I began to learn more, I found that the disease itself was intellectually fascinating. And then, clinically, it's so challenging.
Dr. Kulkarni:It's complex. It demands, like, a nuanced approach to diagnosis, and there are so many management questions that come up. You know, even if you think, oh, well, this is idiopathic pulmonary fibrosis, and, well, we start off with any fibrotic therapies. And each patient responds differently to therapy. Their, clinical course is unpredictable, and that takes skill and compassion.
Dr. Kulkarni:And, you know, I I just found this field really fascinating. So what began as, like, an academic interest then grew into a deeper commitment. And by the time I was done with fellowship, I knew this is what I wanted to do, that I wanted to help people living with pulmonary fibrosis, try to make, like, a meaningful difference in the lives of these patients. Trying to make an impact on how patients live with this disease is something that has become a very deep passion for me.
Zach:That's that's amazing. So next, tell me a little bit about, you know, what really goes on with ILD patients when a patient gets diagnosed for you and for the patient? What what's the experience that's going on for for each of you?
Dr. Kulkarni:That's a that's a very important question. You know, living with pulmonary fibrosis involves a lot more than just managing a progressive lung disease, a disease where we don't know what the disease course might look like, where there's a
Zach:lot of
Dr. Kulkarni:unpredictability. It deeply affects a person's identity, their relationships, and really what it means for life for them. You know, even the time that they have left, not knowing how the next day might look like, how they're gonna work with all the challenges that come with it. And understanding that, especially from the physician standpoint, it's not really as intuitive because we are trying to talk to our patients about so many different complex aspects of the disease itself, but the treatment options and managing the medication, monitoring the side effects that we really like to not connect with our patient on that humanistic level at every clinical visit. Right?
Dr. Kulkarni:So that's something that we need to think about more. I mean, we don't have a way to measure. There there are patient reported outcome measures, but that's not something we can easily use in clinic, or be able to get objective data to look at. We really need to think about from the patient standpoint, what does giving them a diagnosis of idiopathic pulmonary fibrosis or any other pulmonary fibrosis or interstitial lung disease means? Because as I mentioned, like, you know, not everybody knows enough about this disease.
Dr. Kulkarni:There's limited knowledge, and there's a lack of accurate, accessible information. I mean, you if you just get on the Internet and start looking, I mean, there's so many websites that don't have accurate information, but the patient doesn't know that. They don't know what they're looking for. And trying to understand that from the patient's perspective becomes really important. We recently published a survey in our attempt to understand the perspectives of people living with pulmonary fibrosis, and this actually this paper actually has several quotes that we got from our from several of the participants of the study.
Dr. Kulkarni:One of the quotes, you know, when said one participant, when asked about what it was to receive a diagnosis of IPF, felt like early on, you're waiting to die, and then afterwards, you just get to the point where you wanna hurry up and live. How do these patients perceive that diagnosis? I mean, it's it's shocking. You're giving them a diagnosis that's chronic. You're telling them they're gonna be on medication for the rest of their life.
Dr. Kulkarni:It's it's really, you know, a shocking moment for them and the caregivers. And so trying to navigate that becomes really important. Oftentimes, a lot of that first initial visit is all about, you know, helping our patient understand. But then as the disease progresses, the aspects of the conversations with our patients really change. Right?
Dr. Kulkarni:Because this disease comes with breathlessness. There's increased fatigue. There's decreased exercise capacity. There's increasing dependency, and patients often, you know, experience this loss of roles within the family, roles within their workspace if they're still working. And then as the disease progresses further, there's a loss of independence and that spontaneity that comes with, you know, with life.
Dr. Kulkarni:They're not able to just say, okay. I'm gonna get up and go because, well, I don't know if I have enough oxygen to get to that from point a to point b. Do I have enough oxygen to be able to walk through the mall or go grocery shopping? And then, you know, some patients have severe side effects from the medications, and and they're like, you know, I can't really go out because I'm scared that I'll have diarrhea, or I can't really eat out because that makes me nauseous. You know, these are these are real aspects that our patients are living with.
Dr. Kulkarni:And you compound that with this whole unpredictable nature of the disease. And, the patients and caregivers really at that point are grappling with grief, and there's the fear of dying from the or, you know, the fear of not knowing what tomorrow's gonna bring. And, you know, that's where from the physician perspective, we need to play a bigger role. We can do this by listening to our patient, but really thinking about shared decision making. How can we talk about every aspect of of management, and what can we do to help our patients honor what really matters most for our patients?
Zach:And I I like how you bring up, you know, there's there's also the caregiver education piece of this as well. And, you know, their experience is an important part and, you know, kinda curious if you could expand too. Because I imagine, like, you're trying to help patients make the best decisions for themselves and educate them based on where they are. But in that moment, they're you know, if they're going for the moment of a diagnosis, they're in a state of shock and trying to understand, like, what does this mean for my life? They're going through similar kind of moments that that can be shocking or or you don't know how they're gonna feel in different ways when the disease progresses, where these quality of life things come up.
Zach:And so it's easy to say, hey. It's important to do education, but, like, it's actually a challenge to kinda figure out how how do we kinda meet these people where they are and help them get the information they need in a way that they can hear it at this moment too.
Dr. Kulkarni:Yeah. You're you're absolutely right. No. It's just it's not just about the patient at that point. You know, trying to understand what the caregiver is going through is is important.
Dr. Kulkarni:I mean, it's remarkable how much, a lot of our caregivers that I've seen adapt to the patient's needs, start understanding what is required. But, again, education does play an important role and and trying to be supportive to them and see what resources can we provide for the caregivers for them to be able to help the patient, I think becomes becomes crucial. And a lot of support groups are now starting to do that for patients' caregivers as well. So there's not only talks that are geared towards helping the patient understand the disease, but there are also talks that are geared towards helping caregivers help their family members. And I think that's really beautiful to see.
Dr. Kulkarni:You know? That's evolving. The Pulmonary Fibrosis Foundation is trying to understand more of the patient's caregiver's perspective. And so there's actually a community registry that is open currently where it's not not just understanding the patient's side of the disease and the progress, but also trying to understand what it means for the caregivers and how they are working around this diagnosis of a progressive chronic disease, which comes with high morbidity and mortality and what they're doing to help their loved ones.
Zach:What stands out to me is and you might be quite similar to me, but kinda curious. When you talk about, like, the variability of responses that people have for lung disease, some people would be like, oh, I don't wanna like, I wanna have control over where this goes. You see it seems like an opportunity or like, oh, there's this is something I'm that that kind of, you know, draws you in in some way. I I love that because I because I think, you know, for a lot of, you know, physicians, like, there's a lot of things that are kind of, like, textbook and, like, this, then that, this you know, these are the guardrails. Your response is very different than than what think a lot of people would say when it comes to that.
Zach:So, yeah, we're curious about more more about, like, what what you're seeing in the variability and what you think draws you to it.
Dr. Kulkarni:That's a great question. Right? So when we think about unpredictability in IPF, let's start with thinking about the diagnosis. So if you sit in in our multidisciplinary conference, which is multifaceted, we have pulmonologists, radiologists, and pathologists in the room talking about a patient, trying to figure out what the diagnosis is. That brings about the nuance that that is this disease, right, the complexity of this disease.
Dr. Kulkarni:Now, I mean, if it is a typical presentation of patient, you know, older male patient who is a former smoker, comes in, doesn't really have much exposures, and the CT pattern looks like it is what we term as usual interstitial pneumonia pattern. We're like, oh, yes. This is idiopathic pulmonary fibrosis, and we'll hear the treatment options, and we go from there. But that, you know, doesn't mean that all patients fit into textbook definitions of these different types of interstitial lung diseases. So IPF is one one of the interstitial lung diseases, but there are so many others like autoimmune related lung disease, exposure related lung diseases, like hypersensitivity pneumonitis, or occupational related diseases, smoking related conditions.
Dr. Kulkarni:And there's so many more that trying to understand what which type of interstitial lung disease we're working with is the very first step. And that is often what leads to diagnostic delays, especially when we're thinking about patients who are not seen at tertiary care centers, who are seen in smaller clinics where the educational awareness is and not in-depth when it comes to interstitial lung disease, which, you know, can behave like several other conditions, that's where the diagnostic delays come in. And so it's really, like, trying to put together this facet when it comes to diagnosis is important. And then there's the prognosis. Right?
Dr. Kulkarni:There's that's a whole another can of worms. When it when it comes to prognostication and what the clinical course might look like for our patient with pulmonary fibrosis, it's variable. Majority of the patients have some form of slow progression, but there are some patients who are rapid progressors. And while we've done a lot of research in understanding the different biomarkers, blood based biomarkers or CT scan based biomarkers, we're using AI as a tool now. It's still you know, we haven't been able to standardize any of this process.
Dr. Kulkarni:And so when the patient who looks up on the Internet, you know, and comes to me or like, well, the Google says I have three to five years to live. You know? That's when all of these questions come up is how do we tell our patient what their prognosis is? What does a variable response to treatment or a variability in how the disease, will progress, really means for them? So, yes, there is a lot of, like, loss of control or what we can do and tell our patients, but that's medicine.
Dr. Kulkarni:You know? That's how that's the art of medicine, and we just have to go with it on a day to day basis.
Zach:Yeah. Now No. I love how you embrace that because I you know, and I think you started getting into it. You you being in Birmingham, there there are people that, you know, come from all over, from rural areas to to see you that might have had different levels or or different resources related to care prior to to when they come to you. And so for you to kind of, like, you know, roll up your sleeves and be curious and figure out how you can kinda connect dots for each individual, It's pretty remarkable.
Zach:I I think, you know, is is was that intentional? Did you kind of, like, design for for yourself to kind of, you know, take on a challenge like that? Or, you know, how how did you come to kind of be this position that that is helping kind of, you know, solve solve what what might have been mysterious to many people who live in, rural areas? Yeah. How did that come together?
Dr. Kulkarni:Yeah. And and I think, you know, you answered part of it. It's just where where I'm practicing. Yeah. All practice settings are variable.
Dr. Kulkarni:The types of patients you see, are variable. Right? So living in Alabama with UAB being the only, pulmonary fibrosis care center network site really serve a large patient population. So it's all you know, we're the only center serving the state of Alabama, but then there's also the panhandle of Florida, Mississippi, some parts of Tennessee and Georgia too. And and patients live in variable settings here.
Dr. Kulkarni:So learning to work with, you know, what are the needs of our urban patient population versus the rural patient population became really important really quickly. You know, we know from a lot of studies, not just in pulmonary fibrosis or ILD space, but other lung diseases or other chronic condition that patients living in a rural community face geographical isolation. There's limited access to health care, whether it be, like, outpatient access. Like, for patients living with pulmonary fibrosis, it's access to medications, access to labs for monitoring, access to oxygen, and then, like, even for the for the removed is clinical trials access. These are things that come very easily for patients who live in the urban area.
Dr. Kulkarni:It's much more accessible. And so we really had to start work thinking about it and trying to understand how best we could help these patients who are driving three, four hours to see us. And that really was how I got kind of involved in this. And then working with the Pulmonary Fibrosis Foundation who have been fantastic. There is a rural health outreach committee that started thinking about ideas about, you know, what are these unique challenges faced by our people living with pulmonary fibrosis, living in the rural areas, and starting to think about what can we do to bridge this gap, what can we do to improve outcomes among these patients, and what can we do to, like, benchmark, whether we're successful in improving outcomes for these patients living in rural communities.
Zach:Yeah. I I love how you bridged into, you know, and advocacy as well. You know, for your role, you know, what curious about, like, your relationship with advocacy, how you see your role in it. I know you also have, you know, other kind of national leadership roles, but curious about your perspective on, like, the role of advocacy as it relates to the work that you do.
Dr. Kulkarni:Yeah. So advocacy in, you know, in medicine becomes really important and even more so for rare diseases like pulmonary fibrosis. Right? Advocacy organizations organizations like Pulmonary Fibrosis Foundation play a very crucial role in in improving access to medications and improving access to oxygen. I mean, right right now, there's a lot of work going on around the SOAR Act.
Dr. Kulkarni:Has been leading efforts towards that. And, you know, advocacy, not just from the physician standpoint, but also then from the patient standpoint, I think patient participation in these advocacy groups, become equally important.
Zach:That's great that that you kinda make that connection. And I'm also British too, you know, your your leadership roles across the national societies and research networks you're in. Curious about how that's enabled you to kinda have an impact on the future of ILD care as well.
Dr. Kulkarni:I think each role has its own impact. You know, there are different levels of participation at the national level. For example, working with American College of Chest Physicians has given me the opportunity to work on educational initiatives. Like I'd mentioned earlier, pulmonary fibrosis really presents or the symptoms of IPF can present very similar to some of the other common conditions, especially like COPD or cardiac conditions. You know, it's generally shortness of breath or decreased exercise capacity that brings these patients to the physician.
Dr. Kulkarni:And oftentimes, what we've seen is that there's an extensive cardiac workup done before we start the or, like, you know, we're starting on inhalers for COPD management. And, you know, there's there's a gap of about one to two years before a patient actually gets to a diagnosis of pulmonary fibrosis. And so to that aspect, working with ACCP CHAS has really helped me participate in educational initiatives. We've built several educational tools to talk about how to think about IPF in your initial differential diagnosis, what can we do to help physicians out in the community identify IPF earlier, how to help them identify the various exposures through, like, a toolkit and videos on what CT patterns to look out for, what the diagnosis can be has been one of the forefront efforts from that organization. So there's the bridging specialties with I l for ILD that was, created about three, four years ago.
Dr. Kulkarni:It was an initiative between CHEST and Three Lakes Foundation that really focused on this aspect of how do we shorten the time to diagnose this. And I think that's where the biggest challenge comes, especially when we think about the general population. And it's not just the rural population. Yes. It's exacerbated within the rural patient population, but also within the urban population, we see the the delay in diagnosis.
Dr. Kulkarni:And so efforts towards education was very important for me, and, you know, leadership roles within this organization really helped with that. And then but then when it comes to research, working with the Pulmonary Fibrosis Foundation has been has been fruitful. And as mentioned earlier, thinking about what we can do to help with our, patients living with in the rural areas. We've been working on some initiatives to bridge some of those gaps. And so, really, like, I think each role within the different organizations has really given me a chance to work on different aspects of improving patient care and outcomes in in pulmonary fibrosis.
Zach:Amazing. I might come back around to your point around time to diagnosis, but curious, you know, with your involvement and and kind of it's since being a member of these organizations, you're actually helping kinda drive them forward. What is there anything about it that's been, like, surprisingly more rewarding than you were expecting? Is there anything about yeah. You know, I don't know if it's you you went in thinking it'd be one thing, but actually something else happened that you you weren't expecting that was kinda cool?
Dr. Kulkarni:No. I think it's just, you know, what has been rewarding for me is all the interactions that I'm having with the different stakeholders within the space. I think, you know, not one person by themselves can change how things are for the disease right now. And as I often tell my patients, it's always, like, when it comes to clinical trial participation, it's a two way street. Like, they don't help us, we can't help them.
Dr. Kulkarni:And it's the same way, you know, working with academic physicians who are vested in improving care and for patients living with pulmonary fibrosis, physician scientists who are looking at understanding the path of pathogenesis of the disease, trying to find new targets to treat the disease. And then when it comes to patients themselves, a lot of our patients are now much more active. They're participating in patient support groups and advocacy groups. And then you move over to all the organizations that are, again, invested in improving outcomes for patients living with pharmacy with pulmonary fibrosis. And then finally, the pharmaceutical companies who are putting in the effort to develop, new therapeutic options for the for all types of pulmonary fibrosis.
Dr. Kulkarni:And I think this interaction really has been something that was very rewarding, and it has helped me continue to build on this human connection with our patients, but continue to learn every day from the science. And and then finally, really getting to, you know, helping improve outcomes in patients with PF.
Zach:Yeah. It sound it sounds like you're able to, like, really build true relationships kind of across the community. And you brought up something about, like, a two way street. I think I liked where where you're going with that. Say say more about that two way street comments about, you know, clinical trial participation patients because I think you're articulating something, I think, that that's that can be maybe pretty impactful.
Dr. Kulkarni:Absolutely. Now, you know, when it comes to, you know, living with pulmonary fibrosis, it's just not about the disease. What we have to understand is what impact it really has on the patient both at the emotional and the physical level. And that that humanistic dimension, it's beyond medical facts and the objective clinical data that we get in clinic. And we often overlook that because we're just kind of getting through patient after patient.
Dr. Kulkarni:But what we need to understand is, you know, what does my patient know about the disease? Now, yes, they have the physical and the emotional impact of the disease itself, but what do they know about the disease? How much do they understand about the disease? And then even more so when it comes to clinical trial participation, you know, the patient's understanding of clinical trials and how this can impact their life, how it can impact the field is you know, it varies widely. But as we understand more, talk to more patients, do more surveys, this understanding and the usual common themes that are involved with it has been evolving.
Dr. Kulkarni:A lot of patients, especially those with idiopathic pulmonary fibrosis and patients who are involved in patient support groups or are talking to other advocacy organizations understand how important clinical trials is to develop the field, to develop new therapeutic options. And and so that's where the, you know, the two way street comes in. We, as physicians, really do wanna help our patients, and we want to participate in clinical trials. But, also, at the same time, if our patients don't understand how clinical trials work and what their role is in in the drug development space, it really can impact the timeline of the development. And so that's kind of where I started using that terminology to help our patients understand, you know, how this works, what does it mean to participate in a clinical trial.
Dr. Kulkarni:And, you know, of course, it's human nature. We all want to know, like, what's in it for me. And we can't really, like, promise anything when it comes to clinical trial part participation. Right? We always start off with, well, there is a placebo arm, so I wouldn't know whether you're getting the actual study medication or not.
Dr. Kulkarni:But, you know, there is still, like, the possibility that there is an open label phase where you might actually get access to a cutting edge therapy before anybody else has access to it or, you know, that you're actually contributing to medical knowledge. And, unfortunately, you know, especially with the geographical location where we are right now, you know, some patients do worry about being, you know, and that's words that some of our patients have used. Right? And they have fear of side effects. When it comes to IPF, I mean, the two medications that we currently have approved, they already have several side effects, which makes tolerating these medications difficult.
Dr. Kulkarni:A lot of our patients try to work through these side effects and even in spite being on reduced doses, have to modify their lifestyle to be able to continue taking these medications. And so there is a fear of additional side effects of the study medication itself, or there's a misunderstanding of how randomization and placebo works. And so really, like, building around what it means to be in a clinical trial and explaining that to a patient becomes really crucial.
Zach:Yeah. That's, extremely resonant and extremely inspiring as well that you've kind of created that space. Because I I think a lot of people who who kind of work in clinical trials, like, you know what data you're supposed to collect. You know, you there's usually so much complexity in just operating it. To go beyond it and create the space both for you to provide education to help, you know, patients understand what you know, where they are, what's going on in their surroundings.
Zach:But then also encourage the space as the way to success for them to share what's going on emotionally, behaviorally, physically, not just the stuff that you have to, you know, put when when you're entering data, that you understand that that's success and that that's what drives faster impact is remarkable. I I've seen parallels in my business the same way. When in in my business, I thought at first, oh, like, you know, success is finding a patient that meets eligibility, getting them to you know? And there's, like, a do they convert all the way? Really, what was driving success was something similar where it's like creating space for the patients, creating space for the research sites, you know, creating space for the sponsors, and kind of figuring out, hey.
Zach:What's what's all this stuff that's also you know, which we thought of as ancillary, but actually is what's really important in driving things forward. So, two way street, I'm gonna borrow. I I I really love that, and, it's, but that's really what it is in in driving research impact and as fast as possible. People don't think of, like, oh, that extra space speeds you up. That's it's absolutely what does.
Dr. Kulkarni:So Absolutely.
Zach:Yeah. I love that.
Dr. Kulkarni:Let me bring that on you since this is the space that you've been working on, you know, in terms of helping sites improve recruitment or getting patients access to sites that they're not otherwise that they don't have? Like, how how did you get into that space? How did you start thinking about bridging that gap?
Zach:Yeah. Thanks. You know, you talked about your kind of, you know, initial story where, like, you had a family thing and then see your your mom's asthma. You became interested respiratory. You had mentors that kinda showed.
Zach:You know, I I think for me, like, I've seen more and more of what's possible over time. And so I, you know, I at first, it started with, like I I saw that there was a gap between advocacy and research. Like, I you know, in my previous framing was around, like, how do you, you know, build a start up from scratch? And a lot of that is done by finding your evangelist users who care the most and connecting them to your product development process. And I I saw advocacy as that piece in clinical research.
Zach:Pace these patient advocacy groups have so much that they care about related to moving research forward, bring them into not just, like, early design process. We started the company ten years ago. They they weren't as involved then as they they are now in design, but also in the participation process and giving feedback as they go. And as as we learn more about, like, you know, what's actually going to drive better research, that's when we realize, like, oh, yeah. Diversity really does impact this stuff, and we can't just think of diversity in terms of ethnicity, or gender.
Zach:Like, it there's people that have had different types of care coming into the clinical trial. And if we're gonna create, impactful, you know, medicines that people will trust, you know, we we wanna kind of be honest about, like, this is this is how far it is with each person that's taking it for someone who has, you know, a biological history similar to them. And so so we we kind of observed it, then we kind of fixed it. But, like, it it's it's progressed. And, like, I I think I'm still kind of learning about, like, the impact on rural communities.
Zach:I I wouldn't say that I, you know, have as much knowledge as I'll I'll want to obtain to do this. But, yeah, it's it's a it's a it's a growing knowledge base. But it started with kinda just understanding, like, that these advocacy patients, like, there there's so much value in the patient experience and what that can offer to research. If you break it down, it's actually not so dissimilar to your two way street. It's not so dissimilar from, like, what are these other things, not just the things that you record in your measurements that are happening that that can contribute to, you know, better quality medicine.
Zach:So yeah. You know, in terms of, like, clinical trials, curious about your experience over the years. Yeah. We've we've we've worked with your site and had an amazing experience, you know, in terms of because success isn't always just an enrollment to us. It's it's usually how we're sharing information to get better the next time we're, you know, recruiting a patient, you know, speaking with them, handing over things.
Zach:In your experience, like, what what have been what's been your journey working on clinical trials and, you know, what do you think has kind of shifted over time for you?
Dr. Kulkarni:Oh, it's a great question. Right? Because there's been so much development in terms of how we conduct clinical trials in the IPF space, you know, from having no medications to what we now have two medications that are approved by the FDA, nitsdanib and profenadone. So, like, then how do we incorporate this into our clinical trial design and to what does that mean for our patients? So there's been, you know, the space has rapidly evolved.
Dr. Kulkarni:Think in terms of the conduct of clinical trials, we've learned a lot over time in terms of how much data, you know, going back to that point about just collecting data versus what is meaningful data collection, and thinking about how do we make this easier for our patients. So I think the research is kind of developing more towards a patient centered approach. A lot of the companies now when they're developing clinical trial protocols are not just talking to physicians involved, but also involving patients and patient advocacy groups into this trial design phase. Not you know, this is not coming as, like, we're already running this trial. Let's figure out what's happening.
Dr. Kulkarni:Let's send out surveys to the patients, but rather having them involved at the very initial stages where they can say, well, you know, every three week visit is not something that's easy for patients to do, which we're understanding more and more of. Like, we don't need to get pulmonary function tests every three weeks. Well, I mean, of course, the medication needs to be an infusion given every two weeks. Well, there's no way around that. But what can we do to make this easier for the patient?
Dr. Kulkarni:Because, you know, trying to understand the barriers beyond the emotional aspect of the, you know, limited understanding about clinical trials, there comes the other aspect, especially for a site like us where, like I mentioned, patients drive three to four hours, you know, trying to understand what can we do to make this easier on the patients. I think that process in terms of how we conduct clinical trials has definitely evolved over the last few years.
Zach:Yeah. It's interesting. Right? Because ethical clinical trial design, instead of having placebo control, you have standard care. When standard care might have inherent patient sentiment because there there's, you know, potential side effects, for example, Then you're getting into, oh, well, like, what's the what's the best thoughtful because you wanna have, like, a consistent design, but different people are gonna have different reactions to, like, what the what the control arm is.
Zach:And so that that you're utilizing more and more data to inform an ethical approach that there's kind of a moving target to that ethics and that everyone's engaged in bringing patients into the process. That's that's really wonderful to hear because I yeah. I I know when we started our company ten years ago, that we we wouldn't see that quite as much. So, yeah, that's great. Anything you're excited about in terms of the future of, you know, I ILD or respiratory research?
Dr. Kulkarni:Oh, absolutely. There's so much more to look forward to. You know? Like I said, there's been a lot of focus on trying to make this as patient centered approach as possible, and now we're starting to understand more about the different phenotypes or molecular endotypes of these patients. We're understanding more about the biological pathways involved that, you know, gives us new opportunities for targeted therapies.
Dr. Kulkarni:And so there's so much going on in this space. There are several clinical trials that are ongoing right now, and we're hopefully trying to shift the focus more from let's slow down disease progression to can we halt disease progression to can we maybe get to a stage where we can say, can we reverse the disease? Until then, yes, we're still very focused on early diagnosis. Like I tell my patients, the earlier we diagnose, the higher the chances that the medications will help. But trying to shift that focus of what we're trying to, develop for the field, trying to find new therapeutic strategies that can shift our, how we approach the disease treatment, I think, is really exciting for me.
Dr. Kulkarni:And, of course, you know, artificial intelligence is playing an increasingly important role. I mean, we have several AI assisted imaging tools now that can predict patients that can have progression, that may progress and, you know, in combination with some of the plasma based molecular biomarkers. You know, finding that combination and predicting disease progression really can help with patient enrichment for clinical trials. In fact, there are a couple clinical trials that are now ongoing, which, you know, are focusing on patient enrichment to try to get the highest success. And so there's so much going on in the field right now.
Dr. Kulkarni:It's a very exciting time to be in this space, but that doesn't mean that we're not focusing on the patient themselves. Yes. We're looking at all these objective measures like, you know, what does the CT show? What does the blood biomarker predict? You know, there's a lot more growing emphasis on also improving quality of life.
Dr. Kulkarni:And if you look back over the last few years of the trials that we've done, the drugs, the medications that have been successful, none of them have truly impacted quality of life positively, and that's still an area that needs a lot of work. But we're learning. Right? We're trying to think about how we integrate these patient reported outcomes, how do we leverage real world data through the registries that we have ongoing, and then try to utilize what we learn from that into clinical trials and understanding the impact of these medications on the quality of life. I think that would be our big next step as well.
Dr. Kulkarni:And so as we move forward, you know, the other point that I do wanna bring up and as you mentioned earlier about the ethics of, like, placebo controlled trial and then allowing background therapy versus not. You know? That's another very important aspect. So we're trying to work more and more towards thinking about how can we build, like, perhaps a platform trial. So REMAP ILD is a platform trial that we're trying to build on a global level.
Dr. Kulkarni:And, really, the idea of these platform trials is to try to reduce the time required to in this whole therapeutic development pathway. So can you know, these platforms can really, like, bring in new drugs on a continuous basis, and they can really have, like, one placebo arm that can be utilized for multiple drug development pathways. And that really might change the space. It like, right now, we have multiple different companies doing multiple trials. And then so we have several patients who are on placebo for all these different trials.
Dr. Kulkarni:Like, can we combine all of that and bring it into one platform trial? You know, that's something that we're really working towards, and that will take, like, a multipronged approach, with all the stakeholders. But, you know, we're trying to move the field forward, and there's a lot of excitement.
Zach:That's that's incredible. I mean, that's that's the dream in terms of, like, bringing the industry together to align on, you know, how do we move research forward and, you know, ethically, like, if we can combine placebos from from multiple studies or sponsors, I love that. You know, it's if there's any role I can help play in that, you know, I'd I'd love to. So but, yeah, wanted to last wrap. You know, you mentioned kind of the the mentors that have supported you in your journey to kind of finding the space.
Zach:But if there's anyone else you want to express gratitude for, you know, in helping you on your journey, you know, podcasts like this, we we love to kind of use it as a, you know, platform to express that because, yeah, we didn't we didn't get there without, you know, others doing some great work for us.
Dr. Kulkarni:Oh, absolutely. You know, mentors definitely play a very important role in not only just introducing this field to me, but helping me build on my ideals, helping me get to a stage where I'm able to help my patients. And, of course, you know, family support is always the most important thing, and trying to balance it all has been, very rewarding. But finally, like, most importantly, I think it's what we do for our patients and what the patients actually unknowingly give back to us. Right?
Dr. Kulkarni:I think I still remember one of my patients, as we were talking about, you know, how the disease really impacted him and what it means to, like, navigate around living with it, the hardships, you know, he he said something that really stuck. He felt like he said that I started living with the disease and not dying from it, and that helped change his approach to how he was living with it, and that really, was something that impacted me. It's really what these patients have to say to us and the impact they have on helping me continuing to try to improve outcomes for them. What keeps me in this field, really, is the strength of the patients that I meet. And so I'm thankful for my mentors, my family, and the patients that I've had the privilege of helping and working with.
Zach:Well, I'm grateful you created the space to hear from that patient, but that's how they were progressing too. So thanks for all the great work that you're doing, doctor Kulkarni. It's been a pleasure again to learn a little bit more about your background and history here. And, yeah, looking forward to to staying in touch as well.
Dr. Kulkarni:Thank you. It's been a pleasure being here and discussing the space and the field and my journey. Thank you again for this opportunity.
Leapcure:That concludes our conversation with Doctor. Tejaswini Kulkarni, researcher at the University of Alabama at Birmingham. Her leadership is helping make clinical research more human, more inclusive, and more effective for everyone involved. Thanks for listening, and until next time, stay informed, stay engaged, and keep pushing for better health outcomes for all.