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This is the Leap Together Podcast, where we highlight top leaders driving breakthroughs in clinical research and life sciences.
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Kristiyana:this was an incredibly rewarding process to work with, a lot of different teams, lead my team in clinical development, but also work with, you know, matrix environments with scientists and bioinformaticians, to work on model development and then clinically validate the test, and publish and we launched around the time of ASCO which is a major oncology conference a little over a year ago, and brought the test to the market, seeing how the test is performing now in the clinic and the impact it's making for patients has been incredibly rewarding.
Zach:Hi. Gobst here. I'm the host of Leap Together where I speak with leaders in clinical trials to explore how medical breakthroughs come to life. This episode is brought to you by Leap Cure, the equitable leader in patient engagement and recruitment for clinical trials, hundreds of studies, and millions of patients across more than 50 countries that easily could contribute participation average of over 50%. Visit leadq.com to learn more.
Zach:I'm really excited for today's guests. We have doctor Kristiyana Kaneva, board certified pediatric hematologist, oncologist, and neuro oncologist now leading early stage oncology development at AbbVie. Her journey spans academic medicine, biotech, diagnostics, and now large pharma from treating children with cancer to driving first in human trials and regulatory strategies for novel biomarkers. What sets apart doctor Kaneva apart is her powerful combination of scientific vision and personal empathy. She's helped bring cutting edge diagnostics into real world clinics, advocated for pediatric trial access, built bridges across AI, precision medicine, and patient centered design.
Zach:Kristiyana, thrilled to have you on. Thanks for being on the show.
Kristiyana:Thanks, Zach, and thank you so much for the great introduction.
Zach:Yeah. So Happy to be here. Yeah. Happy you're here as well. So, yeah, you know, what I first like to get into is, just, you know, learning more about what drew you to medicine and specifically pediatric oncology.
Kristiyana:Yeah. Great question. So I was interested in science pretty early on and I decided on medicine when I was in college. I was a biology major, pretty standard track. And I knew I wanted to be a pediatric oncologist pretty early on.
Kristiyana:I think I decided in in college. I did a summer research program at Northwestern where I got to spend some time working on Burkitt lymphoma research in the lab during the summer, while I was a college student and really enjoyed the science. And my, PI at the time brought me into clinic a couple of times and I got to see what patient care was like. Really like the the fact that pediatric oncology has both acute care when kids are sick and in the hospital, as well as this long standing relationship that you build with patients and really with the whole family, with the parents as well. It's really a chronic disease and some of these children are on therapy for several years.
Kristiyana:So really enjoyed that aspect. Again, the combination of the science and also the acute and and chronic care inside and outside of the hospital. And I never really changed my mind from college. I sort of stuck with it through medical school and decided to continue on that journey and ended up completing a pediatric residency and then a pediatric hematology oncology fellowship, and then focused on pediatric brain tumors after that. But but I had had that interest pretty early on and then stuck with it.
Zach:That's cool. Anything you know, you spoke about, you know, the different rewards of maybe different facets of it. But anything surprise you that that you realized, you know, after kind of getting into pediatric oncology that was maybe different than what you thought, maybe more rewarding, more challenging?
Kristiyana:Certainly very challenging. I trained at a very busy pediatric cancer center at Children's Hospital Los Angeles during my pediatric hematology oncology fellowship. And my first week in the hospital, I think I had several patients pass. So it was it's always busy there. I think it was also an unusually busy time with unusually sick patients who unfortunately had very advanced disease that had progressed and passed the again, at my very beginning of my fellowship, and I had completed a pediatric residency before and been through med school and have a honestly, had the unfortunate opportunity to experience death a number of times in the past, but it was I think the totality and frequency of mortality that that surprised me at the beginning and just the the toll that the complexity of patient care and dealing with end of life takes on you when it's day after day over a long period of time.
Kristiyana:And as a fellow, you work in the hospital eighty to a hundred hours a week. You know, this was post work hour regulations. But as a fellow, you really tend to cover the hospital for pretty long periods of time. And Los Angeles is a big catchment area, so we saw patients from pretty far and then, again, a very busy place. And so it it really does take a toll on you.
Kristiyana:So that was just surprising to to experience, but also incredibly rewarding to be able to take care of these sick children. And when a child experienced a positive outcome and we saw someone go in in remission and go back to regular life, of course, it was incredibly rewarding. And so very high highs and and, unfortunately, very low lows.
Zach:Yeah. What what do you think kind of, Joe? Because, like, you know, it's one thing to, like, you know, say, hey. I I wanna be a pediatric oncologist. But then when you get thrown into the realities of, like, you know, the the lows, like, what you described and and you spoke about, yeah, there there are the rewards of when you're able to do something about it.
Zach:But you've you persevered, you know, after kind of really being up close with with these experiences. Where do you where do you think that kind of, like, to continue with pediatric oncology came from? Because, you know, I I think it's it's like, a lot of people when they're younger, you're put on the spot to be like, hey. What do you wanna do when you grow up? And, like, oh, that sounds interesting.
Zach:That's what I wanna do. When you actually experience it firsthand, you kind you kind of get up close to the realities of what it is. You know? For for you, that happened and you kept going, you know, curious you know, what what what kind of shaped you or what you think it comes from that that you were still interested?
Kristiyana:Yeah. And, again, the rewards of of when things went well and and therapies were successful. Unfortunately, there are a lot of gaps in terms of care in pediatric oncology, and that's where we, tend to lag behind in terms of drug development, which is I think what drew me to industry, to try and and bridge that gap. But just support from family was a big part to be able to keep going. And my husband at the time and family and just wanting to make a difference and despite how hard the work was and the day to day responsibilities were, I I had committed to this and it was a long time interest of mine, and so I definitely wanted to see it through and and hopefully use the the learning that I gained through medical training to to then continue to improve care for for children with cancer in the future.
Zach:Yeah. Well, you you certainly and that's probably where I wanna go next in terms of utilizing your learnings. So, you know, how that gets applied into clinical research and and your journey, you know, into diagnostics and biotech and pharma. You know? Interested in kind of how how that came to be, you what what drew you to that as a next step.
Kristiyana:Yeah. So I had an interest in precision oncology pretty early on in my pediatric oncology training career. While I was at CHLA, my mentor was Jackie Biego. She's a PhD scientist who has really been a pioneer for precision oncology in pediatric cancer care, specifically in pediatric brain tumors. She was part of the discovery of SMARCB one, which is an important gene in ATRT or atypical steroid rhabdoid tumor, a rare fortunately devastating pediatric brain tumor, which I think is why I got interested in pediatric neuro oncology as well.
Kristiyana:But I got to work in the lab there and be a part of the personalized medicine department, which is probably one of the largest, if not the largest, pediatric standalone precision medicine department in in the country, and was able to really see everything from the bench to the clinic. So work in the lab on my own research, but also spend some time in tumor boards, in a multidisciplinary setting with pathologists and neurosurgeons and precision medicine specialists and genomic experts to see novel targets for pediatric brain tumors and see some of these mutations that completely change the diagnosis for some patients beyond what we can see under the microscope and when looking at histology. And it was around the time that BRAF and MEK inhibitors were becoming popular for pediatric brain tumors, and we saw some of these brain tumors completely melt away for children without having to undergo toxic radiation therapy, which can be so devastating to the developing brain of a child, especially, as well as toxic chemotherapy. And so I got really interested in precision medicine because of that. And so that was a natural transition then to the diagnostic space and wanting to make a bigger impact.
Kristiyana:And what brought me to Tempest AI a little over five years ago and and wanting to work more on on developing the precision medicine space for both children and adults with cancer.
Zach:Awesome. Such a great progression. And, you know, why do you not just to work in the diagnostic space, but also help, you know, see through diagnostics from origination to commercialization? You know? Curious what that experience was like for you to to actually kinda be a part of, hey, systematically, you know, pediatric oncology.
Zach:Like, we're we're able to kind of commercialize something to improve detection.
Kristiyana:Yeah. So during my time at at at Tempest, I was able to see a lot of change and growth for the company and for the diagnostic and biomarker space in general. Worked on a ton of very exciting projects. My biggest sort of end to end success story was leading a team to help bring a minimal residual disease test from concept to the clinic. And so this was a test that's called XM, and it's a test that allows us to detect residual disease at a very, very low level in the blood of patients with cancer after they've had curative intent therapy.
Kristiyana:So the test that we developed was specifically for colorectal cancer patients. And so these patients can have a blood test about a month after having surgery, and then we can predict the likelihood of their cancer coming back. And then now based on this test and other similar tests on the market, there are a lot of clinical trials that are escalating therapy for patients who, have a higher likelihood of recurrence and then de escalating therapy for others to see if we can both improve outcomes, for patients, but also for patients who do not need additional chemotherapy, decrease toxicity, and decrease this long term morbidity. So this was an incredibly rewarding process to work with, a lot of different teams, leave my team in clinical development, but also work with, you know, matrix environments with scientists and bioinformaticians to work on model development and then clinically validate the test and publish. And we launched around the time of ASCO, which is a major oncology conference a little over a year ago, and brought the test to the market and seeing how the test is performing now in the clinic and the impact it's making for patients has been incredibly rewarding.
Kristiyana:So this particular test is more applicable to adult cancer patients, but, I did work on a number of pediatric cancer initiatives as well when I was at Tempest. I was able to, for example, expand on that comprehensive genome profiling test that essentially looks for a a number of potential cancer genes that may be mutated in cancer patients. I was able to work with the team and include pediatric relevant genes, especially when when looking at potential cancer predisposition genes that are very important in the pediatric population. Worked on a number of research projects on a large data study with Dana Farber looking at IDH mutant gliomas, as well as another study with UCLA on osteosarcoma looking at the genomic and, immune landscape. So, really had an incredible opportunity to work with some, amazing experts in academia and in biopharma and in the diagnostic space and really enjoyed my work there quite a bit.
Zach:Yeah. I think that's fantastic, because, you know, it's one thing to kind of drive a medical breakthrough with this diagnostic. But, you know, once once, you know, on your way there, you're kind of building a community of people that can also you open up a lot of doors and other avenues to to other breakthroughs. And so that you're able to kind of immerse and and kinda connect connect with so many others and as well kind of, like, find more use cases and find ways to kind of really pinpoint better ways to help people. That's that's really, really incredible.
Zach:And then, yeah, you know, catches up to speed on kind of, you know, where where you are now, where what you're taking on next, and your your thoughts.
Kristiyana:Yeah. So I transitioned to a new job about six months ago. I'm at AbbVie now working on oncology early clinical development. So made a a pretty big jump from drug dev sorry, from diagnostic development to drug development, and actually took a step back in terms of an actual title in order to be able to diversify my skill set. I really wanted to learn more about drug development, and and I felt that was the missing piece in my cancer experience and the ability to make an impact for cancer patients.
Kristiyana:I had the clinical aspect, the diagnostics, and biomarker aspect, and really wanted to immerse myself more deeply in drug development. And it's been a great transition so far. I've really enjoyed working at AbbVie and working with the oncology early development team. The work there essentially involves bringing novel molecules from the bench to the clinic and through the phase one or first in human clinical trial. So I work closely with colleagues from discovery who are at the bench, again, identifying novel targets or or novel molecules or drugs that we can use to fight cancer and and working on preclinical studies, testing the drug in in animals, and then where my team comes, is, the next step.
Kristiyana:So taking these molecules that have shown efficacy and safety in animal models and then moving them, to the clinic, and that involves preparing the clinical trial design, thinking about end to end planning and how the drug would eventually get to the clinic if we are successful. And then interacting with the FDA to submit an IND application or an investigational new drug application, and then starting a phase in one or first in human trial where the goal is to find the maximum tolerated dose. And and if successful, if we are able to demonstrate safety and if we're able to demonstrate some early efficacy in in the first in human setting, which is typically reserved for patients who, have advanced disease, so metastatic, progressed patients. If we can demonstrate an efficacy signal there and demonstrate that the drug is safe, then we can hand it off to later phases of development to to our lead development colleagues. But it's been it's been a very rewarding job so far.
Kristiyana:I've learned a lot over the last six months. Certainly, has felt like drinking from the fire hose and a very different experience than working in a smaller diagnostic or or health tech company, but has certainly allowed me to to get broader experience.
Zach:Yeah. And I love that you can bring that to the preclinical translational early setting because you have a background in, you know, providing care in pediatric oncology and, you know, taking a diagnostic, you know, to the clinic. You know, sometimes there's that disconnect between, like, what's going on in discovery Like like, there's there's only so much thinking that can go on because the all of the nuance that goes into into discovery is so many molecules that aren't. So, like, you've gotta, you know, pick the right one, and that's, there's so much to that complexity and challenge, and I'm sure you're learning plenty about that. That it sometimes becomes, something that they they don't think about as much as, well, what's gonna happen next?
Zach:And and you have that depth of understanding in terms of, well, where is this all going next, and how do we connect make sure we're connecting the dots at at an earlier stage. So but you're jumping outside your comfort zone to do that. It's it's so amazing. It's so valuable to to kind of how we think about science. So and that, you know, you're not so focused on title right now that you care about just kind of, like, being a part of connecting all that.
Zach:That's really amazing.
Kristiyana:Yes. Certainly. Yeah. It certainly has been challenging, but but, yeah, very rewarding as well.
Zach:Yeah. When we had to chatting ahead of this, there there were a few things I I wanted us to touch on because, you know, you you have this breadth of experiences in, you know, care and research. One of which I think is really important is the way that we think about, you know, p d pediatric oncology and and the way we think of, like, kind of therapeutics for pediatrics in general as, you know, what what's most common is something that that might not make the most sense. And you kind of alluded to, like, if you can identify genes up up front, there there's a way that you can avoid chemo. But, you know, what would start to me, it would and it was really an to me was just, you know, how how we should be thinking more and more about, you know, kind of pediatric treatment in general.
Zach:We'd we'd love for you to kind of share your perspective. I don't wanna put words in your mouth. But
Kristiyana:Yeah. But I Certainly. Yeah.
Zach:But but yeah. You know, I I you know, it would it'd be great to get kind of your latest thinking on that.
Kristiyana:Yes. I mean, I think it's not a surprise probably to anyone that biotech companies and and pharma companies are invested in developing drugs that can serve a larger part of the population, and that's typically adult patients with cancer. However, there has been regulatory guidance over the last half a decade plus to have a pediatric plan for any molecule or any target that's relevant for pediatric cancer patients. So the paradigm has really shifted from looking at a specific diagnosis, whether it's pediatric leukemia or a pediatric brain tumor or pediatric sarcoma, versus adult cancer subtypes which tend to be different, to focus on the biology or really zooming in and what is the disease on the molecular level. And a lot of the time, those targets between adults and children are shared.
Kristiyana:So regardless of the specific part of the body that the cancer affects, the the molecular target may be the same, which means that the drug that we are developing for an adult cancer indication may be relevant to a pediatric cancer indication. And there are a lot of efforts now, because mainly driven by the this regulatory guidance to have a pediatric plan to to always think about every drug you're developing, could there be application to the pediatric, cancer, population and, and and looking at some if if there is a relevant target, thinking about some preclinical studies and and and the FDA is actually looking for that pediatric plan now when there is a relevant target. The if you go on the website, there is a list of relevant targets where, you should be very thoughtful, if if you're we're gonna drug for one of those relevant targets. But even beyond that, a dynamic space, and we we are developing new drugs all the time. So I I really enjoyed how thoughtful AbbVie has been on this front in particular.
Kristiyana:There's a pediatric center of excellence at AbbVie. And so in my short time here, I've been involved with this team and have started to think about, some of the programs I'm on and and some others on how to be thoughtful about really every drug we're developing, asking that question, could this be applied to a pediatric population? And could we be developing the drug in in pediatric patients in parallel with the adult population? And and so I I think this is really important, and I think that it it's great that companies are taking this FDA guidance seriously. And and I'm I'm hoping that in the future, this will result in more therapies for pediatric cancer patients to really try and and bridge the gap.
Kristiyana:I think historically, pediatric cancer development has lagged behind. And interestingly, this makes pediatric oncologists more adventurous and innovative with therapies. What I haven't observed in the clinic and what I was surprised by when I went into industry and and saw how adult cancer, specialists approached care in the pediatric space, you just don't have the luxury of having that much data, and there's been less studies overall even where there may have been a relevant target in the past. And so a pediatric oncologist may have a a look at a single case report and see that a drug that was for a similar target worked in a an adult patient and then go with it and try it because in in a setting where a patient has no other options, right, where they've exhausted all the standard of care options and, this is really their only chance, of trying something new. And so this is not uncommon, And a lot of the pediatric cancer therapies or pediatric therapies in general may be off label or in a compassionate use setting versus on the adult side, there's so much data for especially for the more common cancers, and so people tend to stick more to the actual guidelines and and and have the luxury of having data on on many, many patients for for these drugs.
Kristiyana:But but I do see that the we're slowly working on on bridging this gap, and, I am hopeful for the future, for for more, and better drugs developed for pediatric cancer patients.
Zach:Yeah. I I think it's great that that AbbVie's taking that approach. You know, when when I think about, like, you know, the patient recruitment side, I think there's there's a similar challenge where if we try to, like, copy and paste, you know, how do you get adults to be educated about joining a study, that that's not exactly the perfect process in a lot of cases for how do you recruit, you know, for pediatric studies. There's a lot of, you know, different you know, not just, you know, parent involvement, but, you know, quality of life and, you know, in a way that they think about risk and, you know, consent. There's so much it's it's different, and it'd be great to be, you know, starting from that place and then applying, you know, similar to what you're saying and, you know, just the therapeutic side.
Zach:So I I think there's a world of possibilities starting in pediatric and and building out. And so but but you've that you're kind of, you know, taking that, you know, two large pharmas. Think fantastic. I don't wanna take too much more of your time, so I have one I got a couple more questions. I you know, I'm curious if there's anything out there that you're kind of really excited about in terms of the future of research right now, you know, in terms of Yeah.
Kristiyana:Yeah. I mean, I think the immuno oncology space is very exciting. I think we've made a lot of progress, and there's a lot of progress to be made. I think in vivo, CAR T therapies are very exciting. So unlike conventional CAR T therapy where you need to take the patient's blood to engineer the drug for each individual patient, which takes a couple weeks, and then give the drug back to them and have to give them chemotherapy in between.
Kristiyana:Many patients can't afford to wait. The new generation of CAR T therapies is engineered in the body, and so it's off the shelf therapy. And so it's still in very early development, and and many companies are working on this. But I think there's a lot of promise there if we're successful to improve access for patients. So currently, this therapy is really accessible to larger academic centers that have a lot of resources.
Kristiyana:It's expensive to manufacture, and the the new generation, again, if if it works as we hope, would really disrupt the space and improve access globally for patients with varying resources and may potentially be, like, less toxic, may potentially be even outpatient therapy. And and so it's really exciting to to think about the possibilities there.
Zach:Great. You know, I I think, I mean, a podcast you know, podcast in general can be a great opportunity to kind of express gratitude for the people who have either been mentors or, you know, just important members of your support team that helped you kind of, you know, see more purpose in your work. Any anyone come to mind that you'd like to kinda shout out? That's been an important part of your journey.
Kristiyana:Yeah. I mean, I've had the incredible opportunity to have some amazing mentors during my education, training, and career. I already mentioned Jackie Biego, I think. She was instrumental. She was my mentor while I was at CHLA.
Kristiyana:And then at Tempest, I've had a couple of amazing female leaders who really empowered me and inspired me to be successful and and have the drive to work hard. One was Kim Blackwell, who was the chief medical officer officer at at Tempest when I started. She was my boss at the time, really an amazing mentor who made sure I always had a seat at the table and and really helped me bring my career to the next step and and I think saw value in the work that I did before I even was able to see it myself. And then my most recent manager at Tempest was Holla Numeric, who's the chief development officer there, and she's also an incredible oncologist and an incredible leader of the organization, and and also inspired me to work hard and and gave me a lot of opportunities during my time there, which I don't take for granted. And, yeah, I'm very, very thankful for for that great mentorship.
Zach:Oh, yeah. Thanks. Thanks for sharing. Yeah. Shout out to them.
Zach:Kristiyana, it's it's very heartwarming to kind of hear your journey and and kind of how you're taking all these different experiences and excited for what's to come from your work that that AbbVie grateful for for what you've been doing for the space for years now. Yeah. Thanks for being on the show and, yeah, we look forward to staying in touch.
Kristiyana:Great. Thanks, Zach. Take care.
Zach:Stay in touch.
Kristiyana:Great. Thanks, Zach. Take care.
Leapcuire:That wraps up our conversation with doctor Kristiyana Kaneva. From caring for children with cancer, to helping bring precision diagnostics into real world clinics and now guiding first in human oncology programs at AbbVie, her journey is a reminder that the best breakthroughs happen when scientific rigor is paired with deep empathy. We're grateful for her leadership in advancing biomarker driven medicine, expanding thoughtful pediatric development plans, and pushing the field towards therapies that are not only innovative, but responsibly designed for the patients who need them most. Thanks for listening, and until next time, stay informed, stay engaged, and keep pushing for better health outcomes for all.