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Stella Vnook: Building the Precision Oncology Future at Kaida BioPharma!

Life Science Success · 2026-07-31 · 47 min

0:00--:--

Key moments - from our scoring

Substance score

56 / 100

Five dimensions, 20 points each

Insight Density12 / 20
Originality10 / 20
Guest Caliber14 / 20
Specificity & Evidence11 / 20
Conversational Craft9 / 20

Stella Vnook brings a rare combination of large-pharma operational expertise and startup entrepreneurship to oncology. After spending two-thirds of her career at companies like Merck, she pivoted to founding Kaida BioPharma to address the translational gap between academic research and clinical trials - motivated partly by her mother's ovarian cancer. The conversation explores the harsh realities of moving from scientific discovery to commercial viability: the importance of CMC (Chemistry, Manufacturing, Controls) optimization before FDA submission, the risk of scaling failures that can halt patient enrollment, and the role of CDMOs and AI in accelerating development without skipping critical steps. Kaida focuses on a potential first-in-class prolactin antagonist for women's oncologies (ovarian, endometrial, triple-negative breast cancer), with a mechanism that both induces tumor cell death and re-sensitizes resistant patients to platinum therapy. Vnook also discusses the evolving funding landscape post-patent cliff, arguing that companies must de-risk their first indication efficiently and adopt milestone-based fundraising rather than bolus funding. Her 25-year framework for evaluating whether academic assets should spin out, apply for grants, or change indications offers a practical decision-making tool for founders navigating uncertainty.

Key takeaways

  • →Manufacturing scalability and CMC optimization must be completed before IND submission and phase one dosing, not discovered mid-trial, as Kaida learned from a prior company that dosed three patients successfully but then couldn't scale the product.
  • →The prolactin antagonist mechanism works by both blocking growth signaling (estimated to affect ~80% of ovarian cancers) and re-sensitizing platinum-resistant patients to existing therapies, enabling initial positioning as an add-on therapy before potential monotherapy expansion.
  • →Funding for early-stage biotech is increasingly concentrated after phase one/two completion, forcing startup-stage companies to adopt leaner operations, offshore phase one trials, and milestone-based funding strategies rather than relying on traditional bolus investments.
  • →AI and advanced CRO/CDMO partnerships can meaningfully accelerate R&D timelines (e.g., cell counting, optimization algorithms) without compromising rigor, but only if paired with disciplined completion of each development step rather than skipping validation.
  • →The path from academia to startup to commercialization requires asking different critical questions at each transition point: IP readiness and mechanism translability at academic stage, market timing and competitive positioning at startup stage, and manufacturing constraints at scale stage.

Guests

Stella Vnook

Topics in this episode

triple negative breast cancerProlactin antagonist (G129R)Ovarian cancerEndometrial cancerCMC (Chemistry, Manufacturing, Controls)CDMOs (Contract Development and Manufacturing Organizations)IND (Investigational New Drug)CROs (Contract Research Organizations)AI in drug developmentPlatinum-resistant ovarian cancer

Questions this episode answers

Why did Kaida BioPharma have to restart its IND and recalibrate manufacturing?

A prior company had dosed three ovarian cancer patients with impressive tumor reduction and safety results, but couldn't scale the biologic product for additional patients. Kaida acquired the asset to optimize scalability and manufacturing before re-engaging the FDA for phase one, ensuring a wide dose-ranging window and reliable supply for clinical trials.

How does the prolactin antagonist mechanism work in ovarian cancer?

The biologic (G129R) blocks the prolactin receptor, which is a growth signaling pathway estimated to drive ~80% of ovarian cancers. This both activates autophagy (direct cancer cell death) and eliminates the downstream proliferation cascade, while also re-sensitizing platinum-resistant patients to taxol and platinum therapies they may have become resistant to.

What is Stella's decision-making framework for whether academic research should be spun out?

Over 25 years, she developed a scoring system that evaluates whether technology is ready for spinout, should remain in academia, apply for grants, change indication focus, or pursue other paths. It asks the right questions about IP readiness, commercial scalability, market timing, and manufacturing feasibility to avoid the common mistake of spinning out discoveries before they're truly ready.

How has the fundraising environment changed for early-stage biotech companies?

Capital is now concentrated after phase one/two completion due to large pharma patent cliffs and M&A momentum; early-stage companies raising for phase one face a funding gap. The strategy is now to de-risk the first indication with lean operations, potentially conducting phase one outside the US, and transitioning to milestone-based fundraising tied to inflection points rather than upfront bolus funding.

What role can AI and CDMOs play in accelerating clinical timelines?

AI and modern CDMOs can optimize manufacturing processes (e.g., scale calculations, cell counting, batch analytics) and reduce R&D turnaround time without compromising quality. However, the key is using these tools to complete each development step more efficiently, not to skip critical validation steps like manufacturing scale-up, CMC, analytics, and toxicology before IND submission.

What our scoring noted

Our reviewer’s read on each dimension, with quotes from the episode.

Insight Density

12 / 20

The episode contains genuine insights about translating academic science to startups, manufacturing scalability challenges, and founder readiness frameworks, but is padded with lengthy personal narratives and repetitive affirmations that dilute density. Stella delivers useful operational lessons (CMC importance, dose-ranging planning, milestone-based fundraising) but the host allows meandering answers without pressing for specifics.

a lot of things can not be what they seem is the transition from academia to a startup. So a lot of questions that I didn't know to ask, is the asset ready for that transition? Is the IP ready?
don't skip scale that manufacturing before you start your phase one clinical trial. Really do the due diligence to understand you have enough product manufactured at scale. Um, don't skip cmc

Originality

10 / 20

While Stella's personal origin story (mother's ovarian cancer driving mission) is authentic, the core frameworks and advice - manufacturing scalability, CMC due diligence, de-risking first indication, combining brainstorming with pragmatism - are well-trodden in biotech discourse. The 'decision-making tool' mentioned is never explained or shown. No counterintuitive takes or first-principles thinking emerges.

I realized that one of those patients we talk about whose um, sort of wait line just got longer because strategically that asset got deprioritized was uh, my mom
the name of the game now, and this is definitely what we're doing in Kaeda, is de risk. Your first indication. You know, we used to think large platforms, and I was of that mindset at some point as well.

Guest Caliber

14 / 20

Stella is a genuinely credible operator: 25 years in pharma (14 at Merck), multiple startup CEOs, CDMO experience, and current founder at Kaida with a pre-clinical asset moving toward Phase 1. She has skin in the game and real operational scars. However, no recent major exits or dominant market wins are mentioned, and her company is early-stage. She is substantive but not a household name or proven mega-success.

I've been in Pharma for 25 years and I've made a deliberate decision early on that I'm going to literally do almost every job
two thirds of my career spent in large pharma. 14 years of those were at Merck. And then about five, six years ago, I became startup CEO

Specificity & Evidence

11 / 20

Stella provides some concrete details (Merck tenure, three-patient dosing story, 80% of ovarian cancers related to prolactin mechanism, 25-30% patient eligibility for existing folate-receptor drug), but largely avoids numbers on funding raised, current patient cohort size, timeline to Phase 1, Kaida's exact stage, or competitive landscape metrics. Claims about AI acceleration and manufacturing optimization lack supporting data or examples.

We estimate, based on some studies about 80% of cancers are related to this mechanism of action.
those three patients that were dosed, they performed really well. Impressive tumor reduction, incredible safety protocol. But after patient number three, they couldn't scale the product.

Conversational Craft

9 / 20

Host Don asks broad, softball questions and rarely pushes back or probe deeper. When Stella talks about her 'scoring system,' Don doesn't ask to see it or understand its criteria. Follow-ups are affirmations ('Yeah, it's good to hear you guys...') rather than challenges. The host shares his own story instead of using air time to extract more from the guest. No disagreement or productive tension surfaces.

Yeah, it's ultimately, um, just so important because, I mean, you and I were talking ahead of, uh, you know, ahead of going live here
Yeah. And I think that, I mean, I think it's important because it kind of comes to that, um, that point of like, um, you know, hey, look, is this thing still just an interesting research project or is this something that actually could eventually be a New treatment

Conversation analysis

Computed from the transcript - who did the talking, and the words that came up most.

Share of words spoken

  • Speaker C70%
  • Speaker B28%
  • Speaker D1%
  • Speaker A1%

Most-used words

patients18important14phase14path13large12startup12hear12scale11female11pharma10part10experience10strategy9outside9clinical9feel9

Episode notes

Send us Fan Mail In this episode of the Life Science Success Podcast my guest is Stella Vnook. Stella is the CEO, Co-Founder, and Executive Board Chair at Kaida BioPharma, where she is advancing precision oncology therapies and bringing her experience as a serial biotech entrepreneur, investor, and life sciences leader to the future of cancer treatment. 00:00 Welcome to the Podcast 00:38 Meet Stella Vnook 01:23 From Big Pharma to Startups 04:58 Thriving as Startup CEO 08:08 Mission Driven by Family 10:27 Hard Lessons in Translation 15:08 Building Kaida BioPharma 18:12 Fundraising in a Tough Market 22:33 De Risking and Milestones 25:03 Faster to Clinic with Rigor 29:12 Women Leading in Biotech 35:47 Precision Medicine Outlook 38:17 Inspiration and Concerns 45:46 How to Connect and Wrap Up

Full transcript

47 min

Transcribed and scored by The B2B Podcast Index.

Speaker A: On this podcast you'll find interviews with high performing successful individuals in life sciences on a weekly basis. We cover their proven methods, principles, strategies and mindsets to implement new technologies that scale to meet the needs of people in our world.

Speaker B: Welcome to this episode of Life Science Success. For those of you who don't know me, my name is Don and I'm a digital marketer in life sciences. And so with that, let me just bring in my guest today. So my guest is Stella Vanuk. Uh, Stella is a serial biotech entrepreneur, investor and CEO, co founder and executive board chair at Cadia Biopharma. So with that, uh, welcome Stella. It's great to have you on.

Speaker C: Thank you so much. It's wonderful to be here.

Speaker B: Yeah, it's great. It's great to have you here. And I mean, I really look forward to this conversation because I was looking into the things that you're working on, Acadia, and um, I mean, a lot of the work just seems amazing. And so I'm looking forward to this conversation as well and just really wanting to explore the organization. But before we get into that, could you just tell me just a little bit about yourself and what was it that led you to where you are today in the biotech world?

Speaker C: Well, maybe I'll skip to summarizing that. I've been in Pharma for 25 years and I've made a deliberate decision early on that I'm going to literally do almost every job in order to hope one day, uh, to be at the helm of the company and knowing what that function actually does. So I did. I spent my time, uh, checking every box and that led me through a lot of operational M and A and other experiences, I would say two thirds of my career spent in large pharma. 14 years of those were at Merck. And then about five, six years ago, I became startup CEO, which was quite a transition. Um, many have tried, not many have succeeded. And, um, you ask why? I think because when I was part of the large company, we have had the privilege of seeing so many innovative products and companies and sometimes we would make decision to acquire. And uh, midway through an acquisition or when acquisition happened, the strategy for a large company which was completely outside of my control, has changed. So that was no longer a strategic initiative or whatever we choose to call that. And that strong science that initially probably took, um, you know, six months to 12 months to go through the deal and the excitement that I would imagine it felt because now I'm on the other side to sign, um, would disappear. But what Most importantly, it's those patients that had the hope of maybe getting that treatment would not. So I've learned quickly that great science will maybe get you halfway there. But then it's about manufacturing, scalability, strategy, partnering, and ultimately I wanted to be in control of getting the company far enough into its corner clinical trials. So when the decision to acquire is made, the only path forward would be to commercialize the asset.

Speaker B: Yeah, it's ultimately, um, just so important because, I mean, you and I were talking ahead of, uh, you know, ahead of going live here and uh, you know, a bit of my history is I've been involved in a lot of these deals as well in the past and most of my work was on the operational side. Like, how do you, how do you take a company that was really small and move it forward? And so many companies, I think that, I think, think that, you know, look for the midst of science and sort of not finished yet. If we get acquired, what's going to happen is the investor is going to help us get finished? Well, no, normally the investor wants their money out, so they very clearly want a path forward. So I think that's an important, important place to get to as well.

Speaker C: Absolutely. And I think that there is a lot that I have learned what it's like to be on the other side because the measure of success is very different.

Speaker B: Yeah. And I mean, can you maybe just, um, expand, you know, on that a little bit more and you know, tell people from your experience, what, what have you seen and you know, how is the experience a little different?

Speaker C: Well, first of all, um, coming from, um, any large organization, in my case large pharma, into any cash strapped, uh, fractional environment where, you know, I, um, you know, one day you're presenting to investors. By the way, you're also the person who's putting the deck together. You're also the person who's putting the website together and um, in between all of that, you're also looking at R and D strategy and clinical trial design, if you know how to. Or then, you know, you're working with fractional people. But in order to work with fractional people, you have to know enough about R and D strategy, IND strategy, clinical design, in order to even understand which fractional people do you hire, who is the right fit.

Speaker B: Right. Yeah.

Speaker C: She had to understand that their work is relevant. So it quickly becomes a ground where there's zero tolerance for mistakes. Not because you have some overarching performance plan, but, but because every mistake can set you back, um, if not months, definitely Quarter because you then you had to go and review your R and D strategy or that clinical design or have another conversation with fda. So I quickly realized that where most people would be frightened, I actually thrived. I, uh, got to tell you, I was scared to death. And I loved every second of it because I felt like I could finally apply every piece of knowledge, education, that textbook experience and all of that. Almost 16 years at that time of large pharma, from theory to load bearing application. And um, it's, it, it definitely keeps you feeling alive and in control. I mean a lot of things are outside of your control. But you do feel that the um, this team that you've created, this asset that you govern, um, those patients that you've become so passionate about, they almost feel like your extended family, um, is, is your new world. And that's, that's rewarding when it works.

Speaker B: Yeah, yeah. And I mean, I think, I think you touched on something that I, that I think every entrepreneur that comes to the, to the show here kind of, um, you know, touches on as well. Like look, I, I wanted to do this, but I wanted to do it at a deeper level, um, as well. Which kind of leads me to my next question for you. So you, I mean whenever you look at your history from Merck to entrepreneurship, I sort of um, envision like this person leaving the big corporate world and going to these smaller companies to work with them. But also, can you tell me just a little bit more about what is it that drew you to entrepreneurship and then how did your early experiences shape the way that you became a leader as well?

Speaker C: Well, uh, to me it was a personal experience and I know that everybody has their own story. Um, I realized that one of those patients we talk about whose um, sort of wait line just got longer because strategically that asset got deprioritized was uh, my mom. So ovarian cancer was not on anybody's strategic plan 10 years ago. And um, as a matter of fact, all the studies were in academia and preclinical. There was not a single ah, company that was even moving assets to phase one. And I realized that there, there is a problem here because there are so much great signs at universities. When I started looking at preclinical work and publications, but none of it is being translated. So to me it was a, a personal decision to take the hard leap. And I knew it was going to be hard, um, because a transition of that magnitude can never be easy when you learn to rely on certain infrastructure. And that has completely been taken. Um, and Changed. It's never easy. Right. So you feel like the ground is moving beneath you. But, um, I had a mission. I had a mission of getting more assets from academic setting to a startup and then from that startup environment into a clinic so more patients can actually at least be part of the clinical trials. That's how that story began.

Speaker B: Yeah. It's ultimately so important. Right. And, um, it's not an easy journey, I don't think, um, for any, um, startup. But whenever I think about, you know, the, the women's health side of things as well, I feel like there's an additional battle that's, that's there, uh, in terms of getting funding and getting attention and all these sorts of things. But, um, I lost my mother to ovarian cancer as well, and so very familiar with that battle and not, uh, a pleasant one to watch, especially whenever you're younger. So, um, I remember, I remember it well.

Speaker C: So sorry to hear that.

Speaker B: I appreciate that. So navigating the leap from scientific discovery to commercial viability, though, um, is, is a very difficult sort of journey. What, uh, have been some of the hardest lessons that you've learned across your ventures in translating science to treatments that actually research patients, reach patients.

Speaker C: So I think of it as two pathways and pathway number one, where I had to learn, uh, a lot of things can not be what they seem is the transition from academia to a startup. So a lot of questions that I didn't know to ask, is the asset ready for that transition? Is the IP ready? The way that academic studies are performed, it's really to harness discovery and publication to spread knowledge. Well, that discovery in publication doesn't really translate into a commercial scalability. So what you may seem as an exciting discovery, you have to really ask a lot of questions how that mechanisms of action is going to translate into human. And then the second path is startup to a commercial scale. So let's say you've answered the first questions and then you have your startup. And then there is another set of questions that you realize that you haven't asked was what is the market that I'm launching into? Because most people, when they think about an indication, they think about today. But most products we think about are launching into five to ten years from now. And so when we're looking at the competition, we're looking at market assessment, it's important to keep that in mind because we keep talking about we're n of 1 and then next thing you know, you're n of 10 and you're not prepared. Um, another learning was Even when you transition from a startup to a commercial scale. And this is really about um, Kaeda, because when it works beautifully, when you're measuring things in gram scale, when you start measuring things on kilogram scale and you're really looking at your clinical trial design of 26 patients and you did not maybe think about, well, how are those do dose ranging studies are going to work? How many doses do I really need? That's when you can get in real trouble. So before Kaeda was formed, um, this Assad was part of another company that dosed three patients. And that's why I became very passionate about Kaida, because those three patients that were dosed, they performed really well. Impressive tumor reduction, incredible safety protocol. But after patient number three, they couldn't scale the product. So it was a tough decision, I would imagine. I was not part of that organization. But they had to inform the patients the trial would not continue in the form investors. And that is not something we ever want to see. So the team that has taken the asset, which uh, I eventually became a part of as a co founder and has decided we're going to do things right this time around, we're going to optimize the scalability and manufacturing for this asset. So we know, uh, there's a wide range for those ranging studies for those patients above and beyond where we can scale this to. This is just some of the examples that honestly, when I was in large pharma, I was more on a commercial side. Rarely have I thought about, you know, CMC and scalability because it was somebody else's job.

Speaker D: Right?

Speaker C: M. Now, you know, thank God I had, uh, you know, my two years with cdmo. I learned all about manufacturing and all the processes because now I understand what it is. But if somebody did not have that experience, I'm not even sure it's that easy to learn that quickly in order to adjust. Here you are in the lab running in vitro study and, you know, a year later you're being asked to submit to fda, uh, your IND plan. Most people, when they look at the CMC criteria, they're hoping to provide something to satisfy the requirement. Not really. Thinking about this is not a backbone exercise. You really need to think through it.

Speaker B: Yeah, for sure. I mean having that, having that experience definitely has to help you. But, um, uh, I would imagine that there's a whole journey that you're going through at Kaeda. Um, so can you tell us a little bit about Qaeda biopharma and then also, um, what is the company's mission?

Speaker C: So our mission is to provide oncology, um, treatments for patients, ah, with um, underserved populations. In this case we're talking about women oncology, we're focusing on ovarian cancer because I mentioned there were three patients that were already dosed. So we know um, how important this product would be once uh, it's on the market. But then we're also going to do endometrial cancer, triple negative breast cancer and array um, of other indications. And really what we're talking about is a potential first in class prolactin antagonist, which is a biologic that blocks prolactin receptor, which is a, um, growth signaling pathway that drives meaningful share, I would say, of Aryan cancers. We estimate, based on some studies about 80% of cancers are related to this mechanism of action. And I think it's important to understand the mechanism of action is actually quite simple if you think about it. So it activates cell death, which is what we call autophagy. And when G129R engages with prolactin receptor antagonist, it fails to trigger the downstream cascade that creates that wild prolactin cascade of um, what we call it non stoppable tumor growth. So why it matters is because it's a direct tumor kill mechanism and therefore because it has this mechanism to induce cancer cell death, it's, it holds proliferation which means it no longer replicates. So think about it this way. It doesn't cause the fire, but it, what makes the fire grow stronger. Right. So we stop the proliferation and then we also address the chemo resistance which is very important in ovarian cancer because some of the therapies that we still use as primary therapies, the first therapy we put patients on are taxols and platinum therapy. And patients do well, but they often become resistant because uh, of our mechanisms of action, we can actually resensitize a patient to this platinum therapy. So we anticipate our initial strategy would be to go after those um, platinum resistant patients, um, as an add on therapy. But in the future we could very well stand on our own as a monotherapy.

Speaker B: Very interesting. So let's talk a little bit about funding. So what are One of the big, one of the biggest challenges that I continually hear about and watch companies face as well is just the challenges with regards to funding. How have you navigated fundraising? Um, and then also how has your approach evolved over time as the market and investor sentiment has shifted?

Speaker C: Um, funding continues to be an interesting obstacle to overcome because we hear um, positive movement, uh, on several spheres. Number one, we all Hear about there's a massive patent cliff and large pharma. So therefore, um, there must be a great opportunity for M and A. And that's true. We see a lot of momentum and that's really exciting. And for us though, most of that activity is after completed phase one or phase two. So for Kaeda, we're raising money right now, as I mentioned, to recalibrate our manufacturing. So that means that we need to create a new cell bank and then reappear in front of FDA asking for permission to start our phase one. Again. That comes to another question. Uh, with investors, the money is out there and that's a good thing. However, how the money is distributed and to whom has changed. So there is a lot of interest in um, AI driven, almost fintech, like um, approaches to pharma. Also you have recently, especially in the past few years, quite a momentum in acquiring assets that have completed their phase one outside of us, which we know is much cheaper and faster. Which leaves uh, companies in the startup phase raising money to do their phase one, uh, continuously looking for who is the right investor that would invest in us. Now we have adopted in a way that we also would like to do our maybe phase one outside of us because it is cheaper. Um, not sure if it's faster, but we have become very good at only spending on what we need and when we need it. So in the way this, the scarcity on investment has made us more thoughtful, more agile, um, and made us think outside of the box. But the fact is there is this gap that we're looking to how to adjust our strategy. How do we raise money based on milestones and inflection points rather than just bolus. I have a dream and that will ultimately create probably leaner, more effective companies. But it's, I feel like 2026 is that transition year that we just need to adopt.

Speaker B: Yeah, I've seen, I mean I, uh, unfortunately I've seen a lot of companies not only struggle, I've seen companies, you know, fall off the map, unfortunately that you know, I knew were around or working on things that were way too early. Um, and you know, even though they'd heard about um, the fact that they could be receiving early stage funding, unfortunately it wasn't coming. But I do think there are other companies that are a little further along that, you know, one, not only will they survive, they also will come up with lot, a lot more, I guess I would call them innovative ways of, of dealing with these situations. And so that's the reason for the question. But uh, I mean, it's good to hear that you guys sort of, you know, are thinking of lots of ways to possibly deal with the current environment. And, um, and I agree with you as well. I mean, I hear about a fair amount of M and A activity as well in our space. And I mean, I definitely, you know, know that this has got to be on the minds of large pharmaceutical companies. Just thinking about, you know, hey, look, the. If we don't step in and do something, essentially these companies may not be there whenever we do need them. Uh, and so we may have to invest now where we typically wouldn't do that.

Speaker C: And that is the heart of my concern, honestly, because if you remember where I started, what excited me about being in the space is to make that, uh, difference, to create that bridge, that framework, to be able to take the company through phase one, into phase two, and then put it in the larger infrastructure. I think the name of the game now, and this is definitely what we're doing in Kaeda, is de risk. Your first indication. You know, we used to think large platforms, and I was of that mindset at some point as well. But now we really want to be focused on that first asset, taking it to clinic, completing that phase one in the most lean, efficient, um, and accelerated way possible. That means working with fda, maybe working with outside countries that we have a good experience with, and just getting that phase one completed. And that is our goal at Kaeda. And honestly, I think through all of this, um, trial and error, I created my own scoring system. Believe it or not, I know I had to do it. So I get so many questions from founders and universities. Are we ready? Do we get sponsored, spun out? Do we stay in, you know, what about, you know, the current environment? So I, I created, um, um, think of it as a decision making tool that now I don't have to think too long. I just run through my tool and I can tell you in about 10 minutes whether you should stay in, apply for a grant, you're ready to be spun out, change your indication, or however else you can play the field. It helps the technology now, um, especially with AI, it really enables faster decision making only if you know the right questions to ask. And I have been tracking over the last 25 years the right questions and the wrong questions to ask.

Speaker B: Yeah, and I think that, I mean, I think it's important because it kind of comes to that, um, that point of like, um, you know, hey, look, is this thing still just an interesting research project or is this something that actually could eventually be a New treatment or new. New company, you know, at, at that level.

Speaker C: Exactly.

Speaker B: Yeah. So, um, in terms of clinical development timelines and regulatory hurdles, I mean, I know that they could be daunting as well. What strategies have you found to be most effective at accelerating the path from the lab to the clinic without compromising rigor or patient safety?

Speaker C: Well, I think the right framing for this is really complete one step before starting another. I think we cannot compromise quality, um, over speed. And I think that sometimes people finding a hard time, um, navigating that because you do want to go fast, but you don't want to skip the important parts of your research. So, um, don't skip scale that manufacturing before you start your phase one clinical trial. Really do the due diligence to understand you have enough product manufactured at scale. Um, don't skip cmc, um, um, analytics or toxicology. I think the way that we can save is there's a lot of innovation at R and D level that incorporates AI and truly AI. When I was a CEO of Licarta, I remember we incorporated AI into calculating how many cells are in each encapsulate. And it used to take several technicians and maybe all day, and then here it is in seconds. So there is a way to accelerate if you partner with the right CRO. A lot of the CDMOs are now incorporating AI. So that means, for example, for our product Biologic, they would be able to tell you what is the most optimal way to scale this. And that would. If you're open to it and you run a test analysis or test badge, then yes, it's another thing you do. But you will know what is the optimized way for you to scale this. So I think that we have the right technologies, if you know, the right vendors to, um, save time appropriately by utilizing, um, algorithms, AI, true experts. And I think that then you can really focus again on that first asset, getting that through phase one, because that's where, that's the way the capital works. The capital works on inflection points, um, concentrating around your inflection points. Right. It's all about what's the next step. So getting, not skipping steps, but truly completing each step, uh, smarter and faster is, is what I've learned works best.

Speaker B: Yeah. And I, I mean, I, I, um, it's interesting because I, I have a panel that I'm working on right now for an AI discussion. So we'll have, in probably a month or so, we'll have a nice AI discussion. We'll go from drug discovery all the way through to um, areas of pharmacovigilance and things like that. Just looking at where AI is touching in our space, I continue to hear, um, new ways that I haven't heard before. Uh, and it's always interesting to hear, um, ways that the technology is being leveraged in a very smart way to help us get to an answer faster.

Speaker C: Well, absolutely. I'm excited to see when we can really shorten the time on massive animal studies that we may no longer need. I'm excited to see how we can accelerate, uh, our path forward with utilization of technology and advanced analog systems. We've been talking about this for a long time, and what I've read is FDA is very supportive, but I have not yet seen a single drug being approved by, you know, bypassing animal, um, studies that would really accelerate our path forward. Um, and I think that we're hopefully somewhere close to that, um, to be a reality.

Speaker B: Very good. So, as a female founder in our industry, where women remain underrepresented at the leadership level, um, what has been your experience, um, and you know, are. What are your feelings in terms of, you know, things that, you know, have worked for you as well as things that you think need to change?

Speaker C: Um, I really have never felt as a, um, female anything until I became a CEO of a startup. Because when I was in large pharma, it was very, I don't know, agnostic, at least in my experience. You know, I was a manager and then a director, and in this. And sure, there were quite a few more males, but maybe I was lucky and I had a very good female leaders and male leaders. And I feel like I had an equal balance of mentors that came from both sides. And then when I came to a startup world, it was astounding. And I think it's, um, it's less about deliberate exclusion and more about who is actually in the room. So roughly 92% of, um, major venture partners and venture firms are men. And then one day I was presenting to the audience and realized that, oh my God, I am the only female in the room. So I think it's. It's, um, three quarters of firms still, um, don't have female partners and a lot of, um, female CEOs, right. CEO by itself. I feel like an island on itself. It's you. You're quite isolated from the rest of the community. And if you don't have a, uh, huge network, which now we have more female CEOs, but when I started out, there really weren't any. It's quite intimidating. Um, I Found it to be inspiring. I think one of the greatest feedbacks that I ever received was long ago when I started my career, maybe 30 years ago, I had one of those 10 year career plans. I don't even know if people still do those, but one of those plans we were asked to say, where are you going to be in 10 years? And I was so naive to say that on my development plan that I was going to be um, a CEO. And I remember my manager at the time really meant well, but said that maybe you should downgrade your expectations and just because somebody tells you that you should want it less, you don't actually want it less. In my case, that invigorated me to want it more. So, um, brings me back to, I think we need to change it from a fairness argument to make it a inspirational argument. You know, in my career I've made a point to mentor a lot of female, uh, founders. Sometimes, you know, I would step in as their CEO, sometimes I would step in, in their board and sometimes I would just be their advisor and mentor just to tell them, I got you. Because I think we don't do that enough. And that's part of my mission personally to be able to say, there are people that will support you, you're not on your own island. And, and eventually maybe those 92% of um, uh, male dominated venture funding will um, go down to at least 70. And that actually would prompted me to start a venture studio because I realized that there aren't really venture studios that are operated by a woman. And I felt like I had so much experience and ran so many companies that I would have a lot to offer for those founders who feel like they cannot relate to, um, other audience. Um, so. But there's definitely a lot that we need to do.

Speaker B: And I just want to echo a bit of that because I mean, in case anybody's listening to this or um, comes across us at a later point, just in the audio version or whatever, um, I think it's important to see people do the thing that you want to do. Like, you know, this manager that you had that looked at your plan that said, you know, hey look, you know, maybe you should downgrade your, your career plan. Um, you know, had he seen other people or she's seen other people, you know, go from where you were to CEO, it would have been a natural sort of thing. You know, oh, I've seen other people do it, here's how they've done it, or here's, you know, other things. And I think, um, you Know, I've been a part of large corporations as well. We have like, these, um, like the DEI groups where it's like, um, you know, women's network or whatever. And there was one particular one that I was leading as a leader for women. And, um, I remember at one point having a conversation with the other senior female leaders and just saying, look, I, as much as I appreciate being able to help, I also know that there are people in this company that want to see how do they get to your level and above. So, I mean, having you mentor them is much more important than me mentoring them. But if there is is a vacuum or a void, I'll take the, that challenge and step in and I'm happy to do it. But at the same time, I sort of laid out the challenge back to the other, the other leaders in this organization to say, look, I, uh, right now I can't fully represent the people here, but I can do what I can to support them.

Speaker C: So, yeah, I think you're so right. I want to just reiterate what you said. It's hard to see the path when there is none. So it's true. When I was writing that review, there were not any female CEOs in pharma, so how could they have been? I believe that that is what I'm meant to do, so therefore I'm marching by my own too. But now we have beacons. We have a North Star, we have a path. Maybe that path is not so widespread. We're working on this, but we definitely do have support. Um, and a lot of it is also not just about female, but about younger entrepreneurs and giving them the confidence that they can do it.

Speaker B: Absolutely. So you speak frequently about the future of precision medicine. Where do you see the field heading in the next five to 10 years? And then what excites you most about the possibility?

Speaker C: Well, what is a precision medicine? I think we started talking about a precision medicine when we had an uprise of biomarkers. That means that we can specifically design a medicine based on that person's profile, biology, chemistry, um, their biomarkers, makeup. And we see that in ovarian cancer as a true success and path in the right direction because, uh, we have a product that's now on the market, even though it's only for 25, 30% of patients, but it's based on the alpha folate receptor. So patients that do have, that are eligible for that treatment. And that is really the essence of precision medicine. I think that as we become more aware of what is the meaning of precision medicine. So we really need to keep defining it because precision medicine is getting confused with personalized medicine. And now we just start integrating a lot of things that, um, maybe don't belong together. But we do make huge efforts in our discovery of biomarkers and how to create precise drugs that only apply for tumor specific or other specific conditions related to that biomarker. We can even stretch it as far as gene specific. Right. But it's really targeted to that specific biological marker. I am very excited about it. I think there's room though in oncology for both because depending on how far the tumor has spread or what stage we call the tumor is, whether it's stage one, which is localized, or stage three, when it's really spread into lymph nodes or other organs, we might need a combination of a broad spectrum approach and that precision approach. So I think that there's room for both. We always talked about combination therapy in oncology. It's just we really never were quite sure what the combination is and now we definitely have more, more clarity. So I'm very excited about what the future holds when it comes to that.

Speaker B: Yeah, absolutely. What inspires you?

Speaker C: Probably the founders who design or draw their own map. Um, we no longer have to draw the map blindly. So the more people will turn this murky, dusty road into a clear, starlit map, the more we'll follow and go through the gates. So that excites me that I'm able to be part of this ecosystem. I mean, that's what I do. Um, this massive, insane mission. Right? Um, the helping startups, being in a startup and creating the scoring system, the venture studio advocating for Kaeda, um, even though it's been a challenging road, um, staying true to what we need to. The more people that will draw their own map, the more we're going to have those brave souls that will figure out how AI is integrated into medicine and how to bypass, um, animal studies and how to maybe integrate the approaches we use and operational efficiency in fintech into pharma world, that will open up new opportunities for us. Um, so I am inspired by people that ride their own path, that are certain that what they have is unique, but, but they have the true passion to achieve something novel.

Speaker B: And I hear a lot of, I hear a lot of both, um, this idea or vision. And I just want to try and clarify a little bit, but I hear both in your description. This vision of being able to color outside of the lines, but also at the same time continue forward even whenever things are tough because we're all smart people. It's just a matter of finding the way. What's the path?

Speaker C: Yeah, sometimes coloring outside the lines comes up with, uh, a new treatment. Right. So I'm all for coloring it, but I want to, you know, be mindful of. We want to manage our time wisely. Right. So we want to be able to look outside, figure out if what you have been doing is still the right thing to do. Look, 10 years from now, if you're launching that product into 10 years from now, MAP make a decision that, yep, this is still the right indication, the right strategy, the right regulatory path, and then every year or so go back and recheck it and then stay on that course. But, you know, do try to challenge the system and, but be pragmatic about every year or so coming back to where am I? Is the market still the same? Is my mission and vision still the same?

Speaker B: Very important. What concerns you?

Speaker C: Probably things that I cannot control, uh, such as policy and regulatory, um, posturing. Obviously, a lot of companies were very, um, affected by the NIH funding. Low. Right. The gap. And, um, what we're hearing in FDA being understaffed, we very much rely on fda. We want FDA to be overstaffed. We want things to go fast and lean because this is our inflection point. So I think that things that provide operational risks are concerning to me because. Because I can't really fix it right away. Perhaps potentially I could go to Washington D.C. and lobby, but that means I have to stop doing what I'm doing. So it's not likely in any near future. So it would be great that we actually figure out a more, um, operationally efficient way to adopt policies, especially fda, NIH and so forth, that impact, uh, our industry that doesn't cause additional disruption.

Speaker B: Yeah, absolutely. And, um, thank you for sharing that last question. What excites you?

Speaker C: Um, I think what excites me the most right now is looking back, watching where I have started. That, um, scientist that had no idea will actually become a CEO, venture studio, um, motivator and, um, moving academic research towards clinical trials over and over. Never would I have imagined I would have multiple exits under my belt and, um, you know, creating my own companies because I actually have a roadmap on how to do that now. So that excites me about where I am, but that also excites me about this industry. Nowhere else that you could say, you could start expanding cells, ah, at the bench, and years later, whatever that is for someone, you can take your invention and build a company around it, and actually see that, see that it's in humans. Um, I think it's a powerful way to attribute all the work and all the disciplines or studies that one has done and see it come to fruition. There's also a lot of changes in healthcare. We're changing reimbursement, we're changing healthcare structure. We're, you know, at the same time changing a lot of regulatory pathway. And there's all these people that are forming, um, advisory companies and podcasts. Like, what you're doing. Right. You don't need to be doing that, but you are so passionate about it and you're great at it, allowing us to share our voice. So I feel like this, this industry excites me within itself. I am so happy to be part of this ecosystem. Um, people that know me through LinkedIn, um, always the first one to answer the question. I don't know you, but I have this question. Unless it's a pitch. Right. Um, but I think that we are a very welcoming community and it's exciting to be part of this evolution.

Speaker B: Yeah, it's funny because I, I mean, I oftentimes rely on my friends and connections as well to just say, hey, look, I know, you know, this person. I don't want them to think I'm trying to pitch them. I want to try and build a relationship or whatever. And so, you know, I oftentimes am reaching out, like, you know, help, help me get connected. Because otherwise we all get this, um, constant, um, onslaught of people sending us stuff that aren't really, aren't really in the, in our sphere. And then, um, you know, we wonder why. So I greatly appreciate that, that as well. And, and uh, your vision in terms of, you know, the excitement in this industry, I think is phenomenal as well, because, I mean, I think it's a good time, both from a technology standpoint, but also, um, just watching the innovation that's going on as well is important and critical to us as well. Um, one last thing before we go. So, um, how could people find you? How can they get in touch with you? What are ways that people can connect with you? What's the best way?

Speaker C: The best way is either connect to me on LinkedIn or ask me a question on LinkedIn. Obviously you can go to kaedabiopharma.com and there's, um, a section that you can contact anyone in the company. Most of those emails will come to me. Um, and I welcome a conversation about anything the industry, um, oncology or Kaida specifically.

Speaker B: Uh, perfect. So, Dr. Dr. Stella Vanuk thank you so much for being on the Life Science Success podcast. I greatly appreciate you being here, and thank you for sharing the story of Kaeda and everything that you've done in the industry as well. It's. It's exciting to hear.

Speaker C: Thank you so much. It's been truly a pleasure.

Speaker D: Thank you for listening to Life Science Success. Uh, for complete details about this podcast, including show notes, how to get in touch with guests, and more episodes, please visit www.lifesciencesuccess.com. if there's someone you'd like for us to invite to the show as a guest, please let me know by sending me a message at the podcast website. Please click subscribe on your favorite podcast app, share the podcast, or tell a friend about it. And last but not least, rate the podcast.

Speaker B: Thank you again.

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