Creating a new path in women’s health: Oriana Papin-Zoghbi

[00:00:00] We're building a community around women's health so that no one is overlooked. Subscribe to the overlooked newsletter so you can be part of that community. When we look back, we want to be able to say, you know what, we had a lasting impact in transforming women's health.

[00:00:17] This is Oriana Papin-Zoghbi. I am the CEO and co-founder of AOA Diagnostics. AOA Diagnostics is a women's health startup that's working in oncology. And as the CEO of a startup, Oriana inhabits a world of innovation, technology, fundraising, and high stakes dealmaking.

[00:00:36] This story is about one of those deals in particular. It's Saturday night. I am getting ready to put my daughter down. She is 10 weeks old at this point. I got an email on my phone and which I learned that the deal terms were being changed. We were fundraising.

[00:01:05] And I have been in sales and I've been in business development all of my career before starting AOA. So I faced a lot of rejection, right? You sell innovation and you know that not everybody is going to be on board and you face a lot of rejection.

[00:01:17] About four weeks before our demo day, I had my daughter. Demo day. That's tech industry speak for when startups present their ideas and their businesses to potential investors to raise around a funding. And I said, if everything was smooth and I would have a successful delivery, etc.

[00:01:38] I still wanted to pitch demo day and I still wanted to raise the round because I knew that we were getting a lot of momentum and I didn't want to miss out on this opportunity and thankfully it worked out and I was able to pitch demo day

[00:01:49] and we got so much traction and we're putting our round together and everything was going incredibly well. And in the 11th hour, the mechanism in which we were going to do our round was being changed. And I remember sitting down on the bed.

[00:02:11] It was this moment of panic that everything I was working towards and everything I was doing was going to go down the drain. As I sat on that bed, I thought, was this all for nothing?

[00:02:27] I remember calling my co-founder Anna, I was late at night and I was at this point, you know, beaten. And I remember thinking, I gave up so much to get to this moment. I gave up time with my daughter.

[00:02:42] I gave up my maternity leave, you know, whatever semblance is that would look like. I worked like day in, day out through breastfeeding, through pumping, through investor meetings, through everything to get around.

[00:02:56] I mean, it was record. We've done it in two months and for at the 11th hour, something like this to change so significantly. At that time, I realized the passion we have for AOA is what's going to help us overcome what we're going through right now

[00:03:13] because nobody's done what we are doing and there is such an important need and there's a huge problem we need to solve. So I remember hanging up the phone with Anna and saying, let's talk about this tomorrow and let's game plan what we're going to do.

[00:03:27] And then the next day we did. We knew the deal terms and changing the deal terms in this way, we would lose some investors that, you know, would not come along

[00:03:40] and we may have to start again and we may have to pick up the round and it was going to take longer and et cetera, et cetera.

[00:03:47] And then the next day we rolled it out and we spoke to many investors and many people and some did walk away naturally, but the majority stayed.

[00:03:56] And so for people to continue to come along with us despite changing deal terms right before a close or whatever it may be, gave me that validation I think that people were in this because they believed in the team, because they believed in this problem,

[00:04:13] because they believe that we can build the solution. And yeah, and then you kind of pick yourself up from that defeat, remind yourself why you're doing it. Keep going. You're listening to Overlooked and I'm Golda Arthur.

[00:04:26] Not so long ago, it seemed to me that finding a way to get ahead of ovarian cancer was impossible.

[00:04:33] If you listen to the first season of Overlooked or know anything about ovarian cancer, you'll know that we can't see it coming because there's no way to screen for it.

[00:04:42] So we find it when it's too late and that's why most women don't survive. I used to think of it as a lost cause.

[00:04:49] But now there's a ton more innovation in women's health than there used to be in the form of a new wave of biotech startups who have committed to taking on hard problems, including ovarian cancer.

[00:05:01] In this episode, I'm talking to Oriana Papenzogbi about innovation and investment in women's health startups. This is a world that sits at the intersection of science, health and business. We'll hear terms like demo days, regulatory approval, angel investors and ROIs, return on investment.

[00:05:26] We've got a term for any tech startups which create products for women, FemTech. I don't love this term. I think it's kind of unimaginative, but it is a category of tech startups that's blossoming.

[00:05:39] Oriana's company, AOA Diagnostics is in the FemTech category and one of their big projects is a diagnostic tool for ovarian cancer, a welcome bit of innovation in an area of cancer where the needle hasn't moved for decades.

[00:05:54] Her co-founders are Alex Fisher and Anna Jeter and the company has just opened their first lab in Denver, Colorado. We start with a mini biology lesson, just a heads up for all my fellow liberal arts majors.

[00:06:06] To understand what AOA is doing, you have to first learn about biomarkers. Biomarkers are a biological molecule that point to something. They're a sign that something is normal or abnormal in our bodies. So that's where I began my conversation with Oriana.

[00:06:22] Tell me about these biomarkers and how you work with them. Yeah, I'm going to take a step back on how we came across them too. So we, Anna and I, Alex were the co-founders, had been working in women's health for quite some time.

[00:06:36] This has been almost 15 years ago before the word FemTech existed or women's health was on Dr. Jill Biden's radar. And we've been working across the continuum of how do you improve diagnostic care for women? Oftentimes many diseases are overlooked or under researched.

[00:06:53] And so we came about starting AOA with this problem of how can we continue to build diagnostics for women's health? But none of us are scientists or engineers or doctors.

[00:07:03] So we knew that we were never going to be able to build it ourselves and we knew we had to partner. And that's when we had read about 90% of medical innovation stays in academia and that there is this untapped potential sitting in research.

[00:07:15] And how could we be that partner to help translate it and bring it out to patient care? And that led to an introduction to Professor Saragovia at McGill University, amongst many other academics that we met with. But Professor Saragovia's research was truly the most groundbreaking.

[00:07:33] It was where we discovered gangliocides. It was where we learned about the power of these biomarkers and the fact that nobody today had developed them into diagnostic tools. What are gangliocides? Actually, these are molecules that are on the surface of tumor cells.

[00:07:57] And what we know in the research is that they're being shed into the blood. What we also know, and this is from decades of research, right? The existence of this molecule was not discovered by Professor Saragovia or AOA. We're thinking about how do we apply them?

[00:08:10] But the idea that they, you know, the oncogenic markers that they can be correlated to specific diseases in oncology, but certain gangliocides are also in, for example, neurogenerative diseases such as Alzheimer's. And the idea that they begin at the tissue level and are being shed into the blood,

[00:08:28] all that's been in the research. And what Professor Saragovia began with was developing a mechanism to actually detect and quantify them in the blood, which was the basis and the principle of AOA's foundational sort of research and discovery

[00:08:44] is how do we take something that's been published, something that's somewhat known, and how do we transfer that into diagnostic tools that can actually impact the patient? How can we do this in a way that's reliable, that's reproducible, that's accurate?

[00:09:00] How can we do this in a way that will meet the analytical validation bar that is required for a clinical diagnostic? How do we then apply this to a disease condition where there is an enormous unmet need such as ovarian cancer?

[00:09:13] And that's the thesis of what we're doing with gangliocides today. So that is, you know, starting with the work of, as you call it, translating that you guys are really kind of in a new area, right?

[00:09:31] The infrastructure, I'm assuming you're sort of beating a path, a new path in this way, is that right? We were talking on our team and we were thinking that we need to hire a gangliocide scientist on our team.

[00:09:41] We need to hire somebody that has this expertise and bring him in-house and help us figure this out, right? When you're doing something so uncharted, like let's bring in all the experts together. You know, we've got scientific advisors, we'd worked with a lot of academics

[00:09:54] who really provided enormous valuable insight, but again that translational part was missing. And so in the six months that we went out to go and hire this person, lo and behold inside at AOA, we became the gangliocide scientist. That's what somebody from my team said to me.

[00:10:10] And she said, I don't think we're going to find them because they don't exist and we've become them. And so it's not been without its up and down, but it's been incredibly exciting.

[00:10:20] Well, I can just imagine, but I want to talk about those up and downs a little bit, right? And I can tell in your voice as well that you're really excited by this work. But tell me about the down bit. I'm always ready with a metaphor.

[00:10:32] They're always bad metaphors. But you know, I imagine that you and your team are sort of like just hacking your way through this forest. There's no path forward. You're like, we need someone with like a big knife that can bulldoze through this.

[00:10:45] And then you just build your own knife that you can like cut, cut at the weeds and kind of make a path. A hundred percent. Yeah. No, you've nailed it. Yes. That's great because, you know, you're going where no path exists in creating one in your wake.

[00:11:00] But tell me about what is pushing you back or what is what you're working against a little bit? You know, one of the first ones was what I alluded to is we had to develop the expertise

[00:11:13] and it was very challenging in the early days because it was like navigating a forest not knowing in which direction you were going and not even knowing what tools you could use

[00:11:22] because are were you going to damage the beautiful leaves that were actually going to be really important to you? Or was it okay to cut it out? And that is so perfectly resembles even in how we were doing our sample prep, right?

[00:11:33] And what we were putting in, were we denaturing or hurting the sample or was it actually going to improve our process? And so the path of uncharted discovery is one that in science can be really cyclical because when something doesn't work, you don't know why it doesn't work.

[00:11:49] Is it the origin which is, is it the disease condition or is it the tool that you are developing that doesn't work? It is unpredictable timelines. You can plan out your experiments, but you can't plan which will succeed and which will fail.

[00:12:03] And having unpredictable timelines makes it so challenging to run a business that is built on hitting milestones on time so that you can unlock the next gates of capital so that you can hire the next round of people so you can get a bigger lab space.

[00:12:17] And so navigating the uncharted waters while at the same time having to keep a business afloat is incredibly challenging. On top of that, navigating what we're doing in ovarian cancer is different to what anybody has done before. I mean, you know the space.

[00:12:37] People are looking at screening women that have genetic conditions. People are looking at women above a certain age that are a risk factor. Nobody's been talking about women that go to the doctor with vague abdominal symptoms

[00:12:48] and the fact that they represent a huge population and the fact that they get missed, right? Which meant educating clinicians that this was real, that this was not women saying that they had too much pizza.

[00:12:59] Educating the FDA on how to design a clinical study that had never been done before. So we bit off a lot. I am proud to say, you know, often people say you bit off more than you can chew.

[00:13:11] We can chew what we bit off, you know, to use your metaphors. But it's been and it will continue to be an uphill battle. And I think the thing that makes it possible 100% of the team that is around AOA

[00:13:25] from the scientists and the clinical team and everybody that's in-house to the advisors and the board members and the investors that are rallying behind us as well. Why has there not been this much innovation to date in this space in the first place?

[00:13:42] I guess I'm loosely asking, like why is there a force in the first place? I think there are two things that relate to both ovarian cancer and women's health. Generally across the board, conditions that only affect women or predominantly affect women

[00:13:54] or affect women differently are very severely under research because they're mostly underfunded. So if you think about the entire spectrum of things that can be researched and diseases that can be researched, things that affect 50% of the population,

[00:14:15] like our ovaries, you know, has been something that's been severely neglected. I'm happy to see the progress that is being made, but that has left that it's 2024 and we don't have enough data on how conditions affect women.

[00:14:29] We don't have enough clinical evidence to show how medical practice is different for women. And most importantly, we have not had the opportunity to invest in solutions for diseases that affect women such as ovarian cancer. To compound that, ovarian cancer is a very challenging disease.

[00:14:52] The biology is different. The reproductive organs are challenging to access. So in other situations where we may be able to go in somewhat noninvasively to just get a sample of the tissue to do a biopsy, we can't do that in ovarian cancer.

[00:15:08] We have to fully remove the ovary in the fallopian tube. Ovarian cancer spreads incredibly fast and so even when women are showing up, by the time they get a diagnosis it's often late stage disease because of the biology of this disease.

[00:15:20] And to compound it, it's what's known as a low incidence disease. The actual number of cases of ovarian cancer in any given year is not as much as breast cancer or maybe some other cancers. However, what's often neglected is the death rate.

[00:15:38] The number of women that die of ovarian cancer is three times more than any other gynecological condition. And so we've essentially ended up in a place where it's perceived as a disease that may not affect too many people. It's severely underfunded and it's under researched

[00:16:02] and all that lack of focus has placed us in a situation where women are going to the doctor or saying something is wrong and doctors don't have a way to assess that. Yeah, it's such a combination, sort of like a perfect storm of factors there

[00:16:18] and you outline that so well. It's hard to think about the survival rate being as low as it is but I think it's very important to center it, as you say. Going back to the point of innovation, your company is in a category that's broadly known as FemTech.

[00:16:35] I can't get comfortable with that term if I'm being honest. But FemTech, you know, there's a lot of hype around it and it's great. Should we all get behind FemTech? I have a love-hate relationship with the term FemTech. I appreciate what marketing and comms have done

[00:16:55] for the industry overall and in raising awareness and in elevating the class and in, you know, really sounding the horn on how big the problem is. And I think I don't understand necessarily why we had to come up with a new term

[00:17:18] when women's health as a term and as an industry already existed and this idea that we need to make something tech-y to make it fashionable or, you know, appealing, I don't know. Sure, you know, if it elevates the class overall, sure.

[00:17:38] The challenge that I experience with it is that we've now entered into this ecosystem where definitions and categories are used differently by different people and it's not necessarily a terrible thing, but you will have many FemTech investors

[00:18:00] who will say, well, I won't invest in anything, you know, women's health that requires regulatory approval. And you're like, okay, but much of the disease conditions are not going to be solved with solutions that don't need regulatory approval, like therapeutics or diagnostics or devices.

[00:18:17] You've seen a shift in, you know, tech investors wanting to enter the space that have certain expectations on timelines or ROI's, which again, when you're in healthcare are not necessarily the same. You have significant amount of risk from a science side

[00:18:32] and from a regulatory side and from a payer side. And so it's one of those things that I think over the next decade is going to significantly evolve and I think we will see a merging of women's health and FemTech

[00:18:45] in a way that provides clarity and union across the needs, right? Which is, I think we're all working towards the same goal. The status quo for women is terrible. We need to elevate it and that ranges in solutions from clinics

[00:18:57] to service providers to digital solutions to device diagnostics, therapeutics. Like everything is needed. There isn't one thing that's less of or more of. And as we come together, and I do think it's an next decade kind of momentum as we come together as an ecosystem,

[00:19:14] we will really start to see the fruits of everybody's labor elevate the class overall and the mingling of what would have maybe been historically life sciences versus tech come together in a way that does elevate the system. Yeah. Yeah. I can't wait for that day to get here.

[00:19:29] Let me go back to the specific work that your company is doing. I know you mentioned to me that you have just opened a new lab in Denver. Tell me what is the end goal? Like, is it a diagnostic tool for a variant cancer?

[00:19:43] And when will you know when you've actually got there? The end goal with AOA is to transform women's health. And the way that we do that is by bringing to market diagnostic tools for various women's health conditions by being advocates for patients,

[00:19:56] by stomping on the grounds of policy, right? By elevating the funding in the space generally. And so that's sort of our end goal. When we look back, we want to be able to say, you know what? We had a lasting impact in transforming women's health.

[00:20:10] How we plan to get there is by first developing a diagnostic tool for ovarian cancer. When do we believe that we will have gotten there? Is that when this product is in the hands of providers and is actively being adopted to be used for patients?

[00:20:26] It's not when we, you know, submit a publication. It's not when we get our FDA, you know, letter. It's when this is in the hands of providers and it's serving patients. And that requires, you know, commercialization. That requires payer engagement.

[00:20:39] And so that pathway is one that will require significant investment and time and we're devoted to that mission. From there, we envision really deploying this Ginglius Eye technology into various different women's health cancers to really follow the path that we did for ovarian cancer

[00:20:55] into other areas as well. So, Mariana, you are so passionate about this work. I tell people all the time, if you're not passionate about doing something that's never been done and starting a startup, don't do it because the passion that carries you, it's not the success.

[00:21:12] There's far more failure than the success. It's the passion that carries you. Okay, so I want to start to wrap up, Orianna, by asking you a pair of questions that I ask everybody on the show. In the work that you do and from where you sit

[00:21:48] in this kind of big field of women's health, what do you think has been most overlooked and where is that inequality felt most deeply or most intensely? I think this will be specific to me because this is what we've experienced. In the field of women's health,

[00:22:10] I think diagnostics over all has been severely overlooked. We are too quick to prescribe things to women without really understanding where the root of the issue is. Over 30% of women that were diagnosed with ovarian cancer were first prescribed an antidepressant. Over 10% were treated for a UTI.

[00:22:37] It is not enough to treat our symptoms. It is not enough to take the data from studies that have primarily involved men. It is not enough to exclude pregnancy and pregnant women from research and to be so quick to treat things

[00:22:57] and not do the work required to understand. I don't put this on providers. I do not put this on doctors. I do not put this on medical malpractice. I put this on as an industry. We do not put enough value on diagnostics

[00:23:15] from payers, from innovators, from the ecosystem on what it takes to actually understand what a woman is going through. The right image and tools, the right blood tests or what it may be. I think that is across the spectrum from ovarian cancer to endometriosis

[00:23:36] to preeclampsia to menstrual pains that are debilitating. Giving more medications does not solve the problem for a woman. From there, to answer your second question, is it also incredibly inequitable on how it is rolled out? In my world today, which significantly focuses on early cancer detection,

[00:23:59] I am positively encouraged by the advancements that we're making in terms of liquid biopsy that were how we're looking to do things in a less invasive way. And I'm discouraged at how much of it is centralized to laboratories in the United States

[00:24:17] and how much of it does not have any type of insurance or payer coverages and forces the burden of cost on patients. There may be a population in the U.S. that can benefit from this, but there is an enormous population in the U.S.

[00:24:35] and an even greater one outside of the United States that does not benefit from innovation because the way it is developed does not take into consideration different types of healthcare systems. I worked extensively in Africa, in the Middle East, in Europe, in South America

[00:24:54] on rolling out at the time HPV and cervical cancer screening. A disease that is mostly eradicated in the United States is still highly prevalent in other areas. Cervical cancer is the only cancer in the world that is 100% preventable. It is one of the few screening modalities

[00:25:15] that has proven to work. And yet because the way that these technologies were originally developed, it excluded an enormous population. Simple things as much as women that would have to travel eight hours to get to a screening site. Systems that require running water,

[00:25:31] advanced technicians, expertise, power, et cetera, and healthcare systems that don't employ that or that don't have that. And so we're neglecting, and it's incredibly inequitable to an enormous population when innovation advances without taking them into consideration. And that's what we're trying to do differently at AOA, right?

[00:25:52] I mean, I wish I could guarantee success, but I could say it is at the core of who we are. One of the reasons to get into the weeds a little bit that we want to develop a distributable kit is so that this can be a test kit

[00:26:04] that can be sent out to labs all over the world on a system that is compatible with labs, with most labs in the world, rather than doing this as a single site centralized place where we collect all the samples because we know that that decreases access

[00:26:19] and makes it a lot more inequitable. Orianna, thank you so much for talking to me today, and I wish you and AOA the best of luck in your work. Thank you for having me here today. This was a great conversation.

[00:26:31] Overlooked is written and produced by me, Golda Arthur. Jessica Martinez-Dios is the show's associate producer. Tell us what you think of the podcast by leaving us a review on Apple Podcasts, Spotify, or wherever you're listening to this. And thanks for listening.