BTO_Dorottya Nagy-Szakal: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Emmanuel Fombu:
Welcome to Bite the Orange. Through our conversations, we create a roadmap for the future of health with the most impactful leaders in the space. This is your host, Dr. Manny Fombu. Let's make the future of healthcare a reality together.
Emmanuel Fombu:
Good morning, good afternoon, good evening, good night, ladies and gentlemen. Thank you and welcome to another episode of Bite the Orange. And today we have a very special friend and a very special guest that probably needs no introduction, and she's an expert in something very interesting that we talk about today, and that's the microbiome and the work that she is doing at Biotia, a company that comes out of my alma mater, Cornell. So I have to mention that because she's a Columbia alumni, but I'm glad we could provide her some employment, so that's a good thing, and I thank you for sharing your Columbia knowledge with us. So today I'm having a very special guest, like I mentioned before, Dr. Dorottya Nagy-Szakal. I think I said, I pronounced that correctly. Is that correct, Doro?
Dorottya Nagy-Szakal:
Yes, absolutely, and thank you so much, Emmanuel, for having me here. I'm very excited to have this conversation with you.
Emmanuel Fombu:
It's an honor. It's an honor to have you on the show. I've had several conversations with you about what you're working on, and I think it would be great to share that knowledge with the audience today. I think it's something very special that you're working on, something very transformative. And not only is the concept of the microbiome important, but also the AI that you bring in by genomics is also solid. So tell us about yourself to begin with. Who are you?
Dorottya Nagy-Szakal:
Yes, I am the chief medical officer at Biotia and also a research assistant professor at SUNY Downstate. But overall, I am a female clinical scientist, a translational scientist, and my goal is to bring novel technologies to the bedside. So I have an M.D. and a Ph.D. and decided to bring these innovative technologies, to have the patients have the bridge to translate to physicians and provide all the data that's needed to have, and I'm specifically focusing on infectious disease diagnostics. I started as a pediatrician, but very early on I was introduced to the sequencing technology. This is a technology that can actually identify the genomic information of different pathogens, bacteria, viruses, and we were able to see the microbiome and understand these pathogens. And that brought me to the bedside to use these technologies and bring these infectious disease diagnostics to improve the regular gold-standard that's right now available.
Emmanuel Fombu:
Thank you for that, and great background, of course. And I think from a general perspective, if I'm a listener and I have no idea whatsoever what you are talking about, and I say let's start off with a basic element of what is the microbiome and why is it important?
Dorottya Nagy-Szakal:
Yes, so the microbiome is like trillions of bacteria that are living in our body. We have like around two kilograms of microbes in our guts and we call them the second brain because besides, they help us in digestion and they have different helping function to the human body. They release metabolites and they can affect different functions. For example, one of the most exciting studies that I have been working on at Columbia University was to explore the gut-brain axis, how these microbes can affect brain function, fatigue, depression, for example, but these microbes can have, to train the immune system, so they have several functions that help us. The problem is that life is not always perfect, so we have sometimes disruption of these microbes that could be anything external, for example, an antibiotic course or different diet. And then there is this disruption in the microbiome, it's called dysbiosis. Then it can relate and link to different disorders or consequently with different disorders, the microbiome can change and it has a huge impact on health outcomes as well.
Emmanuel Fombu:
So are you saying that the bacteria that we have in our body, because when most people think about bacteria, they think an infection, right? But you are saying that this bacteria is in our bodies, especially in our guts, have a second brain and that influences how we actually function?
Dorottya Nagy-Szakal:
Yes, absolutely, and we have all these bacteria in every body cells, in our gut, on our skin, everywhere in our body, and they are actually helping us when they are in a symbiosis with our human house.
Emmanuel Fombu:
But that's kind of tricky because if I remember basic biology or microbiology, looking at microbes, they have life or the life span of a microbe isn't that long, right? So the idea that microbes in my body could influence my mood and influence all the things in my body, how is that possible? I mean, do they transfer this knowledge to other bacteria down the road? How is that possible?
Dorottya Nagy-Szakal:
So we live with these microbes and we feed them with our different diets, and as soon as there is like some, so these microbes can release different metabolites and can trigger the immune system, can affect gut-brain function, so they live with us very healthy. But the problem, when there is a disruption and different mircobes can overgrow and can cause different symptoms, their metabolites increasing and these dysbiosis happen, there is a disruption in the symbiosis. What's really exciting that we can use these microbes for different diagnostics to predict who is, for example, in higher risk, develop different disorders, or we can use the manipulation of these microbes to affect different health outcomes. So now there is a lot of research going into how we can change the microbiome and can have an impact on how medications affect, for example, patients in cancer, chemotherapy, and cancer treatments. There are different diseases, and that was a huge milestone last week, that the ... cell treatment, which is a pathogen infection, the FDA were very favorably provided, kind of, not authorization, but into the way of approval of a drug that can affect the microbiome as a complex bacterial therapy and can we can start treating soon patients with the manipulation of the microbiome, which is quite exciting for the field.
Emmanuel Fombu:
This is quite fascinating information. So if we go back to Biotia, right, the company you work for right now, so what is the key problem that you turns off?
Dorottya Nagy-Szakal:
Yeah, this technology that was used to discover all these microbes, so this can specifically can identify different pathogens, and what we do at Biotia is focusing on precision infectious disease diagnostics, so we use this sequencing technology to match with our database of pathogens and specifically identify the pathogens, but besides the telling what kind of species strain we can find in different human specimens, we can also tell about additional information about these species, such as virulence and resistance. So what we can do in the end, we can provide the clinical report, for the physicians, that's going to tell them what these specific species can respond to and they can provide the right antibiotics. And this is a huge problem right now that, for example, infectious disease physicians, they treat patients empirically, over 90%, they don't exactly know what causing agent of the infection. They choose broad-spectrum antibiotics, there is an increase in resistance. And there are some reports that showing that by 2050, and I love to say this number to shock people, but by 2050, they predict that 10 million people are going to die from an infection, that we don't have a ... for this. So starting right now, forcing and supporting antimicrobial stewardship by giving physicians the right tool to diagnose these pathogens and tell what these species are resistant to and have the physicians at the bedside, it's very critical in the next couple of years.
Emmanuel Fombu:
Which is very interesting because as you mentioned, your gut and your brain, they talk back and forth to each other, right? And they connect probably through millions of nerve cells, and scientists, and I've read some reports, actually, some papers that scientists have linked certain changes in the gut microbiome to stress depression, anxiety, like you mentioned, and some studies that actually show the connection between this and this is like dementia or Alzheimer's. And even though it's not certain yet, like I mentioned, one study actually found that people with Alzheimer's have less diverse microbiomes. So does that mean that you need more diversity in your microbiomes, or should you have less diversity? What is good?
Dorottya Nagy-Szakal:
Yeah, it seems like the more diverse the microbiome, the better. So in many chronic disorders, we see that there are like overgrowth of some species, there is a shift in the microbes and there is a decrease in the diversity of the microbes. So, and we see that the industry is moving towards using microbiome complex, like bacterial cocktails to improve on the diversity, have healthy humans, and also patients to improve on their health outcomes when there is a decrease in the diversity.
Emmanuel Fombu:
Which takes us back to the beginning of this, the microbiome ... something that I read about that I thought was quite interesting, that your microbiome is like a fingerprint, right? Your microbiome is unique to you as an individual, and some of it may come from your mother depending on how you were born. And several studies that have shown that maybe babies born to like vaginal delivery, right, have a different makeup of the microbiome as opposed to someone that was born to a C-section, for example, right? And then there's a linkage between people going through C-sections and they're more likely to grow up having allergies to certain things. Is that something that you've read about? Am I correct with whatever?
Dorottya Nagy-Szakal:
Yes, absolutely, there are a lot of environmental effects that can affect the infant's microbiome based on for example, as you mentioned, the way of delivery that can robustly change the microbiome. But let me tell you another example, one-third of pregnant women receive antibiotics during the last trimester of their pregnancy because of some infections, and that means that that's going to disrupt the maternal microbiome that can affect the infant microbiome. And why is it super important? Because the first two years of the development of the microbiome is critical. That's when there is the biggest change in the microbiome developing into the diversity that's going into a healthy adult microbiome. And if there is any disruption either through the maternal-infant transmission or during the first two years of life, when again, infants frequently gets antibiotic, there's a disruption of the microbiome. That's actually, again, many of the functionalities that I mentioned, such as the immune system training and other functionalities, can affect disease development later in life.
Emmanuel Fombu:
So with that being said, so what is normal, right? And so that, we have many kind of yogurts like probiotic yogurt, so if you mention microbiome, I think the average person listening is thinking, oh sure, I get my probiotics. When I get more probiotics, I'm not asking for a medical decision here, what people should do, but what's the recommendation? If you take probiotics, for example, does that help with diversity?
Dorottya Nagy-Szakal:
Yeah, and healthy microbiome is a really good question. My favorite study was the Human Microbiome Project that started in 2009 when I actually went to Texas Children's Hospital and Baylor College of Medicine, and that's how I was involved with this field and the sequencing, and the first study on the human healthy microbiome was 500 medical students from the medical center. And I don't know if you recall how healthy your diet was during medical school, how healthy you felt during medical school, but it's a little bit questionable, so we would rather, I prefer to say, the control population's microbiome, but that was like a baseline, and we used that baseline in many studies after for comparison. And it's really challenging to study the microbiome because all these environmental effects, such as diets, that's like daily changing and can affect the microbiome and the microbiome can actually respond very quickly. Within 24 hours, you see some changes, maybe not that robust when you switch to a completely different diet or start a medication, but still there is like a dynamic changes in the microbiome. So it's really challenging to study and you need to have some very strict questionnaires, for example, to have your control population ready to collect microbiomes.
Emmanuel Fombu:
I mean ... volumes ... and there are tons ... information, right, just a number of bacteria that live in the gut or the skin, in general, we have the microbiome is intense. Which brings me to the point of how biology uses AI in this particular setting, so tell me about that. So because you're not just a microbiome company and discussing this piece of ocean, you actually have a digital health component to this and that innovative aspect of how you leverage AI, so tell us about that.
Dorottya Nagy-Szakal:
Yeah, I was really excited when I joined Biotia because we, and they saw the vision that we have this ability to build out software tools that can have to translate this giant genomic information very quickly and can provide the report, and I have been doing that at the university on my own, took one patient sample for a day to do that and we wanted to digitalize that, make it super quick and actionable. So we have been building different metagenomic tools to translate this pathogen genomic informations into an actionable clinical report for the physicians. This is cloud-based and super quick, and what's really exciting that right now all these computational advances actually have led us to bring this Metagenomic translation to the bedside and have an infectious disease. So what we focus right now is more on pathogen discovery, pathogen detection, and we work with the regulatory agencies to bring this to the bedside and have support all those gold-standard technologies, that's now in the infectious disease that are very, very limited, sometimes very slow, and not giving a definitive diagnosis for the patient.
Emmanuel Fombu:
So right now, what is your ideal client? Right, I know very early phases of development, so ... I do plan right now. And first of all, before that, I forgot to mention the actual higher clearance, right, certification, right, which is a big deal, right? And I know something that when we talked with you, something very proud about, and congratulations on that piece of it. So to expand more about what the ... of CLIA, what makes you different, and the CLIA side of it, and also tell me what your ideal target client is right now.
Dorottya Nagy-Szakal:
Yes, so we go out to New York State. We are clinical lab approval, and this accreditation is the highest standard in the United States to have a high-complexity molecular diagnostic lab. So I'm very proud of the team, it was quite a lot of work, and what we do is trying to bring these assays and software to the approval to use it at the bedside. And what's exciting is that during the pandemic, infectious disease got into the focus. Regulatory is understanding better how different mutations, for example, in a virus can affect therapeutic response. They understand sequencing technologies, so leveraging that, and we have been working with the FDA and we got FDA approval on our COVID software technology. So now translating that to the bacteria and focusing on different specimen types to approve and get the diagnostic test with that, but it's going to be some long way to make it into full approval.
Emmanuel Fombu:
So what has been the biggest challenge so far? I mean, clearly, one, explaining why the microbiome is to people, this is one complicated. Two, getting the CLIA lab accreditation is another piece of this, but what has been the biggest challenge you face so far?
Dorottya Nagy-Szakal:
Yeah, I feel like working with the regulatory is it's quite challenging and I have really good conversations during the pandemic because they put so much effort into support or diagnostics in the infectious disease space. So I'm excited to continue and see that effort from them. What's really, has been challenging because it's not coming from the physicians, and I feel like the physicians are ready to change the gold-standard technologies. They are excited about this technology, but they need to see more data on clinical utilization at the bedside. So what we do right now, we are focusing on high-risk patient population and specifically oncology patients where having an infection that's very critical. it's actually the second leading cause of death in these patients, so it's very frequent. They can go into substates and that can expand or delay their actual chemotherapeutic protocols as well, it's high mortality and in the increased costs for the healthcare system. So we focus on cancer patients right now and building out clinical studies to show the utilization that, with our technology, with sequencing at the bedside, how we can improve the diagnostic decision, narrow down the therapeutics, and help the physicians. And on the global side, we can use these to fight against antimicrobial resistance, that's again, like one of the biggest threats right now we are facing.
Emmanuel Fombu:
Which is quite fascinating what you do and you're tackling things on multiple fronts and I'm sure it challenges also, focus on what, the right area to focus on, right? But I think picking the oncology space and the infections and the outcomes in that space makes you a perfect candidate for Bite the Orange kind of podcast, because what you're doing is groundbreaking and fits perfectly in that category of things. So what does the future of this industry look like for you? What you think will happen in the next five years, ten years that you hope?
Dorottya Nagy-Szakal:
Yeah, I really hope, one of my dream is to not to have to provide a fax number for the hospitals or the lab. So I really want to see the fax machines removed from the hospitals. I'm very excited about the digitalization of medicine and healthcare and with these giant datasets right now, we again, we have these computational advances to utilize all those data. So we actually working with our hospital platform datasets where we have these fully de-identified patient datasets, that's very exciting because we can test some of our machine learning and prediction models using that. So what's really exciting to bring these platforms to other companies and support them to test their AI and bring these kinds of AI models prediction for different diseases to the healthcare to help and drive the physicians. And again, it's not removing the physicians from the bedside, but helping them, to direct them to make the right decisions to help the patients.
Emmanuel Fombu:
Thanks a lot. So anyone listening, if you believe in what Doro is fighting for and what she's working hard for, and you believe that we should have no fax machines or fax numbers the next ten years, please make sure you bite the orange and #BitetheOrange and #Biotia ... that's why I stop there. ... Biotia, #WomenInScience and #SmartWomen. Thank you for joining us today, Doro, it's a great place to run up, and I would love to have you on another episode of Bite the Orange.
Dorottya Nagy-Szakal:
Thank you so much, Emmanuel. It was really fun to talk with you.
Emmanuel Fombu:
Thank you for listening to Bite the Orange. If you want to change healthcare with us, please contact us at info@EmmanuelFombu.com or you can visit us at EmmanuelFombu.com or BiteTheOrange.com. If you liked this episode and want more information about us, you can also visit us at EmmanuelFombu.com.
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