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Miruna Sasu is on a mission to use real world data (RWD) to help wipe out cancer. She believes this audacious goal is within reach, and as president and CEO of COTA, a company founded in 2011 by doctors, engineers and data scientists to curate RWD through a proprietary technology using advanced analytics, she is inspiring her team to create a “path to care” for oncology patients.

“I truly believe that real world data and evidence generated from real world data gives us the knowledge and an understanding of patients and what they’re going through … and can help us figure out the right treatment at the right time to save a life,” Sasu says.

Sasu says she was inspired to join the industry as a result of her grandfather’s diagnosis with stage 4 lung cancer.

“He went into remission very quickly after he entered into a clinical trial,” she says. “I decided right then and there I want to do that for other people and I was going to go work for the company that made it possible for my grandfather to go into remission and saved his life. That was Bristol Myers Squibb.”

Having earned her data and analytical stripes as head of innovation and digital health at Bristol Myers Squibb and later as head, clinical trial feasibility and data science at Johnson & Johnson, Sasu says she has learned that data success starts with a strong internal infrastructure.

“My advice to biotech and pharma companies is to build part of the organization that is just in charge of bringing real world data in and forming a data strategy for the entire organization,” she says. “It’s as simple as that. I say it’s simple, but it’s not that simple.”

Sasu, who has always wanted to be a CEO, is setting a progressive culture at COTA and is driving teams to do something different.

“Over the past 18 months we have built tremendous assets, we have built a lot of data, we’re doing a lot of research work,” she says. “Folks have been working immense hours and have done a tremendous job toward our mission, which is to create clarity in cancer.”

Sasu’s vision of the future of data in the industry is analogous to a layer cake.

“The data is the foundational layer and then analytics are placed on top of that, and on top of that is what folks call artificial intelligence, but what I would call machine learning or advanced analytics methodologies” she says. “Real world data is just the beginning.”

In this week’s WoW podcast program, Sasu shares how real world data can be used to transform cancer care, her advice to women looking to get to the C-suite and why she believes “feedback is rhetorical.”

Welcome to WoW, the Woman of the Week podcast by PharmaVoice, powered by Industry Dive. In this episode Taren Grom, editor-in-chief emeritus at PharmaVoice, meets with Miruna Sasu, president and CEO, COTA. 

Taren: Miruna, welcome to the WoW podcast program.

Miruna: Thank you very much, Taren. It’s great to be here.

Taren: Miruna, you have a bold mandate and I would love to dig into this. It’s building a future where RWD (real-world data) will help wipe out cancer. Tell me about your vision and why this is a driving purpose for you.

Miruna: Yeah, I’m really happy to. Real-world data has become a big part of my life for quite some time now. I’ve been working with real-world data and evidence for many, many years. Specifically in the oncology space. It matters to me, it should matter to everyone, but I truly believe that real-world data and evidence generated from real-world data is an enabler for giving us the knowledge and an understanding of patients and what they’re going through. Knowing what’s going on with a patient and what they’re going through can help us figure out the right treatment at the right time to save a life.

So I truly believe that and I started working in this industry to be able to make real-world data available in all of the appropriate ways that it can be available for analysis for folks who are doing research in oncology and many other indications, as well. I believe that data and using data can give us an understanding of how patients can be treated and how can we extend their lives.

Taren: That’s fantastic, and what a noble cause because, as we know, oncology and cancer is just so prevalent in our society. The closer we can get to the patient and figuring out how to help them I’m all for. I understand you have identified three best practices for pharmaceutical companies that can help them fine tune their enterprise RWD or data strategy. What is your advice?

Miruna: This is a great question. I boil it down to one thing. Honestly, this is the one thing I would say to any pharmaceutical or biotech company. Put an infrastructure in place, which means put a team in place, to allow for gathering, understanding and figuring out which real-world data assets to bring into the organization and what you can use them for across the drug development process. It’s as simple as that. I say it’s simple, but it’s not that simple.

You have to bring people in who are in charge of doing this. If you don’t do that then it falls on the corner of the desk of your oncology development lead or folks that are doing other things. So if you’re letting other folks who are already busy take care of this other very, very important task and don’t have folks that are doing that work, specifically that work, then it’s very difficult to push forward on implementing real-world data in all of the aspects of drug development.

These people that would be sort of sitting there and have their hands in real-world data would have an understanding which data assets are the best assets to bring in the house, which data assets are applicable to discovery, for example, discovering new medicines versus developing them in the clinic versus commercializing them outside the clinic, which assets are particularly good at figuring out signals that might help you understand if a patient might be more prone to a certain type of disease or to a certain adverse event and things of this sort. Without having that knowledge base in house and really creating a space for it it’s very, very difficult to be good at it. And it will be a drag on the organization to be utilizing real-world data because everybody will say, ‘oh my gosh, I have my job and everything else going on and so I have to add this new layer of things into it.’

My advice is build a part of an organization that is just in charge of bringing real-world data in and forming a data strategy for the entire organization.

Taren: That’s excellent advice. You piqued a question for me when you were talking about data and different types of data. I thought, huh, aren’t all data equal? But apparently not. So certain data are better for different applications?

Miruna: No, that’s a really good question, actually. Not all data are created equal. For example, in the real-world data space a lot of folks say, “What types of data exist? What is real-world data?” Real-world data can come in different forms. For example, real-world data can be in the form of claims data, so insurance claims. Insurance claims data is really big data. It’s wide but it’s very shallow. So it only contains a little bit of information about the patient. That’s not very helpful when you’re trying to figure out if a patient is going to, for example, do well on a particular drug versus another. But it is helpful in understanding how much people are paying for drugs and what they’re experiencing.

But, there are other types of data. Another example, which is an example that my company COTA actually works quite diligently and well on, is electronic medical records and curated and abstracted electronic medical records. This is not quite as big of a data asset, but it’s very deep. So it gives a lot of information about what the patient is going through, completely de-identified of course so no one actually knows who these folks are. But, it does give a lot of information about the diagnosis and what they were treated with and how did they do on that particular treatment so that you can really look to see, okay, so if I treat this person with this medicine how long are they potentially going to live? Or are they going to experience any side effects? Or are they more likely to be able to do something, for example, like keep their job while also going through treatment? Are they moving around well? Are they feeling well? That type of thing.

Electronic medical records data is sort of deeper data that allows you to ask more specific questions about the biology of the disease and the population of the patients that you’re trying to treat. Whereas, for example, claims data is a bit more shallow information that can give you other types of insights, like how much should a drug be priced at and things like that. So very different and very useful for different types of analysis. For example, someone who is within a pharma company who doesn’t know those nuances might potentially license one type of data versus another type of data that could be much more useful for them.

Taren: Thank you very much for that explanation. How does real-world data differ from real-world evidence? Or are they closely linked? Sometimes they’re used interchangeably.

Miruna: That’s a great question, actually. The question is how does real-world data differ from real-world evidence. They’re actually very closely linked. Real-world data is the stuff that enables the evidence. So if you analyze the data you’re creating evidence. So essentially the real-world data that my company, COTA, puts together is a file that gets exported or seen by a particular organization, they license that data. What they do with it, the analysis that they produce from it and the analysis that we produce from it, is the evidence that’s needed to answer a whole bunch of different questions by different stakeholders.

Taren: Well, I love this whole idea about the data and how it can help move science forward. Have you seen any practical examples of how it has done so so far in your organization or through your experience?

Miruna: Yeah, I’m actually really happy to speak on this topic. COTA is one of two organizations in the world that have achieved regulatory approvals using our electronic medical records data. What that means is that we’ve been able to help life science companies go to FDA and make a case that their drug should be approved on market. The FDA has approved the drug with a cohort of patients that we have provided as a part of what’s called an external control arm.

One use case for this kind of deep, real-world data that comes from electronic medical records is what we call external control arms, which is basically on a clinical trial when you go to put together a control population and then the treatment population, that control population typically is treated with standard of care drugs. Well, when you have a data set of people who have been treated with standard of care drugs you no longer actually need to enroll patients into that arm. Which is great because all of the patients that you enroll can be treated with the exploratory medicine.

The database that we provided was used then as an external control arm and was approved by FDA. We actually have three approvals in the United States and one in Europe with that type of external control arm.

Taren: Congratulations. That’s exciting.

Miruna: Yeah, bit kudos to the team on that.

Taren: That’s amazing. Just to shift tracks a little bit here let’s move on to your role as President and CEO. Both of which you were named less than 18 months ago. What has been some of the biggest aha moments or learnings that you have experienced since taking over the company?

Miruna: I’ve had a lot of aha moments. I think the first one – so I’ve always wanted to be the chief executive officer of a company. I was actually on the trajectory to potentially joining the C-suite at these larger life science companies in my previous life prior to COTA. When I came to COTA I was really looking to lead an organization to really do something more and different. What we did here, because I’ve been working with companies like COTA for quite some time, I know the industry very, very well. In fact, I’ve probably worked with almost every single player in the space and have seen their data and have seen their teams, et cetera.

When I came to COTA I said what I want to do is make more of what COTA has. Because I very much valued the data that I had from them while I was a buyer of data. What I wanted to do was make more of it. And not just make more of what they already had, but also broaden the scope. In order to do that you need to have investment. But you don’t just need to have investment in terms of financials, you also have to have investment from teams.

And one thing that I have to say, and again huge kudos to COTA’s management team here, I walked into an organization where people were ready to go. They had great attitudes, they were ready to go. So we put the vision on the table and everybody just drove it forward.

Really, over the past 18 months we have built tremendous assets. We have built a lot of data. We’re doing a lot of research work. The aha moment here is it’s not about just financial investment, it’s also about the people that are at the table that need to invest their time and their energy and their emotional state into what you’re doing. These folks have been working immense hours and have done such a tremendous job because our mission is to create clarity in cancer. That’s my aha moment truly, it’s really about people and their dedication and their time, and I’m just so appreciative of that.

Taren: That’s awesome. You talk about putting the vision forward, and obviously as the CEO you set the tone for the organization in terms of the culture. How are you defining the culture in terms of what your vision is?

Miruna: I love this question. COTA’s culture is extreme high performance in a very well grounded attitude. Everyone is very kind and giving of their time. It’s very mission oriented here. We are all here to make cancer not an issue going forward. In short I think that’s what I would say.

Taren: Very good. You talked about some of the roles you’ve had previously at big pharma companies. You’ve had a very successful, multi-faceted career, starting as a statistician and then moving over to the USDA and then into industry at BMS, then J&J. The common thread is data. Let’s start with your apparent love of statistics. Where did this stem from?

Miruna: Honestly, now that you say that, my love of statistics, I actually hated math while I was in school. I used to say, “Who needs calculus? Who needs statistics?” I know that seems like that’s crazy now because this has been my career, but that’s the truth.

My love for statistics came as I was in my doctorate degree. Statistics became a tool, it became a crutch because I had a ton of data and I had to – this is out of necessity, right, of course as everybody would say. I needed to analyze the data so I decided to go to the statistics department at Penn State University. They said, “You know this costs money. You have to have money for this.” I was like, “What?”

I had money, but I didn’t want to give it to that. I wanted to get a new PCR machine. I said, “You know what? I’m going to learn how to do this.” Then I did.

Taren: I love that.

Miruna: That’s really how it began.

Taren: Did you get the PCR machine?

Miruna: I sure did.

Taren: Oh, good.

Miruna: And I analyzed my own data, too. Tons and tons of data. It was great.

Taren: Wow. As somebody who failed statistics twice in college I am so appreciative of those who have the brain who can make all that happen. I am totally envious. Can you share some of the highlights of your career that have led to your current CEO role? As I said you’ve had a very multi-faceted career. What are some of those highlights for you?

Miruna: Absolutely. I started in academia. I actually started with a professor and advisor who said to me, “I’m actually building you as a peer.” He had so much invested in me and then at the end of my doctorate degree I said, “I don’t want to be your peer, I want to go into industry.” But, I love and respect him still to this day. Really he was very instrumental to me doing what I did with my career, actually. He said, “Okay, let’s pivot, let’s get you some opportunities so that you can see what it’s like to be in industry.”

That was a big moment for me because I worked at Penn State in academia for a little while, while I was figuring out what I was going to do with my career. I actually landed at the Department of Agriculture and Food Safety because much of my degree’s research was in plant biology. I thought this is what I had really wanted to do.

Another moment that changed my trajectory was when my grandfather was diagnosed with stage four lung cancer. I said you know what? He actually entered a clinical trial, he went into remission very quickly after he entered the trial. I said, “I want to do that for other people,” because he was such a big influence in my life. I decided right then and there I was going to go work for the company that made it possible for my grandfather to go into remission and saved his life. That was BMS.

I tried every which way to get into BMS and finally I did. I worked in early development clinical trials within the biostatistics department there, so looking at discovering new molecules and testing new molecules. Then I moved to different roles and had increasing responsibility within BMS to the point where my last role the company had asked me to build a digital health strategy for the whole company. I was very honored and blessed to have had that opportunity, as well. That is how I started getting to know real-world data and real-world evidence.

Having done what I did at BMS, J&J sort of saw what was happening and they said, “Come do it for J&J. Come over here and do this.” I was able to build a clinical trial feasibility and data science team there and infuse real-world data and real-world evidence into J&J’s processes, as well. That’s kind of how I got to COTA and how I was able to understand and really build a path to this place where, again, like you said the underlying theme here is data. But really how I’ve used it has changed over time.

Taren: That’s fascinating. So you went from Hightstown to New Brunswick, huh?

Miruna: I sure did.

Taren: Well, thank you and thank you for sharing that story about your grandfather. I talk to so many folks and it’s because a family member or a friend was impacted by some disease that really led them to this purpose-driven career. Given the fact that you are in this data space what are some of the top trends you are tracking? We hear a lot about artificial intelligence, we’re hearing a lot about digital strategies, we hear a lot about RWD and RWE. What are the things you’re looking at?

Miruna: I’ll tell you a little bit about how I’m thinking about this. So you said artificial intelligence. I’m typically a very positive person in a lot of ways, but I am I think what I would call a realist in the artificial intelligence space. I am tracking artificial intelligence, but I wouldn’t call it that. I would call it machine learning.

Artificial intelligence to me is something that we probably won’t see for many years, and that is reasoning. Currently there’s no machine that can reason. A lot of machines can take in data and can make decisions based on the data that they have, but outside of that data they’re not able to reason. From my point of view that’s what artificial intelligence is. Machine learning is something that I’m definitely tracking and we use here at COTA every day. We use natural language processing, as well, which is just a fancy way of saying we pull important data into structured fields from big paragraphs. That’s what that really means. So natural language processing is another thing that we’re tracking.

We’re also tracking I think what I would call advanced analytics methodologies. Those really are the traditional statistical methodologies, but also new ways of being able to handle data. All of that to say that I think of what we’re doing and the future of this industry in sort of like a layer cake type of analogy way. The data being the foundational layer and then analytics being placed on top of that, and on top of that what folks call artificial intelligence but what I would call machine learning or advanced analytics methodologies. The real-world data or any data is just the beginning.

Taren: I love that. I love that analogy of the layer cake and thinking about what is that next step to get us to that intuitive place. It’s pretty fascinating. When do you think that – if you look into your crystal ball when do you see this all coming together in I don’t want to say a perfect moment but really making those leaps?

Miruna: We’re on the precipice right now. I think we are, I think we are. Real-world data is decent, it’s pretty good in the oncology space. But not that great in other therapeutic areas, like cardiology, immunology, brain disorders, other types of diseases. They just haven’t built those data sets yet. They’re at a different place than where I think oncology is. That still needs to be built in those areas.

In oncology I think we’ve made some really great strides. We’re at the place where we can start to place those advanced analytics techniques on top of the data layer of the cake. Now it’s about getting folks to understand what types of questions that they can ask or they should be asking of the data. That’s a really exciting place to be in. Whereas I think the other therapeutic areas still have a ways to go in that space. But in a lot of ways oncology is quite ahead of the game.

Taren: Fantastic. I am optimistic to see where you’re going to take us. Shifting gears a little bit, you sitting in the C-suite, you obviously have to know that you’re a role model to other women, especially in this data statistics space where there just aren’t as many women as there are men. What does this responsibility mean to you? Do you consider yourself to be a role model?

Miruna: Yeah, I actually don’t take this lightly. It’s an honor and a privilege to have been named Chief Executive Officer of COTA. It was an honor and a privilege to come into the C-suite of a company that is so data and analytics forward. I actually find that a lot of women reach out to me and say, “How did you make that decision? What happened? How did you get there?” The answer is I had a lot of help, I had a lot of role models myself.

I actually have a pretty robust development strategy for people in general, but certainly women, as well. That if someone reaches out to me and says, ‘hey, I really would like some help getting to a place in my career that I want to achieve,’ whatever that is, I actually will take folks on every year and will mentor them and will hopefully try to pave a path for them. I have had the benefit of that with some of my mentors and role models and I would like to provide that back. I feel like I’m very honored by it, but I also feel like it’s a great responsibility and I do feel that if we don’t do this for each other then who will? That’s sort of my point of view on that. I’m absolutely humbled by it because there are folks that are asking me questions that I, myself, hold as mentors and friends and I hold in very high regard, as well. I’m just totally humbled and honored by it.

Taren: Fantastic, and kudos to you for widening the path for the next generation to come. You mentioned a robust development strategy. What are some of those keys? What are some of those key pieces of advice that you offer to other women who you might be mentoring or even sponsoring who are looking to get into the C-suite?

Miruna: Sure, so the first thing that I ask everybody, and I know this probably sounds crazy at some level, but I ask them, “What is your ideal role to retire out of?” I let them sit with that for a bit. What that does is it fast-forwards your thinking. You think, okay, well say I want to be CEO of a company like COTA when I retire or in five years or ten years or whatever it is, whatever trajectory you’re on, it lets them sort of sit and think about what do I have to do from where I am now to get there. What are the things I have to learn? What are the roles I will have to traverse? What titles do I need to have? How many people do I need to lead? It sort of gets them thinking about these types of things.

Then I bring it back to today and I say, “Okay, so what’s step one?” I’d say that’s sort of part of my playbook with folks as I’m mentoring them is think about the role you’re going to retire out of, what’s your ideal role, what is that going to look like for you? Then bring them back to today and say what’s the next step to achieving that today.

Taren: That’s a great way to look at it. It breaks it down into tangible pieces. It can be so big that it’s almost impossible to envision. But if you bring it down to those tactical steps it really makes a lot of sense.

Miruna: Exactly.

Taren: Fantastic. You’ve given us some of the pieces of advice you provide to others. Is there a piece of advice that you have received that has resonated with you over the years?

Miruna: Yeah. Someone said to me – and I’ll tell you about this, feedback is something that I really value. Someone said to me one time, “Feedback is rhetorical.” That was a bit of a game changer for me. I like people, I want people to like me. I want people to like each other. Often what I would do is I would receive feedback and try to mold myself to that feedback because I wanted those folks that were giving me the feedback to like me and appreciate me, et cetera.

I stepped back when I received that piece of advice and I sort of said, “You’re right, feedback is rhetorical.” So there’s two things here. One is even if I don’t think that I am doing something in a certain way, this person perceives that I am. So, therefore, their perception is what matters. Not what I’m actually doing. What they see is what they experience. That’s number one.

Number two, I don’t have to take every piece of feedback. I think that’s really important and I would give the same advice. All of us are sort of trying to feel our way into different situations and potentially get to what I would consider or what everybody would consider their successful spot, you don’t have to always do what is advised of you. You have to also see it through the other person’s eyes.

Taren: I think that is great advice. I love that. Feedback is rhetorical. Because you’re right, everybody kind of tries to mold themselves to what somebody wants them to be, but that’s not always the best thing to do. I think that’s great advice. I’ve loved our conversation, it’s been fascinating. I’m going to end as I always do, and you shared a really poignant story with us about your grandfather already. Was that your wow moment or is there another one that you can share with us that either changed the trajectory of your career or has left a lasting impression on you?

Miruna: That was my wow moment. My grandfather’s diagnosis came as a complete shock and he was a really big part of our lives. When it happened it just was a game changing point in my life. I do feel that even if you don’t have a wow moment where a loved one is potentially diagnosed with a disease that could end their life in two to three months, I do feel like everyone goes through experiences that leave an impression on them.

And the other part of this, and this is something that my grandfather always said just going back to the feedback piece, feedback is a gift. The moment that really changed the way I was going to proceed with my career is when my grandfather’s diagnosis changed. That was when he went into remission. He said to me, “Don’t let anyone stop you.” That is something that I will forever hold as my gift from him, because I feel it’s really brought me to where I am today.

Taren: Your grandfather, a wise man, very wise. That is awesome. Well, thank you very much for sharing that very personal story. It’s been so delightful to speak with you. I can’t wait to see what COTA does next and what you do next to achieve your vision of making RWD a game changer for oncology and cancer. Best of luck to you and continued great success. Thank you so much for being part of our WoW podcast program.

Miruna: Thank you so much, Taren. It’s been great to be here.

Thanks for listening to this episode of WoW, the Woman of the Week podcast. For more WoW episodes visit PharmaVoice.com.