Putting the Patient First in Clinical Trials
Episode

Karen Correa, Vice President and Head of Global Clinical Operations at Takeda Pharmaceuticals

Putting the Patient First in Clinical Trials

Welcome to the LabOps Leadership Podcast!

 

In this episode, Karen Correa, Vice President and Head of Global Clinical Operations at Takeda, talks about her overseeing global clinical operations and trials across multiple therapeutic areas. She discusses putting the patient first by focusing on developing decentralized clinical trials, increasing diversity, mitigating risks, and cross-pollinating with other companies and industries. She shares her thoughts on learning how to be a leader and finding the proper message delivery to reach your audience. Karen points out the importance of collaboration and making an impact by helping others.

 

Tune in to this episode to learn how the work Karen Correa does at Takeda is making a difference in LabOps!

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Putting the Patient First in Clinical Trials

About Karen Correa:

Karen Correa has been in the healthcare industry for over 30 years. She got her Bachelor of Science at East Carolina University, her Master’s at Central Michigan University, a Ph.D. at Trident University Internation, and a Pharmaceutical Management Certificate at Cornell University. She is currently the Vice President and Head of Global Clinical Operations at Takeda Pharmaceuticals, where she oversees a global clinical operations team overseeing a multitude of clinical trials across multiple therapeutic areas. She has combined clinical research experience in various therapeutic areas at a full-service Contract Research Organization (CRO) and a Pharmaceutical/Biotech Company. Her primary emphases are in project management, clinical monitoring, and clinical operations. She has experience in clinical development training and management, recruitment and retention with a focus on specialized populations, and study coordination and clinical laboratory. She is also the proud mother of a blended family of five amazing adult children and six grandchildren.

 

Lab Ops_Karen Correa: Audio automatically transcribed by Sonix

Lab Ops_Karen Correa: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Samantha Black:
By building a platform to share challenges, network, and thoughts from leaders, the LabOps Leadership Podcast is elevating LabOps professionals as well as the industry as a whole. With the intent of unlocking the power of LabOps, we deliver unique insights to execute the mission at hand, standardize the practice of LabOps, their development, and training. Welcome to the LabOps Leadership Podcast.

Kerri Anderson:
Hi, I’m Kerri Anderson. I’m going to be the co-host today, and I’m one of the co-founders of the LabOps Unite Group.

Samantha Black:
Thank you, Kerri. We’re on today with our very special guest, Karen Correa, who is Vice President, Head of Global Clinical Operations at Takeda. What a mouthful! Karen, thank you for joining us today!

Karen Correa:
Thank you, Samantha and Kerri, for having me, I feel like I’m excited, I’m honored to have this discussion with you guys, so this is great.

Samantha Black:
Awesome. Well, we’re excited to learn a little bit about you. So if you could just start us off by telling us who you are, how you got to where you are today.

Karen Correa:
Awesome, awesome. So as you stated, my name is Karen Correa. I am the proud mother of a blended family of five amazing adult children and six grandchildren. I have had the opportunity to be in this industry for over 30 years. I started right out of college not knowing what I wanted to do, and I started out in a lab! I worked at Ciba-Geigy doing genetics research in the RTP, or we say Research Triangle Park Area, had a great job, and it was really nice great team, but realized it was not for me, but I needed something else. So I moved on, I had the opportunity to work at a site and doing clinical trials. I had the opportunity to work at CRAs. I worked at large farmers such as Pfizer and Sanofi, now I’m at Takeda, and I’ve worked at small biotechs as well. And I oversee a global clinical operations team overseeing a multitude of clinical trials across multiple therapeutic areas. So that’s my background, and that’s kind of how I moved up that ladder, and it’s been an exciting journey for me.

Samantha Black:
Yeah, I love that. I love origins in the RTP too, because I also have those, so I always appreciate that. No, that’s incredible. I think it’s a really exciting field, and it’s exciting just to like see how you progressed all the way through the ranks, all the way up to nearly almost the top, which is amazing, I love that. So can you just tell us a little bit more about the work that you’re doing and like your key focus areas in clinical operations that you’re focused on?

Karen Correa:
Oh, absolutely. So as you can imagine, with clinical operations, we’re always focused on patients first. Takeda has, one of the values that I just love the best, is called patient trust, reputation, and business, which means all of our decisions are focused around the patients first. Any decision that we make, we think about the patient first. How will it impact the patient? How will the patient respond? What does it do for the patient? What is it not do for the patient? And then we look at trust, reputation, and business. So what we’re doing is overseeing our clinical trials and different therapeutic areas such as rare hematology. We’ve got oncology, we have cell therapy, we have GI, we have neuroscience. So we have a multitude of different areas that we see. We have, I have a team of clinical operation managers and clinical operations program leads, and their job is to oversee the clinical trials from its infancy to its closeout. And we’re all the way through with submission, working with inspection readiness, working with the FDA and EMA and different regulatory agencies, so it’s exciting. Some of the things that we’re working on, one thing that’s near and dear, which I’ll always bring up is, what’s my master’s and my Ph.D. dissertation, is diversity in clinical trials. So we have a piece of our processes where it used to be an initiative in my prior organizations, but we actually have staff that focus on diversity in clinical trials, and that’s our goal, to make sure that the trials that we do are going to that are going to impact the patients that will take those drugs, that they are actually included in the clinical trials. Make sure we have enough women. If, you know, if there’s a, you know, an even amount of women in the trial. Make sure there’s enough minorities from different diverse backgrounds. Make sure we have enough different gender disparities, you know, to make sure we have enough elderly population it might need to be impacted or a younger generation. So we just look in that piece. So we’re working on a lot of different areas in that way as well. So it’s a lot, it’s fun and it’s fast-paced. That’s the whole thing with clinical trials and drug development. People don’t understand it’s fast-paced. Got a lot to do in a little bit of the time because the goal is to get it to the market and reach our patients.

Samantha Black:
Yeah, no, that’s incredible. I think that that piece is pretty misconstrued, I think. You know, I think that clinical trials take three years, five years, you know, they take so long, but during that time, there’s so much that goes into that and so much on the people side, but also on the scientific side as well. Like there’s so many people in the background who are just working to make this happen all at once, and I think that’s an incredible effort, so I applaud you for that. I’m just wondering, you know, what the company is doing. I know you mentioned the different therapeutic areas, but you know, what is Takeda’s kind of approach to that development, you know, from the science side all the way through the clinical, like what are some key things that are important for speeding innovation within your company?

Karen Correa:
So some of the things that we do that a lot of companies are focusing on is focusing on our digital aspect. We’re trying to make sure we utilize an AI, we’re trying to make sure we use an innovation. Like one of the things that’s new, you’ll hear a lot in clinical trials, is decentralized clinical trials. We’re trying to take the trial to the patient instead of trying to make the patient come to the trial. So decentralized clinical trials is an opportunity for us to have maybe a piece of our trial or a portion of our trial or even, one day, all of our pieces of that trial to be actually at the patient’s home. So imagine someone like you and I, we get busy, our schedules are busy. Imagine if you have something and you want to be in a clinical trial, you’re like, I can’t take off work or I can’t leave the house, I got my kids, I have this, I got a schedule, then I got to get to the site, it might be an hour or 2 hours away, so how can I make this more convenient for the patient? So I think that being able to look at all of that innovation, so we are embracing all of that and COVID taught us a lot. When we got to stay home for two years, I think we all learned that we can do a lot from this house, as many of us see. So that was the same thing with clinical trials. While we recognize that the patient needs to have that activity and that doctor-doctor contact, we recognize there’s a lot of activities that can be done in the home of the patient, kind of like when we have home health. You know, if a patient is sick and discharged from the hospital, they have a home health agency that comes and we do that so we can utilize some of those learnings and apply that to clinical trials so the patient doesn’t have to be inconvenienced so much to come to the office. Telehealth is a big thing that we see now. Having the opportunity, I don’t know if you’ve had a telehealth visit, I know recently I had to have a telehealth visit and I’m like on a screen, I’m looking at my doctor, and we’re talking and describing what’s going on, I’m like, wow, this is, I can’t think I could fathom something of this nature 10, 15, 20 years ago in our lifetime. So it’s kind of like The Jetsons today. So I don’t know who to, you know, that’s, they were on it, you know, but that’s kind of the concept. And I think that’s something that we’re really looking into, because we feel like that’s going to be able to allow us to have more patients in our clinical trials, have us to be, have it be more convenient and to keep our patients on trust. It’s not only going to recruit a patient but to retain a patient because they’re not going to be lost to follow-up because they don’t have to try to work this into their everyday schedule. So those are just one of the things that we’re doing. So even from the efficacy of our protocol development, we’re looking at what pieces of this protocol can be decentralized so that some of the things that we’re looking at, and I think it’s really, really good, you know, it’s good for the patient. Again, that’s where we start.

Kerri Anderson:
Yeah, yeah. I think that’s great. So a lot of what you’re doing is new and I’m just curious, I’m sure you come across many struggles while you’re going through these new processes. Can you talk a little bit about some of these struggles and how you Takeda have overcome them?

Karen Correa:
So I think Takeda, like every other company, we recognize that there’s going to be struggles with new, any type of new innovations. It’s kind of like you got to, you know, how we all got our first cell phone if you remember the big heavy duty phone, and it looked like, oh my gosh, I’m carrying this around, what is wrong with me? But I was so excited because everybody else had one. And then we went to the flip phone and then the BlackBerry and all that, it evolved to the smartphone that we have today, but it didn’t start off, and it had troubles, you had, your call got lost, and you had to change phones, you couldn’t keep all your contacts from your prior phone. Remember all these kind of, you couldn’t keep the same number, all types of things like that. When you think so, I try to use those same type of examples because that’s the same type of thing you’re going to see any type of technology that we see within clinical trials. So we have to make sure that we have, you know, we’re always utilizing, our vendors that we work with, they’re always trying to update their systems, you know, making sure they don’t have any type of situation where they could be hacked or things like that, any malware problems, we’ll try to make sure it’s updated. We also try to make sure it’s convenient so that each patient can understand it, you’ve got translation issues. So there’s so many things, and I won’t say issues, but concerns, things that you have to overcome. What I think that we do, and I see that all of the companies are doing, is that we’re looking at what we call risk mitigation. So at the beginning of a trial, we look at what are the potential things that can go astray and how can we mitigate. So I think is putting good risk mitigation plans in place so that we can properly prepare for those mishaps, those challenges that they come because they’re going to come. There is nothing perfect. You know, someone told me one day, if you’re looking for perfection, you might as well stop because you can’t have perfection in an imperfect world with imperfect people. So we’re human, things are going to happen. So it’s more of just knowing that it’s going to happen and being able to proactively plan and proactively mitigate, have a process in place, know what’s going, and you know what, something else, a word that I, Adam Grant, a great writer, says, is that you’ve got to be able to pivot quickly. So that’s the …, that we’re always thinking about how to pivot quickly. So we have a lot of portfolio review enter discussions so that when we see those leading indicators not going in the right direction, how can we pivot? That’s the piece that’s, I think is real critical.

Kerri Anderson:
So this lab operations community that we’ve started, one of our big focus is, lab operations is kind of an area that’s siloed in companies a lot of times, and it, maybe just one or a team of a few people and you have no one to talk to. And so our community was created in order to help each other be able to bounce ideas and bounce press practices. And I’m curious, in your opinion, what do you think lab operations is doing to help bring drugs to the market faster? And do you think, can you think of one thing or something you’ve seen or heard that can make a difference in LabOps?

Karen Correa:
Oh, that’s a very, I think the only thing that I could, that would stand out to me when I think of lab operations is when organizations are not, when we’re sharing. So I think it’s the cross-pollination from one industry to another or multiple industries coming together. So I think when I started out in this industry 30 years ago, I worked at Company X and all I knew was what Company X did. I think that the white papers, the conferences, the roundtables, I think those discussions, those opportunities allow for us to learn from each other, and you’ll say, someone do a case study and you’re like, whoa, that happened during your, when you were doing, I’ll take a specific lab situation, oh, you were doing some type of data analysis and you’ve got this issue, maybe you were doing a database lock and you were doing reconciliation and you were doing stuff with PKs, or you would do, like anything, and you’re like, Oh, that issue, and you’re learning from other companies. And it’s not that people are providing there, someone say the dirty laundry, it’s more of them providing, this is what we did and this is how we overcome it, and we want to help you prevent that. Because at the end of the day, no matter what company you work for, we’re all looking towards how do we better the health of our people, how do we better the health of patients? That’s, because I’m a patient, you’re a patient, our family members are patients. So it doesn’t matter what company, if someone comes up with the resolution, I want to hear about it. And I think that the pharma company, the biotech companies, labs, all types of organizations, how we are now coming together and sharing practices, I think is the greatest benefit that I’ve seen in 30 years. And I can honestly say I don’t recall that. I remember conferences, but it was more of like, let’s make this connect, let’s make this business. But now it’s really, this is more astray and this is how we got there. So now I think that type of learnings is what’s making us better as an industry. And I think another big piece is COVID taught us that. We came together as one world saying we have got to fight this pandemic. We couldn’t do this in a silo. We would have never gotten beyond, got to the point we are today if we would have did this in a silo. And if we didn’t learn anything else with COVID, that’s how we should charge our situations with cancer and rare diseases and challenges with our health of our pediatrics, our elderly. It’s important.

Kerri Anderson:
I love to hear that because I feel the same way. And, you know, it’s one of those things I love about this industry is seeing different companies come together for the shared vision and goal of helping patients.

Karen Correa:
Absolutely. It’s going to make us stronger because I tell people, all the time is COVID the last pandemic? Probably not. Is it going to be the last situation? We got monkeypox, we got other things coming. We cannot live in a silo, in a glass house, or it’s all about me. We all still have our own goals and we have our own situations and we still want to do well individually, but we also have to come together as a unity when it comes to the well-being of our nation, our world.

Kerri Anderson:
Yeah, absolutely. So you’ve had this incredible career, and I’m curious to know kind of a two-part question here. What’s the biggest lesson you’ve learned so far? And then, second part is, I think all of us are always learning and continuing to learn in our careers, and so what’s something you’re right now working to learn?

Karen Correa:
Well, I think the biggest lesson I’ve learned is that you don’t know everything. You’re always growing. And I think when you’re young and you’re right out of college, you think you know everything and you’ve got this chip on your shoulders all about you, but when you learn that you know nothing, you know absolutely nothing, you come with a little bit more of a humble spirit, and that’s kind of where I am. I’m, you know, 52 going on 53. I’m an extremely humble person. I don’t care. I can learn from the person that just started an industry or someone who’s been industry for 50 years. You can learn from anyone. And I think that when you have that humble spirit, you just grow as a person, and I think you can develop more. I think you can become more, and something that someone told me, a leader first needs to learn how to follow. So I focus on following and then I just let my leadership be natural. And I just, that’s just kind of what I believe in, you know? I’d rather be at the back pushing my team, and then in the front pulling my team, and then on the side carrying my team. Like I’m in all, wherever I need to be in that circle, that’s where I’m going to be. And I think that was something I had to learn over time, and it took me a while because at first I just didn’t know, like, I didn’t, a lot of times we don’t have maybe the right guidance that, they don’t teach you that in high school and they don’t teach you that in college. You know, everything is technical and tests and stuff, but they really don’t teach you leadership and they don’t teach you about the development. I think now I’m on the alumni board of my university and so I know there’s a lot more development in those types of skills, but they weren’t there 30 years ago, for sure, for me. So I think continuing to provide those type of skills for people is so drastically important. And what was your second question? I want to make sure I don’t forget it because it was so important.

Kerri Anderson:
What are you learning right now?

Karen Correa:
Oh, wow, I’m always learning. I think I’m trying to learn how to continue to articulate my message to a different audience. I am learning, when I think of diversity, for example, diversity could come in so many areas, five-year, senior, senior leaders of an organization, and then you have those who are at a different level in your organization, and you have people in different groups, and you have people at different companies, and then you have different people, different education, different backgrounds, or different cultures. So with that, you have to remember that you are constantly trying to reach your audience and find that right message delivery. And I don’t know if, I’m just being very honest, you just, you know, to be your authentic self, you got to sometimes still tailor that to certain people. Like, I’m from Jersey, I talk, well from North Carolina/Jersey, I talk fast. So I’ve got to remember sometimes that for some people I got to slow down and I don’t always want to do that because I want to be like right in there. And then some people are so passionate and it’s so exciting. That kind of pushes some people away, they can’t handle all my excitement. So you really, and you know, and I tell people that as a leader like that, you are constantly trying to figure out where you’re at on the field, the playing field. Am I pitching? Am I throwing? Am I catching? Where am I at in that process? Because at each one of those playing points, you’re responding differently and you’re acting differently. Not that you’re changing who you are, you’re just reading your audience. And I think that’s, so it’s that executive presence and that’s a skill. That’s a real big skill.

Samantha Black:
Yeah, I love that, that’s amazing. I think that’s so, so, so much awareness, and I think that it’s so translatable into every single industry, every single person. And I think that’s the important thing here, right? Like we’re developing leaders and we want really good people leading us like you and just people who have excitement and dedication and are just excited about what they’re doing. So I love that, and I think that’s something that people can really remember as they’re climbing the ladder, be encouraged, that they’re not the only ones. Like their bosses are still figuring it out too.

Karen Correa:
Absolutely, that’s really important. And I think you know what I look at people like starting out in their career, one thing I always tell someone is don’t never have, don’t be so busy or so special that you can’t help someone else. There’s nothing worse than thinking that you’re so like, I personally, I just talked about being humble. I will smile and talk to anyone, I will give anything I can. Sometimes I overextend myself, I try not to, but I do. I’m probably a little bit behind on my LinkedIn messages and I know so, but I try my best to respond. I try to give even if it’s quick. If someone’s like, can I just have five? I’m like yes, I’m gonna give you 10 minutes, what is it that you want me to tell you, or how can I help you? Because I truly believe I lived this life. I tell everyone you got one chance at this life. It’s not a dress rehearsal. And once you close your eyes, you don’t get another chance. So you should do everything you can to make every day as powerful as you can for yourself and for everyone that you impact. People are not going to remember, you know, oh my gosh, why am I going blank in her name right now? Because I read all of her stuff. But people are not going to remember what you’ve given them, they’re going to remember how you made them feel, and that is critical. So I want to make sure that when people remember me, they’re like, oh, I remember her. She was giving, she was humble, she gave, she did, whatever, whatever. I don’t want them to remember. Oh, I was like, I just want to leave a great impression on who I am and who I can be, and what I want to be. And I want to leave that for someone else because, again, I only get one chance at this life.

Samantha Black:
That’s amazing. And so, on that note, if people wanted to keep up with you and the work that you’re doing and just stay in touch, how would they do that? How would they find you, Karen?

Karen Correa:
Oh, LinkedIn. I’m on LinkedIn. I am on social media. I am on Facebook, I’m on IG, but that you’ll hear more about me and my personal life, which is still public because I’m a pageant girl, so you can hear about that. But that’s my, I tell everybody, that’s my downtime because you got to have a downtime. I don’t care what it is. You’ve got to have something that you do that’s passionate where you could just be yourself. I don’t know, some people run marathons and we play golf tournaments. Everybody, you know, everybody does whatever. Some people cycle, whatever makes you have that wellness, have that balance because if you don’t have that balance, it’s going to show at work, too. You don’t have a, you know, those people, you call, you know, that miserable Megan, you know, Megan. You know, that’s where it comes from because there’s not a balance in that life. You have to have a balance in your life. So please, you can hit me up on any social media. I try my best to respond, if I don’t just ping me and say, hey, you haven’t responded, and follow me. I mean, like I said, if I can help you become a better person, I have, and I can close my eyes and know that I’ve done something great for someone else, that’s the best gift anyone could ever give me. I love when people come back and say, oh, my gosh, I got that job, or I got that promotion, or I was able to do that presentation, or I was invited to speak at that conference or whatever, and I’m like, yes! I’m like, so excited because I’ll be someone else’s greatest cheerleader.

Samantha Black:
Awesome. This is amazing.

Kerri Anderson:
Yeah, I love that. I love your enthusiasm for life, too.

Samantha Black:
Yeah, it’s amazing. Karen, thank you so much again for sharing your story with us and how you started in the lab and you have progressed. And just your energy and your spirit, I really enjoyed it, and I hope that others are encouraged by this. But thank you so much for your time. That’s all we have time for today, but we really appreciate it.

Karen Correa:
All right. Thank you so much, Samantha. Thank you, Kerri. Please stay in touch. I’m only a phone call, text message, away.

Samantha Black:
Great, and that’s all we have. See you next time on LabOps Leadership Podcast.

Samantha Black:
Thank you for tuning in to this episode of the LabOps Leadership Podcast. We hope you enjoyed today’s guest. For show notes, resources, and more information about LabOps Unite, please visit us at LabOps.Community/Podcast. This show is powered by Elemental Machines.

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Things You’ll Learn:

  • At Takeda, Karen leads a global clinical operations team that oversees many clinical trials across therapeutic areas from infancy to closeout.
  • One of Takeda’s values is Patient Trust, Reputation, and Business, which means all their decisions are focused on the patients.
  • Decentralized Clinical Trials are taking trials to patients instead of vice versa. 
  • The future of clinical trials would ideally be doing them at the patient’s home.
  • Cross-pollination between industries can make a difference in LabOps since all healthcare companies want to improve people’s health.
  • You should do everything possible to make every day as powerful for yourself and everyone you impact.

Resources: