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This is the Leap Together podcast, where we highlight top leaders driving breakthroughs in clinical research and life sciences.
In rare disease, it's not necessarily about the thousand patients that you treated. It might be two, but you know, you hear success stories about those two patients and that's what drives me to do it again.
Zach:Hi, Zach Gobst here. I'm host of the Leap Together podcast where I talk with leaders in clinical trials and patient advocacy to explore how medical breakthroughs come to life. This episode is brought to you by Leapcure, the leader in patient engagement recruitment for clinical trials. Leapcure's equitable and empathetic process accelerates research while empowering patient advocacy. Hundreds of studies, millions of patients across 50 countries have used LeapCare to combine.
Zach:For a participation average of 62%, visit leapcure.com to learn more. Today's guest, I'm really excited about having on today is, Liza Micioni with over twenty five years of experience in clin ops, project management, and medical affairs. Liza brings a comprehensive understanding of clinical development strategy, protocol design, clin ops, and stakeholder management across a wide range of therapeutic areas. She has a proven track record of successfully managing complex clinical trials, leading teams and operations, developing robust training programs, fostering strong relationships with vendors and key stakeholders. Liza's passionate about driving innovation in clinical research, improving patient outcomes, and advancing the development of life saving therapies.
Zach:And I'd like to add, you know, Liza's been, one of the more special clin ops leaders I've been able to to meet with over the years. From the interactions I've had with her, she's always been thoughtful and candid about how to make a teamwork and, you know, how to impact patient lives. Liza, welcome to the show.
Liza:Glad to be here.
Zach:Yeah, excited we get to do this. Wanted to start by kind of having you share a little bit more about how you got into the space, what made you interested in clinical research, And what's kind of hooked you to stick around?
Liza:As most people who have ended up in clinical research, we didn't necessarily plan to start here. So I went to college for pharmaceutical marketing, thought that I would sell drugs when I got out of school, interviewed for several sales positions, and at the time I was told that I needed to go sell copiers first. And in the midst of doing those interviews, I realized that I am so not a salesperson. But being part business and part science in college, I worked at a pharmacy from the time I was young. I was always interested in the area of pharmaceuticals.
Liza:So I started at the bottom at a CRO way back when, a couple years out of college, and worked my way up and kind of did every position at the CRO from a project administrator all the way through to a lead CRA at the time. And I realized that there are doctors that want to talk to you without you having to sell them something. And so it still kept me in the world of pharmaceuticals, but it was a totally different direction that you're coming into the field in. And so the more I got involved and as I grew through clinical operations, I realized that I'm actually helping patients. And so I did rare disease for a long time.
Liza:And in rare disease, it's not necessarily about the thousand patients that you treated. It might be two, But you know, you hear success stories about those two patients. And that's what drives me to do it again.
Zach:You know, curious, you spoke about kind of like what you were expecting with the doctor interaction to be selling and how you've kind of had this space to do more than that. What was your journey there? And like, what have you observed about how you've been able to develop kind of meaningful relationships with the doctors and physicians involved in research?
Liza:So I think that's something that not to pat myself on the back, I do well. I'm very good at talking to physicians. I'm not a physician, so I'm not going to pretend to be one, but I will talk to them about, you know, what our treatment paradigms like and what is diagnosis like of a disease and because they're teaching me as we're moving along. And so there's always something to learn every therapeutic area I've ever been in was new at one time because I'm not focused in any one area. So I always use the time with physicians to learn as much as I can from them.
Liza:But I also found that by having those relationships, especially on the clinical operations side, they then want to do work for me because they know me. They know that if they reach out to me because they have an issue, I will respond to them. I mean, had physicians, one of the companies I worked for, I wasn't really in the clinic operations space. I had moved to medical affairs, but he was having an issue and no one was answering him. And so years later he reached out to me because he knew that I could find somebody to help him.
Liza:And so those are the relationships that are important. Even now, if I needed to find a specialty at an institution, I could reach out to any of those physicians and ask, you know, who should I call? I know it's not necessarily them, but they can certainly put me in touch with others. And so the physicians that are, you know, kind of they do a lot of research, but they also sometimes have practices, sometimes they don't. They do want to advance medicine, and so they are more than willing to teach you something, give you information, help you along.
Zach:I like that. And a couple of things I want to jump on from your response will come up. But, you know, building those physician relationships, you mentioned kind of learning from them. The stakes, you know, to get physician engagement is not always very simple. Usually these folks are very busy.
Zach:They have a lot going on day to day. They're accustomed to not being bothered with something that they're not asking for, that you're able to kind of win these over and become their go to person, be reliable and be supportive and kind of be on their team. It isn't a simple thing, you know, curious about some of the kind of events or insights that have come up that kind of help you kind of form those deeper relationships? Because many in the space kind of might think like, Oh, I'm gonna have a call to physician and I'm gonna have this relationship because this call is here. And really, there's a lot more to building those relationships.
Zach:And so interested in what you've seen there.
Liza:Yeah, so one of the things that I was fortunate enough to do at one of the positions I was in, I had the opportunity to attend the medical conferences. And so I would go, and this was years ago, not a ton of years ago, but there used to be the big book of abstracts. And so I would actually flip through the entire book and figure out what physicians were in our study did I want in my study, had experience, we're doing a talk on something, you know, related to the indication we were working on, and I would, for lack of a better word, stalk them at these meetings, and I would go to their presentations, I would listen to them, and I would make a point to introduce myself at the end of their presentation. And a lot of times they had a line of people, and I would just walk up and say, I'm Liza Machoney. I'm from such and such organization.
Liza:You know, you're one of our our PIs will be in touch soon or something like that. So every time they ran into me, I introduced myself again. And so they sort of just kind of knew like, well, if nothing else lies is going to show up, especially at small companies. There's a lot of times they, you know, they go through ups and downs and there's turnover and it was like I was kind of the constant that was always there and I wasn't there to talk to them about anything other than, you know, I'm in charge of your study and I know you're one of our sites and I'll come out and see you someday. That's sort of how a lot of my relationship started because I had the opportunity to go to these meetings and there was one time I saw somebody's name tag and I introduced myself and he looked at me and said your company lost me a lot of money and it was actually the company prior to like an acquisition like it was way back.
Liza:It didn't have anything to do with the products we were working on and I just looked at him and I'm like I'm sorry. Like I didn't even know what to say because I didn't know him at all and then we laughed about it years later. But once I started these relationships, to me, it's such a big difference between talking to someone on the phone and having no idea what they look like or what their personality is like and their mannerisms and contacting someone when you've met them to say, hey, I know you're super busy, but I really need you to sign this today and they'll sign it. You know, I I went to a new company at one point and we were in a similar indication as a previous company, and they were talking about one of the physicians who wouldn't sign their CRFs, and I was like, give me a second, and I texted him and I was like, hey, I'm at this company now, and I heard that you're not doing this, and I need you to do it today. And so it's just all of those personal relationship.
Liza:It's not just you know them, you've emailed them, that it's such a difference when you actually meet people in person. And so I may be one of the select few who still think that in person investigator meetings are important and face to face meetings and virtual meetings just lose so much that you can't get, you know, you can't understand people's personalities or, you know, that's just different when you don't when you've never met them.
Zach:Yeah, it sounds like, you know, the way that you were approaching those events strikes me as like there's it starts with like a genuine curiosity and a genuine interest in them as a person and supporting kind of their endeavors when they're it's not just like, hey, the first interaction is not I need this from you. It's that comes when needed, if needed. It starts with a great space of support and caring, which is a part of like what helps make clinical trials run at the end of the day when you do need the ICF documentation, whatever it might be. So, you mentioned working across a number of different therapeutic areas and getting to see the outcomes for patients. Interested in some of the things that you would have never expected when you started in this space across working in different indications and seeing the impact that you're able to have in clinical research on different patient lives.
Liza:So, like I said, sometimes in rare disease, especially it's about the individual patients and not the group of patients or everyone, you know, it was successful. We met our primary endpoint. Sometimes you don't meet your endpoint, but you do have those stories of my patient never felt better and they were able to do this. They were able to go for a walk. They were able to, you know, teach their college class.
Liza:Like there were so many stories like that that make such an impact because there are some disease areas. Well, yes, it's great to advance medicine. I don't want to say you're not saving lives. You're improving lives, but it's not a life or death situation. And so sometimes those therapeutic areas you realize just how sick some of these individuals are, you know, and they can't make it to the clinic and they can't, you know, they haven't been able to, you know, walk up and down stairs for three years or, you know, one time where, and this has nothing to do with clinical research, but it's a side note, my son did a volunteer project.
Liza:And while he was doing the project, they built a ramp for a gentleman who was wheelchair bound since COVID. And he said when they finished it, he literally rolled down down the ramp and down the street and like just left like he was so excited to get out of his house. And to me sometimes that's like those are the exciting stories about the developments we're making. You know, you might not be able to get a drug to market, but if you improve that patient's quality of life for the, you know, the last couple years or those are the things that are important because it's every individual. It's not necessarily, you know, I'm not going to save everyone in The US.
Liza:I know that. And I may not improve all of their lives, but I find working on development projects that are meaningful make a big difference for me too. Because I've done a little of everything and some of them you kind of look at like, yeah, everyone's okay.
Zach:Yeah.
Liza:And then you do another one and you're like, wow, I'm really making a difference in this person's life, like just by giving them drug for three months.
Zach:That hit something for me. You know, I, about five, six years into to Leap Cure, we did this exercise on like, what's our vision? Where where do we wanna be? And, you know, ten years, three years, and working our way back. And after working in this space, if you asked me this when we first started the company, it'd be like, oh, speed up clinical trials, make sure they don't take as long, connect advocacy, all the stuff that's really important.
Zach:Working in it for five years and kind of interacting with the patients, what actually became more important was some of the stuff that you're kind of describing, which is giving space to meet patients where they are, figure out what matters to them, really be a partner to them in the process. And we've kind of redesigned our company around like that's the stuff that feels the most special and both to us and the patients, it's those kinds of interactions along in their journey when patient is in a really tough spot, we're trying to kind of give them support beyond just their participation. And so to see that that's kind of become the driver for you as well is awesome. Because like sometimes we don't talk outside of our walls about this stuff all the time. Right.
Zach:Talk about this is our capabilities, how we do it, but we don't always kind of get into like, Oh, this is our why. We keep doing this for, you know, ten years for me at Lead Cure, and twenty five for you in the space.
Liza:And I love it. Like, it's funny like you know you talk about like what would happen if you won the lottery and I'm like I still like what I do, you know, I I don't want to as much as I'd like to sit on a beach for the rest of my life. I do love what I do and I am making a difference as as small as that might be. And that's important. Somebody told me, you know, years ago, if you don't love what you do, you shouldn't be doing it.
Liza:Yeah. And so for the last twenty five years, you know, I've had clearly ups and downs along the way, but I love what I do and I still do.
Zach:That's awesome to hear. And yeah, glad you're still out of your tenure in the space is more than twice mine, but glad to hear that that path has continued to serve you. Because it's the same thing for me. Like people ask like, you've been running this company ten years, like, are you gonna exit? I was like, I can't, I don't feel like exiting it.
Zach:And it's not to say that like, helping get to, you wouldn't be in the space this long if you weren't actually driving outcomes. Like, I think that's a part of being able to reach more people, impact more people. It's just the driver kind of shifts. Yeah, very cool. And then, as we kind of move into a world that's looking to like utilize AI more or become more innovative in our approach to clinical operations, I'm sure you've seen a few cycles, but maybe what's going on is different and exciting in different ways.
Zach:Interested in your thoughts in terms of kind of the future of clinical operations.
Liza:So AI is everywhere, obviously, and to be honest, I'm not the first adopter of new things. I need to like really see it and understand how it works. And I think this isn't answering your question yet, but I think one of my struggles at the moment is that everyone has AI and I am struggling to figure out who's doing what and what do I actually need. Yeah. Because, you know, you look at websites for different companies and they sound great, but you're not quite sure what it means, you know.
Liza:So I find that right now I'm struggling with a little of that. I have found a couple companies that I think are doing things I need them to do, but then there's, you know, new companies that pop up constantly and it's like, I don't know if they're better. I don't know if I need them. So I think there are some great companies that have come up recently. I think there's a lot of ways to make clinical operations easier because in the twenty five years I've done this, while some things have gotten easier, there are some things that haven't changed in twenty five years, and we haven't figured out a way to make it easy.
Liza:I also wonder, Do I need to hire a company that can do that for me? Or is it something that we can do ourselves? And those are the things I'm not a technology person. So those are the things that I'm just not sure yet, But I do think that there are definitely some resources out there that are making it easier to find sites find patients, you know, figure out your data, you know, all of those things. It's just all of those things cost money.
Liza:And so if we can figure out how to do it ourselves, that would be great. I'm just not sure exactly where it's going to go. I do think it's super helpful. I think there are definite ways that AI and technology help. But at the same time, of the technology we've used in clinical trials over the years, even though we've been using it for ten years and there's 10 different options, none of them are great.
Zach:Yeah.
Liza:So I, you know, I I think there's I mean, I feel like AI is here where it's not going away, so we might as well utilize it, but I think we need to figure out the best ways to utilize it without spending so much time. Just trying to utilize it.
Zach:Yeah. Yeah. That no, there's a lot of hidden costs, you know, it's a little bit of a meta topic for me where like we are kind of helping clients with this challenge, But then as an organization, we're looking at it for ourselves as well. If our company wants to like do a rebrand or kind of a new marketing campaign, how does AI fit into that? And there's a lot of folks that can promise certain things, but like, how long is it going to take to get the right thing to actually make this work?
Liza:And I'm not sure that as a patient I would want to talk to a bot.
Zach:Right. Yeah.
Liza:To tell me something because to be honest, when I go on websites and I just have a simple question and I try to ask the question, I never get the answer and I get really annoyed.
Zach:Yeah.
Liza:So that's where I struggle as a patient. Are they going to have the patience to talk to an AI bot and not a person?
Zach:Yeah.
Liza:And that's something I haven't quite wrapped my head around to figure out how I feel about it.
Zach:You know, coming back to kind of when we spoke about like the way that you would initiate relationships with physicians, like how does a bot express curiosity? Does a bot kind of like help physicians feel supported? Like we're really listening? Yeah, there's ways where you can technically say yes, but is it going to come across in the same way? And I think that in the future, maybe there is something that does something like that, but that technology might not be ready today or the process might not be ready or might not be your challenge to go take on.
Zach:You know, another thing about clin ops is you are kind of the person that makes sure everything works. Like, there's a lot of kind of ideas, but you're held accountable to, like, actual outcomes. And sometimes you work in kind of large organizations where, like, that's not how most individuals are empowered. You're kind of in a different style of role where like, it's not just about doing something that's innovative or it's going to, you know, sell the right narrative to the right people. It actually has to kind of, the proof is in the pudding.
Zach:And like, if something isn't functioning, you're gonna feel the pain and curious about your thoughts after years in a role where you really are accountable to getting outcomes for your studies. Yeah. How does it take and like how do you how do you build resilience in a role like that? Because to be doing that for twenty five years is pretty remarkable.
Liza:So because I've I've sort of done every job from a project administrator all the way to head of clinical operations and every job in between at every level different periods of time, the accountability is different. And so for the last, I don't know, probably ten years, I've been heading clinical trials or heading a program of clinical trials. At one point, I went on a job interview and the quality director asked me I can only have two and it was within timelines within budget or high quality, right? And I'm sure other people have been asked this question to on interviews and and, you know, I thought about it for a while and I was like, you know what? I get that time is money and you know quality is obviously super important or you're getting nowhere but within budget, when you're at small companies, you might need to extend it a month but you'll actually get it done properly.
Liza:Time and the budget part, I think it depends on the company. I've been at companies where it's more focused on one or the other, and so sometimes I think those things flip flop. Quality is obviously important. I don't know that anyone has ever been on a clinical trial that started and ended within budget and within their original timelines because things just happen. One of my bosses and I have argued in the past about timelines because, you know, it's like, well, you know, the CRO decided that we were doing these timelines, and now we're outside of those timelines.
Liza:But there's nowhere to explain, but the FDA had comments or we went back and changed the protocol again or, you know, there's a lot of things that happen. Like, you're accountable for all of those things throughout the clinical trial, but I think it's important to understand the whys of why something's out of budget or why something's not on time. The quality thing you shouldn't have to explain because that should be like the priority all the time. But I think a lot of times, and I've done a lot of educating over my career about budgets and explaining to other departments who don't quite understand that yes, we're using, you know, X number of funds, but now we need to move them over here and I'm not actually spending more money, I'm just changing where they go. And there's a lot of nuances to clinical trials, I think holding people accountable is one thing.
Liza:Knowing to ask the right questions is also super important, especially to different departments. Since I've worked at several small companies, not everyone had the same level of understanding of how their department might affect my department. What it means when they need to package drug or they need to repackage drug or relabel or, you know, and their delays then become my delays, but they were only thinking in their world and not mine. So a lot of times it's it's important. I've always tried to have cross functional meetings so that even if you have no idea what half the team's talking about, at least hear it.
Liza:And the more you hear it and ask questions, you'll hopefully understand more to the whole process and not just your little corner of the world. So I think that's really important because while, you know, clinical operations kind of I don't want to say runs everything, but they you know, that's where everyone comes for the updates on where are we? There's a lot of other players in that that aren't just me and that I really have zero control over. So it's important that the team all works together and understands and learns as we go. I've done studies where it's like the company was doing their first phase two study and half the team had experience and half the team was on the younger side and didn't have experience and we had to figure it out.
Liza:And so people tend to learn along the way, but I think it's important that the communication is there because you really need all of those functions and not just clin ops.
Zach:Makes total sense. Going into this podcast, I asked what would make this podcast a win for you, Liza, and you mentioned, which I loved, was to get people thinking more outside the box. Your intention about this podcast isn't the same as everyone's attention on our podcast. It's really to kind of give help support people in their thinking. When you think about kind of outside the box thinking, what comes to mind for you when it comes to clin ops?
Zach:Because in some ways, we are kind of following a strict scientific method. There is a box, but there's something about thinking outside the box too.
Liza:Over the years, just based on some of the projects I've been on, was like, and this was not something we did, but drug needed to get somewhere and it wasn't going to get there. So it was like, well, can we ship it from that country to The US so that at least it's in The US? And then when we're ready to ship it to wherever it has to go, then we can ship it. As everyone knows, exports and imports tend to take way longer than we all think they do. And so if we don't know how long it's going to take to get to The US, can we at least send it to us?
Liza:You know, so we've done things like that. At one point, I was on a study where we had equipment that had to get to Korea. And I don't know if I should say this, but it had to get to Korea and we were having a really hard time getting it there. And it was going, I think, from Europe to Korea. And I had a colleague who was going to Korea to see his family, and he brought it.
Liza:I worked with a consultant one time who was in South America and she needed a laptop and it was cheaper for her to fly to Miami to pick it up than for us to try to get it to her. So there are things like that. Like we're not, you know, it was her laptop for work, so it wasn't like we were breaking any laws. It was not a trial laptop, but things like that. Sometimes just need to think outside of the box like we need to get this done.
Liza:We need to figure out how to do it. You know, at one point it was we need to return drug and the CRA is not available. Okay, great. I'll go. I've hopped on planes and gone places and done things that aren't really in my job description, but it was like we have to get it done today.
Liza:So if somebody needs to do it, I will do it and not that I think everyone should hop on planes like me, but things like that that are not, you know, it's not brain surgery. It's not rocket science. It's like this needs to get from here to Pennsylvania tomorrow. Okay, can we hire a courier? Like FedEx can't do it.
Liza:Whatever those types of things I think are important. One, it shows that we can think outside the box and that we'll figure it out regardless. I am not a big believer in we hired a CRO and the CRO needs to figure it out. If they're not figuring it out. I will help them figure it out.
Liza:I think we just need to think about alternative ways to get things accomplished, especially when it's an urgent need.
Zach:I really like that response. It's really refreshing because it's it's there's a lot of like kind of startup mentality in that, you know, oftentimes like especially in like the early days of a startup. Like if you can't find a way to get little things done like a startup might not survive. And so yeah, you do have to hop on a plane to kind of go take that, you know, investor call or investor meeting in person or you do have to kind of find find the scrappy way to kind of like drive your first, you know, sales engagements or whatever And it might that you're ready for that twenty five years into your career running clin ops is awesome. Because I, you know, when I look back on, you know, all the things that helped me kind of build leap year, it's often kind of those moments that I I think of with a lot of pride that like, yeah, I didn't wait for things to come to me.
Zach:Like, I was kind of clever about how to kind of make things work. And I mean, you know, and sometimes I can attribute a lot of the successes that feel most impactful to me to those little moments. So
Liza:right. That's the stuff that I think is exciting about my job.
Zach:Yeah, that
Liza:like I get to come up with those, you know, how are we going to figure it out moments? Yeah, and I think that's what always keeps me interested and depending on the company, sometimes it's like, well, we don't care how much it costs, just figure it out. And other times it's like, we can't pay for this, so you still have to figure it out. Yeah.
Zach:I think what served me over time is to kind of see issues as opportunities. And I think in clinical operations there will always be issues. So there will always be those opportunities to kind of creatively pump. So yeah, so
Liza:I'm a big I used to say it at one of the companies I worked at. I'm like it's a teachable moment because I worked with a group of individuals that didn't have as much experience as others I had worked with and there was a lot of those. So I everyone's like, you know, so and so messed up. I'm like, no, it's a teachable moment and we are all going to learn from this. And you know my my first question every time somebody would tell me like, my god, something happened and what are we going to do?
Liza:I'm like, do we have any patients on drug? And if they answer was no, I'm like, it's it's fine. We'll figure it out. There's no safety issue here. We will figure it out.
Liza:And so I have always tried to teach people along the way because people mess up. I mean, I've messed up. There have been things that I've done and then I think about it later and I'm like, oh, maybe I shouldn't have done that. And I think we all do that and I think we need to learn from it and make ourselves better.
Zach:That's awesome. And I think like, you know, another thing, you know, reflecting on Leap Cure's impact, it's been working with folks that kind of have your mentality that see these things as a teachable moment that stay us against the problem instead of us against each other. There are times where you're just not working with someone who's the right fit. You're not getting the right give and take, and, you know, it's unfortunate. But to kind of default, to try to see it that way and work together through things, That that's how I've been able to kind of drive, you know, some of the most, you know, impactful outcomes for, you know, my company, and and it seems to be serving how you've been going about this
Liza:for a while. Absolutely. It was a pleasure. Thank you so much for having me.
Zach:Likewise, Liza. Enjoy the conversation a lot.
Leapcure:That wraps up our conversation with Liza Misioni. Her decades of expertise in clinical operations and her dedication to innovation and patient impact are a reminder of how strong leadership can move research from a possibility to reality. Thanks for listening, and until next time, stay informed, stay engaged, and keep pushing for better health outcomes for all.