78 - Revolutionizing Clinical Trials with Collaborative Approach with Advarra's Elisa Cascade

Welcome to Listening with Leaders. I'm Doug Noll, lawyer turned peacemaker. I teach executive leaders how to listen to emotions rather than words so that they can become the leaders everyone wants to follow. And I teach those same leaders how to be authentically present, available, and connected to their families despite being insanely busy. I have learned that we are 98% emotional and only 2% rational. Learning how to listen to emotions is, in my experience, the foundational skill of life. Stick around to the end of the show and I'll reveal how you can be on our next guest in 15 to 20 minutes. So let's get started. Elisa Cascade, welcome to Listening with Leaders. You are the Chief Product Officer for Advara, which can be found at advara.com. Welcome to the show.

Thank you so much for having me here today, Doug. I appreciate it.

You know, I did your Authority Magazine interview and I was just captivated by your career. And so I was wondering, for those that haven't seen the interview, maybe you could give us a little bit of your backstory. Sure, sure.

I'd love to. So I started out as a pre-med econ major. God knows what you do with one of those. I'm not quite sure, right? And I fell into healthcare consulting. Like, I didn't even know that healthcare consulting existed. And I had the good fortune to do a lot of work related to pharmaceuticals. We did market research, strategy, pricing, reimbursement, and got into health economics and outcomes research. And the strategic consulting firm that I worked for got acquired by Quintiles, which is now IQVIA, one of the big CROs in the clinical trial industry. And I went into their late-phase business and started learning the late-phase business, Phase 3B4 clinical trials. And from there, had the opportunity to start a, a, what we call the digital patient unit, where we grew a community of 2.7 million patients and we're working with them to support recruitment for clinical trials, but also to do direct-to-patient studies. The real bleeding edge of what's happening today called DCTs or decentralized trials. But I learned a very good lesson through all of that. Um, actually two lessons, I would say. Number one, from an industry perspective, we need the sites. The sites are key. And number two, it's really hard to be on the bleeding edge of innovation in a CRO who's made their entire reputation based on SOPs.

Okay.

And so if you're doing things differently, it's tough.

All right. So we got a lot of acronyms here for the totally like myself. We got to de-jargonize. So let's see, you said CRO. What's a CRO?

CRO is a contract research organization. They are the organization that helps do a clinical trial. So the pharmaceutical companies, some of them may choose to do a study on their own. Some of them may contract with one of these big contract research organizations, clinical research organizations, to support execution. And some may do a mix, keep some of the services in-house and outsource some of the services.

And what does Advara do?

So kind of wound my way through my career and pivoted from sort of more Phase 3B, Phase 3B4, late-phase study designs. 3B4, to de-jargonize, is after a product has been submitted to the FDA or approved by the FDA. And so I was focusing in that area, but then did a pivot in my career where I was able to leverage my background in the industry and my knowledge and, and strategic consulting ability and really got into the product discipline. And so I would have the fortune to work on a number of different products in the clinical research industry. And the latest is, is here at Advaro. So what Advarra does today is we are a leader in clinical trial technology and services. We have a, um, one of the leading US, what we call institutional review boards. Those are ethics review boards. They are an independent body that will look at a research protocol and say, is this fair and safe for our patients in a clinical trial? But that is in essence a technology-enabled service. In addition to that technology, we have technology that supports clinical trial sites and technologies that supports the collaboration between the site, the study sponsor, and the clinical research organization. All of those things.

My head's buzzing. So when you talk about the site, what are we talking about when we talk about the site?

So sites in clinical research are the sort of individuals who are actually doing the research.

These are the physicians or the researchers or the chemists or the compound, whoever it is, the Moderna people who are figuring out what, how to— they're building vaccines of some kind and they're the ones that are creating the true technology that will save lives, hopefully.

So here's where we are. Moderna comes up with a compound, right? Like, like a COVID vaccine.

Right.

But they need to go through a series of tests. To see if it's safe and effective.

Got it.

And so they progress a compound through a series of clinical trials. To do those clinical trials, you need an investigator, and that investigator has staff at their site. They are the ones who are recruiting the patients, uh, and collecting the data associated with the clinical trial. So they could be large academic medical centers, they could be freestanding sites. That only focus on clinical research and everything in between.

Got it. So the site is where the investigator lives to do the, do the investigation to test the hypothesis around the whatever, whatever is being tested. Got it.

Exactly. They're the ones collecting the data.

And then, and then who are the other players involved in this very complex process?

There's a very complex process. I think you're right. And it's funny. Sometimes you lose the perspective when you're in it every single day with these, we call them the TLAs, right? The 3-letter acronyms. They just become sort of part of the language. So basically what happens today is, or what happened historically is everybody used paper and now we're sort of bringing that into electronic data capture so that we can actually review it identify errors, clean up any discrepancies sooner. But then it started moving into process facilitation. So instead of like just passing around spreadsheets of different information, now it's all about how can you automate that workflow to make it easier to, and also to enable connectivity of these different systems with other source systems. So let me give you an example. If you're a hospital and you're doing clinical research and you're also doing patient care, you need to know when do I bill the patient's insurance because they've come to the hospital for something completely unrelated to the clinical trial, and when do I build the study budget? Uh, and so we've got technology that helps them do that, that's then connected into their billing and finance systems internally within the hospitals as well. I think that ultimately, and this is where I'm very excited about what Advara does, is because we've got technology in multiple places, we really have an end-to-end picture from the study start all the way to the study completion. The idea being, if we can integrate data across all of this, you're going to get faster delivery times. Higher quality information, and it's going to be more efficient for the sites. Because at the end of the day, one of the biggest challenges that we have in clinical research is being able to recruit enough patients and having enough sites to be able to collect the data associated with the clinical trial.

I can just imagine not only recruiting patients, but I mean, you got all these regulatory constraints you got to deal with too.

Exactly.

It becomes very difficult. All right, so I think we got the big picture, sort of, in the— I can look down 50,000 feet and sort of see through the clouds and sort of see what you're talking about. Let's talk about you, for example. What is it that gets you really excited in the morning to get up and go to work?

I have to tell you, I think it's the people. I think it's partly the people and partly what I do. I kind of feel like if you don't love what you do, it shows. And when you do love what you do, you come with this energy and enthusiasm that I think is contagious and motivating to other people who are working alongside you.

I mean, as I ask you questions to try to educate myself, I can see there's this palpable enthusiasm and excitement. I mean, you, you obviously love what you do.

I do. I really do. And it's funny, just as a quick personal aside, I am a mom of twin boys who just graduated college in May. Yeah, yeah, last month. 2 boys graduated college and that's it. Just those 2.

Yeah. That's a major landmark.

It's like my greatest accomplishment for sure. But I guess where I'm going with that is that I kind of feel like I'm at the stage in my career where if I'm not excited and getting out of bed every morning about what I do, then it's not worth it, right?

And isn't that a blessing, to get up every morning and say, oh joy, what do I get to do today?

Exactly, exactly. Yep.

What do you think it is that's unique that you bring to the table that nobody else has?

You know, it's interesting, um, coming from a strategy consulting background, it's a little bit different than the traditional background in the clinical research industry. A lot of people in clinical research came up with a bio degree or a psychology degree or some kind of public health degree, but don't necessarily have that consulting skill set, which was my initial skill set that I had. And I, I saw this when our consulting firm got acquired by, um, the clinical research organization, is that we very quickly got— became internal consultants because the ability to ask questions, to listen, to find pragmatic solutions to issues that they have, and to think out of the box and think differently. I think that that's been such a wonderful beginning and a skill set that has served me well in this position.

I can see how people coming up through the hard sciences would not develop those skills. Um, that's not, that's not part of the curriculum.

No, no, not at all. And one of the things that I think has been a tenet of myself is that I'm very much a facilitative leader. Meaning I really try to drive everybody forward through facilitation, asking questions, listening for feedback. And, and what I've found is that if you can guide them with the questions to come up with the answers themselves, then you really have real buy-in.

Right.

And then you have the real enthusiasm because it's now a shared idea. Between everybody on the team, not something that's being just directed from top down.

Well, that gets me to my— the pivotal question I ask in this podcast, and that is, how important is listening in your work?

Yeah, for me, it's critical, absolutely critical, day in and day out. And I, and I would say that in two ways. The first is, as a leader, that's the only way that you're going to get the support of your team and be a leader and not a director. And then secondly, being a chief product officer, you have to listen to the feedback. Everybody is a customer. We have internal customers, we have external customers and users, and in order to be successful, we have to develop the features that they need. And all of that is through listening.

So what happens when you— I'm sure I'm, I'm making an assumption here, but I'm sure you face messiness every now and then. People get into disagreements. How do you, as a leader and executive, how do you manage that messiness?

It's a really good question. First of all, let me just say that I feel like one of the mantras that we have is this concept of ruthless prioritization right now, right? It's a good word, right? Ruthless prioritization. The reason that I say that is that there's so many good ideas. I, I don't think that there's bad ideas. There's lots of good ideas. And the challenge becomes, how do you prioritize them? And it's not that we'll never do something. The question is, what do you do them in terms of sequences? And this to me is where some of the rubrics that we use come in handy. So we actually do have user feedback sessions as part of our release planning process. And we score things jointly. So everybody buys into the scoring of how valuable the feature is and how urgent it is.

Uh-huh.

Because you could have something that's valuable that may not be time sensitive. It might be what we call evergreen. And so I think the process itself drives itself to be collaborative because everybody is hearing the priorities and jointly agreeing. We have a fixed capacity that we can use, and how can we use that capacity to its greatest?

So you're getting feedback from your customers, internal and external, about what they desire in the software, what features they desire, what functions they desire. And I can imagine you get hundreds, if not thousands, of ideas coming through, right?

Absolutely.

And you've gotta figure out, and you've got a pool, a resource of coders, programmers, people, software engineers who can dedicate their time to solving these problems. And the challenge then is to say, all right, of all these ideas for this next quarter, this next two quarters where we're gonna roll out new features, what is urgent and what is gonna be most useful?

Absolutely.

And that's kind of your job is to figure that out.

I would say to lead the team to figure it out, right? Because I've got a team of individuals. Yeah. Who, who do that. And I would say at the end of the day, the way that I, I would say exert my influence is more about trying to keep them on task of saying we need a theme. We need to sort of release a chunk of things that move the needle forward. Because if you do 10 different things, there are these little pieces You're really not gonna make a meaningful difference.

Got it.

And, and so I, I feel like there's a way to influence them by asking what's the major theme in the release? And again, helping to guide them, but they've gotta do the work, right? I mean, we're here to support them and to guide them and to be an SME, a subject matter expert where they need it. But ultimately can't do it all yourself. There's no way you can be successful doing it all yourself.

Yeah, that makes sense to me. I mean, I think about how many times on all the different software programs and platforms I use, there's these big announcements about, oh, this is the new greatest and latest, and I go look at it and say, eh, nah, right? The PR people got ahead of the development people and it turns out to be nothing. It seems to me that you have more, you build more persuasive capacity with your users when your major releases really do have something major in them.

Yeah. And where I've been guiding this team, and I've done this in previous jobs as well, is that the more transparent you can be with your customers, again, both internal and external, the better it is. And, and actually you buy yourself more time through that closer relationship because you acknowledge that what they gave to you was important. They may see one of their items that's coming in the next release and they may see another in two, sort of 2 releases down the road, but by giving them that transparency in that sequence that we're going to move in, again, it's all about this bringing everybody along with you. So transparency is really huge for me.

So who are the typical customers for Advara outside, outside users? Are they the sites?

Definitely the sites, but also the pharmaceutical companies. And clinical research organizations. I'm going to park patients for a second because I will come to them. But I think one of the things that really makes Edvara special is we're trying to facilitate the collaboration between all of those different stakeholders and automate the process between them.

So I'm just imagining here, I imagine that you have— let's say you've got a trial that's ongoing and there's a centralized place where people can log in and find information, data that they're interested in. They can track the progress, they can look at the data, they can, you know, as you said, you've got the different billing directions on a decision tree where billing goes. Am I imagining that's kind of how this all works?

Absolutely. But I can give you a case example that's just a little bit more, I think, can paint a better picture of it.

Okay, good.

So One of the things that happens in a clinical trial is that in order to start up a new clinical trial site, you have to collect a series of essential documents. So let's say that you've got a template of 35 documents that you've got to collect from every single one of the sites on the trial. Having a workflow software that can facilitate the collection of that data becomes very helpful. And having dashboards and reports that people can use to monitor where you sit in that process becomes very valuable as well. And that's what I mean by everybody collaborating together. And you can extend it. Oh, sorry.

I was going to say that sounds very useful. And I presume the templates now become standardized. So everybody's— you've got 10 different sites. They're all using the same template. So you're going to collect the same data. You're not going to have to kind of interpret what is, what does this site mean versus what this site means.

Exactly. I'd say it's 80/20 rule. We do see some differences by country, for example, where you might need something slightly different because they tend to be global in nature. But, but I think where our industry is going to go through a transformation is that everybody is starting to buy into the automation, the workflow process solutions. But they're thinking them as individual point solutions. And at the end of the day, the user experience becomes very challenging. The transparency becomes very challenging because you're trying to knit together all these different point solutions. But what makes Ivara different is that we actually have an end-to-end solution that can go all the way from the site's own technology through the, what we call startup document collection, through training all the way through the ethics submission and be able to track the status along the entire lifecycle.

That's— I can't even imagine how people were able to do that before this technology.

Spreadsheets. Like, I cannot tell you spreadsheet trackers like you would not believe was the norm.

Wow. Huh. Yeah, I can see, I can see how this is a very powerful tool for people. And I can see why you're so excited because, you know, you're really facilitating the development of products that can ultimately save lives. And the fastest—

Absolutely.

And the more efficient and more expeditious that process. I mean, look at Moderna and Pfizer and all the COVID stuff. I mean, that stuff was put out in record time and saved hundreds of millions of lives.

Absolutely. It's interesting. So outside of my day job, I'm vice chair at ACRP, which is the Association of Clinical Research Professionals. I'm going to give you the acronym definitions now. It's in our earlier conversation, right? And it's really challenging for the clinical research sites. We see a phenomenon where we kind of call it one and done, where it's such a challenging process that these sites will do one study and then never participate in a study again. And these poor sites, when you have this collection of point solutions, have like 20 different logins all on one study. If you can imagine, like different software you're going to, different logins, different passwords. It's really, really complex. And I think what's going to make us as an industry be better is to be more site-centric in our views and to help them by having this one single uniform experience. That they can use from the study start all the way through closeout of the study.

Amazing. Well, you've educated a dumb country lawyer pretty well.

So it's really, really interesting. We had our annual conference at the end of April, and one of the things that we talked about was if you're a lawyer, you would say, I am a lawyer. If you're a doctor, you say, I am a doctor. And we don't say, "I am a clinical research professional," because nobody knows what that is. So you can sit there and you can ask a site, "What do they do?" And they say, "Well, I participate in clinical trials that test the safety and efficacy of new drugs to bring new treatments to market for patients." It's a very different experience, and it's unfortunately an area that people don't know a lot about, yet it's so important for our healthcare.

Absolutely. This has been really illuminating for me, as I knew it would be. I have one more question for you, and I'll let you go because I know you're busy. What's one thing about you, Elisa, that we would never know unless you revealed it to us?

I am training to be a Pilates instructor. I teach— you guys are missing the facial expression, but I teach on the weekends. I've got a couple of, like, private lessons and standing group classes that I teach on the, on on the weekends. I'm two-thirds of the way through my certification, getting the highest level of certification hopefully later this year. But I love it and I love being able to help people. I love the fact that people come into the studio with whatever is bothering them. It could be pain, it could be distraction from work. They completely focus on a session and they leave with better posture, and with just a better mind-body connection. It's been incredibly rewarding.

Good for you. It's so interesting. I've done Pilates before, and I really like it a lot. We have a new Pilates studio here locally, and I live in a very small town out in the middle of nowhere. My wife just told me last night, guess what? We're going to Pilates next week. I said, yes.

Remember we mentioned the kids going off, finishing college?

Right.

Well, when you have twins, they're, they're leaving, and then you're done. Like, you got to find something, and this was my thing, and I just absolutely loved it.

Good for you. Well, Elise, it's been such a pleasure talking with you. Thank you so much for your time today.

Oh, thank you so much for having me.

Doug Noll here. Thank you so much for listening to Listening with Leaders. If you are a successful executive leader who would like to be on this program, please visit podcast.dougnull.com/podcast. If you got something out of this interview, would you please share this episode on social media? Just do a quick screenshot with your phone and text it to a friend or post it on the socials. If you know someone that would be a great guest, tag them on the social media to let them know about the show and include the hashtag Listening with Leaders. I love seeing your posts and guest suggestions. We are regularly putting out new episodes and content. To make sure you don't miss any episodes, go ahead and subscribe. Your thumbs up, ratings, and reviews go a long way to help promote the show and mean a lot to me and my team. Want to know more? Go to my website, DougNoll.com, or follow me on LinkedIn, Facebook, and Instagram. That's @DougNoll. @DouglassEnoll. Thanks for listening, and we'll see you on the next show.