2150 - How Technology is Advancing Clinical Research with Lesous Consulting LLC's Dr. Tia Warrick

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1:05With us right now, it's Dr. Tia Warwick. Dr. Warwick, it's great to have you. You are the CEO of Lesseus Consulting. Lesseus Consulting. Is it Lesseus or Lesseus Consulting? What is it? It's Lesseus. Lesseus Consulting. All right. To our friend that's listening, don't lean on my pronunciation. We have the direct link in the podcast app you can click on so you can follow along. uh and and dr tia before we kind of get going and talking about your superpowers um i understand that uh you you enjoy a good reality show i do i'm currently watching i'm love i'm watching love is blind which is a new season that just came out it seems really promising i've watched every season thus far and i don't know i think it's really cool the concept and the social experiment of it all And what's the concept is that they're getting to know each other, but they can't see each other, right?

2:04Yes. Yeah. So they're talking to a wall and then they propose to each other through and then they meet each other after they've been proposed to and they go straight to their honeymoon. whoa oh does that ever work out where there's like you know i would naturally where my brain is thinking now is like there could be someone that could be like a two in terms of looks but personality they're like an eight or a nine and they match with someone that does that happen it happens way too often and to see their reactions when like the big reveal happens and like their eyes go big and they try their best not to be shallow but you can clearly see that's not their type or so it usually doesn't work out oh my gosh okay i'm gonna have to find some clips you might get me hooked into it um my my wife's guilty pleasure i i watch from time to time is uh since since we're we're confessing on our reality show uh real housewives of salt lake city is hers So that's a good one.

3:05That's a good one. Oh, man. Talk about taking that formula up to a 10. Those are some those are some fights. OK, well, Dr. Tia, I'd love to learn about you have a very esteemed background. Tell me about the work that you do. Absolutely. Well, thank you. I have a bachelor's degree in biology and a master's in public health and epidemiology and my doctorate's in clinical health. And I've always been really passionate about the intersection between public health and clinical health. And so I found that intersection specifically in clinical research, working with biotech and pharma companies through the essentially overseeing clinical research and clinical trials.

3:49So I started as a clinical research coordinator at a hospital and kind of worked my way up in the industry to a CEO. So I like to say I've worked from a CRC to a CEO. And I worked in various roles overseeing the process for a clinical trial, working with patients, looking at data integrity, all the way up until FDA approval for a drug or medical device. Can I ask you something, just because this came up in a podcast, and it was on the topic of all of the GLP-1 drugs that have been coming out and Manjaro being one of them. And there were a lot of complaints that the drugs are just really expensive.

4:27And I don't want to get too much into this. But I think one thing that deserves to be noted is that to develop something that actually can be brought to market is a very intensive, long and expensive process. And I actually had no idea. I thought all of that money was just going into marketing. and truth be told, no, there is a ton of money that needs to go into R &D. And a lot of times that money that goes into R &D, it's just gets shelved because it turns out to be non-viable. Can you maybe cast a little, I think you know a little bit about this world. Can you enlighten us? Absolutely. Yeah.

5:10So about 80 % of clinical trials fail. So before they even think about doing investigational research in a human. They probably did about 10 years of research in animals just to prove that it could potentially be safe. So they did 10 years before that. And then they have to get a lot of investment to get millions and millions of dollars just to do the human investigation portion and only for 80 % to fail and only 20 % to have success. So by the time that they have to work with the hospitals, they have to procure all the materials and they oversee for any project, about 800 people works on any given project for clinical research, investigational medical device or drug.

5:52And so they have to pay all those people for the entire span of the studies. By the time that they actually do, that small 20 % that actually makes it and gets FDA approval, they have to recruit and make all that money back. And then they also have to have enough money to do the general manufacturing, right? Now they need to mass produce this approved drug. And so unfortunately, throughout all those timelines and money that they, you know, promised they'd pay their investors back, they have to recruit it somehow, unfortunately. But I do have some really great things with Laces Consulting, like AI and other tools that I've created to kind of combat and think about efficiencies and gaps to hopefully, you know, combat those high prices.

6:35So I'd love to about that. Yeah. Well, and I think that that's, I think that we're on the precipice of a very exciting time for, you know, research and development in this area because of AI. I think that, you know, years down the road when we can, when quantum computing starts to become more of a reality, I've seen some really exciting things around that. But, you know, I remember read, I think I read one article where they said, in theory, what we hope is that, you know, drugs that are taking us 10, 15 years can actually be brought to market in three to five years or one year because we're able to just do things so much more efficiently.

7:20I don't know if you've got your ear to the track on any of that or like, you know, how things have been progressing. I mean, we are definitely not one year out. We still have a way to go. No, no, no. No, meaning that that's in theory that day could come. And it's still going to take a while before we get there. But the promise is something that I think we should all feel some optimism around. Absolutely. Especially with this move in innovation for biometric data, where we're constantly collecting data and big data and what that all means and centralizing data and compiling data. All of that is being discussed right now.

7:59easier ways to decentralize trials and make it more collaborative and easier on the patient so they don't have to continuously go to the hospital. They can do a lot of those measures and assessments right from the comfort of their own home. So there's a lot of great things that are happening in the innovation space that can really, you know, accelerate that timeline. But right now we're looking at an average about eight years for any given clinical trial. and you know the clinical research industry I like to call it a little dinosaur like we are really excited about all the really amazing innovative things but we are very slow when it comes to adapting them and you know being okay with that type of change but I embrace the change and I am more than willing to be on that side of pushing the research into the innovative process with every other industry right now.

8:51Right you know and rightly so when we're talking about you know, conquering big challenges out there and doing it well and doing it right the first time. And obviously we're talking about people's health and, you know, we want to reduce risk and, you know, and that sort of thing. So I get it. Dr. Tia, can you tell us a little bit about the work that you do today? What do you do specifically and who do you work with? Yeah. Yeah, absolutely. So I specifically build skills-based competency courses. So there are two things that I do, education and AI technology solutions. So both of them are, they work in congruent to essentially solve the big problem of efficiencies in the clinical research industry.

9:34I'm looking at an organizational level and also an individual level. So the skill-based competency courses that my business, Laces Consulting, offers focuses on job-specific skills. It's exactly in the name. So there's a lot of courses out there that does a lot of general information. There are a dime a dozen for the clinical research industry. However, there are so many people that look at a particular job and look at all the different job functions or description. And I know how many times have you read a job and you go, okay, yeah, I can do that portion. I can do that portion. Oh, I can't do that.

10:07I can't do that. I'm not really comfortable doing this. And you feel like, oh, maybe I can do 60 % of this job. And then because of that, you don't apply. Right. Right. And so it's really important to note that a lot of these skills are things that you learn only through experience. Right. So unless you actually fell into the role or knew somebody or applied and got the job, a lot of these skills aren't learned right until you're on the job. So I'm trying to think about how we can give people experience without wasting years for them to acquire them. And then from there, the retention is a huge issue in the corporate world.

10:42So only for them to acquire them and not stay long enough for that company to benefit. And for that individual to not be in a space where they felt like they can stay there long term. And so those skills-based competency courses focuses on job-specific skills. So for example, if you're looking to be a business manager in clinical research and you're looking at one of the skills they're asking for is being able to develop a proposal or develop business defense slides. I specifically develop courses that looks at those particular skills so that you can go through those courses and get certified and say, yes, I know how to do this specific job function.

11:19And there's many different courses like that that you can take to feel empowered and really confident in your role, no matter where you work. And it also helps companies as well, because if they see that certification, they know for a fact you went through the course that's been specific to clinical research and you know what you're doing when you're coming in. So it could be very helpful on many fronts when we're thinking about career development. Yeah, yeah. What is the, I mean, for those of us on the outside who don't work in that space, can you give us maybe a feel for, you know, people and people leadership?

11:54And I'm interested in kind of the supply and demand of people in the field and not just, you know, kind of folks that are going into the field and kind of exiting the field, but also kind of like professional development, that sort of thing. Can you help us understand that world a little bit? Yeah, I mean, it's very broad. When you think of clinical research, there's so many different roles that you can choose and go into. And usually when you're thinking about breaking into the clinical research industry, you typically start, many people start working at a hospital or academic institution, right?

12:31That's where most people get their first experiences from. But there are some people who get a lucky break. They know somebody, maybe they started a lab or a vendor and then they work their way up. But the biggest players in where you want to work in clinical research or where the majority of people are employed is with the pharmaceutical company, the biotechnology company, or the third party company, which is called a CRO or a contract research organization. These organizations are what the pharma and biotech companies, they work with and they go into a contract with. And they are the ones that essentially look over and oversee and conduct the clinical trial with humans on their behalf, right?

13:10So those biotech and pharma companies may have gotten all the preclinical work done and they're ready to now start the research into humans. They usually contract with the CRO who does all of the work for them. They help find the doctors who has the patients. They help submit all the regulatory submissions and paperwork. They supply the what we call clinical research associates to monitor those patients data to make sure everything is accurate. it, any type of regulatory and safety, every single thing you can think of, we oversee all of it at a CRO level. And we work with hospitals around the world or whatever selected sites for that trial.

13:49And so there's a lot of ways to get into the clinical research industry. Oftentimes, you know, people try to go through recruiters to find jobs or they apply right on the job website. It's a very competitive market and it's actually really hard to get into. So as many jobs as there are, it's so complicated to find a job where you feel confident or a job where your resume or CV truly shines through enough that they think that you would be a good fit. So it's very complicated, the process. But I would say my biggest advice, if you are looking to break into the industry, is to really truly look at jobs that are, especially if you have no experience, entry-level roles.

14:31All you need is to have your foot in the door. Once you do, everything else opens for you. And so I think that the hardest part is not navigating the industry, but it's getting into it in the first place. Yeah. Get in. And once you're in, you know, things are much smoother sailing. Dr. Tia, tell me about like, so you're providing educational resources. How is that implemented within, are you working within a particular research lab or I just want to understand who it is that you connect with and then provide your resources? Absolutely. So I and I have a small team of e-learning developers, but I create all the course curriculums.

15:19I have worked in various roles. So I've worked as a person in BD to develop RFPs and processes, standard operating procedures. I've worked as a CRC, which is a clinical research coordinator, a clinical research associate, a clinical trial leader, a project manager, a senior project manager, a director. I've worked as an epidemiologist. I've worked as now a CEO. So I've worked in so many different roles and I've overseen so many different roles. I've trained every single role and every single component when we think about clinical research from pharmacovigilance to data management. And so I'm really, really skilled in the training.

15:57I have a background in teaching. So I develop those courses and I work with my team of e-learners to help design those courses that are specific to skills-based competency. And I have my own e-learning platform in which we develop and essentially provide those courses. They're completely online. They're interactive. They're case-based. So you're not just, you know, listening to somebody speak to you and you get a certificate at the end of it to validate, you know, what you've learned. And there is a quiz or an exam that you have a chance to like really test that knowledge. And those certificates are good for two years.

16:39So we are constantly updating the courses, the information to ensure that they are aligned with standards such as FDA, other world regulatory authorities, and the ICH guidelines, which is the International Consortium of Health. They come together and they create something called the ICH guidelines, which is all of the ethical guidelines that we need to follow for research. And so we just make sure we're aligned with all regulatory and institutional practices as when we develop our courses. And so the justification, so who would, is it individuals that make the investment or would it be? Yeah. Oh, really?

17:18Yeah, so individuals can make the investment, but I've also have it so that if there are, let's say, institutions or even companies, especially startup companies who need to train specific roles. Oh, just do it that way. Listen, if there are leaders listening, don't rely on your, you just go ahead and plunk down the money, make this available. Talk about the justification, why that makes business sense. Because like - And what a ridiculous question, but I'm going to ask it anyway. Why does it make sense to invest in your team members' education and professional development? Okay, there you go.

17:51That's the world's biggest softball. Yeah, I mean, if you invest in your own people, right, they're going to invest in you, right? And if you give them the skills that they need to feel confident in their job, you reduce the risk of burnout. you reduce the risk of them feeling like they don't have support in the environment and you increase your retention, right? It costs more money to replace somebody than it, you know, and you save money by not having to constantly go through the recruiting process, not constantly having to find somebody else to fulfill that role, the time you lose during that, and then having to retrain a new person on all of your processes.

18:27And to do that cycle over and over again, costs a lot of companies to lose money. So investing in them by allowing individuals a part of an organization to take my courses will be beneficial. And so definitely, I would say organizations are more than welcome to buy my courses. And so I didn't want to make it just specific to organizations. You know, there's plenty of individuals who want to just better themselves. So it's open to individuals to buy on their own. But definitely, I think from an organizational level, it would make the most impact in the industry. Yeah. All right. Dr. Tia Warwick, your website is Lesus Consulting.

19:07We've got the direct link. When somebody goes there, what would you recommend they do? Do you have a lot of resources here, of course, including the courses that you offer? Yeah. Yeah. So I would say the first thing I recommend them to do is ask the question, am I going on this website as an individual looking to develop my career? Am I going on this website as a company looking to find different resources and efficiencies to develop my company, right? So think of it as those two separate sections, right? Based off of that, I can guide you. If you're looking at as an individual, definitely check out the e-learning courses and other career development tools, speaking opportunities and engagement.

19:51and you can reach out and we can help with a lot of different, you know, career advising, career pathway, and just making you feel really confident in whatever role or career pathway you want to achieve. If you're looking at it from a company standpoint, we also have those e-learning forces, but we also have technology solutions as well. And the biggest technology solution we have is called ASUS and essentially is an amazing AI that helps with a lot of different things. and we're thinking about clinical research. And so usually, you know, contracting, budgeting, feasibility of finding patients and sites can take a long time and months.

20:31And those months cost money. So if you are interested in how we can shorten that timeframe or accelerate that startup for you to get patients into your trial quicker, ASUS can be a phenomenal AI tech solution that develops budgets in minutes, tracks a lot of different comments for contracting when we're thinking about two legal departments with a lot of things to say and simplify those processes between two parties. If you're thinking about where to find your patients as an epidemiologist, I understand analysis. I understand distribution of disease. So with my background in epidemiology, it was very easy to build a program that truly finds the patient where you will have the best opportunity to enroll in your trial.

21:21So I'm just trying to set up everybody for success with the efficiencies so that you can hopefully get your treatment to FDA approval and being that 20 % of success. Love it. Dr. Tia Warwick, doctor of health science, epidemiologist, and CEO of Leducan, Lee Seuss. I'm so sorry. Lee Seuss Consulting. Obviously, my credentials don't carry me too far in the ability to speak English. Dr. T, it's been such a pleasure having you. Thank you so much for joining us. Yeah.

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