Revolutionizing Clinical Trials: A Technological Leap Forward | The Pair Program Ep48

Welcome to The Pair Program from hatchpad, the podcast that gives you a front row seat to candid conversations with tech leaders from the startup world. I'm your host, Tim Winkler, the creator of hatchpad, and I'm your other host, Mike Gruen. Join us each episode as we bring together two guests to dissect topics at the intersection of technology, startups and career growth. Hey everyone, welcome back to The Pair Program. Uh, Tim Winkler here with Mike Gruen. Mike, we were kind of chatting a little bit earlier about, uh, you know, some. Some vacation plans on my, on my docket, but I was curious what, what you got, uh, lined up or is it, uh, going to be a, a dry summer for you? It's going to be a dry summer. Oh, no. Is it kids related? Is it the kids? No, I mean, so, um.

Yeah, so both of my sons are in Boy Scouts or, sorry, BSA. They've rebranded. Um, uh, and so they have some scouting things going on over the summer. And, um, so we're mostly low key. We're thinking maybe a weekend here, a weekend trip there, but nothing, no big summer plans, um, Because they have big summer plans, my wife and one of my, no, I guess just got back from the Florida Keys where they did a whole snorkeling, like high adventure thing. It's awesome. Yeah, good for her. Uh, yeah, exactly. Um, it was work. They were like camping on an island. Like she was like, it was fun, but it was hard. So, um, and then, um, and then both of them have, um, a big long week, um, in Goshen, uh, Virginia. Uh, cool.

All

right. Well, I will. When I'm out, when I'm out in the Outer Banks, uh, the Outer Banks, uh, you stopping off anywhere else on the way there? Yeah, we're doing a bush garden

stop off out in Williamsburg. So, uh, you know, for, for those, uh, that have listened to the last few episodes, I've got a 18 month old daughter, so this'll be her first time, you know, jumping onto some Some of the, you know, the teacups, I don't know what, what, what these, uh, the, the kids at that age can ride, but, uh, you know, I'm, I'm pretty sure she's, uh, going to be an adventure seeker. So looking forward to getting her out to an amusement park. Awesome. Cool.

All right. Well, I just came back from Greece. So. Oh, dang. You just trumped everybody on the call, but you asked me for the past three years, I've done nothing.

Where'd you go? What, what islands did you, did you hit up?

We went to, you know, we started in Athens, which was. Not that great. You know, it's all dirty and graffiti filled and with 50, 000 other people at the Parthenon, that was the highlight. And then we flew to Mykonos, which is sort of a party island. And, uh, we weren't that crazy about that one. And then Naxos was probably our favorite, which is, uh, you know, a less developed island. And, uh, uh, we went hiking and stuff there in the middle of it. Very cool. And the last one was Santorini, which is probably the most beautiful, you know? Yeah. Beaches and sunsets and all that.

Absolutely. Yeah. We did, uh, uh, Athens, meno and, and Santorini. I think those are, yeah, that's gonna be the, yeah. The, the most frequented, uh, destinations, but, um, Mm-Hmm. did you take the ferry? I take it then just to, to get out there? Yeah. I, the, the ferries in between the islands. Yep. Nice. Very cool. Well, now we got to ask Harsha, anything that you can trump, uh, a Greece trip with, or?

Of course. The Virginia beach always trumps everything else. All right. Now I know, I guess I have a sense of humor. I have two daughters and both of them love the beach. So we spent, uh, uh, Fourth of July, long weekend and at the beach. It was fun.

Yeah. Virginia beach is, is a, is a great area and not far as well. So, um, well, we'll, we'll, we'll have to say that, uh, it doesn't quite Trump the Greece trip, but we'll, we'll give you credit for at least getting away. Uh, better than Mike's lazy summer. I would

https: otter. ai

He has a lot more money as a result of my trip to Virginia Beach. Uh,

let's jump into today's episode. So again, this is going to be one of those episodes where we get to mash up a, a startup founder with one of their customer partners and talk through how a solution is delivered, uh, specifically we'll be focusing in on the healthcare space for this use case. Uh, we'll learn a little bit more about some interesting technology being built to to help streamline clinical trials. So today we have, uh, Harsha Rajaseema, uh, the founder and CEO of Jiva Clinical Trials, uh, and Professor Larry Cheskin, a professor at George Mason University's College of Public Health. With a focus in nutrition. Uh, so Harsha, Larry, thank you both for joining us on The Pair Program. Excellent. So before we dive in, we do kick things off with a, a fun segment called pair me up. Here's where we all go around the room. We spit ball a complimentary pairing of our choice. Mike, you lead us off. What, uh, what do you got for us

today? So, yeah, so, uh, mine is kids and pets. Um, I, uh, I grew up with a lot of pets, um, a lot of pets, uh, and we have, um, Uh, my family has cats and a turtle and I was talking earlier today with a coworker about like getting a dog and I said, Oh, you know, my kids are older and I sort of wish we'd gotten a dog when they were younger because I like dogs. Um, I mean, I like all animals. There's people ask me all the time. Like, my cat person, dog person, they have, they're different. Um, I like both. Um, but I do like dogs a lot anyway. So, uh, uh, kids and pets. That's where we go. Kids and pets.

Yeah, I mean, I think that's, that's a great parent. I mean, I, I know as a kid, it was like a constant harassment on my parents. It's like, you need a dog, you need a dog. So, you know, but it, you had to lead up to that. So we had like multiple hamsters, you know, all kind of, you know, Suffered tragic deaths. Uh, somehow as a, as a kid that couldn't keep a hamster alive, they were able to still, if they die, you know, let's get you an upgrade. She's got a dog. Yeah. It was a family dog. The hamster was mine, but, um, but yeah, kids and pets, I dig it. Um, I'm gonna, I'm gonna jump in real quick and, uh, go with road trips and car washes. Um, so again, we're going on, on vacation, uh, end of this week. And, um, uh, getting the car kind of just, you know, tidied up beforehand, making sure you have a comfortable space to, to, uh, to sit in for, you know, whatever it is, six, seven hours, uh, is always something that we do before any road trips. So, uh, car washes and road trips also, they'll do a little bit of like, uh, um, if you do it at a spot that's got like a little mechanical, do a little check on, on some of the, uh, essentials, make sure you're good to go with tires and everything else. But, uh, Um, that's, uh, that's my pairing for, uh, for the day and let's pass it over to the guest. So, uh, why don't we, we start with you, Harsha, a quick intro and your pairing.

Great. Um, hi, um, this is Harsha Rajasimha, founder of Jiva Clinical Trials. Um, my background is I'm a computer science engineer turned, uh, genomics data scientist. Um, we are currently on a mission to, um, modernize clinical research with, uh, human centric software and CRO solutions. Uh, headquartered here in northern Virginia from a pairing point of view, um, I, I guess a lot of kids, uh, and plants, um, no animals, uh, as I grew up in a vegetarian household and also, uh, not really, uh, pets, uh, uh, that are, uh, Not plants, so

so so plants as, as the pets, absolutely.

Clovering plants, some vegetables and stuff that can go in into the edible side of the kitchen.

Nice. Yeah. That's a first. That's a first on the show. Um, Larry, how about yourself? Quick intro in your pan.

Well, I'm, I'm Larry Cheskin. I'm a physician by training and a professor of nutrition, uh, at the school of public health. At George Mason University, and I also work, uh, now as an adjunct professor at Johns Hopkins. And, uh, I see patients and I do a lot of weight control and, you know, uh, weight is a big issue in the United States and around the world. And, uh, the pairing, I guess I can talk about, uh, not to be repetitive and they're not exactly pets, but my wife and I rescue, uh, farm animals, uh, at our, uh, uh, farm in New York. farm in, in, uh, Ellicott city, Maryland, and we've got everything from Horses and mules, ponies, uh, goats, sheep, uh, and pigs. So, uh, and we had a chicken right in the house in our kitchen an hour ago. Uh, cause it had what's called a bumble foot, which is like a bleb that they develop on their feet and then they can't walk real good and my wife was trying to do minor surgery, uh, on the, the bumble foot, uh, uh, get it to go down a little.

Interesting. What's up? Polar opposite parents here between our guests, our

animals, we're,

we're, uh, I know I was just going to say, it sounded like my house

vegetarian.

That's funny.

That's cool. Yeah. Mike, you were just saying

that. Yeah. I mean, I grew up with lots of farm animals. The difference is some of them we ate, um, and, uh, we definitely did not have pigs, but, uh, we did have the goats and horses and stuff like that. Um, so that's, that's very cool. I think this is also the first episode we've had no alcohol, uh, mentioned as

alcohol or food foods. Uh, yeah. Yeah. Nice. First of a kind. Awesome.

Great show. Thank you.

Welcome folks again. Thanks for joining us. And, uh, let's go ahead and transition into the heart of the episode. So as I mentioned, we're going to be talking to a tech startup founder, Harsha, to hear more about, uh, this health tech company, Jiva clinical trials, how they're working with a, a customer Parker customer partner and breaking down, you know, how this strategic partnership came to be. First and foremost, I do wanna expand on the story and the impact of GVA clinical trials. So I'll start with you, Harsha, you know, what inspired you to start this company and, and what problems are you solving?

Yeah, so, uh, great question Tim. Uh, you know, coming outta NIH and FDA as a postdoctoral scientist and, um, uh, being part of multiple startup, so, so I. Change the world, but how exactly to change? Where is the unmet need? Uh, where can I help people? Uh, was a question as I was going through early part of my career more as a data scientist. And, uh, as I stumbled upon my own personal experience of becoming a dad to. Three kids and, uh, one of the kids, uh, born in 2012 had a rare genetic disease. And, um, so, uh, we lost, uh, the same year. Uh, and so that, uh, inspired me to think more in terms of, um, what these rare genetic diseases are, what type of diseases. And I was good. Good news was I was kind of professionally. Already involved in the, um, genomics and precision medicine area, uh, coming from NIH and FDA. But, uh, uh, uh, uh, experiencing the loss of a child is something that, uh, really, uh, uh, uh, inspired me to, uh, Think, uh, what can be done about diseases like that, um, and there is much hope for some of those diseases, but not all diseases can be treated or cured, but certainly diagnosis was a big challenge. And so I spent several years, um, working for a startup leading their clinical genomic test that can diagnose thousands of diseases in a single, uh, exome sequencing test. And, uh, then coming out of that, uh, moving into therapeutic development, consulting for big pharma, uh, while I was working for, um, Dell services, entity data services over the years, um, uh, first time looked at how inefficient the process of bringing new treatments through the regulatory process was. One in 10 drugs make it through the valley of death. Nine outta 10 drugs fail, and it takes, uh, nine years to 12 years, um, on an average going from first in human studies through the regulatory review and process, uh, very inefficient, very expensive. Average cost had exceeded two and half billion to get one drug to market. And as, uh, I looked at that problem, uh, there's just massive IT infrastructure that goes into, uh, executing one clinical trial at a big global pharma. And there's a lot of, uh, early stage, uh, biotech companies that where innovation is happening for, say, cell and gene therapy or, uh, novel modalities, uh, that don't have the resources that big pharma have. And they have to execute these studies, identifying and stitching together 20, 30 different software tools, laboratories and samples and a lot of workflows that all have to happen in a quite a complex workflow to make one clinical trial successful. So I thought there was a huge opportunity and a unmet need to one, getting early diagnosis and then getting them to clinical research and. Uh, also only one or 2 percent of the American population are actually being. Uh, accessing the clinical research enterprise, uh, while, uh, while 99 percent of the people are still not engaged in the clinical research process. Of course, during the pandemic, suddenly, you know, everyone heard about clinical trials about the vaccine and it was a, uh, the silver lining, as they say, of raising mass awareness at the population scale about clinical research and how they can be lifesaving. So. And so that's led to, uh, it's a year before the pandemic is when I founded Jeeva to essentially bring efficiency and human centric approach to executing clinical research. And that that was the inspiration, uh, along the way, you know, I also had a younger brother who was suffering from diabetes and the complications of that who is, who was in his early thirties. Um, Lost his life, um, as a result of the complications coming out of, uh, diabetic retinopathy and nephropathy and other, um, complications. So, uh, both these family members, um, inspired me, but the entrepreneurial bug was already there. So I, I just got the direction to see where I could make a difference.

Well, it's a inspiring story and, um, you know, I'm sorry to hear about the loss, um, as a parent that also has, uh, as a, as a, as a person that lost both of their parents to cancer, um, can relate to the, uh, motivation to want to. Figure out solutions to problems. Um, one of which my mom, you know, she was, uh, diagnosed with multiple myeloma and, uh, you know, it was a, still a fairly, you know, early stage kind of cancer that hasn't been, uh, a ton of research done on. So we, we had a, uh, an entry point into, um, getting into some of these, some of these trials. Uh, and I can tell you that the, you know, this would have been in 2000. Yeah. 16, uh, and, uh, it was a very frustrating experience. There was just wasn't a, a clean entry point to understand what the options were, you know, what were the results from other, um, patients. And, um, and so, you know, when I, Discovered what you were, you were building. I had a personal interest in, in wanting to hear more and also just, yeah, grateful that there's folks like yourself, entrepreneurs like yourself out there that are, you know, uh, pushing the needle forward to, you know, to solve some of these problems because, uh, it is, is truly a problem and it's, it's a. It's one that, you know, when lives are on the line, it's, it's, you know, how quickly can we move to, to, to expedite things?

it's one of those things where it's one of the most complex human endeavors that are undertaken in getting one drug through the regulatory process. And multiple stakeholders have to do their jobs, um, in a very coherent, consistent, like collaborative manner. And, uh, what's surprising me is. Even today, um, 90 percent of clinical trials are run, conducted on 10 percent of the world's population. 90 percent of the world is not engaged in clinical research. At all, uh, to a great extent. And so I think there is huge opportunity to take clinical research to the patient's homes and, uh, enabling remote patient engagement and, um, involvement in clinical research, after all, they are the people who are, who are being helped by these pharma companies in developing drugs and digital therapeutics and novel modalities. So. That's a mission that I think I'm willing to put in whatever best I can.

Yeah. And, you know, I want a couple of quick hits on, uh, Jeeva and then we'll, we'll, we'll jump over to Larry here in a second. Um, what's, what's the, the, the size of the company from a headcount perspective? You know, have you received any. Funding to this point is it, you know, been venture capital grants. Uh, tell us a little bit about, uh, you know, the specifics of the company.

Absolutely. So we are a Delaware corporation headquartered in Virginia, uh, received various grants from the Virginia Commonwealth, uh, governors, uh, com commercialization fund, um, as well as, uh, Investments from the Virginia venture partners. So we are a portfolio of that. And, uh, as a Hokie and affiliate faculty at George Mason, I have not had any trouble attracting talent, um, you know, seeking internships and full time opportunities and so on. So we are a team of 15, um, people and an advisory board, a board of directors and several investors for all, um, rooting for us and supporting in our mission. Uh, so we are at a seed stage and we are just out, um, starting to raise a series a round.

Okay. Excellent. Yeah. And, uh, at the end of this, we'll, we'll, uh, have a little bit more of a few questions to plug, uh, you know, the types of roles that you're hiring for as well. Um, but, uh, uh, before we dive a little bit deeper into, you know, what, what Jeeva is doing, um, uh, at a more granular level, let's, let's pass it over to Larry real quick, Larry, how, um, yeah, tell us a little bit about your background, um, and then, uh, how did you and, and Harsha kind of cross paths.

Yeah. So, um, I've been, uh, in medicine, you know, uh, since I was not quite a teenager, but soon thereafter. And, uh, uh, I've always been very interested in research and not so much laboratory research, you know, working with, with mice and cells, um, but in working with people. So that's, uh, called clinical trials or clinical research. And this is where, um, you're often taking things that were originally done, uh, as research in animals and cells and applying them to humans. So it's often a big leap, uh, because things that work in cells or animals don't necessarily work in humans. So it's necessary to do things in a very rigorous, organized fashion. And the kind of gold standard is what's called a randomized controlled trial. So I've been involved in doing these sorts of studies, um, and an RCT for short, randomized controlled trial, uh, is randomized. That means that it's very important because very often we're influenced by what we think is going to happen. Um, and many people have heard of the placebo effect. So if I give you a pill and say, you know, Mike, this is going to change your life, um, you may laugh, uh, but it will probably change your life a little bit. Even if it turns out it's a pill that does nothing, it's a sugar pill. Um, and, uh, when you give people medicines, for instance, and that's one of the main treatments, uh, that we use in healthcare, You have to know whether the effect is greater than if I gave you a sugar pill. Because the sugar pill is going to do something for many people. So, um, you, uh, randomize people to whether they're going to get the sugar pill or the active drug that you're testing. And that, uh, uh, is a controlled setting and you don't let the person know what they're getting. And you'd also, it's called double blinded. It's not just the patient that doesn't know what they're getting, but it's the, the, the person giving out the drug that doesn't know what they're giving. Uh, so it's a double blind. Um, and the only one that's going to know is as you're analyzing the final data, you have to eventually look at who got what, uh, to know whether the people who got the active drug did any better than the people who got the placebo drug. Um, so a randomized control trial is called the gold standard of testing things because any other method of testing a treatment, you're always concerned about, well, did it really Do the effect because of the treatment, or is it because you're paying attention to people, uh, and you're giving them care, uh, and that's going to make them somewhat, uh, better, you know, unless they've been run over by a truck, attention is going to be useful. Um, even in things that you think of as not being all that treatable like cancer. Giving people attention and caring, uh, has a positive benefit. Anyway, so, um, what's also important is that we understand the triggers and the things that increase our risk of getting things like cancer that was mentioned earlier. And being in a nutrition department, um, and treating people with obesity, I'm convinced that nutrition is a very important factor in, uh, our health and our future. So, um, one of the things, uh, we wanted to do was study, not the people that are usually studied. So in healthcare, you study people who already have cancer, uh, and you see what treatment works in them. And that's clearly very important. But in some ways, even more important is to understand who's at risk and who, what you can do to reduce people's risk of becoming a patient, uh, down the road. So we wanted to do a study, not of older people with diseases already, but of young people before they got diseases. And George Mason undergraduates seemed like a really good group to study because they're very diverse. It's a very diverse university. It kind of mirrors the United States and to some extent the world. Um, so, you know, very often when studies were done in past years, it was restricted to middle class, upper middle class white guys, uh, because those are the people who are running the studies and those are the people they tended to recruit and the results were applicable to middle class white guys. Um, and yet you want it to be applicable to a broader range of people. And we've learned over the years that middle class white guys are not necessarily representative of, you know, what other populations like women and minorities and people of different, you know, uh, ethnic origins, um, are going to be at risk for an experience. So. George Mason undergrads, the perfect mirror of the United States. And, uh, we wanted to know what they do, what they eat, what their physical activity is, what their mental health is, what their attitudes are, um, and follow them throughout their time at George Mason as undergraduates for four, four, four years, at least, and see how that evolved. And it so happened that we started this around the time Harsha was starting, um, Jiva, and uh, it was right before the pandemic. And so our first, it's called a cohort, the, the year, the freshmen in 2019 are the first group that we studied, the first cohort. And that was before the pandemic. Um, so we have data on a bunch of young adults. Uh, and we limited it to, you know, we didn't want the people returning to college at age 50. We wanted the people, you know, who recently graduated from high school and were starting college because they were the ones who were in essence, the The cleanest, the purest in terms of understanding what diet and other health behaviors are going to do. All right, I'm going on far longer than you wanted me to probably, but we turn to Harsha to help us with organizing and making that kind of study happen.

Yeah, interesting, uh, study also, uh, nice shout out to George Mason. I'm a, uh, alumni as well. So, uh, love to see, uh, the university continuing to grow.

The IRB has just given us permission to, uh, ask alumni. To, uh, uh, fill out, see what happens, you know, when you're out of the, the cloistered environment of the university,

I'll connect with you after the pod. We'll see, we'll see if I could submit my data. Um, all right. So, so now I think we've painted a good picture of, of how, you know, you all kind of came into connection. Now I'd like to just talk a little bit more about, you know, how has the Jiva clinical trials technology. Help streamline a study like this, you know, where, where were there gaps, uh, along the way with, within some of this clinical research that your technology is, is solving those pain points. Harsha.

Yeah. Great question, Tim. Um, and, um, you know, when I was, uh, getting started, we had a team from Mason. Um, we went out to what is called the NSF I Corps program after graduating the Mason's ICAP program. The innovation, commercialization, um, um, acceleration program, which essentially encourages you to get out of the building, go talk to customers and figure out what their pain points are before you build anything, right? And, uh, to even make a decision whether there is a need for, uh, unmet need in the industry that you are trying to fill. If not, most companies fail because they build something nobody wants or nobody cares about. And we, we didn't want to fall into the trap and we are thankful for having met, uh, Bob, uh, uh, Smith and, uh, Josh Green at the GMU iCAP who got us oriented in this fashion very early on, and that did a whole lot of good. So when we started speaking with Larry. We learned the various, uh, existing tools. Um, and so randomized control clinical trials, like Larry said, have been running since 1950s, and so it's nothing new. Although the electronic and digital aspects are more recent, uh, from the early two thousands is when the d guidance of 20 data capture. Electronic data, but not so much also resulting in silos and point solutions, some for managing the clinical study as a project, some for managing just the data part of it entered by the clinical researchers, some for patient engagement, and soon after 2019 was the pandemic. And so suddenly we were in a new norm. A state of confusion for a period of time before we gotta a new norm. And so, uh, that resulted in a lot of remote engagement type technologies and tools that came about very rapidly in a very short period of time. And so we realized as we were starting to build out the tech in 2019 and 2020, that, uh, uh, informed consent is the divine contract between the researchers and the patients. And we needed, uh, to ensure continuity of clinical research during the pandemic. We needed a way to obtain electronic signatures and informed consent remotely beyond what a DocuSign would do. I mean, it's not just the signature, but did the subjects actually understand What they are getting into the risk and benefit and can we verify comprehension? So we designed a, um, human centric informed consenting platform that could scale and then ability to collect patient reported outcomes data directly from the patients on text messages, email, questionnaires and surveys with complex branching logic and skip logic. So, when we spoke with Larry, they were already using existing tools, one for managing the study, one for doing the questionnaires and surveys. They had a rather 90 minute questionnaire and a 60 minute questionnaire with 900 questions. With depending on male, female and other questions, they would answer specific set of group of questions that were unique to them and so needed a very robust platform. So, what was exciting for us was to really address these inefficiencies. We had to bring everything in 1 login in 1 centralized unified platform. And so while we started building point solutions in the beginning. It soon became apparent that we needed to bring these point solutions in a unified platform, which we did over the last five, six years. But when we started working and collaborating with Larry, the opportunity was really to save time for the clinical researchers in and avoiding having to log into three different places. They only had to have a single login. And into a single tool where all the data was in one place.

Yeah. So it's, it sounds to me like, uh, you know, it, the pandemic kind of, it fueled a lot of this because everything was kind of going a bit more online at that time anyways, but. Um, having a unified platform to where, you know, the ease of getting, uh, folks to, you know, to, to, to get on board, to get their information uploaded. Um, it's half the battle, I think, in a lot of these studies. Right. And so, um, getting that out and presented, um, seems like a, a great use case. So that was your, you know, what, what was the kind of like, I guess the first iteration of this was. Is, is Larry's, um, you know, and, and the George Mason study one, one of the earlier ones that you all have done or, you know, is this something that you've been iterating on, you know, over, you know, number of years at this point?

Absolutely. It, it's been a, uh, work in progress, iterating, uh, you know, we are on a journey to really, uh. The, uh, effect the randomized controlled clinical trials in phase 1, phase 2, phase 3, ultimately leading to a submission to the regulators like FDA for review and marketing approvals. And so to really get to that phase 3. Uh, which are the largest, uh, uh, sample size or, um, largest clinical trials before approval. And of course, phase four post market studies can also be much larger. And there are observational studies like the one that Larry mentioned, where there is, we are not really giving any, um, using drugs or interventions. But rather measuring what what's going on, the behavior, lifestyle, food, nutrition, and so on. So these observational studies are low risk, where we are gathering data, analyzing data, and understanding from a scientific curiosity and drawing correlations and insights, clinical insights and health insights, which is really a gold mine of data that can be used to answer a variety of different questions. Uh, but ultimately, this is the starting point where we, uh, validated our platform in an academic, uh, research setting, uh, then leading towards, uh, building, uh, the more randomization and. Electronic data capture as per the FDA guidance leading to more regulated clinical trials in early phases, phase one, phase two. So that's where the company is today and we are working our way eventually towards those larger phase 3 trials leading to regulatory submissions. And so that's, that's basically the baby steps needed to get through in this regulated environment.

That's cool. One of the things I think about, like what startups a lot is focus and not like sort of. Not having that sort of focus because as you were talking about your platform and what it's capable of doing right as an outsider, I can't help but like, think, oh, I see applicability here and I see applicability there and I see applicability there. And if you have like the wrong people involved, I feel like it's very easy for a company. Sort of lose its path and I, um, I'm curious, like, have you found that to be the case if you've been like razor focused and not had to, like, really deal with that? Or like, have you got like, it sounds like that's the case that you guys have been pretty laser focused on on what you want to achieve. But I'm curious, like, have you experienced those? Like, Oh, we could maybe we should pivot into this or maybe we could help in that space.

Um, absolutely. We have had to go through some, some pivots as the industry has been moving rapidly since the pandemic, you know, uh, and otherwise slow. Uh, adopter of technology, life science industry. Wait, there are slow adopter. Oh, yeah,

absolutely. Sarcasm, uh, cued.

Yeah. You know, in healthcare, it said that, um, While hundreds and thousands of new applications and digital tech is being developed and thrown and marketed every day, the actual part of delivering care between a doctor and a patient, that's seldom changing, right? I mean, it is changing a little bit. Relative to how much tech is being talked about and new tools being developed. And so, uh, the other thing that I was thinking about when Larry was speaking about the importance of nutrition in obesity and others, there is an old adage in, um, ancestral Indian families that says essentially to the effect that those who understand how to speak, we'll never have battles or fights. And those who understand how to eat will never have disease. And so that's how important knowing what to eat, how much to eat and when to eat and all that, it's an art and science. Uh, and it's kind of ancestral wisdom that kind of gets passed on and it gets lost in the mix as to why we do what we do and, uh, all that, but, uh, Where I was going with this is, um, essentially, uh, the clinical research, um, industry has been moving as we, we have been developing. And so we had to pivot. And what we realized is if we have to stay in the academic observational, Uh, clinical studies, uh, space, that's one thing, but our vision is really to help speed up therapy development process, uh, life saving treatments for rare genetic cancer and other severe diseases where the requirements are much more stringent and the bar is higher from a regulatory point of view. And so, uh, we have been continuously innovating and adjusting to the new guidelines that came out during the pandemic. Many of those guidances have remained, some of them have gone, and even though regulators are encouraging more remote patient engagement. The industry has not necessarily embraced it as much after the pandemic went away. Uh, some have gone back to the old way of doing things, but we are somewhere in a hybrid study state now. And so we had to adapt to this hybrid mode of running clinical studies. And as the platform evolved, we took those into consideration in pivoting. Another thing we learned is that just throwing tech at the problem is not the solution. No, we need to bring tech with people who are trained to use the tech in a compliant way, along with standard operating procedures and the quality management, which is so critical in the space. And so, uh, people process technology all in together to offer either a software solution or software plus CRO solution or a contract research organization. Where it's a turnkey solution where we can take on a protocol and help execute the full study. And that's where we, uh, we are now collaborating with Larry and Mason in ways in which we can bring additional clinical research and trials into the Commonwealth. For testing medical devices or drugs and other products, um, where, um, necessarily we don't need a hospital system, right? A clinic is sufficient in many, many instances, especially for low risk type products. So we're super excited about the pivots we had to make and doing them at the right time. Uh, and also just being part of this DMV, uh, investor ecosystem. We, we got. Early guidance coming down. Hey guys, you know, you may want to cut some cost and stay put the market is not looking When the recession came about in 2022 and so on. So we had to take certain corrective measures, uh, at the right, uh, in a timely fashion as well.

I'm just curious from a, like a business development perspective, Harsha, you know, um, you know, how, how do you, uh, how do you put together that plan to, to get. You know, your technology in the hands of, you know, for example, this is in a, in a university kind of setting, you know, what, what, how are you prioritizing like, you know, your target market? What does that target market look like? And then. Um, how do you, how do you get that technology injected in?

Yeah, great question. You know, our ideal customer is really clinical stage, biopharmaceutical, nutraceutical, uh, medical device companies that are getting through their early, uh, clinical studies. And, uh, academic medical centers and professors can be important collaborators for us, uh, in, uh, teaming up with our software solution and the CRO solution. As ultimately, it's the clinical researchers who can guide what endpoints need to be measured and how we can demonstrate safety, efficacy of a product, right? Whether it's a drug or a device. And so, uh, that's how we approach it is with the mindset that. We need to sell to, uh, clinical stage, early stage biopharmaceutical sponsors and collaborate with academic, uh, clinical researchers to make this all work well with our human centric efficient software platform.

Yeah. And I, you know, just kind of scanning your background in the past as well, um, then you spent some time at NIH, I guess throughout your career, some of those, um, you know, previous relationships, how have those played into. You know, helping you advance this company, if it's. Through partnerships, through funding, what have you, I'm, I'm, I always like to see like, uh, you know, that journey and then pick a part, you know, how, how this stop here helped you in this current position of, you know, being an entrepreneur.

Yeah, no, great question. And, uh, rightly so, uh, right from my elementary school friends, all the way through my, um, last job, uh, where I held at entity data, I think every. Where I had several people who have played an important role in my journey already. Um, whether as like one of the 25 investors who have put their money into the company. Or making, uh, warm introductions and connections or simply providing their time, you know, offering, uh, an hour of time talking to people who are involved in clinical research, uh, from Virginia Tech. When I went to grad school there from one to seven, uh, the School of Medicine was not yet established, but uh, it later got established or, um, and, and so, uh, there is Carilion Clinic and vt, uh, som now. So, I had the opportunity to go back to my alma mater and participate in the RAMC Regional Acceleration Program there in the Roanoke Blacksburg Technology Corridor, which further took me more from where NSF I Corps left us into Further validating the value prop product market fit and so on. So, so I think, uh, uh, from, uh, everywhere, uh, from elementary school till now, I've had numerous touch points. You know, my wife has invested in the company, uh, as well as, uh, uh, several people that I have spoken with, um, uh, who have helped in many different ways, even on LinkedIn. Every day I am amazed at how people have never met even till date are coming forth with a generous spirit of support and mission, you know, uh, parents affected by rare diseases. appreciating, uh, how we are supporting NF1 clinical trials. We just paid a pledge here today that we are going to make our software platform available to all NF1 clinical trials, which means there's only one patient in the FDA regulated clinical trial for a, it's an ultra, ultra rare disease. There is no other patient affected by the disease. And The regulators are going to make it possible for them to try a new therapy like an antisense oligotherapy or some novel therapy on one patient and for how much budget would there be for a one patient clinical trial and to support these families we have made the software platform fully available at no cost to them. Wow, that's wonderful.

And so, you know, it's an area that we, we dive deep into on the, on the podcast, actually, um, you know, uh, we, we've been talking a bit, a bit about it more into, uh, settings like within the government, like defense tech, right. Uh, you know, this, this, uh, kind of changing of the guard where, There's, uh, it's known that, you know, uh, they can't keep up, uh, at the speed of some of the commercial technology that's out there. How do we take commercial technology, inject it into more regulated industries like defense, you know, healthcare is obviously a, uh, uh, a fantastic example of this as well. And it sounds like, you know, Jiva clinical trials is really hitting a, um, a sweet spot in a very specific area, uh, to, to move innovation forward. Yeah.

Absolutely. You know, we have a SBIR proposal due with NIH fast track proposal, uh, the Virginia Venture Partners, uh, have a phase zero grant from VIPC, uh, to submit these phase one, phase two SBIRs. And, uh, inspired by the study at Mason, um, we are actually proposing several state and local governments to create a database of, um, all citizens in, say, um, the Commonwealth of Virginia. If we can gather all the data and centralize that and make that available for biomedical research, that can be a gold mine of data, uh, especially over a period of 5, 10, 15 years. Thank you. Repository like that, right? Uh, and then make it available to the biotech industry to, to analyze, draw insights from AI and machine learning to identify what subset of patients would need what, like even healthy, uh, aging disease, right? As people are naturally get diagnosed with new conditions. And there are similar programs from NIH, the All of Us Research Program or the Million Veterans Program of the VA and others. So I think there's a lot of opportunity here to essentially Take clinical research to every household

before we kind of close on the main topic and transition to our final segment. Uh, any, any final words from you, Larry, in terms of, you know, the, the partnership, the experience you've had and where you see the, the future of, uh, this type of partnership between Jeeva and George Mason.

I think one of the major benefits to partners, uh, with Jiva is that it frees up researchers and scientists and clinicians from the sort of, and you've all heard about, increasingly practitioners spend more and more time, you know, filling out paperwork. And dotting the I's and crossing the T's and justifying, you know, what their decisions are and the sort of services and platform that Jiva provides enables me to focus on what, you know, is maybe the highest use of my effort, which is to create new knowledge. And hopefully advance, uh, the fields that I'm working in.

Yeah. Well said, um,

Mike, did you have something I didn't know if you were going to, no, no, I was just thinking about the, how much, like when you have, um, the nice thing about startups, right. They're usually very responsive to the needs of a customer or client, especially an early adopter, that type of stuff. And if you can get that right partnership, um, it's amazing what the two can sort of achieve together. Um, and just, you know, what Larry is talking about, sort of, you know, Rang true with my experience as well. And so that's probably what you picked up on was, um, because I think that is a great, that's a great thing, right? When you're, you want to focus on delivering your service and you want to find someone, you want to offload that and working with a startup, if you were to try and find like a big, large company or big con, you know, whatever things get missed and they're not really in it necessarily for the, for the same reasons, there's not that alignment of, um, purpose. So it's always awesome to say.

Yeah, that's why I love this format because you kind of hear it, you kind of hear it firsthand. So it's, that's cool.

Yeah, you're absolutely right. It's been a valuable collaboration with Larry in getting guidance as we were building out early on as well and over the years helped us mature and build all the right features to save researchers anywhere from 30 percent to 70 percent of their time and effort and burden involved in operational and logistical part of clinical research so they can actually focus more on science and medicine. And that's, that's, that's been our motto right from the beginning is to save time and speed up the process and drive efficiency.

Yeah, it's also just a great entry point, right? I think, um, you know, having that case study under your belt and then building on that and expanding into XYZ universities along the East Coast. You know, I think there's a. A lot of opportunity there for a, a startup to, um, yeah, to really get their technology in the hands of users that at scale, which is usually a large struggle, uh, to begin with.

It's, uh, uh, it's an exciting time. Tim, uh, you know, with, uh, a lot of the ai, uh, investments going in the drug discovery space, um, yeah. Uh, there is, uh, more candidate drugs being predicted by ai. Then the ability to test them in clinical trials and so, uh, efficient, uh, AI driven software platforms for clinical trial is going to be, uh, super critical to get through the next wave of drug candidates and novel therapies. So we are excited to be where we are, uh, especially in the Commonwealth of Virginia, where. We have a coordinated clinical research network with 14 hospitals in across the commonwealth connected. So, um, I'm excited about our collaboration with Mason and the VCCRN to bring, attract more clinical trials to the, this region as well.

Yeah, absolutely. I mean, DMV is just a hotbed for, for health tech and, uh, you know, have so many large government organizations here too. To kind of help aid with some of that. So, uh, good location to, to build a health tech startup. We've got a couple of upcoming episodes, uh, specifically around like navigating the, uh, compliance maze and, and, and health tech, and then, um, you know, the future of, of AI and healthcare as well. So. Um, this will be a good kind of kickoff to, you know, a short mini series and some of our health care episodes. Um, excellent. Well, I do want to make sure that we save enough time here for the final segment, which is the five second scramble. So, uh, this is going to be just a fun segment where we do a little bit of a rapid fire Q and A. Uh, we'll ask a little bit of business, a little bit of personal, um, Mike, why don't you lead us off with Larry and then I'll get, uh, uh, get to Harsha. Sounds good. All

right. And also, uh, the questions will be different, so don't take notes. Um, so yeah, so Larry, uh, what's like one piece of advice you'd give founders of health tech startups we're looking for or working with?

Um, I guess I would tell them to listen, uh, because, you know, most startups have a product and a way of doing things. And you know, the, the best advice I can give is to, you know, make sure that you're being responsive to the needs of the client.

Um, Transcribed by

https: otter. ai

Um, what do you think is the biggest challenge facing college students in 2024, aside from like debt?

Biggest challenge facing college students is the, the changing economy and the changing skillset. that you need to function in that economy. Um, so, you know, when I graduated from college, you, you majored in a field, you, you, uh, studied up, you learned it, and you went into a job where you were in a place and you had a boss and, uh, you showed up every day. And now there's virtual work, there is AI that can potentially replace or supplement much of what you're doing. And you need to really understand what the new landscape is like and adapt.

Yeah, if you are in the junior or senior year this year, then you have a very difficult choice of whom to vote in the presidential election as well.

That's

a

challenge. What's the biggest challenge facing college educators in 2024?

I would say that working with a very diverse group of students who have had all sorts of experiences and all sorts of, uh, inclinations can be very, uh, challenging and exciting at the same time. Awesome. George Mason is a perfect example of the diversity, uh, uh, uh, factor.

Um, don't doubt it. Um. Uh, what's the best piece of advice you've ever been given?

Follow your instincts.

Uh, what's a book you think every entrepreneur should read?

I don't know. I've never read any entrepreneurial books.

Awesome. I love it. That's the, uh, that's a great answer. Great question, Mike. What was that? Great question, Mike. You know. Ask Harsha that one. I mean, you never know. Um, they can't all be winners. All right. So, uh, what was your favorite cereal as a kid?

Uh, Cheerios. I like the name. I like the taste. And I learned recently, it's got some oat fiber.

You do anything with them or just plain with milk?

Can I just play with him in the milk?

Uh, I used to at least put some sugar on there, uh, when I was little, um,

I wasn't allowed to,

um, what's the, uh, largest land animal you think you could take in a street fight?

Hmm. I think probably a, uh, a sheep who would be pushing it on our farm and they like to headbutt. Yeah. So if you're alert though, and you see it coming, you can probably, uh, defeat them. Uh, but if you turn your back, you're in deep trouble.

Nice. Um. Hmm. Hmm. What's the most, uh, what's one piece of outdated technology you can't live without?

I don't use my protractor anymore or my slide roll. Um, so, um, outdated.

That you just can't live without. I still have a

VCR. All right. I've got a whole collection of tapes. I don't play him that often, but I don't want to get part with him. Yeah, that's a

great answer. That is actually my son and I were just talking about, he was asking if we had a VCR. I can't remember why. And I was like, no, we don't.

Yeah, we've got one just to watch old family videos, you know, old holiday gatherings.

But I did get rid of the beta Mac some years ago.

Oh,

nice. Good for you. You guys don't even know what that is. Probably

my family is one of the first ones. We had a beta and then we went to VHS. I'm older than I look. Um, and my dad's in TV. Um, so, uh, what's the charity or, uh, corporate philanthropy that's, uh, near and dear to you?

The Burley Manor Animal Sanctuary. Not that I have any vested interest in this, but www. burleymanorretreat. org, that's, that's our farm. Yes, I picked up on it.

Awesome. Um, last question. If you could live in any fictional universe, which one would you choose?

Hmm. This is going to date me also, but the Jetsons. Nice. Nice. One of my favorite shows when I was a young kid. Really good.

Any particular reason?

Cause I always liked science fiction and flying around. Nice. Yeah. Where's my flying car?

Yeah. I was going to say Star Trek could have been, uh, another one after our intro calls. All right. Thank you much. Good stuff. All right, Harsh. You ready? Yes. All right. Uh, describe the culture at Jiva clinical trials.

So we have a culture of, uh, uh, get it done and do it right. Um, I, and, uh, essentially that's what helped us in, um, saving time, being efficient ourselves internally, because we are trying in the business of helping clinical researchers be more efficient. And we got to achieve a lot, uh, with very little resources in house. And so, uh, just getting it done is not enough, but doing it right in, in terms of using less of other people's time and other resources, that's, I would say one of the five parts of our culture, but that's the 80 percent of the culture as well.

That's cool. What kind of technologist thrives at Jeeva?

Um, someone who, uh, thinks, uh, who comes with, uh, ideas and understanding of the specific problems we are trying to solve and who aligns with the mission of the organization. You know, uh, we are not just another tech company, um, out there to build a me to solution. Uh, we are here to change the world and so someone who comes with that, uh, mindset, uh, who has motivations and that align with our mission, uh, to make a difference. I think, uh, irrespective of whether it's technologist or, uh, business development or clinical researcher manager. Any role, uh, that's very key is a mission alignment.

Speaking of the roles, what, what kind of tech roles are you hiring for?

Uh, data scientist and AI ML will be, uh, top for next, uh, 12 to 18 months. Uh, as we have, uh, several grant proposals that we are waiting on and also raising capital to Uh, higher and, uh, essentially make now that we have much of, uh, most of the necessary, uh, software modules built out in the unified platform. Uh, the next step is really to drive efficiency and automation, uh, and, uh, capitalizing on the data as we now have over 10, 000 users on the platform, uh, to now look at a I M L, uh, to optimize the workloads.

Describe your morning routine.

Um, I, um, uh, you know, wake up, uh, usually around 7 a. m. and get, uh, uh, ready for my 8 a. m. call. Uh, and before that, I try to do some pushups and some mild workout, uh, to get some blood flowing. And I start usually with my product team in the morning. I keep 8 a. m. to 10 a. m. block for product and technology thinking time with the team sometimes and without the team on my own. But 10 a. m. onwards is my, Um, sales and business development time with customers. Uh, but, uh, the morning is product. What about breakfast is breakfast breakfast? It depends on my wife. If, if, uh, uh, because I come down, I go straight into my meetings and most of the time, my wife. Uh, if she's home, she brings me breakfast. And so I closed my camera and grab a quick,

this sounds like an entrepreneur. Right there. Oh yeah. What's an area of tech that you are most excited to see impact the healthcare industry in the next five years?

Yeah. So I think, uh, AR, VR, um, uh, especially in, um, remote patient engagement, uh, given for to our mission of taking clinical research to, uh, patient's homes. Engaging patients, uh, remotely, uh, involves that augmented reality, virtual reality. Uh, can make a big difference in not making them feel like they are not physically present in, in, in the ambience and, uh, in, in the place that they are imagining, like a clinic or a hospital or whatever that is. Uh, so I think that, uh, coupled with the tech we have already built and continuing to innovate, I think ARVR could be a useful add on to us.

What is your favorite app on your phone? LinkedIn. Nice. What's a charity or corporate philanthropy that's near and dear to you?

Um, uh, philanthropic organization that I, uh, founded, uh, about six years ago, the Indo U. S. organization for rare diseases, um, uh, which, uh, mission to bridge collaborations among various stakeholders of rare disease research. And patient advocates between United States and Indian subcontinent. Um, essentially it's near and dear to me at various levels. You know, uh, one it's personal because of my connection to rare disease. Uh, and two, it's personal because of my connection to my biological motherland and adopted motherland. Uh, bringing all together and my professional career. So it's pretty much like. Uh, and so that's my favorite, uh, cool.

Yeah. We'll plug that in the show notes as well. When the, when the episodes released, um, if you could have dinner with any celebrity past or present, who would it be with,

uh, Bill Gates?

Nice. Yeah. What is the worst fashion trend that you've ever followed?

I, I, uh, I have tried a piece of cloth called lungi, uh, which is basically like you just wrap around, uh, your, the lower part of your body without, there's no shorts. Well, we'll

have to get

photo evidence of this. I'll send you a video of the dance. Uh, you know, there's something called Lungi dance, uh, with, with music. So I'll, I'll share that. It's fun. How do you, how do you spell it? L U N G I.

Okay. We're, we're looking this up right after we wrap.

You can Google Lungi dance, L U N G I dance and you'll find it.

Awesome. Okay. Uh, and the last question, what was your dream job as a kid?

Um, to be a ticket collector. A ticket collector on a train, so I could travel all around the country. A

good answer. Um, awesome. Oh, that is a, a wrap on the episode. I wanted to thank you guys again for, for joining us. You've been both fantastic guests. Uh, thanks for sharing your knowledge and the, the clinical research and trial space. And, uh, of course we're rooting for you all to Continue advancing in the space, uh, that you're working in and moving the industry forward. So thanks for joining us on the pod. Thank you. Thanks for having us.

Some great questions.

Appreciate it. Thank you all.