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

Jul 30, 2024

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

In this compelling episode of The Pair Program, we dive into the intersection of cutting-edge technology and clinical research with two distinguished guests: Dr. Lawrence Cheskin, a pioneer in obesity research, and Harsha Rajasimha, the innovative founder of Jeeva Clinical Trials. Join us as we explore how their unique expertise is transforming the landscape of clinical trials and healthcare.

Dr. Cheskin, a Professor at George Mason University and former Director of Clinical Research at the Global Obesity Prevention Center, shares his extensive experience in combating obesity through rigorous clinical investigation and public health initiatives. His work in mHealth and behavioral interventions has significantly advanced obesity treatment and self-management.

Harsha Rajasimha, CEO of Jeeva Clinical Trials, brings a fresh perspective to clinical trial execution with his company’s modern platform designed to streamline trials and enhance efficiency. Inspired by a personal tragedy involving a rare genetic disease, Harsha’s mission is to provide universal access to clinical trials, making a profound impact on both rare and common diseases.In this episode, we discuss:

  • The journey from startup inception to practical healthcare solutions.
  • How Harsha’s personal experiences shaped his mission and the development of Jeeva Clinical Trials.
  • Dr. Cheskin’s commitment to obesity research and the intersection of his work with modern technology.
  • The collaboration between Harsha and Lawrence to drive innovation in clinical trials.
  • The challenges and strategies in integrating new technology into clinical settings and reaching target markets.

Tune in to hear how these leaders are working together to revolutionize clinical trials and make a significant impact on healthcare.

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Transcript
Tim Winkler:

Welcome to The Pair Program from hatchpad, the podcast that gives you

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a front row seat to candid conversations

with tech leaders from the startup world.

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I'm your host, Tim Winkler, the

creator of hatchpad, and I'm

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your other host, Mike Gruen.

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Join us each episode as we bring

together two guests to dissect topics

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at the intersection of technology,

startups and career growth.

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Hey everyone, welcome

back to The Pair Program.

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Uh, Tim Winkler here with Mike Gruen.

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Mike, we were kind of chatting a little

bit earlier about, uh, you know, some.

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Some vacation plans on my, on my

docket, but I was curious what, what

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you got, uh, lined up or is it, uh,

going to be a, a dry summer for you?

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It's going to be a dry summer.

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Oh, no.

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Is it kids related?

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Is it the kids?

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No, I mean, so, um.

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Mike Gruen: Yeah, so both of my sons

are in Boy Scouts or, sorry, BSA.

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They've rebranded.

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Um, uh, and so they have some scouting

things going on over the summer.

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And, um, so we're mostly low key.

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We're thinking maybe a weekend here,

a weekend trip there, but nothing, no

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big summer plans, um, Because they have

big summer plans, my wife and one of

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my, no, I guess just got back from the

Florida Keys where they did a whole

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snorkeling, like high adventure thing.

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It's awesome.

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Yeah, good for her.

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Uh, yeah, exactly.

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Um, it was work.

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They were like camping on an island.

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Like she was like, it

was fun, but it was hard.

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So, um, and then, um, and then

both of them have, um, a big long

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week, um, in Goshen, uh, Virginia.

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Uh, cool.

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Tim Winkler: All

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Mike Gruen: right.

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Well, I will.

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When I'm out, when I'm out in

the Outer Banks, uh, the Outer

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Banks, uh, you stopping off

anywhere else on the way there?

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Yeah, we're doing a bush garden

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Tim Winkler: stop off out in Williamsburg.

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So, uh, you know, for, for those,

uh, that have listened to the last

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few episodes, I've got a 18 month old

daughter, so this'll be her first time,

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you know, jumping onto some Some of

the, you know, the teacups, I don't

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know what, what, what these, uh, the,

the kids at that age can ride, but, uh,

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you know, I'm, I'm pretty sure she's,

uh, going to be an adventure seeker.

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So looking forward to getting

her out to an amusement park.

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Awesome.

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Cool.

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Lawrence Cheskin: All right.

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Well, I just came back from Greece.

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So.

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Oh, dang.

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You just trumped everybody on the

call, but you asked me for the past

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three years, I've done nothing.

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Tim Winkler: Where'd you go?

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What, what islands did

you, did you hit up?

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Lawrence Cheskin: We went to, you

know, we started in Athens, which was.

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Not that great.

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You know, it's all dirty and graffiti

filled and with 50, 000 other people at

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the Parthenon, that was the highlight.

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And then we flew to Mykonos,

which is sort of a party island.

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And, uh, we weren't that

crazy about that one.

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And then Naxos was probably

our favorite, which is, uh, you

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know, a less developed island.

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And, uh, uh, we went hiking and

stuff there in the middle of it.

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Very cool.

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And the last one was Santorini, which is

probably the most beautiful, you know?

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Yeah.

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Beaches and sunsets and all that.

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Tim Winkler: Absolutely.

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Yeah.

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We did, uh, uh, Athens,

meno and, and Santorini.

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I think those are, yeah,

that's gonna be the, yeah.

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The, the most frequented, uh,

destinations, but, um, Mm-Hmm.

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did you take the ferry?

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I take it then just to, to get out there?

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Yeah.

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I, the, the ferries in

between the islands.

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Yep.

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Nice.

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Very cool.

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Well, now we got to ask Harsha,

anything that you can trump,

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uh, a Greece trip with, or?

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Harsha Rajasimha: Of course.

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The Virginia beach always

trumps everything else.

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All right.

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Now I know, I guess I

have a sense of humor.

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I have two daughters and

both of them love the beach.

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So we spent, uh, uh, Fourth of

July, long weekend and at the beach.

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It was fun.

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Tim Winkler: Yeah.

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Virginia beach is, is a, is a

great area and not far as well.

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So, um, well, we'll, we'll, we'll have

to say that, uh, it doesn't quite Trump

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the Greece trip, but we'll, we'll give

you credit for at least getting away.

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Uh, better than Mike's lazy summer.

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I would

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Harsha Rajasimha: https: otter.

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ai

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Lawrence Cheskin: He has a lot more

money as a result of my trip to

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Virginia Beach.

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Uh,

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Tim Winkler: let's jump

into today's episode.

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So again, this is going to be one of

those episodes where we get to mash up

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a, a startup founder with one of their

customer partners and talk through

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how a solution is delivered, uh,

specifically we'll be focusing in on

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the healthcare space for this use case.

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Uh, we'll learn a little bit more about

some interesting technology being built

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to to help streamline clinical trials.

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So today we have, uh, Harsha Rajaseema,

uh, the founder and CEO of Jiva

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Clinical Trials, uh, and Professor Larry

Cheskin, a professor at George Mason

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University's College of Public Health.

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With a focus in nutrition.

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Uh, so Harsha, Larry, thank you both

for joining us on The Pair Program.

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Excellent.

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So before we dive in, we do

kick things off with a, a fun

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segment called pair me up.

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Here's where we all go around the room.

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We spit ball a complimentary

pairing of our choice.

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Mike, you lead us off.

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What, uh, what do you got for us

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Mike Gruen: today?

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So, yeah, so, uh, mine is kids and pets.

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Um, I, uh, I grew up with a lot of pets,

um, a lot of pets, uh, and we have,

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um, Uh, my family has cats and a turtle

and I was talking earlier today with a

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coworker about like getting a dog and

I said, Oh, you know, my kids are older

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and I sort of wish we'd gotten a dog when

they were younger because I like dogs.

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Um, I mean, I like all animals.

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There's people ask me all the time.

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Like, my cat person, dog person,

they have, they're different.

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Um, I like both.

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Um, but I do like dogs a lot anyway.

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So, uh, uh, kids and pets.

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That's where we go.

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Kids and pets.

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Tim Winkler: Yeah, I mean, I think

that's, that's a great parent.

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I mean, I, I know as a kid, it was like

a constant harassment on my parents.

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It's like, you need a dog, you need a dog.

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So, you know, but it, you

had to lead up to that.

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So we had like multiple hamsters,

you know, all kind of, you

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know, Suffered tragic deaths.

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Uh, somehow as a, as a kid that

couldn't keep a hamster alive, they

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were able to still, if they die,

you know, let's get you an upgrade.

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She's got a dog.

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Yeah.

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It was a family dog.

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The hamster was mine, but, um,

but yeah, kids and pets, I dig it.

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Um, I'm gonna, I'm gonna jump

in real quick and, uh, go with

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road trips and car washes.

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Um, so again, we're going on, on

vacation, uh, end of this week.

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And, um, uh, getting the car kind of

just, you know, tidied up beforehand,

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making sure you have a comfortable

space to, to, uh, to sit in for,

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you know, whatever it is, six,

seven hours, uh, is always something

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that we do before any road trips.

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So, uh, car washes and road trips

also, they'll do a little bit of like,

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uh, um, if you do it at a spot that's

got like a little mechanical, do a

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little check on, on some of the, uh,

essentials, make sure you're good to

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go with tires and everything else.

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But, uh, Um, that's, uh, that's my

pairing for, uh, for the day and

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let's pass it over to the guest.

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So, uh, why don't we, we start with you,

Harsha, a quick intro and your pairing.

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Harsha Rajasimha: Great.

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Um, hi, um, this is Harsha Rajasimha,

founder of Jiva Clinical Trials.

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Um, my background is I'm a

computer science engineer turned,

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uh, genomics data scientist.

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Um, we are currently on a mission to,

um, modernize clinical research with, uh,

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human centric software and CRO solutions.

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Uh, headquartered here in northern

Virginia from a pairing point of view,

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um, I, I guess a lot of kids, uh,

and plants, um, no animals, uh, as

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I grew up in a vegetarian household

and also, uh, not really, uh, pets,

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uh, uh, that are, uh, Not plants, so

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Tim Winkler: so so plants

as, as the pets, absolutely.

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Harsha Rajasimha: Clovering plants,

some vegetables and stuff that can go

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in into the edible side of the kitchen.

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Tim Winkler: Nice.

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Yeah.

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That's a first.

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That's a first on the show.

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Um, Larry, how about yourself?

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Quick intro in your pan.

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Lawrence Cheskin: Well,

I'm, I'm Larry Cheskin.

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I'm a physician by training and

a professor of nutrition, uh,

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at the school of public health.

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At George Mason University, and I

also work, uh, now as an adjunct

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professor at Johns Hopkins.

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And, uh, I see patients and I do a

lot of weight control and, you know,

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uh, weight is a big issue in the

United States and around the world.

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And, uh, the pairing, I guess I can

talk about, uh, not to be repetitive

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and they're not exactly pets, but my

wife and I rescue, uh, farm animals,

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uh, at our, uh, uh, farm in New York.

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farm in, in, uh, Ellicott city,

Maryland, and we've got everything

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from Horses and mules, ponies,

uh, goats, sheep, uh, and pigs.

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So, uh, and we had a chicken right in

the house in our kitchen an hour ago.

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Uh, cause it had what's called a bumble

foot, which is like a bleb that they

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develop on their feet and then they can't

walk real good and my wife was trying to

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do minor surgery, uh, on the, the bumble

foot, uh, uh, get it to go down a little.

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Tim Winkler: Interesting.

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What's up?

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Polar opposite parents here

between our guests, our

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Lawrence Cheskin: animals, we're,

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Mike Gruen: we're, uh, I know I was just

going to say, it sounded like my house

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Tim Winkler: vegetarian.

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Lawrence Cheskin: That's funny.

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Tim Winkler: That's cool.

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Yeah.

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Mike, you were just saying

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Mike Gruen: that.

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Yeah.

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I mean, I grew up with

lots of farm animals.

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The difference is some of them we ate,

um, and, uh, we definitely did not

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have pigs, but, uh, we did have the

goats and horses and stuff like that.

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Um, so that's, that's very cool.

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I think this is also the first episode

we've had no alcohol, uh, mentioned as

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Tim Winkler: alcohol or food foods.

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Uh, yeah.

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Yeah.

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Nice.

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First of a kind.

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Awesome.

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Lawrence Cheskin: Great show.

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Thank you.

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Tim Winkler: Welcome folks again.

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Thanks for joining us.

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And, uh, let's go ahead and transition

into the heart of the episode.

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So as I mentioned, we're going to be

talking to a tech startup founder, Harsha,

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to hear more about, uh, this health tech

company, Jiva clinical trials, how they're

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working with a, a customer Parker customer

partner and breaking down, you know, how

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this strategic partnership came to be.

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First and foremost, I do wanna

expand on the story and the

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impact of GVA clinical trials.

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So I'll start with you, Harsha, you know,

what inspired you to start this company

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and, and what problems are you solving?

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Harsha Rajasimha: Yeah,

so, uh, great question Tim.

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Uh, you know, coming outta NIH and FDA

as a postdoctoral scientist and, um, uh,

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being part of multiple startup, so, so I.

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Change the world, but

how exactly to change?

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Where is the unmet need?

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Uh, where can I help people?

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Uh, was a question as I was

going through early part of my

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career more as a data scientist.

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And, uh, as I stumbled upon my own

personal experience of becoming a dad to.

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Three kids and, uh, one of the kids, uh,

born in:

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And, um, so, uh, we

lost, uh, the same year.

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Uh, and so that, uh, inspired me

to think more in terms of, um,

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what these rare genetic diseases

are, what type of diseases.

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And I was good.

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Good news was I was

kind of professionally.

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Already involved in the, um,

genomics and precision medicine

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area, uh, coming from NIH and FDA.

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But, uh, uh, uh, uh, experiencing the

loss of a child is something that, uh,

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really, uh, uh, uh, inspired me to, uh,

Think, uh, what can be done about diseases

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like that, um, and there is much hope

for some of those diseases, but not all

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diseases can be treated or cured, but

certainly diagnosis was a big challenge.

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And so I spent several years, um,

working for a startup leading their

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clinical genomic test that can

diagnose thousands of diseases in a

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single, uh, exome sequencing test.

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And, uh, then coming out of that, uh,

moving into therapeutic development,

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consulting for big pharma, uh, while

I was working for, um, Dell services,

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entity data services over the years, um,

uh, first time looked at how inefficient

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the process of bringing new treatments

through the regulatory process was.

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One in 10 drugs make it

through the valley of death.

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Nine outta 10 drugs fail, and it takes,

uh, nine years to 12 years, um, on an

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average going from first in human studies

through the regulatory review and process,

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uh, very inefficient, very expensive.

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Average cost had exceeded two and half

billion to get one drug to market.

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And as, uh, I looked at that problem, uh,

there's just massive IT infrastructure

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that goes into, uh, executing one

clinical trial at a big global pharma.

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And there's a lot of, uh, early stage, uh,

biotech companies that where innovation is

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happening for, say, cell and gene therapy

or, uh, novel modalities, uh, that don't

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have the resources that big pharma have.

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And they have to execute these

studies, identifying and stitching

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together 20, 30 different software

tools, laboratories and samples and

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a lot of workflows that all have to

happen in a quite a complex workflow

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to make one clinical trial successful.

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So I thought there was a huge

opportunity and a unmet need to one,

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getting early diagnosis and then

getting them to clinical research and.

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Uh, also only one or 2 percent of the

American population are actually being.

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Uh, accessing the clinical research

enterprise, uh, while, uh, while 99

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percent of the people are still not

engaged in the clinical research process.

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Of course, during the pandemic,

suddenly, you know, everyone heard

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about clinical trials about the vaccine

and it was a, uh, the silver lining,

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as they say, of raising mass awareness

at the population scale about clinical

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research and how they can be lifesaving.

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So.

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And so that's led to, uh, it's a

year before the pandemic is when I

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founded Jeeva to essentially bring

efficiency and human centric approach

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to executing clinical research.

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And that that was the inspiration, uh,

along the way, you know, I also had a

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younger brother who was suffering from

diabetes and the complications of that

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who is, who was in his early thirties.

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Um, Lost his life, um, as a result of

the complications coming out of, uh,

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diabetic retinopathy and nephropathy

and other, um, complications.

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So, uh, both these family

members, um, inspired me, but the

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entrepreneurial bug was already there.

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So I, I just got the direction to

see where I could make a difference.

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Tim Winkler: Well, it's a inspiring story

and, um, you know, I'm sorry to hear about

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the loss, um, as a parent that also has,

uh, as a, as a, as a person that lost

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both of their parents to cancer, um, can

relate to the, uh, motivation to want to.

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Figure out solutions to problems.

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Um, one of which my mom, you know,

she was, uh, diagnosed with multiple

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myeloma and, uh, you know, it was

a, still a fairly, you know, early

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stage kind of cancer that hasn't

been, uh, a ton of research done on.

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So we, we had a, uh, an entry

point into, um, getting into some

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of these, some of these trials.

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Uh, and I can tell you that the, you

know, this would have been in:

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Yeah.

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16, uh, and, uh, it was a

very frustrating experience.

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There was just wasn't a, a clean

entry point to understand what the

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options were, you know, what were

the results from other, um, patients.

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And, um, and so, you know,

when I, Discovered what you

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were, you were building.

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I had a personal interest in, in wanting

to hear more and also just, yeah,

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grateful that there's folks like yourself,

entrepreneurs like yourself out there

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that are, you know, uh, pushing the

needle forward to, you know, to solve

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some of these problems because, uh, it

is, is truly a problem and it's, it's a.

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It's one that, you know, when

lives are on the line, it's,

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it's, you know, how quickly can we

move to, to, to expedite things?

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Harsha Rajasimha: it's one of those things

where it's one of the most complex human

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endeavors that are undertaken in getting

one drug through the regulatory process.

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And multiple stakeholders have to do

their jobs, um, in a very coherent,

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consistent, like collaborative manner.

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And, uh, what's surprising me is.

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Even today, um, 90 percent of clinical

trials are run, conducted on 10

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percent of the world's population.

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90 percent of the world is not

engaged in clinical research.

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At all, uh, to a great extent.

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And so I think there is huge opportunity

to take clinical research to the

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patient's homes and, uh, enabling

remote patient engagement and, um,

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involvement in clinical research,

after all, they are the people who are,

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who are being helped by these pharma

companies in developing drugs and digital

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therapeutics and novel modalities.

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So.

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That's a mission that I think I'm

willing to put in whatever best I can.

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Tim Winkler: Yeah.

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And, you know, I want a couple of quick

hits on, uh, Jeeva and then we'll, we'll,

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we'll jump over to Larry here in a second.

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Um, what's, what's the, the, the size of

the company from a headcount perspective?

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You know, have you received any.

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Funding to this point is it, you

know, been venture capital grants.

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Uh, tell us a little bit about, uh,

you know, the specifics of the company.

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Harsha Rajasimha: Absolutely.

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So we are a Delaware corporation

headquartered in Virginia, uh,

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received various grants from the

Virginia Commonwealth, uh, governors,

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uh, com commercialization fund,

um, as well as, uh, Investments

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from the Virginia venture partners.

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So we are a portfolio of that.

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And, uh, as a Hokie and affiliate

faculty at George Mason, I have not

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had any trouble attracting talent,

um, you know, seeking internships and

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full time opportunities and so on.

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So we are a team of 15, um, people and an

advisory board, a board of directors and

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:

several investors for all, um, rooting

for us and supporting in our mission.

351

:

Uh, so we are at a seed stage

and we are just out, um, starting

352

:

to raise a series a round.

353

:

Tim Winkler: Okay.

354

:

Excellent.

355

:

Yeah.

356

:

And, uh, at the end of this, we'll,

we'll, uh, have a little bit more of a few

357

:

questions to plug, uh, you know, the types

of roles that you're hiring for as well.

358

:

Um, but, uh, uh, before we dive a

little bit deeper into, you know, what,

359

:

what Jeeva is doing, um, uh, at a more

granular level, let's, let's pass it

360

:

over to Larry real quick, Larry, how,

um, yeah, tell us a little bit about your

361

:

background, um, and then, uh, how did

you and, and Harsha kind of cross paths.

362

:

Lawrence Cheskin: Yeah.

363

:

So, um, I've been, uh, in medicine,

you know, uh, since I was not quite

364

:

a teenager, but soon thereafter.

365

:

And, uh, uh, I've always been very

interested in research and not so

366

:

much laboratory research, you know,

working with, with mice and cells,

367

:

um, but in working with people.

368

:

So that's, uh, called clinical

trials or clinical research.

369

:

And this is where, um, you're often

taking things that were originally

370

:

done, uh, as research in animals and

cells and applying them to humans.

371

:

So it's often a big leap, uh, because

things that work in cells or animals

372

:

don't necessarily work in humans.

373

:

So it's necessary to do things in

a very rigorous, organized fashion.

374

:

And the kind of gold standard is what's

called a randomized controlled trial.

375

:

So I've been involved in doing

these sorts of studies, um, and

376

:

an RCT for short, randomized

controlled trial, uh, is randomized.

377

:

That means that it's very important

because very often we're influenced

378

:

by what we think is going to happen.

379

:

Um, and many people have

heard of the placebo effect.

380

:

So if I give you a pill and say, you

know, Mike, this is going to change your

381

:

life, um, you may laugh, uh, but it will

probably change your life a little bit.

382

:

Even if it turns out it's a pill

that does nothing, it's a sugar pill.

383

:

Um, and, uh, when you give people

medicines, for instance, and that's

384

:

one of the main treatments, uh, that

we use in healthcare, You have to

385

:

know whether the effect is greater

than if I gave you a sugar pill.

386

:

Because the sugar pill is going

to do something for many people.

387

:

So, um, you, uh, randomize

people to whether they're going

388

:

to get the sugar pill or the

active drug that you're testing.

389

:

And that, uh, uh, is a controlled

setting and you don't let the

390

:

person know what they're getting.

391

:

And you'd also, it's

called double blinded.

392

:

It's not just the patient that doesn't

know what they're getting, but it's

393

:

the, the, the person giving out the drug

that doesn't know what they're giving.

394

:

Uh, so it's a double blind.

395

:

Um, and the only one that's going to know

is as you're analyzing the final data,

396

:

you have to eventually look at who got

what, uh, to know whether the people who

397

:

got the active drug did any better than

the people who got the placebo drug.

398

:

Um, so a randomized control trial is

called the gold standard of testing things

399

:

because any other method of testing a

treatment, you're always concerned about,

400

:

well, did it really Do the effect because

of the treatment, or is it because you're

401

:

paying attention to people, uh, and you're

giving them care, uh, and that's going

402

:

to make them somewhat, uh, better, you

know, unless they've been run over by a

403

:

truck, attention is going to be useful.

404

:

Um, even in things that you think of as

not being all that treatable like cancer.

405

:

Giving people attention and

caring, uh, has a positive benefit.

406

:

Anyway, so, um, what's also important

is that we understand the triggers

407

:

and the things that increase

our risk of getting things like

408

:

cancer that was mentioned earlier.

409

:

And being in a nutrition department,

um, and treating people with

410

:

obesity, I'm convinced that nutrition

is a very important factor in,

411

:

uh, our health and our future.

412

:

So, um, one of the things, uh, we

wanted to do was study, not the

413

:

people that are usually studied.

414

:

So in healthcare, you study people

who already have cancer, uh, and you

415

:

see what treatment works in them.

416

:

And that's clearly very important.

417

:

But in some ways, even more important

is to understand who's at risk and who,

418

:

what you can do to reduce people's risk

of becoming a patient, uh, down the road.

419

:

So we wanted to do a study, not of older

people with diseases already, but of

420

:

young people before they got diseases.

421

:

And George Mason undergraduates

seemed like a really good group to

422

:

study because they're very diverse.

423

:

It's a very diverse university.

424

:

It kind of mirrors the United

States and to some extent the world.

425

:

Um, so, you know, very often when

studies were done in past years, it

426

:

was restricted to middle class, upper

middle class white guys, uh, because

427

:

those are the people who are running the

studies and those are the people they

428

:

tended to recruit and the results were

applicable to middle class white guys.

429

:

Um, and yet you want it to be

applicable to a broader range of people.

430

:

And we've learned over the years

that middle class white guys are not

431

:

necessarily representative of, you know,

what other populations like women and

432

:

minorities and people of different,

you know, uh, ethnic origins, um, are

433

:

going to be at risk for an experience.

434

:

So.

435

:

George Mason undergrads, the

perfect mirror of the United States.

436

:

And, uh, we wanted to know what they

do, what they eat, what their physical

437

:

activity is, what their mental health is,

what their attitudes are, um, and follow

438

:

them throughout their time at George Mason

as undergraduates for four, four, four

439

:

years, at least, and see how that evolved.

440

:

And it so happened that we started

this around the time Harsha was

441

:

starting, um, Jiva, and uh, it

was right before the pandemic.

442

:

And so our first, it's called a

cohort, the, the year, the freshmen

443

:in:

we studied, the first cohort.

444

:

And that was before the pandemic.

445

:

Um, so we have data on

a bunch of young adults.

446

:

Uh, and we limited it to, you

know, we didn't want the people

447

:

returning to college at age 50.

448

:

We wanted the people, you know, who

recently graduated from high school

449

:

and were starting college because they

were the ones who were in essence,

450

:

the The cleanest, the purest in terms

of understanding what diet and other

451

:

health behaviors are going to do.

452

:

All right, I'm going on far longer than

you wanted me to probably, but we turn

453

:

to Harsha to help us with organizing

and making that kind of study happen.

454

:

Tim Winkler: Yeah, interesting, uh, study

also, uh, nice shout out to George Mason.

455

:

I'm a, uh, alumni as well.

456

:

So, uh, love to see, uh, the

university continuing to grow.

457

:

Lawrence Cheskin: The IRB has just

given us permission to, uh, ask alumni.

458

:

To, uh, uh, fill out, see what happens,

you know, when you're out of the, the

459

:

cloistered environment of the university,

460

:

Tim Winkler: I'll connect

with you after the pod.

461

:

We'll see, we'll see if

I could submit my data.

462

:

Um, all right.

463

:

So, so now I think we've painted a

good picture of, of how, you know,

464

:

you all kind of came into connection.

465

:

Now I'd like to just talk a little

bit more about, you know, how has

466

:

the Jiva clinical trials technology.

467

:

Help streamline a study like this, you

know, where, where were there gaps, uh,

468

:

along the way with, within some of this

clinical research that your technology

469

:

is, is solving those pain points.

470

:

Harsha.

471

:

Harsha Rajasimha: Yeah.

472

:

Great question, Tim.

473

:

Um, and, um, you know, when I was, uh,

getting started, we had a team from Mason.

474

:

Um, we went out to what is called

the NSF I Corps program after

475

:

graduating the Mason's ICAP program.

476

:

The innovation, commercialization,

um, um, acceleration program, which

477

:

essentially encourages you to get out

of the building, go talk to customers

478

:

and figure out what their pain points

are before you build anything, right?

479

:

And, uh, to even make a decision whether

there is a need for, uh, unmet need in

480

:

the industry that you are trying to fill.

481

:

If not, most companies fail

because they build something

482

:

nobody wants or nobody cares about.

483

:

And we, we didn't want to fall into

the trap and we are thankful for having

484

:

met, uh, Bob, uh, uh, Smith and, uh,

Josh Green at the GMU iCAP who got us

485

:

oriented in this fashion very early

on, and that did a whole lot of good.

486

:

So when we started speaking with Larry.

487

:

We learned the various,

uh, existing tools.

488

:

Um, and so randomized control clinical

trials, like Larry said, have been running

489

:since:

490

:

Although the electronic and

digital aspects are more recent,

491

:

uh, from the early two thousands

is when the d guidance of 20

492

:

data capture.

493

:

Electronic data, but not so much also

resulting in silos and point solutions,

494

:

some for managing the clinical study as

a project, some for managing just the

495

:

data part of it entered by the clinical

researchers, some for patient engagement,

496

:and soon after:

497

:

And so suddenly we were in a new norm.

498

:

A state of confusion for a period

of time before we gotta a new norm.

499

:

And so, uh, that resulted in a lot of

remote engagement type technologies

500

:

and tools that came about very rapidly

in a very short period of time.

501

:

And so we realized as we were starting

to build out the tech in:

502

::

is the divine contract between

503

:

the researchers and the patients.

504

:

And we needed, uh, to ensure continuity

of clinical research during the pandemic.

505

:

We needed a way to obtain electronic

signatures and informed consent remotely

506

:

beyond what a DocuSign would do.

507

:

I mean, it's not just the signature,

but did the subjects actually understand

508

:

What they are getting into the risk and

benefit and can we verify comprehension?

509

:

So we designed a, um, human centric

informed consenting platform that

510

:

could scale and then ability to collect

patient reported outcomes data directly

511

:

from the patients on text messages,

email, questionnaires and surveys with

512

:

complex branching logic and skip logic.

513

:

So, when we spoke with Larry, they

were already using existing tools,

514

:

one for managing the study, one for

doing the questionnaires and surveys.

515

:

They had a rather 90 minute

questionnaire and a 60 minute

516

:

questionnaire with 900 questions.

517

:

With depending on male, female and other

questions, they would answer specific set

518

:

of group of questions that were unique to

them and so needed a very robust platform.

519

:

So, what was exciting for us was to

really address these inefficiencies.

520

:

We had to bring everything in 1 login

in 1 centralized unified platform.

521

:

And so while we started building

point solutions in the beginning.

522

:

It soon became apparent that we

needed to bring these point solutions

523

:

in a unified platform, which we

did over the last five, six years.

524

:

But when we started working and

collaborating with Larry, the opportunity

525

:

was really to save time for the clinical

researchers in and avoiding having

526

:

to log into three different places.

527

:

They only had to have a single login.

528

:

And into a single tool where

all the data was in one place.

529

:

Tim Winkler: Yeah.

530

:

So it's, it sounds to me like, uh,

you know, it, the pandemic kind

531

:

of, it fueled a lot of this because

everything was kind of going a bit

532

:

more online at that time anyways, but.

533

:

Um, having a unified platform to where,

you know, the ease of getting, uh, folks

534

:

to, you know, to, to, to get on board,

to get their information uploaded.

535

:

Um, it's half the battle, I

think, in a lot of these studies.

536

:

Right.

537

:

And so, um, getting that

out and presented, um, seems

538

:

like a, a great use case.

539

:

So that was your, you know, what,

what was the kind of like, I guess

540

:

the first iteration of this was.

541

:

Is, is Larry's, um, you know, and, and

the George Mason study one, one of the

542

:

earlier ones that you all have done or,

you know, is this something that you've

543

:

been iterating on, you know, over, you

know, number of years at this point?

544

:

Harsha Rajasimha: Absolutely.

545

:

It, it's been a, uh, work in

progress, iterating, uh, you know,

546

:

we are on a journey to really, uh.

547

:

The, uh, effect the randomized controlled

clinical trials in phase 1, phase

548

:

2, phase 3, ultimately leading to a

submission to the regulators like FDA

549

:

for review and marketing approvals.

550

:

And so to really get to that phase 3.

551

:

Uh, which are the largest, uh,

uh, sample size or, um, largest

552

:

clinical trials before approval.

553

:

And of course, phase four post market

studies can also be much larger.

554

:

And there are observational studies

like the one that Larry mentioned,

555

:

where there is, we are not really giving

any, um, using drugs or interventions.

556

:

But rather measuring what what's

going on, the behavior, lifestyle,

557

:

food, nutrition, and so on.

558

:

So these observational studies are

low risk, where we are gathering data,

559

:

analyzing data, and understanding

from a scientific curiosity and

560

:

drawing correlations and insights,

clinical insights and health insights,

561

:

which is really a gold mine of

data that can be used to answer

562

:

a variety of different questions.

563

:

Uh, but ultimately, this is the starting

point where we, uh, validated our

564

:

platform in an academic, uh, research

setting, uh, then leading towards, uh,

565

:

building, uh, the more randomization and.

566

:

Electronic data capture as per

the FDA guidance leading to more

567

:

regulated clinical trials in early

phases, phase one, phase two.

568

:

So that's where the company is today

and we are working our way eventually

569

:

towards those larger phase 3 trials

leading to regulatory submissions.

570

:

And so that's, that's basically the

baby steps needed to get through

571

:

in this regulated environment.

572

:

Mike Gruen: That's cool.

573

:

One of the things I think about,

like what startups a lot is

574

:

focus and not like sort of.

575

:

Not having that sort of focus because

as you were talking about your platform

576

:

and what it's capable of doing right

as an outsider, I can't help but

577

:

like, think, oh, I see applicability

here and I see applicability there

578

:

and I see applicability there.

579

:

And if you have like the wrong

people involved, I feel like

580

:

it's very easy for a company.

581

:

Sort of lose its path and I, um,

I'm curious, like, have you found

582

:

that to be the case if you've been

like razor focused and not had

583

:

to, like, really deal with that?

584

:

Or like, have you got like, it

sounds like that's the case that you

585

:

guys have been pretty laser focused

on on what you want to achieve.

586

:

But I'm curious, like,

have you experienced those?

587

:

Like, Oh, we could maybe we

should pivot into this or maybe

588

:

we could help in that space.

589

:

Harsha Rajasimha: Um, absolutely.

590

:

We have had to go through some,

some pivots as the industry has been

591

:

moving rapidly since the pandemic,

you know, uh, and otherwise slow.

592

:

Uh, adopter of technology,

life science industry.

593

:

Wait, there are slow adopter.

594

:

Oh, yeah,

595

:

Tim Winkler: absolutely.

596

:

Sarcasm, uh, cued.

597

:

Harsha Rajasimha: Yeah.

598

:

You know, in healthcare, it said that,

um, While hundreds and thousands of

599

:

new applications and digital tech

is being developed and thrown and

600

:

marketed every day, the actual part of

delivering care between a doctor and a

601

:

patient, that's seldom changing, right?

602

:

I mean, it is changing a little bit.

603

:

Relative to how much tech is being talked

about and new tools being developed.

604

:

And so, uh, the other thing that I was

thinking about when Larry was speaking

605

:

about the importance of nutrition in

obesity and others, there is an old

606

:

adage in, um, ancestral Indian families

that says essentially to the effect

607

:

that those who understand how to speak,

we'll never have battles or fights.

608

:

And those who understand how

to eat will never have disease.

609

:

And so that's how important knowing what

to eat, how much to eat and when to eat

610

:

and all that, it's an art and science.

611

:

Uh, and it's kind of ancestral wisdom that

kind of gets passed on and it gets lost

612

:

in the mix as to why we do what we do and,

uh, all that, but, uh, Where I was going

613

:

with this is, um, essentially, uh, the

clinical research, um, industry has been

614

:

moving as we, we have been developing.

615

:

And so we had to pivot.

616

:

And what we realized is if we have to

stay in the academic observational,

617

:

Uh, clinical studies, uh, space, that's

one thing, but our vision is really

618

:

to help speed up therapy development

process, uh, life saving treatments for

619

:

rare genetic cancer and other severe

diseases where the requirements are

620

:

much more stringent and the bar is

higher from a regulatory point of view.

621

:

And so, uh, we have been

continuously innovating and

622

:

adjusting to the new guidelines

that came out during the pandemic.

623

:

Many of those guidances have remained,

some of them have gone, and even

624

:

though regulators are encouraging

more remote patient engagement.

625

:

The industry has not necessarily embraced

it as much after the pandemic went away.

626

:

Uh, some have gone back to the old

way of doing things, but we are

627

:

somewhere in a hybrid study state now.

628

:

And so we had to adapt to this hybrid

mode of running clinical studies.

629

:

And as the platform evolved, we took

those into consideration in pivoting.

630

:

Another thing we learned is

that just throwing tech at the

631

:

problem is not the solution.

632

:

No, we need to bring tech with people who

are trained to use the tech in a compliant

633

:

way, along with standard operating

procedures and the quality management,

634

:

which is so critical in the space.

635

:

And so, uh, people process technology all

in together to offer either a software

636

:

solution or software plus CRO solution

or a contract research organization.

637

:

Where it's a turnkey solution

where we can take on a protocol

638

:

and help execute the full study.

639

:

And that's where we, uh, we are now

collaborating with Larry and Mason in ways

640

:

in which we can bring additional clinical

research and trials into the Commonwealth.

641

:

For testing medical devices or drugs and

other products, um, where, um, necessarily

642

:

we don't need a hospital system, right?

643

:

A clinic is sufficient in many,

many instances, especially

644

:

for low risk type products.

645

:

So we're super excited about

the pivots we had to make and

646

:

doing them at the right time.

647

:

Uh, and also just being part of

this DMV, uh, investor ecosystem.

648

:

We, we got.

649

:

Early guidance coming down.

650

:

Hey guys, you know, you may want to

cut some cost and stay put the market

651

:

is not looking When the recession

came about in:

652

:

So we had to take certain corrective

measures, uh, at the right, uh,

653

:

in a timely fashion as well.

654

:

Tim Winkler: I'm just curious from

a, like a business development

655

:

perspective, Harsha, you know, um,

you know, how, how do you, uh, how do

656

:

you put together that plan to, to get.

657

:

You know, your technology in the hands

of, you know, for example, this is in

658

:

a, in a university kind of setting, you

know, what, what, how are you prioritizing

659

:

like, you know, your target market?

660

:

What does that target market look like?

661

:

And then.

662

:

Um, how do you, how do you get

that technology injected in?

663

:

Harsha Rajasimha: Yeah, great question.

664

:

You know, our ideal customer is really

clinical stage, biopharmaceutical,

665

:

nutraceutical, uh, medical device

companies that are getting through

666

:

their early, uh, clinical studies.

667

:

And, uh, academic medical centers and

professors can be important collaborators

668

:

for us, uh, in, uh, teaming up with our

software solution and the CRO solution.

669

:

As ultimately, it's the clinical

researchers who can guide what

670

:

endpoints need to be measured and

how we can demonstrate safety,

671

:

efficacy of a product, right?

672

:

Whether it's a drug or a device.

673

:

And so, uh, that's how we approach

it is with the mindset that.

674

:

We need to sell to, uh, clinical

stage, early stage biopharmaceutical

675

:

sponsors and collaborate with academic,

uh, clinical researchers to make

676

:

this all work well with our human

centric efficient software platform.

677

:

Tim Winkler: Yeah.

678

:

And I, you know, just kind of scanning

your background in the past as well,

679

:

um, then you spent some time at NIH,

I guess throughout your career, some

680

:

of those, um, you know, previous

relationships, how have those played into.

681

:

You know, helping you advance

this company, if it's.

682

:

Through partnerships, through funding,

what have you, I'm, I'm, I always

683

:

like to see like, uh, you know,

that journey and then pick a part,

684

:

you know, how, how this stop here

helped you in this current position

685

:

of, you know, being an entrepreneur.

686

:

Harsha Rajasimha: Yeah,

no, great question.

687

:

And, uh, rightly so, uh, right from my

elementary school friends, all the way

688

:

through my, um, last job, uh, where

I held at entity data, I think every.

689

:

Where I had several people who have played

an important role in my journey already.

690

:

Um, whether as like one of

the 25 investors who have put

691

:

their money into the company.

692

:

Or making, uh, warm introductions and

connections or simply providing their

693

:

time, you know, offering, uh, an hour of

time talking to people who are involved in

694

:

clinical research, uh, from Virginia Tech.

695

:

When I went to grad school there from one

to seven, uh, the School of Medicine was

696

:

not yet established, but uh, it later got

established or, um, and, and so, uh, there

697

:

is Carilion Clinic and vt, uh, som now.

698

:

So, I had the opportunity to go back

to my alma mater and participate in

699

:

the RAMC Regional Acceleration Program

there in the Roanoke Blacksburg

700

:

Technology Corridor, which further took

me more from where NSF I Corps left

701

:

us into Further validating the value

prop product market fit and so on.

702

:

So, so I think, uh, uh, from, uh,

everywhere, uh, from elementary school

703

:

till now, I've had numerous touch points.

704

:

You know, my wife has invested in

the company, uh, as well as, uh, uh,

705

:

several people that I have spoken

with, um, uh, who have helped in many

706

:

different ways, even on LinkedIn.

707

:

Every day I am amazed at how people

have never met even till date are

708

:

coming forth with a generous spirit

of support and mission, you know, uh,

709

:

parents affected by rare diseases.

710

:

appreciating, uh, how we are

supporting NF1 clinical trials.

711

:

We just paid a pledge here today that we

are going to make our software platform

712

:

available to all NF1 clinical trials,

which means there's only one patient

713

:

in the FDA regulated clinical trial for

a, it's an ultra, ultra rare disease.

714

:

There is no other patient

affected by the disease.

715

:

And The regulators are going to make

it possible for them to try a new

716

:

therapy like an antisense oligotherapy

or some novel therapy on one patient

717

:

and for how much budget would there

be for a one patient clinical trial

718

:

and to support these families we

have made the software platform

719

:

fully available at no cost to them.

720

:

Wow, that's wonderful.

721

:

Tim Winkler: And so, you know, it's an

area that we, we dive deep into on the, on

722

:

the podcast, actually, um, you know, uh,

we, we've been talking a bit, a bit about

723

:

it more into, uh, settings like within

the government, like defense tech, right.

724

:

Uh, you know, this, this, uh, kind of

changing of the guard where, There's, uh,

725

:

it's known that, you know, uh, they can't

keep up, uh, at the speed of some of the

726

:

commercial technology that's out there.

727

:

How do we take commercial technology,

inject it into more regulated

728

:

industries like defense, you know,

healthcare is obviously a, uh, uh,

729

:

a fantastic example of this as well.

730

:

And it sounds like, you know, Jiva

clinical trials is really hitting a, um,

731

:

a sweet spot in a very specific area,

uh, to, to move innovation forward.

732

:

Yeah.

733

:

Harsha Rajasimha: Absolutely.

734

:

You know, we have a SBIR proposal due

with NIH fast track proposal, uh, the

735

:

Virginia Venture Partners, uh, have

a phase zero grant from VIPC, uh, to

736

:

submit these phase one, phase two SBIRs.

737

:

And, uh, inspired by the study at Mason,

um, we are actually proposing several

738

:

state and local governments to create

a database of, um, all citizens in,

739

:

say, um, the Commonwealth of Virginia.

740

:

If we can gather all the data and

centralize that and make that available

741

:

for biomedical research, that can be

a gold mine of data, uh, especially

742

:

over a period of 5, 10, 15 years.

743

:

Thank you.

744

:

Repository like that, right?

745

:

Uh, and then make it available to

the biotech industry to, to analyze,

746

:

draw insights from AI and machine

learning to identify what subset of

747

:

patients would need what, like even

healthy, uh, aging disease, right?

748

:

As people are naturally get

diagnosed with new conditions.

749

:

And there are similar programs

from NIH, the All of Us Research

750

:

Program or the Million Veterans

Program of the VA and others.

751

:

So I think there's a lot of

opportunity here to essentially Take

752

:

clinical research to every household

753

:

Tim Winkler: before we kind

of close on the main topic and

754

:

transition to our final segment.

755

:

Uh, any, any final words from you,

Larry, in terms of, you know, the,

756

:

the partnership, the experience you've

had and where you see the, the future

757

:

of, uh, this type of partnership

between Jeeva and George Mason.

758

:

Lawrence Cheskin: I think one of

the major benefits to partners,

759

:

uh, with Jiva is that it frees

up researchers and scientists and

760

:

clinicians from the sort of, and

you've all heard about, increasingly

761

:

practitioners spend more and more

time, you know, filling out paperwork.

762

:

And dotting the I's and crossing the

T's and justifying, you know, what

763

:

their decisions are and the sort of

services and platform that Jiva provides

764

:

enables me to focus on what, you know,

is maybe the highest use of my effort,

765

:

which is to create new knowledge.

766

:

And hopefully advance, uh, the

fields that I'm working in.

767

:

Tim Winkler: Yeah.

768

:

Well said, um,

769

:

Mike Gruen: Mike, did you have something

I didn't know if you were going to,

770

:

no, no, I was just thinking about

the, how much, like when you have, um,

771

:

the nice thing about startups, right.

772

:

They're usually very responsive to the

needs of a customer or client, especially

773

:

an early adopter, that type of stuff.

774

:

And if you can get that right

partnership, um, it's amazing what

775

:

the two can sort of achieve together.

776

:

Um, and just, you know, what Larry

is talking about, sort of, you know,

777

:

Rang true with my experience as well.

778

:

And so that's probably what you picked

up on was, um, because I think that is

779

:

a great, that's a great thing, right?

780

:

When you're, you want to focus on

delivering your service and you want to

781

:

find someone, you want to offload that and

working with a startup, if you were to try

782

:

and find like a big, large company or big

con, you know, whatever things get missed

783

:

and they're not really in it necessarily

for the, for the same reasons, there's

784

:

not that alignment of, um, purpose.

785

:

So it's always awesome to say.

786

:

Tim Winkler: Yeah, that's why I love

this format because you kind of hear

787

:

it, you kind of hear it firsthand.

788

:

So it's, that's cool.

789

:

Harsha Rajasimha: Yeah,

you're absolutely right.

790

:

It's been a valuable collaboration with

Larry in getting guidance as we were

791

:

building out early on as well and over

the years helped us mature and build all

792

:

the right features to save researchers

anywhere from 30 percent to 70 percent of

793

:

their time and effort and burden involved

in operational and logistical part of

794

:

clinical research so they can actually

focus more on science and medicine.

795

:

And that's, that's, that's been

our motto right from the beginning

796

:

is to save time and speed up the

process and drive efficiency.

797

:

Tim Winkler: Yeah, it's also

just a great entry point, right?

798

:

I think, um, you know, having that

case study under your belt and then

799

:

building on that and expanding into

XYZ universities along the East Coast.

800

:

You know, I think there's a.

801

:

A lot of opportunity there for a,

a startup to, um, yeah, to really

802

:

get their technology in the hands of

users that at scale, which is usually

803

:

a large struggle, uh, to begin with.

804

:

Harsha Rajasimha: It's, uh,

uh, it's an exciting time.

805

:

Tim, uh, you know, with, uh, a lot

of the ai, uh, investments going in

806

:

the drug discovery space, um, yeah.

807

:

Uh, there is, uh, more candidate

drugs being predicted by ai.

808

:

Then the ability to test them in

clinical trials and so, uh, efficient,

809

:

uh, AI driven software platforms for

clinical trial is going to be, uh, super

810

:

critical to get through the next wave

of drug candidates and novel therapies.

811

:

So we are excited to be where

we are, uh, especially in the

812

:

Commonwealth of Virginia, where.

813

:

We have a coordinated clinical

research network with 14 hospitals

814

:

in across the commonwealth connected.

815

:

So, um, I'm excited about our

collaboration with Mason and the

816

:

VCCRN to bring, attract more clinical

trials to the, this region as well.

817

:

Tim Winkler: Yeah, absolutely.

818

:

I mean, DMV is just a hotbed

for, for health tech and, uh,

819

:

you know, have so many large

government organizations here too.

820

:

To kind of help aid with some of that.

821

:

So, uh, good location to, to

build a health tech startup.

822

:

We've got a couple of upcoming episodes,

uh, specifically around like navigating

823

:

the, uh, compliance maze and, and, and

health tech, and then, um, you know, the

824

:

future of, of AI and healthcare as well.

825

:

So.

826

:

Um, this will be a good kind of kickoff

to, you know, a short mini series

827

:

and some of our health care episodes.

828

:

Um, excellent.

829

:

Well, I do want to make sure that we save

enough time here for the final segment,

830

:

which is the five second scramble.

831

:

So, uh, this is going to be just

a fun segment where we do a little

832

:

bit of a rapid fire Q and A.

833

:

Uh, we'll ask a little bit of business,

a little bit of personal, um, Mike, why

834

:

don't you lead us off with Larry and

then I'll get, uh, uh, get to Harsha.

835

:

Sounds good.

836

:

All

837

:

Mike Gruen: right.

838

:

And also, uh, the questions will

be different, so don't take notes.

839

:

Um, so yeah, so Larry, uh, what's

like one piece of advice you'd give

840

:

founders of health tech startups

we're looking for or working with?

841

:

Lawrence Cheskin: Um, I guess I would

tell them to listen, uh, because,

842

:

you know, most startups have a

product and a way of doing things.

843

:

And you know, the, the best advice

I can give is to, you know, make

844

:

sure that you're being responsive

to the needs of the client.

845

:

Mike Gruen: Um, Transcribed by

846

:

Lawrence Cheskin: https: otter.

847

:

ai

848

:

Mike Gruen: Um, what do you think is

the biggest challenge facing college

849

:students in:

850

:

Lawrence Cheskin: Biggest challenge facing

college students is the, the changing

851

:

economy and the changing skillset.

852

:

that you need to function in that economy.

853

:

Um, so, you know, when I graduated

from college, you, you majored in a

854

:

field, you, you, uh, studied up, you

learned it, and you went into a job

855

:

where you were in a place and you had a

boss and, uh, you showed up every day.

856

:

And now there's virtual work, there

is AI that can potentially replace or

857

:

supplement much of what you're doing.

858

:

And you need to really understand what

the new landscape is like and adapt.

859

:

Harsha Rajasimha: Yeah, if you are in the

junior or senior year this year, then you

860

:

have a very difficult choice of whom to

vote in the presidential election as well.

861

:

Mike Gruen: That's

862

:

Tim Winkler: a

863

:

Mike Gruen: challenge.

864

:

What's the biggest challenge

facing college educators in:

865

:

Lawrence Cheskin: I would say that

866

:

working with a very diverse group

of students who have had all sorts

867

:

of experiences and all sorts of,

uh, inclinations can be very, uh,

868

:

challenging and exciting at the same time.

869

:

Awesome.

870

:

George Mason is a perfect example of

the diversity, uh, uh, uh, factor.

871

:

Mike Gruen: Um, don't doubt it.

872

:

Um.

873

:

Uh, what's the best piece of

advice you've ever been given?

874

:

Lawrence Cheskin: Follow your instincts.

875

:

Mike Gruen: Uh, what's a book you

think every entrepreneur should read?

876

:

Lawrence Cheskin: I don't know.

877

:

I've never read any entrepreneurial books.

878

:

Mike Gruen: Awesome.

879

:

I love it.

880

:

That's the, uh, that's a great answer.

881

:

Great question, Mike.

882

:

What was that?

883

:

Great question, Mike.

884

:

You know.

885

:

Ask Harsha that one.

886

:

I mean, you never know.

887

:

Um,

888

:

they can't all be winners.

889

:

All right.

890

:

So, uh, what was your

favorite cereal as a kid?

891

:

Lawrence Cheskin: Uh,

892

:

Cheerios.

893

:

I like the name.

894

:

I like the taste.

895

:

And I learned recently,

it's got some oat fiber.

896

:

Mike Gruen: You do anything with

them or just plain with milk?

897

:

Lawrence Cheskin: Can I just

play with him in the milk?

898

:

Mike Gruen: Uh, I used to at

least put some sugar on there,

899

:

uh, when I was little, um,

900

:

Lawrence Cheskin: I wasn't allowed to,

901

:

Mike Gruen: um, what's the, uh,

largest land animal you think

902

:

you could take in a street fight?

903

:

Lawrence Cheskin: Hmm.

904

:

I think probably a, uh, a

sheep who would be pushing it

905

:

on our farm and they like to headbutt.

906

:

Yeah.

907

:

So if you're alert though, and you see it

coming, you can probably, uh, defeat them.

908

:

Uh, but if you turn your

back, you're in deep trouble.

909

:

Mike Gruen: Nice.

910

:

Um.

911

:

Hmm.

912

:

Hmm.

913

:

What's the most, uh, what's one

piece of outdated technology

914

:

you can't live without?

915

:

Lawrence Cheskin: I don't use my

protractor anymore or my slide roll.

916

:

Um, so, um, outdated.

917

:

Mike Gruen: That you

just can't live without.

918

:

I still have a

919

:

Lawrence Cheskin: VCR.

920

:

All right.

921

:

I've got a whole collection of tapes.

922

:

I don't play him that often, but

I don't want to get part with him.

923

:

Yeah, that's a

924

:

Mike Gruen: great answer.

925

:

That is actually my son and

I were just talking about, he

926

:

was asking if we had a VCR.

927

:

I can't remember why.

928

:

And I was like, no, we don't.

929

:

Tim Winkler: Yeah, we've got one

just to watch old family videos,

930

:

you know, old holiday gatherings.

931

:

Lawrence Cheskin: But I did get

rid of the beta Mac some years ago.

932

:

Mike Gruen: Oh,

933

:

Lawrence Cheskin: nice.

934

:

Good for you.

935

:

You guys don't even know what that is.

936

:

Probably

937

:

Mike Gruen: my family is

one of the first ones.

938

:

We had a beta and then we went to VHS.

939

:

I'm older than I look.

940

:

Um, and my dad's in TV.

941

:

Um, so, uh, what's the charity

or, uh, corporate philanthropy

942

:

that's, uh, near and dear to you?

943

:

Lawrence Cheskin: The Burley

Manor Animal Sanctuary.

944

:

Not that I have any vested

interest in this, but www.

945

:

burleymanorretreat.

946

:

org, that's, that's our farm.

947

:

Yes, I picked up on it.

948

:

Mike Gruen: Awesome.

949

:

Um, last question.

950

:

If you could live in any fictional

universe, which one would you choose?

951

:

Lawrence Cheskin: Hmm.

952

:

This is going to date me

also, but the Jetsons.

953

:

Nice.

954

:

Nice.

955

:

One of my favorite shows

when I was a young kid.

956

:

Really good.

957

:

Mike Gruen: Any particular reason?

958

:

Lawrence Cheskin: Cause I always liked

science fiction and flying around.

959

:

Nice.

960

:

Yeah.

961

:

Where's my flying car?

962

:

Tim Winkler: Yeah.

963

:

I was going to say Star Trek

could have been, uh, another

964

:

one after our intro calls.

965

:

All right.

966

:

Thank you much.

967

:

Good stuff.

968

:

All right, Harsh.

969

:

You ready?

970

:

Yes.

971

:

All right.

972

:

Uh, describe the culture

at Jiva clinical trials.

973

:

Harsha Rajasimha: So we have a culture

of, uh, uh, get it done and do it right.

974

:

Um, I, and, uh, essentially that's what

helped us in, um, saving time, being

975

:

efficient ourselves internally, because

we are trying in the business of helping

976

:

clinical researchers be more efficient.

977

:

And we got to achieve a lot, uh,

with very little resources in house.

978

:

And so, uh, just getting it done

is not enough, but doing it right

979

:

in, in terms of using less of other

people's time and other resources,

980

:

that's, I would say one of the five

parts of our culture, but that's the

981

:

80 percent of the culture as well.

982

:

Tim Winkler: That's cool.

983

:

What kind of technologist

thrives at Jeeva?

984

:

Harsha Rajasimha: Um, someone who, uh,

thinks, uh, who comes with, uh, ideas and

985

:

understanding of the specific problems

we are trying to solve and who aligns

986

:

with the mission of the organization.

987

:

You know, uh, we are not just

another tech company, um, out

988

:

there to build a me to solution.

989

:

Uh, we are here to change the

world and so someone who comes

990

:

with that, uh, mindset, uh, who has

motivations and that align with our

991

:

mission, uh, to make a difference.

992

:

I think, uh, irrespective of whether it's

technologist or, uh, business development

993

:

or clinical researcher manager.

994

:

Any role, uh, that's very

key is a mission alignment.

995

:

Tim Winkler: Speaking of the

roles, what, what kind of

996

:

tech roles are you hiring for?

997

:

Harsha Rajasimha: Uh, data

scientist and AI ML will be, uh,

998

:

top for next, uh, 12 to 18 months.

999

:

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.

::

Tim Winkler: Describe

your morning routine.

::

Harsha Rajasimha: 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,

::

Tim Winkler: 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?

::

Harsha Rajasimha: 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.

::

Tim Winkler: What is your

favorite app on your phone?

::

LinkedIn.

::

Nice.

::

What's a charity or corporate

philanthropy that's near and dear to you?

::

Harsha Rajasimha: 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.

::

Tim Winkler: 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,

::

Harsha Rajasimha: uh, Bill Gates?

::

Tim Winkler: Nice.

::

Yeah.

::

What is the worst fashion trend

that you've ever followed?

::

Harsha Rajasimha: 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

::

Tim Winkler: have to get

::

Harsha Rajasimha: 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.

::

Tim Winkler: Okay.

::

We're, we're looking this

up right after we wrap.

::

Harsha Rajasimha: You can Google Lungi

dance, L U N G I dance and you'll find it.

::

Tim Winkler: Awesome.

::

Okay.

::

Uh, and the last question, what

was your dream job as a kid?

::

Harsha Rajasimha: Um, to

be a ticket collector.

::

A ticket collector on a train, so I

could travel all around the country.

::

A

::

Tim Winkler: 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.

::

Lawrence Cheskin: Some great questions.

::

Tim Winkler: Appreciate it.

::

Thank you all.

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