Episode 129

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Published on:

5th Nov 2024

Spaulding Clinical with Cassandra Erato

This week, I'm joined by Cassandra Erato, the CEO of Spaulding Clinical. Cassie joins to talk about the vital role clinical research plays in advancing medicine. Spaulding Clinical specializes in phase one testing of new drug products before they move on to later stages of testing. Cassie talks about the impact of their research, including a significant study related to the opioid epidemic. We also touch on Spaulding Clinical's commitment to community involvement and supporting the next generation of healthcare professionals.


Links referenced in this episode:

Transcript
Fuzz Martin:

Hello, Washington County.

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Thank you for tuning in to

Fifteen Minutes with Fuzz.

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I am your host, Fuzz Martin, and this is

a show about positive things happening in

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and around Washington County, Wisconsin.

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And you know what?

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Every four years, we could use a little

extra positivity between neighbors, right?

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Thanks.

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Right.

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Especially today.

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So, uh, thanks for pulling this

show up on your podcast, player.

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I appreciate you, neighbor.

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This week, I am joined by Cassandra

Erato, the CEO of Spaulding Clinical.

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Spaulding Clinical is a clinical

research facility located right

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here in West Bend in the former St.

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Joe's Hospital facility, and not enough

people know exactly what they do there.

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And It's some pretty important work,

so let's all learn about it together.

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With that, here are 15

minutes on Spaulding Clinical.

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With Cassie Erato on

Fifteen Minutes with Fuzz.

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Cassie, thanks so much for joining me

today on Fifteen Minutes with Fuzz.

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For those who are listening who

might not be familiar with Spaulding

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Clinical, can you give us a high

level overview of Spaulding Clinical?

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What your organization does and

the role that clinical research

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plays in advancing medicine.

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Cassandra Erato: Yes, so every new

drug product that needs to come to the

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market in the United States or globally

needs to go through three phases of

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testing, Phase 1, 2, and 3, to determine

if the drug is safe and effective

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and how it's absorbed in the body.

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And we do phase one testing, so that's all

in, normal healthy volunteers, although

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we do a little bit in later phase, but,

that's basically in healthy volunteers

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to determine if the drug is safe and

how it's absorbed in the body before it

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moves on to the next phases of testing.

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Fuzz Martin: So then once it's done

there, if it, if it passes, it goes

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on to the phase two and then phase

three, is that, and then eventually

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FDA approval or something like that.

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Is that how that works?

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Yes, exactly.

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Okay, very good.

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So what kinds of trials then

are done at Spaulding Clinic?

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How does that, it's all,

all medicine kind of things?

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Cassandra Erato: Yes, we

really see everything.

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So we're working with

primarily smaller biotechs.

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So we, our customers can be

pharmaceutical companies or biotechs.

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Because we're a smaller company, we

work really well with small biotechs.

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But it's every type of, therapeutic area.

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We work in infectious disease, in mental

health, CNS, in, really everything.

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The only thing we don't really touch

is oncology because you can't give

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that in normal healthy volunteers.

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Oh, sure.

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Fuzz Martin: Okay.

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Because radiation and things

like that a lot of times.

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Yeah.

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Okay.

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Very good.

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And, uh, I'm sure you have.

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You know, there's NDAs and confidentiality

and those kind of things, but are there

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any, organizations that you could mention

that maybe people might be familiar with

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that may have passed through Spaulding

Clinical here in, in Washington County?

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Cassandra Erato: Yes.

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So, I can talk about this one because

it's published in public papers, but,

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um, we work a lot with the Food and

Drug Administration, with the FDA.

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So they're not testing new drugs,

obviously, but they ask us to test

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products to inform their policy.

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So we've tested sunscreen

products for them to determine

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if it's absorbed into the blood.

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Opiates, a lot of different products.

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Fuzz Martin: Okay, very good.

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From a, a subject standpoint, so you,

again, you're looking for, you're in

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phase one, you're using healthy subjects.

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Can you walk us through a typical

trial, start to finish, you know,

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How does someone get signed up

to be a participant in the study?

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You know, do they stay at your facility?

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How long are they there?

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Those kind of things.

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Cassandra Erato: Yes.

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So, they would call into our recruiting

department to set up an appointment

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and the recruiter will go through their

medical history and make sure that

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they're healthy and can participate.

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Then they come in for a screening

appointment and that's about three hours.

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where we do a physical exam, medical

history, and just basically check that you

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meet all of the criteria for the study.

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Then you'll receive a phone

call within the next couple

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of weeks if you're accepted.

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You check into the trial.

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Trials can be anywhere from two

days to 20 days, and um, but

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a typical is about five days.

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You check into the unit, you go through

that whole screening process again

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to make sure you're still healthy,

still qualify, and We check all of the

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luggage coming in to make sure there's

no food or drug products coming in.

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And then you check into the study floor,

which is a former hospital facility.

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So it feels like you're staying

in a hospital, but a lot of people

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also say it feels like summer camp.

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So you're there with maybe 20 other

people, and then you go through each

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study day, stay there overnight,

and then check out at the end.

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Fuzz Martin: And these studies, I

assume, are all different types of

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people from young to old and, Yes.

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Different, you know, walks of life

and those kind of things, right?

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Mm hmm.

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Because you, you have to test

all kinds of different drugs

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and those kind of things, right?

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Cassandra Erato: Yes.

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It's typically 18 to 55 years old.

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Okay.

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Although we're recruiting

55 to 85 right now.

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And, It's all ethnic backgrounds, and

we also have, we have college students,

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we have people in their 40s who are

doing it as additional income, we have

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a ton of Etsy businesses, college

students, huge variety of people.

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Fuzz Martin: And do people come in

from all around for this, or are they

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mostly here in southeastern Wisconsin?

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Cassandra Erato: If it's a

longer trial, we see people

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from all over the United States.

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If it's a quick, short two days and

they need to come back frequently,

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then it's around the Milwaukee area.

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Fuzz Martin: Very good.

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After the trial is over, do

the participants ever see the

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results of the study, or are

they just, mostly Not typically.

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Yeah,

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Cassandra Erato: don't know.

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Sometimes if there's a paper

published, they'll know.

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Fuzz Martin: Sure.

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Okay.

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Do you have any kind of clinical success

stories that you can talk about, maybe

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share, over the years of how clinical

research through Spaulding Clinical has

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helped advance medicine and healthcare?

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You know, the things that have

happened here in West Bend, Wisconsin

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have helped kind of globally or

nationally, the healthcare industry?

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Cassandra Erato: Yeah, I mean, there's

a lot of them, but I'll talk about one

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from recently about three years ago.

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We did a trial for the FDA They are

with the opiate epidemic in the United

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States They were looking at if you're

giving opiates with an antidepressant

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or with an antipsychotic Does that

increase the chance of overdose or

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respiratory depression and we found

that it did with Antidepressants, so

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if a random college student is on an

antidepressant and somebody at a party

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hands them an opiate, they should know

they're at a greater risk of death.

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So, and there was a, JAMA

article published on that.

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So, incredible study.

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Fuzz Martin: Very good.

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So, Spaulding Clinical has

been around since:

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Your organization is very prominent in

the community and known for giving back.

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What are some of the organizations

and programs that Spaulding

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Clinical supports in our community?

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Cassandra Erato: We're really

centrally we work with the United

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Way and support United Way and for a

long time, Randy Spaulding has been,

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ahead of a campaign year, but really

throughout the year we're holding

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constant fundraisers to support United

Way because they have so many amazing

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programs that support the community.

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Fuzz Martin: Very good.

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You've been with Spaulding for a while.

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17 years, is that right?

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Yes.

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So you started as a clinical

research coordinator.

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I wrote these all down so you know.

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I didn't memorize these.

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You were a nurse practitioner, director of

clinical operations, the chief operating

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officer, and then in 2020 became CEO.

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So you've been, you've seen

every aspect of the business.

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What have been some of your most

Rewarding experiences along that journey.

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Cassandra Erato: Absolutely central

to that is the most difficult times.

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So all our most challenging

times have made me grow so

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much individually as a person.

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Beyond that, we had a.

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Since we were founded, we have a really

large cardiac safety component where we're

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passionate about long QT syndrome and the

people that, you know, random high school

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student that dies on the basketball court

because they didn't know they had that.

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So we have a medical device that

detects that, but recently we did

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a trial for a drug to treat that

and it actually showed promise.

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So that was extremely rewarding

to see that come to fruition.

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And last, you know, in our earliest

days when we were first starting

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the company, we were there, there

was nine of us and we were there

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around the clock and I had babies.

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I had two infants at home and, we

were able to set up a, a daycare

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facility in the building so that

I could see them and be with them.

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And that was an awesome part.

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It was before we had customers,

but we were just, I would

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be there during the day.

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My husband would stay all night.

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So, that was a very

rewarding part of the job.

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Fuzz Martin: So, now, as CEO, what are

some of the values or guiding principles

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that drive the way that you and your

team, work at Spaulding Clinical?

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Cassandra Erato: Well, we have four

values that we were founded based on.

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They were heroic ambitions,

ingenious solutions, self

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awareness, and loving care.

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But one that's dear to me is

self awareness, and it's just

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about knowing yourself, knowing

your strengths and weaknesses.

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And I try to, I strive for that every

day, and I'm human, I make mistakes, but

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in all of the teams, it's about putting

aside your own ego and knowing, doing

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what's the greater good for the company.

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Fuzz Martin: And then speaking

of work, you have a wide range

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of careers at Spaulding Clinical.

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You need nurses, pharmacists,

doctors, phlebotomists, paramedics,

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and on and on, people working in

management and those kind of things.

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What's your approach to creating a

workplace that supports, professional

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growth, a sense of community, and,

and, and like in your growth, I

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mean, you, you started, and, and

grew your career over 17 years.

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How do you, how do you support that?

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Cassandra Erato: So clinical research

is extremely challenging, and a lot

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of people don't know what it's like.

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So we operate what's like a small

hospital and we're recruiting

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people who are coming from local

hospitals and healthcare facilities.

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But when they come into clinical

research, it's so different.

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So we're trying to coach people on what

that's like before we're hiring them.

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But sometimes you just don't know,

drawing blood in a hospital is very

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different than having to collect it on the

second for 20 people in a row and under

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a high pressure situation with a bunch

of people watching over your shoulder,

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sometimes a pharmaceutical sponsor.

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So but once people get through

that first year and realize it is

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for them, it's not for everybody.

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Once they get through that, there's

tremendous growth opportunity.

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And we have a lot of people there

for a long time that really enjoy it.

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Also, we're a family business, and

we try to create that environment.

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And, that's what our employees have said

for so long, that it feels like a family.

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It feels like that community.

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Fuzz Martin: You said you, you had started

with, what was it, nine, nine employees?

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Mm hmm.

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And what are you at now?

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What's

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Cassandra Erato: About 200.

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Fuzz Martin: About 200, wow, okay.

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And, um, how do you invest in

training and kind of supporting that?

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Well, I mean, even It's, there's

a lot of talk about the need

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for healthcare professionals.

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How do you support that next

generation of medical professionals

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here in Washington County?

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Cassandra Erato: Yeah, so we do a lot

of work with the local high schools.

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With Slinger, West Bend, Kewaskum.

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We've had them tour through the facility.

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I just talked to an AP

psych class yesterday.

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It's giving them that exposure to research

because so many of us at Spaulding say,

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you know, when I was in nursing school,

we didn't hear anything about this.

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West So it's giving them exposure

to know that this world exists.

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And then, , the technical college, we

have a pharmacy program with Concordia.

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We're always trying to

expose to our world.

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And then once you're in the door and the

opportunity for career growth within this

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industry is tremendous because there's

only 70 sites like ours in the world.

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Once you get through.

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You know, that initial shock of

the research environment, but then

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you start putting the work in.

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You can go from being a tech

at entry level to charge

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staff to then a study manager.

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And study manager life is really,

really difficult, but if you put

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four or five years in on that, you

now have a world opened up to you

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that is incredible for advancement.

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We've had so many people come through

in the study manager position.

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And are now working across the

country and in clinical research.

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Fuzz Martin: Great.

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Looking into the future for Spaulding

Clinical, what do you, what are

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some of your goals for the company?

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Cassandra Erato: Well, when Randy

Spaulding founded the company, it was

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based on being technology advanced

and using that to allow good drug,

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better drugs to come to market.

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So when these small biotech companies

have limited funds, How do we use that

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technology to help them get their results

faster so they don't run out of money

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before they get the drug to that point?

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And we have largely accomplished

that, but we want to expand it.

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So we're this small company

in West Bend, Wisconsin.

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We need to really spread the word in the

industry of who we are, and that takes a

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lot of marketing dollars and sales effort.

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So we're putting a lot into that.

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But second is to continue

to expand that technology.

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We have.

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The world of AI coming in right now.

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And a lot of our industry doesn't

know how to deal with new tech

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because we're slow and regulated,

but we're experienced with that.

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So we're really, investing

a lot in that right now.

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Fuzz Martin: Sure.

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Wrapping up, if somebody wants to

learn more about first working with

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Spaulding Clinical, what, what would

be the best way for them to, to reach

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out or to find out more about them?

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Cassandra Erato: They would

go to Spauldingclinical.

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com and there's a jobs, careers page.

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Submit your resume there, but I

highly recommend putting in a email

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or a cover letter talking about

why you're interested in research.

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Fuzz Martin: Very good.

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And then if somebody wants to

test the waters with perhaps

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becoming a, uh, a subject, I,

I don't know what to call them.

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Is that a subject?

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Is that participant?

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Participant, there you go.

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What is the, the best method

for them to go about them?

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Cassandra Erato: They

would go to SpauldingPays.

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com.

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Fuzz Martin: Okay, SpauldingPays.

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com.

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All right, very good.

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Well, Cassie, thanks

so much for coming in.

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And, it's great to have you and learn

more about Spaulding Clinical because I

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drive past it all the time and I know,

I knew very little but now I feel like

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I, I know a lot more and I, I appreciate

you, uh, Shedding some light for us.

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Thank you.

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Cassandra Erato: Yes.

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Thank you so much for having me.

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Fuzz Martin: Thank you again to

Cassandra Erato of Spaulding Clinical

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for joining me on this week's

episode of Fifteen Minutes with Fuzz.

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As always, if you ever have

an idea for the show, it's

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real easy to suggest it to me.

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The first way is to go to my

Suggest a Guest form on my website.

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Simply go to fuzzmartin.

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com slash guest, And fill in the form.

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It's fuzzmartin.

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com slash guest, or you can just

email me fuzz at fuzzmartin.

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com.

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That is fuzz at fuzzmartin.

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com.

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New episodes come out on Tuesdays.

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The show's available wherever

you're listening right now, as

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well as on Apple podcasts, Spotify,

YouTube, and at fuzzmartin.

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com.

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Or, you know, a host of other podcast

players too numerous to mention.

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Thanks again for listening and I will

talk to you again next week right

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here on Fifteen Minutes with Fuzz.

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About the Podcast

Fifteen Minutes with Fuzz
Showcasing the positive things happening in Washington County, Wisconsin.
Fifteen Minutes with Fuzz showcases positive people, events, and organizations in and around Washington County, Wisconsin, with host, Fuzz Martin. Fuzz is a local business owner (EPIC Creative) and a former radio personality (92.5 WBWI - now Buzz Country). New episodes launch on Tuesday mornings. https://fuzzmartin.com

Whether you're in West Bend, Kewaskum, Slinger, Hartford, Germantown, Richfield, Jackson, or anywhere else in the area, 15 Minutes with Fuzz serves the community with fun and positive people, places, events, and attractions.

About your host

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Fuzz Martin

Fuzz Martin is a partner and Chief Strategy Officer at EPIC Creative in West Bend, Wis.