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November 5, 2024 • 15 mins

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.


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Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Fuzz Martin (00:09):
Hello, Washington County.
Thank you for tuning in toFifteen Minutes with Fuzz.
I am your host, Fuzz Martin, and this isa show about positive things happening in
and around Washington County, Wisconsin.
And you know what?
Every four years, we could use a littleextra positivity between neighbors, right?
Thanks.
Right.

(00:29):
Especially today.
So, uh, thanks for pulling thisshow up on your podcast, player.
I appreciate you, neighbor.
This week, I am joined by CassandraErato, the CEO of Spaulding Clinical.
Spaulding Clinical is a clinicalresearch facility located right
here in West Bend in the former St.
Joe's Hospital facility, and not enoughpeople know exactly what they do there.

(00:53):
And It's some pretty important work,so let's all learn about it together.
With that, here are 15minutes on Spaulding Clinical.
With Cassie Erato onFifteen Minutes with Fuzz.

(01:14):
Cassie, thanks so much for joining metoday on Fifteen Minutes with Fuzz.
For those who are listening whomight not be familiar with Spaulding
Clinical, can you give us a highlevel overview of Spaulding Clinical?
What your organization does andthe role that clinical research
plays in advancing medicine.

Cassandra Erato (01:34):
Yes, so every new drug product that needs to come to the
market in the United States or globallyneeds to go through three phases of
testing, Phase 1, 2, and 3, to determineif the drug is safe and effective
and how it's absorbed in the body.
And we do phase one testing, so that's allin, normal healthy volunteers, although

(01:55):
we do a little bit in later phase, but,that's basically in healthy volunteers
to determine if the drug is safe andhow it's absorbed in the body before it
moves on to the next phases of testing.

Fuzz Martin (02:09):
So then once it's done there, if it, if it passes, it goes
on to the phase two and then phasethree, is that, and then eventually
FDA approval or something like that.
Is that how that works?
Yes, exactly.
Okay, very good.
So what kinds of trials thenare done at Spaulding Clinic?
How does that, it's all,all medicine kind of things?

Cassandra Erato (02:27):
Yes, we really see everything.
So we're working withprimarily smaller biotechs.
So we, our customers can bepharmaceutical companies or biotechs.
Because we're a smaller company, wework really well with small biotechs.
But it's every type of, therapeutic area.
We work in infectious disease, in mentalhealth, CNS, in, really everything.

(02:51):
The only thing we don't really touchis oncology because you can't give
that in normal healthy volunteers.
Oh, sure.

Fuzz Martin (02:56):
Okay.
Because radiation and thingslike that a lot of times.
Yeah.
Okay.
Very good.
And, uh, I'm sure you have.
You know, there's NDAs and confidentialityand those kind of things, but are there
any, organizations that you could mentionthat maybe people might be familiar with
that may have passed through SpauldingClinical here in, in Washington County?

Cassandra Erato (03:13):
Yes.
So, I can talk about this one becauseit's published in public papers, but,
um, we work a lot with the Food andDrug Administration, with the FDA.
So they're not testing new drugs,obviously, but they ask us to test
products to inform their policy.
So we've tested sunscreenproducts for them to determine
if it's absorbed into the blood.

(03:33):
Opiates, a lot of different products.

Fuzz Martin (03:35):
Okay, very good.
From a, a subject standpoint, so you,again, you're looking for, you're in
phase one, you're using healthy subjects.
Can you walk us through a typicaltrial, start to finish, you know,
How does someone get signed upto be a participant in the study?
You know, do they stay at your facility?
How long are they there?
Those kind of things.

Cassandra Erato (03:54):
Yes.
So, they would call into our recruitingdepartment to set up an appointment
and the recruiter will go through theirmedical history and make sure that
they're healthy and can participate.
Then they come in for a screeningappointment and that's about three hours.
where we do a physical exam, medicalhistory, and just basically check that you
meet all of the criteria for the study.
Then you'll receive a phonecall within the next couple

(04:16):
of weeks if you're accepted.
You check into the trial.
Trials can be anywhere from twodays to 20 days, and um, but
a typical is about five days.
You check into the unit, you go throughthat whole screening process again
to make sure you're still healthy,still qualify, and We check all of the
luggage coming in to make sure there'sno food or drug products coming in.

(04:40):
And then you check into the study floor,which is a former hospital facility.
So it feels like you're stayingin a hospital, but a lot of people
also say it feels like summer camp.
So you're there with maybe 20 otherpeople, and then you go through each
study day, stay there overnight,and then check out at the end.

Fuzz Martin (04:58):
And these studies, I assume, are all different types of
people from young to old and, Yes.
Different, you know, walks of lifeand those kind of things, right?
Mm hmm.
Because you, you have to testall kinds of different drugs
and those kind of things, right?

Cassandra Erato (05:13):
Yes.
It's typically 18 to 55 years old.
Okay.
Although we're recruiting55 to 85 right now.
And, It's all ethnic backgrounds, andwe also have, we have college students,
we have people in their 40s who aredoing it as additional income, we have
a ton of Etsy businesses, collegestudents, huge variety of people.

Fuzz Martin (05:33):
And do people come in from all around for this, or are they
mostly here in southeastern Wisconsin?

Cassandra Erato (05:37):
If it's a longer trial, we see people
from all over the United States.
If it's a quick, short two days andthey need to come back frequently,
then it's around the Milwaukee area.

Fuzz Martin (05:46):
Very good.
After the trial is over, dothe participants ever see the
results of the study, or arethey just, mostly Not typically.
Yeah,

Cassandra Erato (05:56):
don't know.
Sometimes if there's a paperpublished, they'll know.

Fuzz Martin (05:59):
Sure.
Okay.
Do you have any kind of clinical successstories that you can talk about, maybe
share, over the years of how clinicalresearch through Spaulding Clinical has
helped advance medicine and healthcare?
You know, the things that havehappened here in West Bend, Wisconsin
have helped kind of globally ornationally, the healthcare industry?

Cassandra Erato (06:21):
Yeah, I mean, there's a lot of them, but I'll talk about one
from recently about three years ago.
We did a trial for the FDA They arewith the opiate epidemic in the United
States They were looking at if you'regiving opiates with an antidepressant
or with an antipsychotic Does thatincrease the chance of overdose or
respiratory depression and we foundthat it did with Antidepressants, so

(06:47):
if a random college student is on anantidepressant and somebody at a party
hands them an opiate, they should knowthey're at a greater risk of death.
So, and there was a, JAMAarticle published on that.
So, incredible study.

Fuzz Martin (07:01):
Very good.
So, Spaulding Clinical hasbeen around since 2007.
Your organization is very prominent inthe community and known for giving back.
What are some of the organizationsand programs that Spaulding
Clinical supports in our community?

Cassandra Erato (07:15):
We're really centrally we work with the United
Way and support United Way and for along time, Randy Spaulding has been,
ahead of a campaign year, but reallythroughout the year we're holding
constant fundraisers to support UnitedWay because they have so many amazing
programs that support the community.

Fuzz Martin (07:32):
Very good.
You've been with Spaulding for a while.
17 years, is that right?
Yes.
So you started as a clinicalresearch coordinator.
I wrote these all down so you know.
I didn't memorize these.
You were a nurse practitioner, director ofclinical operations, the chief operating
officer, and then in 2020 became CEO.
So you've been, you've seenevery aspect of the business.

(07:53):
What have been some of your mostRewarding experiences along that journey.

Cassandra Erato (07:59):
Absolutely central to that is the most difficult times.
So all our most challengingtimes have made me grow so
much individually as a person.
Beyond that, we had a.
Since we were founded, we have a reallylarge cardiac safety component where we're
passionate about long QT syndrome and thepeople that, you know, random high school

(08:20):
student that dies on the basketball courtbecause they didn't know they had that.
So we have a medical device thatdetects that, but recently we did
a trial for a drug to treat thatand it actually showed promise.
So that was extremely rewardingto see that come to fruition.
And last, you know, in our earliestdays when we were first starting
the company, we were there, therewas nine of us and we were there

(08:41):
around the clock and I had babies.
I had two infants at home and, wewere able to set up a, a daycare
facility in the building so thatI could see them and be with them.
And that was an awesome part.
It was before we had customers,but we were just, I would
be there during the day.
My husband would stay all night.
So, that was a veryrewarding part of the job.

Fuzz Martin (09:04):
So, now, as CEO, what are some of the values or guiding principles
that drive the way that you and yourteam, work at Spaulding Clinical?

Cassandra Erato (09:13):
Well, we have four values that we were founded based on.
They were heroic ambitions,ingenious solutions, self
awareness, and loving care.
But one that's dear to me isself awareness, and it's just
about knowing yourself, knowingyour strengths and weaknesses.
And I try to, I strive for that everyday, and I'm human, I make mistakes, but
in all of the teams, it's about puttingaside your own ego and knowing, doing

(09:37):
what's the greater good for the company.

Fuzz Martin (09:40):
And then speaking of work, you have a wide range
of careers at Spaulding Clinical.
You need nurses, pharmacists,doctors, phlebotomists, paramedics,
and on and on, people working inmanagement and those kind of things.
What's your approach to creating aworkplace that supports, professional
growth, a sense of community, and,and, and like in your growth, I

(10:01):
mean, you, you started, and, andgrew your career over 17 years.
How do you, how do you support that?

Cassandra Erato (10:07):
So clinical research is extremely challenging, and a lot
of people don't know what it's like.
So we operate what's like a smallhospital and we're recruiting
people who are coming from localhospitals and healthcare facilities.
But when they come into clinicalresearch, it's so different.
So we're trying to coach people on whatthat's like before we're hiring them.

(10:28):
But sometimes you just don't know,drawing blood in a hospital is very
different than having to collect it on thesecond for 20 people in a row and under
a high pressure situation with a bunchof people watching over your shoulder,
sometimes a pharmaceutical sponsor.
So but once people get throughthat first year and realize it is
for them, it's not for everybody.

(10:49):
Once they get through that, there'stremendous growth opportunity.
And we have a lot of people therefor a long time that really enjoy it.
Also, we're a family business, andwe try to create that environment.
And, that's what our employees have saidfor so long, that it feels like a family.
It feels like that community.

Fuzz Martin (11:09):
You said you, you had started with, what was it, nine, nine employees?
Mm hmm.
And what are you at now?
What's

Cassandra Erato (11:14):
About 200.

Fuzz Martin (11:15):
About 200, wow, okay.
And, um, how do you invest intraining and kind of supporting that?
Well, I mean, even It's, there'sa lot of talk about the need
for healthcare professionals.
How do you support that nextgeneration of medical professionals
here in Washington County?

Cassandra Erato (11:32):
Yeah, so we do a lot of work with the local high schools.
With Slinger, West Bend, Kewaskum.
We've had them tour through the facility.
I just talked to an APpsych class yesterday.
It's giving them that exposure to researchbecause so many of us at Spaulding say,
you know, when I was in nursing school,we didn't hear anything about this.
West So it's giving them exposureto know that this world exists.

(11:55):
And then, , the technical college, wehave a pharmacy program with Concordia.
We're always trying toexpose to our world.
And then once you're in the door and theopportunity for career growth within this
industry is tremendous because there'sonly 70 sites like ours in the world.
Once you get through.

(12:15):
You know, that initial shock ofthe research environment, but then
you start putting the work in.
You can go from being a techat entry level to charge
staff to then a study manager.
And study manager life is really,really difficult, but if you put
four or five years in on that, younow have a world opened up to you
that is incredible for advancement.
We've had so many people come throughin the study manager position.

(12:39):
And are now working across thecountry and in clinical research.

Fuzz Martin (12:43):
Great.
Looking into the future for SpauldingClinical, what do you, what are
some of your goals for the company?

Cassandra Erato (12:51):
Well, when Randy Spaulding founded the company, it was
based on being technology advancedand using that to allow good drug,
better drugs to come to market.
So when these small biotech companieshave limited funds, How do we use that
technology to help them get their resultsfaster so they don't run out of money
before they get the drug to that point?

(13:13):
And we have largely accomplishedthat, but we want to expand it.
So we're this small companyin West Bend, Wisconsin.
We need to really spread the word in theindustry of who we are, and that takes a
lot of marketing dollars and sales effort.
So we're putting a lot into that.
But second is to continueto expand that technology.

(13:34):
We have.
The world of AI coming in right now.
And a lot of our industry doesn'tknow how to deal with new tech
because we're slow and regulated,but we're experienced with that.
So we're really, investinga lot in that right now.

Fuzz Martin (13:47):
Sure.
Wrapping up, if somebody wants tolearn more about first working with
Spaulding Clinical, what, what wouldbe the best way for them to, to reach
out or to find out more about them?

Cassandra Erato (13:59):
They would go to Spauldingclinical.
com and there's a jobs, careers page.
Submit your resume there, but Ihighly recommend putting in a email
or a cover letter talking aboutwhy you're interested in research.

Fuzz Martin (14:10):
Very good.
And then if somebody wants totest the waters with perhaps
becoming a, uh, a subject, I,I don't know what to call them.
Is that a subject?
Is that participant?
Participant, there you go.
What is the, the best methodfor them to go about them?

Cassandra Erato (14:23):
They would go to SpauldingPays.
com.

Fuzz Martin (14:26):
Okay, SpauldingPays.
com.
All right, very good.
Well, Cassie, thanksso much for coming in.
And, it's great to have you and learnmore about Spaulding Clinical because I
drive past it all the time and I know,I knew very little but now I feel like
I, I know a lot more and I, I appreciateyou, uh, Shedding some light for us.
Thank you.

Cassandra Erato (14:42):
Yes.
Thank you so much for having me.

Fuzz Martin (14:46):
Thank you again to Cassandra Erato of Spaulding Clinical
for joining me on this week'sepisode of Fifteen Minutes with Fuzz.
As always, if you ever havean idea for the show, it's
real easy to suggest it to me.
The first way is to go to mySuggest a Guest form on my website.
Simply go to fuzzmartin.
com slash guest, And fill in the form.

(15:06):
It's fuzzmartin.
com slash guest, or you can justemail me fuzz at fuzzmartin.
com.
That is fuzz at fuzzmartin.
com.
New episodes come out on Tuesdays.
The show's available whereveryou're listening right now, as
well as on Apple podcasts, Spotify,YouTube, and at fuzzmartin.
com.
Or, you know, a host of other podcastplayers too numerous to mention.

(15:29):
Thanks again for listening and I willtalk to you again next week right
here on Fifteen Minutes with Fuzz.
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