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January 15, 2025 42 mins

Discover FRESH 3D bioprinting with Mike Graffio, CEO and co-founder of Fluoform3D. Having met at Carnegie Mellon University, Mike and Adam Feinberg have been on a mission to revolutionize the field of bioprinting, focusing on creating replacement tissues and organs without introducing foreign substances into the body. Mike shares the captivating journey from their engineering days in the 1990s through a pivotal 2015 conversation that transformed their research into a thriving startup and onto achieving significant milestones like developing living cardiac tissues and heart valves by 2018.

Our conversation uncovers the next frontier in 3D bioprinting, particularly the promising strides in islet cell replacement therapy for diabetes. You'll hear about how the FRESH bioprinitng propels this innovative field forward. With breakthroughs in small animal models showing potential for diabetes management, we explore how the team is gearing up for more extensive studies and human clinical trials. This episode also delves into their strategic fundraising efforts and partnerships to bring these advancements to life.

Summary:

• Overview of Fluoform3D and its founding story 
• Explanation of FRESH Technology and its significance in bioprinting 
• Current progress in cardiac applications and in vitro tissues 
• Ongoing projects related to therapeutic applications  for type I diabetes
• Insights into navigating funding and building investor relationships 
• Discussion on regulatory pathways and interactions with the FDA 
• Emphasis on company culture and team dynamics 
• Recommendations for industry insights and staying informed about bioprinting trends

Show Notes:

Instagram interview with Mike in 2021
Fluidform3D website
Breakthrough publication in 2019 made it to the cover of Science magazine-"FRESH 3D Printing Used to Rebuild Functional Components of the Human Heart"
YouTube Video: https://youtu.be/BJbReV0v7Co

 



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Transcript

Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Jenny Chen (00:01):
Today I had the pleasure of interviewing Mike
Graffio, ceo and co-founder ofFluoform3D, a 3D bioprinting
startup out of Carnegie MellonUniversity focusing on key
applications using freshtechnology also known as
freeform reversible embedding ofsuspended hydrogels.
I have always been impressedwith how Mike and his team

(00:23):
navigate the challenging task ofcommercializing life-changing
tissue engineering deep tech,and I hope this conversation can
serve to guide and motivatemore scientists and
entrepreneurs in this space.
Enjoy, all right, I think weare started.

(00:43):
Hey Mike, hey Jenny, I can'tbelieve you're in my office.

Mike Graffeo (00:47):
It's so good to be here.

Jenny Chen (00:48):
Thank you for having me.
I think we met like what 2018?

Mike Graffeo (00:54):
Yeah, late 18, early 19, something like that.

Jenny Chen (00:56):
Yeah, so time flies.

Mike Graffeo (00:59):
It's hard to believe it's been almost six
years.

Jenny Chen (01:01):
Most marriages already ended by now and you're
still the ceo of flipform 3d,which is incredible, because I
know it's an adventure for youand, uh, I think why don't we
just start with that?
That you're.
I know we did a.
We did an interview with mike acouple years back and at that
time you actually had a giantspeaker, a beaker with a big

(01:27):
heart printed in the beaker.
So, yeah, if people wereinterested, we can include a
link in the notes to see whatthat does look like.
But why don't you share with usyour founding story?

Mike Graffeo (01:39):
Sure, yeah.
So the story actually starts along time ago my co-founder,
adam Feinberg, at CarnegieMellon.
He and I have known each othersince the 90s.
We were co-op engineerstogether as undergraduates and
we both sort of fell in lovewith this idea of how do we use
engineering to solve problemsaround the need for replacement

(02:03):
tissue organs, things like thatand it led us both down a path
that we've kind of been on eversince.
I spent my careercommercializing new technologies
in the life sciences devices,combination drug device products
, therapeutics and Adam went offto do his PhD, do his postdoc

(02:24):
at Harvard and then has been atCarnegie Mellon ever since.
At Carnegie Mellon they spent agood deal of time in the early
teens looking at the fieldaround 3D bioprinting and asking
the question what's it going totake to make this
translationally relevant?
How are we going to make 3Dbioprinting into something that

(02:44):
we could actually build,something that could treat a
condition inside of a human?
And they came to the conclusionthat they needed to develop a
new way of thinking aboutbioprinting.
What they needed to do wasfigure out how to do bioprinting
without introducing chemistriesthat don't exist inside the
body.
So you know a lot of work wentinto developing what became

(03:05):
Fresh 3D bioprinting and in 2018, you know they were ready to
start thinking about how do weturn this into a company, how do
we start doing this work atscale?
Adam and I had been in touch,so I met with him, met with the
postdocs and PhDs in his lab whobecame my co-founders, and we
spent a good deal of timeputting together a plan and

(03:29):
putting together how we thoughtit made sense to build out a
business, and we incorporatedthe company in 18.
We started working on firstgetting a license from Carnegie
Mellon and then raising moneyand getting things off the
ground, and that was really howit started.

Jenny Chen (03:43):
Do you still remember the first conversation
you had with Adam, when he firstsaid hey, mike, I got an idea
for a company?
Or did you approach him to say,hey, I think what you're
working on is worth.
You know a company as acommercialization idea.

Mike Graffeo (03:57):
Yeah, so there were two conversations.
I remember them both prettywell.
In 2015, I think it was, therewas a publication out of their
lab in Science Advances, andCarnegie Mellon did a lot of PR
around it, and it was sort ofthe first evidence that this new
bioprinting technology Freshactually worked.

(04:18):
And so I had reached out and Isimply said listen, this is the
coolest thing that I've everread about.
You know, remember that ifyou're ever thinking about
trying to start a company orwhatnot, you know, don't forget
you've got friends in industrylike I'd be happy to help.
And he wrote back and you knowthis is very Adam about this.
He wrote back and said listen,you know, appreciate it, excited

(04:39):
about it.
The technology is going to begreat, but it's not ready for
prime time yet.
We've got to do more work first,and it's a great, you know, you
let me know whenever it makessense In late 17,.
I was thinking about thatconversation.
I don't know why, but it justsort of popped into my head and
I had been having the thoughtprocess of whether I wanted to
keep working in, you know,larger companies.

(05:00):
At that time I was with amid-cap publicly traded company,
Insulate Corporation, where Iled business development, and I
was really missing my time atstartups.
I'd spent six years in startupsprior and I was starting to
think about whether there wassomething that made sense to do.
So I reached back out to Adamand I said you know, hey, I
remember it wasn't quite readyfor prime time, Would love to

(05:21):
get an update.
And he replied pretty quicklyand said how fast can you get
out to Pittsburgh?
I've got something I'd reallylike to show you, Nice.
And so what I saw?
I was out in Pittsburgh in Ithink it was January of 18.
And that was when you know,this was before the paper that
came out in science in 2019.
That was when we saw.
I saw for the first time thework that my co-founders have

(05:43):
been doing building was when wesaw.
I saw for the first time thework that my co-founders have
been doing building, you know,living beating cardiac tissue
that was recreating complexarrhythmias, and the ability to
build heart balance out ofcollagen, and all of the work
that ultimately became this, youknow, the most cited paper in
all of bioprinting.

Jenny Chen (05:57):
I get to see all of that a year and a half before
the rest of the world did I doagree that 2018 and 2019 are the
most exciting years, at leastfor bioprinting, because I
remember your paper gotpublished and I remember
Volumetric paper got publishedas well, both on the cover of
Science Magazine within monthsor whatever, which is quite
exciting.
You know, we really thoughtwe're going to have a beating

(06:20):
heart that's going to becompletely bioprinted.

Mike Graffeo (06:23):
back then, I mean it's still going to happen right
.

Jenny Chen (06:25):
So what's going on with the heart project for now?

Mike Graffeo (06:28):
So there's been some really exciting
developments in the cardiacspace, including some work that
we did at the company buildingin vitro cardiac tissue.
We're able to demonstrate thatwe can build tissue in the lab
that can pick up signals in theprocess of drug discovery that
really can't be picked up inexisting assays.
That's been really cool.
We've got a uh, we've got onecommercial partner with that

(06:50):
that is seeing some really greatresults.
So what we we really like thethe, the signal that we've
gotten out of the work thatwe've done in cardiac that we
can build highly differentiatedrelevant tissue in vitro.
But what's much more exciting,I think, is the work that's
being done in vivo and you knownow we can sort of talk about it
because Adam and team havefinally presented on it.

(07:13):
But there's been a consortiumof researchers using our
technology to develop apulsatile heart conduit for a
congenital heart disorder calledsingle ventricle disease and
they've made enormous progressand they've actually seen
extended in vivo results thatare really really compelling.

(07:35):
So basically, think aboutpicking up the function of the
right ventricle and pulsingblood, pumping blood out to the
pulmonary system, and this isjust published.

Jenny Chen (07:48):
So this is not even yet published, but just
presented for the first time,just about a month or two ago.
If there's any link, just sharewith us and I will add to the
notes and share what we saidyeah, happy to.
Now I think it will be lopsidedto talk about other applications
without going back to thefundamentals, which is what is
fresh technology.
I think I have a pretty goodidea.

(08:11):
I mean, we all have a good idea.
But for people who don't knowwhat it is, do you mind if we
just kind of verbalize what itis?

Mike Graffeo (08:17):
Absolutely so.
You know, the idea that cameabout and became the technology
the company's founded upon wasthe notion that, if you take
most of 3D bioprinting, the coreproblem that needed solving was
biology cells, proteins.
They don't behave like plasticwhen we deposit them, they don't

(08:39):
stay where we put them.

Jenny Chen (08:40):
Right.

Mike Graffeo (08:40):
And so most of the field has spent a lot of time
working on how do we modify theinks, how do we change the
chemistry, how do we veryrapidly fix those things?
And it's really limited thematerials we can work with and
it's made it so that you knowit's made some very cell
unfriendly environments.
It's made it very challengingto do bioprinting in the way
that we'd really like to.

(09:00):
We'd really like to.
So my co-founders spent the timeto figure out hey, what if we,
instead of 3D bioprinting bydepositing materials in open air
, what if we immobilize thosematerials inside of a gel?
And by doing that and the workthat it took to figure out what
kind of gel would work andmaking it a yield stress

(09:22):
material, so the gel would beself-healing but it could
release at a body temperature.
So it was all still sort ofphysiologically friendly.
What really became interestingwas there were three core
benefits of doing this sort ofinside of a gel printing Benefit
.
One was we could immobilizethose materials so they could
stay in place long enough to gothrough the native self-assembly

(09:43):
processes that all of biologyhas access to.
It just takes longer thancooling a plastic down.

Jenny Chen (09:49):
Yeah.

Mike Graffeo (09:50):
Number two is you know, we build those gels out of
a series of tiny little gelatinmicroparticles.
And so we can incorporate themicroparticles into the
filaments that are printed.
And that allows us to control alevel of surface porosity in
what we print that can't reallybe recreated any other way.
It allows us a level ofresolution that's much, much

(10:10):
smaller than the filaments thatwe print.
So I describe to people thinkabout, like the dimples on the
surface of a golf ball.
We can sort of tune how muchdimple or not we get that
patterning.
That porosity that we can buildallows us to control how much
cellular and vascularinfiltration happens when we
implant these things in the body, and so that's a level of

(10:32):
control that's really, reallyexciting.
And then the third thing iswe're able to build inside of an
environment that outside ofthose microparticles is
basically aqueous.
So we now have a directchemical interface with what
we're building.
It allows us to take advantageof not just pH-driven gelation
mechanisms but enzymatic andionic-driven mechanisms.

(10:54):
So we have a level of chemicalcontrol that means we can print
with a much broader palette ofbiomaterials, and we can do it
all leveraging the nativeself-assembly mechanism.
Now the thing that is, I think,the most powerful about this
technology I could talk aboutthis technology all day.

Jenny Chen (11:11):
I'm inviting you over.

Mike Graffeo (11:12):
I appreciate it.
Yeah, the thing that I'm mostexcited about and that I think
is really transformative in thisspace is it allows, it serves
as a really, really powerfulvascularization plaque.
So we have seen data the firstdata was published in Science in

(11:35):
2019, where we showed, you know, taking a small disc of
collagen and implanting thatsubcutaneously in the mouse when
you cast it, versus fresh printit with exactly the same
materials.
Otherwise, the casted materialsees no vascularization in vivo
whatsoever.
The fresh printed material seesextensive vascularization and
that's really driven by thatsort of porosity effect that we
talked about, but also thenative sort of chemical

(11:57):
self-assembly that happens.
So that becomes really excitingbecause vascularization has
been the biggest challenge inall of tissue engineering, writ
large not just in bioprintingbut everywhere.
So that's been sort of the coreunlock for what became our lead
program now.

Jenny Chen (12:14):
Do you remember NASA had a vascular challenge
program that award a milliondollars.

Mike Graffeo (12:20):
I do.

Jenny Chen (12:21):
Were you young enough to remember that, because
I know that's many years ago.

Mike Graffeo (12:24):
I was out at NASA Ames for one of the big meetings
that they had.
I remember it well.
In fact, I we I do reallybelieve that the vascularization
data that we have now has farsurpassed what was shown for
that yes, and is a lot moreclinically relevant.

(12:47):
So it's actually instead ofsort of solving for how do we
win the NASA challenge.
The team at Carnegie Mellonkept their heads down and said
how do we win the?
Let's make something that canactually be implanted in the
body.

Jenny Chen (13:00):
Absolutely.
I have you know I'm not reallyfollowing the masterization
aspect closely in the lastcouple of years, but I can tell
a lot of hard work has been putin that's not totally publicized
.
Now, speaking of publicizedfresh technologies, you and I
probably on LinkedIn a lot andyou can see a lot of videos that
looks just like fresh printvideos.

(13:20):
People are printing all kindsof stuff.
How do you differentiate that?
Because you know, are theyusing your technology or are
they having their own differentkind of fresh technology?
How should I approach thesenews or share or publications?

Mike Graffeo (13:43):
It's a great question At its core.
In the United States we live ina first-to-file IP environment
and the team at Carnegie Mellonwas the first to file.
There were a few other groupsthat had done some very similar
work and we're fortunate to bethe ones to whom the patent was
issued.
So we have the foundational IPon all of the embedded printing

(14:08):
inside of a gel type approaches.
So if you see anything thatlooks like 3D printing embedded
inside of a gel that'll bereleased later on, that's
effectively our IP.
Now there's a lot of groups inacademia that are doing that.
We love it.
We think it's fantastic.
It does nothing but sort ofpromote that.
This is the most widely adoptedand the most powerful and

(14:28):
useful 3D bioprinting techniquein the world.
The world and at some point, asthose applications that
researchers are developingelsewhere you know, intend to
move out of the lab and intocommercialization, we look
forward to working with them toeither facilitate us taking that
in or them taking a license outto fresh and making that
available.
I think there's far moreapplications than any one

(14:51):
company can develop themselveshere, given the power of the
platform.

Jenny Chen (14:54):
And you guys have the exclusive license rights to
the license we do.
Okay, that's fantastic.
Now San Francisco and Bostonare expensive cities to travel
to and you're not here to see me.
Obviously, you're here for theJP Morgan Conference, and why
don't you tell us what kind ofnews you brought to the

(15:14):
conference and what are some ofthe agenda on your schedule,
your calendar, next couple days?
You know what are you lookingforward to yeah.

Mike Graffeo (15:23):
so you know it starts about well about a year
and a half ago, where there wassome data that came out of the
lab at Carnegie Mellon and Adamslab that really showed some
compelling reasons to believethat we could build our first
therapeutic application.
They had done a ton of workwith the organization that at

(15:43):
the time was known as JDRF it'snow known as Breakthrough T1D
and that had been focused on theidea that in islet cell
replacement therapy, one of thebig challenges is how do we get
enough blood supply to theislets that we transplant.
And so when they saw the dataout of the science paper, they
said listen, is there any waythat we could work together to

(16:04):
identify how can we help bettervascularize islets using your
technology?
Based on the data that they saw, we spun up a therapeutic
program inside of fluid form.
That's now our biggest area offocus, and so for the last year
we've been developing all of thesmall animal data demonstrating
that we can build using ourfresh printing technology.

(16:24):
We can build an implant thathas islet cells, that has ECM
proteins, that is able to beimplanted subcutaneously, that
vizes rapidly and thatdemonstrates function.
So the data that we're here topromote we're really excited
about is our now it's almostfour months data where we take a
diabetes model of a mouse.

(16:44):
Take a mouse, we inducediabetes, we see blood sugar
levels go up reallysubstantially, really quickly,
and then we do our implant andwe see those blood sugar levels
come back down to normal andstay there now out for several
months.
So we've seen data that we'rereally excited about and we are
basically taking that now out tothe next level to move out of

(17:05):
the small animal models into thelarge animal models that will
be required to go to the FDA for, ultimately, a human trial.
So we're out here to sharethose data.
We're actually actively, youknow, raising our series A, and
so the course of the nextseveral days we've got meetings
with investors, with strategicpartners, some company
presentations, and reallyfocused on making sure that

(17:26):
we've got the ability to go anddo these large animal studies.

Jenny Chen (17:30):
And you allow me to tell people how much you're
raising.

Mike Graffeo (17:33):
Of course, yeah, okay.

Jenny Chen (17:34):
So yeah, studies, and you allow me to tell people
how much you're raising, ofcourse, yeah, okay.
So yeah, if, guys, you have $25million time to write to Mike,
that's the best type offundraising Just one check and
done with it.

Mike Graffeo (17:44):
Well, you know, as fundraising is never an easy
process and it's about finding,you know, both the capital that
you need, but it's also aboutfinding the kind of partnership
that you need for a long haul.
These are these are reallysignificant endeavors, right To
get to the stage of doing humanclinicals and then to take it
out to the market and ultimatelytry to cure disease for a lot
of patients.
So what you're looking for is alike-minded group of people who

(18:04):
believe in the mission, believein the value and really want to
help in any way that they can.

Jenny Chen (18:10):
Now your ideal profile of investor.
Would this be a corporate VCfrom a large company, a pharma
company, or it could be just anykind of traditional VC?
What is your ideal profile atthe moment?

Mike Graffeo (18:31):
So it's a good question.
So it's a good question.
The way I think about it isthere's really three categories
of investor type four categoriesof investor types who have
active interest in this kind ofspace.

Jenny Chen (18:42):
Yeah.

Mike Graffeo (18:43):
You described.
There's the corporate VCs whohave an interest in type one in
general, so that's one discretecategory.
There's the classic biotech VCsthat also make sense.
There's what I would call thesort of biology adjacent tech
VCs and then, last but not least, there are, you know, family
offices and individuals who,where diabetes has been a big

(19:03):
part of their life and it's animportant area to them.
For us, you know, I wouldn'tsay we have a preference of one
over the other or an ideal.
What we're really focused on isfinding the right people who
share our vision that asubcutaneous treatment that is
minimally invasive, is easilyretrievable and is highly

(19:24):
engrafted, so it's viable andit's durable, that that's the
thing that actually opens uptreatment to the millions of
people with type 1 around theworld.
So for us, that's the realcredit, it's that
like-mindedness around themission, because I think listen,
it's a startup, every startuphits difficult days and you know
that that shared missionmatters when you're trying to

(19:46):
solve problems like that.

Jenny Chen (19:48):
Yeah, well, now going back to this other new
technology that you guys have,we actually chatted a little bit
before this podcast that thereare a couple competitors out
there, potentially and when, infact, probably already
commercializing.
Would you like to elaborate onthis a little bit so we have a
general understanding what thespace is like?

Mike Graffeo (20:07):
of course, yeah.
So you know, in this spacetoday there are, I would say, a
few different approaches that goback, some as far back as 30
years ago.
So there's a commercial productthat was approved by the FDA
about a year ago by a companycalled Cell Trans, the Lantedra
product, and that's a humancadaver donor islets that are

(20:29):
infused into the portal vein andpatients who get that therapy,
they need to be on systemicimmune suppression for the rest
of their life.
It's a great option for patientswho have very, very poorly
controlled diabetes or maybepatients who are already on
immune suppression for anotherreason.
The majority of people withtype 1 would not make the trade

(20:50):
to say, listen, I'll give up myimmunity for the ability to no
longer have to take insulinshots.
So that, as a treatment, is abig step in the right direction,
but it's not enough.
There's other groups out there.
Vertex made a very big splashin the space a few years ago
buying sematherapeutics, andthey're definitely the most

(21:13):
advanced of kind of the next genof therapies.
They've got a terrificportfolio of ip around the
induced pluripotent stem cellsand you know getting those to
behave uh, in an islet likefashion, and so now they're in
the clinic in what was justannounced that they had done a
phase one, two and they've nowconverted that into a phase one,
two, three with another cohort,and so this is a really

(21:36):
exciting development because,unlike the Lantigera product,
that product will be stem cellderived, so there's no
limitation on the sourcing of it.
There's no you know there's noonly you can only treat so many
patients.
It'll be a much more kind ofbroadly available treatment, but
that still requires systemicimmune suppression, more kind of
broadly available treatment,but that still requires systemic

(21:57):
immune suppression.
Then there's a couple ofcategories of programs behind
that, including the programsthat are centered around what
I'll kind of call broadly, youknow, a encapsulation-based
approach.

Jenny Chen (22:09):
I definitely have seen that before.
One of them is actually in theBay Area.
I forgot the name.

Mike Graffeo (22:13):
Yeah, so there's a few different people have been
working on encapsulation for 20,25 years now.
Uh, going back to the originalislet cell transplant work where
they realized, boy, if we can'tprotect this from the immune
system, it doesn't matter whatwe transplant, right?
So encapsulation, you know,these are groups like the what
was formerly sigalon, which isnow owned by by Eli Lilly, and

(22:35):
the really beautiful work that'sbeen done by the group at
Aspect Biosystems inencapsulation inside of a 3D
printed environment and there'sbeen some really exciting
developments there.
At its core, encapsulationalways kind of competes with
vascularization, so there's onlyso much nutrient and blood
supply you can get when you'retrying to encapsulate the cells.

(22:57):
And there are signs of promise.
There's also signs of challenge.
Cigalon had to shut down one oftheir major programs because of
late stage fibrosis of theencapsulated cells and really
the materials that are used forencapsulation.
The long-term kind of fibroticimpact is really unclear right

(23:20):
now.
So our belief is thatencapsulation is still a
challenge.
It's not a soft problem and itreally won't be until you see
some compelling phase three data.

Jenny Chen (23:29):
Are these considered cell therapy in a category?

Mike Graffeo (23:32):
They are.
It's interesting.
Cell therapy in a category?
They are, it's.
It's interesting.
You know, cell therapy in ourindustry generally is referring
to like car t and these are onetime you inject the cells they
do the job and the job is over.
So we see now with the um, withthe type one application, we're
starting to see the moniker ofcell replacement therapy as a

(23:53):
little different from celltherapy okay and so cell
replacement therapy.
The cells are designed to go inand do the job from then until
forever or for however long thatyou can achieve that.
So you know, I think we use theterm cell replacement therapy,
ok, and to me that's that's justsort of a bridge to going from
cell therapy to tissue Right.
It's.

(24:13):
Ultimately these will be tissuetherapeutics.
We're not quite ready to talkabout that in the industry today
.
It's sort of one step too farfor the way that most people
think about it today.
But I think this will be theapplication, that's the bridge.

Jenny Chen (24:27):
I mean, I think we're talking about it because
the next thing we're thinkingabout is the regulatory pathway,
because it's such a brand newthing.
Actually, a couple months ago Isaw out of jennifer lewis's lab
they have an implant for breastcancer that's vascularized, but
it's an implant plus cells init.
You know, I'm just wondering,like is your isocell implant

(24:50):
similar in terms of the kind ofcombination device this is?
I mean, how do you categorizeit when you apply for any kind
of FDA pathways, like, where dothey put you?

Mike Graffeo (25:02):
Yeah, so you know, with our type one indication,
that will definitely be acombination product.
Okay, you know the Center forBiologics will be the lead on it
, because the cells do theprimary mode of action.

Jenny Chen (25:14):
I see.

Mike Graffeo (25:15):
But the CDRH will be involved because there's
going to be cells deposited inan extracellular matrix scaffold
and so CDRH, the devices center, will definitely be involved,
and for us the CDER will also beinvolved.
Cder, because our intent forour type 1 application is to
load a local release, a kind ofa depot of immunosuppressant

(25:38):
just in the area of the implant.
So we envision all three centersinvolved from the FDA's
perspective.
There are other products thathave done that.
It's not a first of kind andfortunately for us, the cells as
the primary mode of action fortype one is not unfamiliar to

(25:58):
the agency.
So we think from a regulatorystrategy perspective it makes a
lot of sense to start hereBecause while there are
definitely some open questionsto answer, the road is actually
somewhat clear to see how itwill play out.

Jenny Chen (26:11):
Yeah, you know, it's really funny.
Last Thursday we had a demo day, as you know, and a couple of
investors, I mean, I heard theword doge quite a few times.
Do you think doge is going tohelp?

Mike Graffeo (26:25):
You know it's an interesting question.
I've been working with the FDAfor 25 years.
I've got four different FDAapprovals in my career and I
probably have a different pointof view on this than a lot of
folks, which is I've generallyseen out of the FDA that when
you work with them the right waythere's a tremendous
willingness to work withindustry to solve real problems.

(26:46):
So I'm not sure that you knowFDA is broken and it needs a lot
of fixing and overhaul is theright kind of mentality here.
I think in general most folksat the FDA want to see novel
therapeutics get to patientsfaster.

Jenny Chen (27:01):
Yeah.

Mike Graffeo (27:01):
So I think that you know, are there
opportunities for efficiency?
Absolutely Do.
I think that you know theefforts that are being promoted
right now through Doge will bepotentially helpful.

Jenny Chen (27:13):
It certainly could be, or somewhere else maybe, tax
for tax reasons.

Mike Graffeo (27:17):
Yeah, well, I mean , listen, there's inefficiency
everywhere.
Right, it's complicated, andit's complicated for a lot of
reasons that didn't just happenovernight.
So are there chances to dothings better?
I'm sure of it.

Jenny Chen (27:28):
Yeah, I mean I've encountered people who have to
deal with the EU, have to dealwith Singapore EU, you know,
have to deal with Singaporegovernment, chinese government,
all these different regulatorybodies for healthcare, and
everybody pretty much agreesthat FDA is probably the best
entity to look up.
And you know, I would say okay,of all the bureaucracies, they

(27:51):
probably actually I mean in myopinions I think FDA is probably
the best of all thebureaucracies I've seen.
So I mean in my opinions, Ithink FDA is probably the best
of all the bureaucracies thatI've seen so far.

Mike Graffeo (27:57):
I think that's right.
I think that there's, you know,in the in all the different
kind of mentalities.
It's not just a what's thepaperwork required, it's kind of
what?
What's the psychology behindwhy it's being done that way?
I've always found FDA to bevery done that way.

(28:18):
I've always found FDA to bevery, you know, just laser
focused on as long as we can getcomfortable that the risk is
managed.
We want to see the benefits outthere for patients.

Jenny Chen (28:23):
Yeah, I think they're actually pretty
innovative and try to be on topof things in terms of technology
.
Now, moving away from theserious technology regulatory
talk, I want to go back to howyou build your company, because
how many people you have now inyour company?

Mike Graffeo (28:38):
So we have 12 people today.
Okay, we've been, you know, acouple of different phases of
the company, so one time we werea little bit larger than that.
When we moved away from the invitro models back towards the
therapeutic focus, we, you know,got a little bit leaner to be
just really focused on that.
Um, we've had, uh, you know, acouple of people join the team
recently, some really top tierscientists that we've been able

(28:59):
to add to the team, which isreally great yeah, so when you
just started, was adam, you justtwo of you there were three of
us at the beginning, okay, andthat was andrew or

Jenny Chen (29:08):
that's right, andrew .
Yeah, that's right.
And then, how do you um build ateam?
Because I, you know, noticedabout you, mike, is that you
have incredible soft skills.
You're a very personable personand you always show up.
I think that's the mostimportant thing for founders.
So tell us what are yourchallenges of building a team?
How do you make sure you havethe right team behind you for

(29:31):
what you want to do?

Mike Graffeo (29:33):
Well, I think that the um, you know there's a
couple of things that are reallyimportant there.
You know number one uh, youknow, you know when a lot of
people get into whether it'sentrepreneurship or leadership
or otherwise, you get reallywrapped around the axle, first
on what do I do, what's theright thing to do, and the piece
that I emphasize with my teamand we've got some really

(29:53):
tremendous young early careerleaders in our team that are
growing and developing Iemphasize all the time to them
that what you do matters, but itdoesn't matter anywhere near as
much as why you do it.
You do matters, but it doesn'tmatter anywhere near as much as
why you do it.
When you care very much aboutthe mission and when you care
very much about the people thatyou're working with to achieve
that mission, you can get awaywith not always doing the right

(30:16):
thing, because people know howmuch you care and so they'll
give you a little bit more rope,which lets you then try on and
go do the things that you feellike you feel really important
about with a little bit less.
Oh my God, did I mess it up?
And I think that's really theunderrated thing that we
understand about the world today.
When I was in my early career,people held up Steve Jobs as the

(30:40):
picture, perfect example of howto do things right.
And I got I don't know six,eight years later and Steve Jobs
was held up as exactly theexample of what not to do
because he was this or that orthe other thing.
I look back at it and I say Ithink he was a terrific example
of when you care that much aboutthe product, your customers and

(31:03):
your people, even if you messup a lot and you know, let's not
say it any other way, I couldbe a jerk Even then the kind of
loyalty that you cultivatebecause of how much you care is
infectious.
So that's that's really numberone.
Like, if you're doingentrepreneurship, startup world,

(31:25):
and you don't have that like Icare so much about this down to
my bones, you're probably not inthe right spot.
That's a really important pieceof it.

Jenny Chen (31:34):
Yeah, I'm feeling like I.
I.
I loved Elon Musk for thelongest time, until recently.
I have to say he's acting alittle bit out of my comfort
zone, but I feel like he's thekind of person too.
He's why he's, he answers whypretty well, for the last decade
or so, except now.
I don't know what's what isgoing on, what's going on with

(31:55):
him, but it's alwaysentertaining.
That said, now if you have anew member coming in to your
company, how do you mentor him?
Do you advise him to readcertain books to get onto the
same page with you guys, or geta coach?

(32:16):
How do you incorporate this newmember into to make sure this
person is comfortable?

Mike Graffeo (32:22):
Well, I can share with you a couple of examples
the way that we think about whenwe hire, you know, a talented
new scientist or engineer andshe comes on board and we want
to get them up to speed reallyquickly.

Jenny Chen (32:34):
Yeah.

Mike Graffeo (32:35):
The first thing that we tend to do is to say,
okay, you know, we're alwaysprinting something.
We've always got some level ofinteresting work going on in the
lab implants in the animalfacility, otherwise so we want
to get them hands-on reallyquickly.
And so it's super important tosay, all right, let's get up in
the lab, spend some timeshoulder-to-shoulder with our

(32:56):
engineers, understand why weload the syringe the way that we
do, understand why we programthe G-code the way that we do
and path things the way that wedo, because this avoids this
kind of trade-off and thisactually sets things up better.
This incorporates porosity alittle bit differently.
We're experimenting with thiskind of shape versus that.
We're experimenting withdifferent concentrations of
cells and otherwise.

(33:16):
We want to get you in there andliving and breathing the
printing process, and that's inlarge part because we can hire
tremendously talented peoplewith backgrounds in biology and
otherwise, and they can ask muchbetter questions when they
understand why the technologydoes what it does.
So, shoulder to shoulder in thelab, seeing the experiments,

(33:39):
understanding, you know peoplehave a million questions when
they start yeah they want toknow why wait?
how does this do that?
What's going on with this?
So all of that happens in thelab.
You got to be in there.
You got to have the nitrilegloves on.
That's step one.
Step two is spending the timewith my co-founders, with Adam,
with Andrew Hudson, who've beenliving and breathing.

(34:01):
How do I think about tissueengineering using fresh for now,
10, 12 years and just saying,all right, you know, let's
really dig in on you, know what,what this technology unlocks
and how you can use it.
And then you know with, uh,with our PhD hires.
So we just brought in a reallytalented scientist.

(34:22):
Uh, she's got a greatbackground in islet cell biology
.

Jenny Chen (34:25):
Yeah, you said you, you hired a new scientist
recently, right we?

Mike Graffeo (34:28):
did yeah, and so one of the first things that we
do.

Jenny Chen (34:30):
Do you want to give her a shout out?

Mike Graffeo (34:32):
So yeah, so Fadma Dogan just joined our team about
a week ago.
She's been a tremendous hirefor us.
We're really fortunate to havebeen able to bring her into the
company and one of the firstthings that we do is to say
listen.
You know, we've got a weeklyscience meeting.
We bring all the PhDs togetherand that's where we talk about
data interpretation andexperimental design, thinking

(34:52):
broader picture around.
What are we doing next to makesure that we're asking and
answering the right questionsbasis?
We have the forum for that.
You can really quickly get upto speed and understand.
Okay, these are the questionsthe company's wrestling with
right now.
What kind of input do I have onthese questions?
And I think it's also reallyimportant to me that, just

(35:13):
structurally, we create spaceand we really want those
questions to come out, so we tryto create an environment that's
going to draw those questionsout.
I don't like to reference SteveJobs multiple times in a podcast
, but one of my favoriteleadership quotes was one of his
where he said listen, we don'thire smart people and tell them
what to do.
We hire smart people so thatthey can tell us what to do.

Jenny Chen (35:36):
I like Steve Jobs.
I think he's a great guy,except I won't work for him and
also I didn't have theopportunity to work.
But yeah, I love him too.
So Adam is studying chronicmelan at the moment, are you

(35:57):
guys?

Mike Graffeo (35:58):
how do you guys get together and continue to
have the cohesiveness, eventhough at different lab
locations?
Yeah, so Adam's our CTO.
He's been our CTO since wefounded the company.

Jenny Chen (36:03):
Right.

Mike Graffeo (36:04):
And he's a brilliant scientist who's done
some of the most advanced workin this field.

Jenny Chen (36:09):
For a long time.
Absolutely, he published everysingle paper.
I was like I want to read that.
Absolutely, he picked the righttopic.

Mike Graffeo (36:14):
His lab.
They do phenomenal work and hislab is, by and large,
leveraging this technology inmost of what they're doing.
So it's also really fertileground for early, early stage
R&D for what the company will bedoing next.
So if you want to know whatFluidform is going to be doing
in three, four, five years, gotake a look at some of the
things that are happening insidethe lab at Carnegie Mellon.

Jenny Chen (36:36):
Well, he published a paper focusing on AI and
bioprinting a couple of yearsback.

Mike Graffeo (36:40):
Yeah, one of the earliest ones in the field.

Jenny Chen (36:42):
So I wonder when you guys are going to use AI to put
AI in your pitch deck.

Mike Graffeo (36:46):
Well, stay tuned 2025, we've got some really
exciting developments.
There will be several things onthat front.

Jenny Chen (36:53):
Look forward to it.
Well, you have so many thingsto do in life.
How do you balance, I mean,when you first wanted to start
this startup kind of high risk,I would say.

Mike Graffeo (37:06):
Everyone is yeah.

Jenny Chen (37:08):
How did your wife respond to it?

Mike Graffeo (37:12):
I am incredibly blessed to be married to a
partner who has a lot ofpatience and understanding
around when I get lit up aboutan idea, like letting me run
with it.
So, you know, we we had a longtalk.
I told her I was missingstartups and I think maybe I

(37:33):
wanted to do it again, and she,you know, wanted to ask the
questions like help meunderstand what it is that
you're thinking about and why,and you know what is it that
makes you feel like that's theright thing for you.
And you know, when we, when wehad that discussion, she was
really supportive of it.
So you know, I feel reallyblessed that she was that that
she was able to say to me look,if this is what you got to do,
like, go do it, but just go doit well, um, and so, yeah,

(37:57):
having that kind of support andpartnership has made a huge
difference.

Jenny Chen (38:01):
I mean, that is probably one of the few choices
in life that's really impactfulin our lives as our life
partners.
Okay, well, final question foryou For 2025, okay, I personally
think the source of informationis extremely important for our
daily life and decision-making.

(38:22):
How do you, what are some ofthe recommendations you would
have for people to get the bestinformation available, either
for bioprinting or biotech orlife in general?
Do you have any recommendationsfor people's like reading list,
podcasts, youtube channels andstuff?
Just throw it out there, sure.

Mike Graffeo (38:42):
Sure Well, first off, if you're interested in
learning about bioprinting, Iwould start with the Fluidform
social channels.

Jenny Chen (38:48):
Okay, yes, we'll share the link we definitely
have.

Mike Graffeo (38:51):
we've got some really good material there.
There's more coming.
We're going to be able to be alittle bit more public about the
work that we're doing and whywe're so excited about it.
So follow along there Twitter,linkedin and, of course, if
you're looking to know what'sgoing on in the 3D bioprinting
world, even larger than justfluid form, you should be
following along with 3DHeal.

Jenny Chen (39:08):
Oh, thanks, that's kind of you.

Mike Graffeo (39:10):
And then you know, I think, just broader.
You know so when it comes towhat's going on in
biotherapeutics writ large.
I get most of my daily updatesfrom the group at Stat News,
which is a subsidiarypublication out of the Boston
Globe News, which is asubsidiary publication out of
the Boston Globe.
The reporters there do anawesome job and it's really easy
to stay on top of what's goingon in the industry Kind of the

(39:32):
single source there.
There's other really greatresources Endpoints News and
others that are terrific, but Ithink that picking one or two of
those and staying on top of itreally helps.
One or two of those and stayingon top of it really helps For
me.
The other thing that I thinkabout is what am I doing to
cultivate?
You know the sort of sense ofsteadiness in the world and I've

(39:54):
spent a lot of time at theintersection of.
You know different philosophiesand approaches around this, but
I think whether you're gettingsome daily psychological
nourishment from you knowsomebody like Ryan Holiday and
the daily stoic practices, oryou know Buddhism or religious
traditions or otherwise, theconsistent theme of remember

(40:19):
there are things in this lifeyou can control and things in
this life that you can't, andyou really ought to be focused
on the things in life that youcan control, which largely
exists between the ears.
Um, that's really nourishingand really helpful, because you
know it's it's all hard, there'sno, there's no easy path in
anything anymore.

Jenny Chen (40:36):
Do you find different books to get that
piece of philosophical calmnessor do you just go to a one
source?
You know that like a set ofquotes or app or something for
that kind of comfort.

Mike Graffeo (40:49):
Yeah, so I love reading books.
I read all kinds of books.
If Ryan Holiday publishessomething, I'll read it.

Jenny Chen (40:55):
He's just he's a must read as far as I'm
concerned.

Mike Graffeo (40:58):
Absolutely.
I think that you know there's alot of that message woven into,
if you like, podcasts, woveninto various of the Tim Ferriss
interviews as well.
Several of those are great andI think that when you, you know,
when you, depending on areligious, inclination.

Jenny Chen (41:18):
Most of the world's religious traditions also teach
that in one way or another.
Right, exactly, yeah, I agree.
I think religion actually onfundamental stuff, is similar to
one another.

Mike Graffeo (41:24):
Absolutely yeah.
Be a good person, try not toworry about the stuff you can't
control.
These are universal things.

Jenny Chen (41:30):
Yeah, I actually just finished the book how to
Think Like a Roman Emperor.
I don't know if you've heard ofthat I've heard of it.

Mike Graffeo (41:38):
I've not read it.

Jenny Chen (41:38):
It's a newer version of a regurgitation of Marcus
Aurelius' meditation, and that'sexactly what I said Just be.
The goal is actually not to behappy.
The goal is to be a good person, so I will end on that note.
Thank you very much, mike, forjoining us in the studio today
with our duct taped camera andovernight shipped microphones.

(42:01):
Thank you very much.

Mike Graffeo (42:03):
Thanks for having me, it's been great.

Jenny Chen (42:04):
Come by next time.
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