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Episode 70 - Paula Soteropoulos · The BioHub - by Avetix

0:05
So welcome back to the episode of the Bio Hub.
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Today, we're joined by 1 of biotech's most respected and
0:10
accomplished leaders in Paula Sauteropoulos.
0:13
With more than 30 years of experience, Paula has built a
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remarkable, remarkable career spanning early stage innovation,
0:19
drug development, commercialization and executive
0:22
leadership. Paula was the founding CEO of
0:24
CEO of XEA Therapeutics, where she led the company through a
0:27
successful IPO and brought multiple rare disease therapies
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to market. Paula currently serves on
0:33
multiple boards and is a venture partner at 5:00 AM Ventures.
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And prior to that, she held senior leadership roles at
0:39
Moderna and spent over 2 decades at Genzyme.
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So join us today as we'll talk through Paula's journey and
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Soma's first I and D approval as well as her role at 5:00 AM
0:49
ventures. So Paula, thanks so much for
0:52
coming on. How are you I'm.
0:53
Great. Thank you for having me.
0:55
Pleasure to be here. Yeah, it's a pleasure to have
0:58
you on as well. So let's start with a little bit
1:00
about you then. So can you talk us through your
1:02
journey through the field and what inspired you to pursue a
1:05
career in biotech? Oh sure, I have to say it was
1:09
probably somewhat by accident that that I fell on by when I
1:14
was young. I was always interested in in
1:17
health and figuring out how things worked and but medical
1:22
school was financially inaccessible to me.
1:24
So it was something that I put out of my mind.
1:27
And I stumbled into biotech in the mid 80s when I was a
1:30
freshman undergraduate at Tufts University.
1:33
I had a friend who was doing graduate program in biochemical
1:37
engineering and I would visit with him in the lab, pepper him
1:41
with questions. And it was just fascinating to
1:45
me. And he just said, yeah, why
1:46
don't you go talk to my advisor? You're always in here, you're
1:48
always asking questions. And it was the mid 80s, early
1:52
days of, of the biotech industry.
1:55
And I think I just was enamored by the potential of what you
1:59
could do with biology and, and really transforming health and,
2:05
and bringing innovations. And so I switched from being a
2:08
liberal arts undergrad major to biochemical engineering.
2:12
I went to Graduate School and from that's how I started.
2:17
I never really knowing what I never really looking at the
2:22
career as long term as an engineer.
2:24
It was really biotech that got me into the start of this path.
2:31
So you've held leadership roles at both larger companies like
2:34
Genzyme and early stage start-ups.
2:37
How have those experienced shape your approach to leadership and
2:40
company building? So during my 2 decades at
2:43
Genzyme, I had the opportunity to take on many roles and grow
2:48
in many different capacities, starting from an engineer.
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And ultimately when I left there, I was running global
2:55
businesses. But in between, I took on roles
2:58
that in some cases no one wanted to do, or they were the
3:02
difficult assignments, or I didn't have the specific
3:05
experience to take those on. And what was wonderful about the
3:09
environment. And I credit so much to Henry
3:11
Tamir who was the late CEO of Genzyme, who was a mentor to me
3:17
for giving me opportunities to take on goals where I may not
3:20
have had experience. So from engineering, I went over
3:23
more into the business unit leading operations.
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But then I I LED programs through clinical development all
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the way from early stage through approval.
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I was able to run global launches and had business
3:38
development responsibility and so really was able to get a lot
3:43
of the experience that cuts across a full integrated
3:47
business and really set me up for my future as a CEOI mean, I
3:51
never went into this thing. Oh, what someday I want to run a
3:54
biotech company. It it was never about that.
3:57
It was always about being able to increase my impact and be
4:01
able to take on more and more responsibility and and Genzyme
4:05
was such a wonderful environment for that.
4:09
And again, the, you know, we went through a lot of tough
4:13
times. And so I think that a lot of the
4:15
resilience that I think is important in in this industry
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having great resilience because things go wrong.
4:21
It was really things I learned at Jenthon because nothing goes
4:25
right in clinical in, in, in biology, you have to expect the
4:30
those setbacks, but have to have to persevere and, and the value
4:34
of what impact you have in biotech is, is, is so worth it.
4:37
So a lot of that was rooted in my, my early learnings at
4:41
Genzyme and then also how I mentor people.
4:46
I think because of the direct mentoring that I received and
4:49
the opportunities I received, I, I really tried to give that back
4:52
and, and ensure that I'm allowing room for people with,
4:56
with that I work with to grow from, from Genzyme.
5:00
We were acquired by Santa Fe and I stayed there for, for two
5:03
years after that acquisition. I think that when you're asking
5:08
about, you know what, what is shaped you that probably shaped
5:10
more of what I don't want in a sense good company, but for me,
5:14
I, I don't have the DNA for 100,000 person company.
5:17
I really like the fast, nimble decision making and the but I
5:23
learned, I think what the larger companies, the strategic farmers
5:26
need and how they make decisions and need to make portfolio
5:30
choices that will feed their long term gas.
5:35
And so as being in venture today, it's, it's very good for
5:39
me to understand what a large pharma really does need because
5:43
many times we are building these companies to feed to, you know,
5:48
and build out their portfolios. I then went to Moderna and I, I
5:52
think one of the key learnings there that was continued on for
5:54
my, my Genzyme learning is really around
5:56
entrepreneurialism, being fast, agile, It's bringing an exciting
6:02
new technology forward. I was there very early.
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I was probably the 20th employee.
6:06
There was no COVID at the time. So we this was very early in the
6:10
technology and we had to balance the many possibilities of this
6:16
innovative technology with, you know, bring bringing in funding,
6:21
not always diluted funding partnerships.
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So those were also important lessons for as as I take take
6:28
took forward to building my own companies.
6:32
And then then I think I was ready for ICSE.
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I was a company that I launched, we spun out of Ionis and I built
6:40
with my team that company from first employee to 300 employees,
6:45
as you noted earlier, took the company public and we launched a
6:50
couple of rare disease drugs. And it was a company that had a
6:54
very strong culture, mission and, and, and focus on the why.
7:00
And it was probably one of the, you know, one of the most
7:04
wonderful jobs that, that I had to really have the privilege to,
7:08
you know, build, build a company and a very strong culture and
7:12
know that we were making a, a difference for patients.
7:15
So I, I would say those are the, some of the, the things I would
7:18
say that helped shape, you know, you know, my learnings and, and
7:22
career and moving forward. Very good.
7:27
And were there any defining moments in your career that
7:29
significantly influence your path or philosophy?
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I would call this a defining moment because it's probably
7:39
multiple moments. It's a defining culture.
7:41
And that that was Jen Simon and I mentioned the late CEO Henry
7:46
Tamir, as is my most important mentor and sponsor for the, the
7:51
two decades I was there. And actually and beyond, he
7:53
continued to be a mentor even after I left at Genzyme.
7:58
But my very strong focus on patients really does come from
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the learnings from Genzyme and, and Henry, he really fostered an
8:09
environment that, as I mentioned, allowed me to grow
8:13
and, and set up the, the capabilities to I think lead
8:19
companies. And I think it's important the,
8:22
the things I mentioned earlier, you know, encouraging people to
8:25
take risks and, and driving innovation.
8:27
I don't think we're going to do anything extraordinary in this,
8:31
in, in, in this biotech industry if we don't take risks.
8:36
And it's not just taking risks on, on, on the biology, it's
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taking risks on people. I think there's a tendency many
8:41
times to try to find someone who fit exactly.
8:45
OK, they've done this before. We'll put them in that position.
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And that's not the way Henry was.
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It wasn't the way Turnzine was. It was OK, this person has
8:52
exhibited these incredible characteristics.
8:55
They've, they've persevered, they've done these amazing
8:57
things. We're going to put them over
8:58
here. So it's, it's thinking about
9:01
moving people not up a ladder, but across lattices, giving them
9:04
that, that experience. I, I think those, those were
9:07
probably the, the most important things.
9:09
And I call them, you know, it's it, that's, it's not a specific
9:13
defining moment, but it's a collection of all those moments.
9:19
But there was 1 defining moment for me and specifically with
9:23
Henry that I, I remember I was in his office and he was the
9:27
first person that said to me, you know, you are not leading
9:32
from your authentic self. He said, when we have a
9:34
one-on-one, I see who you are. I see your passion, I see your
9:37
drive, your creativity. But when you're presenting in
9:39
front of a larger group of execs, you know, you're very,
9:44
maybe the engineer would come out and, you know, very
9:47
calculated me to, to show all of the things that we've done and,
9:52
and not not really show who I am and, and that authenticity.
9:56
It was the first time I think for me that I could take a step
10:00
back and say, OK, who, who am I really?
10:03
How do I want to lead? What is my authentic voice?
10:06
And I have taken that through the rest of my career.
10:10
It is really shaped how I've become a leader or a peer, A
10:16
colleague, someone who really listens, someone who is not
10:21
afraid to share personally what drives me, what's important to
10:26
me and allowing space for the other person to do so.
10:29
And I think it creates incredible connections.
10:33
And also people want to follow someone that they really know
10:37
who they are, what they believe in, what they're, why is their
10:39
that true authentic self. So I think that shapes me
10:43
tremendously as a leader and how I then built cultures later.
10:49
Very good. And one of the boards that you
10:51
sit on is En Soma, which you've helped launch from the ground
10:56
up. And the company has now reached
10:57
its first Ind milestones, which is exciting.
11:01
What does that milestone mean to you personally and to the future
11:04
of En Soma? Yeah, it's really been a
11:07
privilege to be involved in in En Soma from the seed and
11:11
launching the company to where we are today.
11:14
And you know, I started the company, I started the company,
11:19
I'm running it and then and now I'm chairman of the board and
11:21
have a wonderful CEO today and, and still involved, but not, not
11:26
in the day-to-day. But maybe as I answer that, let
11:29
me back up a little bit just to give the context of what ENSOAM
11:33
is all about, because I think that's important in, in into why
11:37
I'm excited. So in SOMA we're pioneering
11:40
really A next generation of of an in vivo approach to
11:43
genetically engineer hemopoietic stem cells and and we believe
11:47
this will broaden access to curative genetic medicines with
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a durable one time delivery. And that's important because if
11:55
you think about modifying hemocratic stem cells, think
11:59
about ex vivo treatments for sickle cell or, or, or beta
12:04
thalassemia or, or car T. Those have these really long
12:07
arduous journeys. Your the patient has to be
12:11
hospitalized, their stem cells have to be mobilized and removed
12:15
from the body. They get chemoablation, then
12:19
they get the modified cells introduced back from the body.
12:22
And then there's a month long recovery time.
12:25
All of that is in it could be months and months in the
12:27
hospital for, for patients. What we're looking to do is a
12:32
one time delivery in an outpatient setting.
12:35
I mean it's, it's it's truly transforming.
12:39
It's a big bold idea. I mean that's how we started.
12:42
It was a big bold idea. And the hemopoietic stem cell is
12:46
the most powerful stem cell in the body.
12:50
And from there, the cell lineages, you, you, you move
12:52
into T cells, myeloid cells, B cells, etcetera.
12:55
The possibilities of what you can modify and then in turn
12:59
modify disease really is, is quite extraordinary.
13:03
And so to be now, you know, months away from our first
13:10
treatment of a patient, it is huge.
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It's, it's, you know, been quite a, a journey to get here.
13:17
And before we started the company, there were years,
13:19
decades of work that was done by, by our, our founders.
13:24
But the technology has, I think the most important thing for me
13:29
is, is the ability. And if you think about that
13:32
ability to do an outpatient setting, it opens up
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accessibility, accessibility to patients that would otherwise
13:41
never have the opportunity to have these really truly
13:45
modifying genetic advances. It also allows us flexibility
13:50
and opens up opportunities in more diseases, types of diseases
13:54
cause in our, in our technology, we're able to put in very large
14:00
gene insertions to very small precise genetics.
14:03
So we can do either gene editing or gene insertions.
14:05
So very wide range of, of diseases.
14:10
So incredible moment for us. The, it's just to the, the first
14:14
program that we're moving forward is an excellent chronic
14:21
granny lomatose disease, I'm going to call it CGD.
14:23
It's a bit of mouthful. It's a, it's a rare immuno
14:26
deficiency with a very, very high need on these patients
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experience recurrent and severe bacterial or fungal infections
14:35
and they have a significantly short shortened lifespan there.
14:38
There really is no treatment for them but stem cell
14:42
transplantation and a small ex vivo study had shown curative
14:47
results. So that gives us high confidence
14:49
in our approach. So we know if we can modify the
14:51
stem cell, we have the potential to cure these patients.
14:54
So now this particular study that we're doing really is the
14:59
first one to validate our technology.
15:02
First, of course, for CGD in these patients, it's important.
15:06
But what we will show will also support all the other programs
15:11
in our pipeline, which will include other rare diseases like
15:14
sickle cell and other opportunities in oncology
15:18
because we will be able to show it safe and that we can truly
15:22
modify these stem cells. So very excited about it.
15:28
Yeah, sounds exciting. And you mentioned that in SOMA
15:30
initially was a bold idea. How was the vision from that
15:35
bold, bold idea? How has that evolved through the
15:37
journey from then to now? Ind filing.
15:42
Yeah, I mean, it's, it's probably taking a little bit
15:45
longer, you know, than I expected as we all do.
15:49
But part of it is not because the technology didn't work.
15:51
I think it's what's been amazing is we have made steady progress
15:56
all along, which is which has been incredible.
15:59
What's evolved perhaps is what is the right first target for us
16:04
to be looking at. We we moved from, if you think
16:08
about when we started the company, it was actually in
16:10
COVID. So that was a whole other
16:13
challenge hiring the leadership team starting for you Zoom or I
16:19
remember our CSO, we took a walk in the woods like really far
16:22
away from each other. So that that had its own
16:25
challenges. And we have people, we set up
16:28
our first labs and we could only have so many people in the lab
16:31
at the same time. Very interesting to to set to
16:34
start to launch a company that way.
16:36
I don't think that's how we expected it would be.
16:38
But hey, again, that's where you get the grit and perseverance.
16:41
I think we have a very the resilient team and you know,
16:47
I've just been so thrilled with the steady progress that the
16:50
team has made along the way. But the, the, the market also
16:54
changed though, from a financial perspective, you know, we
16:57
started in a, in a time where biotech that was flush with
17:00
money to a time right now where I think people are making
17:04
different types of choices in, in investments.
17:07
So we've had to pull back on some of the ambition from the
17:12
standpoint of how many things we can do at the same time.
17:15
And I think that's the toughest thing, you know, when, you know,
17:19
wow, we're making progress. This really could work.
17:21
This really could have a huge impact and, and OK, but we can,
17:25
we don't, we have to, we have to you know, focus a lot of our
17:28
funding and our efforts on our lead program.
17:31
We have other programs behind it, but probably can't move them
17:34
as aggressively as we we would have liked.
17:36
So that that's probably a shift that I didn't expect.
17:40
Yeah, good. And you, you mentioned a couple
17:42
of challenges then, but what were some of the biggest
17:45
challenges that some of the team faced in getting to this point
17:49
as well? And how did you you guys
17:50
overcome that? Yeah, I, I think I would say
17:55
that it is probably the biggest challenge is we have had, you
18:02
know, the, the technology work in a particular or, or making
18:05
progress and then to, to say, well, we're going to have to
18:08
hold and pause here. And the result of that was we,
18:13
we, we had to have a layoff, for example.
18:17
And it's really frustrating to have to do that, right.
18:20
When you say, well, it's not because the, the technology
18:22
didn't work, it's working and we're making progress and, and
18:26
we have a great team, but we had to make, we have to make those
18:30
decisions. And look, it's the right thing
18:31
to do. I think in investors by rights
18:35
need to make sure that they, their investments are de risked
18:38
and and that is what our, our first CGD program will do not
18:44
only for CGD itself, but as I mentioned, but for the other
18:49
pipeline program. So you know, they of course you
18:53
know, continue to put money in, but say, OK, when we show, OK,
18:57
it's safe. We know that we can transduce
19:00
the specific cells that we're looking for.
19:02
All right now we can see that we could do that in some of these
19:05
other other areas. So set back, yes, it it
19:09
definitely was disappointing, but a necessary thing that an an
19:13
appropriate thing and with my investor hat, you know, I see
19:16
yeah, we've we've got to do that.
19:18
Investors are responsible for giving, you know, a certain
19:22
amount of returns to their LP's. Investors take significant risk
19:26
if you think about this industry investing in these companies
19:30
that we don't know if it's going to work and and so we have to do
19:33
it responsibly. So very appropriate.
19:39
Yeah, good. And just taking it back, so your
19:41
current role as a venture partner at 5:00 AM Ventures, can
19:44
you share a bit of the firm's origin story and even maybe
19:48
something to do with like the types of companies you would
19:50
typically invest in as well? Yeah. 5:00 AM Is is a venture
19:58
capital firm focusing on life sciences.
20:00
Founded in 2002 and, and really focused on solving important
20:06
healthcare needs and mostly through cutting edge
20:09
breakthroughs in, in, in medicine and science.
20:12
I mean, we're not a type of firm that does me two type of
20:16
opportunities. And so we are primarily
20:19
therapeutics, but do you have some devices and services, but
20:23
mostly therapeutics? We, so I will tell you when I,
20:30
when I, when I left at CEA and I, they started and, and we were
20:34
starting in SOMA, I was also at the same time talking to
20:37
different venture firms, but I knew I wanted to get involved in
20:40
venturing. I, I gravitated to 5:00 AM
20:42
because of, of the people, of course.
20:45
But there, there was always a strong drive to, to company
20:48
building. And for me that's, that's what I
20:50
wanted to do. I don't have the traditional
20:52
venture background. I want to bring my company
20:56
building my operating experience to the company and that is the
21:00
philosophy of 5:00 AM working really closely with portfolio
21:05
companies, not just having these passive board roles, but really
21:09
hands on. When we start, the companies
21:11
sometimes come going in and, and assuming an operating role, but
21:16
really staying close to the company, supporting them through
21:19
growth. You know, when it, it could be,
21:22
you know, really folks who have a good scientific background or
21:26
development or even just the close relationship with
21:29
investors as the company's going through financing.
21:33
So it, it, it's again, a very hands on close relationship, but
21:38
certainly not a, a, a, a firm that, when they're working with
21:41
a company that tries to tell the management how to run a company,
21:44
it really is about working with them and enabling them to, to,
21:49
to be successful. So the, the, the again, I think
21:54
I mentioned, you know, generally early stage, but we're also
21:59
doing things that are corporate spin outs and, and right now
22:03
most especially because where the market is looking at product
22:07
opportunities that have a shorter development life cycle,
22:10
you know, faster to the, the clinic and to an important
22:14
clinical proof point. OK.
22:18
And what makes the start up stand out to you personally when
22:22
looking at potential investments for 5:00 AM?
22:27
Yeah. So as a general sense, a start
22:30
up, you know, ideally would would have some validated
22:33
biology. Many times it's the team who are
22:38
the people that are behind it. For me personally, my lean is in
22:45
terms of the areas I look at is, is rare disease just because of
22:48
my 30 plus years in rare disease.
22:50
But also right now in the past few years, I've been very
22:53
focused in, in Women's Health. And the reason I think it's
22:56
probably the same reason that I gravitated to rare disease.
22:59
I I, I am looking to do something with their needs and
23:04
tremendous innovation and when Women's Health is an area where
23:09
there has been just a lack of investment and a lack of
23:14
understanding of the true biology of women's complex
23:17
biology and the effect of hormones on on many diseases.
23:21
And, and so I really am hoping to, you know, help move forward
23:27
innovative solutions, you know, this these areas of high and
23:32
again, both rare disease Women's Health that have a a profound
23:35
impact on on people's health, aside from the therapeutic areas
23:41
that I look at them. And as I mentioned, you know, it
23:44
it as we think about what is a good start up, you know, what is
23:48
the foundational signs ideal situation?
23:51
Has the biology been validated that by the way, it's very hard
23:54
in in Women's Health because of the lack of investment.
23:57
If there's clear clinical endpoints or biomarkers, well
24:00
that makes that clinical development regulatory path
24:03
easier and that that DE risks a little bit more.
24:06
Also, has there been precedence from a clinical regulatory path?
24:09
All of these things, you know, tick the box for DE risking
24:13
those investments. Are there motivated Kols and
24:16
patients around this particular disease so that again you can
24:20
start to think about commercially, what could be the
24:24
success, What's the competition like?
24:27
What, what would market access look like?
24:29
All of those things I do think about very early when I'm
24:33
looking at an opportunity, even though it could be decades away
24:37
from thinking about pricing and market access, you need to know
24:39
that you have that path. So those are the things I look
24:41
at. Has your experience as an
24:44
operator influenced the way that you now think about venture
24:47
investing? Yeah, absolutely.
24:50
I, I mean, it's the way I, I look at teams and the potential
24:54
for success of those teams. You know what, what it takes to
24:57
start a team from scratch and, and, and build a company while
25:03
you're executing on very aggressive and ambitious goals
25:06
and ensuring the expectations of investors are front and center,
25:10
which I, I mentioned before, in my, my experience in
25:15
development, regulatory, commercial path.
25:19
I mean, all, all of those things are critically important to how
25:24
we assess these new opportunities and investing, you
25:29
know, can't just be cool science.
25:31
I think that was happening a few years ago with a lot of
25:33
investors. Wow, this is just cool science.
25:35
And, but you really have to make sure.
25:36
Does it translate to humans? Can we get it through, you know,
25:39
clinical development? What are the regulatory?
25:41
So all of those things having run a company, having brought
25:45
things from early stage all the way through commercial are, are
25:49
critically important. And then the other area with my
25:54
experience in small companies is, is having the experience to
26:00
having negotiated and LED many strategic partnerships with
26:04
large companies. They're like Novartis, Pfizer,
26:06
AstraZeneca, Takeda. When I'm looking or talking or
26:12
working with a, a, a new venture, we are always thinking
26:17
about that lens, you know, what are the capital needs of the
26:19
company? Are there strategic
26:21
opportunities? What are these strategic farmers
26:23
going to be looking for? Are they interested in this
26:27
technology? Because we don't want to just
26:29
get funding for non diluted funding from investors.
26:32
We need to also look at these, I'm sorry, diluted funding from
26:35
investors. We need to look at these non
26:37
diluted sources from strategics and frankly that validates for
26:41
investors that there if there's a strategic interested, you
26:44
know, maybe there's a possible exit opportunity.
26:47
So again, the collective of all my experience, very much so I
26:52
think is is critically important to how I think about investing
26:56
in companies. Very good.
26:59
Well, look, thanks so much for coming on and and helping us out
27:02
with this. I know we had some technical
27:04
difficulties, but I think you've given a, yeah, I think in Somers
27:08
look like they're, they're having a tremendous journey and
27:10
I'm, I'm looking forward to following that.
27:12
And yeah, thanks for giving us a run through your role at 5:00 AM
27:15
as well. I think that's a really
27:17
interesting perspective. So yeah, thanks again for
27:20
helping us out. It's a pleasure and you know,
27:23
really privileged to share some of the things that I've I've
27:26
done and so thank you for having me.