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The Start-up Making IVF and Egg Freezing Faster and Less Awful · Core Memory

0:01
SPEAKER_01: We are in a society where women deserve better solutions,
0:06
SPEAKER_01: that birth rates are declining,
0:07
and we think that the right way to solve it is to allow people
0:10
who do want to have
0:11
SPEAKER_01: children ability to do so when they feel ready.
0:28
SPEAKER_00: Hello, everyone.
0:30
SPEAKER_00: Welcome to another episode of the Core Memory Podcast.
0:33
SPEAKER_00: Today, we'll be joined by Dina Radekiewicz.
0:36
SPEAKER_00: She is the co-founder and CEO of Gamito,
0:41
and I will be heading into a subject matter that I am certainly
0:46
far from an expert on,
0:48
which is women's reproductive health and biotech around all of
0:54
these issues.
0:54
SPEAKER_00: But Dina, she's
0:58
SPEAKER_00: pretty remarkable.
0:58
SPEAKER_00: She's very young,
1:00
SPEAKER_00: she's a doctor,
1:01
she's accomplished all kinds of things in her 20s that would
1:07
astound just about anyone,
1:08
SPEAKER_00: and has started this company that is doing
1:11
Pretty spectacular things with IVF technology and potentially
1:16
down the road with
1:17
SPEAKER_00: menopausal technology.
1:19
And it was something I just felt was undercovered and deserving
1:23
of attention.
1:25
SPEAKER_00: And with that, we'll turn it over to Dina.
1:32
SPEAKER_00: Hello, Dina.
1:34
SPEAKER_01: Hi, thanks for having me today.
1:37
SPEAKER_00: Thank you so much for coming on.
1:39
I feel like I'm going to embarrass myself on this podcast
1:43
wading into women's
1:46
SPEAKER_00: reproductive health.
1:47
SPEAKER_00: This is a field I am actually super interested in.
1:51
SPEAKER_00: I just wouldn't say it's my forte.
1:54
SPEAKER_00: So anyway, I hope you're here to be my guide anyway.
1:59
SPEAKER_00: I want to dig into everything you guys do and...
2:05
SPEAKER_00: and your story and the technology is fascinating.
2:07
SPEAKER_00: And I think maybe,
2:09
SPEAKER_00: um,
2:09
SPEAKER_00: just need a little explaining for some people,
2:11
SPEAKER_00: but you know,
2:12
SPEAKER_00: I wanted to start at a particular place where I thought it might be,
2:16
SPEAKER_00: um,
2:16
SPEAKER_00: a way for people to understand what gameto is up to.
2:20
Uh,
2:21
as I understand it last December,
2:24
there was a very special baby born in Peru.
2:28
SPEAKER_00: That was really the first, um,
2:31
SPEAKER_00: One of a big major milestone for your company and your technology.
2:35
SPEAKER_00: Can you tell us about this baby?
2:39
SPEAKER_01: Yes, absolutely.
2:40
SPEAKER_01: I mean,
2:41
SPEAKER_01: a lot of founders would say that their company is their baby,
2:44
SPEAKER_01: but on December 7th last year,
2:47
SPEAKER_01: that term got a completely new meaning for me and everyone at Gameto.
2:52
And at Gameto,
2:53
as you mentioned,
2:54
we're a company that leverages cell engineering
2:57
and induced pluripotent stem cell technology,
3:00
so iPSC,
3:01
for which Yamanaka won a Nobel Prize.
3:04
And we take these induced pluripotent stem cells and make cells
3:07
of the female
3:08
SPEAKER_01: reproductive system.
3:09
We use these young iPS-derived ovarian cells to mature eggs
3:14
outside of the body and
3:15
change an outdated process of IVF and egg freezing that hasn't
3:19
changed since the
3:20
SPEAKER_01: birth of the first IVF baby happened in 1978 in the United Kingdom.
3:25
So what we've had on December 7th of last year was the first
3:30
baby in the world,
3:31
SPEAKER_01: it was really a medical first,
3:32
SPEAKER_01: not just a milestone for gameto,
3:35
SPEAKER_01: with IPSC technology,
3:36
SPEAKER_01: where the eggs of a woman were not matured inside of her body fully,
3:42
SPEAKER_01: but the final step of maturation was done outside of the body,
3:46
co-cultured with our young ovarian support cells that were
3:50
derived from induced
3:51
SPEAKER_01: pluripotent stem cells,
3:52
SPEAKER_01: therefore mimicking a young ovary in a dish.
3:56
And then leading to that maturation process,
3:59
after which the eggs were obviously fertilized.
4:02
SPEAKER_01: Months later, embryos implanted.
4:04
SPEAKER_01: And then a healthy baby girl was born.
4:08
SPEAKER_00: Yeah,
4:09
and we're going to unpack IPSCs for everybody here in a little
4:13
bit because it's a
4:14
SPEAKER_00: topic I'm fascinated in.
4:15
But so the premise,
4:18
a big one premise,
4:19
an early premise of the company is that you're trying to
4:23
make the ivf process more convenient um possibly cheaper and
4:30
and to have some of
4:31
this um like you just mentioned this the maturation of of these
4:36
cells actually take
4:37
place um in a dish and and to reduce the number of hormone
4:43
injections women have to
4:44
SPEAKER_00: have during the ivf process and so this was the first
4:48
This was the first baby that really bore out all this
4:52
technology that you've been
4:53
SPEAKER_00: working on for years.
4:55
SPEAKER_01: Yeah, absolutely.
4:56
And maybe to kind of go into what is the current process and
4:59
why this matters.
5:01
SPEAKER_01: As I mentioned, IVF, truly a miracle of science, right?
5:05
SPEAKER_01: Since that year,
5:06
SPEAKER_01: since Lise Brown was born,
5:08
SPEAKER_01: over 10 million babies have been born with the technology.
5:11
I'm sure there in the audience,
5:14
so many grateful families to IVF technology.
5:18
SPEAKER_01: But I also do know that women who have gone through the patient journey
5:23
SPEAKER_01: have had a very difficult time.
5:26
SPEAKER_01: And the statistics show that right now to go for IVF or egg freezing,
5:31
SPEAKER_01: whether or not it's a male or female problem,
5:34
SPEAKER_01: like I think this is important to mention that,
5:36
SPEAKER_01: yes,
5:37
SPEAKER_01: like we're altering the female patient journey.
5:39
SPEAKER_01: But in reality, like infertility is everyone's problem.
5:42
SPEAKER_01: About 40 to 50% of infertility is also male related.
5:46
SPEAKER_01: And that is only talking about heterosexual couples, right?
5:50
Like even a lot more same-sex couples allow on science to build
5:53
their families.
5:53
SPEAKER_01: So this is really like a problem that is affecting us as a society.
5:57
SPEAKER_01: We're having children later.
5:59
SPEAKER_01: And more and more people need to access these services.
6:02
SPEAKER_01: Now, when you look at these services...
6:05
SPEAKER_01: A patient journey hasn't changed.
6:07
SPEAKER_01: For a woman to mature and get enough eggs in one cycle,
6:10
she needs to go for about 10 to 14 days twice daily injections
6:14
of hormones.
6:15
SPEAKER_01: In today's day and age,
6:16
SPEAKER_01: these hormones are still urine derived from some women,
6:18
SPEAKER_01: like marketed today in the United States,
6:21
SPEAKER_01: or some are recombinant.
6:23
They cause a lot of unwanted effects because you're giving like
6:27
hormones to the
6:27
whole body to act on one own cell type of little tiny ovaries
6:32
at the back of your tummy,
6:33
SPEAKER_01: right?
6:33
SPEAKER_01: So you're kind of acting everywhere in the body.
6:36
We know that hormones control everything and to act on woman's
6:41
own support cells.
6:42
So you're acting on her own support cells to try and say,
6:45
hey,
6:45
can you mature more eggs?
6:46
SPEAKER_01: Yeah.
6:47
SPEAKER_01: So, and that's only one cycle, right?
6:50
SPEAKER_01: And then on average,
6:52
SPEAKER_01: today in the US,
6:53
SPEAKER_01: which is one of the highest success rates of IVF in the whole world,
6:56
SPEAKER_01: a woman needs about three cycles for a baby.
6:59
And let's remind yourself that nobody's doing and spending all
7:01
this money and time
7:03
SPEAKER_01: for fun,
7:03
SPEAKER_01: right?
7:03
SPEAKER_01: Like ultimately people do want a baby.
7:06
SPEAKER_01: So that's where like the pain,
7:08
SPEAKER_01: the physical burden,
7:09
SPEAKER_01: the emotional burden,
7:10
SPEAKER_01: the side effects,
7:12
SPEAKER_01: the risks as well,
7:13
SPEAKER_01: like really compound and become like,
7:16
SPEAKER_01: A very difficult journey.
7:18
SPEAKER_01: So what we say, you know, with Fertillo is that we really change that.
7:21
It's a disruptive technology that is changing this
7:25
multi-billion dollar hormone
7:26
SPEAKER_01: injection market and saying,
7:27
SPEAKER_01: like,
7:28
SPEAKER_01: do we really need this?
7:29
SPEAKER_01: Why treat the woman when you could treat her eggs?
7:32
SPEAKER_01: And because our cells are iPS-derived, they're epigenetically young.
7:37
So you effectively give every woman this young ovary or young
7:40
follicle to be more
7:41
SPEAKER_01: precise in a dish.
7:42
SPEAKER_01: So you leverage a little bit of stimulation inside of the body.
7:46
With a fertility process,
7:47
a woman,
7:48
depending on her ovarian reserve,
7:49
would still have...
7:50
SPEAKER_01: up to zero to two or three injections.
7:54
SPEAKER_01: And then you then undergo a same egg retrieval process where the eggs are
7:58
SPEAKER_01: extracting outside of the body.
8:00
SPEAKER_01: And then the eggs are co-cultured for about a day in the laboratory,
8:03
SPEAKER_01: after which they're washed,
8:05
SPEAKER_01: denuded,
8:05
SPEAKER_01: enzymatically,
8:06
SPEAKER_01: completely cleaned.
8:07
SPEAKER_01: And then they can be frozen or fertilized.
8:09
SPEAKER_01: So it's kind of like changing like a marathon into a three-mile run and
8:13
SPEAKER_01: I'm actually training.
8:14
I'm registered for a half marathon next week and I haven't done
8:17
any training and
8:18
SPEAKER_01: that's already a burden.
8:19
SPEAKER_01: So imagine like a marathon where you tell somebody,
8:22
SPEAKER_01: hey,
8:22
SPEAKER_01: can you run like a marathon three times?
8:24
SPEAKER_01: Or, hey, can you do a three-mile run two or three times?
8:27
So like it becomes immediately more accessible,
8:29
more likely to be repeated.
8:31
SPEAKER_01: And then all of the unwanted effects mentally, physically...
8:35
SPEAKER_01: financially as well, hopefully kind of decline as well.
8:39
SPEAKER_01: And in our studies,
8:41
SPEAKER_01: you obviously mentioned the first life birth,
8:43
SPEAKER_01: but Fertilo,
8:44
SPEAKER_01: which is the product that I'm describing,
8:46
the program of this for maturation of eggs outside of the body
8:50
derived from stem cells,
8:51
SPEAKER_01: as we call it,
8:52
SPEAKER_01: is already cleared in many markets around the world.
8:56
SPEAKER_01: I saw that.
8:57
SPEAKER_01: during pregnancies.
8:59
SPEAKER_01: And we actually got clearance.
9:01
SPEAKER_01: So we're now starting our phase three trial in the United States,
9:04
which I believe is probably the first phase three trial of any
9:08
IPSC technology.
9:10
SPEAKER_01: And this time just happens to be in IVF.
9:14
SPEAKER_00: And I wanted to talk about that.
9:16
SPEAKER_00: Yeah, I saw that it was approved in so many countries already.
9:20
SPEAKER_00: So the U.S.
9:21
SPEAKER_00: is just
9:24
SPEAKER_00: You can fully do this at about, what was it?
9:26
SPEAKER_00: I saw it was like eight or nine countries, I think.
9:29
SPEAKER_01: Yeah, and it's growing.
9:32
SPEAKER_01: But it goes around to kind of what is the designation of the product.
9:35
SPEAKER_01: I think that is where,
9:38
SPEAKER_01: was one of the biggest challenges of running this company,
9:40
SPEAKER_01: is that when you start a biotech or any deep tech company,
9:44
SPEAKER_01: you always start with a premise,
9:45
SPEAKER_01: look like,
9:47
SPEAKER_01: if this works,
9:47
SPEAKER_01: it's going to be awesome.
9:49
SPEAKER_01: I'm going to help the world.
9:50
SPEAKER_01: Everybody's going to...
9:51
SPEAKER_01: You know,
9:51
SPEAKER_01: you make the world a better place,
9:53
SPEAKER_01: you build a great business,
9:55
but then you start with that risk that you don't really know if
9:58
it works because
9:58
SPEAKER_01: you can't really bootstrap and test it in your garage,
10:01
SPEAKER_01: right?
10:01
SPEAKER_01: Like, it's not how these companies are.
10:04
SPEAKER_01: However,
10:04
SPEAKER_01: you know,
10:05
SPEAKER_01: an additional challenge of our company was like,
10:07
SPEAKER_01: okay,
10:07
SPEAKER_01: even if I make this to work,
10:09
SPEAKER_01: like,
10:09
SPEAKER_01: how is this going to be approved?
10:12
SPEAKER_01: Like, what is this?
10:13
SPEAKER_01: And from the very beginning,
10:14
working even with different regulatory experts from different
10:18
countries and even in
10:20
SPEAKER_01: the same kind of jurisdiction,
10:21
SPEAKER_01: in the same regulatory authority,
10:24
SPEAKER_01: they would say,
10:25
SPEAKER_01: well,
10:25
SPEAKER_01: you know,
10:25
SPEAKER_01: this is a device because it is used outside of the body,
10:29
SPEAKER_01: no action inside of the body,
10:30
SPEAKER_01: so...
10:32
SPEAKER_01: Legally, it makes the definition of a device.
10:34
SPEAKER_01: And then to add an additional caveat I haven't mentioned,
10:37
SPEAKER_01: but this concept of maturing outside a body is not new.
10:40
SPEAKER_01: We did not invent it.
10:43
SPEAKER_01: It's as old as IVF.
10:44
SPEAKER_01: Recorded births go from 1991,
10:47
SPEAKER_01: but there are some kind of hybrid forms that have happened even before.
10:52
SPEAKER_01: Over 10,000 babies have been born with this technology.
10:54
SPEAKER_01: They're FDA-approved products for this.
10:56
SPEAKER_01: It's mostly kind of a very much media solution, not a cell therapy.
11:01
SPEAKER_01: like we do, and they were all cleared as devices.
11:05
And then in some places,
11:07
in vitro practices of IVF are not regulated at all.
11:10
SPEAKER_01: They're excluded from regulations.
11:12
SPEAKER_01: And then in some places,
11:13
SPEAKER_01: like in the United States,
11:14
SPEAKER_01: ultimately they've said,
11:15
SPEAKER_01: look,
11:16
SPEAKER_01: this is a living cell product,
11:18
SPEAKER_01: so we will classify it as a biologic.
11:21
So I think the time to market and the level of evidence you
11:24
need to prove in
11:26
SPEAKER_01: studies to get approved
11:29
SPEAKER_01: Went from,
11:30
are you completely excluded from pharmaceutical regulations
11:32
because we just do not
11:33
SPEAKER_01: regulate in vitro practices?
11:34
SPEAKER_01: Are you reproductive tissue?
11:36
SPEAKER_01: Are you a device?
11:37
SPEAKER_01: Or are you a biologic?
11:39
And that is something that is really every jurisdiction had to
11:43
set a regulatory
11:45
SPEAKER_01: precedent because this is such an innovative product for a lot of them.
11:49
And you talked about,
11:51
you know,
11:51
part of this is I've seen you give other talks.
11:54
SPEAKER_00: I mean, this is about...
11:57
SPEAKER_00: This two-week process of all these injections you usually have to take,
12:02
SPEAKER_00: does it fit in with people's lifestyle,
12:05
SPEAKER_00: how busy they are?
12:06
SPEAKER_00: It's a lot of work.
12:08
And so you mentioned already,
12:10
maybe you have to do one,
12:12
two,
12:13
three injections.
12:15
SPEAKER_00: You also mentioned going,
12:16
SPEAKER_00: because I know people who've done this,
12:18
SPEAKER_00: where they have to go for multiple rounds of these treatments,
12:22
SPEAKER_00: and it gets up to what,
12:23
SPEAKER_00: like 20,000?
12:25
SPEAKER_00: If you start per cycle, right?
12:29
SPEAKER_00: So it's expensive.
12:30
And it just wasn't clear to me in everything I read about you
12:34
and your company.
12:35
SPEAKER_00: I got the convenience part,
12:38
but I wasn't sure if this cuts down potentially on the number
12:41
of rounds that you
12:42
SPEAKER_00: have to do.
12:44
Yeah,
12:44
so I think some of these questions are still early in the technology.
12:48
I can comment on the data that we have,
12:50
that we have published and that we're about to publish.
12:52
SPEAKER_01: So there are a few ways of looking into that.
12:56
SPEAKER_01: So far,
12:56
SPEAKER_01: what we have shown is that with our process,
12:59
SPEAKER_01: you get about the same number of healthy good embryos per cycle.
13:04
SPEAKER_01: Similarly,
13:05
SPEAKER_01: in places where we are approved,
13:08
SPEAKER_01: the pregnancy rates are as good as IVF in those clinics.
13:12
SPEAKER_01: There are some potential signals that in certain patient populations,
13:16
but we actually already know this concept of in vitro
13:18
maturation works better,
13:20
SPEAKER_01: like women with polycystic ovarian syndrome,
13:22
SPEAKER_01: women with high ovarian reserve.
13:25
SPEAKER_01: egg donors, egg freezers, that this could work better.
13:29
SPEAKER_01: But I think right now we're still in that early process.
13:33
SPEAKER_01: We're still collecting more data.
13:34
What we do know already from kind of doing and we published
13:38
that paper in fertility,
13:39
SPEAKER_01: civility science last year,
13:41
SPEAKER_01: for example,
13:42
SPEAKER_01: about the side effects and the ability to repeat,
13:45
SPEAKER_01: right?
13:45
SPEAKER_01: So what I think we're certainly collecting this year
13:50
SPEAKER_01: is data in specific patient group to see,
13:51
SPEAKER_01: okay,
13:52
like this looks to be potentially more effective in this
13:54
patient population,
13:55
SPEAKER_01: let's prove it.
13:56
And that's the data that,
13:57
you know,
13:57
we don't yet have in robust,
13:59
large patient numbers.
14:00
But one other thing that you already can say is that you look
14:04
at women who've done
14:05
SPEAKER_01: one cycle of IVF and one cycle of Fertillo,
14:07
SPEAKER_01: and then the women who've done a Fertillo cycle,
14:10
SPEAKER_01: 92% say,
14:11
SPEAKER_01: yes,
14:11
SPEAKER_01: I would do it again.
14:12
SPEAKER_01: And again, it's only, you know, two to three days.
14:15
SPEAKER_01: And so it's about the repetition number, right?
14:18
Because ultimately you need a few cycles for the majority of
14:21
people to get a baby.
14:23
SPEAKER_01: So already from that point of view, you're more likely to get it.
14:28
And I don't want to go in detail on the pricing because
14:30
obviously it differs from
14:31
SPEAKER_01: one jurisdiction to another.
14:32
SPEAKER_01: And the final pricing is usually done after approval.
14:35
SPEAKER_01: And we therefore don't yet have U.S.
14:37
pricing because we're just starting our phase three trial right
14:40
now and hope to
14:42
SPEAKER_01: start recruitment in a couple of weeks.
14:44
SPEAKER_01: But essentially,
14:47
SPEAKER_01: current hormone injections are about $4,000 to $5,000,
14:49
SPEAKER_01: depending on where you cut it per cycle.
14:51
SPEAKER_01: And you don't need that many.
14:53
SPEAKER_01: You also don't need the clinic monitoring.
14:55
So we do believe that this should be a more accessible solution
14:59
as well in all
15:01
SPEAKER_01: jurisdictions where it's launching.
15:03
So kind of like just from a convenient side effects and access
15:07
point of view,
15:07
SPEAKER_01: if you're more likely to get to that 3%,
15:10
you're more likely to get a baby already,
15:12
but more studies are currently being in development.
15:15
And also our phase three trial will also look at our pregnancy
15:18
rate in the United States,
15:20
SPEAKER_01: which would be an important data point.
15:22
SPEAKER_00: Okay.
15:24
Let's get into some of the science and please,
15:27
I'm just a reporter dolt,
15:29
so correct me as we go.
15:31
SPEAKER_00: But I think...
15:34
SPEAKER_00: Somehow,
15:34
SPEAKER_00: out of the first handful of shows that we've done,
15:37
SPEAKER_00: we're talking about IPSC all the time.
15:39
I think this is like the only podcast that I know of that's
15:44
following all this
15:45
SPEAKER_00: closely at the moment.
15:46
SPEAKER_00: But it's these induced pluripotent stem cells.
15:50
SPEAKER_00: For people who have heard some of our other shows,
15:53
SPEAKER_00: it's like this amazing technology where,
15:55
SPEAKER_00: as you mentioned,
15:56
SPEAKER_00: Dr.
15:56
SPEAKER_00: Yamanaka won a Nobel Prize for this in 2012.
16:00
SPEAKER_00: He found a way to take
16:02
SPEAKER_00: basically any cell,
16:03
you could take a skin cell off an animal and hit it with these
16:08
four proteins,
16:09
SPEAKER_00: this combination of proteins that they call transcription factors,
16:12
SPEAKER_00: and reverse it back to the stem cell state.
16:16
And then we found that then you can mature those cells forward
16:22
again and turn them
16:23
SPEAKER_00: into whatever you want,
16:25
SPEAKER_00: a brain cell,
16:26
SPEAKER_00: a neuron,
16:26
SPEAKER_00: a heart cell,
16:27
SPEAKER_00: a liver cell.
16:29
SPEAKER_00: And so in this particular case,
16:31
SPEAKER_00: You're,
16:32
SPEAKER_00: you're turning at least some of,
16:34
SPEAKER_00: I know you have a wide range of,
16:36
SPEAKER_00: of areas where the company is hoping to go,
16:38
SPEAKER_00: but in this particular case,
16:39
SPEAKER_00: it's,
16:40
SPEAKER_00: it's ovarian cells,
16:41
SPEAKER_00: right?
16:41
SPEAKER_00: I mean,
16:41
SPEAKER_00: so you're taking,
16:43
you're synthetically making a stem cell and then turning it
16:47
into an ovarian cell
16:49
SPEAKER_00: and then,
16:50
SPEAKER_00: and then having those ovarian cells do their,
16:52
SPEAKER_00: do their jobs on the,
16:54
SPEAKER_00: on the embryo,
16:54
SPEAKER_00: right?
16:56
SPEAKER_01: Well, not on the end, Maria, on the human end.
16:58
SPEAKER_00: Sorry, sorry, on the end.
17:00
SPEAKER_01: But other than that, you don't need me here.
17:04
SPEAKER_01: But you've explained it very well.
17:07
SPEAKER_01: I would say,
17:07
SPEAKER_01: I think honestly,
17:09
SPEAKER_01: obviously I'm biased,
17:10
SPEAKER_01: but I do believe this area of cell engineering holds a great promise.
17:15
We've certainly had kind of waves of hype of regenerative
17:20
medicine and other,
17:21
SPEAKER_01: but I do think now we're at the right time where we can see actually the
17:26
the benefits of these technologies because a lot of scientific
17:29
major problems have
17:31
kind of been solved or about to be solved or look like we're
17:35
getting there slowly.
17:36
SPEAKER_01: So I think certainly with induced peripotent stem cells,
17:41
SPEAKER_01: We are at that place that,
17:42
SPEAKER_01: you know,
17:42
SPEAKER_01: they're not embryonic stem cells,
17:44
SPEAKER_01: they're not human derived.
17:47
SPEAKER_01: They can be synthetic,
17:49
SPEAKER_01: as you say,
17:50
SPEAKER_01: they can be ethically,
17:52
SPEAKER_01: they can be sourced,
17:53
SPEAKER_01: they can be mass manufactured.
17:55
SPEAKER_01: And that is, I think, like a good way to drive the field forward.
18:00
For example,
18:01
for Gamito,
18:03
we've licensed from ReproCell,
18:05
a company from Japan,
18:07
probably or
18:09
the world's first female allergenic induced pluripotent stem
18:12
cell line that was fully GMP.
18:14
And then we took that line and as you said,
18:16
converted with transcription factors.
18:19
SPEAKER_00: Sorry, what's GMP there?
18:21
SPEAKER_00: What is GMP?
18:21
SPEAKER_01: Well, it's like good medical, it's a kind of a good way of manufacturing.
18:27
So I think that is where we're the highest standard of
18:31
manufacturing because
18:32
SPEAKER_01: perhaps in the United States,
18:34
SPEAKER_01: we are regulated as a biologic.
18:37
SPEAKER_01: And our way of manufacturing is regulated like a cell therapy.
18:42
SPEAKER_01: So more similar to CAR T cell therapies or other cell therapies, right?
18:47
SPEAKER_01: So I think that's probably a good way to explain it.
18:50
SPEAKER_01: Because every time you have a biologically active product,
18:54
SPEAKER_01: there are challenges in manufacturing.
18:56
SPEAKER_01: So those are some scientific challenges that we had to solve to provide.
19:00
Now we have at-scale manufacturing in the United States and are
19:04
able to provide the
19:06
SPEAKER_01: world's IVF,
19:07
SPEAKER_01: over 4 million IVF cycles.
19:10
SPEAKER_01: Now we are lucky that Fertillo is also,
19:13
SPEAKER_01: I would say,
19:14
an easier way to bring back to the clinic and to commercialize
19:18
a cell therapy
19:19
SPEAKER_01: derived from endosporipartin stem cells.
19:21
SPEAKER_01: And you might ask why?
19:23
SPEAKER_01: Well,
19:23
the reason is because we treat a few cells in a dish outside of
19:29
the body with no
19:30
SPEAKER_01: immune system.
19:32
SPEAKER_01: And some of the remaining challenges from these like stem cells,
19:34
SPEAKER_01: when they converted to a brain cell or a cell of the pancreas,
19:37
curing your dementia or your diabetes is how do you produce
19:41
enough cells that you
19:42
SPEAKER_01: can inject into a whole human body,
19:44
SPEAKER_01: not 20 eggs.
19:45
SPEAKER_01: And then how do you ensure
19:47
that these cells are then not rejected by the body because,
19:51
you know,
19:52
they're synthetic,
19:52
right?
19:52
SPEAKER_01: They're mass manufactured and they're yours.
19:55
SPEAKER_01: When again, eggs don't have an immune system, but our bodies do.
19:59
So I think some of these remaining issues of what they call immunogenicity,
20:03
SPEAKER_01: that's that immune rejection,
20:05
SPEAKER_01: but also cost-effective at scale manufacturing,
20:08
SPEAKER_01: are...
20:09
SPEAKER_01: currently being sold for some other programs.
20:12
SPEAKER_01: And we have a program that is dealing with those issues as well.
20:15
SPEAKER_01: But for TLO, it's therefore a great first application.
20:19
SPEAKER_01: And I think,
20:20
SPEAKER_01: honestly,
20:20
SPEAKER_01: it has been a little bit overlooked because everybody went for,
20:25
SPEAKER_01: oh,
20:25
SPEAKER_01: like the standard biotech suspects or like the sexy biotech areas.
20:30
SPEAKER_01: And women's health and IVF was never really scoring there,
20:34
SPEAKER_01: even though I hope by the end of this podcast,
20:36
I'll convince people it is one of the most exciting areas of
20:39
biotechnological
20:41
SPEAKER_01: breakthroughs to happen this decade.
20:44
SPEAKER_01: But it wasn't there.
20:45
And I think that's where we had the first mover advantage is
20:48
that even as a small company,
20:50
SPEAKER_01: we saw it as an opportunity.
20:51
SPEAKER_01: And obviously, like me being a woman, I had skin in the game.
20:55
SPEAKER_01: I understood the problem.
20:57
SPEAKER_01: I really wanted it solved.
20:58
SPEAKER_01: I came up with a program idea when thinking about my own egg freezing.
21:01
SPEAKER_01: I was definitely the target market I was going for at the time.
21:04
SPEAKER_01: So...
21:06
SPEAKER_01: I think that's why this is a great first wave.
21:08
SPEAKER_01: And I think IPSCs hold a great promise,
21:11
SPEAKER_01: but there are still some of these challenges that we have to overcome.
21:16
Although I've seen some great papers come out there about kind
21:19
of immune covering
21:21
SPEAKER_01: and other ways.
21:23
And there are a couple of companies really paving the way for
21:26
all of us in this space.
21:27
SPEAKER_00: No,
21:28
SPEAKER_00: I mean,
21:29
SPEAKER_00: you know,
21:29
SPEAKER_00: not to go super easy on you or whatever,
21:33
SPEAKER_00: I guess,
21:33
SPEAKER_00: but yeah,
21:34
SPEAKER_00: I mean,
21:35
SPEAKER_00: I was shocked because I've been covering,
21:37
SPEAKER_00: like I mentioned,
21:37
SPEAKER_00: IPSCs,
21:38
SPEAKER_00: especially in the longevity field.
21:41
SPEAKER_00: There's so much exciting work going on,
21:44
SPEAKER_00: but it's really hard to push the stuff from the lab into the real world,
21:49
SPEAKER_00: and there's problems happening.
21:51
beyond what you mentioned where sometimes you fire these back
21:55
up as a liver cell
21:58
and it's just kind of overheated and it turns into a teratoma
22:01
and starts forming
22:02
SPEAKER_00: tumors in the body.
22:05
SPEAKER_00: It's been a challenge.
22:06
SPEAKER_00: You could tell that this technology is
22:09
SPEAKER_00: has so much, I get, at least I get really excited.
22:12
SPEAKER_00: I mean,
22:12
it seems like a miraculous kind of thing that we've learned in
22:16
this process of life
22:17
SPEAKER_00: that we can reverse engineer and just to,
22:21
SPEAKER_00: so I was shocked anyway that you were already,
22:23
SPEAKER_00: I had no idea that not only were you so close in the US on the clinical,
22:28
SPEAKER_00: the third stage of the clinical trial,
22:29
SPEAKER_00: but the babies had already been born with some of this technology.
22:33
SPEAKER_00: And on this point, you know, I mean,
22:37
Your company,
22:38
you position it sometimes more broadly as almost like a female
22:45
aging company.
22:46
SPEAKER_00: And this first product is just one of where you're hoping to go.
22:51
SPEAKER_00: I've seen you talk a lot about
22:54
exploring where this technology could be used to treat
22:58
menopause and a variety of
23:00
SPEAKER_00: female health issues.
23:02
But I enjoy how you describe the female aging process as being
23:10
so different to the
23:11
SPEAKER_00: male aging process.
23:13
SPEAKER_00: Can you explain that to the audience?
23:17
SPEAKER_01: Yeah,
23:17
SPEAKER_01: well,
23:17
I think the part that you're describing is the way we form our
23:21
sex cells or gametes,
23:23
SPEAKER_01: right?
23:23
SPEAKER_01: That process of gametogenesis.
23:25
And one could argue that gameto is kind of changing the playing
23:29
field of gametogenesis,
23:31
right?
23:31
SPEAKER_01: Hence the name.
23:34
And that is perhaps the main difference that I,
23:36
you know,
23:37
I sometimes talk about.
23:38
And that is that,
23:39
you know,
23:39
we as women were born with definite number of eggs.
23:42
All the eggs that,
23:43
you know,
23:44
we've ever had were born while we were still in utero.
23:47
SPEAKER_01: So,
23:48
SPEAKER_01: you know,
23:48
SPEAKER_01: there are all these jokes like,
23:49
SPEAKER_01: oh,
23:49
SPEAKER_01: I was actually in my grandma's tummy,
23:51
SPEAKER_01: you know,
23:52
SPEAKER_01: right?
23:52
Because I came from my mother's egg that was formed while she
23:55
was still in my
23:56
SPEAKER_01: grandma's tummy while my grandma was pregnant.
23:58
SPEAKER_01: So, yeah.
23:59
SPEAKER_01: Therefore, you're born with a finite number of eggs.
24:01
SPEAKER_01: By the time you get your first period, you've already lost a lot.
24:03
SPEAKER_01: And there's variations, like different times, there's a thousand.
24:06
But let's say when you have your first period,
24:08
you have about 400,000 eggs or so.
24:11
And then,
24:11
you know,
24:11
you lose them throughout your life,
24:13
whether or not they mature.
24:14
SPEAKER_01: You know, I could lose a few even during this podcast.
24:18
And,
24:20
you know,
24:20
by the time you want to use them,
24:21
you've already have lost a lot.
24:24
SPEAKER_01: And that time when you want to use them has been changing, right?
24:27
SPEAKER_01: And there were current socioeconomic and demographic factors.
24:30
SPEAKER_01: I think the age of the first birth has been going higher and higher.
24:36
SPEAKER_01: And ultimately what we have shown is,
24:39
SPEAKER_01: and what we have found is that yes,
24:41
SPEAKER_01: it's around the age of mid thirties where,
24:43
SPEAKER_01: you know,
24:43
women are super young and every other organ that also declines
24:48
as we age declines
24:50
SPEAKER_01: more in synchrony with each other,
24:51
SPEAKER_01: right?
24:51
SPEAKER_01: Like her kidney function also declines as we age.
24:54
SPEAKER_01: If you look at the
24:55
SPEAKER_01: glomerular filtration rates,
24:57
SPEAKER_01: the function of the kidney filtration units,
25:01
SPEAKER_01: it also goes down as you age,
25:02
SPEAKER_01: and that's why you have age-corrected factors.
25:04
SPEAKER_01: But you will really start seeing it,
25:06
SPEAKER_01: unless you have some disease,
25:08
SPEAKER_01: from 60,
25:09
SPEAKER_01: 70 years old and onwards.
25:10
SPEAKER_01: Whereas with ovaries,
25:12
SPEAKER_01: you're starting to see a decline in function in your mid-30s,
25:15
SPEAKER_01: and then a complete stopping of that function
25:18
SPEAKER_01: around the age of 50, right?
25:20
SPEAKER_01: The median age of menopause is 51 in the United States.
25:23
SPEAKER_01: So that's a function which is, you know, it's a bit odd, right?
25:26
SPEAKER_01: Like, why are all my organs like aging like this way?
25:30
SPEAKER_01: And this one is totally aging out of sync with the rest.
25:33
SPEAKER_01: Like, why are you failing me when I want to use you?
25:36
SPEAKER_01: If you go back to first principles, doesn't,
25:38
SPEAKER_01: Doesn't make much sense.
25:39
SPEAKER_01: And I think that's why we said,
25:41
SPEAKER_01: okay,
25:41
SPEAKER_01: well,
25:41
SPEAKER_01: you know,
25:42
SPEAKER_01: ovaries age faster than the rest of the woman's body.
25:44
SPEAKER_01: Therefore,
25:45
SPEAKER_01: women now spend,
25:46
SPEAKER_01: you know,
25:46
SPEAKER_01: two-thirds of our lives infertile,
25:48
SPEAKER_01: and then about half of our life in this stage post-menopause,
25:50
SPEAKER_01: where we do have a higher burden of chronic disease,
25:54
SPEAKER_01: which if you study basic pathways,
25:56
you can see that some of them have clear connections to the
25:58
lack of hormones that
26:00
SPEAKER_01: our ovaries produce,
26:01
SPEAKER_01: right?
26:01
SPEAKER_01: Like ovaries are an endocrine organ, not just...
26:06
SPEAKER_01: So from that point of view,
26:08
SPEAKER_01: the kind of premise of gameto is,
26:10
SPEAKER_01: look,
26:11
SPEAKER_01: if,
26:11
SPEAKER_01: you know,
26:12
SPEAKER_01: you lose that ovarian function,
26:13
can we provide you solutions that prevent that decline from
26:17
causing you harm?
26:19
SPEAKER_01: And the first version of that is Fertila, which is tackling infertility.
26:24
SPEAKER_01: And we mentioned why, right?
26:28
SPEAKER_01: easier to do.
26:30
SPEAKER_01: And we've already kind of got it done.
26:31
SPEAKER_01: We've established manufacturing.
26:33
SPEAKER_01: We've proven in large human groups that it works.
26:35
SPEAKER_01: We've published studies.
26:36
SPEAKER_01: We've got approvals.
26:37
SPEAKER_01: We're in the phase three.
26:39
And then you essentially could allow a shorter way for women to
26:45
freeze their eggs,
26:45
SPEAKER_01: access fertility preservations,
26:47
SPEAKER_01: or access reproductive care.
26:49
SPEAKER_01: And there's now compelling data and more and more data is coming, right?
26:52
SPEAKER_01: Like egg freezing is also a new technology, but there's more data that...
26:56
SPEAKER_01: The age of when you freeze your eggs is basically kept.
27:01
SPEAKER_01: So let's say I freeze my eggs at 28,
27:02
SPEAKER_01: like late 20s are,
27:04
SPEAKER_01: you know,
27:04
SPEAKER_01: for a lot of doctors,
27:05
SPEAKER_01: a good time to freeze your eggs.
27:06
SPEAKER_01: And then you want to use them at 38 if you're healthy,
27:09
SPEAKER_01: if you exercise,
27:10
SPEAKER_01: if you don't smoke,
27:12
SPEAKER_01: you know,
27:12
SPEAKER_01: you look after yourself.
27:13
You could have the success rate of a 28-year-old because that's
27:16
when you froze your eggs.
27:17
SPEAKER_01: Like the uterus, the womb, does not age like your ovaries.
27:21
SPEAKER_01: So that kind of is a great way to allow you maybe six,
27:24
seven more years to reach both your family goals and everything
27:29
you want to have.
27:30
SPEAKER_01: And there have been numerous studies that have shown that a lot of women,
27:33
SPEAKER_01: even those that do become mothers,
27:35
SPEAKER_01: run out of time.
27:37
SPEAKER_01: They don't reach their family goals.
27:39
SPEAKER_01: And it's very easy to understand why.
27:42
SPEAKER_01: So I think that's for TILA.
27:44
SPEAKER_01: And then beyond that,
27:45
SPEAKER_01: we look at,
27:46
SPEAKER_01: okay,
27:46
SPEAKER_01: menopause and early menopause,
27:49
the condition called primary ovarian insufficiency that affects
27:51
about 1% of women is,
27:54
SPEAKER_01: you know,
27:54
SPEAKER_01: what happens during that menopause transition.
27:56
It's a very brutal reduction in all the hormones your body has
28:01
been using to make.
28:02
Eight out of 10 women report some symptoms during perimenopause
28:06
and menopause,
28:07
SPEAKER_01: like hot flashes and brain fog and
28:12
SPEAKER_01: Then some minority experience more severe mental health,
28:16
SPEAKER_01: physical health,
28:17
SPEAKER_01: sexual health symptoms.
28:18
SPEAKER_01: But then later on, it can lead to bone decline.
28:21
SPEAKER_01: It can lead to vaginal dryness.
28:22
SPEAKER_01: It can lead to pain and urination.
28:24
SPEAKER_01: It can lead to increased risk of cardiovascular disease.
28:27
SPEAKER_01: New and new papers suggest even a link with dementia.
28:30
SPEAKER_01: So then you argue,
28:31
SPEAKER_01: okay,
28:31
SPEAKER_01: like,
28:31
SPEAKER_01: is there something...
28:32
SPEAKER_01: Right now,
28:33
SPEAKER_01: there's this hormone replacement therapy that...
28:36
SPEAKER_01: still kind of doesn't have too much data on.
28:40
SPEAKER_01: It is probably the best band-aid that we have for a lot of people,
28:43
SPEAKER_01: but we can certainly kind of do better.
28:45
SPEAKER_01: So the idea with our second program,
28:47
SPEAKER_01: which we called Amino,
28:49
SPEAKER_01: is where we leverage the same cell engineering technology
28:52
But we're basically making an implant that you would put in
28:57
your arm or a vaginal
28:58
ring that can provide real-time hormone replacement that you
29:02
need and therefore
29:03
delay some of these symptoms and chronic disease that occur
29:08
during menopause that
29:08
SPEAKER_01: you could wear for a few years and delay that.
29:11
SPEAKER_01: And potentially,
29:12
SPEAKER_01: this is still very early,
29:14
delay some of the symptoms that come with age and the onset of
29:17
these conditions.
29:18
SPEAKER_01: And
29:19
SPEAKER_01: We have secured some funding for, for that program and, um, our, um,
29:25
SPEAKER_01: doing now animal work with the first prototype of the implant.
29:29
So hopefully,
29:29
you know,
29:30
we've started some of the IND enabling studies for phase one.
29:32
SPEAKER_01: So it's a much earlier program,
29:34
but obviously could have an even bigger impact potentially on
29:38
kind of the health of
29:40
SPEAKER_01: women globally,
29:41
SPEAKER_01: right?
29:41
Because not in the conditions that affect every woman as they
29:46
go through menopause,
29:47
SPEAKER_01: if they,
29:47
SPEAKER_01: you know,
29:48
SPEAKER_01: feel that they want some medical treatment.
29:51
SPEAKER_00: Is that, and is that...
29:54
SPEAKER_00: Is IPSC derived as well, or is it just a totally different?
29:57
SPEAKER_01: Everything is IPSC derived.
29:58
And the nice thing is that with a lot of things that we've done
30:00
with Fortilo development,
30:03
SPEAKER_01: we have already solved a lot of things like master cell banks,
30:07
SPEAKER_01: a lot of things,
30:08
SPEAKER_01: right?
30:08
SPEAKER_01: Like, okay, what are good standards of manufacturing?
30:11
SPEAKER_01: Even a lot of things that we had to patent.
30:13
SPEAKER_01: I mean, being the first mover in an area.
30:16
SPEAKER_01: It's very painful.
30:19
It's very painful because there's very little precedent and
30:23
it's hard because you
30:24
SPEAKER_01: have to figure out your own vendors and then vendors don't even know,
30:27
SPEAKER_01: okay,
30:27
like what is considered truly like highest standard of
30:31
manufacturing for these stem cells?
30:33
And then you're like,
30:33
okay,
30:34
I need like a robot and a way to fill my vials.
30:37
But like,
30:38
well,
30:38
nobody has filled the vials with stem cells at this low cell dose.
30:41
SPEAKER_01: So we have to make our own way of doing it.
30:43
SPEAKER_01: So we've actually ended up
30:45
SPEAKER_01: The nice thing is that at the tail end,
30:47
you have a lot of these know-hows and a lot of patents in IP
30:52
that you've created.
30:53
Honestly,
30:53
it's just as a byproduct of trying to solve and get your
30:57
product down.
30:57
SPEAKER_01: So our manufacturing team has been
31:00
SPEAKER_01: very,
31:00
SPEAKER_01: very busy and,
31:02
SPEAKER_01: um,
31:02
has managed to solve some of the hardest problems in IPSEs
31:05
because we just have no other,
31:06
SPEAKER_01: no other way.
31:07
SPEAKER_01: And we can now leverage some of that for,
31:09
SPEAKER_01: for other programs once they go to more,
31:12
SPEAKER_01: a larger clinical scale.
31:13
SPEAKER_01: Right now, as I mentioned, we're just doing animal work for amino.
31:15
So with amino,
31:18
I mean,
31:20
what,
31:20
what sort of cells are you looking to,
31:23
to create in the lab?
31:25
So if you look at kind of what we call these ovarian support cells,
31:29
right?
31:29
SPEAKER_01: Like,
31:29
SPEAKER_01: I mean,
31:29
SPEAKER_01: my dad is a professor of embryology and histology,
31:32
and he'll probably get a heart attack if I call them all
31:34
ovarian support cells.
31:35
SPEAKER_01: But these are different types of like granulosa, tica cells.
31:38
But ultimately,
31:38
like,
31:39
you know,
31:39
in our ovaries,
31:40
we have eggs and we have these support cells.
31:42
SPEAKER_01: And these support cells broadly, very broadly, sorry, dad, do two things.
31:46
SPEAKER_01: One is they help eggs mature, right?
31:49
SPEAKER_01: And that's why you leverage for rutillo.
31:51
SPEAKER_01: And then the other thing, they secrete the hormones, right?
31:53
SPEAKER_01: So estrogen,
31:55
SPEAKER_01: progesterone,
31:56
SPEAKER_01: like androgens that we also make as women that affect our drive,
31:59
SPEAKER_01: lean muscle mass that we also lose post-menopause.
32:03
SPEAKER_01: These are not made by the eggs.
32:04
SPEAKER_01: These are made by these support cells.
32:06
SPEAKER_01: Okay.
32:07
For amino,
32:08
you could already leverage that second function of the support cell.
32:10
SPEAKER_01: So you leverage kind of the same support cell technology.
32:14
SPEAKER_01: It's just that because you're putting them inside of the body,
32:17
SPEAKER_01: you cannot just inject the cells,
32:18
SPEAKER_01: right?
32:19
SPEAKER_01: Like it's not kind of how it's going to work.
32:21
SPEAKER_01: And you want to ensure that they're, so we have an encapsulation method.
32:27
SPEAKER_01: Then you want to ensure that they can obviously not escape that capsule,
32:31
that they can be taken in and out at any time because these are
32:33
hormone producing cells,
32:34
SPEAKER_01: right?
32:35
SPEAKER_01: Like
32:36
SPEAKER_01: We know that that was a problem with some of the HRT,
32:38
SPEAKER_01: hormone replacement therapy studies before.
32:41
SPEAKER_01: And often the reason why women don't go for hormone replacement,
32:46
SPEAKER_01: they say,
32:46
SPEAKER_01: well,
32:46
SPEAKER_01: you know,
32:46
SPEAKER_01: I'm worried about the risk of breast cancer.
32:49
SPEAKER_01: So it's a common cancer, right?
32:51
SPEAKER_01: Like if you,
32:52
SPEAKER_01: you know,
32:52
SPEAKER_01: live long enough,
32:54
SPEAKER_01: one in nine women,
32:55
SPEAKER_01: you know,
32:55
SPEAKER_01: happen to develop breast cancer.
32:57
SPEAKER_01: So you want to ensure that if you're at risk or if you're worried of
33:00
SPEAKER_01: Anything like that happens, you can always take it in and out.
33:03
SPEAKER_01: Also that you have that choice, right?
33:05
SPEAKER_01: That you think,
33:07
SPEAKER_01: okay,
33:07
SPEAKER_01: I need this therapy to go down,
33:09
SPEAKER_01: push this onset of menopause,
33:11
SPEAKER_01: feel good,
33:11
SPEAKER_01: keep my lean muscle mass,
33:13
SPEAKER_01: keep certain parameters fixed.
33:15
SPEAKER_01: well, and then you can taper down.
33:17
SPEAKER_01: So it has to be taken in and out,
33:19
but it also needs to be able to release the hormones so that
33:23
they can provide that
33:25
SPEAKER_01: real world replacement.
33:26
SPEAKER_01: So it's an encapsulation of the cells.
33:29
And then we'll actually leverage some of the technology of the
33:32
contraceptive devices.
33:34
SPEAKER_01: So we kind of use very similar model because that has been proven.
33:37
SPEAKER_01: It works well.
33:38
So we kind of use some of that and if that's how we've made the
33:43
first prototypes
33:44
SPEAKER_01: that we're testing in animals.
33:46
SPEAKER_01: But then again,
33:46
SPEAKER_01: obviously,
33:47
SPEAKER_01: as you know,
33:47
SPEAKER_01: in IND enabling work,
33:50
there's obviously depending on experimental data ability and to
33:54
change and iterate
33:55
SPEAKER_01: depending on the results you get.
33:57
SPEAKER_01: So I think like we're hoping to build
33:59
an implant like a ring or like an implant that you can put here
34:02
in an arm,
34:03
SPEAKER_01: take in and out,
34:04
SPEAKER_01: provides real-world hormone replacement.
34:06
SPEAKER_01: You don't have the negative consequence of menopause.
34:09
SPEAKER_01: You push away these conditions that come with aging,
34:12
SPEAKER_01: like osteoporosis and so forth for a few years,
34:14
SPEAKER_01: and then you could stop wearing it.
34:17
SPEAKER_01: But you've kind of got,
34:18
SPEAKER_01: again,
34:18
SPEAKER_01: a few more years in a more gradual transition,
34:22
not like an abrupt transition that you lose 80% of hormones
34:25
within a year and
34:27
SPEAKER_01: You don't feel good, which is what a lot of women report.
34:31
SPEAKER_00: Okay.
34:32
SPEAKER_00: All right, this is where I have potential to embarrass myself greatly.
34:39
SPEAKER_00: When I've seen you talk about this before, you mentioned that
34:43
SPEAKER_00: I believe this is what you say.
34:45
SPEAKER_00: Humans are unique in experiencing menopause,
34:50
SPEAKER_00: except for whales that also seem to go through the same process.
34:55
SPEAKER_00: I always see you throw out this fact,
34:57
SPEAKER_00: but I was so fascinated as to how we know this and why we think this is.
35:04
SPEAKER_01: Yeah,
35:04
SPEAKER_01: so,
35:04
SPEAKER_01: I mean,
35:04
I had the pleasure that I spent some time at the Buck Research
35:07
Institute where I
35:08
SPEAKER_01: had the visiting research scientist post and I worked closely with Dr.
35:12
SPEAKER_01: Jennifer Garrison.
35:13
SPEAKER_01: And I'm a doctor, like I've only studied humans.
35:15
I've spent like six months doing little humans and that
35:18
honestly already felt too weird.
35:21
SPEAKER_01: So I have not studied these whales, nor animals, nor checked personally.
35:24
SPEAKER_01: So I just want to protect myself there.
35:27
SPEAKER_01: The work that Jennifer,
35:28
SPEAKER_01: Dina,
35:29
and me are also at the Buck Institute right now are doing and
35:32
what they report.
35:33
SPEAKER_01: And there has actually been some follow-on studies,
35:35
but so far we've shown that other similar animals do not
35:41
develop and experience
35:42
SPEAKER_01: ovarian aging the way we do in humans.
35:44
SPEAKER_01: I think that is what we do now.
35:46
Evolutionary biologists say that it is really only humans and
35:49
these four types of whales.
35:51
SPEAKER_01: Some studies have reported, this is a newer paper,
35:55
SPEAKER_01: that certain primates in captivity would develop menopause,
35:59
but they don't know if it's the captivity that causes it and
36:02
just a different way
36:03
SPEAKER_01: of life that's more similar to human life.
36:06
SPEAKER_01: Or is it that like in wildlife, we never really caught it.
36:09
SPEAKER_01: So I think there is some kind of measuring in other areas.
36:13
SPEAKER_00: That's what I kept wondering is like, who's measuring this here?
36:16
SPEAKER_01: Yeah, so it's a bit difficult.
36:17
SPEAKER_01: However,
36:17
I think like what we do know is that animals that we routinely
36:20
test on and study do
36:23
SPEAKER_01: not have it.
36:23
I think that is very important because not only that women's
36:26
health has been
36:27
SPEAKER_01: perhaps a neglected area for some other reasons.
36:31
SPEAKER_01: Also,
36:31
like if you look at other therapeutic areas where you don't
36:34
have good animal models
36:36
SPEAKER_01: to study in their standard disease.
36:37
SPEAKER_01: And when you have, I mean, models in the first place, right?
36:41
Like if you don't have good ways to study and test things,
36:43
you won't develop things that work.
36:45
SPEAKER_01: Look at examples of pulmonary fibrosis, right?
36:48
Like it has been a graveyard for drug development despite
36:50
billions of dollars being
36:51
SPEAKER_01: injected in the biggest companies competing with,
36:54
SPEAKER_01: you know,
36:54
SPEAKER_01: very little ultimately changing.
36:56
SPEAKER_01: Why?
36:56
SPEAKER_01: Because it's a very,
36:58
SPEAKER_01: the way you kind of induce it often in animals,
37:00
SPEAKER_01: at least in the early days,
37:02
SPEAKER_01: science has advanced,
37:03
SPEAKER_01: but in the early days would be
37:05
SPEAKER_01: You take two layers of the lungs, the pleura, right?
37:07
SPEAKER_01: And you burn it with a chemotherapy drug.
37:09
SPEAKER_01: And you say, this is fibrosis.
37:11
SPEAKER_01: So similarly,
37:12
SPEAKER_01: for a lot of these infertility menopause testing,
37:15
SPEAKER_01: what you would do,
37:16
SPEAKER_01: you would take mice,
37:18
SPEAKER_01: you'd burn their ovaries with a chemotherapy drug,
37:20
SPEAKER_01: like a doxorubicin vincristin.
37:22
SPEAKER_01: And you say, okay, they're infertile.
37:24
SPEAKER_01: They don't have a very infarction.
37:25
SPEAKER_01: They're in menopause.
37:26
So that's not how majority of women will experience infertility
37:29
and menopause,
37:30
right?
37:30
SPEAKER_01: Like some women will after intense whole body chemotherapy,
37:34
SPEAKER_01: which is why there's this whole concept of pre-chemotherapy,
37:39
SPEAKER_01: egg freezing fertility preservation,
37:41
SPEAKER_01: particularly for young women.
37:42
SPEAKER_01: However, vast majority of us, it's a more gradual decline, right?
37:47
SPEAKER_01: So I think
37:49
SPEAKER_01: I think that concept is more similar for that.
37:51
SPEAKER_01: And also that it's odd.
37:55
SPEAKER_01: And maybe that it's not necessarily even a biological imperative.
37:59
SPEAKER_01: I think that's the other way why that fact is interesting.
38:01
SPEAKER_01: And because it's so bombastic,
38:02
SPEAKER_01: like humans,
38:03
SPEAKER_01: four types of whales,
38:04
SPEAKER_01: I think it just makes people interested to read about the topic.
38:07
SPEAKER_00: I was fascinated.
38:08
SPEAKER_00: I just...
38:10
SPEAKER_00: I just wanted to know more, yeah.
38:13
SPEAKER_01: And there were two.
38:13
I think there's one that the age of menopause is associated
38:16
with women's life expectancy.
38:17
SPEAKER_01: Again, not causal necessarily, but associated.
38:21
SPEAKER_01: And there were some reports, and I think this is...
38:25
SPEAKER_01: Again,
38:26
SPEAKER_01: it's not something that I have myself personally tested,
38:28
SPEAKER_01: but there are some reports that the age of menopause of your sister,
38:31
SPEAKER_01: it could be associated with your own life expectancy as a man,
38:35
SPEAKER_01: right?
38:35
So I think those are some of these things that just show us how
38:39
interesting this
38:40
area of ovarian aging is for studying aging as a whole and how
38:48
potentially by
38:49
SPEAKER_01: looking at ovaries,
38:51
SPEAKER_01: because they age so much faster,
38:53
we could potentially kind of come to some important insights
38:58
about the aging
38:59
SPEAKER_01: process in a more time-efficient way.
39:03
SPEAKER_01: So I think, like, scientifically, it's very interesting.
39:06
SPEAKER_01: But obviously,
39:07
SPEAKER_01: you know,
39:07
SPEAKER_01: in the company,
39:08
SPEAKER_01: we're very much focused on products that we know we can develop in,
39:11
SPEAKER_01: like,
39:12
SPEAKER_01: a timescale that works for companies and tests and then bring to market.
39:16
SPEAKER_01: But the whole field potentially holds a lot more
39:20
SPEAKER_01: answers that could be helpful for us.
39:22
Yeah,
39:22
I wanted to ask you about that because I'd seen you mention
39:25
that before.
39:28
SPEAKER_00: If ovaries,
39:29
SPEAKER_00: yeah,
39:29
if they are aging at this accelerated rate where with almost
39:34
all these therapies we
39:35
SPEAKER_00: want to test on people,
39:37
it's one of the huge problems of the aging field is you don't
39:41
want to wait 70 years
39:43
SPEAKER_00: for a
39:44
SPEAKER_00: to test the therapy to see how it's,
39:46
SPEAKER_00: it's working is,
39:47
SPEAKER_00: yeah,
39:48
SPEAKER_00: I guess obviously people have known this,
39:50
SPEAKER_00: is this just your sort of typical case of,
39:53
SPEAKER_00: of women's women were placed,
39:55
SPEAKER_00: you know,
39:56
SPEAKER_00: further down the,
39:59
we just haven't spent as much time looking at this as we should
40:02
have because people
40:03
SPEAKER_00: weren't interested enough in women's health or,
40:05
SPEAKER_00: or why have we not,
40:07
SPEAKER_00: you know,
40:07
SPEAKER_00: been studying this,
40:08
SPEAKER_00: this,
40:10
SPEAKER_00: this organ and this phenomenon more closely.
40:13
SPEAKER_01: Yeah, well, I think I'm not so much of a speculative person.
40:17
SPEAKER_01: Why haven't we?
40:18
SPEAKER_01: I think it's just like, if something is worth doing, let's do it.
40:20
SPEAKER_01: That's more of my approach.
40:21
SPEAKER_01: But I think ultimately...
40:23
SPEAKER_01: it also goes like, where was an easy way to test it, right?
40:26
SPEAKER_01: Like it's a scarce resource ovaries, right?
40:28
Like we were talking about that you go through two weeks to get
40:32
a couple of eggs out.
40:33
SPEAKER_01: You want to maximize them as much as possible because,
40:36
SPEAKER_01: you know,
40:36
SPEAKER_01: per cycle,
40:37
SPEAKER_01: you have about one third of a chance of getting that baby.
40:40
SPEAKER_01: So I think like, and ovaries are not easily accessible, right?
40:43
SPEAKER_01: Like,
40:44
SPEAKER_01: to get sample from.
40:45
SPEAKER_01: It's not like getting a skin biopsy.
40:47
SPEAKER_01: So I think like we just didn't have the primary source.
40:50
And that's why I think with some of our technology where you
40:54
can have a full lab of
40:56
SPEAKER_01: totally synthetic,
40:57
SPEAKER_01: IPS-derived,
40:59
SPEAKER_01: human-like ovaries.
41:00
And we have shown that these ovaries beat previous animal
41:03
chimeric models with some
41:05
SPEAKER_01: primary tissue as well.
41:08
SPEAKER_01: We had a collaboration through one of our scientific advisor,
41:11
SPEAKER_01: Professor Phil Georgian of John Hopkins,
41:14
SPEAKER_01: where certain organ donors,
41:17
SPEAKER_01: obviously ovaries are not transplanted between humans,
41:19
SPEAKER_01: right?
41:19
Like a heart or a liver could save another life,
41:22
but ovaries were not,
41:22
so we...
41:23
SPEAKER_01: had the program that we were studying these ovaries to look at,
41:26
SPEAKER_01: okay,
41:26
SPEAKER_01: like,
41:27
are these IPS ovaries sufficiently similar to different ovaries
41:31
from humans?
41:33
And we've shown that they are,
41:36
and we can kind of look at the ovaries of different ages.
41:40
SPEAKER_01: So we do have that program,
41:41
SPEAKER_01: which is their third kind of platform program that we call D-Ovo,
41:45
SPEAKER_01: where you really can kind of build a lot of different ovaries.
41:48
SPEAKER_01: They can live in the lab for, you know, a lot of, a few months.
41:52
SPEAKER_01: They can, you can use them to rapidly test certain things.
41:54
SPEAKER_01: You can induce slightly different age of the ovary.
41:57
SPEAKER_01: So potentially it is something to test.
42:00
I think certain skepticism perhaps comes from where people say
42:04
this question,
42:04
SPEAKER_01: oh,
42:04
SPEAKER_01: well,
42:05
how many drugs have translated from ovarian biology into kind
42:08
of your medicine?
42:09
SPEAKER_01: Like it's more likely to come from certain other animal models.
42:12
SPEAKER_01: That's a fair argument, but you know, it's also...
42:15
SPEAKER_01: Doesn't mean that it won't.
42:17
There are some studies in academic centers now looking at
42:21
certain therapies that
42:23
SPEAKER_01: have some speculation for aging to potentially look at in ovaries.
42:28
SPEAKER_01: I think it's at the place where it's a very interesting concept.
42:34
Nobody really knows if it can,
42:37
but yes,
42:37
is it an interesting area of study?
42:39
SPEAKER_01: I believe so.
42:41
And okay,
42:42
I want to learn more the time we have left about your background.
42:46
SPEAKER_00: Before we do that,
42:47
SPEAKER_00: one last question along these lines,
42:49
SPEAKER_00: just of stuff that I thought that you were talking about.
42:52
I saw you say somewhere that women were not required to be
42:57
included in clinical
42:59
SPEAKER_00: trials until 1993.
43:00
SPEAKER_00: And I mean, is that obviously, I guess that's true.
43:05
SPEAKER_00: I mean, it just seems so stunning to me.
43:08
SPEAKER_01: Yeah, well, that is with NIH-funded trials, and yes, that is correct.
43:12
SPEAKER_01: And I think with animal research,
43:13
SPEAKER_01: I believe female mice were not required to be included in clinical trial,
43:17
SPEAKER_01: I think,
43:17
SPEAKER_01: until either 2011 or 2016.
43:18
SPEAKER_01: That's why I need to check.
43:20
SPEAKER_01: But we're definitely talking the 21st century.
43:22
SPEAKER_01: So I think...
43:25
Yeah,
43:26
that's the reason why I think it's the most exciting area to be in.
43:29
Because you're talking about a TAM,
43:31
a total adjustable market of half of the population.
43:34
And there's so much low-hanging fruit when it comes to basic
43:38
biology because we
43:39
SPEAKER_01: haven't studied it.
43:41
When I first went into medical school,
43:42
I was thinking maybe I'll be a cardiologist.
43:44
And since the Framingham Heart Study and all of the beautiful
43:48
double-blind RCTs and
43:50
SPEAKER_01: so many therapies...
43:52
SPEAKER_01: It's very hard to come with new treatments.
43:54
You see that novel treatments in cardiology are looking at gene
43:58
therapies for your
43:59
SPEAKER_01: cholesterol synthesis and small RNA.
44:02
SPEAKER_01: It's just very hard.
44:03
In women's health,
44:04
you could just go and look,
44:06
this is one pathway that's known.
44:08
SPEAKER_01: We know what it does.
44:10
SPEAKER_01: It's not drug.
44:11
SPEAKER_01: It's easy to make a molecule.
44:13
SPEAKER_01: It could work.
44:15
SPEAKER_01: It's a lot easier to get lucky.
44:17
SPEAKER_01: I think in biotip,
44:17
SPEAKER_01: you always need to get a little bit lucky,
44:19
SPEAKER_01: but it's a lot easier to get lucky.
44:21
So I think like now we're in this golden age of women's health
44:24
biotech because it
44:25
SPEAKER_01: is one of the most exciting areas to be in.
44:27
SPEAKER_01: And honestly,
44:29
like I think Amito is just at the forefront of that and is
44:31
going to start that wave
44:33
SPEAKER_01: for people to realize.
44:34
SPEAKER_01: And if you look at, for example, obesity,
44:37
SPEAKER_01: Nobody cared about it.
44:38
SPEAKER_01: You know,
44:38
SPEAKER_01: even a couple of years ago,
44:40
SPEAKER_01: people felt like it's not an area that could be solved pharmacologically.
44:42
SPEAKER_01: And now it's one of the hottest areas because people catch up.
44:45
SPEAKER_01: So I think similarly, that's going to happen with women's health.
44:50
SPEAKER_01: Just understudied, apply like existing clinical and scientific methods.
44:56
To the half the population has not been studied and there's so
44:58
much catch up work,
45:00
SPEAKER_01: develop therapies that work,
45:02
SPEAKER_01: you know,
45:02
SPEAKER_01: translate,
45:03
SPEAKER_01: scale them.
45:03
It's a very simple model where you can derive value and I think
45:07
make a lot of money.
45:08
Well,
45:09
and,
45:09
you know,
45:10
you used that word that they were not required to be in
45:13
clinical trials.
45:14
SPEAKER_00: I mean, so were they just not?
45:16
SPEAKER_00: Yeah, I mean, they must have been using some female mice.
45:21
SPEAKER_01: Yeah, it's hard to go when there is no requirements in recording.
45:25
SPEAKER_01: I think if you look at,
45:26
SPEAKER_01: and this is perhaps a homework for both of us,
45:30
SPEAKER_01: to look at,
45:30
SPEAKER_01: you know,
45:30
SPEAKER_01: what percentages were women in some of these research studies.
45:34
SPEAKER_01: And usually, if you look at, it's below kind of,
45:39
SPEAKER_01: 50%.
45:40
SPEAKER_01: And I think it's just about like,
45:42
SPEAKER_01: you know,
45:42
SPEAKER_01: you should study treatments in populations that you're going to treat,
45:45
SPEAKER_01: right?
45:45
SPEAKER_01: Like this has nothing to do with anything else.
45:47
It's just like you want to ensure that the study and the paper
45:49
you're reading as a
45:50
doctor includes the patient you're going to treat so that you
45:54
can leverage some of that.
45:56
knowledge and results from the trial to make your clinical
45:59
decision and advise the
46:00
SPEAKER_01: patient on what they should do ultimately.
46:03
So I think like some of it comes from the fact that obviously
46:07
like when we were
46:08
SPEAKER_01: worried about pregnancy and there have been,
46:11
SPEAKER_01: as you know,
46:12
SPEAKER_01: like
46:13
drug scandals of extreme harm of certain medications causing
46:20
harm for newborn babies.
46:23
SPEAKER_01: So that could have also,
46:25
SPEAKER_01: you know,
46:25
SPEAKER_01: played the role certainly about like,
46:26
SPEAKER_01: where do I feel like more cautious about experimentation?
46:30
SPEAKER_01: But I think right now,
46:31
and certainly like that's another potential use case of our
46:35
Diovo ovaries,
46:36
SPEAKER_01: right?
46:36
SPEAKER_01: Like before you test,
46:40
SPEAKER_01: you know,
46:40
SPEAKER_01: enroll women in clinical trials,
46:42
SPEAKER_01: particularly of childbearing age,
46:43
SPEAKER_01: like you could test it in like ovaries and look at,
46:46
SPEAKER_01: is there something ovary specific,
46:48
SPEAKER_01: human-like that I should be aware of before I test it on a human being,
46:51
SPEAKER_01: right?
46:51
SPEAKER_01: Yeah.
46:52
SPEAKER_01: And right now,
46:52
I believe you do kind of two generation of rats and we see if
46:55
they can reproduce.
46:55
SPEAKER_01: So you would do an animal varipotoxicology study,
46:58
SPEAKER_01: but potentially in addition,
46:59
SPEAKER_01: you could do this,
46:59
SPEAKER_01: right?
47:00
There are certain ways where you need a whole organism to do
47:03
certain kind of
47:04
SPEAKER_01: kinetic studies,
47:05
SPEAKER_01: right?
47:06
SPEAKER_01: Like where does it go?
47:07
SPEAKER_01: Does it deposit in some organ?
47:08
SPEAKER_01: Does it deposit in the liver or the spleen?
47:10
SPEAKER_01: But then there are certain ways where you want to kind of look at
47:13
SPEAKER_01: The actual organ itself, is there something that it would cause?
47:16
SPEAKER_01: So that could be an added layer.
47:17
SPEAKER_01: So I think ultimately, historically, women were less studied.
47:21
I think that is a broadly true statement that we can agree on
47:24
without knowing the
47:25
SPEAKER_01: percentages of women in every clinical trial that's been conducted.
47:29
SPEAKER_01: And therefore...
47:31
SPEAKER_01: You know,
47:32
SPEAKER_01: if you can do the catch-up work,
47:34
study and bring a lot of value and a lot of suffering for a lot
47:38
of conditions from
47:40
SPEAKER_01: infertility to menopause to endometriosis,
47:43
SPEAKER_01: polycystic ovarian syndrome and a couple of others.
47:47
SPEAKER_00: Okay.
47:48
SPEAKER_00: That was helpful.
47:49
SPEAKER_00: Thank you.
47:50
SPEAKER_00: Just to go over your background a little bit.
47:52
SPEAKER_00: I mean, I think you were, I saw you were on the Forbes 30 under 30 list.
47:58
SPEAKER_00: That I'm sure is very exciting.
48:00
SPEAKER_00: It must also be frightening as well.
48:02
SPEAKER_00: There's a strange track record of people on that list.
48:07
SPEAKER_00: Do they prepare you for that?
48:10
SPEAKER_01: Well, I mean, I think I don't have much to comment on it.
48:15
SPEAKER_01: A lot of people,
48:15
SPEAKER_01: if you do basic math,
48:18
SPEAKER_01: I think they name quite a lot of people on 30 under 30,
48:22
SPEAKER_01: and there's a 30-inch list,
48:23
SPEAKER_01: and how many years have been going,
48:24
SPEAKER_01: and you can name five or six.
48:27
SPEAKER_01: So actually, it's a small percentage, so it doesn't bother me a lot.
48:30
SPEAKER_01: I just go back to the math.
48:32
SPEAKER_00: I was, I was just, I'm just, bad joke.
48:35
I would say it was a good coverage for the company in general,
48:42
at least for us.
48:43
SPEAKER_01: Like a lot of people afterwards reach out being like,
48:45
SPEAKER_01: oh my God,
48:46
SPEAKER_01: wow,
48:46
SPEAKER_01: I was just thinking about doing IVF like freezing.
48:48
SPEAKER_01: I'm really excited about your solution.
48:50
SPEAKER_01: So overall for us, it was a, as a positive.
48:52
SPEAKER_01: And as I said, statistics is small.
48:54
SPEAKER_01: So you're more likely to,
48:55
SPEAKER_01: you know,
48:56
fall in like a banana or get hit by a bus and I still go out on
48:59
the street.
48:59
SPEAKER_01: So it's fine.
49:02
And you were,
49:04
I think you were born in Serbia or grew up in Serbia,
49:07
right?
49:07
SPEAKER_01: I was born in Serbia, yes, in East Serbia.
49:10
SPEAKER_00: And then you got your degrees and your medical degree in the UK.
49:14
SPEAKER_00: You mentioned your dad.
49:16
SPEAKER_00: It sounds like he was either a professor or a doctor as well.
49:20
SPEAKER_01: Yeah,
49:20
SPEAKER_01: I mean,
49:20
SPEAKER_01: he went to medical school,
49:22
SPEAKER_01: but then stayed in academia,
49:25
SPEAKER_01: so did not practice medicine,
49:28
SPEAKER_01: and he is a professor of histology and embryology niche in Serbia,
49:31
SPEAKER_01: my hometown.
49:32
SPEAKER_00: Oh, so he's still in Serbia.
49:34
SPEAKER_00: But honestly,
49:34
SPEAKER_00: I mean,
49:35
SPEAKER_00: this field,
49:37
SPEAKER_00: roughly,
49:37
SPEAKER_00: I mean,
49:40
SPEAKER_00: you grew up thinking about some of this stuff.
49:43
SPEAKER_01: I indeed did.
49:45
SPEAKER_01: So I went to the lab,
49:47
SPEAKER_01: obviously they had some,
49:48
SPEAKER_01: you know,
49:48
slightly less technical equipment than there is in the US and
49:52
the resources here,
49:53
SPEAKER_01: but they were,
49:54
SPEAKER_01: I was looking at microscope,
49:55
SPEAKER_01: I was looking at placental tissue and villi,
49:58
SPEAKER_01: that was his first,
49:59
SPEAKER_01: that was his main dissertation project.
50:03
I was definitely fortunate to kind of grew up in a lot of
50:06
science background in embryology.
50:08
SPEAKER_01: And then ultimately, as you say, I ended up in a similar field.
50:12
SPEAKER_01: My mom is an entrepreneur and my dad is a professor of embryology and I'm
50:17
SPEAKER_01: technically an embryology entrepreneur.
50:18
SPEAKER_01: So very much, you know, a mix of the two.
50:21
SPEAKER_00: Yeah, absolutely.
50:22
And then,
50:23
yeah,
50:23
I'm always curious about doctors who really lean into being entrepreneurs.
50:29
SPEAKER_00: I mean,
50:29
it just seems like you've already made such a huge commitment
50:32
to your studies and
50:34
SPEAKER_00: all the tests and the effort to get that degree.
50:37
SPEAKER_00: And obviously, it's not like you're going super far afield.
50:40
SPEAKER_00: And I could see how maybe you probably think…
50:45
SPEAKER_00: could help even more people this way,
50:47
but it must be a difficult decision on some level to go so hard
50:52
into the business
50:52
SPEAKER_00: world after you've worked so hard to get that degree.
50:58
SPEAKER_01: Yeah, well, I mean, if you look, that is true.
51:01
SPEAKER_01: And yes, certainly it was.
51:05
And there are certain,
51:05
perhaps,
51:06
areas that you miss from clinical practice.
51:08
SPEAKER_01: But on the other hand, again, I'm not an outlier there.
51:11
SPEAKER_01: I'm an outlier in many things.
51:12
SPEAKER_01: That one, not.
51:13
SPEAKER_01: Because if you look at,
51:14
SPEAKER_01: for example,
51:15
SPEAKER_01: biotech,
51:15
SPEAKER_01: biopharma,
51:16
SPEAKER_01: even mainstream pharma CEOs,
51:18
SPEAKER_01: most of them are MDs that have done medical training,
51:21
SPEAKER_01: work for a
51:22
SPEAKER_01: couple years or,
51:23
SPEAKER_01: you know,
51:23
not like the whole product and went into the industry and
51:26
ultimately ended up there.
51:27
SPEAKER_01: So I think a medical degree is,
51:31
SPEAKER_01: I mean,
51:31
SPEAKER_01: a lot of people say,
51:32
SPEAKER_01: well,
51:32
SPEAKER_01: you know,
51:33
SPEAKER_01: now Chad GPT knows more than you.
51:34
SPEAKER_01: And what were you doing?
51:35
SPEAKER_01: Just memorizing books.
51:36
But I think it's a great degree that prepares you for a lot of
51:40
things because
51:41
ultimately you study humans and a lot of business is making
51:45
human relationships.
51:46
SPEAKER_01: A lot of hiring is
51:48
doing exactly that,
51:50
like trying to understand,
51:52
like,
51:52
how does this person work?
51:55
SPEAKER_01: How do they work on their stress?
51:57
SPEAKER_01: A lot of business is forming a relationship of trust,
52:00
SPEAKER_01: which is very similar to what you would do in a patient consultation.
52:03
SPEAKER_01: When you try to form trust in like,
52:05
15 minutes with someone who's never met you before and they're
52:08
about to tell you
52:09
the biggest secrets some things that they perhaps are
52:13
themselves embarrassed of so
52:15
i think like some of these things um are actually very helpful
52:19
another element is
52:20
just brutal hard work like med school is not easy and nobody
52:23
cares you know like
52:24
they're like yes these are this is anatomy and you gotta know
52:26
it by tomorrow and i
52:27
don't care you don't understand your book like go and do it and
52:31
you go figure it
52:32
SPEAKER_01: out and i remember the first time i read
52:34
SPEAKER_01: grace anatomy for students.
52:36
SPEAKER_01: It's not even the original one I have in the background.
52:38
It's the four students,
52:39
but also it's thick,
52:40
just more diagrams,
52:41
slightly less text heavy.
52:43
SPEAKER_01: And I was like, I don't understand any of it.
52:45
SPEAKER_01: And then, you know, four weeks later, I was like, oh no, I'm a master.
52:47
SPEAKER_01: I was doing like my cadaver dissection, pointing everything.
52:50
SPEAKER_01: So I think that those are just good skills to have in life.
52:53
SPEAKER_01: And that's why med school is good.
52:54
SPEAKER_01: Like it's hard work and you learn a lot of things.
52:57
SPEAKER_01: And I think it provides it with a good
52:59
SPEAKER_01: understanding of like holistic human biology, what patients want.
53:05
SPEAKER_01: I also practiced as a physician for a little bit.
53:09
And I think those things have made me a much better biotech CEO
53:13
because ultimately
53:14
SPEAKER_01: what am I trying to doing?
53:15
SPEAKER_01: I'm trying to build things that will ultimately help patients.
53:19
SPEAKER_01: And if I don't understand that...
53:22
SPEAKER_01: I feel like a lot of it can be missed.
53:25
SPEAKER_01: So yes, it is a step up, but I feel like it's a natural one.
53:28
SPEAKER_01: And for me, it was a better decision.
53:32
SPEAKER_01: And I like kind of things moving really fast.
53:35
SPEAKER_01: I like the daily challenges.
53:37
SPEAKER_01: I like the different type of challenges that I face.
53:41
SPEAKER_01: I like the basic science angle, working with people.
53:44
And I have enjoyed learning about the business angle on the job
53:48
over the past decade,
53:49
for sure.
53:52
SPEAKER_00: It's a fascinating story.
53:54
SPEAKER_00: We'll put some show notes along with this,
53:59
but we haven't even had time to get into all the things you've
54:03
accomplished in your
54:05
SPEAKER_00: career in your 20s.
54:06
SPEAKER_00: It's quite staggering.
54:08
SPEAKER_00: Just to close out,
54:10
to give people a feel for where your company is going and the
54:14
big picture,
54:15
SPEAKER_00: we outlined...
54:17
your current product and then the one that you're trying to
54:21
develop around menopause.
54:22
SPEAKER_00: And,
54:23
SPEAKER_00: and I,
54:23
SPEAKER_00: you know,
54:24
SPEAKER_00: I just didn't have a sense as to,
54:26
SPEAKER_00: um,
54:27
SPEAKER_00: is this going to be a company that you think just has many,
54:31
SPEAKER_00: or I,
54:31
SPEAKER_00: you know,
54:32
SPEAKER_00: I don't know the number,
54:32
SPEAKER_00: but like,
54:33
SPEAKER_00: uh,
54:33
SPEAKER_00: several therapeutics aimed,
54:36
SPEAKER_00: um,
54:36
SPEAKER_00: uh,
54:37
aimed at women or you know are these first two products really
54:40
the the anchor and
54:41
those are meant to be these giant giant businesses and I I just
54:45
didn't I wanted to
54:46
SPEAKER_00: get a picture of like where you think all this this goes
54:49
Yeah,
54:49
well,
54:50
I think like right now we're a small,
54:52
nimble,
54:52
but very mighty team.
54:54
SPEAKER_01: I always say that a unicorn is built by unicorns.
54:58
SPEAKER_01: And I think like I'm very fortunate that I have a lot of really great,
55:02
SPEAKER_01: motivated,
55:03
SPEAKER_01: hardworking colleagues on my team who are all unicorns.
55:09
And right now we're laser focused to get going with our phase
55:12
three trial.
55:12
The information about specific sites,
55:15
we're going to be at 15 different states in the U.S.
55:19
SPEAKER_01: starting to recruit.
55:19
SPEAKER_01: That is an incredibly exciting project.
55:22
SPEAKER_01: The biggest undertaking we've done is a company.
55:25
SPEAKER_01: We're also working through
55:29
providing Fertilo to the places that we are clear to
55:33
commercialize where there is a
55:34
SPEAKER_01: lot of interest.
55:35
SPEAKER_01: So we're now available.
55:38
SPEAKER_01: So for interested patients in Australia with Virtus Health IVFA,
55:44
SPEAKER_01: which is one of their largest clinic,
55:45
SPEAKER_01: you know,
55:46
SPEAKER_01: top five largest clinics globally.
55:47
SPEAKER_01: We're looking to expand across Asia Pacific,
55:49
SPEAKER_01: Latin America,
55:50
SPEAKER_01: and certain Middle Eastern regions next year.
55:53
SPEAKER_01: So really kind of
55:54
trying to do the final clinical development as well as early
55:59
commercialization and
56:00
SPEAKER_01: strong post-market work of Fertillo.
56:02
SPEAKER_01: We think that in itself is huge.
56:05
We're looking currently for partners in Japan because we are in
56:10
a society where
56:12
SPEAKER_01: Women deserve better solutions.
56:14
SPEAKER_01: The birth rates are declining.
56:15
And we think that the right way to solve it is to allow people
56:18
who do want to have
56:19
SPEAKER_01: children ability to do so when they feel ready.
56:22
SPEAKER_01: So I think that's where our solution can help.
56:24
SPEAKER_01: And so the priority for now is to get that going.
56:27
Inside,
56:28
obviously,
56:28
in the company,
56:29
we are advancing the menopause solution.
56:31
As I mentioned,
56:32
we have our other platform for ovarian health,
56:35
ovarian disease testing.
56:37
SPEAKER_01: A lot of it is now kind of just...
56:40
SPEAKER_01: In the lab itself,
56:42
SPEAKER_01: we certainly will be opportunistic if new opportunities arise,
56:45
but are kind of sequencing different programs and currently
56:48
funding these two to
56:49
SPEAKER_01: advance to the clinic to ensure capital efficiency.
56:54
SPEAKER_01: And then
56:55
SPEAKER_01: We'll see where things take us.
56:57
SPEAKER_01: I think we have a lot on our plate right now.
57:00
SPEAKER_01: And I'm really, really excited.
57:01
I mean,
57:01
to see Fertillo change lives and the amount of interest after
57:08
that first life birth.
57:09
SPEAKER_01: It has really been insane.
57:11
And I think that's where we really want to meet the demand and
57:15
bring it safely and
57:16
appropriately into hands of people who want it and need it and
57:21
cannot wait for it.
57:22
SPEAKER_01: It's an easier way to build their families.
57:25
focus uh for for next year and probably foreseeable future it
57:30
seems like like
57:31
plenty to do uh thank you thank you so much for your time i
57:36
feel like i i learned a
57:38
great deal and it's um it's just it's like amazing to see um
57:43
really like the
57:44
SPEAKER_00: progress you made in a relatively short time and and as a
57:50
SPEAKER_00: I don't know how I ended up as an IPSC nerd, but here I am.
57:54
SPEAKER_00: It was really exciting to see what you've done with the technology.
57:58
SPEAKER_00: So thank you.
57:59
SPEAKER_00: Thank you so much for your time.
58:01
SPEAKER_00: And definitely keep us posted on how things go.
58:05
SPEAKER_01: All right.
58:07
SPEAKER_01: Well, thanks so much for having me.
58:08
SPEAKER_01: It was a pleasure chatting with you.
58:13
SPEAKER_00: Core Memory is hosted by me, Ashley Vance.
58:17
SPEAKER_00: Our guest today was Dina Radegovich.
58:19
SPEAKER_00: The show is produced by me and David Nicholson.
58:23
SPEAKER_00: Our theme song is by James Mercer and John Sortland.
58:28
SPEAKER_00: And the episode is edited by the John Sortland.