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The Regulatory Aspect of Digital Pathology and Translational Medicine w/ Esther Abels

The Regulatory Aspect of Digital Pathology and Translational Medicine w/ Esther Abels

Today’s podcast is about the regulatory aspect of digital pathology and how it fits into the space between research and clinical use called translational medicine.

The podcast guest, Esther Abels, is a regulatory expert in digital pathology and a female leader in the field. She was involved in the team effort that brought the first Phillips clearance of a whole slide scanner to the attention of the FDA.

Translational research has the potential to bridge the gap between discovery and clinical practice. Its goal is to use evidence from research to target diseases and apply the insights in the clinic.

Digital pathology is seen as a tool to expedite the development pipeline for drugs and medical devices through the use of algorithms and AI.

There are however regulatory requirements that need to be taken into consideration when developing and using digital pathology tools. For example tissue image analysis tools used to support clinical decisions need to adhere to the FDA’s guidance for software as a medical device.

The FDA is also working to define data sets that can be validated and reused for algorithm development.
There are ongoing efforts in Europe and the US to draft laws and frameworks related to artificial intelligence and validation techniques for AI tools.

It is a best practice to engage with the FDA early and this process for drug and medical device companies starts with a pre-submission to the FDA, seeking advice and discussing the approach. To be successful the role of a regulatory architect is crucial in overseeing the process and guiding it from point A to B to Z.

In addition to being a regulatory expert in the digital pathology field, Esther is also the immediate past president of the Digital Pathology Association (DPA).  Because digital pathology brings people together from various fields, including pathologists, toxicologists, lab personnel, regulatory experts, and clinical development personnel, during her presidency Esther focused on collaboration between those different fields.

Esther Abels is a regulatory consultant who can be found on LinkedIn and her YouTube channel, which features helpful guidance and information videos.

And if we are not connected already, let’s connect on LinkedIn!

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this episode’s resources

transcript

Aleksandra: [00:00:00] If you’re working in digital pathology, or at least
you’ve heard that the research application of digital pathology, they’re not really
regulated or very slightly regulated, whereas the clinical application part, the
clinical use of digital pathology is strictly regulated and you don’t have any
regular room there.

But there is this space in between called translational research or translational
medicine, the place where the research meets medicine. So you can ask
yourself, how do I approach it from the regulatory perspective? Do I have all
the freedom from research or do I have to strictly obey the regulatory guidance
on the clinical side?

Today my podcast guest is gonna answer this question.

Today my episode guest is Esther Abels, the regulatory expert in digital
pathology for me.

She’s the person that brought digital pathology to the eyes of the fda, and we’re
gonna be talking about the translational aspect and use of digital pathology in
translational research. [00:01:00] But Esther is not only a regulatory expert she’s
also a female leader in the digital pathology space. That’s why I invited her for
March episode to celebrate the International Women’s Day.

So without further do, let’s dive into it. Welcome digital pathology trailblazers.

Esther is definitely a female digital pathology leader. So I’m gonna start Esther
with the most famous things that you did. You were part of a different digital
pathology companies. But one thing that I will always remember you for, you
are the person who brought digital pathology to the FDA with the first Phillips
clearance of the whole slide scanner.

And the other thing that I think is worth mentioning is that you are the
immediate past president of the Digital Pathology Association, a female
president, not the first, because there were already female president or at least
one I know Dr. Boy was. And we’re gonna circle back to this experience as a
female leader in digital pathology later in the podcast episode.

But now tell the listeners about [00:02:00] you and who you are and what you
do. Give a little intro to yourself.

Esther: Thanks Alex, and thanks for having me. And you might remind me of
the Philips scanner. That was the first one to the attention of the FDA getting
the clearance. But I also wanna highlight. Of course a team effort, and it’s
something that we did as a team.

We collaborated also with competitors, also with the Digital Soldier
Association, and that contributed that we got this accomplished. But a little bit
more background about myself, I studied biomed mental health sciences
because already at a young age, I really was interested in prevention of diseases.

I was always thinking like, why would you wait till you have symptoms if you
can prevent a disease?

And education in this part is very important. And I recall that one of the
colleges I went to is that we were talking about pathology, and it impressed me
so much. I recall that really inspired me because that really showed me how a
body has balanced, like how it keeps itself in balanced.

Having [00:03:00] said that, I also became very interested to help patients. Of
course, you wanna prevent diseases, but when you see the suffering and also
that there is medication available to help patients, I became very interested in
that as well. So that’s also how I started. I started in pharma working on clinical
development of pharmaceutical therapies.

I was accountable for registration studies of drugs to bring them to market
globally, as well as prove concept studies. So that’s actually how do you take
into account everything that you develop in the pipeline over the drug, right?

You think about ethics, you think about formulation. Is it safe, is it effective?
Is it also feasible to have that accepted in a certain country? For example, we
worked on opioids and we all know that is difficult to get on the markets in the
us so we took that all into account when developing our drugs from that I went
to medical devices because I realized okay, when you have a good drug, if you
really wanna make it work, you always need to have a good diagnosis.

So just go hand in hand. So I wants [00:04:00] to learn more about that and
that’s why I started sets medical device company. And first what we need is was
develop the scanner so that you can start using the images and all the data that
you collect with ads to really start building a foundation, a data base. Start
clustering data and identify maybe new signatures, new features that can help
finding new targets in the human body to be attacked, so to say, by the drug.

That’s something that I’m working on right now as well, and what I really like
about it is also not thinking only about the technology, but think beyond that.
because we have great technology, but what does it help us? If there’s no
clinical utility, what does it help us if you cannot bring it to the patients?

So I think you really have to think about okay, this is the technology great at
school, but then take the next step. What does it do? Does it really help
patients? Does it bring value to the healthcare provider who has to use it? That’s
actually what I enjoy a lot combining those four assets from regulatory, clinical
quality, and pharma [00:05:00] and the medical device, and use that to help
bringing innovations to patients.

Aleksandra: I have my recent guests were really the personification of the
bridge in digital pathology, incorporating experiences and education from
different fields. And you also are uniquely positioned to talk to so many people
that are involved. Like you emphasize, it’s a team effort, but you need to be able
to talk to everybody in the team so that everybody is on the same page.

Esther: Yeah.

Aleksandra: And in your background, I definitely see this vast amount of
experience and training that technology can be cool. Research, you can discover
cool stuff but what does it even help us if we cannot bring it to the patient? That
brings me to the main topic of this episode, translational research.

How do you translate those cool technologies into something that’s clinically
usable? What is translational research first and the second thing, how do you
bridge this? How do you use those insights later for patients? And you’re gonna
be talking about [00:06:00] this at the Tricon conference in March, but let’s talk
a little bit about that.

Esther: Yeah. So what is translation medicine? I would say you involve a lot of
science. You use whatever you do in research and in discovery. Use that
science, use the evidence that you create there to build a foundation to also see
okay, how can we now use this, what we have collected to target a kind of a
disease and apply it also into clinical practice?

So it’s really like, how can we ensure what we discover in research outside
human body. Or using like digital tools or using anything else, what you use in
the lab environment, for example. But then deep to mind how can you use that
and apply it, what you have discovered using the science and the evidence facts
to apply that in clinic.

So that is how I would like to translate it. And then bringing it to your question,
can you apply digital pathology and how to do that? And also what I’m
discussing [00:07:00] indeed, a tricom on March 7th, let me start off with this.
See there, there’s a trend of course in the digital health and in personal
healthcare.

That’s what we see and we see that medicine is changing rapidly because of this,
and it’s not only drugs and digital, but it’s also related to budget, yet
reimbursement, workforce, those kind of things.

Aleksandra: Speaking about reimbursement, I did forget mention that we
already had a podcast episode together and this is where we were talking about
that.

So if anybody’s interested, I’m leaving the other episode with Esther in the show
notes, so go ahead and listen to that one as well.

Esther: Ah, yeah, that was a good episode as well. I enjoyed it. I enjoy always
your question, so thanks. Going back to that, an increasing demand also for the
personal treatments, personal healthcare, there’s also an increasing demand
based on that, on healthcare itself, and so that means that there is a higher
workload, but also that we need to ensure that the parts are going to be
shortened the paths to bring it to a patient.

It’s not only the development, but also the [00:08:00] usage of that. So how can
a healthcare provider get easy use? I give a few examples. There will be much
more, but what I think, what is the needs right now in drug? And also in the
tools. I think what is needed is that we’re gonna develop this cool technology
that we are using that accompanies the disease itself and already early onwards.

And that we then can advance those certain diagnostic tools or other tools to
help that. So with that, you creating efficiency, gains. And you can already
show very early on with science that there is effectiveness and that’s also being
used by, if you look back at the Covid, right? There was already earlier on
animal data, for example, that has been used to gather evidence that was used.

To mine nets to use, digitization to do simulation, computer models. Those kind
of things have been used to accelerate the development and the safety and
effectiveness testing because usually you would’ve taken much more data, much
more testing in the lab [00:09:00] and in inpatients than what was done now
because of that digitization, because we live in this era, and I think that’s also
where I see the areas of growth for digital pathology and also for medicine.

I believe that we can expedite that development pipeline for both. By using
digitization, we can now by using algorithms, by using ai, we can start
clustering data. And I’m probably preaching to the choir here, but what I see is
that there are certain diseases which certainly have a common denominator.

And with pathology, for example, they do have that in the phenotype
expression. And that can be morphological, that can be things that we cannot
see with the eye. And also using a microscope or spatial biology, for example, it
can be a combination of that. And people always also think about, might it be
with other omics?

Yes, absolutely. Might it be with other patient data like we start clustering, for
example, geographies, food patterns, all those kind of things. And that’s where I
[00:10:00] believe that pathology is one of the last areas in medicine that is
becoming digital, and that’s not for a reason. We all know how difficult it is
with pathology.

Not saying that the other ones are not complex, but pathology is just different
than radiology or genomics. That is something that we can really tap into in that
potential next to that by using that already early ons to discover new targets.

You can also. To expedite that, to use digital pathology to expedite, to go to a
new target because everything, what you do in pathology, you can do digital.

But digital can go much faster than what a human can do if you use it in the
right way. So therefore, I believe that’s an opportunity for digital as well. And
then there’s another opportunity in digital, which using it. In the clinical
development itself. With clinical trials, you can automate so many processes.

You can also, what I believe and is that you can easier identify the patients that
should be recruited in your study. You can have more precision, you can
standardize, you can [00:11:00] harmonize. So with that, you can decrease your
patient’s sample size, for example. And with that, you’re enriching your patient
pool.

As such, you need less number needed to treat, and you go faster to your drug
developments. Plus you might also have earlier failure rates. And that’s
something that we also wanna know because you wanna kill your drug early if it
doesn’t work or if it’s not safe, there I see the entire pipeline I see advantages
also in pathology itself.

You can use digital pathology to optimize your own pathology tools within your
lab. You can help to develop medical device development tools, for example.

And that’s something I know that FDA is doing at the moment, at their own
labs. I believe there are many opportunities.
Aleksandra: What are they doing? Esther, do you have any insights?

Esther: Yeah, so.

Aleksandra: I need to have somebody from the FDA to talk about it, but if you
have any insights, let us know what they’re doing.

Esther: Yeah. On a high level, because I’m not involved that much anymore. In
the beginning I was involved with reviewing the protocol and the studies, but
it’s Dr. Brandon Galles.

[00:12:00] He’s from the osel, that’s the office for Scientific Engineering labs in
the fda. And what they’re doing is they’re working with digital pathology to
define certain data. That you can validate and when you have a common
denominator and general principles for those data sets, you can reuse them over
and over in any clinical study or any development of an algorithm without
having to go to the fda when you are going with your medical device itself, or
with your drug by saying, oh, we have something discovered.

This is our validation set. Can we use it? And then you have Ds to review it. It
says, yes, no, how did you do it? Now he developed something that you can say,
okay, this is a general validation set. That can be reused and you don’t have to
show over and over again that it’s a good data set.

Aleksandra: See, I need to talk about this on the podcast as well.

Esther: Yeah.

Aleksandra: I need to make a note.

Esther: So mental notes.

Aleksandra: When Yeah, totally. So when I was working in the translational
research space, like bringing it to the bench, it was work with the [00:13:00]
genetic data, with the bioinformatics that they would give us insights to the
pathology department.

Then we would look for a confirmation in the slides stained with certain
markers, and the markers were already guided by the gene expression. And then
we would design algorithms and try to quantify them and try to figure out, okay,
can we somehow stratify patients? Can we use this? You mentioned medical
devices, can this then down the road be used as a companion diagnostic?

So two technologies, the digitization of the slides itself, which is now non
hurdle, I would say, because we already know that this is okay and there are
procedures for that. The other one is tissue image analysis. If you could tell me
what are the regulatory concerns or things that you have to consider when you
wanna use endpoints generated from tissue image analysis for guiding your
decisions or guiding your research and I guess the most, the highest [00:14:00]
regulatory hurdle to guide diagnostic decisions in a clinical trial.
Where do you look up the information? How shall I be compliant with this?

Esther: And that’s actually a great question because if you look into all the
guidance that is out there, there is so much with regards to FDA has lot of
guidance for industry with software as a medical device, so you need to start
with that.

And of course, the standard things regards to what is risk, those ISOs you need
to include. Now, recently, they have also included some standards, I have to
say, that now is being regarded as a recognized standard. So you can reuse that
standard in your submission files by saying, okay, we have followed this
standard.

We are compliant with it. So they trust that method that you use. It is okay and
validate. Of course you have to show that you do that. But having said that’s
something that you can of course and need to start off to look for those
guidance’s. I know in Europe, they’re now working on a draft act, which is then
becoming, of course, the law, and that is on artificial intelligence and how to
use [00:15:00] that and how to apply it.

There’s a lot ongoing also within the FDA, going back again to the us there is a
standard framework already out there that is also in draft, and they’re using that
also to optimize, like how can you apply this validation technique, these general
principles to any AI tool that has been developed.

Aleksandra: So is this already available for the general public or is it still not
published?

Esther: Yeah, not yet that’s one in the FDA that’s published, but it’s draft.

Aleksandra: Okay.

Esther: We expect.

Aleksandra: We can draft guidance.

Esther: Yeah, draft framework they call it. So it’s, this one is not the guidance.
So there’s a small, new arms again.

Aleksandra: Steve. No I’m not an expert in those nuances.

Esther: If you would get, yeah,

Aleksandra: but that’s okay.

Esther: That’s why I’m here.

Aleksandra: I’m asking because I wanna include it in the show notes of this
episode. So that would be a very good resource. So everybody who’s listening,
check the show notes. It’s gonna be there. Okay, good.

Esther: Yeah, and it’s good to ask because you know everybody has their own
expertise. You now know that it’s there and when you need to [00:16:00] know
the details, you call out for the regulatory experts and they can guide you in how
to apply it.

Then with regards to that framework, that the developing, that’s also a
suggestion in there that you, whatever you change in your device after it has
been approved or cleared, if you put that already, Initial submission from your
device that you’re clearing at that moment. If you say, this is the change that I’m
gonna apply, this is the method that I’m going to use, these are the acceptance
criteria, then the suggestion is that they accept that once you make a change to
your device, according those principles and those methods, then it goes
smoothly through a review process.

So I think that’s a great advantage because we know how fast AI can change,
how fast software and algorithms change. That’s the idea, right? We wanna be
faster or we want to speed up the innovation that’s there and what else?

What I think how you can use it then in your clinical trials and also in your
entire drug development pipeline or in your device development pipeline, is
actually. Use the validation [00:17:00] principles, because I know from
experience, and I also know that the FDA usually looks into, if you’re using a
device for your endpoint measurements or a arrival that you use to build your
statistics on and your analysis, then you want to have that device validated.

Prefer, of course, that it is a device. That is being regarded as being, giving the
correct endpoints or the correct measurements so it is easier and more efficient
for a for a direct company or for whomever is going to submit the file that the
device has already been cleared or approved. Now, if that’s not been done.

Aleksandra: Question, so let’s say there is a Kai 67 approved algorithm on the
market and you wanna use the Kai 67 quantification as your end point then it
would be recommended to use this very algorithm and not develop your from
scratch, or not necessarily.

Esther: It’s, I would say it’s the easiest way with less risk.
But having said that, I believe that we also are in this stage and at this in this
[00:18:00] point of time, in this era, we can also collaborate with the FDA and
discuss with them. Because if you have your own developed case, 67. app and
you’ve validated according to your own quality management system, and you
can show you have verified, it’s validated according to what it’s supposed to be
doing, then there’s no one who can argue you cannot use it because it all comes
down and it sounds easy, and in one way it is easy, but it also had a devils in the
details.

But it also come down to is this device safe? Is it doing what it’s supposed to
do? And then show me why you believe it’s safe. That’s actually do no harm.
Aleksandra: How do you engage in those discussions with the fda?

Esther: Yeah, and I think that is for a drug company or a device company,
easier than, for example, for a clinical research organization who works in now
who works for the sponsors like the pharma and the medical device to execute
those studies.

But what you usually do is you write a pre-submission to the FDA by asking
and say, Hey, we’re seeking your [00:19:00] advice. We would like to know if
we can use this approach and then you discuss it with them for companion
diagnostics. That’s of course the same process, but what the difficulty is that
you’re not only there with your own drug, you’re also there with your diagnostic,
and you have to do it together.

And then also within the FDA, it’s becoming more complex because now they
have to combine. And indeed, the device group with the direct group Plus and
all the experts. Digital health experts. So we see that this is expanding rapidly,
but it’s key because all the stakeholders are involved and you need to have an
architect within the regulations who can understand all these dimensions and
piece it all together, making sure that the puzzle is right.

It’s an architecture, actually, architecture structure. Having an architect, a
regulatory architect.

Aleksandra: Yes. I never looked at it that way. It totally is parallel to an IT
infrastructure where you have to know the systems, you need to know the
workarounds. You need to know what matches with what. No wonder you need
the regulatory expert.

And [00:20:00] I think this is a good point to mention that in addition to all the
other things that you’re doing, you also offer regulatory advice. So if anybody
who’s listening is at the point where they need regulatory advice, this is your
architect. This is the person who can guide you from wherever you are in your
process to wherever you wanna get in a compliant manner.

Esther: And in addition, I wanna add, it’s also because of that architect you,
what the advantage is that you also need to understand, the clinical drug
development pipeline, the medical device development pipeline. So having all
these levels of expertise and incompetent skills and pharma, regulatory quality,
knowing about GCP, knowing about the quality system, regulations, all those
kind of things that’s all required.

Aleksandra: And I see experts come into the drug development pipeline at
different points in the pipeline, and you get very focused on what your expertise
is and what you’re contributing to, but it’s not your task to oversee the whole
[00:21:00] process. And then a person like you oversees the process and can
guide the process from point A to B, to C to Z.

So that’s, you’re a bridge, you’re at the bridge.

Esther: And thanks for bringing it up because what I think also I’m a strong
believer, and there’s also, by the way, paper about it from the DPA, is that you
have the total product life cycle of a medical device. Actually also of course,
from a drug, their need to know is, you do this indeed as a team.

You have all your different experts, but involving each other from the infant
state. That is crucial. You need to have your team in place. So I think also
bringing up digital pathology that brings people together because thinking about
what do you do with digital pathology? You need to have pathologists.

You need to have toxicology. You need to have the lab. You need to have the
regulatory person who knows, can I submit this student FDA? And needs to have
someone from clinical development understanding like, oh, if you did that there,
then we don’t have to do it in a clinical study, or we have to be careful and
implement in the clinical study.

So I think it’s saying [00:22:00] that it’s a team effort, and that comes back also
to how the Phillips medical device was cleared. It’s always a team effort. You
need to put all the pieces of the puzzle together. And again, I believe that is
mostly done by the regulatory person knowing all the things like how can we
optimize that submission?

If you have dis intended use, then maybe you should do that in your verification
and you can leave it out of your validation and that’s how you can be smart and
accelerate.

Aleksandra: I totally agree. So I was part of a validation GLP good laboratory
practice validation effort of primary digital pathology read for preclinical
pathology at Charles River Laboratory.

And the regulatory person was my go-to person to ask, can I even do it? You
have all those ideas based on your expertise and how you can prove based on
your expertise that something is working. If it’s not gonna fly with the
regulators, don’t even start. Yeah. I had a really good experience this team
experience.

And like you say, digital pathology is everyone patho, it’s called pathology. So
the first person you would think, pathologist, and that’s [00:23:00] it. That’s so
not it. And that’s why Digital Pathology Association has members from all
different aspects of digital pathology. So let’s talk about your presidency.

How was it to be a president? How did one become a president and what did
you do during your presidency.

Esther: Yeah, actually within the DPA, within the Digital Ology Association, I
became a member in 2011. That’s when I also started with digital
ophthalmology at Phillips, and that’s where I also started to join the Digital
Ophthalmology Association Regulatory Standard Task Force.

And was working on that and making sure, of course, with the whole start
imaging validation guidelines. Those kind of things we did as a collaboration
and then became part of the board and taking part of discussions and
memberships and then at a certain moment, and of course there is a opportunity
to think about, do I wanna get in the executive committee and then you can
apply for that every year there have we rotate the presidency and you start as the
secretary and then you gradually you [00:24:00] go into the presidency role. I
applied for that role of the being the secretary. I think it was five years before
you become the president. Might also be four years before you become
president.

Aleksandra: Long term plan.

Esther: Yes. You need to learn all the ins and outs, right? And then you are
becoming the president. And I think that’s also good because then you have
continuity in your executive committee team. And also that’s why I’m still there
as the immediate past president to whatever is there that I ensure that. You
know what I’ve done that is not being lost and that is transferred to the next
president.

So I’m also very happy that this can be transferred into the capable hands of Dr.
Panish. He’s the current president and he has his goals, of course, and I had the
goals last year. I was focusing most on collaboration, building a foundation and
network to connect all the elements for precision medicine, and with that, also
linking that to reimbursements.

So those two topics were highest on the agenda and I also, if I look at that, we
have accomplished it.

Aleksandra: [00:25:00] How did you do it?

Esther: Yeah, we have accomplished a lot, so thanks for asking. It was really a
fantastic year. I really enjoyed it and I’m very proud and more so grateful that I
have been able to serve this community and being then the president of a board
and of a DPA who accomplished so lot, we had pathology visions.

And what I noticed is there was a general vibe, there was a burst. We were sold
out with over,

Aleksandra: I know over 700 people.

Esther: Yes, almost 800. And also the booth spaces, they were all sold out. And
when you were walking there, I really felt that burst of excitement of people.

Talking together, sharing information, sharing knowledge, and I was so
appreciative of that because I’m a strong believer in when you share knowledge,
you help each other to perform.

It’s not giving away your competitive advantage, it’s just helping each other to
penetrate that market and to help the community. That’s how I see it. And I
believe now with having seen that this past year, and of course we have to see
how it goes, but I see it Turning point. Digital Path is [00:26:00] putting lab at a
very different perspective.

It’s now in the middle of all, we will change lab medicine to everyone’s benefits,
everyone’s advantages. And what we are doing with DPA, we’re connecting these
elements and with that we are growing the network. We help guiding care
providers what to test, when to test, those kind of things. And that also
contributes to, okay, what is then the clinical utility?

How can we get there? So that contributes to that reimbursement and we
collaborate, for example, going back to increasing that collaboration. We also
collaborate with a lot of allied societies, and one of them is, for example, the
cap. Now we collaborate with them, we collaborate with USCAP, with API many
more, but we are there for each other.

We have collaborated efforts. We identify what is. So that we have mutual
benefits for the community to create synergy, and going down back to
reimbursement is also where CAP had a major role. They arranged that we now
have these reimbursement codes [00:27:00] in category three codes. Yeah.

Aleksandra: Yes the codes.

Esther: Yeah. Yeah. Finally here.

Aleksandra: So for those who are outside of the us, the reimbursement in the
US is based on having a code for a procedure or for something you do for a
patient. If you don’t have a code, even if it’s like the best thing and it’s gonna
save their lives, you might have problems with getting reimbursement for that.

Yes. I educated myself a little bit on the codes and I was pretty surprised how
many codes there are for just scanning slides Esther?

Esther: Yes?

Aleksandra: Can you elaborate on that?,

Esther: I had that too. Like why do they make it so complex? But you know
what?

Aleksandra: That’s what it is. But they are there.

Esther: They’re there. And with having said like that, we have that
collaboration with the cap CAP. There was a great talk also by the C A P
members and he presented how they came to this reimbursement code and how
it actually works, how to apply for such a code, and I think that was a great
presentation and also very well received by the community. Having said that,
we [00:28:00] worked mainly on those collaborations and the reimbursement
trajectory.

I also realized the reimbursement trajectory we just started. So there’s so much
more to do. And that’s something that I personally am very interested in and I’m
still working on.

Aleksandra: And there is a podcast by the DPA, the Digital Pathology
Association has the podcast also beyond the scope. And there is an episode
dedicated to the code.

So I’m gonna link to this as well for everybody who wants to understand this a
little bit better. It’s complex, but if you wanna be active in this space and
actually be financially viable, this is your mean to that end. So definitely go
ahead and check the link as well. Esther, as I said at the beginning, not the first
female president, but you were a female leader in the digital pathology space.

This is March and 8th of March is the International Women’s Day. So I am
inviting woman leader in the digital pathology space, and you’re an important
leader in this space. How is it to be a female leader? Did you ever have a
situation where you were made [00:29:00] conscious of your gender? Did it in
any way affect the how you do things, where you show up, how you show up?

Tell me about your experience as a female leader in the digital pathology space.

Esther: Yeah. Actually, what I would like to it’s a rhetorical question, but what
I’m always thinking, and I give you a little bit of history as well. What I’m
always thinking, like, why do we need to ask this question?

Aleksandra: That’s rhetorical question, but I wanna put it out there.

Esther: Because I’m thinking also back to in my professional career that I was
once offered a course somewhere to say, okay, this is a course for women
leaders. And of course I was grateful and appreciative that I could go to that
course because I was selected.

But on the other hand, I felt also like, why do women have to go to a course.

Why is it not men? So having said that, I no longer ask myself that because you
never get the answer. So what I’m all about and what I would like to share here,
and that’s what I find more important, is equal rights and [00:30:00] most for all,
that we all respect each other for who we are and what we do.

Doesn’t matter what position you’re in, if you’re a leader, if leader, if you are
working in digital technology, if you’re an engineer, if you’re a regular, It
doesn’t matter if you’re the janitor of the building, you are as important to help
the entire team to function because can you imagine if the janitor is not there?

You know who switched on the lines, who you’re not getting those kind of
things. So we cannot get things done. So I believe we all do this. We have the
same purpose. It might be in a different area of expertise, but by sharing
knowledge and doing as such, we function as a team, and with that we built that
foundation.

And you have heard me talking about foundations before. So with that, we build
a foundation where we help to grow, where we build trust. And with that, you
get the best out, each one of us. And only then, We can be successful, only then
we can serve the patient.

Aleksandra: Thank you so much. Thank you so much for those great insights.
Before we finish, I wanna let the listeners [00:31:00] know if they would need
your advice as a regulatory advisor, regulatory consultant. Where can they find
you? What’s the way to contact you? And I’m gonna leave this in the show notes
as well.

Esther: That’s perfectly fine. So I’m on LinkedIn so you can use my LinkedIn.
There’s also a link to YouTube channel and I’m trying to keep that one updated
with some helpful guidance’s, more information video, so to say.

So it’s not really build out yet, but I just started this and I really enjoy doing so.

So I would say go to the LinkedIn page. That’s the easiest steps where you can
find everything about me and how to get in contact with me.
Thank you for asking. Yeah,

Aleksandra: I’m gonna definitely link your LinkedIn and link your YouTube
and if any of the digital pathology place YouTube channel subscribers are
interested in the regulatory aspect, then I’m gonna point you to that channel.
Thank you so much and I wish you have a great day.

Esther: Thank you. Thanks to you too, and wish you a great day as well.

Aleksandra: Thank you. You stay till the end, and that lets me know that you’re a real digital pathology trailblazer. Thank you for this, and I know [00:32:00] I threw a lot of resources at you during the episode. There are all gonna be linked in the description below.

But there is one more resource that I need to tell you about.

Do you remember the live event from last year, “Bridging the gap between pathology and computer science” with the computational pathology group from Radboud University Medical Center?

Now all the lectures together with audio files and transcripts are gathered for you in one ad free place on the special portal.

You can view them, listen to them, read them in a distraction free environment.
And get the most out of it, even if you were their life. And you know what? You can share it with whoever you want, because it’s there for you forever for free.

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