March 21, 2023 • 18 mins
How can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.
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James C. Taylor (00:03):
We all have one, although how well my particular one works is up
for debate, but did you realize therewas such a thing as institutional memory?
There is, and we'll talkabout it with Kerin Ablashi.
This is Insight at Biologics.
(00:26):
So Kerin, if you would pleasetell everybody about yourself.
Kerin Ablashi (00:29):
Oh, sure James.
So my name's Kerin Ablashi.
I am a technical writer consultantwith Biologics Consulting.
I've been with Biologicsfor 17 years, over 17 years.
I'm a technical writer.
My focus is C M C.
I don't focus on other areas, so Idon't want to talk about those 'cause
I don't know anything about them.
Prior to that I was with a small company,so I've seen some of the challenges
(00:53):
of working in a very small companydoing product development and knowing
about getting everything documented.
And before that I was with whatis now BioReliance and I was
with them for almost 11 years.
So I've seen sort of a bigger companythat already had systems in place.
So I really do understand someof the challenges for smaller
(01:17):
companies and also bigger companies.
And then I've also seenthis with our clients.
We would interact with clients thatare from pre I N D, all the way
to doing their BLAs and even afterdoing post licensure submissions.
So I've seen companies, workedwith companies, worked in and
with companies at all stages ofpharmaceutical product development.
(01:41):
And anybody that needs to get moreinformation about me is free to
go to our website and check me outon Biologics Consulting's webpage.
James C. Taylor (01:50):
So, Kerin, what is institutional memory?
Kerin Ablashi (01:54):
Well, James, if you do an internet search, which, you can always
trust everything on the internet , butif you do an internet search, you'll
see that the definition is the storedknowledge within an organization.
So this is basically applicableto pretty much any organization.
It could be, you know, your company.
(02:15):
It could be, you know, your church.
It could be pretty much any organizationor maybe even some people would consider
their families to be an organizationwhere you have institutional memory.
It's stored knowledge of what'shappened in the past, how you've
done things, why you've done things.
Maybe you know, especially atholiday time, you have a lot
of different family traditions.
(02:35):
Why have you done those?
So it's that kind of thing.
But we're going to talk aboutit, obviously, not as it applies
to your family or anything.
We're going to talk about how itapplies to pharmaceutical development,
development of drugs, and,
James C. Taylor (02:49):
Okay.
Kerin Ablashi (02:49):
biologicals.
James C. Taylor (02:50):
All right, so you say how it applies to what we do.
Why is institutional memoryimportant in what we do?
Kerin Ablashi (02:59):
Well, I would say a, a lot of it it's because, well, we have
to, you know what we do, we have toprovide the FDA with a lot of data if
you want to get your product approved.
Right?
James C. Taylor (03:10):
Right.
Kerin Ablashi (03:10):
That's just, that's just how it goes.
The FDA or any other regulatorybody, we need a lot of data.
When you got a lot of data and a lotof, if you're doing product development,
any kind of product development, Iimagine, but I, I only know about this.
You need to know what you didand why, what worked, what didn't
work, when it did work, whatwere you using that made it work?
(03:31):
So all this stuff has to be writtendown and so , that is one challenge,
which is getting people to writethings down, which I worked with
when I was back in my small company.
That's a topic for another day, isjust getting people to write it down.
So we need to know why thingswere done, how things were done.
So what we've been seeing, James,especially since Covid, is there's
(03:54):
been a lot of people changing jobsand moving from here to there, and
a lot of people transitioning out.
When you're at a company, you know,there's always that one person or
two people, or if it's a big companymore than that, who know everything
and how everything's been done.
But if those people leave and they gosomewhere else or something happens
(04:16):
to them, those people leave, you don'tknow why did you use this formulation?
Why did you do it, uh, this way?
Why, you know, why did you pickthis particular way of doing things?
What was the starting material you used?
You don't know any of that.
You're a new person.
You come in and you haveno idea what you've got.
(04:38):
Some people have stuff stored inlab notebooks, other people have
it stored on a database over here.
People don't know what they have.
And what we're seeing is becauseof this high turnover and, and I
have talked to colleagues that someother clients are actually having
this issue is because of the highturnover we are seeing submissions
(05:00):
are becoming maybe stalled or...
So what, what I'm saying is basically,so what we're seeing is that
because of the high turnover, peopledon't know what data they have and
that's actually hindering gettingregulatory submissions put together.
And in some cases this is actuallydelaying the regulatory submissions.
(05:21):
And as we all know, and as myboss loves to say, time is money.
So if you are delaying your regulatorysubmission, that's actually can have a
lot of negative impacts on your company.
James C. Taylor (05:33):
It reminds me of a story that I heard circling back just a little
bit to the family that you said we weren'tgoing to talk about, about how everybody
in a particular family would cut off oneend of the ham before putting it into the
roaster for Christmas dinner, and at onepoint the young children didn't know why.
(05:54):
So they asked the olderpeople who didn't know why.
So they asked the older people and theyeventually got back to great grandma
who said, oh, I just used to cut off theend because my roasting pan was small.
And you're not going to know what youhave or why you do if you don't document
what you have and why you do it.
Kerin Ablashi (06:12):
And that's exactly true, but even just
documenting isn't the whole thing.
Okay.
So we had a client way back.
. It was a big company that bought alegacy product, so they bought this
company and clearly whoever hadworked on this had documented a lot.
Okay?
Because they had hundreds and hundreds ofboxes of paperwork on this product and.
(06:37):
The company that bought it had tostore this at Iron Mountain because
there was so much data, and then theyended up having to hire an intern to
go through the boxes and figure outwhat they had and what they didn't.
Because yeah, people had done a greatjob documenting, but nobody knew what
they had because they didn't have.
A central warehouse for that information.
(07:00):
So they didn't know what they hadand where it was, so they might
have had everything they needed,but they, they couldn't even show
it because it was sitting in boxes.
James C. Taylor (07:12):
So it's more than just writing it down.
It's--
Kerin Ablashi (07:15):
Exactly.
James C. Taylor (07:16):
It- it's making sure that the institution, beyond
any of the individuals, comprehendwhat it is that they have.
Kerin Ablashi (07:25):
Comprehend it.
Yes.
And, and in comprehending, knowwhere it is, know what it is.
So another company that we work with isa, you know, big company and they've got
facilities all across different placesaround the world, and each place has its
own database, or even within that, someof the product areas have, or functional
(07:49):
groups have their own databases.
So you've got a formulations departmentthat's done beautiful, lovely work,
but the product development peopledon't know what they've done.
James C. Taylor (08:00):
Right.
Kerin Ablashi (08:01):
Because nobody can see what anybody else has done.
James C. Taylor (08:04):
All right.
Kerin Ablashi (08:04):
So this is where it's institutional memory, what's been
done, what's the big, you know, whatdo we have, what knowledge do we have?
And trying to understand that.
And you know, so, and then when you gowith small companies-- I mean, the company
where I used to work, people would justjot things down in their lab notebooks.
(08:25):
That's great, but you've gota whole bunch of lab notebooks
and nobody knows what's in it.
James C. Taylor (08:29):
Right.
Kerin Ablashi (08:29):
So unless there's a central warehouse somehow for this information,
you don't really know what you have.
James C. Taylor (08:38):
All right, so how do you make a good institutional
memory structure in your company?
How do, how do you have it sothat you just don't have a bunch
of random lab books, as you said?
Kerin Ablashi (08:49):
So there's a variety of ways.
, and you know, in an ideal world,you'd have your company buy in,
and from the beginning you'dget a knowledge management--
there's knowledge management managementsoftware out there that you can get, and
you'd have people who have the whole,their job is to, you know, when somebody
(09:10):
does the report and they've beautifullydocumented everything they've done.
The report goes to somebody who willthen go through and parse out the
information they need to keep they,and then they catalog the report in
the correct places and everything.
And these people would have timeto do this and, and they'd have
management buy-in, and then you'dhave all the functional groups happy
(09:33):
to participate in this institutionalmemory activity or storage activity.
Right?
James C. Taylor (09:41):
Right.
Kerin Ablashi (09:42):
But we don't live in a perfect world.
Nobody, you know, everybody,everybody's already ahead of
you've, you're already there.
You're already like, oh, great.
Now I've got all these boxes ofdata, and what do I do with them?
So I've got my hundreds of boxes.
What do I do with them?
So that company hired an intern,because their SMEs were too busy.
And by the way, SMEs cost a lotof money, so they hired an intern.
(10:05):
So that's one way you can do it,is to get somebody to physically
sort through the information.
And, you know, this is a painful wayto do it and it's doesn't get done
really fast, but it is one way to do it.
But you start by making a database.
You, you put everything into adatabase, you put everything in
a place where people can find it.
(10:25):
But first you have torealize you have the problem.
So that's where Biologicscan come in and help out.
You're going to do your submission.
We can come in and help you with agap analysis, and we can kind of see
what you have and then we can helpyou figure out all those reports that
(10:45):
you've got that are sitting around.
What do you need?
We do have people, like me, who work ata little bit lower rate than our SMEs.
It is extremely expensive and it willsave you money to have the intern
come in and do all that instead ofhaving your SMEs do it or having a
highly paid senior consultant comein and sort through your boxes.
(11:06):
That that would be a poor use of money.
So Biologics can come in before youget started on your submission, we can
look at all your documents that you,not all your documents, but we can look
at what you have for your submission.
We can kind of help you seewhat you've got, where things
are, and we can help you.
I mean, we could even havepeople come in before.
(11:27):
We do send people to facilitiesthat can help you set things
up before you even get going.
But most people are not in that place.
Most people are, well, we've got all thisinformation and now we've got to kind of
wrangle it and get it together so we canhelp you and all your, you know, work
with the different groups to put theinformation together in one central place.
(11:48):
We can help you prepare a centraldatabase of a sort, you know, listings
that will help you to figure out whatyou do have and help you identify
where you're missing information.
James C. Taylor (12:00):
So we can provide both the ounces of prevention if
you're lucky enough to realizeyou need this in the first place,
or the pound of cure afterward.
Kerin Ablashi (12:07):
Yeah, and unfortunately most of us end up in the pound of
cure because, you know, it's great.
But you know, most companies whenthey get started are so keen to get
going that you know, they don't,or, and / or they don't have the
money to get to put this in place.
But if you do have it in place and, andyou know, the sooner you start with this,
(12:28):
the better because if you do have it inplace, say that you do have turnover.
People leave.
You get somebody new in, theycan look in a central place and
they've got this information.
Oh, that's what we did.
Oh, that's why we cameup with that formulation.
James C. Taylor (12:43):
Okay.
Kerin Ablashi (12:43):
Oh, because we based it on this and here's the report
that explains what we did, whatwe tried and what didn't work.
And it also helps youwhen you troubleshoot.
You're troubleshootingsomething, something went wrong.
Oh, okay.
We see that when we did thisthis other time, this one thing
caused something else not to work.
James C. Taylor (13:03):
Right.
Kerin Ablashi (13:03):
And it really does help with a lot of things down the road.
So yeah, the sooner you can implementthis, get, you know, do it yourself
or call somebody like us, we can tocome in and help you, the, the better
off you can be and, uh, you know,get your submissions in more quickly.
James C. Taylor (13:21):
Awesome.
So now, This is great for a small tomedium size company where the decision
maker can go in and start, set things up.
But what if you're in one of these superultra ginormous companies, like one I was
at at one point in my career and you know,you're lucky to get them to allow you to
(13:43):
change the color of paper on your desk.
What can you do for someone in a largercompany with institutional memory needs?
Kerin Ablashi (13:55):
Well, that's a good question because that goes back into the
company buy-in because you do have tohave some somebody believing that there's
got to be some, you know, reason for thismemory to be captured in a single place.
Frequently that is because you know,you need to get this mission done,
you're going to do your b a, becausenow you're talking about a huge
(14:17):
mondo company that's needs to do,you know, they want to do their BLA.
We can come in and work with youand work with the different groups.
We can go in to the different sitesif it's needed, or you know, now post
Covid, everything's done virtually.
We can do a lot of work with you and,you know, I've worked on BLAs virtually
(14:40):
where we were working with differentgroups who did not know, you know,
we were pulling the reports and goingthrough and helping them identify what
information they needed, and that wasall being pulled together, working with
the, you know, it's a bigger company.
They did actually have some staffto help house the information
and put them more, you know, putthings into a more global central
(15:03):
place so that people could find it.
So we can work with you with thesystems you have, because we realize
that, you know, you're not going tobe able to just take everything you
have and redo it and start all over.
So we kind of have to work with whatyou have so we can work with you to work
within your systems, but more, we canalso help you to talk amongst yourselves
(15:28):
because sometimes the groups don't talkand it just-- Sometimes just having a
dialogue helps and, and by having to havethese meetings, as you know, having us
in there helps to facilitate intercompanydiscussions, if that makes sense.
James C. Taylor (15:45):
Yes.
Yes it does.
So let me ask you, because thishas been fascinating to me, but
sometimes people have a little,little trouble boiling things down.
What would be the Too long didn't listenversion of what we just talked about?
Kerin Ablashi (16:02):
Okay, so the too long didn't listen is:
You got to know what you have.
You have to know what you have, whyyou did it, you know, so, it means
it's all got to be written down.
But we knew that anyway 'cause we allbelieve in our GMPs and everything,
so we know we got to write it down.
But we really need to have a centralizedsharing of knowledge, be it in a
(16:28):
database, be it using knowledgemanagement system, but it needs to be a
corporate culture of trying to understandwhat went before and appreciate it.
And you know, coming back to the familyanalogy, you know, there's a reason
why things were done a certain way.
(16:49):
We don't always know what it was.
Sometimes it's silly, like cuttingoff the end of the roast and just
because of the pan, and now everybodyelse does it, but sometimes there is a
reason like cutting off the end of theroast because it didn't fit otherwise,
you know there's a reason for it.
Knowing what you have is reallyimportant and will save you
(17:10):
time and money down the road.
If the experiments are there anddocumented and you know about it, you
don't have to repeat them, so it's goingto save you time, money, headaches, help
your submissions get in faster, help yourpeople focus on what's really important
to moving your product forward insteadof repeating what's already been done.
James C. Taylor (17:31):
Thank you to Kerin Ablashi for joining us.
Now if you'd like more information,you can email Kerin or any of us
at insight@biologicsconsulting.com.
That's Insight at BiologicsConsulting, all one word, dot com.
Also, we'd love it if you'd like,subscribe to, rate, and review our show.
The executive producer of Insightat Biologics is Kris Kraihanzel.
(17:53):
This episode was producedand edited by James C.
Taylor.
The technical supervisor is Jeff Wease.
The insight at Biologicstheme is by Tom Rory Parsons.
I'm James C.
Taylor.
Thank you for joining us and pleasecome back for more Insight at Biologics.
We all have one, although how well my particular one works is up
for debate, but did you realize therewas such a thing as institutional memory?
There is, and we'll talkabout it with Kerin Ablashi.
This is Insight at Biologics.
(00:26):
So Kerin, if you would pleasetell everybody about yourself.
Kerin Ablashi (00:29):
Oh, sure James.
So my name's Kerin Ablashi.
I am a technical writer consultantwith Biologics Consulting.
I've been with Biologicsfor 17 years, over 17 years.
I'm a technical writer.
My focus is C M C.
I don't focus on other areas, so Idon't want to talk about those 'cause
I don't know anything about them.
Prior to that I was with a small company,so I've seen some of the challenges
(00:53):
of working in a very small companydoing product development and knowing
about getting everything documented.
And before that I was with whatis now BioReliance and I was
with them for almost 11 years.
So I've seen sort of a bigger companythat already had systems in place.
So I really do understand someof the challenges for smaller
(01:17):
companies and also bigger companies.
And then I've also seenthis with our clients.
We would interact with clients thatare from pre I N D, all the way
to doing their BLAs and even afterdoing post licensure submissions.
So I've seen companies, workedwith companies, worked in and
with companies at all stages ofpharmaceutical product development.
(01:41):
And anybody that needs to get moreinformation about me is free to
go to our website and check me outon Biologics Consulting's webpage.
James C. Taylor (01:50):
So, Kerin, what is institutional memory?
Kerin Ablashi (01:54):
Well, James, if you do an internet search, which, you can always
trust everything on the internet , butif you do an internet search, you'll
see that the definition is the storedknowledge within an organization.
So this is basically applicableto pretty much any organization.
It could be, you know, your company.
(02:15):
It could be, you know, your church.
It could be pretty much any organizationor maybe even some people would consider
their families to be an organizationwhere you have institutional memory.
It's stored knowledge of what'shappened in the past, how you've
done things, why you've done things.
Maybe you know, especially atholiday time, you have a lot
of different family traditions.
(02:35):
Why have you done those?
So it's that kind of thing.
But we're going to talk aboutit, obviously, not as it applies
to your family or anything.
We're going to talk about how itapplies to pharmaceutical development,
development of drugs, and,
James C. Taylor (02:49):
Okay.
Kerin Ablashi (02:49):
biologicals.
James C. Taylor (02:50):
All right, so you say how it applies to what we do.
Why is institutional memoryimportant in what we do?
Kerin Ablashi (02:59):
Well, I would say a, a lot of it it's because, well, we have
to, you know what we do, we have toprovide the FDA with a lot of data if
you want to get your product approved.
Right?
James C. Taylor (03:10):
Right.
Kerin Ablashi (03:10):
That's just, that's just how it goes.
The FDA or any other regulatorybody, we need a lot of data.
When you got a lot of data and a lotof, if you're doing product development,
any kind of product development, Iimagine, but I, I only know about this.
You need to know what you didand why, what worked, what didn't
work, when it did work, whatwere you using that made it work?
(03:31):
So all this stuff has to be writtendown and so , that is one challenge,
which is getting people to writethings down, which I worked with
when I was back in my small company.
That's a topic for another day, isjust getting people to write it down.
So we need to know why thingswere done, how things were done.
So what we've been seeing, James,especially since Covid, is there's
(03:54):
been a lot of people changing jobsand moving from here to there, and
a lot of people transitioning out.
When you're at a company, you know,there's always that one person or
two people, or if it's a big companymore than that, who know everything
and how everything's been done.
But if those people leave and they gosomewhere else or something happens
(04:16):
to them, those people leave, you don'tknow why did you use this formulation?
Why did you do it, uh, this way?
Why, you know, why did you pickthis particular way of doing things?
What was the starting material you used?
You don't know any of that.
You're a new person.
You come in and you haveno idea what you've got.
(04:38):
Some people have stuff stored inlab notebooks, other people have
it stored on a database over here.
People don't know what they have.
And what we're seeing is becauseof this high turnover and, and I
have talked to colleagues that someother clients are actually having
this issue is because of the highturnover we are seeing submissions
(05:00):
are becoming maybe stalled or...
So what, what I'm saying is basically,so what we're seeing is that
because of the high turnover, peopledon't know what data they have and
that's actually hindering gettingregulatory submissions put together.
And in some cases this is actuallydelaying the regulatory submissions.
(05:21):
And as we all know, and as myboss loves to say, time is money.
So if you are delaying your regulatorysubmission, that's actually can have a
lot of negative impacts on your company.
James C. Taylor (05:33):
It reminds me of a story that I heard circling back just a little
bit to the family that you said we weren'tgoing to talk about, about how everybody
in a particular family would cut off oneend of the ham before putting it into the
roaster for Christmas dinner, and at onepoint the young children didn't know why.
(05:54):
So they asked the olderpeople who didn't know why.
So they asked the older people and theyeventually got back to great grandma
who said, oh, I just used to cut off theend because my roasting pan was small.
And you're not going to know what youhave or why you do if you don't document
what you have and why you do it.
Kerin Ablashi (06:12):
And that's exactly true, but even just
documenting isn't the whole thing.
Okay.
So we had a client way back.
. It was a big company that bought alegacy product, so they bought this
company and clearly whoever hadworked on this had documented a lot.
Okay?
Because they had hundreds and hundreds ofboxes of paperwork on this product and.
(06:37):
The company that bought it had tostore this at Iron Mountain because
there was so much data, and then theyended up having to hire an intern to
go through the boxes and figure outwhat they had and what they didn't.
Because yeah, people had done a greatjob documenting, but nobody knew what
they had because they didn't have.
A central warehouse for that information.
(07:00):
So they didn't know what they hadand where it was, so they might
have had everything they needed,but they, they couldn't even show
it because it was sitting in boxes.
James C. Taylor (07:12):
So it's more than just writing it down.
It's--
Kerin Ablashi (07:15):
Exactly.
James C. Taylor (07:16):
It- it's making sure that the institution, beyond
any of the individuals, comprehendwhat it is that they have.
Kerin Ablashi (07:25):
Comprehend it.
Yes.
And, and in comprehending, knowwhere it is, know what it is.
So another company that we work with isa, you know, big company and they've got
facilities all across different placesaround the world, and each place has its
own database, or even within that, someof the product areas have, or functional
(07:49):
groups have their own databases.
So you've got a formulations departmentthat's done beautiful, lovely work,
but the product development peopledon't know what they've done.
James C. Taylor (08:00):
Right.
Kerin Ablashi (08:01):
Because nobody can see what anybody else has done.
James C. Taylor (08:04):
All right.
Kerin Ablashi (08:04):
So this is where it's institutional memory, what's been
done, what's the big, you know, whatdo we have, what knowledge do we have?
And trying to understand that.
And you know, so, and then when you gowith small companies-- I mean, the company
where I used to work, people would justjot things down in their lab notebooks.
(08:25):
That's great, but you've gota whole bunch of lab notebooks
and nobody knows what's in it.
James C. Taylor (08:29):
Right.
Kerin Ablashi (08:29):
So unless there's a central warehouse somehow for this information,
you don't really know what you have.
James C. Taylor (08:38):
All right, so how do you make a good institutional
memory structure in your company?
How do, how do you have it sothat you just don't have a bunch
of random lab books, as you said?
Kerin Ablashi (08:49):
So there's a variety of ways.
, and you know, in an ideal world,you'd have your company buy in,
and from the beginning you'dget a knowledge management--
there's knowledge management managementsoftware out there that you can get, and
you'd have people who have the whole,their job is to, you know, when somebody
(09:10):
does the report and they've beautifullydocumented everything they've done.
The report goes to somebody who willthen go through and parse out the
information they need to keep they,and then they catalog the report in
the correct places and everything.
And these people would have timeto do this and, and they'd have
management buy-in, and then you'dhave all the functional groups happy
(09:33):
to participate in this institutionalmemory activity or storage activity.
Right?
James C. Taylor (09:41):
Right.
Kerin Ablashi (09:42):
But we don't live in a perfect world.
Nobody, you know, everybody,everybody's already ahead of
you've, you're already there.
You're already like, oh, great.
Now I've got all these boxes ofdata, and what do I do with them?
So I've got my hundreds of boxes.
What do I do with them?
So that company hired an intern,because their SMEs were too busy.
And by the way, SMEs cost a lotof money, so they hired an intern.
(10:05):
So that's one way you can do it,is to get somebody to physically
sort through the information.
And, you know, this is a painful wayto do it and it's doesn't get done
really fast, but it is one way to do it.
But you start by making a database.
You, you put everything into adatabase, you put everything in
a place where people can find it.
(10:25):
But first you have torealize you have the problem.
So that's where Biologicscan come in and help out.
You're going to do your submission.
We can come in and help you with agap analysis, and we can kind of see
what you have and then we can helpyou figure out all those reports that
(10:45):
you've got that are sitting around.
What do you need?
We do have people, like me, who work ata little bit lower rate than our SMEs.
It is extremely expensive and it willsave you money to have the intern
come in and do all that instead ofhaving your SMEs do it or having a
highly paid senior consultant comein and sort through your boxes.
(11:06):
That that would be a poor use of money.
So Biologics can come in before youget started on your submission, we can
look at all your documents that you,not all your documents, but we can look
at what you have for your submission.
We can kind of help you seewhat you've got, where things
are, and we can help you.
I mean, we could even havepeople come in before.
(11:27):
We do send people to facilitiesthat can help you set things
up before you even get going.
But most people are not in that place.
Most people are, well, we've got all thisinformation and now we've got to kind of
wrangle it and get it together so we canhelp you and all your, you know, work
with the different groups to put theinformation together in one central place.
(11:48):
We can help you prepare a centraldatabase of a sort, you know, listings
that will help you to figure out whatyou do have and help you identify
where you're missing information.
James C. Taylor (12:00):
So we can provide both the ounces of prevention if
you're lucky enough to realizeyou need this in the first place,
or the pound of cure afterward.
Kerin Ablashi (12:07):
Yeah, and unfortunately most of us end up in the pound of
cure because, you know, it's great.
But you know, most companies whenthey get started are so keen to get
going that you know, they don't,or, and / or they don't have the
money to get to put this in place.
But if you do have it in place and, andyou know, the sooner you start with this,
(12:28):
the better because if you do have it inplace, say that you do have turnover.
People leave.
You get somebody new in, theycan look in a central place and
they've got this information.
Oh, that's what we did.
Oh, that's why we cameup with that formulation.
James C. Taylor (12:43):
Okay.
Kerin Ablashi (12:43):
Oh, because we based it on this and here's the report
that explains what we did, whatwe tried and what didn't work.
And it also helps youwhen you troubleshoot.
You're troubleshootingsomething, something went wrong.
Oh, okay.
We see that when we did thisthis other time, this one thing
caused something else not to work.
James C. Taylor (13:03):
Right.
Kerin Ablashi (13:03):
And it really does help with a lot of things down the road.
So yeah, the sooner you can implementthis, get, you know, do it yourself
or call somebody like us, we can tocome in and help you, the, the better
off you can be and, uh, you know,get your submissions in more quickly.
James C. Taylor (13:21):
Awesome.
So now, This is great for a small tomedium size company where the decision
maker can go in and start, set things up.
But what if you're in one of these superultra ginormous companies, like one I was
at at one point in my career and you know,you're lucky to get them to allow you to
(13:43):
change the color of paper on your desk.
What can you do for someone in a largercompany with institutional memory needs?
Kerin Ablashi (13:55):
Well, that's a good question because that goes back into the
company buy-in because you do have tohave some somebody believing that there's
got to be some, you know, reason for thismemory to be captured in a single place.
Frequently that is because you know,you need to get this mission done,
you're going to do your b a, becausenow you're talking about a huge
(14:17):
mondo company that's needs to do,you know, they want to do their BLA.
We can come in and work with youand work with the different groups.
We can go in to the different sitesif it's needed, or you know, now post
Covid, everything's done virtually.
We can do a lot of work with you and,you know, I've worked on BLAs virtually
(14:40):
where we were working with differentgroups who did not know, you know,
we were pulling the reports and goingthrough and helping them identify what
information they needed, and that wasall being pulled together, working with
the, you know, it's a bigger company.
They did actually have some staffto help house the information
and put them more, you know, putthings into a more global central
(15:03):
place so that people could find it.
So we can work with you with thesystems you have, because we realize
that, you know, you're not going tobe able to just take everything you
have and redo it and start all over.
So we kind of have to work with whatyou have so we can work with you to work
within your systems, but more, we canalso help you to talk amongst yourselves
(15:28):
because sometimes the groups don't talkand it just-- Sometimes just having a
dialogue helps and, and by having to havethese meetings, as you know, having us
in there helps to facilitate intercompanydiscussions, if that makes sense.
James C. Taylor (15:45):
Yes.
Yes it does.
So let me ask you, because thishas been fascinating to me, but
sometimes people have a little,little trouble boiling things down.
What would be the Too long didn't listenversion of what we just talked about?
Kerin Ablashi (16:02):
Okay, so the too long didn't listen is:
You got to know what you have.
You have to know what you have, whyyou did it, you know, so, it means
it's all got to be written down.
But we knew that anyway 'cause we allbelieve in our GMPs and everything,
so we know we got to write it down.
But we really need to have a centralizedsharing of knowledge, be it in a
(16:28):
database, be it using knowledgemanagement system, but it needs to be a
corporate culture of trying to understandwhat went before and appreciate it.
And you know, coming back to the familyanalogy, you know, there's a reason
why things were done a certain way.
(16:49):
We don't always know what it was.
Sometimes it's silly, like cuttingoff the end of the roast and just
because of the pan, and now everybodyelse does it, but sometimes there is a
reason like cutting off the end of theroast because it didn't fit otherwise,
you know there's a reason for it.
Knowing what you have is reallyimportant and will save you
(17:10):
time and money down the road.
If the experiments are there anddocumented and you know about it, you
don't have to repeat them, so it's goingto save you time, money, headaches, help
your submissions get in faster, help yourpeople focus on what's really important
to moving your product forward insteadof repeating what's already been done.
James C. Taylor (17:31):
Thank you to Kerin Ablashi for joining us.
Now if you'd like more information,you can email Kerin or any of us
at insight@biologicsconsulting.com.
That's Insight at BiologicsConsulting, all one word, dot com.
Also, we'd love it if you'd like,subscribe to, rate, and review our show.
The executive producer of Insightat Biologics is Kris Kraihanzel.
(17:53):
This episode was producedand edited by James C.
Taylor.
The technical supervisor is Jeff Wease.
The insight at Biologicstheme is by Tom Rory Parsons.
I'm James C.
Taylor.
Thank you for joining us and pleasecome back for more Insight at Biologics.
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