December 13, 2022 • 21 mins
You may not have everything that you need when it comes to making a drug or device submission. How do you know? With a gap analysis. David Pepperl explains it in our conversation.
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James C. Taylor (00:02):
Gap analysis isn't figuring out how to
fix Michael Strayhan's teeth.
So what is gap analysis?
When do I need it?
How do I use it?
Hi, I'm James C.
Taylor of Biologics Consulting andjoining me to answer those questions
is David Pepperl, Senior consultantand leader of our non-clinical team.
This is Insight at Biologics.
(00:33):
Hi.
Now for people who don't knowyou quite as well as I do, why
don't you tell 'em a little bitabout who you are and what you do?
David Pepperl (00:42):
Sure.
James.
My name is David Pepperl.
I'm a pharmacologist and toxicologist withBiologics Consulting, and I've been with
the company for a little over 18 years.
I've got a background in pharmacology,toxicology cell and molecular
biology, and I've been consultingfor a little bit over 20 years.
(01:02):
In drug development, productdevelopment, and regulatory affairs.
I've been with, again, Biologicssince about 2004 and heading up the
non-clinical team since about 2015.
And now
James C. Taylor (01:16):
I want to get into gap analysis.
I looked up a little bit aboutit when I found out I was
going to be interviewing you.
But I don't really understand alot about it, so this will be a
perfect opportunity for anybodyelse in that same boat to learn.
So just broadly, what is gap analysis?
David Pepperl (01:36):
Well, in biopharmaceutical industry, we see a lot of projects
and a lot of clients and sponsorscome to us with, uh, either early
stage projects, middle stage,late stage projects of all sorts.
And uh, a lot of timeswe need a place to start.
They ask for help, assistance with theirprogram, and you need to start somewhere.
(02:00):
You can't just dive into a specificquestion, address the finer points of what
they're asking without first reviewingwhat they have, and doing more of a deep
dive gap assessment is really an earlystage in depth evaluation or assessment
of any client's or sponsor's or company'sdevelopment program, and in our case,
(02:24):
it's usually a biotech developmentfor, say, a vaccine or a cell or gene
therapy, a small molecule medical device.
And it again, essentially what wecan do and what is done with the
gap analysis is an outside group cancome in, review all the data, all
(02:45):
the information on the product, andprovide an assessment of where any
critical gaps or holes in the programmight be for whatever stage they're at.
They may be at Reg filing a regulatorysubmission with the FDA, or they may
be talking to investors.
So it's good to know if there's anycritical omissions or gaps in your program
(03:12):
that may lead to stumbling blocks orclinical hold or some adverse finding
that may halt your development program.
So a lot of what we do is early stageassessments of development program.
For biotech companies to see ifthere's anything critical missing
(03:32):
before they move on to that next step.
And it's good to have somebo, uh, anoutside pair of eyes on one's program
because, you know, it gives a freshperspective, a sort of an unbiased
perspective as to where things stand.
And we would look for those gaps if you.
And the gaps have to be comparedto wherever the company or
(03:54):
sponsor client wants to be.
If they want to file a regulatorysubmission, an IND with the FDA,
or if they want to have a pre-IND,or again, talk to investors.
It has to be against some keymilestone in their program.
So whatever that milestone is,you're trying to identify where
any shortcomings may be and that'swhere the, what the gap would be.
(04:17):
And sometimes a client has just abouteverything they need, and it's just very
minor points that we inform them of.
So it, it can be anythingfrom one to the other.
Quite a broad spectrum.
James C. Taylor (04:29):
All right.
Now, who needs a gap analysis?
David Pepperl (04:35):
Typically, it's any company that's moving toward a critical juncture
in their development pathway or program.
In our case, it's small to mid-sizeor, or even large biotech companies.
Drug.
Or medical device that will belooking, make a regulatory submission
(05:00):
or something along those lines.
And then they have to prepare informationfor regulators and submit that.
And of course you want to gointo the regulatory agencies
with your best foot forward.
So you, you have a dossier you wouldprepare and we prepare that for them.
James C. Taylor (05:22):
Now, you had mentioned that this is done by
someone outside of the project itself.
So who does perform the gap analysis?
David Pepperl (05:38):
Well, typically what we see at least is clients come to
us and as an outside, as a consultingcompany, it's, it's often consultants
or somebody outside the organizationwho would have that fresh perspective
or highly objective perspective.
So usually you want to have a groupor person or persons, depending
(06:00):
on the scope of the gap analysis.
It, it could be, it could be a veryfocused gap analysis of one area,
like non-clinical in my area, orit could be very broad and then
have chemistry, manufacturing,non-clinical, clinical regulatory.
So it, it really depends on what you need.
So if you need a whole consultingorganization, you may just need one
(06:22):
consultant or one outside person.
Maybe it's a academic who's an expertin the field, but it's usually a
group that can provide that broaddevelopment and regulatory expertise.
And somebody again, who's not, youknow, within the program or within the
company, although that could be a case.
(06:43):
In a case of a large company, you might.
Some people who aren't familiar with thatproject and they might look it over, but
in general, it's good to have a, a freshobjective set of eyes on the program.
James C. Taylor (06:57):
So what determines the scope of a gap analysis?
You mentioned that it can be veryfocused or can be very broad.
So what determines thebreadth of the analysis?
David Pepperl (07:09):
Well, most cases, James, they're, they're pretty broad.
They're usually.
All the different disciplinesand our, again, in our case, CMC
chemistry, non-clinical, clinicalregulatory and maybe medical
device if a client has a medicaldevice involved with their program.
But what really drives the breadthand the diversity of the gap
(07:31):
analysis is, is what they have itit, and what they're requesting.
It's best, certainly if you canreview everything, if you can have a
team involved and review everythingthat they have, but sometimes.
Companies or clients will come inand they have a good handle on the
manufacturing and they just don'tknow maybe what they'll need for
(07:52):
the nonclinical, the animal studies,toxicology, pharmacology, or they just
need a second perspective on that.
And sometimes it's the other way around.
It may be they have the nonclinical,but they don't have any cmc.
Over the years I've seen most of them arecomprehensive, covering all the different
areas and, and that's often beneficialbecause we also need to start somewhere.
(08:16):
We need to get, you know, theinformation and digest it and take
it in and consider it in relationto where the client wants to be.
So it's good that if we cando that early stage review.
But sometimes they only needa very focused assessment.
If, if they might have the, theother experts in house already and
(08:39):
they're missing some little aspect orthey're not confident of their data.
Um, those kind of things thatreally drive the, the scope of it.
James C. Taylor (08:51):
Okay.
So you perform a gap analysisand you have an idea of.
You could improve things in your project.
What do you do with that?
David Pepperl (09:09):
Well, again, what we would typically do is take a time, needed to
review the material, go back to possiblybackground material or regulatory
submissions that maybe they've submitted,or just basic data papers, and we would
normally get our notes, our thoughtsin order, and again, compare it to.
(09:33):
They're targeting, whether it be apre-IND or a, a mid stage regulatory
submission or a marketing application,a, a biologic license application,
or a new drug application to the FDA.
Or typically an IND investigation,new drug application, what we're
most accustomed to dealing with.
And then we would write up amemo or dossier to the client
(09:57):
and say, Here's what we reviewed.
We reviewed documents 1, 2, 3, and4, and we found these shortcomings.
We found these findings thatmight impact your program and
indicate how significant they are.
Certain finding number one is minor.
It may not cause any problem, butfinding number two, you can't move
(10:17):
forward unless you address that.
You may need an animal study oryou may need to remanufacture your
product or add some additionaltests to your product qualification,
something along those lines.
So we would prepare a, atleast I prepare a memo.
A document that lays out what documentswere reviewed, and then specify comments
(10:40):
on specific documents, particularlyif there are larger ones like uh,
regulatory submissions or reports,critical reports, and what comments
I might have on those, and then theclient could subsequently use those.
A plan or marching orders and say,Oh, okay, this is what we need
(11:02):
to do, or let's talk about this.
Let's consider, what dowe really need to do that?
We may not have the financialwherewithal to do that, so there's a
lot of things that can come out of it.
But often we'll do these analysesand the clients will discuss
them, and then they'll move on toaddress those gaps and move on to
(11:23):
their next stage of development.
James C. Taylor (11:26):
So, if I'm understanding this correctly, this is a way I'm seeing
of preventing future stumbling blocks.
You know, it's seeing that youcould run into this issue down the
road if you don't correct the areasidentified by the gap analysis, and
that could end up costing you you time.
(11:47):
So taking this little bit of time todo the analysis in the beginning could
actually save you in the long run.
David Pepperl (11:54):
Yeah, exactly.
And I'd say it could be donefor any sort of project really.
And it's just a matter of how muchresources and time you have to put to it.
But again, not only is the gap analysisa great place for somebody like us or
a consulting group to start, when we'reworking with a client, it allows us
to identify those key stumbling blocksand certainly save time and money.
(12:20):
You don't want to go into FDA andthen get a clinical hold, have your
I n D put on hold because you weremissing a study or you missed some
endpoint, or you've had some adversefinding, or you had an impurity in
your manufactured material that you canidentify that and make sure everything.
(12:41):
Is in line.
It may cost more down the road,cost more in the short term, but
then it will save certainly time andsignificant amounts of money potentially.
And certainly sometimes weidentify clients that are doing
more than they need on occasion.
Uh, they may be performing moreor maybe the wrong studies.
(13:05):
That aren't really going to addressthe right questions, and then we
can guide them to say, Hey, thisstudy may not be necessary, but you
may need to do this other study inanother model to properly address
what the regulators are looking for.
It can get the program on track.
(13:25):
It could save clients time and money,maybe help hone the program so, More
focused and more efficient in the end.
James C. Taylor (13:36):
Right.
I was going to say, it looks like youhave two different areas where you can
find efficiencies, both in avoidingproblems and in streamlining your process.
So, all right, I have a studyand I say, David, I want you
to perform a gap analysis.
What do I need to giveto you and your team?
David Pepperl (14:00):
Well, generally, and, and James, a lot of these are performed on
entire program, so you know, we couldlook at a single large study, like you
said, you mentioned, but they could alsobe generally on an entire program so
that they've, they've come up to thispoint and, uh, what they should give us
or what they should provide to any groupoutside group that's performing these
(14:23):
assessments is everything , essentially.
As much as you can, certainly.
Papers that have been published, studyreports, batch records for for produced
material specifications for producing the,the drug or the biologic or um, anything.
(14:45):
And then animal studies, analytical tests.
Essentially everything that, that theycan afford to give us within reason.
The more data that an outsidegroup has to evaluate, the more
comprehensive an assessment that canbe performed just like anything else.
And you have to be careful.
(15:06):
Like if you're submitting things to theFDA, you don't wanna bombard them with
too much, you know, useless detail.
You want to provide them what'ssalient and succinct, right?
But at the same time, for.
What we see, we can take everything.
We can take reports and even, you know,notes or just data and figures, and, and
that's something that helps us too, thatif they provide us with some reports or
(15:31):
just figures and tables, but they don'thave the data presented in terms of a, an
actual study report, that could be a gapbecause you need to have study reports.
You need to have the data writtenup in a, uh, meaningful fashion.
The results and conclusions and methodspresented in a meaningful way so,
(15:53):
Can not only consultants, but thenultimately the FDA can review it.
So in providing us with everything,we can see that well, they have
reports or they don't have reports,so they're lacking something.
So it really boils down to gettingthe reviewing organization or your
consultants as much as possible to reviewon the program so that they can provide
(16:16):
the the best and most comprehensive.
James C. Taylor (16:22):
So you really want to create a broad picture so that you can
see in all the possible problem areas.
That's why you want to give everything.
Now you had mentioned earlier a, adossier is a dossier, usually the way
that the results are presented to the.
David Pepperl (16:46):
Yeah, it might be a memo or a, a write up or an
attachment or a combined assessmentfrom the different consultants.
You may have, again, twoor three different people
working on this gap analysis.
For the client.
And, uh, those can be combined into oneoverall assessment and then that can
(17:06):
be provided to the client and then theycan review it and then say, Oh, okay,
we need to do X, Y, and Z, but otherwisec, A, B and C are okay in those areas
and, uh, we may wanna talk about some ofthese other items and need clarification.
So it's, it's usually a bit of that.
It's, it's a, it's a, it's a write.
(17:28):
That we would provide to the clientafter completing our assessment.
James C. Taylor (17:35):
Okay.
And now I have a kind of aslightly weird question, but it,
it happens in the business world.
So should a sponsor fear a gap
David Pepperl (17:46):
analysis, fear?
No.
I mean, wouldn't you want to know, I guessit's, I guess it's a little bit going to
the dentist and you, you mentioned fear
Everything may be fine and you wannafind that out and you have a checkup
and you get that checkup where, thenagain, you may have a sore tooth and
you go in there and the dentist willtell you what it is and he'll address
(18:07):
it or he or she will address it.
We don't know if we're missing something.
Are we ready?
Sometimes the sponsors, they knowa great deal about their product.
They may know a great deal about,uh, development and all the different
areas, but sometimes there'sjust something that you might.
And that's why it's good to havethat outside perspective and experts
(18:28):
working in the field for years andyears to look at these, the programs
with a fresh set of eyes and with thatregulatory perspective and an outside
perspective to give you that assessment.
And I think you should welcome feedback.
Sometimes it's welcome,sometimes it isn't so much.
It.
I think it's important to know whereyou're at and you don't want to go into,
(18:53):
you don't wanna press forward, you know,with a substandard program for sure.
James C. Taylor (18:58):
You had mentioned in explaining it a little bit about the
dentist and they always say about dentalproblems, you should go in as early as
possible because waiting never makes.
Less of a problem when it comes tothe dentist, and I imagine it works
similarly for a g analysis earlierin the process is generally better.
David Pepperl (19:22):
Correct?
To a degree, yeah.
And that's a good, uh, segueto a point I wanted to make.
You really need to have some substantivedata, whether, you know, you're, whether
it's just chemistry or just nonclinicalor an overall program, you have to.
Some good data for anoutside group to find gaps.
(19:43):
If you are too early and you justhave some ideas and you have thoughts
on where to go, but you haven'treally done any of the studies, you
haven't really manufactured yourmaterial, you may not even be in
position for a gap analysis because.
It's all gaps.
It may be too gappy in that, in thatsense, you know, so what in that, in
that case, what a sponsor or client needsis more of a development plan and, and
(20:07):
that's more of a roadmap to how to getfrom where they're at to their final goal,
whether it's an i n D submission, vlanda, any of the regulatory submission or
talking to investors getting that funding.
But if you're too early, We foundin our experience that some clients
come in and everything is missing.
(20:30):
So it is like, well, you need a plan tomove forward and that can be provided as
well, but it's not really a gap analysis.
So it's really, you have to havesomething substantive to work with and
hopefully the gaps are, are minor and not.
Grand Canyon-esque.
James C. Taylor (20:47):
Thank you to David Pepper for joining us.
If you'd like more information, just emailus at insight at biologics consulting.com.
That's insight atbiologics consulting.com.
The executive producer of Insightat biologics is Kris Kraihanzel.
This episode was producedand edited by James C.
Taylor, technicalsupervisor is Jeff Wease.
The Insight at Biologicstheme is by Tom Rory Parsons.
(21:11):
I'm James C.
Taylor.
Thank you for joining us.
Please come back for moreInsight at Biologics.
Gap analysis isn't figuring out how to
fix Michael Strayhan's teeth.
So what is gap analysis?
When do I need it?
How do I use it?
Hi, I'm James C.
Taylor of Biologics Consulting andjoining me to answer those questions
is David Pepperl, Senior consultantand leader of our non-clinical team.
This is Insight at Biologics.
(00:33):
Hi.
Now for people who don't knowyou quite as well as I do, why
don't you tell 'em a little bitabout who you are and what you do?
David Pepperl (00:42):
Sure.
James.
My name is David Pepperl.
I'm a pharmacologist and toxicologist withBiologics Consulting, and I've been with
the company for a little over 18 years.
I've got a background in pharmacology,toxicology cell and molecular
biology, and I've been consultingfor a little bit over 20 years.
(01:02):
In drug development, productdevelopment, and regulatory affairs.
I've been with, again, Biologicssince about 2004 and heading up the
non-clinical team since about 2015.
And now
James C. Taylor (01:16):
I want to get into gap analysis.
I looked up a little bit aboutit when I found out I was
going to be interviewing you.
But I don't really understand alot about it, so this will be a
perfect opportunity for anybodyelse in that same boat to learn.
So just broadly, what is gap analysis?
David Pepperl (01:36):
Well, in biopharmaceutical industry, we see a lot of projects
and a lot of clients and sponsorscome to us with, uh, either early
stage projects, middle stage,late stage projects of all sorts.
And uh, a lot of timeswe need a place to start.
They ask for help, assistance with theirprogram, and you need to start somewhere.
(02:00):
You can't just dive into a specificquestion, address the finer points of what
they're asking without first reviewingwhat they have, and doing more of a deep
dive gap assessment is really an earlystage in depth evaluation or assessment
of any client's or sponsor's or company'sdevelopment program, and in our case,
(02:24):
it's usually a biotech developmentfor, say, a vaccine or a cell or gene
therapy, a small molecule medical device.
And it again, essentially what wecan do and what is done with the
gap analysis is an outside group cancome in, review all the data, all
(02:45):
the information on the product, andprovide an assessment of where any
critical gaps or holes in the programmight be for whatever stage they're at.
They may be at Reg filing a regulatorysubmission with the FDA, or they may
be talking to investors.
So it's good to know if there's anycritical omissions or gaps in your program
(03:12):
that may lead to stumbling blocks orclinical hold or some adverse finding
that may halt your development program.
So a lot of what we do is early stageassessments of development program.
For biotech companies to see ifthere's anything critical missing
(03:32):
before they move on to that next step.
And it's good to have somebo, uh, anoutside pair of eyes on one's program
because, you know, it gives a freshperspective, a sort of an unbiased
perspective as to where things stand.
And we would look for those gaps if you.
And the gaps have to be comparedto wherever the company or
(03:54):
sponsor client wants to be.
If they want to file a regulatorysubmission, an IND with the FDA,
or if they want to have a pre-IND,or again, talk to investors.
It has to be against some keymilestone in their program.
So whatever that milestone is,you're trying to identify where
any shortcomings may be and that'swhere the, what the gap would be.
(04:17):
And sometimes a client has just abouteverything they need, and it's just very
minor points that we inform them of.
So it, it can be anythingfrom one to the other.
Quite a broad spectrum.
James C. Taylor (04:29):
All right.
Now, who needs a gap analysis?
David Pepperl (04:35):
Typically, it's any company that's moving toward a critical juncture
in their development pathway or program.
In our case, it's small to mid-sizeor, or even large biotech companies.
Drug.
Or medical device that will belooking, make a regulatory submission
(05:00):
or something along those lines.
And then they have to prepare informationfor regulators and submit that.
And of course you want to gointo the regulatory agencies
with your best foot forward.
So you, you have a dossier you wouldprepare and we prepare that for them.
James C. Taylor (05:22):
Now, you had mentioned that this is done by
someone outside of the project itself.
So who does perform the gap analysis?
David Pepperl (05:38):
Well, typically what we see at least is clients come to
us and as an outside, as a consultingcompany, it's, it's often consultants
or somebody outside the organizationwho would have that fresh perspective
or highly objective perspective.
So usually you want to have a groupor person or persons, depending
(06:00):
on the scope of the gap analysis.
It, it could be, it could be a veryfocused gap analysis of one area,
like non-clinical in my area, orit could be very broad and then
have chemistry, manufacturing,non-clinical, clinical regulatory.
So it, it really depends on what you need.
So if you need a whole consultingorganization, you may just need one
(06:22):
consultant or one outside person.
Maybe it's a academic who's an expertin the field, but it's usually a
group that can provide that broaddevelopment and regulatory expertise.
And somebody again, who's not, youknow, within the program or within the
company, although that could be a case.
(06:43):
In a case of a large company, you might.
Some people who aren't familiar with thatproject and they might look it over, but
in general, it's good to have a, a freshobjective set of eyes on the program.
James C. Taylor (06:57):
So what determines the scope of a gap analysis?
You mentioned that it can be veryfocused or can be very broad.
So what determines thebreadth of the analysis?
David Pepperl (07:09):
Well, most cases, James, they're, they're pretty broad.
They're usually.
All the different disciplinesand our, again, in our case, CMC
chemistry, non-clinical, clinicalregulatory and maybe medical
device if a client has a medicaldevice involved with their program.
But what really drives the breadthand the diversity of the gap
(07:31):
analysis is, is what they have itit, and what they're requesting.
It's best, certainly if you canreview everything, if you can have a
team involved and review everythingthat they have, but sometimes.
Companies or clients will come inand they have a good handle on the
manufacturing and they just don'tknow maybe what they'll need for
(07:52):
the nonclinical, the animal studies,toxicology, pharmacology, or they just
need a second perspective on that.
And sometimes it's the other way around.
It may be they have the nonclinical,but they don't have any cmc.
Over the years I've seen most of them arecomprehensive, covering all the different
areas and, and that's often beneficialbecause we also need to start somewhere.
(08:16):
We need to get, you know, theinformation and digest it and take
it in and consider it in relationto where the client wants to be.
So it's good that if we cando that early stage review.
But sometimes they only needa very focused assessment.
If, if they might have the, theother experts in house already and
(08:39):
they're missing some little aspect orthey're not confident of their data.
Um, those kind of things thatreally drive the, the scope of it.
James C. Taylor (08:51):
Okay.
So you perform a gap analysisand you have an idea of.
You could improve things in your project.
What do you do with that?
David Pepperl (09:09):
Well, again, what we would typically do is take a time, needed to
review the material, go back to possiblybackground material or regulatory
submissions that maybe they've submitted,or just basic data papers, and we would
normally get our notes, our thoughtsin order, and again, compare it to.
(09:33):
They're targeting, whether it be apre-IND or a, a mid stage regulatory
submission or a marketing application,a, a biologic license application,
or a new drug application to the FDA.
Or typically an IND investigation,new drug application, what we're
most accustomed to dealing with.
And then we would write up amemo or dossier to the client
(09:57):
and say, Here's what we reviewed.
We reviewed documents 1, 2, 3, and4, and we found these shortcomings.
We found these findings thatmight impact your program and
indicate how significant they are.
Certain finding number one is minor.
It may not cause any problem, butfinding number two, you can't move
(10:17):
forward unless you address that.
You may need an animal study oryou may need to remanufacture your
product or add some additionaltests to your product qualification,
something along those lines.
So we would prepare a, atleast I prepare a memo.
A document that lays out what documentswere reviewed, and then specify comments
(10:40):
on specific documents, particularlyif there are larger ones like uh,
regulatory submissions or reports,critical reports, and what comments
I might have on those, and then theclient could subsequently use those.
A plan or marching orders and say,Oh, okay, this is what we need
(11:02):
to do, or let's talk about this.
Let's consider, what dowe really need to do that?
We may not have the financialwherewithal to do that, so there's a
lot of things that can come out of it.
But often we'll do these analysesand the clients will discuss
them, and then they'll move on toaddress those gaps and move on to
(11:23):
their next stage of development.
James C. Taylor (11:26):
So, if I'm understanding this correctly, this is a way I'm seeing
of preventing future stumbling blocks.
You know, it's seeing that youcould run into this issue down the
road if you don't correct the areasidentified by the gap analysis, and
that could end up costing you you time.
(11:47):
So taking this little bit of time todo the analysis in the beginning could
actually save you in the long run.
David Pepperl (11:54):
Yeah, exactly.
And I'd say it could be donefor any sort of project really.
And it's just a matter of how muchresources and time you have to put to it.
But again, not only is the gap analysisa great place for somebody like us or
a consulting group to start, when we'reworking with a client, it allows us
to identify those key stumbling blocksand certainly save time and money.
(12:20):
You don't want to go into FDA andthen get a clinical hold, have your
I n D put on hold because you weremissing a study or you missed some
endpoint, or you've had some adversefinding, or you had an impurity in
your manufactured material that you canidentify that and make sure everything.
(12:41):
Is in line.
It may cost more down the road,cost more in the short term, but
then it will save certainly time andsignificant amounts of money potentially.
And certainly sometimes weidentify clients that are doing
more than they need on occasion.
Uh, they may be performing moreor maybe the wrong studies.
(13:05):
That aren't really going to addressthe right questions, and then we
can guide them to say, Hey, thisstudy may not be necessary, but you
may need to do this other study inanother model to properly address
what the regulators are looking for.
It can get the program on track.
(13:25):
It could save clients time and money,maybe help hone the program so, More
focused and more efficient in the end.
James C. Taylor (13:36):
Right.
I was going to say, it looks like youhave two different areas where you can
find efficiencies, both in avoidingproblems and in streamlining your process.
So, all right, I have a studyand I say, David, I want you
to perform a gap analysis.
What do I need to giveto you and your team?
David Pepperl (14:00):
Well, generally, and, and James, a lot of these are performed on
entire program, so you know, we couldlook at a single large study, like you
said, you mentioned, but they could alsobe generally on an entire program so
that they've, they've come up to thispoint and, uh, what they should give us
or what they should provide to any groupoutside group that's performing these
(14:23):
assessments is everything , essentially.
As much as you can, certainly.
Papers that have been published, studyreports, batch records for for produced
material specifications for producing the,the drug or the biologic or um, anything.
(14:45):
And then animal studies, analytical tests.
Essentially everything that, that theycan afford to give us within reason.
The more data that an outsidegroup has to evaluate, the more
comprehensive an assessment that canbe performed just like anything else.
And you have to be careful.
(15:06):
Like if you're submitting things to theFDA, you don't wanna bombard them with
too much, you know, useless detail.
You want to provide them what'ssalient and succinct, right?
But at the same time, for.
What we see, we can take everything.
We can take reports and even, you know,notes or just data and figures, and, and
that's something that helps us too, thatif they provide us with some reports or
(15:31):
just figures and tables, but they don'thave the data presented in terms of a, an
actual study report, that could be a gapbecause you need to have study reports.
You need to have the data writtenup in a, uh, meaningful fashion.
The results and conclusions and methodspresented in a meaningful way so,
(15:53):
Can not only consultants, but thenultimately the FDA can review it.
So in providing us with everything,we can see that well, they have
reports or they don't have reports,so they're lacking something.
So it really boils down to gettingthe reviewing organization or your
consultants as much as possible to reviewon the program so that they can provide
(16:16):
the the best and most comprehensive.
James C. Taylor (16:22):
So you really want to create a broad picture so that you can
see in all the possible problem areas.
That's why you want to give everything.
Now you had mentioned earlier a, adossier is a dossier, usually the way
that the results are presented to the.
David Pepperl (16:46):
Yeah, it might be a memo or a, a write up or an
attachment or a combined assessmentfrom the different consultants.
You may have, again, twoor three different people
working on this gap analysis.
For the client.
And, uh, those can be combined into oneoverall assessment and then that can
(17:06):
be provided to the client and then theycan review it and then say, Oh, okay,
we need to do X, Y, and Z, but otherwisec, A, B and C are okay in those areas
and, uh, we may wanna talk about some ofthese other items and need clarification.
So it's, it's usually a bit of that.
It's, it's a, it's a, it's a write.
(17:28):
That we would provide to the clientafter completing our assessment.
James C. Taylor (17:35):
Okay.
And now I have a kind of aslightly weird question, but it,
it happens in the business world.
So should a sponsor fear a gap
David Pepperl (17:46):
analysis, fear?
No.
I mean, wouldn't you want to know, I guessit's, I guess it's a little bit going to
the dentist and you, you mentioned fear
Everything may be fine and you wannafind that out and you have a checkup
and you get that checkup where, thenagain, you may have a sore tooth and
you go in there and the dentist willtell you what it is and he'll address
(18:07):
it or he or she will address it.
We don't know if we're missing something.
Are we ready?
Sometimes the sponsors, they knowa great deal about their product.
They may know a great deal about,uh, development and all the different
areas, but sometimes there'sjust something that you might.
And that's why it's good to havethat outside perspective and experts
(18:28):
working in the field for years andyears to look at these, the programs
with a fresh set of eyes and with thatregulatory perspective and an outside
perspective to give you that assessment.
And I think you should welcome feedback.
Sometimes it's welcome,sometimes it isn't so much.
It.
I think it's important to know whereyou're at and you don't want to go into,
(18:53):
you don't wanna press forward, you know,with a substandard program for sure.
James C. Taylor (18:58):
You had mentioned in explaining it a little bit about the
dentist and they always say about dentalproblems, you should go in as early as
possible because waiting never makes.
Less of a problem when it comes tothe dentist, and I imagine it works
similarly for a g analysis earlierin the process is generally better.
David Pepperl (19:22):
Correct?
To a degree, yeah.
And that's a good, uh, segueto a point I wanted to make.
You really need to have some substantivedata, whether, you know, you're, whether
it's just chemistry or just nonclinicalor an overall program, you have to.
Some good data for anoutside group to find gaps.
(19:43):
If you are too early and you justhave some ideas and you have thoughts
on where to go, but you haven'treally done any of the studies, you
haven't really manufactured yourmaterial, you may not even be in
position for a gap analysis because.
It's all gaps.
It may be too gappy in that, in thatsense, you know, so what in that, in
that case, what a sponsor or client needsis more of a development plan and, and
(20:07):
that's more of a roadmap to how to getfrom where they're at to their final goal,
whether it's an i n D submission, vlanda, any of the regulatory submission or
talking to investors getting that funding.
But if you're too early, We foundin our experience that some clients
come in and everything is missing.
(20:30):
So it is like, well, you need a plan tomove forward and that can be provided as
well, but it's not really a gap analysis.
So it's really, you have to havesomething substantive to work with and
hopefully the gaps are, are minor and not.
Grand Canyon-esque.
James C. Taylor (20:47):
Thank you to David Pepper for joining us.
If you'd like more information, just emailus at insight at biologics consulting.com.
That's insight atbiologics consulting.com.
The executive producer of Insightat biologics is Kris Kraihanzel.
This episode was producedand edited by James C.
Taylor, technicalsupervisor is Jeff Wease.
The Insight at Biologicstheme is by Tom Rory Parsons.
(21:11):
I'm James C.
Taylor.
Thank you for joining us.
Please come back for moreInsight at Biologics.
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