14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa

For smoother sailing with an IND, it can help to have a meeting with the FDA before the IND. But how do you do that and what do you need? Find out from Aleese Hopkins and Samira Shirwa.

Episode Transcript

James C Taylor (00:02):
A friend of mine used to say that he was getting ready to get
ready, but there is value in talkingto the FDA before you start your IND.
To talk with me about why areSamira Shirwa and Aleese Hopkins.
I'm James C.
Taylor and this is Insight at Biologics.

(00:26):
And here are Samira and Aleeseand ladies, if you would just
tell everybody about yourself.

Aleese Hopkins (00:32):
Yeah.
Hi, my name is Aleese Hopkins.
I'm a regulatory affairs managerhere at Biologics Consulting Group.
I've been with the company for alittle over six years and basically
my, my role is to help provideregulatory advice to sponsors to help
get their applications through FDA.
So typically my role were the main pointof contact for, for sponsors to work with

(00:53):
multidisciplinary teams, but we also.
serve as regulatory contacts or U.
S.
agents to liaise on thesponsor's behalf with the FDA.
So we just basically make sure all your,the FDA requirements are met, make sure
timelines are upheld, and just helpbasically the sponsor get their product
through the FDA in the most efficient way.

Samira Shirwa (01:15):
And my name is Samira Shirwa.
I am also a regulatory affairs manager atBiologics Consulting, and I've been with
the company for about three years now.
And similar to Aleese I specializein providing regulatory advice
to clients, and I've been able tosupport many different types of
FDA submissions and participate innumerous early interactions with FDA.

(01:36):
And working alongside our subject matterexperts at Biologics Consulting, I've
been able to provide regulatory insight,To clients at every stage, and I'm
looking forward to sharing some of myexperience on early interactions with FDA.

James C Taylor (01:49):
Perfect.
Because that's what we'regoing to talk about.
So it's good that you want to do that.
All right.
So you're going to do an IND, but youwant to work with the agency before
you start, what types of interactionsare possible before the IND?

Samira Shirwa (02:08):
So there are definitely a few different types
of early interactions that arepossible prior to an IND submission.
Some of the most common ones areINTERACT meetings and pre IND meetings,
and those are the two that we'remainly going to be focusing on today.
Both of these meetings with FDA aregoing to allow you the opportunity
to discuss your study design.

(02:28):
It's going to allow you the opportunityto discuss any potential regulatory
pathways that could help withexpediting your drugs development
process and just overall discussingyour development process with FDA and
ensuring that everything is in alignmentwith FDA's regulatory requirements.

James C Taylor (02:46):
All right.
So, what is the purpose of this?
Why do you do this and what willthe client get out of doing this?

Aleese Hopkins (02:56):
Yeah.
So there's, I mean, there's severalreasons why an early interaction
is helpful and encouraged.
Mainly.
I mean, mainly it's to just get-- FDAsees such a wide range of products
with all the indications and, andit's really, they really have a good
oversight over what's in the marketand, you know, different things that
maybe the average person might not know.

(03:17):
And so getting FDA feedback on yourprogram early actually helps you be
able to implement that feedback early.
And so you're not wasting...
wasting time or resources, you know,conducting a study or nonclinical
study, for example, that isn't going tosupport your product in the long run.
Another, you know, the main reason wouldbe, of course, to just prevent clinical

(03:39):
hold issues because that's really, youknow, the, what you're trying to avoid
when you submit an IND, so these--

James C Taylor (03:45):
Right.

Aleese Hopkins (03:45):
--These interactions, they interact in the pre IND, you can do these
before the IND, so by the time you getto the IND, you should have most of your
issues kind of resolved and figured out.
And, and, I mean, probably the mostlogical, but often overlooked reason
would be just to, because you wantto start a relationship with the
FDA reviewers as soon as possible.
They really get a feel for yourprogram and product early on.

(04:08):
And when they do, it justreally helps streamline reviews.
It helps just communicationthroughout the process.
And it's just a really beneficialway to start your relationship
with FDA as early as possible.

James C Taylor (04:21):
And a relationship is important because you're going
to be working with them throughthe life of the process, correct?

Aleese Hopkins (04:28):
Yeah.
Exactly.
I mean, usually, I mean, reviewersswitch out occasionally, but a lot
of times there's the same, the samereviewers or similar reviewers for most
of the life cycle of your application.
So it's just really helpful to get toknow them ahead of time and get them
familiar with your product ahead of time.

James C Taylor (04:47):
Okay.
So this being A regulatoryagency, there are procedures.
There are things that you have to do.
So in, and that includesin having a meeting.
So how do you go about requesting ameeting and then what can you expect once
one of those meetings are requested.?

Samira Shirwa (05:09):
Exactly.
So there are definitely specific processesand timelines that are involved when
you're going about requesting one ofthese early interactions with FDA, right?
So there are some similarities anddifferences when it comes to the
INTERACT meeting requests and the preIND meeting requests, both of these are
going to involve submission of a meetingrequest and briefing package to FDA.

(05:30):
For the INTERACT meeting, it's goingto be a combined meeting request
and briefing package submission.
But for the pre IND meeting, often themeeting request is going to go out first,
and then that briefing package is goingto go out later on, about 30 days prior
to your scheduled meeting with FDA.
Regarding these specific timelines, theresponse time for both of these meetings

(05:52):
is going to be about 21 days, FDA isgoing to aim to respond and either deny
or grant the meeting within those 21 days.
And for the scheduling of the meetings,if they are granted, INTERACT meetings
are often scheduled within 75 daysand pre IND meetings within 60 days.
And it's really important to make noteof all of these different timelines

(06:13):
and processes, because if there are anykind of delays that you run into, it can
cause your meeting to be pushed back.
It can cause your meetingeven be canceled altogether.
So it's really important that you not onlyare ready to submit your meeting request
and briefing package, but that you meetall of FDA's timelines as best you can.

James C Taylor (06:34):
Okay.

Aleese Hopkins (06:35):
Yeah, exactly.

James C Taylor (06:36):
Go ahead.

Samira Shirwa (06:36):
Yeah.

Aleese Hopkins (06:37):
No, I was just going to reiterate that.
That's something that we really encouragesponsors because you know, for, especially
for the pre IND because you're submittingyour request and package at different
times, it's-- we really encourage sponsorsto have an almost completed package
before the meeting request goes in.
Because a lot of times the, youknow, after 21 days, you really might
only have a week to submit afterthat point, once you find out if

(07:00):
your meeting's been granted, becausesix-- you have to submit the package
30 days before the 60 day meeting.
So it's just, it's really-- there'sa lot of strategy behind how you
develop your pre IND package.
And it's really important becauseI've had meetings that had to be
canceled or postponed because thepackage wasn't submitted in time.

James C Taylor (07:18):
And again, this goes back, at least in my mind to the
whole idea of creating a relationship.
It doesn't really do your relationship alot of good for you to not meet timelines.
So...

Aleese Hopkins (07:32):
Oh yeah, yeah.

Samira Shirwa (07:32):
Exactly.

Aleese Hopkins (07:33):
Yeah.
And also I wanted to addin terms of the process.
As Samira mentioned, theycan grant it or deny it.
There's actually a few differentways if they do, if they do
grant it, there's a few differentmeeting types that you might have.
You can, of course, you can requestwhatever you want, but they're going to
ultimately look at your package and decidewhat they think would be most efficient.

(07:55):
The different types are, so you caneither do face to face, which is
actually kind of rare now, especiallysince COVID, but they do happen.

James C Taylor (08:02):
Right.

Aleese Hopkins (08:02):
And then there's the teleconference, which is turning
into more of a teleconference, videoconference sort of, and then there's
written response only, which iscalled the WRO written response only.
And that's basically just writtenresponses to your questions.

James C Taylor (08:14):
So you can have a meeting that isn't a meeting.
That's just--

Aleese Hopkins (08:17):
Exactly.

James C Taylor (08:18):
--words.

Aleese Hopkins (08:19):
Exactly.
Exactly.
It's just responses.
But if you do get that.
Or any of the meeting types, you dohave a chance to request clarification
or, you know, engage with the FDAafter that, if you need to get any
clarifications on the questions.
Like, if you weren't, if you didn'thave a conference and weren't able
to really talk to them, there's anopportunity within 20 days of the

(08:39):
meeting or written response only thatyou can actually request clarification.
So it's not an end allbe all at that point.

James C Taylor (08:46):
Okay.
All right.
So we, we've talked a littlebit about the, the, the timing,
the timelines and so forth.
So what is the best timingto request either a pre IND
or INTERACT meeting with FDA?

Samira Shirwa (09:00):
Sure.
So, Obviously, we generally adviserequesting these meetings, these
early interactions as soon as youcan in your development process.
Like Aleese said earlier, that candefinitely help to not only minimize
costs, but ensure that you are inalignment with FDA as much as possible.
Specifically for INTERACT meetings,these are going to be requested

(09:22):
prior to a pre IND meeting.
And that's because these are intendedfor novel products and novel products
specifically that may present some uniquechallenges earlier on in development.
So when you're considering requestingan INTERACT meeting with FDA, you have
to have selected an investigationalproduct to evaluate and these INTERACT
meetings are often going to focuson CMC and non clinical topics.

(09:46):
And some of the different areas thatyou might be able to discuss in these
meetings with FDA are talking aboutyour toxicology studies, discussing
some of your manufacturing processes,discussing some of your CMC areas that
can support your first in human study.

Aleese Hopkins (10:04):
Yeah, and the pre IND-- So that's for the INTERACT.
The pre IND is a little bit different.
At the pre IND stage you should bea little bit further along in your
development and it's actually kind ofsubmitted very close before your IND
and so what you're focused on for thepre IND is clinical basically getting.
As much feedback as you canon your protocol synopsis.

(10:25):
So you submit a synopsis with thepre IND package and it gives FDA an
opportunity to look at your synopsisand see, make sure that they agree
with your first in human studies sothat once you get to the IND, you can
help hopefully avoid a clinical hold.
And then, so along those lines, thingsthat you might discuss for pre IND would
be obviously your synopsis, anythingthat could prevent clinical hold.

(10:47):
Really clearly defining your endpoints foryour clinical study is important because
you want to make sure that those, whateverendpoints you have are going to be useful
in supporting a phase two, phase three.
And then also this is, pre IND is a goodtime to talk about different pathways
that might be available to you, likefast track or accelerated approval.
Or if you should go for orphan drugdesignation, this is a really good time

(11:10):
to engage FDA to see if your programmight be a good candidate for that.

Samira Shirwa (11:15):
And one of the things that we really want to emphasize and make sure
that, you know, is made note of is thatfor each investigational product, you have
the opportunity to have just one INTERACTmeeting and one pre IND meeting with FDA.
So it's really important toensure that you're ready to have
these interactions with FDA.

(11:36):
And just so that you can get themost helpful feedback possible from
FDA, the more information you'reable to provide FDA, the more
helpful the feedback is going to be.
So it's really important to ensure yourreadiness and to ensure that you're at
the right stage to request these earlyinteractions because you really only
have one opportunity for each of them.

James C Taylor (11:54):
Okay.
So I, I want to, I want to justtouch on that again, just to
make sure that I understand it.
You want to do this early in theprocess, but you don't want to do
it so early that you don't ask theimportant questions and you don't have
them review the important information.
You want to make sure that you haveas much as you can for this meeting.

(12:18):
'Cause you've only got one shot.
Am I understanding that right?

Aleese Hopkins (12:21):
That is very, very correct.
You definitely don't, you haveto be careful not to, you know,
try to have any of these meetingstoo early because I mean, you
want to get the most out of them.
You, and the more informationyou could provide them.
So the more information you have goinginto it, the more information and
feedback you can get back from FDA.
So there's a really good strategy, youknow, there's a lot of strategy involved
in when exactly to submit meetings forthis so that you actually get the most

(12:46):
helpful feedback before going to IND.
But also because FDA can actually,so, you know, we mentioned what
happens when it's granted, but FDAcan actually deny your meeting.
And they can deny it if they don'tfeel like you're in the right spot.
If they don't feel like you have enoughinformation for them to answer your
questions, if you don't provide the rightinformation in the briefing package.
So these are all things that at BiologicsConsulting, like we help you with.

(13:09):
We can help you look at your program,see where you are, see which meeting type
makes the most sense for where you are,when to submit that, and what information
exactly to include to get the answersyou have to the questions you have.

Samira Shirwa (13:22):
Exactly.
Our, our team, our subject matter expertsare available to and have much experience
with reviewing, you know, all of thesource information to kind of help our
clients assess exactly where they are inthe process and if and when they'll be
ready for an early interaction with FDAand what type of early interaction is
the most suitable one to have with FDA.

James C Taylor (13:45):
Okay.
Is there anything else you wouldwant to leave with a potential
client before we go ahead and, andwrap up our conversation for today?

Aleese Hopkins (13:55):
I mean, you know, just reiterating, just to interact, I
think reaching out to us as early aspossible, once you're trying, once you're
considering, you know, your programas early as you can reach out to us,
the better, cause then we can reallyhelp you guide you as to when exactly
to reach out to us and when would bethe best time to start engaging us.
We could provide, so you can see what,what a application might look like,

(14:19):
what a meeting request might looklike, and what kind of information
FDA typically expects to see.
And then the earlier you can get thatinformation from us, the earlier you
can add it to your time, your owntimelines to make sure, you know,
you're crossing your T's and dottingyour I's and making sure that you
interact with FDA at the best time.
And hopefully that leads to asmooth IND submission and allowed

(14:42):
to proceed to your clinical trials.

Samira Shirwa (14:44):
Exactly.
And these are again, these are freeopportunities to engage with FDA early
on in the development process, right?
So this is one of the best ways thatyou can kind of start that relationship
with FDA, answer-- get FDA to answer anyquestions you might have ahead of your
IND submission to allow for the smoothestIND submission and allow for the overall

(15:05):
smoothest development process throughoutthe course of your development process.

Aleese Hopkins (15:09):
Yeah, exactly.
It's free.

James C Taylor (15:13):
And free's my favorite price.

Aleese Hopkins (15:14):
So take advantage.

James C Taylor (15:17):
All right.
Well, thank you both for comingon and talking with me about this.
And of course, if anybody wants thehelp that you are very much capable
of providing, they can go aheadand contact us and we'll go ahead
and get them in contact with you.
And as to how to contact us.
Just email us [e-mail].

(15:38):
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.
This episode was producedand edited by James C.
Taylor.
The technical supervisor is Jeff Wease.
The Insight at Biologicstheme is by Tom Rory Parsons.

(15:59):
I am James C.
Taylor.
Thank you for joining us and pleasecome back for more Insight at Biologics.