5. When you should hire a consultant, with HeeSun Smaldore

HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.

Episode Transcript

James C. Taylor (00:01):
They say the key to everything is timing.
And that may very well be the casewhen it comes to choosing a consultant.
We're going to talk with HeeSun Smaldoreabout when is the right time to choose
a consultancy like Biologics Consulting.
I'm James C.
Taylor, and this is Insight at Biologics.

(00:32):
And now here is HeeSun Smaldore.
And HeeSun, why don't you tell thema little bit about your background?

HeeSun Smaldore (00:37):
Hi.
So I am the business unit lead of theregulatory project management group
here at Biologics Consulting, and Ihave approximately, let's see, over 15
years of regulatory affairs experience.
Most of my career has been in,on the consulting side, I was
shortly at a clinical C R O.
So I've had experience, you know,seeing the side of running clinical

(01:01):
tri trials, the clinical operations.
Everything.
And then I did publishing for a shortperiod and then landed back in consulting.
So I'm back here at Biologics Consulting.

James C. Taylor (01:15):
We're glad to have you and we're glad to talk to you.
And what you've decided to talk tous about today is a matter of timing,
specifically how you decide whento approach a company such as ours.
Why don't you explain thetimeline of that, the, the,
the, the mechanics of that.

HeeSun Smaldore (01:36):
Right.
So a lot of clients or companies alwayswonder, you know, what is the right time
to seek a pharmaceutical consulting group,right, for their product development?
And there's real, there's no real oneanswer because I guess it's a very broad.
The simple answer is asearly as possible, right?

(01:59):
But then how early can you get to ustoo early where you have no information,
no data, you have no direction.
So it really depends on, I guess,more of what your end goal is.
You know, what's your, are youtrying to develop the product and
then pass it on to another sponsor?
You know?
Do you have investors involved?

(02:19):
You know, are you really tryingto fine tune your formulation?
Are you still in like the earlydevelopment phase, let's say maybe like,
you know, research and development stagewhere you're still trying to figure
things out and what your indicationswill be, all of that early stage stuff,
or are you later stage where you havealready conducted some of your safety

(02:40):
study, let's say, you know, yourpharmacology, your PK talk studies.
You know, you know what thesafety concerns may be, and you
have already started to developyour clinical study design.
You know, we don't know what stagewould be best, but you would know
because you wanna know the directionof what your regulatory pathway may be.

(03:02):
Um, you know, the best timingis if you want to understand the
best regulatory pathway for yourproduct specific to your indication.
And you understand that other companieshave done it a certain way, but there
may be certain nuances particular toyour product where you may need to engage

(03:25):
experts, you know, outside expertiseto guide you through that process.
And the main thing about contactinga regulatory consultant is those
folks may understand specific things.
You know, the division, the reviewdivision that your product will
be submitted to at F D A, they mayunderstand that that particular division

(03:48):
or specific reviewers want X, Y, and Z.
And then your companyexperts may not know that.
They may understand that the basicsof regulatory, but going further into
it, like, okay, what does FDA need?
What will this reviewer expectout of your application?
So that's kind of the major thingthat you want to think of and to

(04:12):
really evaluate internally what canbe handled internally and what is
outside of your expertise, right?
Perhaps you have a couple expertsin house, but you can't figure out.
, you know, the manufacturingside of things.
Then you can contact a consultinggroup and say, okay, you know, I need
to put my manufacturing in place.
I need you to audit our facilitiesor where your product may be

(04:36):
manufactured and all of that.
Maybe you have KOLs that have that.
Expertise from a clinical standpoint,but you need the regulatory expertise
to go hand in hand with that.
So, you know, having key opinion leadersare important, but that may not help
you navigate the whole regulatory space.

(04:58):
So you just need to understand, you know,what the best use of your resources are.

James C. Taylor (05:03):
Okay.

HeeSun Smaldore (05:03):
Depending on your development
stage.

James C. Taylor (05:06):
So, It sounds like to me that what you're saying is one
of the things that a company such asours can bring to the table is, uh,
support in areas in which you mightbe weak or might not have a full
level of subject matter expertise.
Correct?

HeeSun Smaldore (05:22):
Absolutely.
Yeah.
And you know, there are certain milestonesthat sponsors want to reach as well,
and if they don't have the resourcesinternally to reach those milestones.
, we can help you out, navigatethat space and really bring
you to interact with F D A.

James C. Taylor (05:41):
Okay?
Now, one of the things that when Iwas first asked to come to our company
is that I, that I was told about wasthat there was a lot of knowledge
as to what the individual centers.
that projects are given to want.

HeeSun Smaldore (05:58):
Mm-hmm.

James C. Taylor (05:58):
And I think it's beyond just the department that I work in.
I believe the entiretyof Biologics is that way.
So we really know what the regulatoryagencies are looking for, correct?

HeeSun Smaldore (06:09):
Absolutely.
And very specific to the division,the offices and divisions
at CDER, CBER, and C D R H.
You know, our experts understandlike, okay, this specific division.
, they have delays going on right now.
So you should, you know, we cannotify clients and say, you know,
you may expect a couple months delayfor your pre I N D meeting or any

(06:30):
meeting that you are going to request.
So we interact with FD A on a daily basis.
You know, this is our bread and butter.

James C. Taylor (06:39):
Right.

HeeSun Smaldore (06:40):
So we see everything happen, you know, from the FDA side
and then from the sponsor side.
So we're kind of in the middle.
View like we have a bird's eye view.
with drug development.
And so that is how we gain ourexpertise and then inform clients,
new clients coming in and say, "Ohyeah, we've seen this done before."

(07:03):
or "What about this?"
We can strategize and be ableto handle certain situations.
Or provide feedback and a direction thatthey may not think of it internally.
You know, there are specific expeditedpathways that you can take that the
sponsor may not have thought of.
You know, that that comes withincentives once you get to

(07:26):
get to marketing applications.
So there are a lot of avenues thatyou can venture out into if, of
course your product qualifies.

James C. Taylor (07:36):
Now, when you first were explaining the, the timing issue, one of
the things that you pointed out was thatyour goal informs when in the process
you would want to approach a consultant.
So could you elaborate a littlebit, like give a a, a sample or
a case study of how that works?

HeeSun Smaldore (07:55):
Sure.
So a lot of new clients approach us andsay, "We don't know what we're doing."
So it varies.
Right?

James C. Taylor (08:01):
Right.

HeeSun Smaldore (08:01):
So some sponsors will come to us and say, okay,
"We have no clue what we're doing.
I need you to get us to FDA."
And they just don't understandhow detailed the process is.
So they say, "Okay, we'vedeveloped this product.
It's a concept, you know.
It sounds like it works or it will work."

(08:24):
However, they don't know that it willactually work, like the product will
work and that there's no, you know, toxiceffects and the safety has been covered.
They don't have the data yet, so, right.
We will step in at that stage, thatearly development stage and be like,
okay, FDA's gonna expect this, so weneed, you know, we recommend that.

(08:45):
Conduct studies in whatevernonclinical studies, right?
And to understand that you'vecovered practically the basic
stuff before you approach fda.
And now with that, we can advisethe client, depending on what your
results are, and do somewhat of a gapanalysis if you have any data for it.

(09:07):
Be, you know, if you've already conductednonclinical studies, if you have some CMC.
what's your, you know,clinical study design?
What is your intention ongetting, you know, first inhuman?
Um, so all of that information,and we will do a gap analysis
and understand what is the bestregulatory pathway for this sponsor.

(09:30):
You know, like, are youready f to meet with fda?
Or, okay, maybe you're a little prema.
And that way they understand they'renot wasting their time, they're
not wasting FDA's time and theyapproach FDA at the best time.
Well, because if you get to FDA tooearly, then you may not get all the

(09:51):
feedback they that you may need andthey can decline a meeting request.
So that's another thing that can happen.

James C. Taylor (09:58):
Now one of...
I love sayings and one of myfavorite sayings is, "You can't
see the forest for the trees."
It's possible-

HeeSun Smaldore (10:04):
Right.

James C. Taylor (10:05):
-That a sponsor can be too close to what they're trying
to develop to see the pitfalls.
Correct?

HeeSun Smaldore (10:16):
Absolutely.
And we say, another saying is, you know,"They're drinking the Kool-Aid", right?
So you know, they're justso, they have the blinders.
and they're like, "Okay, youknow, we have to do this."
Like, "We have to meet thesemilestones by a certain date
and our product is the best.
It's better than standard of care,you know, and what's out there!"

(10:39):
All of that.
So in their minds, it'sthe best thing out there.
And this is going tobe approved right away.
Like, okay, everything's gonna work outperfectly when they have the blinders on.
But sometimes when you bringin outside consultants, that's
kind of a third party that can.
See it from a different perspectiveto understand and provide guidance

(11:02):
on like, okay, you know, it mayturn out this way or that way.
However, you have to understandwhat the risks are involved.
Or it's, we could say, ohyeah, your product is amazing.
You know, hit all those milestones.
Everything will go perfectly andyour product will be on the market.
You know, it really depends.

(11:23):
But yeah, a lot of.
Clients may have the blinderson, so that's when a consulting
group like ours can come in andreally open up the doors for you.

James C. Taylor (11:35):
Okay, so let, let me ask you this, if you don't mind.
You had mentioned that sometimes a sponsordoesn't really have everything together
or know what they're doing, but whatshould they know or have at the beginning
when they first approach a consultant?

HeeSun Smaldore (11:56):
What they should expect, I guess I would say is whether it be good
or bad advice, take it into consideration.
You know, we can onlyprovide recommendations.
We can't tell you what to do.
And so that's what we tell clientsis we're going to work with you.

(12:18):
The, it's a collaboration.
You know, we're not gonna sayyou have to do X and Y and Z.
Like, this is what you have to do.
Right?
Our role is to provide guidance andfeedback and recommendations on what
the best development process shouldbe for your particular product.
So if you don't takethose recommendations, you

(12:39):
know, lies on the sponsor.
They can go a different route.
It's really entirely up to them.
So I think that's the main expectationI would say for clients that come
to us, you know, there may bethings that you don't want to hear.
As we discussed earlier, some peopleare drinking their Kool-Aid and

James C. Taylor (12:59):
Right.

HeeSun Smaldore (12:59):
We may say you don't have enough data like you need to do
additional studies or you know, maybethink about other pathways or you
know, that's not gonna work with FDA.
That may be something thatthey may not want to hear.
But it, they should hear it because theyneed to see all the different aspects
of drug development and understandthat there are gonna be ups and downs.

(13:22):
There is no straight andnarrow pathway for regulatory.
Um, that's one thing Ipromise , because one sponsor may
conduct their study a certain.
and then another sponsor tries toconduct it the same exact way and you
may not get the same results or you maynot get the same feedback from f d A.
Okay, so there's no onestraight and narrow pathway.

James C. Taylor (13:48):
And, and so as we wrap up here, what would you, like
someone who has just listened to ushave this conversation, what would you
like them to take away with them aspart of their decision making process?

HeeSun Smaldore (14:02):
I would say
reach out to a consulting group, whetherit be a large project where you want
them to handle a full scope of workor just take into consideration maybe
a couple hours of strategy advicefrom a consulting group like ours.
It's very helpful.
That way you have a starting point, agood starting point, or an end point

(14:23):
to be like, okay, that is the milestoneI want to reach, or that's the.
I want to reach because if you're aregulatory person within the company,
you may not know everything from the C MC side, non-clinical, you know, whether
you don't have the device expertise orclinical expertise, whatever it may be.

(14:43):
You know, one person can't know it all.
, I wish I did to be honest.
Then I would be like the best,you know, a brainiac, right?
But unfortunately, I.
But that's the advice I would give anygroup is reach out to a consulting group.
Even if it's a small startupcompany, you may not have the funds
to do it, but a couple hours ofconsulting time from a consulting

(15:05):
firm will get you very, very far.
So I think just initially reachingout and getting maybe three or four
hours of their time, That is valuable,so I definitely recommend that.

James C. Taylor (15:17):
Thank you to HeeSun Smaldore for joining us.
Now, if you'd like moreinformation, just email us at
[e-mail].
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.
The executive producer of Insightat Biologics is Kris Kraihanzel.

(15:37):
This episode was producedand edited by James C.
Taylor, technicalsupervisor 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