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“How To Maximize Your Product’s Potential with a Regulatory Consulting Group” with HeeSun Smaldore

February 9, 2023  •  Podcast  •  HeeSun Smaldore and James Taylor
Posted In Other News & Insights, Biologics News & Insights – Biologics Consulting

Insight at Biologics – Episode 5

On this episode of Insight at Biologics, HeeSun Smaldore, industry expert and Business Unit Lead, shares some helpful thoughts about the intricacies of deciding when to hire an outside consultant. When should you seek out a consulting group? And, what can you expect when you work with a consulting firm? Discover the answers to these questions and more on this episode of Insight at Biologics.


James: They say the key to everything is timing. And that may very well be the case when it comes to choosing a consultant. We’re going to talk with Heon Smaldore about when is the right time to choose a consultancy like Biologics Consulting. I’m James C. Taylor, and this is Insight at Biologics.

And now, here is HeeSun Smaldore, and Heesun, why don’t you tell them a little bit about your background? 

HeeSun: Hi. So I am the business unit lead of the regulatory project management group here at Biologics Consulting, and I have approximately, over 15 years of regulatory affairs experience. Most of my career has been in, on the consulting side, I was shortly at a clinical CRO. 

So I’ve had experience, seeing the side of running clinical trials, the clinical operations of everything. And then I did publishing for a short period and then landed back in consulting. So I’m back here at Biologics Consulting. 

James: We’re glad to have you and we’re glad to talk to you. And what you’ve decided to talk to us about today is a matter of timing, specifically how you decide when to approach a company such as ours. So, why don’t you explain the timeline and the mechanics of that. 

HeeSun: Right. So a lot of clients or companies always wonder, what is the right time to seek a pharmaceutical consulting group, right, for their product development? And there’s no real one answer because I guess it’s a very broad question. The simple answer is as early as possible, right? But then how early? Can you get to us too 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.

Are you trying to develop the product and then pass it on to another sponsor? Do you have investors involved? Are you really trying to fine tune your formulation? Are you still in the early development phase, let’s say maybe, the researching/development stage where you’re still trying to figure things out and what your indications will be?

All of that early stage stuff, or are you at a later stage where you have already conducted some of your safety study, let’s say, your pharmacology, your PK tox. studies, where what the safety concerns may be, and you have already started to develop your clinical study design. We don’t know what stage would be best, but you would know because you wanna know the direction of what your regulatory pathway may be.

The best timing is, if you want to understand the best regulatory pathway for your product specific to your indication, and you understand that other companies have done it a certain way, but there may be certain nuances, particular to your product, where you may need to engage experts, outside expertise to guide you through that process.

And the main thing about contacting a regulatory consultant is those folks may understand specific things that, the division, the review division that your product will be submitted to at the FDA, they may understand that that particular division or specific reviewers want X, Y, and Z. And then your company experts may not know that.

They may understand the basics of regulatory, but going further into it, like, okay, what does the FDA need? What will this reviewer expect out of your application? So that’s kind of the major thing that you want to think of and to really evaluate internally what can be handled internally and what is outside of your expertise, right?

Perhaps you have a couple experts in house, but you can’t figure out the manufacturing side of things. Then you can contact a consulting group and say, okay, I need to put my manufacturing in place. I need you to audit our facilities, or where your product may be 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, having key opinion leaders is important, but that may not help you navigate the whole regulatory space. So you just need to understand, what the best use of your resources are.

James: Okay. 

HeeSun: Depending on your development stage. 

James: So, It sounds to me that what you’re saying is that one of the things that a company such as ours can bring to the table is support in areas in which you might be weak or might not have a full level of subject matter expertise, correct?

HeeSun: Absolutely, yeah. And, there are certain milestones that sponsors want to reach as well. And, if they don’t have the resources internally to reach those milestones, we can help you out and navigate that space. Really bring you to interact with the FDA. 

James: Okay. Now, one of the things that when I was first asked to come to our company that I was told about was that there was a lot of knowledge as to what the individual centers that projects are given to want. And I think it’s beyond just the department that I work in, I believe the entirety of Biologics is that way. So we really know what the regulatory agencies are looking for, correct?

HeeSun: Absolutely. And very specific to the division, the offices and divisions at CDER, CBER, and CDRH. Our experts understand like, okay, this specific division, they have delays going on right now. So we can notify clients and say, you may expect a couple months delay for your pre IND meeting or any meeting that you are going to request. So we interact with the FDA on a daily basis. This is our bread and butter.

[HeeSun laughs.]

James: Right.

HeeSun: So we see everything happen, from the FDA side and then from the sponsor side. So we’re kind of in the middle, like, we have a bird’s eye view, right? With drug development, and so, that is how we gain our expertise and then inform new clients coming in and say, oh yeah, we’ve seen this done before.

Or, we can strategize and be able to handle certain situations. Or provide feedback and a direction that they may not think of internally. There are specific expedited pathways that you can take that the sponsor may not have thought of. That comes with incentives once you get to marketing applications. So, there are a lot of avenues that you can venture out into if, of course, your product qualifies. 

James: Now, when you first were explaining the timing issue, one of the things that you pointed out was that your goal informs when in the process you would want to approach a consultant. So could you elaborate a little bit, like give a sample or a case study of how that works?

HeeSun: Sure. So a lot of new clients approach us and say, we don’t know what we’re doing. So it varies. Right? 

James: Right. 

HeeSun: 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 the FDA, and they just don’t understand how detailed the process is. So they say, okay, we’ve developed this product, it’s a concept, it sounds like it works or it will work. However, they don’t know that it will actually work, like the product will work and that there’s no toxic effects and the safety has been covered. They don’t have the data yet.

James: Right. 

HeeSun: We will step in at that stage, that early development stage and be like, okay, FDA’s gonna expect this, so we recommend that you conduct nonclinical studies, right? And to understand that you’ve covered practically the basic stuff before you approach fda. 

And now with that, we can advise the client, depending on what your results are, and do somewhat of a gap analysis if you have any data for it. If you’ve already conducted nonclinical studies, if you have some CMC data, what’s your clinical study design? What is your intention on getting first in humans? 

So all of that information, and we will do a gap analysis and understand what is the best regulatory pathway for this sponsor. Like, are you ready to meet with the FDA or, okay, maybe you’re a little premature. And that way they understand they’re not wasting their time, they’re not wasting FDA’s time and they approach the FDA at the best time.

Well, because if you get to FDA too early, then you may not get all the feedback that you may need and they can decline a meeting request. So, that’s another thing that can happen. 

James: Now, I love sayings, and one of my favorite sayings is, you can’t see the forest for the trees. It’s possible –

HeeSun: Right.

James: – that a sponsor can be too close to what they’re trying to develop to see the pitfalls, correct? 

HeeSun: Absolutely. And another saying is, they’re drinking the Kool-Aid, right? 

[HeeSun laughs.]

So, they have the blinders on. And they’re like, okay, we have to do this. We have to meet these milestones by a certain date and our product is the best. It’s better than the standard of care and what’s out there? All of that. So in their minds, it’s the best thing out there. And this is gonna be approved right away. Like, okay, everything’s gonna work out perfectly when they have the blinders on. 

But sometimes when you bring in outside consultants, that’s kind of a third party that can see it from a different perspective to understand and provide guidance on like, it may turn out this way or that way. However, you have to understand what the risks are involved. 

Or we could say, oh yeah, your product is amazing. Hit all those milestones. Everything will go perfectly and your product will be on the market. It really depends. But yeah, a lot of clients may have the blinders on, so that’s when a consulting group like ours can come in and really open up the doors for you. 

James: Okay, so let me ask you this, if you don’t mind. You had mentioned that sometimes a sponsor doesn’t really have everything together or know what they’re doing, but what should they know or have at the beginning when they first approach a consultant?

HeeSun: What they should expect, I would say is, whether it be good or bad advice, take it into consideration. We can only provide recommendations. We can’t tell you what to do. And so that’s what we tell clients is we’re going to work with you. It’s a collaboration. We’re not gonna say you have to do X, Y and Z.

Like, this is what you have to do, right? Our role is to provide guidance, and feedback, and recommendations on what the best development process should be for your particular product. So if you don’t take those recommendations, that lies on the sponsor, they can go a different route. It’s really entirely up to them.

So I think that’s the main expectation I would say for clients that come to us. There may be things that you don’t want to hear. As we discussed earlier, some people are drinking their Kool-Aid 

James: Right. 

HeeSun: We may say you don’t have enough data like you need to do. Additional studies or, maybe think about other pathways or, that’s not gonna work with FDA. That may be something that they may not want to hear. But, they should hear it because they need to see all the different aspects of drug development and understand that there are gonna be ups and downs. There is no straight and narrow pathway for regulatory [success]. 

That’s one thing I promise, because one sponsor may conduct their study a certain way, and then another sponsor tries to conduct it the same exact way, and you may not get the same results or you may not get the same feedback from FDA. 

James: Okay.

HeeSun: So there’s no one straight and narrow pathway. 

James: And so as we wrap up here, for someone who has just listened to us have this conversation, what would you like them to take away with them as part of their decision making process?

HeeSun: I would say reach out to a consulting group, whether it be a large project where you want them to handle a full scope of work or just take into consideration, maybe a couple hours of strategy advice from a consulting group like ours. It’s very helpful. That way you have a starting point, a good starting point, or an endpoint to be like, okay, that is the milestone I want to reach, or that’s the target I want to reach. 

Because, if you’re a regulatory person within the company, you may not know everything from the CMC side, non-clinical, whether you don’t have the device expertise or clinical expertise, whatever it may be. One person can’t know it all. 

[HeeSun laughs.] 

I wish I did, to be honest. Then I would be like the best, a brainiac, right? But unfortunately I’m not. But that’s the advice I would give any group, is to reach out to a consulting group. Even if it’s a small startup company, you may not have the funds to do it, but a couple hours of consulting time from a consulting firm will get you very, very far. So I think just initially reaching out and getting maybe three or four hours of their time. That is valuable, so I definitely recommend that.

James: Thank you again to HeeSun Smaldore for joining us. If you’d like more information, just email us at That’s Insight, @ Biologics Consulting, all one word, .com. Also, we’d love it if you’d like, subscribe to, and rate and review our show. 

The executive producer of Insight at Biologics is Chris Kraihansel. This episode was produced and edited by James C. Taylor, technical supervisor is Jeff Weis. The Insight at Biologics theme is by Tom Rory Parsons. I’m James C. Taylor. Thank you for joining us and please come back for more Insight at Biologics.

[Theme music plays.]