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The impact of geopolitics in clinical trial location with Scott Schliebner
7 Plays3 months ago
In this episode, Sylvain Berthelot welcomes Scott Schliebner, Global Head of Drug Development Consulting at Novotech. With over 25 years of experience across CRO leadership roles, Scott brings a unique perspective on how global politics and shifting market dynamics are influencing where – and how – clinical trials are run.
Together, Sylvain and Scott explore the growing uncertainty created by political change, regulatory shifts, and economic pressures, and how these factors are shaping sponsor strategies. From the rise of early-phase studies in Australia and New Zealand, to the diversification of phase III trial geographies, they discuss why sponsors are increasingly reluctant to rely on a U.S.-only model.
Scott explains how geopolitical factors such as trade tensions, FDA staffing challenges, and evolving diversity guidance impact trial planning, and why sponsors must think proactively about data representativeness across regions. The conversation also highlights the scientific – rather than political – benefits of conducting multi-regional trials, ensuring that new medicines reach the patients who need them most.
Tune in to discover how sponsors are mitigating risk, balancing timelines and costs, and navigating the new realities of trial globalization.
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Transcript
Introduction to Clinical Data Trends
00:00:14
Speaker
Welcome to Clinical Data Talks, a podcast brought to you by CRS-Cube.
00:00:19
Speaker
I'm your host, Sylvain Berthelot.
00:00:21
Speaker
Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
00:00:29
Speaker
Today's discussion is driven by what's happening around the world and how it affects the clinical trial industry.
00:00:37
Speaker
My guest and I both work for companies headquartered in Asia Pacific and we're seeing challenging yet interesting geographic dynamics.
Impact of US Market Changes on Clinical Trials
00:00:48
Speaker
Joining me is Scotch Libner and he's Global Head of Drug Development Consulting at Novotech.
00:00:56
Speaker
Now I find it a bit difficult to do his career justice as well as summarize it at the same time.
00:01:05
Speaker
So let's just say that Scott has been in the industry for over 25 years.
00:01:11
Speaker
He's worked at many CROs in very interesting positions.
00:01:17
Speaker
And over the time, he's seen a lot of changes in Dynamics.
00:01:23
Speaker
Hi Scott, thank you for joining me.
00:01:25
Speaker
How are you doing?
00:01:27
Speaker
I'm good.
00:01:27
Speaker
Thank you for having me.
00:01:28
Speaker
Looking forward to the conversation today and great job pronouncing my last name.
00:01:34
Speaker
That's some of the more challenging parts of our session.
00:01:40
Speaker
Well, I'm sure it will be very interesting and I'm sorry for the shortcut I took with the introduction, but you've had such an interesting career that I didn't know where to point the direction, really.
00:01:58
Speaker
So, I think everyone knows that and everyone sees actually that the clinical industry is being challenged.
00:02:08
Speaker
It has been for several months, especially with the changes we're seeing in the US market at the moment.
Why Asia-Pacific is Attractive for Clinical Trials
00:02:17
Speaker
From what you see in your role, how is it impacting sponsors in general?
00:02:25
Speaker
Yes, Sylvain, thanks.
00:02:27
Speaker
There certainly has been a lot of developments.
00:02:29
Speaker
I think the first word that comes to mind is just uncertainty, right?
00:02:34
Speaker
We have political changes, we have a new administration, and that has, of course, carried down to changes within some of our institutions that really impact clinical drug development, namely the FDA,
00:02:51
Speaker
NIH funding, our Centers for Disease Control, things like that.
00:02:55
Speaker
So there's a lot of change and there's a lot of uncertainty about exactly where we are headed.
00:03:02
Speaker
And of course, when there's uncertainty, we have risk.
00:03:07
Speaker
And as you know, our clients and partners in this space are very risk averse and don't like to take a lot of chances on drug development programs that are looking for
00:03:20
Speaker
a little more predictability.
00:03:21
Speaker
So changes we're seeing, whether it's FDA leadership and may have a differing view on vaccines or cell and gene therapy, whether it's cutting FDA staff and having questions if there's actually
00:03:38
Speaker
enough expertise and staffing levels to review drug drug submissions.
00:03:45
Speaker
That's a question.
00:03:47
Speaker
We have tariffs, we have trade wars, we have all kinds of other fun things that are impacting things.
00:03:52
Speaker
And I think it's
00:03:53
Speaker
You know, I think the summary is it's created some risk and some uncertainty within the U.S. and in the conversations I have with sponsors every day, people are now considering more going outside the U.S. or at least
00:04:11
Speaker
considering some other geographies to supplement what they were going to do in a US only strategy.
00:04:16
Speaker
So when you have uncertainty in a region, people start to look elsewhere for other options.
00:04:23
Speaker
And I think that's the conversation that's happening on a daily basis right now.
00:04:27
Speaker
Wow.
00:04:28
Speaker
Okay.
00:04:29
Speaker
And do you see it impacting all therapeutic areas, all phases, or is it specialized in certain areas?
Trends in Trial Diversification
00:04:38
Speaker
Yeah.
00:04:39
Speaker
We cover a broad range of phases and therapeutic areas and geographies, and I think I have some breadth
00:04:46
Speaker
At least the conversations we're having, I guess I see it in a couple of different ways.
00:04:50
Speaker
I think number one on the early phase, phase one, first and human type of settings, we definitely are seeing more interest in Australia, New Zealand and Asia pack for
00:05:06
Speaker
you know, faster startup timelines.
00:05:10
Speaker
We also know the U.S. is expensive in general.
00:05:12
Speaker
So there's some cost savings, of course, to be had.
00:05:16
Speaker
The infamous Australian advantage and other regions in Southeast Asia are less expensive.
00:05:25
Speaker
Regulatory timelines seem to be fairly predictable.
00:05:28
Speaker
There haven't been a lot of changes in those areas.
00:05:33
Speaker
In startup and sometimes the data required is, you don't quite need as much to get started as you do with say at FDA IND.
00:05:43
Speaker
So we see early phase, I think early phase, phase one studies, people are moving to Australia, New Zealand.
00:05:48
Speaker
And then on the other end of the spectrum,
00:05:52
Speaker
for the bigger global phase three registrational studies that are multi-regional in nature, we're starting to see questions around, well, how many patients should we enroll in the US?
00:06:05
Speaker
You should look for a larger percentage of Asian patients in Asia-Pac regions.
00:06:10
Speaker
So I think we're seeing it on the early phase, being able to start fast, but also maybe
00:06:16
Speaker
Later phase, phase three, the phrase, don't put all of your eggs in one basket.
00:06:21
Speaker
I think instead of just a US only strategy, we're seeing a little more diversification of countries that are involved.
00:06:29
Speaker
interesting and so so the early phase do you consider australia was already kind of a hot spot for early phase but do you think that's um like enhanced that uh willingness to go in in australia to do early phase trials
00:06:48
Speaker
It feels like it.
00:06:49
Speaker
I think I'm probably a little biased here in terms of like, you know, companies come to Novatech because we're really well known in that space.
00:06:57
Speaker
So I probably see a little more of that than on average.
00:07:01
Speaker
But I think with the uncertainty, with the challenges, with the questionable timelines, sponsors and specifically even US biotech sponsors are, I think, more open to ex-US studies.
00:07:13
Speaker
Okay, interesting.
00:07:15
Speaker
And especially in phase two, three, I mean, that didn't used to be the case.
00:07:21
Speaker
You said it yourself that you could have US only trials because they're targeted at the US market.
00:07:29
Speaker
So then that's a mitigating action for sponsors to reduce
00:07:35
Speaker
risks, but do you see or do you think that we could go into trials run completely outside of the US or do sponsors still want to be in the US part?
00:07:49
Speaker
Please.
00:07:50
Speaker
Yeah, it feels like the latter.
00:07:52
Speaker
It feels like sponsors still want or perceive a need to be in the US.
00:07:58
Speaker
So whether it's
00:08:00
Speaker
having some data that they're going to eventually come back to the FDA with because they're gonna look at commercializing in the US because the size of the market.
00:08:09
Speaker
There's also other sponsors who view, you know, the legitimacy of US data.
00:08:17
Speaker
I use that phrase in quotes, like the legitimacy being important for say, a new fundraising inflection point, for example.
00:08:27
Speaker
They'll be able to attract more investors if that study is run in the US, perhaps US investors.
00:08:34
Speaker
There's also some prestige associated with some of the more well-known famous sites in the US and running a study at MD Anderson Cancer Center or Memorial Sloan Kettering or somewhere like that, like the Cleveland Clinic carries a lot of weights and a lot of
00:08:53
Speaker
Kind of, yeah, I think prestige and you get some attention from that.
00:08:56
Speaker
So objectively, it might make more sense to go to AsiaPact for timelines and cost savings and predictability.
00:09:03
Speaker
But there still are some other reasons I think people are going to stay in the U.S. at least to be part of a program.
00:09:10
Speaker
I don't think moving away entirely is, I don't think we're seeing too much of that right now.
00:09:15
Speaker
No.
00:09:16
Speaker
Okay.
00:09:17
Speaker
And when it comes to data, because we know that you can't necessarily use all the data you've acquired to submit to specific
Challenges and Strategies in Trial Planning
00:09:30
Speaker
markets.
00:09:30
Speaker
So if you want to submit to the FDA, how do you approach that?
00:09:37
Speaker
Is it possible to use data acquired outside the country?
00:09:43
Speaker
Yeah, well, data is a key part of your podcast, right?
00:09:47
Speaker
Yeah.
00:09:47
Speaker
Common theme throughout.
00:09:49
Speaker
And if we're talking about global data,
00:09:51
Speaker
data from different regions and countries.
00:09:54
Speaker
That's also a very common conversation these days is if I want to run a study in a couple of regions, what percentage of patients do I need in the US for the FDA to accept our data?
00:10:09
Speaker
Or a lot of conversations around Japan and China, like what percentage of patients do we need from these geographies?
00:10:18
Speaker
There's a couple things going on.
00:10:19
Speaker
There's generally a desire from FDA to want data that is representative of the US population in terms of ethnic background and things.
00:10:31
Speaker
Another reason Australia is a good choice for some reasons because of it mirrors the US in many ways.
00:10:37
Speaker
The other kind of angle on this that's again filled with back to that uncertainty word, changes at the FDA and things, there's a big push for these inclusive recruitment campaigns or diversity equity inclusion initiative to ensure that clinical trials were
00:10:59
Speaker
ultimately representative of the population that would hope to benefit from that new medicine or new treatment.
00:11:07
Speaker
So our clinical trials should reflect the population.
00:11:10
Speaker
Well, those diversity guidances have all been kind of removed from the FDA website, right?
00:11:16
Speaker
We have this sort of politically oriented view on that.
00:11:21
Speaker
So
00:11:23
Speaker
uncertainty, using the uncertainty word for the third time today already.
00:11:27
Speaker
We don't know if they're coming back.
00:11:29
Speaker
We don't know if those will be mandated, but those representative
00:11:35
Speaker
Inclusion guidances really impact when you think about data outside the US and in the US.
00:11:42
Speaker
And when you're thinking about a multi-region or multi-country clinical trial, you really need to be thinking about the ethnic background of the patients that will enroll and how do those add up to a population that is hopefully representative of one of the markets you want to go to.
00:12:00
Speaker
There's a little bit of some tiptoeing right now around, you know, should we assume those diversity guidances are coming back?
00:12:09
Speaker
That's probably the most kind of conservative approach is to try to conduct a trial according to those in case those are enforced.
00:12:18
Speaker
Without those guidances, I still think it makes sense.
00:12:20
Speaker
It's still good science, right?
00:12:22
Speaker
We want to run studies that are representative of the overall population.
00:12:26
Speaker
So I think aiming for that and making sure that your data has a mixture of populations that are representative is really the ultimate goal here.
00:12:37
Speaker
It's tricky for sponsors because if you're on a six to seven year long trial,
00:12:47
Speaker
You don't know what the rules will be by the time you submit.
00:12:52
Speaker
Right.
00:12:52
Speaker
You just said we've removed those regulations, but if they come back in six months or even three years, then you might end up, if you're not making the right decision now, you might end up being in a position where your data may not be valid when it comes time to submit.
00:13:14
Speaker
Do you have that kind of discussions with sponsors at the moment?
00:13:20
Speaker
Yeah, a little bit.
00:13:20
Speaker
I mean, you want your crystal ball to be really clear and be able to see the future perfectly.
00:13:28
Speaker
You want to be able to position your study for where regulations and where competition is going to be, not today, but of course in the future.
00:13:37
Speaker
I'm not a hockey fan.
00:13:40
Speaker
I think like there's that famous phrase like Wayne Gretzky, you want to like pass the puck not to where your person is, but to where they're going to be.
00:13:48
Speaker
You want to be sort of anticipatory and proactive.
00:13:52
Speaker
So
00:13:54
Speaker
That is a challenge.
00:13:55
Speaker
And I think, you know, you also have other, we had an interesting conversation with a client last week where they saw their initial phase two data looks like patients with a Caucasian background responded much better than
00:14:11
Speaker
the Asian patients that were enrolled in their study.
00:14:13
Speaker
And this was a Chinese biotech company that was planning on doing most of their future work in China, Taiwan, Southeast Asia.
00:14:23
Speaker
They saw results of like, wait, this seems to work better in Caucasian populations.
00:14:28
Speaker
We need to think about a different strategy now, but we still need to have a certain amount of
00:14:35
Speaker
Chinese patients enrolled to be able to market it in China.
00:14:38
Speaker
We still need to think about the US representation.
00:14:41
Speaker
And then you bring in interesting variables like Taiwan is, do we consider Taiwanese patients Chinese or not?
00:14:51
Speaker
How does the China FDA view that?
00:14:54
Speaker
That gets a little bit political as well.
00:14:57
Speaker
But planning and geography and minimizing risk and wanting to make sure your data is representative,
00:15:05
Speaker
There's a couple of new variables I feel like today that we have to grapple with that we didn't have to think about several years ago.
00:15:11
Speaker
Yeah.
00:15:11
Speaker
Yeah.
00:15:12
Speaker
Yeah.
00:15:14
Speaker
But it's interesting at the same time, what the example you've just shared shows the benefits of doing it.
00:15:20
Speaker
Absolutely.
00:15:21
Speaker
Because if you had a Chinese only population, then your trial might get canceled early.
00:15:32
Speaker
Whereas now you can veer direction.
00:15:35
Speaker
And from where you are, do you see any impact on submission timelines at the moment in the US?
00:15:45
Speaker
Yeah, it's a good question.
00:15:47
Speaker
My colleagues ask me, clients ask us.
00:15:50
Speaker
We do a fair amount of interaction with agencies, lots with the FDA, a little bit with EMA, Korea, Japan, China, MHRA, and your neck of the woods.
00:16:06
Speaker
We've seen only of all the sort of submissions interactions, we've only had one data point that was
00:16:13
Speaker
suggesting a little bit of like a delay and a little bit of a slowdown.
00:16:18
Speaker
So mostly what we see is we read the news and we hear about, you know, a headline that says this delay was, this review was delayed rather, or,
00:16:28
Speaker
questions around staffing and will there be enough people?
00:16:32
Speaker
I have to objectively say, I haven't seen a lot of changes.
00:16:36
Speaker
And do you see any sponsors changing, not direction necessarily, but changing strategy a bit and moving to submissions faster in markets outside of the U.S. to avoid any risks in the U.S.?
00:16:56
Speaker
The risk part is really key.
00:16:57
Speaker
I think that's really what the whole conversation is about today is how do you mitigate risk?
00:17:02
Speaker
Of course, we see a fair amount of companies that are still looking at the US as their ultimate plan, their ultimate commercialization strategy that ultimately will run their pivotal studies in there.
00:17:18
Speaker
But I think you're seeing this parallel path we see a lot of
00:17:23
Speaker
Let's go to Australia, New Zealand, Asia PAC to start our phase one studies, collect good data, collect data that's even maybe representative of the U S and in parallel work on our, um, us FDA IND submission while we're running that phase one study in Asia PAC in parallel, prepare for the next step to be in the U S.
00:17:47
Speaker
That kind of parallel running a study elsewhere while you're getting ready for the U.S. is a way of really using your time well and being efficient.
00:17:56
Speaker
That seems to be the most common path we see right now is go to phase one for Australia.
00:18:02
Speaker
Think about the U.S. for phase two.
00:18:04
Speaker
Okay.
00:18:05
Speaker
So still not a drastic change at the moment.
00:18:11
Speaker
What I'm hearing is that
00:18:14
Speaker
I think you said you don't put all your eggs in the same basket.
00:18:17
Speaker
So more diversification of regions where your phase twos and threes are run, but not necessarily a slow down in terms of submissions to the U S yet.
00:18:32
Speaker
Is that again?
00:18:33
Speaker
Yeah, I think that's fair.
00:18:34
Speaker
I mean, I think the U S market is still, you know, the biggest.
00:18:39
Speaker
We've seen challenges in the industry in the past.
00:18:43
Speaker
I mean, the latest or the last massive one was COVID, obviously, where everyone had to focus on getting medication to existing patients.
00:18:55
Speaker
And we saw an impact on the type of trials that started at that time.
00:19:01
Speaker
We saw a lot more COVID trials and maybe a bit of a slowdown in other areas.
00:19:06
Speaker
But the industry tends to
00:19:09
Speaker
despite it being slow to innovate, as I often say, the industry can adapt relatively quickly in a way.
00:19:17
Speaker
And the impact of COVID, the initial impact within six months was kind of dealt with in a way.
00:19:26
Speaker
Do you expect something similar here?
00:19:29
Speaker
Do you think the dynamics like the geographic dynamics will
00:19:34
Speaker
Yeah.
00:19:34
Speaker
Like come back to a strong position of the U.S. relatively quickly.
00:19:41
Speaker
In the current environments, it's hard to say where we'll go.
00:19:44
Speaker
I feel like there's not a lot of obviously investment right now.
00:19:47
Speaker
And a lot of our biotech companies are thinking about how to preserve cash and make sure their runway goes for a little while because they don't know when they can raise more money.
00:19:59
Speaker
So I think it's kind of preventing a lot of innovation, actually.
00:20:03
Speaker
I think it's just a matter of kind of getting through this phase we're in, managing to do a little more with a little less right now and hope that the world and the environment kind of like changes and evolves and fundraising comes back.
00:20:21
Speaker
So I don't see a ton of innovation.
00:20:23
Speaker
I feel like we're in a little bit more of a survival mode in some regards.
Advice on Adapting to Industry Changes
00:20:28
Speaker
I've got one last question for you, Scott.
00:20:32
Speaker
What's the best piece of advice you've received that you consistently apply in your career?
00:20:41
Speaker
That's a good question.
00:20:44
Speaker
Well,
00:20:46
Speaker
Like a lot of us, I mean, I had some early, I had an early in my career, I had some nice support and a little bit of mentoring and guidance.
00:20:56
Speaker
And I had one gentleman who was my boss pretty early on in my career when I was really figuring out what I wanted to do.
00:21:05
Speaker
And this was in clinical trials, but it was very early on.
00:21:09
Speaker
You know, and he was really adamant about,
00:21:15
Speaker
Like, be a sponge.
00:21:16
Speaker
Continue to kind of
00:21:18
Speaker
get exposed as much as you can, keep learning, keep like paying attention to what's out there.
00:21:27
Speaker
That'll kind of help guide you on like the path that you eventually find yourself on.
00:21:32
Speaker
Just keep getting exposed to different things.
00:21:35
Speaker
Keep trying to be in like a growth mindset, keep learning like a sponge, absorb all that's around you.
00:21:42
Speaker
And if you just kind of have that mentality every day, you'll,
00:21:46
Speaker
You know, you won't get complacent.
00:21:47
Speaker
You'll kind of keep kind of advancing and learning and maybe that'll take you down a pathway of a certain regard.
00:21:54
Speaker
So I found that really helpful.
00:21:56
Speaker
I guess I hadn't thought about that in a while, but I think that that was true.
00:21:59
Speaker
And I think I really try to keep my I try to keep that in mind on a day to day basis is keep learning.
00:22:05
Speaker
Like you said earlier, I've been around in this industry for a little while.
00:22:10
Speaker
We both have some gray hair.
00:22:13
Speaker
And at the same time, there are advances and new things happening every day, whether it's AI driven, whether it's more around
00:22:22
Speaker
data collection, geographies, there's all kinds of incredible new therapeutic modalities coming.
00:22:29
Speaker
You got to keep learning, keep absorbing, keep growing and stay relevant, I think.
00:22:37
Speaker
So I guess that's where I sit on that.
00:22:41
Speaker
Yeah, I like that.
00:22:42
Speaker
And I fully agree, fully agree.
00:22:45
Speaker
And especially I would say in our industry, because
00:22:49
Speaker
We have so many new things that if you don't embrace innovation, new ideas, change, then there will be a point where you are against the industry in a way, against where everyone's trying to go.
00:23:08
Speaker
So, yeah, that's a great piece of advice.
00:23:10
Speaker
Thank you.
00:23:12
Speaker
You're welcome.
00:23:13
Speaker
Thanks for asking.
00:23:14
Speaker
I do think, I mean, there's so much new.
00:23:16
Speaker
And I think if you're of the mindset of, why can't we just keep doing things the way we did them 10, 15 years ago and holding onto that, I think it prevents you from being, advancing, right?
00:23:33
Speaker
And learning and taking advantage of new technologies and things.
00:23:38
Speaker
I think we all need to be
00:23:40
Speaker
And hopefully we're in this industry because we want to do good, we want to help patients and we want to leverage new tools and always be doing things better.
00:23:48
Speaker
So if you're, you know, kind of continual process improvement of ourselves, I think is key.
00:23:55
Speaker
Yep.
00:23:57
Speaker
Well, thank you so much, Scott.
00:23:59
Speaker
It's been so nice to have you on the podcast and yeah, thank you for sharing what you see in the industry.
00:24:07
Speaker
My pleasure to be here.
00:24:08
Speaker
Thanks for your great questions and thanks for having me on.
00:24:11
Speaker
It's a pleasure.
00:24:12
Speaker
And thank you all for watching us or listening to us.
00:24:16
Speaker
Remember to visit our website to find more episodes of Clinical Data Talks.