Transcript
Speaker: Welcome to Clinical Data Talks, a podcast brought to you by CRS-Cube.
Speaker: I'm your host, Sylvain Berthelot.
Speaker: Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
Speaker: Today's discussion is driven by what's happening around the world and how it affects the clinical trial industry.
Speaker: My guest and I both work for companies headquartered in Asia Pacific and we're seeing challenging yet interesting geographic dynamics.
Speaker: Joining me is Scotch Libner and he's Global Head of Drug Development Consulting at Novotech.
Speaker: Now I find it a bit difficult to do his career justice as well as summarize it at the same time.
Speaker: So let's just say that Scott has been in the industry for over 25 years.
Speaker: He's worked at many CROs in very interesting positions.
Speaker: And over the time, he's seen a lot of changes in Dynamics.
Speaker: Hi Scott, thank you for joining me.
Speaker: How are you doing?
Speaker: I'm good.
Speaker: Thank you for having me.
Speaker: Looking forward to the conversation today and great job pronouncing my last name.
Speaker: That's some of the more challenging parts of our session.
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.
Speaker: So, I think everyone knows that and everyone sees actually that the clinical industry is being challenged.
Speaker: It has been for several months, especially with the changes we're seeing in the US market at the moment.
Speaker: From what you see in your role, how is it impacting sponsors in general?
Speaker: Yes, Sylvain, thanks.
Speaker: There certainly has been a lot of developments.
Speaker: I think the first word that comes to mind is just uncertainty, right?
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,
Speaker: NIH funding, our Centers for Disease Control, things like that.
Speaker: So there's a lot of change and there's a lot of uncertainty about exactly where we are headed.
Speaker: And of course, when there's uncertainty, we have risk.
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
Speaker: a little more predictability.
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
Speaker: enough expertise and staffing levels to review drug drug submissions.
Speaker: That's a question.
Speaker: We have tariffs, we have trade wars, we have all kinds of other fun things that are impacting things.
Speaker: And I think it's
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
Speaker: considering some other geographies to supplement what they were going to do in a US only strategy.
Speaker: So when you have uncertainty in a region, people start to look elsewhere for other options.
Speaker: And I think that's the conversation that's happening on a daily basis right now.
Speaker: Wow.
Speaker: Okay.
Speaker: And do you see it impacting all therapeutic areas, all phases, or is it specialized in certain areas?
Speaker: Yeah.
Speaker: We cover a broad range of phases and therapeutic areas and geographies, and I think I have some breadth
Speaker: At least the conversations we're having, I guess I see it in a couple of different ways.
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
Speaker: you know, faster startup timelines.
Speaker: We also know the U.S. is expensive in general.
Speaker: So there's some cost savings, of course, to be had.
Speaker: The infamous Australian advantage and other regions in Southeast Asia are less expensive.
Speaker: Regulatory timelines seem to be fairly predictable.
Speaker: There haven't been a lot of changes in those areas.
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.
Speaker: So we see early phase, I think early phase, phase one studies, people are moving to Australia, New Zealand.
Speaker: And then on the other end of the spectrum,
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?
Speaker: You should look for a larger percentage of Asian patients in Asia-Pac regions.
Speaker: So I think we're seeing it on the early phase, being able to start fast, but also maybe
Speaker: Later phase, phase three, the phrase, don't put all of your eggs in one basket.
Speaker: I think instead of just a US only strategy, we're seeing a little more diversification of countries that are involved.
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
Speaker: It feels like it.
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.
Speaker: So I probably see a little more of that than on average.
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.
Speaker: Okay, interesting.
Speaker: And especially in phase two, three, I mean, that didn't used to be the case.
Speaker: You said it yourself that you could have US only trials because they're targeted at the US market.
Speaker: So then that's a mitigating action for sponsors to reduce
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?
Speaker: Please.
Speaker: Yeah, it feels like the latter.
Speaker: It feels like sponsors still want or perceive a need to be in the US.
Speaker: So whether it's
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.
Speaker: There's also other sponsors who view, you know, the legitimacy of US data.
Speaker: I use that phrase in quotes, like the legitimacy being important for say, a new fundraising inflection point, for example.
Speaker: They'll be able to attract more investors if that study is run in the US, perhaps US investors.
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
Speaker: Kind of, yeah, I think prestige and you get some attention from that.
Speaker: So objectively, it might make more sense to go to AsiaPact for timelines and cost savings and predictability.
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.
Speaker: I don't think moving away entirely is, I don't think we're seeing too much of that right now.
Speaker: No.
Speaker: Okay.
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 markets.
Speaker: So if you want to submit to the FDA, how do you approach that?
Speaker: Is it possible to use data acquired outside the country?
Speaker: Yeah, well, data is a key part of your podcast, right?
Speaker: Yeah.
Speaker: Common theme throughout.
Speaker: And if we're talking about global data,
Speaker: data from different regions and countries.
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?
Speaker: Or a lot of conversations around Japan and China, like what percentage of patients do we need from these geographies?
Speaker: There's a couple things going on.
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.
Speaker: Another reason Australia is a good choice for some reasons because of it mirrors the US in many ways.
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
Speaker: ultimately representative of the population that would hope to benefit from that new medicine or new treatment.
Speaker: So our clinical trials should reflect the population.
Speaker: Well, those diversity guidances have all been kind of removed from the FDA website, right?
Speaker: We have this sort of politically oriented view on that.
Speaker: So
Speaker: uncertainty, using the uncertainty word for the third time today already.
Speaker: We don't know if they're coming back.
Speaker: We don't know if those will be mandated, but those representative
Speaker: Inclusion guidances really impact when you think about data outside the US and in the US.
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.
Speaker: There's a little bit of some tiptoeing right now around, you know, should we assume those diversity guidances are coming back?
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.
Speaker: Without those guidances, I still think it makes sense.
Speaker: It's still good science, right?
Speaker: We want to run studies that are representative of the overall population.
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.
Speaker: It's tricky for sponsors because if you're on a six to seven year long trial,
Speaker: You don't know what the rules will be by the time you submit.
Speaker: Right.
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.
Speaker: Do you have that kind of discussions with sponsors at the moment?
Speaker: Yeah, a little bit.
Speaker: I mean, you want your crystal ball to be really clear and be able to see the future perfectly.
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.
Speaker: I'm not a hockey fan.
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.
Speaker: You want to be sort of anticipatory and proactive.
Speaker: So
Speaker: That is a challenge.
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
Speaker: the Asian patients that were enrolled in their study.
Speaker: And this was a Chinese biotech company that was planning on doing most of their future work in China, Taiwan, Southeast Asia.
Speaker: They saw results of like, wait, this seems to work better in Caucasian populations.
Speaker: We need to think about a different strategy now, but we still need to have a certain amount of
Speaker: Chinese patients enrolled to be able to market it in China.
Speaker: We still need to think about the US representation.
Speaker: And then you bring in interesting variables like Taiwan is, do we consider Taiwanese patients Chinese or not?
Speaker: How does the China FDA view that?
Speaker: That gets a little bit political as well.
Speaker: But planning and geography and minimizing risk and wanting to make sure your data is representative,
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.
Speaker: Yeah.
Speaker: Yeah.
Speaker: Yeah.
Speaker: But it's interesting at the same time, what the example you've just shared shows the benefits of doing it.
Speaker: Absolutely.
Speaker: Because if you had a Chinese only population, then your trial might get canceled early.
Speaker: Whereas now you can veer direction.
Speaker: And from where you are, do you see any impact on submission timelines at the moment in the US?
Speaker: Yeah, it's a good question.
Speaker: My colleagues ask me, clients ask us.
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.
Speaker: We've seen only of all the sort of submissions interactions, we've only had one data point that was
Speaker: suggesting a little bit of like a delay and a little bit of a slowdown.
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,
Speaker: questions around staffing and will there be enough people?
Speaker: I have to objectively say, I haven't seen a lot of changes.
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.?
Speaker: The risk part is really key.
Speaker: I think that's really what the whole conversation is about today is how do you mitigate risk?
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.
Speaker: But I think you're seeing this parallel path we see a lot of
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.
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.
Speaker: That seems to be the most common path we see right now is go to phase one for Australia.
Speaker: Think about the U.S. for phase two.
Speaker: Okay.
Speaker: So still not a drastic change at the moment.
Speaker: What I'm hearing is that
Speaker: I think you said you don't put all your eggs in the same basket.
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.
Speaker: Is that again?
Speaker: Yeah, I think that's fair.
Speaker: I mean, I think the U S market is still, you know, the biggest.
Speaker: We've seen challenges in the industry in the past.
Speaker: I mean, the latest or the last massive one was COVID, obviously, where everyone had to focus on getting medication to existing patients.
Speaker: And we saw an impact on the type of trials that started at that time.
Speaker: We saw a lot more COVID trials and maybe a bit of a slowdown in other areas.
Speaker: But the industry tends to
Speaker: despite it being slow to innovate, as I often say, the industry can adapt relatively quickly in a way.
Speaker: And the impact of COVID, the initial impact within six months was kind of dealt with in a way.
Speaker: Do you expect something similar here?
Speaker: Do you think the dynamics like the geographic dynamics will
Speaker: Yeah.
Speaker: Like come back to a strong position of the U.S. relatively quickly.
Speaker: In the current environments, it's hard to say where we'll go.
Speaker: I feel like there's not a lot of obviously investment right now.
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.
Speaker: So I think it's kind of preventing a lot of innovation, actually.
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.
Speaker: So I don't see a ton of innovation.
Speaker: I feel like we're in a little bit more of a survival mode in some regards.
Speaker: I've got one last question for you, Scott.
Speaker: What's the best piece of advice you've received that you consistently apply in your career?
Speaker: That's a good question.
Speaker: Well,
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.
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.
Speaker: And this was in clinical trials, but it was very early on.
Speaker: You know, and he was really adamant about,
Speaker: Like, be a sponge.
Speaker: Continue to kind of
Speaker: get exposed as much as you can, keep learning, keep like paying attention to what's out there.
Speaker: That'll kind of help guide you on like the path that you eventually find yourself on.
Speaker: Just keep getting exposed to different things.
Speaker: Keep trying to be in like a growth mindset, keep learning like a sponge, absorb all that's around you.
Speaker: And if you just kind of have that mentality every day, you'll,
Speaker: You know, you won't get complacent.
Speaker: You'll kind of keep kind of advancing and learning and maybe that'll take you down a pathway of a certain regard.
Speaker: So I found that really helpful.
Speaker: I guess I hadn't thought about that in a while, but I think that that was true.
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.
Speaker: Like you said earlier, I've been around in this industry for a little while.
Speaker: We both have some gray hair.
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
Speaker: data collection, geographies, there's all kinds of incredible new therapeutic modalities coming.
Speaker: You got to keep learning, keep absorbing, keep growing and stay relevant, I think.
Speaker: So I guess that's where I sit on that.
Speaker: Yeah, I like that.
Speaker: And I fully agree, fully agree.
Speaker: And especially I would say in our industry, because
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.
Speaker: So, yeah, that's a great piece of advice.
Speaker: Thank you.
Speaker: You're welcome.
Speaker: Thanks for asking.
Speaker: I do think, I mean, there's so much new.
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?
Speaker: And learning and taking advantage of new technologies and things.
Speaker: I think we all need to be
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.
Speaker: So if you're, you know, kind of continual process improvement of ourselves, I think is key.
Speaker: Yep.
Speaker: Well, thank you so much, Scott.
Speaker: It's been so nice to have you on the podcast and yeah, thank you for sharing what you see in the industry.
Speaker: My pleasure to be here.
Speaker: Thanks for your great questions and thanks for having me on.
Speaker: It's a pleasure.
Speaker: And thank you all for watching us or listening to us.
Speaker: Remember to visit our website to find more episodes of Clinical Data Talks.
