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How Many Alexes Does It Take To Launch A Drug w/ Daphne Smyth · Lab to Lives

• 0:09
  SPEAKER_01: Welcome to Lab2 Lives, the podcast where we ask how do we get great ideas out of the lab and into people's lives?
• 0:20
  SPEAKER_01: Your hosts are Alexander F.
• 0:24
  SPEAKER_01: We are a team media and developers in the media.
• 0:28
  SPEAKER_01: We are improved comedians who are also working in live talents.
• 0:44
  SPEAKER_01: So whether you're developing a next generation drug, innovating in MedTech, or just curious about how healthcare moves from discovery to impact, welcome to Lab2Lives.
• 0:59
  SPEAKER_00: Hello everybody and welcome once again to an episode of Lab 2 Lives.
• 1:04
  SPEAKER_00: Based on the last episode I was hosting, you may be panicking, but not to worry, we have Ivana here with us today in the studio.
• 1:12
  SPEAKER_00: So uh yeah, no need to panic in that regard this time round.
• 1:15
  SPEAKER_00: We also have with us our guest today who is Daphne Smith.
• 1:19
  SPEAKER_00: Daphne, would you like to introduce yourself?
• 1:22
  SPEAKER_02: Absolutely.
• 1:22
  SPEAKER_02: Thank you, Alex and Ivana, for inviting me.
• 1:25
  SPEAKER_02: Hi, Daphne.
• 1:25
  SPEAKER_02: I'm based in Ireland.
• 1:26
  SPEAKER_02: I have been in the pharmaceutical industry for over 35 years, always in regulatory.
• 1:31
  SPEAKER_02: As such, I've seen many aspects of the industry and lived through many, many developments.
• 1:37
  SPEAKER_02: For context, I started in 1988 at Bio AG in Germany.
• 1:41
  SPEAKER_00: Wow, amazing.
• 1:42
  SPEAKER_00: I will not try and think about what I was doing in 1988.
• 1:46
  SPEAKER_00: Exactly.
• 1:46
  SPEAKER_00: No, I know.
• 1:49
  SPEAKER_02: Or me old, whichever.
• 1:51
  SPEAKER_02: So, you know, I obviously have a broad interest in the business, in management, in developing teams, as well as exploring new possibilities.
• 1:58
  SPEAKER_02: I'm a curious person.
• 2:00
  SPEAKER_02: I like to know what makes people and processes work, and I love developing solutions.
• 2:05
  SPEAKER_02: My current role is leading the regulatory function of Veristat.
• 2:08
  SPEAKER_02: Veristat's a full service and consulting zero.
• 2:11
  SPEAKER_02: And in a consulting function, both me and the team, mainly the team, were involved in a lot of drug development.
• 2:17
  SPEAKER_02: And, you know, it's exciting.
• 2:18
  SPEAKER_02: They're always exciting times.
• 2:20
  SPEAKER_02: I think at the moment, there's a lot of new developments, technologies explored, as well as, and I think that's the reason we we're focusing on this here is the movement of Chinese pharma into the EU and to a lesser extent in the US.
• 2:32
  SPEAKER_02: But that's also a very exciting development of many, of many.
• 2:35
  SPEAKER_00: So thank you.
• 2:36
  SPEAKER_00: Absolutely superb.
• 2:36
  SPEAKER_00: And it's a nice tie-up because we're also very curious people here on the podcast.
• 2:40
  SPEAKER_00: And our first curious question tends to be we have this model of five different areas in healthcare and pharma.
• 2:49
  SPEAKER_00: There's innovation, there is regulation and compliance.
• 2:54
  SPEAKER_00: There is commercialization, there is manufacture, and there's the corporate side.
• 2:59
  SPEAKER_00: I've got those right.
• 3:00
  SPEAKER_00: You're not involved.
• 3:01
  SPEAKER_00: Nice.
• 3:01
  SPEAKER_00: So when we like to place ourselves in these areas, so Stephanie, where do you think you sit in those five areas?
• 3:06
  SPEAKER_02: Quite a few, really.
• 3:07
  SPEAKER_02: I suppose corporate mainly at the moment, with compliance obviously being regulatory, but also with a good bit of commercial.
• 3:13
  SPEAKER_02: So, you know, corporate management, obviously, in a CRO.
• 3:16
  SPEAKER_02: I manage and organize and build regulatory teams as well as advising clients on development.
• 3:22
  SPEAKER_02: Some of the team members are heavily involved, obviously, in compliance as part of drug development.
• 3:26
  SPEAKER_02: And the aim of what we do is obviously to get medicinal products and devices approved and advise our clients on the best way to do that.
• 3:34
  SPEAKER_02: So that's really the commercial element.
• 3:35
  SPEAKER_02: And it's also not just approval, it's also getting them on the market to the patients.
• 3:40
  SPEAKER_02: In past lives, I've been in regulatory in pharma, so I've been also been heavily involved in the other streams innovation, manufacturing, compliance.
• 3:50
  SPEAKER_02: But I agree, I like the concept.
• 3:51
  SPEAKER_02: They're all important elements of the industry.
• 3:54
  SPEAKER_00: Superb.
• 3:55
  SPEAKER_00: No, amazing.
• 3:56
  SPEAKER_00: More open question than uh what is on our minds this week?
• 4:00
  SPEAKER_00: What are the major challenges we're seeing in the industry?
• 4:02
  SPEAKER_00: Uh, is there anything that's really occupying our thoughts in terms of challenges in this lab-to-life journey?
• 4:08
  SPEAKER_01: Well, if I may share a consideration that I've been having recently.
• 4:12
  SPEAKER_01: When a pharmaceutical company or a biotech decides that now it's time to launch our drugs on multiple markets, we often think about the commercial affiliates establishing a sales force, maybe the medical side of things.
• 4:26
  SPEAKER_01: But one of the things that I have found is that it is actually equally important and probably more important to establish that regulatory pathway in the markets that we want to enter into.
• 4:36
  SPEAKER_01: But somehow, several of the biotech foundation I've been speaking to recently, they've been like, that's actually the one mistake that we made is that we went commercial before we established our regulatory presence.
• 4:48
  SPEAKER_01: And I wonder if that may resonate with you, Daphne.
• 4:51
  SPEAKER_02: It does.
• 4:51
  SPEAKER_02: It does.
• 4:52
  SPEAKER_02: It's really interesting, actually, that you bring that up because that is a lot of what we would get involved in is really getting to talk to companies to make them realize, understand the complexity of what they're doing.
• 5:05
  SPEAKER_02: And especially a lot of companies would have maybe a development in one country.
• 5:10
  SPEAKER_02: And the mindset is obviously return on investment.
• 5:13
  SPEAKER_02: So, oh, we'll just bring that to other countries.
• 5:16
  SPEAKER_02: Like you say, that is really, really not easy.
• 5:18
  SPEAKER_02: That is something that needs a lot of planning.
• 5:21
  SPEAKER_02: There's a lot of intricacy.
• 5:23
  SPEAKER_02: As I said, what's on our minds at the moment is dealing with our Chinese clients is really explaining, understanding, and also helping them navigate, especially the EU systems, the different countries, different languages, different processes, the relevance of their development and their drug to the European patient population, which from a regulatory perspective is the focus.
• 5:49
  SPEAKER_02: So they they may have decided our most profitable market is X, but if their drug, their development, the data that they're providing to the regulators doesn't support that the development is relevant to the patient population in the target country, then there are huge hurdles.
• 6:05
  SPEAKER_02: There are huge hurdles.
• 6:06
  SPEAKER_02: And I think that's part of what I was going to say was uncertainty.
• 6:10
  SPEAKER_02: I think there's a lot of uncertainty at the moment, be it from, like you say, which step do we do first to the obviously the geopolitical environment, there's instability.
• 6:21
  SPEAKER_02: I find the industry is very nervous at the moment.
• 6:24
  SPEAKER_00: Well, that's interesting.
• 6:25
  SPEAKER_00: I mean, because I'm used to this a little bit being the other way up, which is sitting here in Europe and working mostly with, you know, European companies, a couple of US companies.
• 6:34
  SPEAKER_00: It's China that's a little bit remote over there and it's hard to know what's going on or what needs to happen there.
• 6:40
  SPEAKER_00: But I guess it's equally the same for maybe someone, Alex sitting in China, looking across to Europe in the US.
• 6:47
  SPEAKER_00: So is well, a two-part question then.
• 6:49
  SPEAKER_00: What is it that you're seeing that are the major challenges for someone sitting in that more remote place and trying to come into a market they perhaps don't know as well?
• 6:58
  SPEAKER_00: And what are we currently losing, say, in the European market by that being a little bit more difficult for people to achieve?
• 7:07
  SPEAKER_02: Excellent question, honestly.
• 7:08
  SPEAKER_02: And so the challenges that the Chinese, specifically Chinese, but any new non-European company face are, like I said, the complexities, the complexities of the systems, the different committees, the different countries, different languages, even though obviously for most developments we'd be looking at, they'll be mainly oncology, it will be the centralized procedure, but they still need to navigate the complexity.
• 7:32
  SPEAKER_02: And the new added complexity is obviously the reimbursement, the HDA, the JCA process.
• 7:37
  SPEAKER_02: But rather than go into all depth and that I could talk forever on this, sorry, but it really is that complexity that needs to be explained and the length of time it takes.
• 7:48
  SPEAKER_02: We're dealing with country companies in various stages of development.
• 7:52
  SPEAKER_02: So quite a few of them have already majorly developed their product in China.
• 7:57
  SPEAKER_02: So that is then a step back for them to go to Europe to then have to think about perhaps I need to do PKPD bridging or I might even need to do a clinical trial.
• 8:08
  SPEAKER_02: And we're having a lot of discussions at that level because for them, obviously, it's around their investment.
• 8:14
  SPEAKER_02: How much investment do I need to get this product on the market?
• 8:18
  SPEAKER_02: Obviously, from a business perspective, that's what they're looking at.
• 8:21
  SPEAKER_02: What we're trying to do is to break this down and also to provide support to, on the one hand, not scare them off, but on the other hand, be realistic.
• 8:30
  SPEAKER_02: You know, to your second point, what are we losing out on?
• 8:33
  SPEAKER_02: If we're too restrictive, we're too complicated, we set the bar too high, we are losing out on major developments.
• 8:40
  SPEAKER_02: Some of the technology and the developments coming out of China are totally fascinating.
• 8:44
  SPEAKER_02: We don't have presence in China yet, but we did visit twice last year.
• 8:49
  SPEAKER_02: We were in Shanghai and we went to bio China in a place called Xu Zhu, which is just outside Shanghai, and it's just fascinating on the space.
• 8:57
  SPEAKER_02: I've been around a long time, but this is such an exciting and interesting development to see that the level of investment, the level of technology, the level of effort being put into the development.
• 9:10
  SPEAKER_01: We are in an interesting stage right now where I was actually not really aware of the big developments that are happening biotech-wise in China until I think last year when I was at a conference and a person showed me the numbers and the statistics of what is actually happening development-wise in China.
• 9:27
  SPEAKER_01: And I was just blown away from my chair.
• 9:30
  SPEAKER_01: Oh my goodness, how did I not know that this major development is happening in our industry?
• 9:35
  SPEAKER_01: But Daphne, can you maybe uh tell a little bit more about what you have experienced, like what is happening in China?
• 9:41
  SPEAKER_02: It's on a scale that's incredible.
• 9:43
  SPEAKER_02: So if I take the example of Shanghai, so the Chinese government has heavily invested in the industry.
• 9:48
  SPEAKER_02: And over the past five to ten years, mainly there was ten years ago, they have a development plan, and they have literally built entire cities with a total infrastructure from schools, hospitals, universities, biotech startup, commercialization, manufacturing, all in.
• 10:07
  SPEAKER_02: We went to this city called Shizhu, and we expected a bio bay, a biotech area that you'd see in any other country.
• 10:16
  SPEAKER_02: We were met with an entire city, a huge city with incredible infrastructure, incredible technology, because we have some certain Chinese clients, so they advise us you need to go to buy a China.
• 10:26
  SPEAKER_02: So we went and they brought me the salespeople, like, okay, we need Daphne, we need regulatory.
• 10:31
  SPEAKER_02: So we went there, not really with very high expectations, just as an exploratory, you'll see what's going on, we meet some clients while we're there.
• 10:39
  SPEAKER_02: But the level of interest we experienced was incredible, absolutely incredible.
• 10:44
  SPEAKER_02: I haven't stood on a commercial stand for about 20 years.
• 10:48
  SPEAKER_02: I end up standing there for three days non-stop until I nearly fell over.
• 10:52
  SPEAKER_02: So yeah, it's fascinating.
• 10:54
  SPEAKER_02: The amount of drugs coming out, the amount of development, the amount of interest.
• 10:58
  SPEAKER_02: We were literally blown away.
• 10:59
  unknown: Yeah.
• 11:00
  SPEAKER_02: Like you said, I'm relatively unaware, even though I had been working with some Chinese clients, you know, still the scale is not something you really internalize on till you've been there.
• 11:08
  SPEAKER_00: It's one of the things that's been a little bit striking about China to me, at least recently, in you know, pharma and healthcare but other areas, is that I think in Europe and the US with our kind of whatever we want to call that North Atlantic setric view.
• 11:22
  SPEAKER_00: I think China's been seen for a long time as a follower in technology in these areas.
• 11:26
  SPEAKER_00: But, you know, perhaps culturally we're having to adjust now to the fact that they're emerging as a leader, and actually a leader who are perhaps getting an advantage out of different ways of doing things that that, you know, works its way into its technology eventually and means that those technologies have their own advantages.
• 11:42
  SPEAKER_00: I'd heard in other areas about exactly what you said, China setting up essentially cities based in nearly entirely around one industry to take advantage of the holistic interaction you can get from that, from having all of these people in one place and this melting pot of what's going on.
• 11:58
  SPEAKER_00: And there probably are advantages of that that we want out of that process that different ways of doing things, way of doing things that we want even in Europe in our treatments.
• 12:07
  SPEAKER_02: I fully agree because it it's a purposeful development and using every technology available.
• 12:13
  SPEAKER_02: And even from the pharmaceutical perspective, we were used to manufacturing in China, to generics, to Me To's.
• 12:20
  SPEAKER_02: But like you say, the innovation, innovation is now coming out of China.
• 12:24
  SPEAKER_01: It is interesting, and also just the model that we are developing drugs in.
• 12:29
  SPEAKER_01: Like in the US, the model is very much VC backed.
• 12:33
  SPEAKER_01: Let's develop drugs based on competition in the market.
• 12:36
  SPEAKER_01: In Europe, it's more driven by laws and regulations, rules.
• 12:40
  SPEAKER_01: And then in China we have this uh intentionality from the state that drugs must be developed, and here is everything you need.
• 12:48
  SPEAKER_01: Like three very distinct settings in which drugs can now come to be, which is mind-boggling, really interesting.
• 12:54
  SPEAKER_01: I like that.
• 12:55
  SPEAKER_00: I mean, I also like that as well, because the other thing I wanted to talk about is about uh this entry in into different markets.
• 13:01
  SPEAKER_00: Because when you were talking about that earlier, Daphne, it reminded me also of my experience.
• 13:05
  SPEAKER_00: Listeners might be able to tell I'm not Danish, I'm actually from the UK.
• 13:09
  SPEAKER_00: And when moving to a new country, it's very easy to assume, well, you know, it's just living the same life, but you're just in a different location.
• 13:16
  SPEAKER_00: And actually, you very quickly find that it's not quite like that.
• 13:19
  SPEAKER_00: So, I mean, the example I quite like to use is in the UK, you know, if there's a red light on the street and there's no cars come in, you know, you take that responsibility into your own hands, then you will walk across.
• 13:30
  SPEAKER_00: And one of the surprising things in Denmark was no, you get to the red light, it can be an empty street for five minutes.
• 13:36
  SPEAKER_00: If that light is red, you're staying on that side of the street.
• 13:39
  SPEAKER_00: And it's probably the case, you know, in this healthcare environment as well, which is there's a way of doing things in China that isn't even talked about.
• 13:46
  SPEAKER_00: It's just a taken for granted.
• 13:48
  SPEAKER_00: But when you come to the EU context, then it can be a completely different ball game.
• 13:52
  SPEAKER_00: Is that the kind of thing that you're seeing as well?
• 13:54
  SPEAKER_02: It is, absolutely, absolutely.
• 13:55
  SPEAKER_02: And I fully agree with you.
• 13:56
  SPEAKER_02: I also moved from Ireland to Germany.
• 13:58
  SPEAKER_02: Exact same experience as well.
• 14:00
  SPEAKER_00: Like, yeah.
• 14:01
  SPEAKER_00: In Berlin at least, they have the very cool green man with the hat.
• 14:04
  SPEAKER_00: That's right.
• 14:05
  SPEAKER_02: Yeah, yeah, exactly.
• 14:06
  SPEAKER_02: I mean, I've traveled a lot.
• 14:07
  SPEAKER_02: It's obviously a different mindset.
• 14:08
  SPEAKER_02: Every country has a different mindset, but it's really, like you said, the holistic view and the technology, the focus on technology.
• 14:16
  SPEAKER_02: Everything we were we thought we were being very ad vi advanced, and we translated our business cards.
• 14:22
  SPEAKER_02: I normally don't carry business cards, but we translate our business cards into Mandarin into Chinese to bring them with us.
• 14:28
  SPEAKER_02: The reaction was A, well, they were delighted that we had taken gone to the effort of translating them into seeing that we don't speak the language.
• 14:35
  SPEAKER_02: But the second one was that's very quaint.
• 14:38
  SPEAKER_00: Yeah.
• 14:38
  SPEAKER_00: Can you do it the old-fashioned way?
• 14:40
  SPEAKER_00: Yeah, I think that's that's the extra direct mention to this as well, because we can go up the various levels in terms of a strategy here.
• 14:46
  SPEAKER_00: Because I think if we do take the case that China is very technologically driven first on these areas, and we think that's good, then we can ask ourselves of how does the European context look?
• 14:56
  SPEAKER_00: And my feeling there is maybe we're not as technologically first as maybe business first.
• 15:02
  SPEAKER_00: And you know, what puts in my head is I know a few years ago, without shaming any names in particular, there were European companies in Pharma doing huge share buybacks.
• 15:13
  SPEAKER_00: Which to me suggests maybe we've got more of a finance orientation, finance-led orientation perhaps, than a technology-led orientation.
• 15:21
  SPEAKER_00: And maybe there's even lessons for us there, depending on how we see the products that come into the market from China perform against what we're doing.
• 15:28
  SPEAKER_00: You know, maybe there's some wider cultural pieces we can take.
• 15:32
  SPEAKER_02: Yeah, that's interesting.
• 15:33
  SPEAKER_02: That's a very interesting perspective.
• 15:35
  SPEAKER_02: Like it.
• 15:36
  SPEAKER_02: Yeah.
• 15:36
  SPEAKER_01: I'm chewing that a little bit because of course pharmaceutical companies are ultimately a business, but they're also a public good because medicine is a public good, health is a public good, at least I would argue.
• 15:48
  SPEAKER_01: And here we are in a situation where we can bring about new drug innovation through different means.
• 15:54
  SPEAKER_01: It sounds like the Chinese development structure is focused on using as much technology as possible to produce the public good of, I assume, both health outcomes, but also the financial benefits of having a thriving biotech sector.
• 16:09
  SPEAKER_01: And in Europe, we take it a different approach.
• 16:12
  SPEAKER_01: We are more cautious about how to use technology.
• 16:14
  SPEAKER_01: We don't want to overuse technology, we don't want to overcomplicate things.
• 16:17
  SPEAKER_01: It will be interesting to see, like 10 years from now, where does this leave us?
• 16:22
  SPEAKER_01: And will the European Union, will we, the individual countries, have to adapt our ways of assessing drugs to accommodate a different model of drug development?
• 16:32
  SPEAKER_00: I think to bring it back to your experience a little bit as well, Daphne, which is that maybe what we're truly talking about here is where we put confidence in our development.
• 16:42
  SPEAKER_00: Is it about taking a technology first approach and delivering a good product and then believing that the financial side sort of sorts itself out from that?
• 16:50
  SPEAKER_00: Or do we go in in a fine with the finances first and and then believe that the technology sorts it out?
• 16:55
  SPEAKER_00: And it it just made me think of your experience, which is that do you, when entering a new market, put the commercial piece first or the regulatory piece first, right?
• 17:04
  SPEAKER_00: And getting the financial side sorted gives you an advantage or gets you a foothold, but maybe it's not the full picture that's needed.
• 17:10
  SPEAKER_02: It is, I agree, because you need both.
• 17:13
  SPEAKER_02: Obviously, you need both.
• 17:14
  SPEAKER_02: Because you see companies in exactly various situations.
• 17:18
  SPEAKER_02: One has fantastic potential for their treatment, maybe good technology but lacking funding.
• 17:25
  SPEAKER_02: And then another may have developed but has ignored or not considered some of the important regulatory factors to actually get the drug approved and the label approved that they need to commercialize.
• 17:38
  SPEAKER_02: So I think if there is, I mean, the the 101 of drug development is if we if we had that, we could we could all retire.
• 17:45
  SPEAKER_02: But it is, I think, and that's the balancing act.
• 17:48
  SPEAKER_02: Our industry is very much a balancing act.
• 17:50
  SPEAKER_02: We have to be adaptable, we have to be flexible.
• 17:53
  SPEAKER_02: We have to, because from a regulatory perspective, from a compliance and from a safety and from a reliability perspective, we always need to focus on the reproducibility of the product, the safety of the product, the in-depth trials and research that needs to be done and proven and validated before we can start treating patients.
• 18:17
  SPEAKER_02: So it's always a juggling act.
• 18:19
  SPEAKER_02: And if you've got a company like a traditional European company with a good solid product, they're just going to forge ahead, do all the studies they need to do, make sure everything is complete and bring a solid product to market.
• 18:31
  SPEAKER_02: But then you come to a smaller biotech that perhaps has something innovative, but are rushing to get the product, to get return on investment, either to sell their asset or to get it on the market.
• 18:45
  SPEAKER_02: So I suppose we need everything.
• 18:46
  SPEAKER_02: We need everything.
• 18:47
  SPEAKER_02: We need all the possibilities.
• 18:49
  SPEAKER_00: Everything, everywhere, all at once.
• 18:50
  SPEAKER_02: Yeah.
• 18:51
  SPEAKER_02: Yeah.
• 18:52
  SPEAKER_02: I think the Chinese element is just another element.
• 18:54
  SPEAKER_02: It's an interesting one, a fascinating one, and one that can bring new technologies, new treatments to our markets, along with what we have.
• 19:05
  SPEAKER_02: You know, the other thing we're seeing broadly in the industry, it's not just the Chinese companies developing their own assets.
• 19:13
  SPEAKER_02: Also quite a few big pharma have bought early stage Chinese assets and are developing themselves.
• 19:19
  SPEAKER_02: So that's another, they're, you know, getting in early and the Chinese companies are materializing their assets early so that and they sell to big pharma who then develop under their own name.
• 19:29
  SPEAKER_02: So that's something that's not terribly visible, but it's definitely also happening.
• 19:33
  SPEAKER_02: Or they are in agreements, you know, there are commercial agreements between some of the larger Chinese pharma companies and the larger ex-China multinational global companies.
• 19:43
  SPEAKER_01: That is interesting because for many years it's been the other way around.
• 19:47
  SPEAKER_01: That's from Europe we would or the US would be selling our assets to Chinese companies who would then take them to the market.
• 19:54
  SPEAKER_01: It's kind of like I'm experiencing joy by the fact that it also goes the other way around now.
• 19:59
  SPEAKER_01: It's super interesting, it really is.
• 20:00
  SPEAKER_01: Yeah.
• 20:01
  SPEAKER_01: I am curious.
• 20:02
  SPEAKER_01: So you have a front row seat to seeing some of the Chinese companies who wish to bring products to Europe, like some of the struggles that they're experiencing with different kinds of regulatory frameworks and expectations that they have from their native market.
• 20:17
  SPEAKER_01: What are some of the surprises that they have for requirements?
• 20:20
  SPEAKER_02: It's the complexity mainly of the EU structure that they have to have an entity set up, that they need to submit a marketing authorization, that in order to they have to have their manufacturing set up, they have to have an importer, they have to everything around, they need the structure in place, and then they need to meet all the requirements.
• 20:40
  SPEAKER_02: And the complexity of the European market, it really is a huge hurdle.
• 20:45
  SPEAKER_02: The US market is more understandable because the structure, the regulatory structure is similar with the IND system and the FDA direct interaction and the more instructive nature of the agency.
• 20:58
  SPEAKER_02: Dealing with the European committees, with the EMA, with all the procedures is huge complexity.
• 21:04
  SPEAKER_02: And it's something they can't have.
• 21:06
  SPEAKER_02: I mean, you can read all the guidelines.
• 21:08
  SPEAKER_02: Obviously, they have all the technology, they have access to all the information, all the guidelines, all the advice, but there's only so much you get from reading guidelines.
• 21:16
  SPEAKER_02: The actual practical navigation of the systems is a huge hurdle.
• 21:21
  SPEAKER_02: That's one.
• 21:22
  SPEAKER_02: And the other is the relevance of their development to the European market, to the European patients.
• 21:28
  SPEAKER_02: Obviously, the agencies are looking for the direct link to the patient population, to the standard of care, to the comparators.
• 21:35
  SPEAKER_02: Um, and that can be a surprise because obviously the drugs were developed in a completely different environment with a Chinese patient population.
• 21:42
  SPEAKER_02: Yeah.
• 21:42
  SPEAKER_00: Yeah.
• 21:43
  SPEAKER_00: I know that one of the contentious issues that can often come up in generating clinical evidence is where trials are performed and what that means in terms of, say, patient populations or the way in which the trial is conducted, is that also an issue here, which is there is good Chinese trial data, but it's not meeting the expected.
• 22:00
  SPEAKER_02: Exactly, exactly.
• 22:01
  SPEAKER_02: The ethnic difference or potential ethnic differences are a huge factor.
• 22:04
  SPEAKER_02: Huge factor.
• 22:05
  SPEAKER_02: We are seeing the Chinese media pharmaceutical industry, how would you call it, transfer of information is open.
• 22:12
  SPEAKER_02: So they're learning, obviously, from what they've seen.
• 22:15
  SPEAKER_02: And that we are seeing quite a few Chinese companies starting to do their phase one, for example, in Australia, or to do a parallel phase one in the US, in order to get that data, particularly in oncology, because they can do that in patients.
• 22:29
  SPEAKER_02: And that's the whole point is to get that data and to make the results relevant.
• 22:34
  SPEAKER_00: Another thing I'm curious about here as well, I mean, just your impression, how much of these moves into Europe are something that have been planned, say from the early stages of a drug versus being an afterthought?
• 22:47
  SPEAKER_00: Because obviously, again, the regulatory piece is always way easier and you get many fewer supplies the earlier that you plan it, because then when you're generating your clinical data, for instance, you can make sure or make the best attempt at generating one piece that is acceptable across regions and all this sort of stuff.
• 23:04
  SPEAKER_00: So is that something that's being done within these uh companies coming from China, or is that still something they yet to catch up with, this kind of earlier stage strategic?
• 23:14
  SPEAKER_02: It's both.
• 23:14
  SPEAKER_02: Like I said, we we've been presented by some companies with fully developed drugs, but other companies, especially some we visited while in China, are already starting, like I said, to do their starting to do their phase one in the US, to open a USI and to do either part or some of their studies in Australia, them being the easiest markets to access for a foreign company.
• 23:35
  SPEAKER_02: So yeah, there's definitely both.
• 23:36
  SPEAKER_02: And I suppose the larger companies are looking for a late return on investment.
• 23:42
  SPEAKER_02: The smaller companies tend to be trying the more broader development.
• 23:47
  SPEAKER_02: Which is interesting.
• 23:48
  SPEAKER_01: That also leads me to another question I have about well, another geography that is featuring in clinical conferences these days, and that is Australia.
• 23:57
  SPEAKER_01: Because all of a sudden everyone is running their trials in Australia.
• 24:00
  SPEAKER_01: So Daphne, would you know what has happened and why is Australia so popular all of a sudden?
• 24:05
  SPEAKER_01: I don't think it's new.
• 24:06
  SPEAKER_01: I think it's always been.
• 24:07
  SPEAKER_02: It's always been.
• 24:08
  SPEAKER_02: Initial CTA in Australia, CTN in Australia is a slower hurdle than if you go to Europe now, okay, we have one system with CTIS, but you're still looking at X number of countries that you need to supply documentation for and a fixed timeline, although that's also improving, but a fixed timeline for review.
• 24:26
  SPEAKER_02: Whereas the review process, the startup process in Australia is faster, always has been.
• 24:31
  SPEAKER_02: Yeah.
• 24:32
  SPEAKER_02: I don't know why it's coming in the news now, but again, maybe I've just seen this go around too many times.
• 24:37
  SPEAKER_00: But no, it's good.
• 24:38
  SPEAKER_00: What I like that we're getting at here is also the way in which understanding different geographic cultures and advantages can help optimize development, right?
• 24:50
  SPEAKER_00: So if if you're maybe doing something very integrated that has drug elements, has device elements, you know, needs a holistic approach, maybe China is the place to try and even develop that, if that infrastructure is there.
• 25:04
  SPEAKER_00: But if you want some fast clinical evidence, maybe going to Australia's good, or if you want a robust regulatory position, probably the EU or the US.
• 25:12
  SPEAKER_00: And so I like the idea, because we're used to thinking quite local, I think.
• 25:17
  SPEAKER_00: An organization is placed within an environment and there's maybe a cluster, there's a bit of one here across the water with Sweden, but that's it.
• 25:24
  SPEAKER_00: Most of the time, even your initial market tends to be, oh well, we'll try and launch first in Denmark because we're a Danish company.
• 25:30
  SPEAKER_00: But that ignores these huge advantages to thinking more globally in my development.
• 25:35
  SPEAKER_02: I fully agree.
• 25:36
  SPEAKER_02: It's definitely an advantage to start there and also to interact with the agencies.
• 25:40
  SPEAKER_02: A lot of companies are very nervous about interacting with agencies, but they're missing out on knowledge, on guidance if they don't do that.
• 25:48
  SPEAKER_00: Well, and they're also friendly, right?
• 25:50
  SPEAKER_00: I mean, I've never met a mean agency person, although maybe I've just been looking.
• 25:54
  SPEAKER_02: No, no, they're trying to help.
• 25:55
  SPEAKER_02: They're trying to help development.
• 25:56
  SPEAKER_02: They've they've no interest in a company developing a drug that isn't going to meet requirements.
• 26:01
  SPEAKER_02: That's that's no good for them.
• 26:02
  SPEAKER_02: So yeah.
• 26:03
  SPEAKER_01: So uh for me as as someone who has never interacted with a regulatory agency, I think the closest I've gotten is walking by the EMA building in Amsterdam.
• 26:12
  SPEAKER_01: Like, what is that like?
• 26:13
  SPEAKER_01: Can you just get a meeting with an agency or how does it work?
• 26:16
  SPEAKER_02: No, no, no, no.
• 26:16
  SPEAKER_02: Obviously, you have to you you do have to inquire, you do have to present questions that are relevant.
• 26:23
  SPEAKER_02: So they're a regulatory agency.
• 26:25
  SPEAKER_02: So if you're looking to do a clinical trial, it depends what advice you're looking for.
• 26:29
  SPEAKER_02: If you're looking to conduct a clinical trial, then you do need to contact the agency.
• 26:33
  SPEAKER_02: You need to present them with the questions that you have to be fair to them.
• 26:37
  SPEAKER_02: If it's something that can be found in a guideline, they will most likely direct you to that.
• 26:41
  SPEAKER_02: Please read the guidelines.
• 26:42
  SPEAKER_02: But if it's something that's worth discussing, you will get an audience.
• 26:46
  SPEAKER_02: It depends on the country, on the question, how long it takes.
• 26:49
  SPEAKER_02: But also nowadays, thanks to COVID, a lot of this can now be done virtually remotely by a telephone conference in writing.
• 26:57
  SPEAKER_02: There's no need to actually travel much anymore.
• 27:00
  SPEAKER_02: But uh generally they're very open.
• 27:01
  SPEAKER_02: And then again, obviously, if you're talking about a marketing authorization eventually, the advice is focused on what you need to do to get that marketing authorization.
• 27:11
  SPEAKER_02: So it's very distinct depending on the question you're asking.
• 27:14
  SPEAKER_02: What agency.
• 27:14
  SPEAKER_02: But in general, agencies are willing to talk as long as the questions are valid and founded.
• 27:19
  SPEAKER_02: You know, you obviously need to do your homework, you need to present the questions, you need to present the background of your question, provide them with documentation with something to read so that they have something to answer your questions based on.
• 27:30
  SPEAKER_00: But yeah, it's funny.
• 27:31
  SPEAKER_00: Actually, it's also another analogy and then I'll just point to the discussion we've been having, because I I think the health and authority and regulatory space is almost its own country, right?
• 27:42
  SPEAKER_00: With its own rules and expectations.
• 27:44
  SPEAKER_00: And one of the things that we always try and emphasize to companies is that uh the regulators, the regulators aren't consultants.
• 27:53
  SPEAKER_00: They can't give people free advice because it's a conflict of interest, well, they can't give people open advice because it's a conflict of interest if they're also assessing things.
• 28:00
  SPEAKER_00: So you need to have that in mind when you're interacting with them to seek information.
• 28:06
  SPEAKER_00: And that really leaves two options open to you.
• 28:08
  SPEAKER_00: One of them is to say, hey, how do you interpret rule XXY?
• 28:14
  SPEAKER_00: And if it's, as you say, a matter of pointing them to the regulation and them saying, we would say generically this means XYZ, then that's one you can do.
• 28:24
  SPEAKER_00: Otherwise, yeah, it's hey, you know, health authority, we think that we want to do this around this product.
• 28:30
  SPEAKER_00: You know, what's your reaction to that?
• 28:32
  SPEAKER_00: I think what one of the trap that people fall into is sort of saying, going to a regulatory agency and saying, hey, how do we do this?
• 28:38
  SPEAKER_00: Yeah.
• 28:39
  SPEAKER_00: And that's like a question that they just can't answer.
• 28:42
  SPEAKER_02: I'll simplify for labor agency will not do your drug development for you.
• 28:46
  SPEAKER_02: They will advise you on what you have to do, but they will not do it for you.
• 28:49
  SPEAKER_02: They can't.
• 28:49
  SPEAKER_02: Well, how could they?
• 28:50
  SPEAKER_02: Yeah.
• 28:52
  SPEAKER_01: So where in Europe is it the best place to build your regulatory department then?
• 28:56
  SPEAKER_01: If you are a global pharmaceutical company that is trying to get the best out of the technology in China, the commercial acumen in the US, and the regulatory expertise in Europe, where where do you go?
• 29:09
  SPEAKER_02: Doesn't really matter anymore.
• 29:10
  SPEAKER_02: If you if you if you want to submit as a pharmaceutical company, if you want to submit in Europe, you need to have a base or you need to work with a company like us who can provide you with a virtual base that you can submit your marketing authorization holders.
• 29:23
  SPEAKER_02: So either you have to decide on establishing.
• 29:26
  SPEAKER_02: But it really doesn't matter which country in Europe you're based out of.
• 29:29
  SPEAKER_00: I'm on my metaphor game again.
• 29:31
  SPEAKER_00: So it sounds like to me that it doesn't matter what country you go to, it matters the quality of your interpreter and your cultural envoy, right?
• 29:38
  SPEAKER_00: Correct.
• 29:39
  SPEAKER_00: In terms of translating between you and them.
• 29:41
  SPEAKER_00: Yeah.
• 29:41
  SPEAKER_01: And it also sounds like going back to the very early metaphor we had with the Alex sitting in Copenhagen and the Alex sitting in China, that that we need like a network of Alexis in all the locations that are communicating and sharing information.
• 29:56
  SPEAKER_02: That is absolutely key.
• 29:57
  SPEAKER_02: Absolutely key.
• 29:58
  SPEAKER_02: Because you can't, the same as I referenced, you can't just read a guideline.
• 30:02
  SPEAKER_02: You need to interpret, you need to know the culture of where you are, you need to know the context.
• 30:07
  SPEAKER_02: You can't just blindly go without having context, without knowing the culture, without knowing everything else that's related to it, that's linked to it.
• 30:15
  SPEAKER_00: Yeah, and that maybe loops back again to one of the first things we discussed.
• 30:18
  SPEAKER_00: Maybe this is why only having the commercial piece is less effective, because the commercial piece gives you access, it gives you maybe resource, but it doesn't give you the understanding of the specific geographic cultural pieces that you also need to be successful in the market.
• 30:35
  SPEAKER_01: Make sense?
• 30:36
  SPEAKER_01: Yeah.
• 30:36
  SPEAKER_01: Well, this is a perfect segue to the quiz part of this episode.
• 30:42
  SPEAKER_01: And now we have spent a bunch of time in China and we've spent time in Europe.
• 30:47
  SPEAKER_01: So now it's only fair we go to the US now.
• 30:51
  SPEAKER_01: Three Europeans going to the US, three Europeans going to the US.
• 30:57
  SPEAKER_01: Yeah, I never worked about that before.
• 30:59
  SPEAKER_01: Yeah.
• 31:01
  SPEAKER_01: So today's quiz is about drugs that the FDA has approved in Q2 2026.
• 31:09
  SPEAKER_01: And I have three questions for for the two of you.
• 31:13
  SPEAKER_01: And each question has three options.
• 31:15
  SPEAKER_01: And I'll give you one question at a time with its options and give you a chance to guess which one is the correct one.
• 31:23
  SPEAKER_01: And we'll see where this goes.
• 31:24
  SPEAKER_01: So, first question: which among these three approved drugs has the highest earning potential in 2032?
• 31:34
  SPEAKER_01: So the first one is developed by AstraZeneca, and so its commercial name is Baxofendi.
• 31:40
  SPEAKER_01: It's an uh autotesterone synthase uh inhibitor.
• 31:45
  SPEAKER_01: It's for hypertension.
• 31:46
  SPEAKER_01: That is option one.
• 31:48
  SPEAKER_01: Then option two is a drug developed by B1 Medicines.
• 31:52
  SPEAKER_01: And its commercial name is B.
• 31:54
  SPEAKER_01: Calzi.
• 31:55
  SPEAKER_01: It's a BCL2 inhibitor for a mantle cell lymphoma.
• 32:00
  SPEAKER_01: And the third option is by Eli Lilly.
• 32:04
  SPEAKER_01: The drug is called Foundale, and it's a GLP1 receptor agonist for obesity or overweight with weight-related comorbidity.
• 32:13
  SPEAKER_01: So, which of these three has the highest earning potential in 2032?
• 32:18
  SPEAKER_01: Shall I give my announcement?
• 32:20
  SPEAKER_01: Yeah.
• 32:21
  SPEAKER_00: Interesting, right?
• 32:22
  SPEAKER_00: I mean, the question here on my mind immediately is size of market versus reimbursement, right?
• 32:28
  SPEAKER_00: The lymphoma example, uh, sort of set alarm bells ringing because cool, you know, oncology, always a high reimbursement, always a great potential to earn.
• 32:36
  SPEAKER_00: Hypertension, huge market.
• 32:38
  SPEAKER_00: I think I will have to go for obesity, just to, hey, it's the trend right now, it's in.
• 32:43
  SPEAKER_00: A lot of people are making a lot of money off it.
• 32:44
  SPEAKER_00: Let that train continue.
• 32:45
  SPEAKER_00: I think it's the obesity one.
• 32:47
  SPEAKER_02: Good.
• 32:47
  SPEAKER_02: Okay.
• 32:48
  SPEAKER_02: I had a choice, a bit like yourself, choice between hypertension and obesity.
• 32:51
  SPEAKER_02: So because you've chosen obesity, I'll go for hypertension.
• 32:53
  SPEAKER_01: Well, thank you both for your choices.
• 32:55
  SPEAKER_01: And the answer is indeed obesity.
• 32:59
  SPEAKER_01: The fascinating thing for me here is that it is the earning potential of the obesity drug is more than 100 times greater than the hypercontrolling.
• 33:09
  SPEAKER_02: Because it's not just obesity.
• 33:10
  SPEAKER_02: Obviously, GLP ones have so many potential applications, yeah.
• 33:14
  SPEAKER_01: When I read this, I was like, whoa, this is what category?
• 33:18
  SPEAKER_00: Such a huge market, as you said.
• 33:19
  SPEAKER_00: It's prevention or the prevention of obesity has so many downstream effects, and then people also want it just personally, right?
• 33:25
  SPEAKER_00: So it's it's just such a big market.
• 33:27
  SPEAKER_01: Very good.
• 33:28
  SPEAKER_01: Let's go to question number two.
• 33:30
  SPEAKER_01: So out of the approved drugs, which percentage would you guess are cancer drugs?
• 33:35
  SPEAKER_01: And I'll give you three options 50%, 13%, or 25%.
• 33:40
  SPEAKER_01: I'll go with 50%.
• 33:42
  SPEAKER_00: Yeah, okay.
• 33:42
  SPEAKER_00: I will I think I'll go for 25 then.
• 33:45
  SPEAKER_00: We can we can keep splitting our answers.
• 33:47
  SPEAKER_00: I've had in my head, I had in my head a third, so I could go either way.
• 33:52
  SPEAKER_00: But uh but uh maybe I'm out of date on oncology, to be fair.
• 33:56
  SPEAKER_00: So uh happy to be proven wrong.
• 33:58
  SPEAKER_01: Well, the right answer is 13%.
• 34:02
  SPEAKER_01: Okay, that's both wrong.
• 34:03
  SPEAKER_01: Yeah.
• 34:05
  SPEAKER_01: Interesting part about this cohort was uh apparently that there was a wide variety of indications that the drugs were being developed for.
• 34:13
  SPEAKER_01: So in Q2, apparently it's been like a mixed bag of diseases.
• 34:17
  SPEAKER_00: I mean, maybe oncology is just getting too crowded nowadays.
• 34:19
  SPEAKER_00: I mean, there's been a lot of companies developing this space for a long time.
• 34:22
  SPEAKER_00: Yeah, maybe it's just people on opportunity.
• 34:25
  SPEAKER_02: There's huge potential.
• 34:26
  SPEAKER_02: I think it's just the narrow market on the quarter, I think.
• 34:29
  SPEAKER_02: But still interesting.
• 34:31
  SPEAKER_00: Very interesting.
• 34:31
  SPEAKER_00: Yeah.
• 34:32
  SPEAKER_00: Which is the same, because as far as I'm aware, there's still a lot of work to do there.
• 34:35
  SPEAKER_00: Yeah, exactly.
• 34:36
  SPEAKER_00: Absolutely.
• 34:36
  SPEAKER_01: And it would be interesting, maybe a Q3 will be like 90% cancer.
• 34:41
  SPEAKER_00: Yeah, yeah, exactly.
• 34:43
  SPEAKER_01: Okay.
• 34:43
  SPEAKER_01: Third question.
• 34:44
  SPEAKER_01: Which disease has received a drug approval every year on average since 1987?
• 34:51
  SPEAKER_00: Again, I have to stop trying to think about what I was actually doing in 1987.
• 34:56
  SPEAKER_01: You keep coming back to it.
• 34:57
  SPEAKER_01: It was a good time.
• 34:58
  SPEAKER_01: No, at some point we'll have to do like Alex confessions from from the same day.
• 35:06
  SPEAKER_01: Okay, so the three options are well SARS-CoV-HIV or hepatitis.
• 35:11
  SPEAKER_01: I think I will have to say HIV because that is when some of the first HIV drugs were approved.
• 35:17
  SPEAKER_00: The timing certainly wants me to say HIV.
• 35:21
  SPEAKER_00: I'm gonna say hepatitis though.
• 35:36
  SPEAKER_00: But that's just my analysis.
• 35:38
  SPEAKER_00: Happy also to be wrong.
• 35:40
  SPEAKER_01: Well, Daphne, you've got this one in the back.
• 35:42
  SPEAKER_01: It is HIV.
• 35:44
  SPEAKER_02: My regulatory myself was about to be damaged there, but we're okay.
• 35:48
  SPEAKER_02: Saved.
• 35:49
  SPEAKER_01: No, it was interesting to do the research for this case and seeing that even though like HIV has been such a big problem.
• 35:56
  SPEAKER_01: Like there have actually been new and new drugs developed for it for a long time.
• 36:01
  SPEAKER_00: Well, I mean the difference in outcomes nowadays is just huge.
• 36:04
  SPEAKER_00: I mean, from literal death sentence to people living long lives, yeah, it's amazing.
• 36:09
  SPEAKER_01: Hepatitis has definitely been like one of those drugs where we have also been developing treatments for forever.
• 36:16
  SPEAKER_01: That's why I put that one in there.
• 36:18
  SPEAKER_01: Yeah.
• 36:18
  SPEAKER_01: I was caught me.
• 36:20
  SPEAKER_00: I fell into your trap.
• 36:22
  SPEAKER_01: All right.
• 36:22
  SPEAKER_01: Well, thank you.
• 36:24
  SPEAKER_01: This was fun, at least for me.
• 36:25
  SPEAKER_01: Watching them struggle like this now.
• 36:27
  SPEAKER_01: All right.
• 36:27
  SPEAKER_01: As we start rounding this episode off, I would be curious to hear from both of you what was one of the parts of the conversation we've had that's uh you're gonna take away from today?
• 36:38
  SPEAKER_01: Something that maybe sparked a new idea or something that you think you'll remember tomorrow morning?
• 36:44
  SPEAKER_00: I actually have two.
• 36:45
  SPEAKER_00: I'm allowed to.
• 36:46
  SPEAKER_00: You're allowed to, yes.
• 36:48
  SPEAKER_00: Okay.
• 36:48
  SPEAKER_00: So the first one is this idea of the strength in in sort of understanding and understanding enough the sort of cultural differences.
• 36:56
  SPEAKER_00: And I mean cultural both in terms of literal cultures across different worlds and how you can have an advantage by understanding you can be faster in Australia or have more integrated development in China or this kind of thing.
• 37:08
  SPEAKER_00: But also in different areas, you know, understanding the mindset of the regulator and how you can better interact with them to sort of get what you need.
• 37:15
  SPEAKER_00: So this understanding of different cultures is my first one.
• 37:18
  SPEAKER_00: The second one is I'm genuinely looking forward to the rise of the network of Alexes.
• 37:23
  SPEAKER_00: I think we'll be benevolent leaders once we have enough of us across all these countries.
• 37:28
  SPEAKER_00: So yeah, really, really stoked for that one as well.
• 37:31
  SPEAKER_02: I love it.
• 37:32
  SPEAKER_02: I second that.
• 37:32
  SPEAKER_02: Oh support the network of Alexis.
• 37:34
  SPEAKER_02: One more Alex! One more Alex.
• 37:37
  SPEAKER_02: Where else can we put them?
• 37:38
  SPEAKER_02: Yeah, I love that.
• 37:39
  SPEAKER_02: And for me, I think it's I really enjoy talking to you to get your different perspective.
• 37:44
  SPEAKER_02: We all get very embedded in our day-to-day lives on our part of the industry.
• 37:50
  SPEAKER_02: I like your top-level overview of how the industry develops and the different possibilities, the different focus, the different influences as to what leads our industry.
• 38:00
  SPEAKER_02: I like that, you know, whether it's the commercial versus regulatory versus location versus the driving forces, I suppose.
• 38:07
  SPEAKER_02: I thoroughly enjoyed that.
• 38:09
  SPEAKER_02: So thank you.
• 38:10
  SPEAKER_01: Thank you so much, Stephanie.
• 38:11
  SPEAKER_01: My my major takeaway has been like our conversation about China, but also we are a global industry.
• 38:19
  SPEAKER_01: And for every single biotech company has to also be global in one way or another, whether it's through finding partners or by being present in multiple locations or tapping into the network of addicts.
• 38:31
  SPEAKER_01: Like every company has to be present and understand what is happening globally.
• 38:36
  SPEAKER_01: And that's for me, that's a great, great thing as an internationalist by heart.
• 38:41
  SPEAKER_01: Here is an area where we actually structurally all need each other to make great medicine for humanity.
• 38:48
  SPEAKER_01: That's a positive note that'll make me wake up happy tomorrow.
• 38:52
  SPEAKER_01: But otherwise, Daphne, if our listeners would like to learn more about you or ask you follow-up questions, where can they find you?
• 39:00
  SPEAKER_01: Sure.
• 39:00
  SPEAKER_02: Work at Verestot, Daphne.smith at Verestart.com, please feel free to email me or contact me.
• 39:06
  SPEAKER_02: Thank you.
• 39:06
  SPEAKER_02: Awesome.
• 39:07
  SPEAKER_02: Thank you so much.
• 39:08
  SPEAKER_02: I'm also on LinkedIn.
• 39:09
  SPEAKER_02: Yes.
• 39:10
  SPEAKER_02: Sorry, that was unspected question.
• 39:12
  SPEAKER_02: The new business chart, LinkedIn.
• 39:13
  SPEAKER_02: I'm not very good at this.
• 39:14
  SPEAKER_02: I'm very old.
• 39:16
  SPEAKER_01: Maybe next time it will include a WeChat link.
• 39:19
  SPEAKER_02: That's right.
• 39:20
  SPEAKER_02: You see, I've stopped my game.
• 39:21
  SPEAKER_02: You're right.
• 39:22
  SPEAKER_02: You're right.
• 39:22
  SPEAKER_02: Okay, wonderful.
• 39:23
  SPEAKER_02: It was lovely to talk to you.
• 39:24
  SPEAKER_02: Thank you so much.
• 39:31
  SPEAKER_01: This was Lab2 Lives.
• 39:34
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• 39:41
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