Product Launch Excellence in Life Sciences

AVT lecturer and IQVIA Thought Leader Sarah Rickwood explores pharmaceutical launch dynamics post-pandemic, stressing regional variations and local health-system understanding. She introduces the Three Pillars of Post-Pandemic Launch Excellence.

Sarah Rickwood (IQVIA)

Get inspired at AVT Business School: https://www.avt.dk/

Transcript

SPEAKER_00 0:02

We're very much welcome uh to this podcast from ABT Business School, uh Voices uh of a business school, as we call these, and this special edition. We have a few of them uh in connection with the launch of our executive life science diploma program here in the fall of 2024, and we're interviewing faculty members and lecturers on the program. And today we have another distinguished uh lecturer uh both on the program and also lecturing a little bit maybe on this podcast, which is uh Sarah Rigbutt, which is uh uh thought leader or the salt leader for the EMIA region at IQVA. And I know Sarah is gonna feel a little bit about her background, she's much better than I am doing that. But she had a very distinguished career in in the industry uh and uh has a background educated uh uh at Oxford, but I've had the pleasure of meeting always often as a keynote as Sarah at various conferences around Europe. But maybe you would fill in a little bit about your background and experience for for the audience, and then we can get on with a little bit on the content.

SPEAKER_01 1:06

Thank you, Caspar, and thank you for inviting me um to talk on this podcast. So, in terms of background, um I've always worked um in the life sciences and healthcare industries, and for much of my career I've worked in ICUVIA or its precursor companies. Now, ICUVIA is quite unique in the sense that um it is the company which has the uh most data on the trends um in the commercial um prescription medicines market, and um at um a point in my career that really intrigued me to understand how um new active substances, innovative prescription medicines um launch and how they do um in terms of um commercial return across countries, what affects that, what drives um the launch environment? So I started writing about launch excellence in 2007, um, a very different prescription medicine market to the market we have now. We were looking at launches from the late 1990s through to the early 2000s at that point. And um it hit a nerve, I think, um, with um pharmaceutical companies because they do want to ensure that the investment that they've made um in bringing a prescription medicine market um to um approval um and um use um is one that um they get the best possible return on, not just for themselves in order to be able to invest further in research and development, um, but also for the patients um who are seeking new treatments. So we've been publishing on the question of launch excellence um once every couple of years, ever since then, um, and we've seen considerable change in the launch environment, particularly, of course, post-COVID, um, because of that.

SPEAKER_00 3:00

Very good. Thank you very much for teeing up uh the theme of of today and and on the program, these things that can create value for all the stakeholders in in the healthcare industry. And and as you nicely framed it, today we're going to talk about launch and launch excellence, and it really fits into what we do on the program in terms of of going to market strategy. So, how do you create most value uh for for the stakeholders? Also, maybe after you through some of the innovation process and so on, some of the other themes on the program. So, so in reading the latest version, and once again, impressive to see how you followed this theme with you and IQV uh uh over the year, maybe just Dana, what what are what are some of the highlights here of the latest kind of overview of launch excellence that that you have published in in the white paper?

SPEAKER_01 3:53

Sure. So the paper we're talking about um is Launch Excellence 8, and that was published in the middle of 2023. And we're looking at um eight major markets. It's the US top five European countries and Japan, um, because those are um typically um 90% of the first five-year cumulative sales of a new active substance. Sorry, I should have added that um China um has also joined um those core markets that we um look at. It's the only um new country um to enter um the core launch markets in the last um decade and a half. The environment that we have now, and this is one of the um key discussion points um within um the paper, is a really, really challenging environment for new active substance launch, except of course for the COVID vaccines and treatments, which up to um the last year or so anyway, um were unsurprisingly extremely strong. And the reason why the post-pandemic environment is particularly challenging, there's definitely been a trend break, is because of the ways the pandemic impacted on the healthcare system that had differentially challenging consequences when you are introducing a new medicine into that system. What I mean by this is really sort of threefold. So, firstly, we know that healthcare systems were hugely challenged and made fragile by the pandemic, and that's not history. It's still the case now. We are still seeing healthcare professional burnout and resignation and stretched resources, we are still seeing suboptimal treatment of patients and working through backlogs, we are still seeing budgetary challenges. That's not a good environment to successfully introduce your new innovation. Any company launching a new product has to think of how they are going to address an environment that is less than optimal for introducing new innovation. Point number one. Secondly, before launching your product as a pharmaceutical company, it's really important to be able to engage with healthcare professionals interactively to answer their questions, to respond to their perspectives about new products, um, to be able to introduce that launch product. Unsurprisingly, in 2020, we saw a huge trend break in the ability of pharma to engage with healthcare professionals. Everything went virtual. And since then, we've been slowly moving back to a situation where doctors are talking to uh pharmaceutical companies representatives again in the real world. But the fact of the matter is, if you look at the ICUVIA data, the volume of interactive engagement, whether that interactive engagement is real world or it's virtual, a call or a Teams meeting or whatever, has not come back to the levels of volume that you saw prior to the pandemic in Europe or Japan or China. Now it has in the US, and that makes a split between the US and the other markets that really, really matter for your launch products. But if you're a pharmaceutical company and you're launching a product, you've got to live with the reality that you may have fewer opportunities to engage with the doctors that matter about your launch product at the moment. Each one matters more. And the last point is a point that isn't just triggered by the pandemic, but the pandemic certainly did not make it um any better, which is we live in times of budgetary constraint for healthcare systems and therefore for prescription medicine um products. And if we think about what's going to happen going forward, where we will have continued demands on healthcare budget from great new innovation in specialty areas like oncology, but we're going to be facing new demands in areas like obesity. That's not going to change anytime soon. So you have healthcare system capacity gaps, you have challenges in interacting and engaging doctors, and you have budgetary challenges, and the triple combination means that launches, on average, there are exceptions, just are doing less well in terms of sales uptake than pre-pandemic appears.

SPEAKER_00 9:01

Great. Thank you, Sarah, for a very elaborate and and um I was only intrigued by take taking note, even though I prepared for this broadcast already, and being a learning person here. Um if I may, so maybe maybe jump down into one and then uh to start out uh around uh engagement. And I I noted that there's there's maybe two aspects to it. One is there's a difference between the US and some of the other uh countries here that we're looking looking into. So the first question uh uh and a later one later on, uh um, do you need kind of a dual dual launch strategy to to do that? Maybe have have a different kind of channel mix? And especially outside the US, how do you mitigate that that lower level of engagement that that's uh possible? Or are there any success stories of how to come around it?

SPEAKER_01 9:54

Okay. Well, what we found in the um launch excellence eight was in this general environment of um lower volumes of interactive engagement, the really commercially successful launches, the launches that outperformed in terms of um sales uptake, were getting higher than average levels of um engagement volume. Um so they're swimming against the tide. Now, they may be doing that for a number of reasons. One of them may be that um in many, possibly not all cases though, um, these are products that are inherently interesting for doctors to engage on because um they are important um step changes in treatment for a given therapy area. We did find, for example, that orphan medicines tended to be resilient in the post-pandemic environment. And one of the learnings from that, um, because of course not every launch is going to be a first-in-class product in an area of um incredibly higher met needs. Some are important steps forward, but they're incremental steps forward, is how can you um create relevant new research um for your product? For example, real-world studies that doctors actually find useful um and want to understand about because um they provide useful insight um for the treatment of patients. So that's something that companies need to think about. How do we create relevant, useful research content? The second thing we noticed about the launchers that um did well was they had a higher proportion, often, of interactive engagement that was virtual. Even though face-to-face engagement with doctors has returned to a greater or lesser extent across countries, even though if you poll doctors, they emphasize the importance of that face-to-face engagement and relationship. The fact of the matter is when you're launching a product, there will be some doctors that you cannot reach in the real world that are still important for your launch. You need to be able to reach them. And I think what the companies that were behind the really excellent launches did was they made the fullest use of the channels that they had available to them to engage all the doctors that were important and relevant um to um the uptake of their launch product. Um and if that had to be virtual, then it was virtual.

SPEAKER_00 12:51

Great, great thanks for a very precise answer and also how you can use different different challenges about what the success stories uh tell us. I'm very curious about the the use you said of also use of evidence or the evidence thresholds as you also describe it in the in the report to elaborate a little bit on that. So aggregating, as you just mentioned, uh more real-world evidence, uh also to show the the cost-benefit, likely. Um, but but also maybe uh you you you you look at the trend of maybe looking at patient outcomes, you know, what kind of other things, once again, when you have limited budgets and so on. Is is that that uh how do you work in that space to maybe demonstrate the value of of your your product towards uh towards payers and so on, both in terms of real-world evidence, but maybe also in in outcome, in examples of that? Okay.

SPEAKER_01 13:48

Well, I think that I'm gonna start with a general trend, um, and then I am going to emphasize that um you really have to do think about the specifics and the detail um for individual um products. General trend first. As we look over the time that I've um done um papers on launch excellence, we've seen an evolution from a situation in the late 1990s, early 2000s when essentially the evidence package was um clinical trial-led. Um, it was about getting um approval um and secondarily about getting um access to budgets. Um and real world was there absolutely, uh, but it was not considered um an equal partner um to the RCT. Now, of course, we have a very different situation where real world data is seen as extremely important, not just because of um HEOR um studies, but for a very wide range of uses, maybe even included in submissions, um, for example, particularly for rare disease um products, um, and is growing um in its utility and also the types of real-world data that can be generated, particularly as we see um, for example, wearable devices and um patient-generated data come into play as well. So that's the milieu that we're in. Of course, within that, if we look at specific products, there's gonna be quite a variation dependent on the area that you're in. If you're in the orphan medicine area, it may well be that real-world data needs to be part of your submissions package because we're talking um about really challenging trials to undertake um with very small number of um patients. On the other end of the scale, um, if we look at the new obesity agents that come in, they have run, um, in the case of Novanordisk for um Wagovi with SELECT huge um CV outcomes trials to um conclusively demonstrate the cardiovascular benefit of um treating the obesity. Um, and we will see um further CV outcomes trials um in the obesity space um going forward. Um, so the first thing to really understand is that um real-world data um and um its combination with clinical data into a fully integrated evidence package is a pretty diverse um thing that um you know you need to think carefully about the needs of um of your product and the disease area that it's in um to really work out the um detail of. But I think that um the the underpinning point um that comes through in all cases um is that um it is um more diverse than it was before, and there is a demand for more evidence than there was um previously. And I think the pandemic has accelerated that because the pandemic changed treatment patterns. It meant that doctors might be treating their patients more remotely than they would have previously. Certainly seen that in the UK, where a lot of GP consultations are remote now. Um, but even in areas like cancer, uh, where of course oncologists practically never saw their patients remotely prior to the pandemic. Now, for, for example, checkups and routine appointments, um, um there's a greater element of remote um um treatment. We see, of course, patients who may be presenting with a particular condition, but they may also have long COVID or other um long-term sequelae um from the pandemic. That all changes treatment practices. Doctors are aware of that. They're saying, well, where's the evidence that says what is the best way for me to treat my patients in this environment? And if you're bringing in a new product, um, I think you've got to have evidence that um answers that question that says how um your product, your new launch, um is going to benefit patients um in today's treatment environment. And that's largely going to be about real-world data, I think.

SPEAKER_00 18:20

Great. Thanks a lot for a very elaborate and and precise answer as well. If I move to the US, and you already told us a little bit of difference in engagement there, uh, but also I think it may be read that in the report, but just US often take up uh a lot of uh it's an important country for launch, you know, take up quite quite a big portion of market. You mentioned some of some of the drugs also being in being here in Copenhagen. Of course, we pay a little bit of attention to to noise, new obesity drug, and then the US is a really important market, for instance. So my question, I don't know if they have data on that, but uh I've also been in uh in in the pharmaceutical company myself, and and there was the question of sequencing. There's something about, you know, how do you do that sequencing? Maybe have the US been such an important market. Uh so sometimes there was an argument to go very fast into the US, you know, given the number of years we have exclusivity. On the other hand, there was this argument on something to discuss whether to have some experience, you know, in some in some of these important markets, if I may say so, in terms of revenue. Do you have any uh any reflections on that or any insight into that trade-off?

SPEAKER_01 19:32

It's a good question. I I have to say that over the time that I've looked at launch, the um sequence of um of launch markets hasn't changed a great deal. Okay. Um it's um been pretty well established. You know, the vast majority of um new global products will launch in the US first, um, then they will come into Europe. And in Europe, um, Germany and the UK have typically been um early launch markets, um, France, Italy, Spain um a little later, a lot of the other European countries um a lot later, um, then Japan and um, you know, historically China was way down um the ranking. The the sort of changes that have happened really um um have been um China moving very rapidly at the um rankings as um its um regulatory reforms and the focus on innovation um really um accelerated the interest for um that market for um innovation, because of course it became the world's second largest pharmaceutical market by value a lot earlier than it became interesting, uh really interesting for innovative prescription medicine launch. Um, and also Japan, which had historically been a um a slow country for the uptake of innovation, becoming a faster one and moving up the sequence as well. The European countries and the um paramount position of the US um didn't so much change. Now we can look for the remainder of the 2020s um and ask will that um continue to um be the case? Because we have got um maybe some um big macro pieces of legislation that um conceivably um could um have an impact. We've got the Inflation Reduction Act in the US, we've got um the European um pharma package of um of legislation. Um they're different in what they're seeking to um achieve. Um they don't necessarily have launch products um um, you know, as directly in their site, in the case of the US, um, anyway. Um and um I don't think it is clear um the way that it could change um sequencing of um of global rollout out of um of launch, um, given that um the US is such a huge contributor um to the um first five years cumulative revenue for the tip. New active substance. It's difficult to conceive that its first launch position is going to change for the vast majority of products. And whilst China has become more important, it's nowhere near threatening the US in terms of its number one position right now.

SPEAKER_00 22:23

Great. Thanks for all the insight and the historical evidence there on that question as well. Maybe just in closing, uh here, as we're burning, burning daylight a little bit, the few hours we have here in December up north here in Cope Megan. Are you curious still on the six-month rule in the report? You know, that this the the as I read it, uh as you're inside this, that the six first six months of a launch is is is very significant for the trajectory of their of the success of a drug. So are there any um insights around that or is um around that six-month rule? Does it vary a little bit from from the um different type of of drugs or therapeutic errorism?

SPEAKER_01 23:08

Okay, well, it's been one of the perennial insights from all of the studies that I've done since 2007, and probably also the one that um I've been um challenged on most um in that time, too, and also agreed with most. So um it's definitely a talking point. Just um for those who don't know uh what the six-month window is, it's it's this um it's the observation from the data that across countries and over time, 80% of launches tend to continue on the trajectory that they've established in their first six months, whether that is a really good trajectory or a poor trajectory, and only 20% of or fewer of launches start on a relatively poor trajectory and then manage to make a significant improvement post six months. So important to establish that because sometimes people say, oh, the six-month window says that if you don't succeed in your first six months, you're never gonna succeed. It doesn't say that. It just says that that first six months is really important. Um and um going from a position where you have um a lower trajectory in that first six months to a really strong trajectory is is really tough. But companies do it, products do do that um on occasion. Far better, however, to plan to be in the group of launches that start well and continue well. And this is where we get to why some companies really welcome this, because it's a call to action about better launch preparation pre-approval. You have to start on the right um foot with your launch, and that means starting your launch preparation early and investing properly. And of course, while it might sound obvious that that is the thing you would do in a big complicated pharmaceutical company where you've got competing priorities, you're trying to make your quarters with your existing portfolio and things, it's actually pretty easy to de-prioritize launch preparation and um say, well, you know, we we can't start this quarter because we've got all these other things, um, and we can't spend this amount, or we can't have um um our medical affairs team uh, you know, start to think about this um this launch in in development at this point. Um and actually um that may well be a false economy for the future of um your new launches and the future of um your company. Of course, it's a challenging message if your product happens to be in the market and happens to be doing less well than you expected in the first six months. So that's why perhaps it's controversial. Now, I think that's the other thing about the six-month window is um, you know, we've seen it consistently over time. We even see it in Launch Excellence um eight. Even with all the big changes that we've seen across the launch environment, um, it's still the case that the vast majority of launches start on the trajectory that they continue. There's been a little bit of loosening up, perhaps because of the pandemic, um, but not enough to break the 8020 um rule. What do I take out of that? You've got to still prepare. There's no substitute for excellent preparation. When we think about multi-channel launches, um, which of course, not multi-channel, multi-indicational launches, which of course many launches um are, you should have considered that with each new indications launch, you've got a new six-month window. So it's not the case that the first um product indication you come in for um is the one that determines the trajectory for all other indications. And of course, many products are multi-um indicational now. Um, so that's something to reflect on too. But it still holds. I'll look at it again in Launch Excellence 9 and see if it continues to hold.

SPEAKER_00 27:25

Great there. Thank you so much. I'm gonna close uh in in in in just just a minute. Any uh final piece uh you want to highlight or that we should that I didn't ask for any in uh considering uh launches um or of something that's especially important of the things you've already mentioned that that we should uh take with us, some of us, or those of you those of you who are our mareteers are bringing uh bringing uh bringing products to market here as the final thought.

SPEAKER_01 27:58

Okay, well, I think we have to look forward because launch is always about understanding the environment that you will go into, not trying to replicate um the environment of the last successful launch. And um, we are going into a tremendously exciting um era um as far as launches are concerned, because the last decade and a bit has been about an increasing focus on specialty products, oncology products, often ultra-specialized um products, and those will continue to be important launches. But now we have new innovation in mass chronic diseases of aging, whether that is obesity, cardiovascular, um, CNS, or elsewhere, pain, arthritis, and so forth. These are areas that when I wrote the first launch excellences were um the leading blockbuster areas. It was primary care environment, and um that went into abeyance, of course. Now we're seeing a new type of mass chronic high prevalence, primary care-led um innovation, and how those products um will be introduced, given all of the um challenges that I've talked about, um, is going to be um enormously interesting. I almost feel like we're starting to come full circle um here. Um, and we've got to ask questions about what learnings do we take from the recent specialty launch era, but also can we reach back in time um to understand some of the primary care rules which may need to be remade um for this new um primary launch era.

SPEAKER_00 29:40

Sarah, thank you so much. Thanks, thanks for your your time, your your your morning, and uh to all our listeners, thanks for for listening in. Uh I just want to say that we're gonna, this is just a small highlight, some small snippets of some of the trends that that Sarah follows in the life science uh markets. Those who are uh more interested and have a further interest in that, you're naturally very welcome to uh to join our program in in a year's time. Sarah's gonna be here around in a year's time visiting uh Copenhagen here, uh face-to-face, where we're gonna discuss some of your real life cases where some of the trends and insights and conditions and best practice that you can apply to your to your projects on the program. So thanks again to Sarah and to everybody listening in and a Merry Christmas here from December 23 from Copenhagen.