Biogen Inc. (BIIB) Management presents at Decentralized Clinical Trials in Focus Conference (Transcript)

Biogen Inc. (NASDAQ:BIIB) Decentralized Clinical Trials in Focus Conference September 26, 2023 10:00 AM ET

Company Participants

Stephanie Manson Brown - Head of Clinical Development and Scientific Innovation & VP at R&D Allergan Aesthetics, AbbVie

Angela May - Head, DCT Strategy & Implementation, Clinical Operations, Bayer

Jane Twitchen - Executive Director, Head, Clinical Trial Accelerator Unit, Biogen

Harpreet Gill - Head of Decentralized Clinical Trial Solutions, ICON plc

Conference Call Participants

Donato Paolo Mancini - Pharmaceuticals Correspondent, Financial Times

Donato Paolo Mancini

[Abrupt Start] and then we'll get started with the conversation.

Stephanie Manson Brown

Hi, everyone. We've had some last-minute technical challenges. So we're talking about decentralized clinical trials and technology. So very topical issues that I've been experiencing. So I'm Stephanie Manson Brown. I'm Head of Clinical Development and Scientific Innovation and Vice President at R&D for Allergan Aesthetics at AbbVie, and I'm be delighted to be part of the discussion today.

Question-and-Answer Session

Q - Donato Paolo Mancini

We are so happy you could join us. There was a risk, we thought for a second that you might not be able to, but we're very happy you're here. Let’s -- I want to remind our audience that we love your questions. There should be a space on the right-hand side of your screen to submit these questions, which will then make it to me and I'll be sure to put them to our panelists. So please, please, please ask away.

So let's start the conversation with, obviously, decentralized clinical trials are incredibly important, hugely valuable for certain parts of the industry, also for patients. They made a huge kind of exploit during the pandemic for obvious reasons. But I would like to ask my panelists, what have your experiences of clinical -- of DCTs been like in the past year and in the past few years and where have you seen the kind of the pros of DCTs emerging and how are you holding these in mind when you make decisions in the clinical space or the regulatory space or whatever space. Why don't we start with Angela and then we'll move on?

Angela May

It's funny actually, Donato, that you mentioned the pandemic because I think there's really two camps there. I think some people really think that it held us back as opposed to pushing us forward. And I think, myself, I think it was a double-edged sword. But what we've really seen now is rather than the whole help, we need business continuity in crazy times to actually, we've seen that life can be more flexible. So why not clinical trials as well? So, with the teams that we're working with, we've seen a lot of really good engagement, people really wanting to change things, to modernize things, because recognizing that we can't stand still with our conduct and that it really needs to get a bit better. So we've seen a lot of engagement from our teams, which is what we've really needed to explore approaches in studies. And yeah, we've had some quite -- well, we're still on the journey, but we've had some interesting findings so far.

Donato Paolo Mancini

Well, could you give us an example?

Angela May

Yeah, I mean, we're -- so two of our -- actually, all of our studies are Phase 3. So it's a bit of a slow burn. But we've two of our studies, we've really managed to pull out some metrics, which, anyone in the space will know that we're obsessed with metrics in clinical trials, but pulling them out for DCT was a bit easier said than done. But we've managed to get some preliminary metrics out of some of our studies and we've seen that maybe some of these promises for supporting recruitment and retention and diversity, actually maybe that's true. So we're seeing some early signals that that really might be the case, which is really, really exciting.

Donato Paolo Mancini

Interesting insight. Jane, what about you? What's your experience been like?

Jane Twitchen

Yeah. So we're similar to Angela, that we've had some exposure to DCT in a number of trials now and we've kind of got two extremes. So we've had real success on some non-interventional natural history trials that we've done in a completely diverse fashion. So we've done a collaboration with Apple called the Intuition Study, where we've used the iWatch, your Apple phone, et cetera, for collecting some data about patients' cognition, brain changes as we go about our daily life. So that's been fascinating and really exciting. The data there has been really useful. We've also done a completely decentralized childhood epilepsy study, which was very much about putting the patient first and really minimizing the impact on these incredibly ill patients' lives. More often than not, though, we're looking at small elements of the protocol. So is there a part of the study that we can deliver in a decentralized fashion? One study that springs to mind that we've started recently is for a rare genetic condition, and the patients that we're bringing into the trial aren't -- they're not even patients, they're pre-symptomatic gene carriers at the time the study starts.

So we wanted to make that run-in period as non-impactful and as hands-off as possible and give those patients a huge amount of choice about how and where they communicate with the medical team who'll take them through the clinical trial. So is that in the home? Is it in a in a sub clinic which is closer to their house than the main investigator site? Is it in a corner pharmacy for their blood draws? So really for that long term run and giving a lot of patient choice. So, yeah, we're beginning along this journey. We've got some good experience. We're still learning along the way. I think Angela mentioned diversity and I think that's one of the drivers that we've seen particularly on the studies that we're now having to or want to have FDA diversity plans in place and really attract all sorts of different people into our study cohorts. I think giving more choice is really the path forward. So that's definitely an area that we're continuing to explore.

Donato Paolo Mancini

When you -- and just to get this on you and this, because it was really interesting, whose idea was it to get the pre-symptom -- to sort of use DCTs for pre-symptomatic patients? Was it physicians? Was it the patients themselves? Was it you? Who drove that decision?

Jane Twitchen

So all of the above. I mean, it was an unusual study for us to really start so early on in the process. And we were very -- we thought that a sort of a flexible protocol with decentralization was the way to go, but we were also very wary that these patients are dealing with a genetic diagnosis they might not be aware of, and there was an ethical responsibility as well, so we wanted to make sure that we got the support right, and that might not be right for every patient. Some patients might want to carry on living their life as normal, others might have a real thirst for knowledge. So the flexibility that DCT gives us was really important and we discussed that with a genetic care physicist as well as investigator sites and patients to get the full remit of feedback.

Donato Paolo Mancini

Fascinating. Stephanie, I see you're back online and I'm very happy that that's the case. The question that we were discussing is what have been your experiences of DCTs? What are the pros that have driven -- what are the benefits that have driven your decision to use them and when you make decisions in this space. So what has your experience been?

Stephanie Manson Brown

So I'm very hopeful that my connection will maintain. So my apologies to my other members on the panel. I really hope that I am not causing any disruption and to any of the discussions. I've been unfortunate, I did manage to hear Angela and Jane's inputs. So, some really great examples and also some -- I think just generally the way that we're approaching things is relatively similar. We've had a lot of learnings along the way, like many people, and we'd already been implementing certain measures with regards to what we've come under the umbrella term of decentralized clinical trials since before the pandemic and since before lockdown, but obviously that was an impetus for everyone across the industry ready to look at enhancing those options.

So just to bring in an example, some of the learnings that we've had is actually by centralizing a lot of our initiatives around decentralized clinical trials. And so large company with multiple studies running in parallel, obviously, this is something that we've made that realization that by bringing a dedicated team in for decentralized clinical trials from an AbbVie perspective has enabled the identification of the commonalities because sometimes [Technical Difficulty] their own clinical trials. But of course, that needs to be done when you are thinking about patient care and obviously the needs as it relates to that particular condition or the compound or asset that you're studying. But there are some commonalities especially when we're talking about patient reimbursement and trial support. So just to share some of our learnings, we have 40 trials happening on the therapeutic side. We've got multiple other trials in the aesthetics and side of things.

And this is where they really identified some commonalities and identical challenges and that the teams were facing and looked to where they could implement certain issues with regards to the management of third-party vendors and making sure that we had a consistent way of reimbursing our patients and ultimately have a more efficient way of solving some of the problems that crop up rather than everybody having to handle and deal with them themselves. And so this is certainly from a more widespread perspective, how we're addressing things. I head up clinical development for aesthetics and aesthetic medicine. And this is an area where we've seen some really great opportunities with respect to enabling more enhanced efficacy measure collection. I'm looking at mobile and image capture for example. That's something that previously patients were having to go into and subjects were having to sites for regular image capture to enable us to be able to identify the evolution of the outcomes there, but we've been working on creating tools that enable the patient to be able to capture that at home and putting in the robust methodology to be able to correlate that to existing photo numeric skills that we use.

Donato Paolo Mancini

That's fascinating, Stephanie. So are you creating specific software for this? Like, for example, apps that patients can put on their phones or how does it work?

Stephanie Manson Brown

Absolutely. So it is software and it's something that we're looking at applying it to all different and types of androids. And just to kind of get some context with imaging, regardless of which field you're talking about, the positioning and the lighting of the patients and the distance from the camera, the angle, et cetera, that's all very much plays with regards to the actual image and the results that you're then capturing. So this is a really important measure to be able to standardize it, to ensure that you've got that consistency. And so absolutely to that point and developing the software to enable that consistency and standardization because ultimately we need to demonstrate to the regulators that we put that robust methodology behind it so that we can provide it as an alternative currently, but then ultimately the future will be looking at and bringing that in as the [super leading] (ph) and some of the endpoints that we're using currently.

Donato Paolo Mancini

Thank you. Harpreet…

Harpreet Gill

Yeah.

Donato Paolo Mancini

What have your experiences been like?

Harpreet Gill

Yeah, so not dissimilar to my colleagues on the panel. I think initially, we saw some drive from the pandemic. I think certainly what we saw at ICON was a little bit of a pullback from going down that -- the decentralized route and there's a level of comfort in going down a familiar route, a traditional route. Saw a little bit of a pullback, but I think now with the guidance from the FDA and the EMA around diversity and also making trials more available, easier for patients to participate in from the EMA, I think that's really driving the debate further and pushing us down a decentralized and more sort of broad thinking route as well. And decentralized, I think, doesn't just mean technology. It's also thinking about some of the other services that can be provided for patients such as community clinics, using the pharmacy, home health, using other services, concierge services, et cetera, just to engage them in the trial and ensure they stay up to date with the protocol, but also supported through the clinical trial and understand the process as well. I think education is a really important piece for the patients.

We need to do a little -- I think we need to be better at educating patients around exactly what it means to be in a more decentralized clinical trial. I think some -- we did have some feedback that some patients thought it would be more complex and that's hopefully not going to be the case in most DCTs. So we've seen a range of things, and certainly from our practical experience in terms of delivering some clinical trials for sponsors, we've definitely seen some real benefits around diversity. I think that is going to be a key part, a key asset of DCTs that you wouldn't see in a traditional trial. And it goes back to the fact that these studies are more accessible. You can generally -- if you're doing things more in your local community, not having to go to a specialized site for all your visits as frequently, that should be, your ability to engage in a clinical trial becomes a lot easier and you get that optionality as well. So I think we've definitely seen that. We had one study where not only did we see a sort of 50% non-Caucasian population, but we also saw 20% of those come from a rural location. So that speaks to, again, diversity, not just from an ethnicity perspective, but also in the social economic factors. Yeah.

Donato Paolo Mancini

That's fascinating. As a reminder to our audience, we want your questions and we want them now. I see a couple are coming in, but we want to have a plethora to choose from. So let's move on to the following point. So I think Jane earlier was saying that there was a -- was there partnership with Apple. And then Stephanie was talking about their own software developments, let's call them that, to kind of follow up on their patients. So what are the challenges that you have encountered in terms of technology and operations in conducting DCTs and are these teething problems that can be addressed easily or are they significant to these structural issues? Why don't we start with Jane, who can hopefully talk about the partnership with Apple as well?

Jane Twitchen

I could do my best to talk a little bit about that. Technology from a kind of mobile infrastructure wasn't as complicated as we expected it to be. I think there's a famous image isn't there of a mobile phone at a concert and sort of 20 years ago there's three in the crowd and now absolutely everybody has a mobile phone. And along with that comes the infrastructure to deal with that. So, looking at Biogen's country footprint, where we usually take studies and where there's a really strong mobile infrastructure, in that particular example, we haven't had huge technology challenges. Where we've had more I'd say challenges or considerations is on what we sort of refer to as the site burden. So what are we going to ask the site to do? How are they going to do it? How are they going to be trained? Do they need access to another portal? I think sites are really fed up with having lots of different logins to lots of different systems and being -- knowing their patients via data rather than patients as individuals. So sort of working through those challenges have been the ones which have been more impactful.

Another point which is maybe moving away from the tech but it just kind of dovetailed quite nicely with some of the comments we've had about diversity that Harpreet and Angela have also shared, I also wanted to raise kind of the operational piece there because we've got the tech part of DCT which is absolutely critical and that's maybe the exciting bit but then as Harpreet and Angela said, we've also got the -- how do we make it easier for our patients in terms of, is someone coming to them, are they going to a clinic, where are they receiving our care? And we, funnily enough, have had more operational challenges with that kind of end of things than we have with the tech. Really simple things, but they're really meaningful to patients. So simple things like, if we see a nurse one month, we'd like to see the same nurse the next month. If I'm inviting someone into my home, I'd like it to be a face I'm familiar with.

Going a step further, I'd like it to be a person that looks like me, so if I've not got white skin, I'd prefer my nurse not to have white skin. So trying to -- if an element of diversity is about making this easy for the patient -- making the patient comfortable, I think those parts are really important and maybe vendors aren't necessarily set up to think about all of those parts yet. And then also some sort of logistical challenges that went with that, that often we've got people coming into the homes and doing blood draws and then the bloods have to be sent off for sampling and that has to happen with dry ice and a courier. So you've got three pieces there coming together, you've got the nurse, you've got the equipment, you've got the courier and it's just, as sort of Stephanie mentioned, having a team of experts who understand that infrastructure, who understand that model, can put that model together for every study without having to invent the wheel from a kind of logistical oversight piece, that's been really critical. So, yeah, I'd be fibbing if I said there weren't tech teething problems, but I really think there were more teething problems. And it's the sort of same old operational things that have some level of complexity to that you've got to navigate.

Donato Paolo Mancini

Thank you so much. Angela?

Angela May

Yeah, I think I would largely agree with Jane, actually. When -- we've had teething problems, I guess, in specific countries, for example, importing, you find out late in the day that there's some weird reason why you can't import this specific device into this specific country. So you have to work around that. And maybe the vendor or vendors that you're using to provide that equipment or tech don't have specific experience in that country. So then you need to deploy your local team with their knowledge to help you. So we've seen things like that. But I think our tech issues have been more with the build. So actually building the platform or the portal or app or whatever in the first place. And the challenge is in making sure that it is fit for purpose, that it doesn't land a whole bunch of burden on your sites and your patients as Jane was saying. So, yeah, we might think it's brilliant and it does exactly what we want it to do, but actually from a site point of view, is it very friendly? So it's been more around that, I suppose. And yeah, making sure that, that build is fit for purpose for the study, but also for the users.

And in particular, so we've got some experience with hybrid designs and also a fully remote, so this is an interventional study with a fully remote design, is the operational pieces, again, that Jane mentioned, but you don't have that fallback option. When you're operating a fully remote study, all of a sudden, your very last resort, which is, well, if it all goes completely wrong, we don't want it to be this way, but the patient can go back to the site, because they were going to go there for the other visit. But the infrastructure is there. You have not got that in a fully remote trial at all. And this patient could be hundreds, if not more, kilometers or miles from their nearest center. So you don't have that fallback option. So it has to work. Whatever that thing you set up has to work. So, the coordinating couriers and dry ice and so on, you don't get another option. Oh, well, we'll just bring the patient into the site the next day, which we have seen in our hybrid trials quite a lot when things haven't worked out in the earlier days. But yeah, you really need to have these very robust backup plans in those instances.

But yeah, I think, as I said, similar to Jane, we've had quite similar experiences, really. It is just those real nuts and bolts, operational pieces that you have to throw away the rulebook, get rid of all your assumptions and start again. And there is a way through it. You just have to think differently. And I think we're quite used to not doing the same thing over and over, but it's a very well-practiced, very well-versed process, setting up your trial, running it, closing it down again, we've done it dozens of times. But all of a sudden, that rule book has completely changed and you have to sort of start being a bit more creative. So it might not be quite such a familiar area for some people, I think. It's definitely a skill that I've brushed up on recently.

Donato Paolo Mancini

Stephanie?

Stephanie Manson Brown

So I'm just listening and nodding. Some fantastic examples shared there. I think just going back to some of the principles, don't introduce new ways from a technology and operational perspective or process unless it's real benefit for us. Of course, that's something that needs to be tangible. We need to monitor and adjust as we're going along and ensuring that we're tracking against some of the issues that arrive. I think one fundamental that's a big learning point and I feel like this is probably a very simple observation but make sure that you're writing in and taking all the different considerations and introducing it right at the beginning, so right into the protocol. I think that that's where there's been some challenges, especially when there's been some interest, let's say, at some of the optionality that the process or new technology has provided is trying to retrofit it and go back later in the stage and make protocol amendments. That's not going to make it easier for anyone. So that has been a very simple lesson learned and something that we are taking into account as we're moving forward.

I think also just listening, and Jane mentioned around the training. Training is imperative. Training is important for the participants, but also the investigators and the sites as well. And this is something that we've actually almost turned into an opportunity. So if you do bring in technology, you're able to actually access the training for investigators in a much quicker time point, but also in a time that suits their scheduling. I mean, gone are the days where we go for the in-person investigator meetings, we can now do the training in a much more interactive way. And one thing that we brought in for aesthetics, for example, and we talk about diversity, we need to make sure that our investigators are ready to make enhancing patient diversity and our patient population success. And so from an imaging point of view, traditionally through different training or even medical training, a lot of the training is done on lighter skins. And so we're ensuring that our technology enables training to take into the nuances and the different presentations of conditions but also anatomical presentations as it pertains to different race, ethnicity, age as well as gender.

We need to be looking at diversity across the board. And then, when we do talk about diversity and some of the potential challenges is of course it provides an opportunity to break down those barriers and obstacles that pertains to potentially some of the proximity to clinical sites. But we also need to keep in mind we don't want to maybe actually further cause issues with regards to divide with accessibility to technology, but also just the comprehension of different tools. And so that then again is a necessary element to make sure [indiscernible] training. And then just on the same topic, when we're looking at capturing adverse events and we also capture injection site responses on some of our device trials for injectable assets, we need to make sure that we are providing that education and accounting for any unintended bias as it pertains to actual self-reporting. Of course, having the real-time monitoring from a safety perspective is a huge opportunity and enables us to be keeping [Technical Difficulty] safety in real time. But we also just need to make sure that the data in is consistent with regards to the context and how it's been captured and how it's been interpreted. So these are just some examples.

Donato Paolo Mancini

You want to come in Jane? Please.

Jane Twitchen

Sorry, Stephanie, she mentioned data and it was a point I meant to raise as a kind of a word of advice that get your data privacy officer involved really, really on. If we're sort of moving through DCT to sort of digital technologies, what is deemed personal data is very fluid. So for example, we've used some devices to measure gait and fall for Parkinson's patients and our data privacy officer quite rightly could say if the right person looks at those, they can identify which patient that is by looking at that patient's data. So, therefore, we need to treat that data in the right way. We need to understand the rules and the regulations for each country. So, we've had a kind of a few false starts where we've assumed that the data maybe is not exempt, but maybe not the same as patient identifiable information or we use it, we haven't necessarily taken that full breadth of advice as early as we should have done. And the other similar point around data and going back to infrastructures and countries is hosting. And I guess it's more of a cost warning. It's don't underestimate your hosting costs because they can be really impactful to your study budget, particularly depending on geography. So just another kind of early look out to make sure you don't forget about those aspects.

Donato Paolo Mancini

Harpreet? Sorry, Stephanie, let's move on with the conversation then we can come back. Harpreet?

Harpreet Gill

Okay, yeah. So just quickly just tech challenges, yes I think a lot of promise early on with some of the technology that was out there without real thought into what this means for the site and the site burden and also for the patient. So it's really important, as my colleagues were saying, to ensure that you understand exactly what the nuances of that technology is. And if you think about digital health technologies in particular, if you're going to use a watch or a sensor, it's got to be right, not just about picking up the correct endpoint, but is it usable for the patient? You have to think that through all the way. And I was struck by, I think it was Jane's sense, it's making those small, looking at the small things in a protocol that can make a difference as to just how applicable the protocol is and how you can adhere to it. It says little things that really do make a difference. And so we've definitely seen some sort of technology challenges, I think. A little bit of over-promising and under-delivering, if I'm sure that resonates with some folks. So I think it's really important just to tease out very carefully some of the risks and challenges.

I think the other piece just around operational delivery as well, the sites, we've got to engage the sites, we've got to support the sites really well. And again, Jane alluded to it, Angela, that we don't want to overburden the sites as well as we've got to think about the patient, but also sites don't want to be tech support. That's not what they're there for. They're there to take care of the patient ultimately and ensure the integrity of the trial at that site. So adding all of these factors can be very, very burdensome. So we need to think about the site contract. Are they being reimbursed appropriately for the work that they're doing? I think there's a line of thought that actually site perhaps is doing less work when they're involved in a decentralized clinical trial and that may [Technical Difficulty] publish materials enough just don't give us what we need at the moment, but what we have found is when we've had that engagement with the regulators, they've actually been really happy to have a conversation, to give feedback, to have several meetings. So I guess my recommendation is just talk to them where you need more, try and talk to them. It doesn't always work, but so far so good.

Donato Paolo Mancini

Thank you so much. I keep getting questions from the audience and I think, not joking, I think we're about 25 minutes. So what I'm going to do is I'm going to combine, I'm going to do a medley of questions, combine one from the audience and I combine them with the talking points that you're familiar with. And here it is. So how do the economics of running a DCT stack up against a traditional CT? What are the expectations in terms of accelerating the CT process as a whole by decentralizing the process which kind of blends in with what are the factors behind the positive impact, the positive fiscal impact of DCTs, what are the benefits beyond cost savings, and where are the returns most compelling, and how can we measure these improved financial outcomes in DCTs? Harpreet, why don't you start answering this?

Harpreet Gill

Yeah, I'll be really concise. So a couple of headlines here. So comparing a DCT to traditional, you're going to see -- you won't -- our experience today is you're not going to see a big difference in terms of baseline cost for delivering that study. However, where you will see a difference, we believe, is in terms of the outcomes. So the outcomes, if those improve in terms of patient retention, you're going to save some money there in the long term. Adherence to protocol, you're going to save something there in the long term. And then there's a third point. It's gone straight out of my head. But generally, just looking at the overall outcomes of the study rather than what's the baseline cost of the study, that's what we need to look at. What are the improved outcomes? Because that way you can see in the long term there's an improvement. We know about protocol amendments. If you don't get it right up front, that there are sort of issues around, as I said, retention, engagement, et cetera, of patients, and adherence to protocol. If you can improve that during the trial by using DCT methods, and we have seen improvements in diversity and retention, certainly at ICON, then you will impact the outcome. So I would say focus on the outcome rather than the baseline budget at the beginning.

Donato Paolo Mancini

Jane, what are your thoughts on economics of DCTs?

Jane Twitchen

Yeah, I think Harpreet has absolutely hit the nail on the head. Our experience is incredibly similar. Advantages are in recruitment and retention, not in operational spend or the cost of doing the trial. I think the only other piece I'd add in is, and this is more about the digital health endpoint development, is there's potential to basically minimize the white space in your clinical development plan because you're thinking about what are my future endpoints going to be when you're earlier in your portfolio. So actually bringing your product to market a little bit earlier. We've got some opportunities that we haven't had before, but cost per study, I think, Harpreet’s hit all the key points.

Donato Paolo Mancini

Stephanie, what are your thoughts on economics of DCTs? Where do you see the biggest kind of benefits?

Stephanie Manson Brown

Well, I would say -- just before I go to benefit, I think it can be maybe a challenge if you are just looking at metrics from an economic and a cost decrease, because then we're going to lose out on opportunities to introduce into the clinical trials. And so therefore, I think if we are so reductive from that element, we will never make progress. But exactly, it is about building all the other metrics and KPIs. I think there are some cost savings that can be done. And we were looking at this from an imaging perspective. So I mentioned earlier about bringing in these mobile-based imaging solutions. And that's something that definitely, when we look at it from the short, near and then to the longer term, we'll definitely provide cost savings. And this is something that will be very important for us then to look at how we recoup the costs that were associated with developing the technology in the first place. And so therefore, it's always a trade-off when we're looking at evaluating the balance there. But I think that this is where by providing, when we're looking at it and the -- at home or the mobile device solutions, this will then enable us to continue to look at cost savings there, but then to continue to invest in and how we can further develop the technology. So there are cost opportunities, but it's not certainly not the sole focus.

Donato Paolo Mancini

Angela?

Angela May

Yeah, I mean, it's difficult to follow now, because everybody's made the main points. But actually, I've got quite a good example of -- which sort of highlights a lot of the things that everyone's been saying. So definitely it's focusing on the outcomes, not the top line that going into your study budget. But we've got a pediatric study where we're deploying, again, optional, but DCT options for these patients to really reduce that patient but also caregiver burden. And we're looking, focusing on the younger cohorts because obviously in Peds you start with the older age groups and move down to the younger ones. Well, you look at these parents with a sick child and probably travelling across the country to get to a specialist center to treat their child's disease and offering up these alternatives, which means they don't have to do that. That journey is going to be quite -- should be very well received. So we've had a lot of input from our KOLs and patient organizations to say, look, this is what we want, do we do want this option?

And in this specific example, because pediatric studies are often part of your, well, the bigger picture of pediatric development with your products lifecycle. If we can recruit an additional X number of patients, and these are small numbers, but if you can attract these patients that the caregivers just wouldn't have consented, this could translate into quite big numbers. And we've sort of modeled a few scenarios and so on and feel that we can make months of difference to the closure of this particular study, which obviously from a life cycle pattern point of view is considerable. So, it's a very specific example, but I think if you really can make that difference, and it just highlights Harpreet's point, if you can really make that difference to when your trial finishes, there's a, there's a huge financial gain that could be made there. And more importantly, that drug gets made available to people that need it earlier.

Donato Paolo Mancini

Let's combine another two questions. I mean, there are seriously some really, really good questions from the audience. So do you, and very, very briefly, lightning round, so do you engage with patients or patient organizations? I'm going to use that as a springboard, Angela, what you just mentioned. Do you engage with patients or patient organizations designed to try a protocol, software education tools, and what has been the impact of DCTs on getting clinical medicines or supplies to patients? Angela?

Angela May

Sorry, I missed. It cut out the last part of that question. Sorry. I can't hear you. Is it just me? I can't hear Donato.

Jane Twitchen

Me neither. Danata, you're cutting out. Maybe between us, we could start on the question about insights from patients, Angela.

Angela May

So, yeah, well, I think we did talk about it a little bit before, didn't we? And I know he was pulling on a point I'd made about this pediatric study. But, I think you need, absolutely, and we talked about it earlier when we talked about end users, didn't we? But you need to engage your patient advocacy groups and whatever. You need to understand the challenges for those people and what it means to them and what it is they're looking for. Because what you might assume, even as a no-brainer, you might assume we should definitely do this, this way, could be completely the opposite in when it actually comes down to it. So I think it's absolutely critical to engage these sorts of organizations.

Harpreet Gill

Yeah, and if I might add, just in terms of, obviously, I can also talk to patients as well, patient efficacy groups, and then during the run-in of a DCT, we can also send out surveys to see how the patient's feeling about being involved in the study. But I would say that one thing that we've heard time and again around the protocol, and this isn't just about DCT frankly, it's more broadly from a patient perspective, is that so often protocols are all about the scientific end point, this piece, maybe what the clinicians think might be useful or the scientists might think is useful. But actually, it's not going to make much of a difference in the quality of life of me as a patient. So why do I care? So we've really got to listen to the patients. What's going to make a difference for them when we develop the protocol? And then you can put that in, think about DCTs as well. What is it about engaging in a clinical trial? What will make it easier? What will make it beneficial for them. So it goes from the protocol, the protocol design, what's in it for me as a patient, but also making it easy for me to engage.

Donato Paolo Mancini

I hope you can hear me now. Can you hear me now?

Jane Twitchen

Yeah. We can.

Donato Paolo Mancini

Hallelujah, amazing. Stephanie, would you like to come in?

Stephanie Manson Brown

Yeah, of course. The patient voice is vital and we do connect with the patient groups to better understand how we can be designing all of the different elements from protocol design and bringing in new technologies. I would say a couple of things and there's research to show that patients and subjects are open to technology and open to the difference and whether that's the new digital wearables or technology being brought in as long as there's education around there. I think we also need to kind of keep in mind that they do like in the main state to have that interaction with their doctors. And so therefore we do need to enable that dialogue is maintained throughout the clinical trial because that'll obviously help with retention as well. And I think also then the diversity piece, we want to be inclusive.

So when we're speaking to patients, we need to keep that in mind. So one patient does not represent all of the patients within a certain condition. And so that is really important to ensure that we're taking in all the different perspectives and bringing that into what we do. And then obviously there is the option then to take those considerations into whether it's end point introduction or even just the accessibility to the tools, for example, and of course the education piece around it. But I think that there are often -- the benefits are understood by subjects in the trial, but obviously there's just about the maintenance of having that access. And there's definitely opportunities in the future as well for and subjects in trials and patients then to be able to have real-time access to some of their data metrics.

Donato Paolo Mancini

We're running out of time.

Stephanie Manson Brown

Oh, sorry. It's a topic that I love, but anyway.

Donato Paolo Mancini

Very briefly, I want you to come in. Thank you. Jane, super briefly.

Jane Twitchen

Super briefly. Along the lines of everybody else, absolutely, patient insights are really key. And also, investigator insights, so protocol simulations from both the investigator and the patient perspective can be really useful. And the other point I was going to make really quickly is don't second guess what the patient wants. We think, someone coming into your home is easiest. Actually, it's an invasion of my privacy. I'd rather go out. So just ask the patient I guess I think is my learning there.

Donato Paolo Mancini

Thank you so much. I want one -- a one word answer from each and every one of you. In what phase -- what clinical phase do decentralized clinical trials make most sense? Jane, one word, one number.

Jane Twitchen

Two.

Donato Paolo Mancini

Okay. Stephanie?

Stephanie Manson Brown

I say two, but I also work on device, so feasibility as well.

Donato Paolo Mancini

Angela?

Angela May

In our experience, three.

Donato Paolo Mancini

Harpreet?

Harpreet Gill

Two and four.

Donato Paolo Mancini

All right.

Harpreet Gill

So all of them.

Donato Paolo Mancini

I'm going to hand over to Harpreet for her closing remarks and then we need to wrap up because I've got...

Harpreet Gill

Yeah. So I just want to thank my panels. It's been a fantastic discussion. Really insightful, really interesting. Some amazing insights have been shared and I think we've all learned from each other and hopefully our audience has as well. I just want to thank Donato for moderating as well. So, thank you very much and I'll hand back to you to wrap.

Donato Paolo Mancini

Thank you. Look, it's been a wonderful, super engaging panel. We're running out of time. Despite the technical difficulties, we made it through. Some really wonderful insights. Thank you for being with us. This video will be available for another 30 days from today. That's it. Thank you very much and good-bye.

Harpreet Gill

Thank you.