All right, thank you, so really excited to be here. We've got some exciting things to show about a pilot that we've done on vocal digital biomarkers and Alzheimer's. I am the associate director of Patient Centricity and Engagement in the Alzheimer's portfolio at Biogen, and here with me I have my colleague Andrew who Andrew, I'll let you go ahead and introduce thanks.
So I managed Riguero.
I am a senior clinical country and sightly that's a really fancy way of saying that I am a liaison between the sponsor and our sites. So we're excited to talk more to you today about this vocal biomarker that we rolled out not too long ago.
And I'll turn it back over to Katie.
Yeah. Yeah, So first I'm going to just start out with a little bit of a roadmap. So how did we arrive at vocal biomarkers for patient ID because I know it is a little bit different. So we started out and I really do like to challenge status quo when it comes to developing strategies for patient engagement. So what we arrived at was a set of problems that I see that we've noticed over time in some of our ad studies, so one of them being pre screening is a big burden. It takes a lot of bandwidth
from the site. It's no secret we've heard it here a bunch that these sites are really really pressed right now. They've got a lot going on, there's tons of saturation. Site turnover is difficult, so I really need to get out and around that. We have the issue that you know, pre screening processes are really really heavy on the taking and not so great on giving back to patients. So we may ask them ten or fifteen questions and a standard pre screener right and they don't necessarily understand why
those questions are being asked, or maybe they're frustrating. And in the end we say, hey, you might be you might be qualified for a clinical trial, but we'll have a site get back to you, and maybe that happens, maybe it doesn't. So the beauty of this is how, you know, how do how do we get out and around that too, How do we give back to a patient and have it be meaningful. One of the other things is that screen failure is really disappointing to patients.
So you know, we think about site morale, and I get into that in the next bullet, But what does that mean for a patient? What does that mean as we go into a diversity too. So we've got people that have taken this leap of faith and they're saying, you know, this is something different, I'm going to give it a try, and then they get to the point of going into the visit and they get their hopes up and that's tough, and that's tough for community relationships
as well. So wanted to kind of think about that. And then the high volume of prescreen and screen failure is really tough on timeline, it's tough on morale, and it's tough on our budgets. So it left us with this question that was, how might we uh just look into a way that we can enhance pre screening process and do something a little different than we've done before and also be able to empower our patients and prevent
site burden and accelerate or enrollment periods. So with that, this is where we get into digital biomarkers.
Yeah, so just to set the stage right, So in Alzheimer's disease in particular, you can imagine that there are a plethora of screening challenges and just to bring some of them up. So, for one, they're frustrating, right you're screening. It's the first time sometimes that you're meeting the site.
You may have gotten a referral to that site, or you may have been brought there from some event or outreach, and it's frustrating because they know that there's something wrong and now you're exacerbating that by doing a plethora of
all these memory and cognitive assessments. The other thing is that doing those assessments from the site side can be restricted due to radar excuse me availability, right, They need to be trained and certify to administer those scals, and oftentimes those raiders are being used for the trials themselves and don't necessarily have the time to do pre screening.
Along with that, if we consider some other options that are available, like PET and MRI, right because you're doing these to establish a diagnosis, it can be overwhelming and disorienting. The other reality is that a lot of trials in Alzheimer's disease require an amyloid PET positive scan, and just doing that alone is expensive, it's time consuming, and finding access to the ligands can be very challenging. Along with that is add it on top of all that is
are the care partner requirements. There's time commitments just taking that time out of work to bring mom or dad into a clinic to just have a screening done or a pre screening done, and then the continuity from caregiver to caregiver. Some of these scales that are admitted start require caregiver input and sometimes the same sun or daughter can't bring mom or dad into the clinic all the time. So there's these challenges and as we thought about this, a solution became available.
So after a lot of time and effort spent looking for what is the right way of doing this? How do we figure this out? How do we solution for this? We arrived at a very small startup. The startup is called Novoic and they have a pre screener that is
a digital biomarker. It is by no means a medical device, It is by no means meant to actually diagnose, but it has high clinical validity and basically by what Novoic's platform does is it's called Storyteller and it's a ten minute assessment where patients hear a story and they are
tasked with telling the story back. So based on the syntax and the patient's voice which is the digital vocal biomarker, and their recall combined together, that gives us an understanding of whether or not the patient may or may not have beta amyloid positivity on PET. It's got high convergent validity to a lot of the different scales that we're using in screening, including in our bands, which is one that we've notoriously seen as a major screen fail reason
for our diverse patients as well. And it's ten minutes. The sites only have to send out a link, the patients are able to do it on any device, and they can do it from the comforts of their home, so it adds a lot of access and it starts a conversation too. So that's the other piece of the differentiation between standard pre screening and this type of assessment is that it starts the conversation about brain health and cognition and what may or may not be going on.
So there's a lot of site benefit as it relates to time, I'm savings, They get results, patients get their results back too, and they kind of can get an idea of what's happening, So that brings us to the impact also on patient experience. Oh gosh, that was not supposed to happen, so sorry, and so patient pre screening. So as we see, it's less invasive. So some places
are doing blood based biomarkers or fluid biomarkers. That does include a that's a blood draw and needle a version is a thing not everybody wants to do that it's easy. It gives awareness around personal cognition. So as I said before, it gives patients with meaningful data that is personal that they can take that and also have a conversation with
their PCPs. So the beauty of it is we're not just saying, hey, come to this trial, but also hey, maybe you want to talk to your primary care physician and understand what's going on, or go get checked out further. And it just starts a general conversation about brain health as well. So we're also interested in that as it relates again to some of the community relationships that we're building when it comes to diversity practices. It is accessible.
It allows sites to meet patients where they are. So that's a really big and important piece that I believe in is meeting sites. Where are patients where they are. We have to give them flexibility. We have to understand that not everybody's the same and it does improve HDP and patient connections. So they're able to have awareness built, they're able to build trust on sharing the experience of going through understanding what's happening with their own cognition.
So as we consider patients, now let's consider sites. Right, So you're thinking, great, this is fantastic, but what's this going to take on for the site as they try to implement this into their processes. One is that there's a partnership that is put into place between NOVOIC and the site as this is implemented, which allows for effective engagement.
There's that direct communication, right, So the site is trained up ahead of time, and that's item number two here to let them know what the output of.
That scale is.
So it's translatable, right, It's not like they're just given a number and the site is left to figure out what that means. Just as in the same way that that information is meaningful to the patient, it's also meaningful to the site because now if they're coming through their database and they're giving this pre screener, right, or maybe they've engaged with somebody at a community event, right, and they give them this pre screen or they give them
that link. Now that information, they'll be able to have just that much more knowledge about that patient and the probability of them being amoid pat positive. Right, those are the patients you want to bring in for these trials. So with that, Novok did multiple live webinar options for site staff. They also had that webinar recorded online. Let's say, you know, a community fair came up on Saturday, and we're going to send somebody out there. They know nothing
about this. They didn't go to the Novok training that we had a couple of months ago.
They have access to that training now, so they could be well equipped.
And Last, but certainly not least, which was really neat about this was a site customization. Like Katie mentioned, it's not a one size fits all, right, So sites had different ideas about how they can implement NOVOK. Some are putting QR codes into mailers and shipping them out to patients.
In the area or people in the area.
Some were again at community fairs, had a QR code or a link. Some had tablets available, So there's all sorts of different ways to implement it, to customize to the site, to engage those potential patients.
Yeah, and so we again gosh quick on the trigger. So we have some real world metrics that we had come up and just want to share some of the results from our initial pilot. And I will say this is just in our site use case, but we did some additional interesting things. So we implemented this in the US and in the UK. What we also did is we partnered with a joined Dementia Research registry that's out in the UK, and we saw a really great adoption
rate really across the board. We got some interesting metrics around patient age. So overall in the US we saw a pretty high completion rate for patients that were over the age of seventy. We did see a bit lower in the JDR registry collaboration. However, that's somewhat reflective of the patient population that's in that registry as well, and then just some of the patients that we're choosing to opt into using the platform. We had assessment completion rate
of fifty percent. Our highest assessment completion rate was actually sixty two percent in JDR. And I will say as far as implementation goes. One of the reasons why is that we had navigators that were actually helping patients with how to complete and they were following up just assessing whether or not they understood it and they whether they needed any additional assistance. Next, we have some additional metrics. So we had a total of one thousand, over one
thousand assignments. So an assignment is essentially a site sending out the link to storyteller to a given patient. We had thirty thirty three percent site adoption rate, which that was over the course of seven months, and there was admittedly a lot going on at that point in time. We've had a pretty busy bit of time with ad and biogen, So then we had six months for the UK that was a higher adoption rate at eighty two percent,
which was quite impressive. I think there's a lot of thought process around will this be adopted x us and the answer is that in the UK there was a very high acceptance. And then we did have only four months for the j D The JDR Collaboration UK had nine hundred assignments, pretty big numbers for only six months, and we ultimately ended up with almost three hundred completions, and then also we had over five hundred completions in the US as well as another what twot eighty in
the JDR collaboration. So really we were pretty enthusiastic about the uptake total. What we saw was, uh, you know, in summary, is just the number of patients that we were able to bring in over a really seven month max period of time was almost six hundred patients with the scoring threshold that was what we had set for our study needs. So that brings us to some of
our conclusions. So one of the things that I would just say is, and I bring it to the table a lot when we're doing something new and we're doing something innovative, I always say enhanced pre screening or anything similar to this. We have to allow trust. We have to allow sites time to trust their backup camera. So I always say, when you're buying a new car, you're always kind of freaked out to trust the backup camera and not look behind you. And the sites need time
for that too. So we'll always have an early adopter, but sometimes we'll have sites that are a little bit concerned and they want to just wait and see, and that's completely fine. It's not necessarily in our wheelhouse or the best idea to just force them into using and trusting it so allow sites some time to trust their backup camera. Adoption of vocal biomarker assessments for identifications save
staff time. So one of the really exciting data points that we found is that we had a site that adopted it into their overall pre screening process completely and it saved them over four hundred hours of site time, which is incredible when you think about the constraints on sites right now. Four hundred hours is huge. And Andrew actually has worked with that site, so I'll allow you to elaborate on that if you'd like.
Yeah, yeah, Actually one of their quotes is the bottom right hand quote there from that USPI. So there's a site down in Florida. You can well imagine there's a very popular elderly community down there in central Florida. They decided that they were going to implement this as part of their clinic each and every day, so they're well poised there. You know, people walk in looking for trials. Wouldn't that be great for all of us? But as
they do this, they have this pre screener. They get ten to twenty people a day, and that's the site that saved the fourger fifteen hours because originally they were administering the Wessler Logical Memory two test, which takes about twenty to thirty minutes, or the r bands repeatable battery that assessment there also takes about thirty minutes. They were reable to reduce that right to a fraction of time just to kind of introduce the scale.
Patient took it on their own.
They got the data back and saved I think that four inser fifteen hours.
I can't recall if that's monthly.
But they the PI was like, this is just revolutionized the way we work here, and they were able to just broaden that funnel to bring people in and already have more of a robust pre screener up front.
Yeah, and then the other point I will make is that digital assessments have high convergent validity. So being able to have that it allows us to keep patients from going into a site for screening that wouldn't otherwise be appropriate or suitable. So we're saving the site time, but we're saving the patient's time as well, and that is really important to us. Andrew, I'll let you take it away for the last three.
Yeah, and as Katie mentions again, it's meaningful data. The patient right ideally can then take this again kind of see progress on their own right. But it's a powerful engagement tool. It gets that conversation going in a sort of fun and gamified way, right, because again it's intimidating. I got to beat with this person and they're going to ask me all sorts of questions. But I can do this in the comfort of my own home, at
my own time. And the other thing that I thought was unique, is Katie pointed out before in that slide with the metrics, is that you know, so often we think age is going to be a barrier technology and age, right, you know, the older folks get the less they want technology, and perhaps that is true, but we did see that age alone should not be the determining factor for whether we introduce novel technologies, because there was a great uptake,
especially in that patient population that was equal to our over seventy years old. And last, but certainly not least, digital vocal biomarkers are strongly positioned to expand access. You can well imagine that if you're not near a brick and mortar site that you can deploy this to somebody in different communities, rural areas where it's hard to get access to sites. It can act as a catalyst to discussions around cognition and add significant value to all stakeholders
that are impacted by that patient identification process. So I think that wraps it up, and we've got a minute left for Q and I.
Wonderful presentation. Fantastic biomarker. What's the regulatory authorities thoughts on this as a biomarker? That's cool.
Yeah, So the interesting thing about this is that we're only using it for pre screening, so there's not really any concern as far as regulatory because it is just helping us pre identify patients, so they're going to still go through all of the new normal screening procedures. But what it does is it changes the bottleneck for sites so that they know that the patients they're bringing in are highly clinically likely to make it into a trial.
But I assume that the more people use it, and the more that you can compare it with other biomarkers, it may eventually become the number one biomarker. And again with using AI and other tools, So it's got great potential. You use it in the UK and the US, there is a common language there. Is it applicable in other countries and would they have to speak English or could it be translatable?
It can be translated and as globally available. And I will say I can't I can't divulge to terribly much. But there are other projects that I have ongoing currently in different use cases that we're looking at just how it performs in some other biomarkers and how that converted validity against those.
And obviously it gives us score. So on the sixty four thousand dollars question is have you tried it yourselves?
Yes? Yes, it's really interesting. Actually there's a demo. We had a demo link and we've all tried it ourselves, and it's kind of fascinating because you sit there and you try it, and you're hearing this story and you go through and you're like, oh my gosh, what is this going to mean? What does this look like? But ultimately it is really easy. It's far more I think it's way more patient friendly. I would much prefer doing that over being asked a bunch of questions and We've
heard that from patients as well. They do much prefer just doing it themselves.
Good. Okay, thank you very much. See you certain say thank you.