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<v Speaker 1>All right, thank you, so really excited to be here.

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<v Speaker 1>We've got some exciting things to show about a pilot

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<v Speaker 1>that we've done on vocal digital biomarkers and Alzheimer's. I

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<v Speaker 1>am the associate director of Patient Centricity and Engagement in

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<v Speaker 1>the Alzheimer's portfolio at Biogen, and here with me I

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<v Speaker 1>have my colleague Andrew who Andrew, I'll let you go

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<v Speaker 1>ahead and introduce thanks.

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<v Speaker 2>So I managed Riguero.

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<v Speaker 3>I am a senior clinical country and sightly that's a

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<v Speaker 3>really fancy way of saying that I am a liaison

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<v Speaker 3>between the sponsor and our sites. So we're excited to

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<v Speaker 3>talk more to you today about this vocal biomarker that

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<v Speaker 3>we rolled out not too long ago.

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<v Speaker 2>And I'll turn it back over to Katie.

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<v Speaker 1>Yeah. Yeah, So first I'm going to just start out

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<v Speaker 1>with a little bit of a roadmap. So how did

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<v Speaker 1>we arrive at vocal biomarkers for patient ID because I

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<v Speaker 1>know it is a little bit different. So we started

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<v Speaker 1>out and I really do like to challenge status quo

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<v Speaker 1>when it comes to developing strategies for patient engagement. So

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<v Speaker 1>what we arrived at was a set of problems that

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<v Speaker 1>I see that we've noticed over time in some of

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<v Speaker 1>our ad studies, so one of them being pre screening

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<v Speaker 1>is a big burden. It takes a lot of bandwidth

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<v Speaker 1>from the site. It's no secret we've heard it here

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<v Speaker 1>a bunch that these sites are really really pressed right now.

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<v Speaker 1>They've got a lot going on, there's tons of saturation.

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<v Speaker 1>Site turnover is difficult, so I really need to get

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<v Speaker 1>out and around that. We have the issue that you know,

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<v Speaker 1>pre screening processes are really really heavy on the taking

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<v Speaker 1>and not so great on giving back to patients. So

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<v Speaker 1>we may ask them ten or fifteen questions and a

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<v Speaker 1>standard pre screener right and they don't necessarily understand why

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<v Speaker 1>those questions are being asked, or maybe they're frustrating. And

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<v Speaker 1>in the end we say, hey, you might be you

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<v Speaker 1>might be qualified for a clinical trial, but we'll have

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<v Speaker 1>a site get back to you, and maybe that happens,

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<v Speaker 1>maybe it doesn't. So the beauty of this is how,

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<v Speaker 1>you know, how do how do we get out and

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<v Speaker 1>around that too, How do we give back to a

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<v Speaker 1>patient and have it be meaningful. One of the other

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<v Speaker 1>things is that screen failure is really disappointing to patients.

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<v Speaker 1>So you know, we think about site morale, and I

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<v Speaker 1>get into that in the next bullet, But what does

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<v Speaker 1>that mean for a patient? What does that mean as

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<v Speaker 1>we go into a diversity too. So we've got people

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<v Speaker 1>that have taken this leap of faith and they're saying,

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<v Speaker 1>you know, this is something different, I'm going to give

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<v Speaker 1>it a try, and then they get to the point

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<v Speaker 1>of going into the visit and they get their hopes

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<v Speaker 1>up and that's tough, and that's tough for community relationships

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<v Speaker 1>as well. So wanted to kind of think about that.

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<v Speaker 1>And then the high volume of prescreen and screen failure

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<v Speaker 1>is really tough on timeline, it's tough on morale, and

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<v Speaker 1>it's tough on our budgets. So it left us with

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<v Speaker 1>this question that was, how might we uh just look

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<v Speaker 1>into a way that we can enhance pre screening process

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<v Speaker 1>and do something a little different than we've done before

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<v Speaker 1>and also be able to empower our patients and prevent

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<v Speaker 1>site burden and accelerate or enrollment periods. So with that,

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<v Speaker 1>this is where we get into digital biomarkers.

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<v Speaker 3>Yeah, so just to set the stage right, So in

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<v Speaker 3>Alzheimer's disease in particular, you can imagine that there are

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<v Speaker 3>a plethora of screening challenges and just to bring some

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<v Speaker 3>of them up. So, for one, they're frustrating, right you're screening.

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<v Speaker 3>It's the first time sometimes that you're meeting the site.

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<v Speaker 3>You may have gotten a referral to that site, or

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<v Speaker 3>you may have been brought there from some event or outreach,

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<v Speaker 3>and it's frustrating because they know that there's something wrong

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<v Speaker 3>and now you're exacerbating that by doing a plethora of

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<v Speaker 3>all these memory and cognitive assessments. The other thing is

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<v Speaker 3>that doing those assessments from the site side can be

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<v Speaker 3>restricted due to radar excuse me availability, right, They need

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<v Speaker 3>to be trained and certify to administer those scals, and

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<v Speaker 3>oftentimes those raiders are being used for the trials themselves

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<v Speaker 3>and don't necessarily have the time to do pre screening.

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<v Speaker 3>Along with that, if we consider some other options that

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<v Speaker 3>are available, like PET and MRI, right because you're doing

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<v Speaker 3>these to establish a diagnosis, it can be overwhelming and disorienting.

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<v Speaker 3>The other reality is that a lot of trials in

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<v Speaker 3>Alzheimer's disease require an amyloid PET positive scan, and just

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<v Speaker 3>doing that alone is expensive, it's time consuming, and finding

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<v Speaker 3>access to the ligands can be very challenging. Along with

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<v Speaker 3>that is add it on top of all that is

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<v Speaker 3>are the care partner requirements. There's time commitments just taking

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<v Speaker 3>that time out of work to bring mom or dad

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<v Speaker 3>into a clinic to just have a screening done or

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<v Speaker 3>a pre screening done, and then the continuity from caregiver

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<v Speaker 3>to caregiver. Some of these scales that are admitted start

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<v Speaker 3>require caregiver input and sometimes the same sun or daughter

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<v Speaker 3>can't bring mom or dad into the clinic all the time.

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<v Speaker 3>So there's these challenges and as we thought about this,

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<v Speaker 3>a solution became available.

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<v Speaker 1>So after a lot of time and effort spent looking

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<v Speaker 1>for what is the right way of doing this? How

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<v Speaker 1>do we figure this out? How do we solution for this?

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<v Speaker 1>We arrived at a very small startup. The startup is

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<v Speaker 1>called Novoic and they have a pre screener that is

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<v Speaker 1>a digital biomarker. It is by no means a medical device,

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<v Speaker 1>It is by no means meant to actually diagnose, but

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<v Speaker 1>it has high clinical validity and basically by what Novoic's

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<v Speaker 1>platform does is it's called Storyteller and it's a ten

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<v Speaker 1>minute assessment where patients hear a story and they are

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<v Speaker 1>tasked with telling the story back. So based on the

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<v Speaker 1>syntax and the patient's voice which is the digital vocal biomarker,

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<v Speaker 1>and their recall combined together, that gives us an understanding

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<v Speaker 1>of whether or not the patient may or may not

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<v Speaker 1>have beta amyloid positivity on PET. It's got high convergent

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<v Speaker 1>validity to a lot of the different scales that we're

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<v Speaker 1>using in screening, including in our bands, which is one

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<v Speaker 1>that we've notoriously seen as a major screen fail reason

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<v Speaker 1>for our diverse patients as well. And it's ten minutes.

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<v Speaker 1>The sites only have to send out a link, the

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<v Speaker 1>patients are able to do it on any device, and

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<v Speaker 1>they can do it from the comforts of their home,

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<v Speaker 1>so it adds a lot of access and it starts

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<v Speaker 1>a conversation too. So that's the other piece of the

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<v Speaker 1>differentiation between standard pre screening and this type of assessment

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<v Speaker 1>is that it starts the conversation about brain health and

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<v Speaker 1>cognition and what may or may not be going on.

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<v Speaker 1>So there's a lot of site benefit as it relates

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<v Speaker 1>to time, I'm savings, They get results, patients get their

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<v Speaker 1>results back too, and they kind of can get an

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<v Speaker 1>idea of what's happening, So that brings us to the

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<v Speaker 1>impact also on patient experience. Oh gosh, that was not

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<v Speaker 1>supposed to happen, so sorry, and so patient pre screening.

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<v Speaker 1>So as we see, it's less invasive. So some places

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<v Speaker 1>are doing blood based biomarkers or fluid biomarkers. That does

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<v Speaker 1>include a that's a blood draw and needle a version

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<v Speaker 1>is a thing not everybody wants to do that it's easy.

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<v Speaker 1>It gives awareness around personal cognition. So as I said before,

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<v Speaker 1>it gives patients with meaningful data that is personal that

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<v Speaker 1>they can take that and also have a conversation with

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<v Speaker 1>their PCPs. So the beauty of it is we're not

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<v Speaker 1>just saying, hey, come to this trial, but also hey,

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<v Speaker 1>maybe you want to talk to your primary care physician

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<v Speaker 1>and understand what's going on, or go get checked out further.

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<v Speaker 1>And it just starts a general conversation about brain health

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<v Speaker 1>as well. So we're also interested in that as it

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<v Speaker 1>relates again to some of the community relationships that we're

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<v Speaker 1>building when it comes to diversity practices. It is accessible.

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<v Speaker 1>It allows sites to meet patients where they are. So

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<v Speaker 1>that's a really big and important piece that I believe

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<v Speaker 1>in is meeting sites. Where are patients where they are.

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<v Speaker 1>We have to give them flexibility. We have to understand

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<v Speaker 1>that not everybody's the same and it does improve HDP

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<v Speaker 1>and patient connections. So they're able to have awareness built,

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<v Speaker 1>they're able to build trust on sharing the experience of

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<v Speaker 1>going through understanding what's happening with their own cognition.

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<v Speaker 3>So as we consider patients, now let's consider sites. Right,

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<v Speaker 3>So you're thinking, great, this is fantastic, but what's this

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<v Speaker 3>going to take on for the site as they try

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<v Speaker 3>to implement this into their processes. One is that there's

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<v Speaker 3>a partnership that is put into place between NOVOIC and

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<v Speaker 3>the site as this is implemented, which allows for effective engagement.

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<v Speaker 3>There's that direct communication, right, So the site is trained

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<v Speaker 3>up ahead of time, and that's item number two here

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<v Speaker 3>to let them know what the output of.

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<v Speaker 2>That scale is.

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<v Speaker 3>So it's translatable, right, It's not like they're just given

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<v Speaker 3>a number and the site is left to figure out

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<v Speaker 3>what that means. Just as in the same way that

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<v Speaker 3>that information is meaningful to the patient, it's also meaningful

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<v Speaker 3>to the site because now if they're coming through their

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<v Speaker 3>database and they're giving this pre screener, right, or maybe

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<v Speaker 3>they've engaged with somebody at a community event, right, and

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<v Speaker 3>they give them this pre screen or they give them

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<v Speaker 3>that link. Now that information, they'll be able to have

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<v Speaker 3>just that much more knowledge about that patient and the

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<v Speaker 3>probability of them being amoid pat positive. Right, those are

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<v Speaker 3>the patients you want to bring in for these trials.

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<v Speaker 3>So with that, Novok did multiple live webinar options for

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<v Speaker 3>site staff. They also had that webinar recorded online. Let's say,

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<v Speaker 3>you know, a community fair came up on Saturday, and

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<v Speaker 3>we're going to send somebody out there. They know nothing

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<v Speaker 3>about this. They didn't go to the Novok training that

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<v Speaker 3>we had a couple of months ago.

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<v Speaker 2>They have access to that training now, so they could

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<v Speaker 2>be well equipped.

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<v Speaker 3>And Last, but certainly not least, which was really neat

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<v Speaker 3>about this was a site customization. Like Katie mentioned, it's

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<v Speaker 3>not a one size fits all, right, So sites had

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<v Speaker 3>different ideas about how they can implement NOVOK. Some are

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<v Speaker 3>putting QR codes into mailers and shipping them out to patients.

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<v Speaker 2>In the area or people in the area.

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<v Speaker 3>Some were again at community fairs, had a QR code

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<v Speaker 3>or a link. Some had tablets available, So there's all

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<v Speaker 3>sorts of different ways to implement it, to customize to

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<v Speaker 3>the site, to engage those potential patients.

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<v Speaker 1>Yeah, and so we again gosh quick on the trigger.

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<v Speaker 1>So we have some real world metrics that we had

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<v Speaker 1>come up and just want to share some of the

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<v Speaker 1>results from our initial pilot. And I will say this

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<v Speaker 1>is just in our site use case, but we did

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<v Speaker 1>some additional interesting things. So we implemented this in the

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<v Speaker 1>US and in the UK. What we also did is

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<v Speaker 1>we partnered with a joined Dementia Research registry that's out

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<v Speaker 1>in the UK, and we saw a really great adoption

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<v Speaker 1>rate really across the board. We got some interesting metrics

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<v Speaker 1>around patient age. So overall in the US we saw

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<v Speaker 1>a pretty high completion rate for patients that were over

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<v Speaker 1>the age of seventy. We did see a bit lower

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<v Speaker 1>in the JDR registry collaboration. However, that's somewhat reflective of

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<v Speaker 1>the patient population that's in that registry as well, and

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<v Speaker 1>then just some of the patients that we're choosing to

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<v Speaker 1>opt into using the platform. We had assessment completion rate

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<v Speaker 1>of fifty percent. Our highest assessment completion rate was actually

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<v Speaker 1>sixty two percent in JDR. And I will say as

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<v Speaker 1>far as implementation goes. One of the reasons why is

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<v Speaker 1>that we had navigators that were actually helping patients with

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<v Speaker 1>how to complete and they were following up just assessing

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<v Speaker 1>whether or not they understood it and they whether they

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<v Speaker 1>needed any additional assistance. Next, we have some additional metrics.

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<v Speaker 1>So we had a total of one thousand, over one

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<v Speaker 1>thousand assignments. So an assignment is essentially a site sending

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<v Speaker 1>out the link to storyteller to a given patient. We

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<v Speaker 1>had thirty thirty three percent site adoption rate, which that

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<v Speaker 1>was over the course of seven months, and there was

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<v Speaker 1>admittedly a lot going on at that point in time.

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<v Speaker 1>We've had a pretty busy bit of time with ad

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<v Speaker 1>and biogen, So then we had six months for the

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<v Speaker 1>UK that was a higher adoption rate at eighty two percent,

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<v Speaker 1>which was quite impressive. I think there's a lot of

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<v Speaker 1>thought process around will this be adopted x us and

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<v Speaker 1>the answer is that in the UK there was a

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<v Speaker 1>very high acceptance. And then we did have only four

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<v Speaker 1>months for the j D The JDR Collaboration UK had

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<v Speaker 1>nine hundred assignments, pretty big numbers for only six months,

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<v Speaker 1>and we ultimately ended up with almost three hundred completions,

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<v Speaker 1>and then also we had over five hundred completions in

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<v Speaker 1>the US as well as another what twot eighty in

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<v Speaker 1>the JDR collaboration. So really we were pretty enthusiastic about

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<v Speaker 1>the uptake total. What we saw was, uh, you know,

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<v Speaker 1>in summary, is just the number of patients that we

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<v Speaker 1>were able to bring in over a really seven month

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<v Speaker 1>max period of time was almost six hundred patients with

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<v Speaker 1>the scoring threshold that was what we had set for

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<v Speaker 1>our study needs. So that brings us to some of

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<v Speaker 1>our conclusions. So one of the things that I would

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<v Speaker 1>just say is, and I bring it to the table

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<v Speaker 1>a lot when we're doing something new and we're doing

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<v Speaker 1>something innovative, I always say enhanced pre screening or anything

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<v Speaker 1>similar to this. We have to allow trust. We have

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<v Speaker 1>to allow sites time to trust their backup camera. So

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<v Speaker 1>I always say, when you're buying a new car, you're

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<v Speaker 1>always kind of freaked out to trust the backup camera

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<v Speaker 1>and not look behind you. And the sites need time

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<v Speaker 1>for that too. So we'll always have an early adopter,

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<v Speaker 1>but sometimes we'll have sites that are a little bit

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<v Speaker 1>concerned and they want to just wait and see, and

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<v Speaker 1>that's completely fine. It's not necessarily in our wheelhouse or

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<v Speaker 1>the best idea to just force them into using and

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<v Speaker 1>trusting it so allow sites some time to trust their

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<v Speaker 1>backup camera. Adoption of vocal biomarker assessments for identifications save

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<v Speaker 1>staff time. So one of the really exciting data points

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<v Speaker 1>that we found is that we had a site that

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<v Speaker 1>adopted it into their overall pre screening process completely and

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<v Speaker 1>it saved them over four hundred hours of site time,

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<v Speaker 1>which is incredible when you think about the constraints on

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<v Speaker 1>sites right now. Four hundred hours is huge. And Andrew

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<v Speaker 1>actually has worked with that site, so I'll allow you

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<v Speaker 1>to elaborate on that if you'd like.

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<v Speaker 3>Yeah, yeah, Actually one of their quotes is the bottom

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<v Speaker 3>right hand quote there from that USPI. So there's a

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<v Speaker 3>site down in Florida. You can well imagine there's a

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<v Speaker 3>very popular elderly community down there in central Florida. They

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<v Speaker 3>decided that they were going to implement this as part

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<v Speaker 3>of their clinic each and every day, so they're well

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<v Speaker 3>poised there. You know, people walk in looking for trials.

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<v Speaker 3>Wouldn't that be great for all of us? But as

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<v Speaker 3>they do this, they have this pre screener. They get

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<v Speaker 3>ten to twenty people a day, and that's the site

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<v Speaker 3>that saved the fourger fifteen hours because originally they were

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<v Speaker 3>administering the Wessler Logical Memory two test, which takes about

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<v Speaker 3>twenty to thirty minutes, or the r bands repeatable battery

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<v Speaker 3>that assessment there also takes about thirty minutes. They were

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<v Speaker 3>reable to reduce that right to a fraction of time

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<v Speaker 3>just to kind of introduce the scale.

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<v Speaker 2>Patient took it on their own.

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<v Speaker 3>They got the data back and saved I think that

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<v Speaker 3>four inser fifteen hours.

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<v Speaker 2>I can't recall if that's monthly.

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<v Speaker 3>But they the PI was like, this is just revolutionized

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<v Speaker 3>the way we work here, and they were able to

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<v Speaker 3>just broaden that funnel to bring people in and already

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<v Speaker 3>have more of a robust pre screener up front.

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<v Speaker 1>Yeah, and then the other point I will make is

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<v Speaker 1>that digital assessments have high convergent validity. So being able

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<v Speaker 1>to have that it allows us to keep patients from

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<v Speaker 1>going into a site for screening that wouldn't otherwise be

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<v Speaker 1>appropriate or suitable. So we're saving the site time, but

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<v Speaker 1>we're saving the patient's time as well, and that is

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<v Speaker 1>really important to us. Andrew, I'll let you take it

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<v Speaker 1>away for the last three.

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<v Speaker 3>Yeah, and as Katie mentions again, it's meaningful data. The

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<v Speaker 3>patient right ideally can then take this again kind of

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<v Speaker 3>see progress on their own right. But it's a powerful

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<v Speaker 3>engagement tool. It gets that conversation going in a sort

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<v Speaker 3>of fun and gamified way, right, because again it's intimidating.

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<v Speaker 3>I got to beat with this person and they're going

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<v Speaker 3>to ask me all sorts of questions. But I can

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<v Speaker 3>do this in the comfort of my own home, at

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<v Speaker 3>my own time. And the other thing that I thought

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<v Speaker 3>was unique, is Katie pointed out before in that slide

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<v Speaker 3>with the metrics, is that you know, so often we

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<v Speaker 3>think age is going to be a barrier technology and age, right,

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<v Speaker 3>you know, the older folks get the less they want technology,

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<v Speaker 3>and perhaps that is true, but we did see that

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<v Speaker 3>age alone should not be the determining factor for whether

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<v Speaker 3>we introduce novel technologies, because there was a great uptake,

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<v Speaker 3>especially in that patient population that was equal to our

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<v Speaker 3>over seventy years old. And last, but certainly not least,

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<v Speaker 3>digital vocal biomarkers are strongly positioned to expand access. You

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<v Speaker 3>can well imagine that if you're not near a brick

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<v Speaker 3>and mortar site that you can deploy this to somebody

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<v Speaker 3>in different communities, rural areas where it's hard to get

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<v Speaker 3>access to sites. It can act as a catalyst to

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<v Speaker 3>discussions around cognition and add significant value to all stakeholders

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<v Speaker 3>that are impacted by that patient identification process. So I

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<v Speaker 3>think that wraps it up, and we've got a minute

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<v Speaker 3>left for Q and I.

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<v Speaker 4>Wonderful presentation. Fantastic biomarker. What's the regulatory authorities thoughts on

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<v Speaker 4>this as a biomarker? That's cool.

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<v Speaker 1>Yeah, So the interesting thing about this is that we're

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<v Speaker 1>only using it for pre screening, so there's not really

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<v Speaker 1>any concern as far as regulatory because it is just

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<v Speaker 1>helping us pre identify patients, so they're going to still

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<v Speaker 1>go through all of the new normal screening procedures. But

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<v Speaker 1>what it does is it changes the bottleneck for sites

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<v Speaker 1>so that they know that the patients they're bringing in

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<v Speaker 1>are highly clinically likely to make it into a trial.

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<v Speaker 4>But I assume that the more people use it, and

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<v Speaker 4>the more that you can compare it with other biomarkers,

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<v Speaker 4>it may eventually become the number one biomarker. And again

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<v Speaker 4>with using AI and other tools, So it's got great potential.

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<v Speaker 4>You use it in the UK and the US, there

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<v Speaker 4>is a common language there. Is it applicable in other

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<v Speaker 4>countries and would they have to speak English or could

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<v Speaker 4>it be translatable?

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<v Speaker 1>It can be translated and as globally available. And I

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<v Speaker 1>will say I can't I can't divulge to terribly much.

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<v Speaker 1>But there are other projects that I have ongoing currently

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<v Speaker 1>in different use cases that we're looking at just how

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<v Speaker 1>it performs in some other biomarkers and how that converted

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<v Speaker 1>validity against those.

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<v Speaker 4>And obviously it gives us score. So on the sixty

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<v Speaker 4>four thousand dollars question is have you tried it yourselves?

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<v Speaker 1>Yes? Yes, it's really interesting. Actually there's a demo. We

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<v Speaker 1>had a demo link and we've all tried it ourselves,

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<v Speaker 1>and it's kind of fascinating because you sit there and

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<v Speaker 1>you try it, and you're hearing this story and you

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<v Speaker 1>go through and you're like, oh my gosh, what is

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<v Speaker 1>this going to mean? What does this look like? But

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<v Speaker 1>ultimately it is really easy. It's far more I think

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<v Speaker 1>it's way more patient friendly. I would much prefer doing

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<v Speaker 1>that over being asked a bunch of questions and We've

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<v Speaker 1>heard that from patients as well. They do much prefer

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<v Speaker 1>just doing it themselves.

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<v Speaker 2>Good. Okay, thank you very much. See you certain say

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<v Speaker 2>thank you.