Speaker 1: All right, thank you, so really excited to be here.
Speaker 1: We've got some exciting things to show about a pilot
Speaker 1: that we've done on vocal digital biomarkers and Alzheimer's. I
Speaker 1: am the associate director of Patient Centricity and Engagement in
Speaker 1: the Alzheimer's portfolio at Biogen, and here with me I
Speaker 1: have my colleague Andrew who Andrew, I'll let you go
Speaker 1: ahead and introduce thanks.
Speaker 2: So I managed Riguero.
Speaker 3: I am a senior clinical country and sightly that's a
Speaker 3: really fancy way of saying that I am a liaison
Speaker 3: between the sponsor and our sites. So we're excited to
Speaker 3: talk more to you today about this vocal biomarker that
Speaker 3: we rolled out not too long ago.
Speaker 2: And I'll turn it back over to Katie.
Speaker 1: Yeah. Yeah, So first I'm going to just start out
Speaker 1: with a little bit of a roadmap. So how did
Speaker 1: we arrive at vocal biomarkers for patient ID because I
Speaker 1: know it is a little bit different. So we started
Speaker 1: out and I really do like to challenge status quo
Speaker 1: when it comes to developing strategies for patient engagement. So
Speaker 1: what we arrived at was a set of problems that
Speaker 1: I see that we've noticed over time in some of
Speaker 1: our ad studies, so one of them being pre screening
Speaker 1: is a big burden. It takes a lot of bandwidth
Speaker 1: from the site. It's no secret we've heard it here
Speaker 1: a bunch that these sites are really really pressed right now.
Speaker 1: They've got a lot going on, there's tons of saturation.
Speaker 1: Site turnover is difficult, so I really need to get
Speaker 1: out and around that. We have the issue that you know,
Speaker 1: pre screening processes are really really heavy on the taking
Speaker 1: and not so great on giving back to patients. So
Speaker 1: we may ask them ten or fifteen questions and a
Speaker 1: standard pre screener right and they don't necessarily understand why
Speaker 1: those questions are being asked, or maybe they're frustrating. And
Speaker 1: in the end we say, hey, you might be you
Speaker 1: might be qualified for a clinical trial, but we'll have
Speaker 1: a site get back to you, and maybe that happens,
Speaker 1: maybe it doesn't. So the beauty of this is how,
Speaker 1: you know, how do how do we get out and
Speaker 1: around that too, How do we give back to a
Speaker 1: patient and have it be meaningful. One of the other
Speaker 1: things is that screen failure is really disappointing to patients.
Speaker 1: So you know, we think about site morale, and I
Speaker 1: get into that in the next bullet, But what does
Speaker 1: that mean for a patient? What does that mean as
Speaker 1: we go into a diversity too. So we've got people
Speaker 1: that have taken this leap of faith and they're saying,
Speaker 1: you know, this is something different, I'm going to give
Speaker 1: it a try, and then they get to the point
Speaker 1: of going into the visit and they get their hopes
Speaker 1: up and that's tough, and that's tough for community relationships
Speaker 1: as well. So wanted to kind of think about that.
Speaker 1: And then the high volume of prescreen and screen failure
Speaker 1: is really tough on timeline, it's tough on morale, and
Speaker 1: it's tough on our budgets. So it left us with
Speaker 1: this question that was, how might we uh just look
Speaker 1: into a way that we can enhance pre screening process
Speaker 1: and do something a little different than we've done before
Speaker 1: and also be able to empower our patients and prevent
Speaker 1: site burden and accelerate or enrollment periods. So with that,
Speaker 1: this is where we get into digital biomarkers.
Speaker 3: Yeah, so just to set the stage right, So in
Speaker 3: Alzheimer's disease in particular, you can imagine that there are
Speaker 3: a plethora of screening challenges and just to bring some
Speaker 3: of them up. So, for one, they're frustrating, right you're screening.
Speaker 3: It's the first time sometimes that you're meeting the site.
Speaker 3: You may have gotten a referral to that site, or
Speaker 3: you may have been brought there from some event or outreach,
Speaker 3: and it's frustrating because they know that there's something wrong
Speaker 3: and now you're exacerbating that by doing a plethora of
Speaker 3: all these memory and cognitive assessments. The other thing is
Speaker 3: that doing those assessments from the site side can be
Speaker 3: restricted due to radar excuse me availability, right, They need
Speaker 3: to be trained and certify to administer those scals, and
Speaker 3: oftentimes those raiders are being used for the trials themselves
Speaker 3: and don't necessarily have the time to do pre screening.
Speaker 3: Along with that, if we consider some other options that
Speaker 3: are available, like PET and MRI, right because you're doing
Speaker 3: these to establish a diagnosis, it can be overwhelming and disorienting.
Speaker 3: The other reality is that a lot of trials in
Speaker 3: Alzheimer's disease require an amyloid PET positive scan, and just
Speaker 3: doing that alone is expensive, it's time consuming, and finding
Speaker 3: access to the ligands can be very challenging. Along with
Speaker 3: that is add it on top of all that is
Speaker 3: are the care partner requirements. There's time commitments just taking
Speaker 3: that time out of work to bring mom or dad
Speaker 3: into a clinic to just have a screening done or
Speaker 3: a pre screening done, and then the continuity from caregiver
Speaker 3: to caregiver. Some of these scales that are admitted start
Speaker 3: require caregiver input and sometimes the same sun or daughter
Speaker 3: can't bring mom or dad into the clinic all the time.
Speaker 3: So there's these challenges and as we thought about this,
Speaker 3: a solution became available.
Speaker 1: So after a lot of time and effort spent looking
Speaker 1: for what is the right way of doing this? How
Speaker 1: do we figure this out? How do we solution for this?
Speaker 1: We arrived at a very small startup. The startup is
Speaker 1: called Novoic and they have a pre screener that is
Speaker 1: a digital biomarker. It is by no means a medical device,
Speaker 1: It is by no means meant to actually diagnose, but
Speaker 1: it has high clinical validity and basically by what Novoic's
Speaker 1: platform does is it's called Storyteller and it's a ten
Speaker 1: minute assessment where patients hear a story and they are
Speaker 1: tasked with telling the story back. So based on the
Speaker 1: syntax and the patient's voice which is the digital vocal biomarker,
Speaker 1: and their recall combined together, that gives us an understanding
Speaker 1: of whether or not the patient may or may not
Speaker 1: have beta amyloid positivity on PET. It's got high convergent
Speaker 1: validity to a lot of the different scales that we're
Speaker 1: using in screening, including in our bands, which is one
Speaker 1: that we've notoriously seen as a major screen fail reason
Speaker 1: for our diverse patients as well. And it's ten minutes.
Speaker 1: The sites only have to send out a link, the
Speaker 1: patients are able to do it on any device, and
Speaker 1: they can do it from the comforts of their home,
Speaker 1: so it adds a lot of access and it starts
Speaker 1: a conversation too. So that's the other piece of the
Speaker 1: differentiation between standard pre screening and this type of assessment
Speaker 1: is that it starts the conversation about brain health and
Speaker 1: cognition and what may or may not be going on.
Speaker 1: So there's a lot of site benefit as it relates
Speaker 1: to time, I'm savings, They get results, patients get their
Speaker 1: results back too, and they kind of can get an
Speaker 1: idea of what's happening, So that brings us to the
Speaker 1: impact also on patient experience. Oh gosh, that was not
Speaker 1: supposed to happen, so sorry, and so patient pre screening.
Speaker 1: So as we see, it's less invasive. So some places
Speaker 1: are doing blood based biomarkers or fluid biomarkers. That does
Speaker 1: include a that's a blood draw and needle a version
Speaker 1: is a thing not everybody wants to do that it's easy.
Speaker 1: It gives awareness around personal cognition. So as I said before,
Speaker 1: it gives patients with meaningful data that is personal that
Speaker 1: they can take that and also have a conversation with
Speaker 1: their PCPs. So the beauty of it is we're not
Speaker 1: just saying, hey, come to this trial, but also hey,
Speaker 1: maybe you want to talk to your primary care physician
Speaker 1: and understand what's going on, or go get checked out further.
Speaker 1: And it just starts a general conversation about brain health
Speaker 1: as well. So we're also interested in that as it
Speaker 1: relates again to some of the community relationships that we're
Speaker 1: building when it comes to diversity practices. It is accessible.
Speaker 1: It allows sites to meet patients where they are. So
Speaker 1: that's a really big and important piece that I believe
Speaker 1: in is meeting sites. Where are patients where they are.
Speaker 1: We have to give them flexibility. We have to understand
Speaker 1: that not everybody's the same and it does improve HDP
Speaker 1: and patient connections. So they're able to have awareness built,
Speaker 1: they're able to build trust on sharing the experience of
Speaker 1: going through understanding what's happening with their own cognition.
Speaker 3: So as we consider patients, now let's consider sites. Right,
Speaker 3: So you're thinking, great, this is fantastic, but what's this
Speaker 3: going to take on for the site as they try
Speaker 3: to implement this into their processes. One is that there's
Speaker 3: a partnership that is put into place between NOVOIC and
Speaker 3: the site as this is implemented, which allows for effective engagement.
Speaker 3: There's that direct communication, right, So the site is trained
Speaker 3: up ahead of time, and that's item number two here
Speaker 3: to let them know what the output of.
Speaker 2: That scale is.
Speaker 3: So it's translatable, right, It's not like they're just given
Speaker 3: a number and the site is left to figure out
Speaker 3: what that means. Just as in the same way that
Speaker 3: that information is meaningful to the patient, it's also meaningful
Speaker 3: to the site because now if they're coming through their
Speaker 3: database and they're giving this pre screener, right, or maybe
Speaker 3: they've engaged with somebody at a community event, right, and
Speaker 3: they give them this pre screen or they give them
Speaker 3: that link. Now that information, they'll be able to have
Speaker 3: just that much more knowledge about that patient and the
Speaker 3: probability of them being amoid pat positive. Right, those are
Speaker 3: the patients you want to bring in for these trials.
Speaker 3: So with that, Novok did multiple live webinar options for
Speaker 3: site staff. They also had that webinar recorded online. Let's say,
Speaker 3: you know, a community fair came up on Saturday, and
Speaker 3: we're going to send somebody out there. They know nothing
Speaker 3: about this. They didn't go to the Novok training that
Speaker 3: we had a couple of months ago.
Speaker 2: They have access to that training now, so they could
Speaker 2: be well equipped.
Speaker 3: And Last, but certainly not least, which was really neat
Speaker 3: about this was a site customization. Like Katie mentioned, it's
Speaker 3: not a one size fits all, right, So sites had
Speaker 3: different ideas about how they can implement NOVOK. Some are
Speaker 3: putting QR codes into mailers and shipping them out to patients.
Speaker 2: In the area or people in the area.
Speaker 3: Some were again at community fairs, had a QR code
Speaker 3: or a link. Some had tablets available, So there's all
Speaker 3: sorts of different ways to implement it, to customize to
Speaker 3: the site, to engage those potential patients.
Speaker 1: Yeah, and so we again gosh quick on the trigger.
Speaker 1: So we have some real world metrics that we had
Speaker 1: come up and just want to share some of the
Speaker 1: results from our initial pilot. And I will say this
Speaker 1: is just in our site use case, but we did
Speaker 1: some additional interesting things. So we implemented this in the
Speaker 1: US and in the UK. What we also did is
Speaker 1: we partnered with a joined Dementia Research registry that's out
Speaker 1: in the UK, and we saw a really great adoption
Speaker 1: rate really across the board. We got some interesting metrics
Speaker 1: around patient age. So overall in the US we saw
Speaker 1: a pretty high completion rate for patients that were over
Speaker 1: the age of seventy. We did see a bit lower
Speaker 1: in the JDR registry collaboration. However, that's somewhat reflective of
Speaker 1: the patient population that's in that registry as well, and
Speaker 1: then just some of the patients that we're choosing to
Speaker 1: opt into using the platform. We had assessment completion rate
Speaker 1: of fifty percent. Our highest assessment completion rate was actually
Speaker 1: sixty two percent in JDR. And I will say as
Speaker 1: far as implementation goes. One of the reasons why is
Speaker 1: that we had navigators that were actually helping patients with
Speaker 1: how to complete and they were following up just assessing
Speaker 1: whether or not they understood it and they whether they
Speaker 1: needed any additional assistance. Next, we have some additional metrics.
Speaker 1: So we had a total of one thousand, over one
Speaker 1: thousand assignments. So an assignment is essentially a site sending
Speaker 1: out the link to storyteller to a given patient. We
Speaker 1: had thirty thirty three percent site adoption rate, which that
Speaker 1: was over the course of seven months, and there was
Speaker 1: admittedly a lot going on at that point in time.
Speaker 1: We've had a pretty busy bit of time with ad
Speaker 1: and biogen, So then we had six months for the
Speaker 1: UK that was a higher adoption rate at eighty two percent,
Speaker 1: which was quite impressive. I think there's a lot of
Speaker 1: thought process around will this be adopted x us and
Speaker 1: the answer is that in the UK there was a
Speaker 1: very high acceptance. And then we did have only four
Speaker 1: months for the j D The JDR Collaboration UK had
Speaker 1: nine hundred assignments, pretty big numbers for only six months,
Speaker 1: and we ultimately ended up with almost three hundred completions,
Speaker 1: and then also we had over five hundred completions in
Speaker 1: the US as well as another what twot eighty in
Speaker 1: the JDR collaboration. So really we were pretty enthusiastic about
Speaker 1: the uptake total. What we saw was, uh, you know,
Speaker 1: in summary, is just the number of patients that we
Speaker 1: were able to bring in over a really seven month
Speaker 1: max period of time was almost six hundred patients with
Speaker 1: the scoring threshold that was what we had set for
Speaker 1: our study needs. So that brings us to some of
Speaker 1: our conclusions. So one of the things that I would
Speaker 1: just say is, and I bring it to the table
Speaker 1: a lot when we're doing something new and we're doing
Speaker 1: something innovative, I always say enhanced pre screening or anything
Speaker 1: similar to this. We have to allow trust. We have
Speaker 1: to allow sites time to trust their backup camera. So
Speaker 1: I always say, when you're buying a new car, you're
Speaker 1: always kind of freaked out to trust the backup camera
Speaker 1: and not look behind you. And the sites need time
Speaker 1: for that too. So we'll always have an early adopter,
Speaker 1: but sometimes we'll have sites that are a little bit
Speaker 1: concerned and they want to just wait and see, and
Speaker 1: that's completely fine. It's not necessarily in our wheelhouse or
Speaker 1: the best idea to just force them into using and
Speaker 1: trusting it so allow sites some time to trust their
Speaker 1: backup camera. Adoption of vocal biomarker assessments for identifications save
Speaker 1: staff time. So one of the really exciting data points
Speaker 1: that we found is that we had a site that
Speaker 1: adopted it into their overall pre screening process completely and
Speaker 1: it saved them over four hundred hours of site time,
Speaker 1: which is incredible when you think about the constraints on
Speaker 1: sites right now. Four hundred hours is huge. And Andrew
Speaker 1: actually has worked with that site, so I'll allow you
Speaker 1: to elaborate on that if you'd like.
Speaker 3: Yeah, yeah, Actually one of their quotes is the bottom
Speaker 3: right hand quote there from that USPI. So there's a
Speaker 3: site down in Florida. You can well imagine there's a
Speaker 3: very popular elderly community down there in central Florida. They
Speaker 3: decided that they were going to implement this as part
Speaker 3: of their clinic each and every day, so they're well
Speaker 3: poised there. You know, people walk in looking for trials.
Speaker 3: Wouldn't that be great for all of us? But as
Speaker 3: they do this, they have this pre screener. They get
Speaker 3: ten to twenty people a day, and that's the site
Speaker 3: that saved the fourger fifteen hours because originally they were
Speaker 3: administering the Wessler Logical Memory two test, which takes about
Speaker 3: twenty to thirty minutes, or the r bands repeatable battery
Speaker 3: that assessment there also takes about thirty minutes. They were
Speaker 3: reable to reduce that right to a fraction of time
Speaker 3: just to kind of introduce the scale.
Speaker 2: Patient took it on their own.
Speaker 3: They got the data back and saved I think that
Speaker 3: four inser fifteen hours.
Speaker 2: I can't recall if that's monthly.
Speaker 3: But they the PI was like, this is just revolutionized
Speaker 3: the way we work here, and they were able to
Speaker 3: just broaden that funnel to bring people in and already
Speaker 3: have more of a robust pre screener up front.
Speaker 1: Yeah, and then the other point I will make is
Speaker 1: that digital assessments have high convergent validity. So being able
Speaker 1: to have that it allows us to keep patients from
Speaker 1: going into a site for screening that wouldn't otherwise be
Speaker 1: appropriate or suitable. So we're saving the site time, but
Speaker 1: we're saving the patient's time as well, and that is
Speaker 1: really important to us. Andrew, I'll let you take it
Speaker 1: away for the last three.
Speaker 3: Yeah, and as Katie mentions again, it's meaningful data. The
Speaker 3: patient right ideally can then take this again kind of
Speaker 3: see progress on their own right. But it's a powerful
Speaker 3: engagement tool. It gets that conversation going in a sort
Speaker 3: of fun and gamified way, right, because again it's intimidating.
Speaker 3: I got to beat with this person and they're going
Speaker 3: to ask me all sorts of questions. But I can
Speaker 3: do this in the comfort of my own home, at
Speaker 3: my own time. And the other thing that I thought
Speaker 3: was unique, is Katie pointed out before in that slide
Speaker 3: with the metrics, is that you know, so often we
Speaker 3: think age is going to be a barrier technology and age, right,
Speaker 3: you know, the older folks get the less they want technology,
Speaker 3: and perhaps that is true, but we did see that
Speaker 3: age alone should not be the determining factor for whether
Speaker 3: we introduce novel technologies, because there was a great uptake,
Speaker 3: especially in that patient population that was equal to our
Speaker 3: over seventy years old. And last, but certainly not least,
Speaker 3: digital vocal biomarkers are strongly positioned to expand access. You
Speaker 3: can well imagine that if you're not near a brick
Speaker 3: and mortar site that you can deploy this to somebody
Speaker 3: in different communities, rural areas where it's hard to get
Speaker 3: access to sites. It can act as a catalyst to
Speaker 3: discussions around cognition and add significant value to all stakeholders
Speaker 3: that are impacted by that patient identification process. So I
Speaker 3: think that wraps it up, and we've got a minute
Speaker 3: left for Q and I.
Speaker 4: Wonderful presentation. Fantastic biomarker. What's the regulatory authorities thoughts on
Speaker 4: this as a biomarker? That's cool.
Speaker 1: Yeah, So the interesting thing about this is that we're
Speaker 1: only using it for pre screening, so there's not really
Speaker 1: any concern as far as regulatory because it is just
Speaker 1: helping us pre identify patients, so they're going to still
Speaker 1: go through all of the new normal screening procedures. But
Speaker 1: what it does is it changes the bottleneck for sites
Speaker 1: so that they know that the patients they're bringing in
Speaker 1: are highly clinically likely to make it into a trial.
Speaker 4: But I assume that the more people use it, and
Speaker 4: the more that you can compare it with other biomarkers,
Speaker 4: it may eventually become the number one biomarker. And again
Speaker 4: with using AI and other tools, So it's got great potential.
Speaker 4: You use it in the UK and the US, there
Speaker 4: is a common language there. Is it applicable in other
Speaker 4: countries and would they have to speak English or could
Speaker 4: it be translatable?
Speaker 1: It can be translated and as globally available. And I
Speaker 1: will say I can't I can't divulge to terribly much.
Speaker 1: But there are other projects that I have ongoing currently
Speaker 1: in different use cases that we're looking at just how
Speaker 1: it performs in some other biomarkers and how that converted
Speaker 1: validity against those.
Speaker 4: And obviously it gives us score. So on the sixty
Speaker 4: four thousand dollars question is have you tried it yourselves?
Speaker 1: Yes? Yes, it's really interesting. Actually there's a demo. We
Speaker 1: had a demo link and we've all tried it ourselves,
Speaker 1: and it's kind of fascinating because you sit there and
Speaker 1: you try it, and you're hearing this story and you
Speaker 1: go through and you're like, oh my gosh, what is
Speaker 1: this going to mean? What does this look like? But
Speaker 1: ultimately it is really easy. It's far more I think
Speaker 1: it's way more patient friendly. I would much prefer doing
Speaker 1: that over being asked a bunch of questions and We've
Speaker 1: heard that from patients as well. They do much prefer
Speaker 1: just doing it themselves.
Speaker 2: Good. Okay, thank you very much. See you certain say
Speaker 2: thank you.