LS 139 - Digitally Tracking Your Medication with Robert McQuade

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Hello everyone. This is your host, Fernando Aries. In partnership with the Hartman Media Company. It is my pleasure to welcome Dr. Robert McQuaid to the show today. Robert is the Executive Vice President and Chief Strategic Officer at Otsuka Pharmaceutical Company. Otsuka is a Japanese company also present in the US which makes a pill with a digital tracking system. He's here to talk to us about this amazing technology. Robert has more than 30 years of experience in the discovery, development and marketing of drugs for the treatment of mental illness. Robert is a graduate of Davidson College and holds a PhD from the University of North Carolina, Chapel Hill. So welcome Robert. How are you today?

Fine, Fernando. Thank you very much for having us.

And I understand you have another person with you. Can you introduce Andrew for us?

Sure. I'll let Andrew introduce himself. Andrew, hi.

Yes, good morning. Andrew Wright. I'm the Vice President of the Digital Medicine and Medical Device Division here at Oatsuka. I've been in the industry on the commercial side for over 25 years.

Excellent. Well, welcome guys.

And just a point of clarification, Fernando. I'm actually a member of Otsuka Pharmaceutical Development and Commercialization Inc. Which is our research organization in the US And Andrew is a member of Otsuka America Pharmaceuticals Inc. Which is our commercial arm in the U.S. excellent.

Than you for that. So Robert, let's talk about this incredible development. This pill with a digital tracking system. The fda, the Food and Drug Administration in the US really took an unprecedented step in my view. Kind of setting us up for the future to ensure that patients with mental disorders take the medicine prescribed for them with this digital tracking system. It's really the first drug in The United States. With this system, it's essentially a tiny chip inside the pill that communicates with a smartphone app. Now, how significant is this in your view?

So, Fernando, we think this really is a significant advance. We believe that this is, if you will, the first digital medicine. And the sensor being inside the pill actually allows physicians to know if a patient is taking their medicine at prescribed in serious mental illness, which are the diseases that are treated by Abilify. Adherence and non compliance are major issues for patients. And we believe this will now allow physicians to know if a patient's actually taking the medicine or not. And beyond, you know, sort of prior technologies which could actually be circumvented, things like opening a bottle with an electronic sensor or things like that. This one actually measures ingestion of a tablet.

That is just fascinating. Now, do you your company, this pill, the Abilify drug, is made to treat schizophrenia, correct?

Well, specifically, Abilify, my site, which is the product with the sensor in the pill, is approved for the treatment of schizophrenia, for the acute treatment of bipolar I disorder, as well as maintenance treatment, and for adjunctive therapy in patients suffering from major depressive disorder. So these are all indications that Abilify had been approved for as a normal tablet, and those indications in adults transferred then to Abilify. My site with the sensor in the pill.

Now, did you choose the combination of the chip with this particular drug for a particular reason?

We did. Again, I think we started from a perception that compliance is a major issue in the treatment of serious mental illness. Many patients discontinue their therapies without telling their healthcare providers. In addition, patients can often their symptoms can worsen and the clinician doesn't know if the symptoms are worsening because the medicine has stopped working or has the patient stopped taking the medicine?

Yeah.

So this now takes that uncertainty out of the question. So we chose Abilify specifically. Obviously, Abilify has also been used by many, many patients over the years. So both the efficacy, tolerability, and safet profile of Abilify has been well established in the past, and clinicians are very used to taking it. So it seemed actually to be an ideal drug for this first digital medicine.

Right, Makes sense. So how does this work? I know that there's different components, right? There's the pill, there's the chip, there's a patch, there's the app. Give us a sense of the entire system here. How does it work?

So there are actually four components to the system. The first is the sensor that's embedded in the tablet. And I should say that this sensor was originally discovered by Prote Pharmaceutical, who is our partner in this project and who we're working with. The sensor in the pill gets into the stomach, and as the pill is dissolved, the sensor is then activated by stomach acid to send a signal. The sensor itself is actually relatively simple. It's made of normal things like silicon, copper and magnesium, and it's about a millimeter in size. So once it's in stomach acid, it sends a signal that's detected by a patch that's worn on the abdomen of the patient. The patch then communicates with the cloud to send a message to the patient's phone that they took the medication, as well as sending a message to a portal where the physician can see that the patient took the medication. So if you will, the four aspects are the sensor in the pill, the patch, the app on the cell phone, and ultimately the portal that the patient and physician can see that measures the pattern of taking the medicine over the course of time.

Now, what comes to mind immediately is, you know, what happens to the electronics, the materials that the chip is made out of. I mean, this is copper and manganese and so on. Is the chip completely safe to consume? What's the process there?

It is. Major components are copper, silicon and magnesium. And the chip just passes through the digestive tract and is excreted via the feces.

So to relying on, you mentioned the stomach acid to activate the transmission of the information to the patch, Is that what you said?

That's correct. Essentially, the stomach acid sets up an environment that creates a electronic signal and that signal is then detected by the patch.

And what's the size of the patch and where is it located? You know, what's that process about?

Let me ask my colleague if he recalls the exact size of the patch. The patch should be located on the lower part of the rib cage, on the abdomen, on the left hand side of the body. Andrew, do you remember the dimensions of the patch?

I can't recall the specific dimensions. It's a band aid size, a large band aid.

And does the patch need a battery of any sort?

The patch does have a battery, and that's contained within the patch.

Yeah, I'm just thinking, you know, how big and how intrusive that patch is. That's kind of where I'm going at with the question.

Let me see if I can get that information for you. I just don't have it at my fingertips. As Andrew said, it's sort of the size of a large band aid. I want to say something on the order of maybe 3 by 2 inches.

Okay, got it. All right, so it's a patch.

We'll try to get you a precise thing and perhaps you can tell your readers later on when we get that information for you.

Okay, excellent. So that's very fascinating. So you have stomach acid activating a transmission from the sensor into a patch, and then this patch that has its own battery transmits the information to an app. And I imagine this app is available on the major iOS for Apple and Android stores.

Correct, Andrew.

So the launch, it will be available on iOS. We are working to make it available on Android as well.

Okay, let's talk about. You talk about the launch. What's the availability, pricing, what's the timeline for the. The drug and. And with the pill?

Sure. So the launch initially is going to be conducted in close collaboration with only a select number of health plans and providers who identify a limited number of patients with schizophrenia, bipolar 1 disorder, or major suppressive disorder. This rollout, limited rollout, is purposeful as having fewer people using the system initially means their prescribers, health plans, and ourselves can really focus on learning from these patients experiences. And then through ongoing feedback from those using the system every day, OTSUCA will further enhance experience for all prospective users of the system. So it really gives us ability to have a high touch model to really understand how to integrate this both into the provider workflow and into the patient's lives.

Now, Andrew, what would be a timeline that you're looking at? Are we talking months or years? You know, especially here in the US listeners that would be interested in this type of a delivery system, what should they expect?

Yes. So we anticipate launching sometime in the first quarter of next year. Once we've had the contracting discussions, we anticipate that for about the first year there'll be with that limited number of select plans, and then it will be iterative. So based on how fast we learn and how fast we operationalize and optimize and get to scale, then we'll continue to grow to a national scale. So it will go as fast as we can, make sure that we can provide the right experience to both patients and their providers.

I'm sure, I'm sure this is very fascinating because I can see, you know, maybe we can explore this a bit. We can envision. I think we can imagine scenarios where we can introduce electronics together with drugs and supplements. Maybe you guys can just talk a little bit about what else do you see this leading us to? What does the future look like if this technology, once it's proven. What else do you think that we can see chips being tied to in the near future and in the long term?

So, for me, it's really about ingestion of the medicine and adherence to the way that it's been prescribed by your physician. While certainly it's a major issue in serious mental illness, in fact, medication adherence is an issue across virtually all diseases. And in theory, this technology should be applicable to many medicines, whether it's a mental illness or even ultimately building a system that can actually remind patients if they forgot to take their medicine in more normal circumstances. Certainly I have a couple of prescribed medications, and there are some days that I forget to take it. I can envision a day down the road that I'd be able to get a reminder from my cell phone that I didn't take my medication that morning like I usually do.

Yeah.

I can also see where it can measure some markers in the blood itself if there's a delivery made by the medicine or any supplement. And it can then sense what the intake, the bioavailability of that drug or supplement is and instantaneously detect whether there's a bigger dose that is needed. You know, I can see where these sorts of precise measurements can be made. Do you know, and your partner with Proteus designing the chip, are you in? Talks about expanding into that arena of measurement, blood measurement, or even digestion system, doing any sort of measurements and seeing the effectiveness of the drug itself.

It's a great question and certainly an intriguing area of medicine to think about. The current system does do some other things. The sensor itself in the pill really doesn't do anything other than measure ingestion at this point in time. It never enters the bloodstream, so it would never be able to monitor something in the bloodstream. On the other hand, the patch that's attached to the ribcage can measure other things. In theory, right now, it measures activity and posture, if you will, which will give us insights into sleeping patterns and the quality of sleep that patients may have while they're taking the medicine. And then, of course, the app itself can have patient recorded information. And in fact, our app asks patients both about their quality of their sleep. So we can measure sleep in two ways. One objective, based on the information on the patch, and the other, subjective, about asking a patient how well did they sleep last night? And it also asks patients about their mood. And ultimately, you can start to correlate some of these activities in building different algorithms. But I can also see down the road, and certainly I think our Colleagues at Proteus are looking at some of this, looking at things like blood pressure and its correlation to taking medicine and other bodily functions generally that are measured by the patch. So I think that there's a world of opportunity here, and we're just beginning to scratch the surface, but I think it's an important first step. We really needed to get this through the agency, and certainly I commend them and some of their vision for this and get it into the real world where we can begin to experiment with it a little more meaningfully.

Yep, I can certainly see that. I think this is just the tip of the iceberg. Now, we briefly talked about the fact that the chip itself just dissolves into the system. Any side effects that you see? Besides the chip itself, does the patch have any side effects? Does the whole system create any discomfort?

Well, the sensor is in the Abilify tablet. So from that perspective, the side effects we see are those that we've seen for many years with Abilify, extrapyramidal symptoms, akathisia, weight gain. These are all things that have been observed with Abilify over the years and which are well characterized and pretty well recognized by the prescribing population. The only unique, if you will, adverse events that we've seen with this system are actually associated with the patch. Because you attach it to your skin, you can have some dermal irritation where the patch sits on the skin, and that has been observed in some patients.

Yeah, that makes sense from the drug itself. Very good. Well, I know we're coming up to the end of the show, and it's definitely been a pleasure talking to you, Robert, and Andrea, as well. Where can people go to learn more? If you can give us any links or point us to any more information about this incredible pill delivery with a digital tracking system.

So they're able to go to the website, which is abilify mysite.com Very good.

Well, thank you, Robert and Andrew. It's been a pleasure having you, and you have a good day.

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