Ensuring Medication Adherence Via Smart Patches With Ategenos' Don DeGolyer

An unfortunately common occurrence, especially with oral administration, is patients missing doses of their medications. In this episode of Sit and Deliver, Founder and CEO Don DeGolyer of Ategenos Phamaceuticals talks with host Tom von Gunden about ways to counter medication non-adherence by using smart transdermal delivery devices for monitoring and administering medicines. 

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Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader

Welcome to another episode of Sit and Deliver. My name is Tom von Gundin, Chief Editor at Drug Delivery Leader and your host for today. Today I am joined by CEO Don DeGolyer from Ategenos Pharmaceuticals, a medical or medicine non-adherence development company. Welcome, Don.

Don DeGolyer, Founder and CEO, Ategenos Pharmaceuticals

Thank you, Tom. I'm delighted to be here, really.

Well, good. It's my privilege to have you here. So, I know that Ategenos is focusing on novel drug delivery technologies, especially to address medication non-adherence. And we'll talk about the technology that involves transdermal smart patches, as I understand it.

But, let's start at that higher level. Tell us about the scope of this medication adherence problem. What does it commonly look like, if you do see it? And just tell us a little bit about what's out there.

Sure. Well, medication non-adherence is a $1 trillion global issue. It's a $500 billion issue in the US alone. And it's often invisible until real harm occurs. And the consequences are very serious. I mean, hospitalization, irreversible events, loss of stability, just to name a few. And the healthcare system assumes patients can remember and comply perfectly. And most non-adherence is unintentional. It's not willful. So really, the key point being non-adherence is a design problem, Tom. It's not a patient problem.

Gotcha. So, I hope that in the rare occasions when I've needed medications myself, I've been compliant. But I think of that as a patient taking pills or capsules. So, is the medication non-adherence problem traditionally — not necessarily caused by that [oral administration] — but is that a contributing factor? That we're asking folks to take things orally?

Yeah, it's a good question. It's really most common in chronic conditions where consistency matters the most. Oral dosing seems convenient, but it relies on daily human memory. And we all know that life gets in the way, especially for aging patients or those with behavioral health conditions. And finally, missed doses often go undetected until there's a health crisis. So oral dosing is, in a word, fragile by design and in real-world conditions, especially.

Gotcha. So, before we move to what you folks are working on, what solutions, if there are any out on the market or in development, have been out there to attempt to address this non-adherence problem? And to what effect? With what limitations?

Right. Everything from reminders, to apps, to software, to smart pill bottles, to ingestibles, and all requiring patients to do more. They add friction, and whether it's charging, scanning, logging, or interacting, they do generate data, but not timely interventions. So, they typically work in pilots, but not at scale. And the bottom line really is if a solution depends on patients behaving differently, the probability of being able to scale is very, very low.

Gotcha. So. I know, not to season you here, but I understand that you have had quite a long career in the pharmaceutical industry. So, I'm interested in the path that led you to your current work as CEO and founder at Ategenos. Is there something, in particular, that got you particularly passionate about and committed to addressing this medication adherence issue?

Right. Well, thanks for that question. Your question makes me think back 20-ish years ago to my days at Novartis. My team and I had responsibility for medication adherence. There was a particular executive committee meeting that I remember where we were reviewing non-adherence data for one of our cancer blockbuster products, Gleevec, which is used to treat chronic myeloid leukemia, also known as CML.

So, maybe just as a little bit of background: In the early 1990s, five-year survival rates for CML were about 30%. Gleevec gets approved by the FDA, and shortly after, five-year survival rates soar to 70%. So real, real breakthrough innovation. Yet, at the time, the data that we were being presented suggested that there was a 30% medication non-adherence rate after Gleevec patients were on this oral therapy for seven months. And this was in the face, like I say, of 40% higher five-year survival rates, Tom. I mean, amazing when you think about it.

And this also, I guess the other part of my journey is this also became personal for me when a family member didn't take her atrial fibrillation medication several days in a row. She suffered a preventable stroke. She fell and broke her hip and has been, really, wheelchair-bound ever since. And so, the insight for me wasn't just this tragedy. It was if patients and caregivers could receive real-time alerts, not relying on that perfect human behavior to remember to take their pills, we could avoid many of these catastrophic health events. And that experience made me see adherence really as a system failure, not a patient failure. And frankly, drug delivery is where that system can be redesigned. My takeaway was, adherence fails quietly, and the consequences are irreversible.

Yeah, gotcha. Well, thanks for sharing some of the background and also the personal story that led you to having this conversation with me about this topic.

So now we've arrived at where you are and what you and the folks at Ategenos are working on. Let's turn to the technology. I understand you have a technology called SmartPatch™. So, tell us about that. How does it work? What's in it? What's it doing?

Sure. Well, maybe just first a little bit around the building of Ategenos. I mean, simply put, Ategenos was built to remove reliance on that perfect human behavior we keep coming back to and focused on designing adherence into the therapy itself. And we use drug delivery as the intervention point, and that led us to really rethink how medication is delivered.

On the SmartPatch™ itself: Most medications rely on patients remembering to take pills every day. And the shift here is we replace that with a multi-day transdermal patch that delivers the medication automatically. And so that matters because the patch also confirms wirelessly that it's been opened, it's been applied, and when it's time for the next multi-day smart patch, so missed doses are detected in real time, not after a hospitalization. And so Ategenos combines transdermal drug delivery with real-time adherence awareness. So, medication works even when, as we say, life does get in the way.

Gotcha. And you mentioned a few minutes ago, or maybe not that long ago, about how you see the arena in which to deal with this as delivery itself, not necessarily the patient. So, can you comment a bit more about that concept or philosophy and also place that in today's environment? Why now to do it this way?

Sure. Well, first of all, remote therapeutic monitoring reimbursement exists today. Payers are demanding measurable ROI. The internet of things is reliable and low cost today, so that's not a small point. Also, regulators are comfortable with connected therapeutics, and AI is only accelerating this. And I guess, finally, what I would say is pharma wants and needs better real-world evidence and lifecycle extensions. I mean, 10 years ago, this was impossible, Tom. Five years ago, it was too early, and today the healthcare system is ready.

Gotcha. Yeah. So, as you're moving to take things to market, I know that the first indication that you're focusing on is bipolar disorder. So, tell us about that focus as an initial launching point.

Sure. Well, we're really excited about our ability to satisfy the unmet medical need here based on some research that we've already done with insurers. We made the insurers part of our development team very early on. That was something that was important to us. And firstly, there are high rates of unintentional non-adherence in this population. Secondly, missed doses lead to rapid destabilization, and consequences include hospitalization and loss of housing, for instance. Current options are daily pills or inflexible injectables. And our smart patch, as we've discussed, will enable consistency and earlier intervention.

Just maybe a quick story I'll share with you: During our market research, we came across a woman who was battling with bipolar I disorder for 45 years, Tom. She lives at home and her daughter is her primary caregiver. Her daughter shared with us that there are a lot of similarities between someone with substance abuse and bipolar: highs and lows, non-adherence, constant turmoil.

And she told us, once her mom starts to feel better, she stops taking her medicine. She also told us that she had her mom write a letter to herself when she was compliant with her medication and doing well to remind her how much better she felt when she was on her medication. So, the stress for these families is palpable and our insight was [that] adherence directly translates to stability, quality of life, and importantly, peace of mind.

Gotcha. Well, thank you for offering that specific example of a patient experience because it's a perfect transition to the way I like to end these conversations for Sit and Deliver. And that is, I like to think about, where do we stand today? And then look out — whether it's near or far, whatever that horizon is — into a future state. So, if these approaches to adherence can develop and move into the market at scale, how do you envision what the landscape for patients and families and caregivers might look like once these options arrive in their worlds?

Well, that's a great way to end the segment. I mean, because the value proposition for each of the stakeholders is significant. I mean, for patients and for caregivers, it's peace of mind, like we've talked about here, and fewer surprises. For clinicians, it's visibility into patterns, not just emergencies. For payers, it's fewer hospitalizations and a lower total cost of care. And for pharma, it's better real-world performance, real-world evidence, and innovative lifecycle management. When everyone benefits in the value chain, we know that adoption will scale. So, for family and caregivers, the hardest part is not knowing. Our platform replaces that uncertainty with peace of mind, Tom.

Gotcha. Well, it all sounds very promising. Thanks for joining me today, Don, to share the work that's being done at Ategenos Pharmaceuticals. And I also want to thank our Drug Delivery Leader audience for joining us for another episode of Sit and Deliver. And we'll see you next time.