Implementing a Transformative MedTech Program to Gather Real-World Data

Spencer Health Solutions

Creating Change Agents to Embrace Digital Health Tech

The following is a re-broadcast of a conversation between Tom Rhoads, CEO of Spencer Health Solutions, and Kelly Roland, Associate Director at Otsuka Pharmaceutical, and moderated by Janet Kennedy during the “People Always, Patients Sometimes” podcast.

One of the foremost conferences in the field of clinical trials is SCOPE (Summit of Clinical Ops Executives) and Spencer Health Solutions served as a premier sponsor of the event. Spencer also co-presented at the conference with a client and collaboration partner, Otsuka Pharmaceuticals. 

Our content was presented on the track that focused on accessing and generating real-world data. The presentation was titled, “Implementing a Transformative Medtech Device Program to Gather Real-World Data.” Our co-presenters were Tom Rhoads, CEO of Spencer Health Solutions, and Kelly Roland, Associate Director, Otsuka Pharmaceutical. In planning this presentation, we decided to show a little bit behind the curtain of how a large pharmaceutical company evaluates digital health technology before it is written into a patient protocol.

Let me set the stage. My name is Janet Kennedy and I’m the host of the “People Always, Patients Sometimes” podcast.

Coming up is a conversation between Tom and Kelly walking through Otsuka’s reasons for creating an internal focus group to evaluate the spencer smart hub. As part of the evaluation, Spencer Health looks forward to having Otsuka learn about and experience our deeper data and a more comprehensive look at how patient real-world evidence can be used to support the patient and improve outcomes. I hope you enjoy this candid conversation between Tom Rhoads and Kelly Roland on “People Always, Patients Sometimes”.

Tom Rhoads: (01:42)
Hi, I’m Tom Rhoads, CEO of Spencer Health Solutions. Spencer is an FDA class one medical device for use with medication management, patient engagement, and data collection. The spencer smart hub is being used in care management for about three years now. And in 2019, we added the clinical trial and commercial pharma division and launched spencer smart hub into both the clinical trial, as well as post-approved commercial pharma applications. We’re really pleased to be presenting at SCOPE this year, and we’re very proud to be joined in the discussion today by our partner in an innovative internal focus group program.

With me is Kelly Roland, Associate Director of Otsuka Pharmaceuticals. Hello Kelly, how are you doing today?

Kelly Roland: (02:23)
Hi, Tom. Thanks so much for inviting me to join you today. I’m excited to be here.

Tom Rhoads: (02:28)
Well, that makes two of us. Kelly, our presentation in the SCOPE track is focused on accessing in generating real-world data, which is having a greater impact on the design and clinical trials and patient programs more than ever before. But before we jump into a discussion of our focus group, could you share any insights on why real-world data is a priority for Otsuka Pharma?

Kelly Roland: (02:49)
Happy to. So as you know Tom, real-world data, real-world evidence – it’s really information that creates action. So using this information, we’re able to not only look at the improved design of clinical trials but also conduct those clinical trials in new and different ways. Better data really lends itself to potentially faster analysis and better drug development overall, with really the aim advancing towards understanding both patients and drugs sooner. So from an operational standpoint, real-world data real-world evidence can enable more efficient, effective clinical trials and hopefully remove any friction for patients, investigators, and sponsors.

Tom Rhoads: (03:37)
Well, it’s interesting cause you know, as we were designing Spencer, the ability of patients to provide data back to the SmartHub was always central to our design. In fact, whether we’re capturing biometric data passively through a Bluetooth connection, or from the patient’s direct response to survey questions. We always wanted to be able to provide multiple layers of health data beyond the moment of medication dispensing, and our program today is really to share a rare insight into how a large pharmaceutical company can bring new technology to their patients and ensure that the internal team has buy-in on the new program. So, Kelly, digital health apps have been around for quite a while; why is the team at Otsuka interested in designing an internal evaluation before introducing Spencer to your patients?

Kelly Roland: (04:21)
Otsuka is a company that’s really dedicated to serving those with unmet medical needs, and we really strive to innovate and defy limitations. When we first evaluated Spencer, we felt it could really help us put the patient at the center of the trial first and foremost. And at the same time, we also knew it would break those current processes and operational logistics that you have for more traditional ways of running a clinical trial. So by getting out of our comfort zone and kind of embracing this new way, this new technology, a new way of doing things, we decided to pilot our own internal focus group, Otsuka only. We could have easily outsourced this to another group to research for us. However, we thought that this internal approach would allow Otsuka functional area champions really, or subject matter experts with that really in-depth personal experience with the device. They could experience firsthand what the patient would experience and help to develop new processes and new solutions based on those insights.

Tom Rhoads: (05:29)
You know, you remind me, as we went to develop Spencer, we developed it from the patient out. So to see pharma taking the same position of understanding firsthand what the patient would experience is truly innovative, and we were obviously thrilled to learn you’d be interested in having your team experience Spencer in person. So maybe let’s break down a few reasons why that’s a good idea.

Kelly Roland: (05:52)
Holding that internal focus group served a few key purposes for us. First, as I mentioned, gather those insights very quickly and you get that firsthand knowledge that you wouldn’t have otherwise. We wanted our teams to look through the lens of the patient, the site, and actually their own functional area when evaluating Spencer. So in the case of Spencer, it’s a new technology, it requires a bit more organization, a little more prep work on the part of the team. And we thought this could be an exciting new approach for us. So our goal was to really set up a focus group so we could better evaluate everything end-to-end from the program set up, data integrations, training materials, and overall how Spencer worked.

Tom Rhoads: (06:38)
So when you think about really the protocol that you’re outlining, why was it important for Otsuka to kind of evaluate Spencer in each of the different roles?

Kelly Roland: (06:47)
So when we’re planning protocols or planning our programs, we really want to anticipate as much as possible where there could be difficulties where there could be challenges. One such area is those new roles and skillsets, quite honestly, that need to emerge when you layer technology and roll real-world data into the mix. In the past, we’ve relied heavily on, I’d say more manual processes together with feedback from patients and sites. But with new digital platforms like Spencer, we can be much more proactive in assessing how a patient’s doing between their clinic visits, especially as decentralized trials become much more common here in the future. But that said, we can better respond as a company if we’ve lived the experience in those key roles. It makes our team more intuitive in designing a protocol, and also a little more creative in the support materials that they bring along as well. So a focus group like this creates a lot of change in the company, but it also creates change agents, I’ll call them because now they’ve lived the experience, they can spread the word to their colleagues and other functions about the tool. They can be that subject matter expert in their function and help others to understand either the value and or challenges of this particular tool. So I think a focus group is a really interesting and a great way to start that change management activity.

Tom Rhoads: (08:15)
That’s a great point. So as we kind of break down the roles, maybe we can take a deeper dive into the patient role for a moment. What were you interested in evaluating as a patient using Spencer in a clinical trial?

Kelly Roland: (08:27)
I said it before. I’ll say it again – I really think this is going to give us invaluable experience from that patient perspective for our greater team. You know, we know we’re working with a tool that has really interesting data around adherence and engagement, and we really wanted to explore that further. You know, we’re asking ourselves questions like, “could spencer cause annoyance or frustration for a particular indication?” “Are there other indications that may lend themselves more readily to a spencer device versus another?” Would the collection of biometric data in the home be more desirable to a patient or caregiver versus having to go to the doctor’s office?” I think if COVID has taught us anything that does seem to be a much more desirable functionality that people are looking at now. All this to say, it’s very different reading about a tool and assessing capabilities versus actually experiencing them and walking in the patient’s shoes.

Tom Rhoads: (09:22)
So when we look at some of the aspects of the platform, how does the ability to gather patients’ answers, post medications, dispense survey questions, factor into your plan for utilizing real-world evidence? For instance, we found some eliminating data on how different individuals – in fact, two different individuals, both were basically 98% adherent – can reveal very different situations for those patients. Just curious, how do your plans factor in for that real-world evidence?

Kelly Roland: (09:50)
So I think, as you indicated, medication adherence is only part of the story. So the questions we ask patients via the Spencer device could potentially provide, I think, some interesting real-world data on how the patient is not only doing from a physical standpoint but also a mental standpoint. I think the data can help us to potentially create algorithms that allow for some of these deeper insights. Wouldn’t it be interesting to have the ability to predict a manic event in a patient with bipolar disorder, for example, using both biomarker data and survey questions before the event even happens? So finding ways to identify signals related to relapse, potentially diabetes control, et cetera. I mean, this would be something that could be explored by asking the right questions at the right time. And these types of scenarios I think are really what excites our team as we kind of look to take those data insights to the next level.

Tom Rhoads: (10:47)
Oh, that is great. It does remind me of the story I mentioned a moment ago. We had two different individuals currently on platform. From a high level, they were picture perfect. They were both basically a hundred percent adherent. They were 98.9% adherent taking their medications during the time prescribed. So you think at this point, check the box and move on; nothing more to see here. When we dug in and began looking at answers to questions, we saw two very different individuals. In fact, there was about a 10-year difference in their age. One was female, one was male suffering from depression as a primary, and other disease comorbidity.

When you dug down into the questions you found that one person was sleeping well, eating well, exercising; in many other aspects, basically was on a very good path, consistent with a high adherence rate. Yet the other person, even with the high adherence rate, was experiencing a totally different outcome. They were not sleeping well, not eating well, not exercising. And their depression was a bit spiraling. Those are the types of data and insights that we all hope to collect. And I think working with a leader like Otsuka to be able to apply, as you said, algorithms, so that we can begin to notice these patterns and alert against these patterns, are critical really for healthcare’s future.

Kelly Roland: (12:11)
Totally agree, Tom. I think that that’s something that our team looks forward to learning more as we push forward. This is exciting.

Tom Rhoads: (12:18)
The funny thing for me is often times we all go out and have a third party evaluate something for us, and then they give us a report and we read our reports and we make assumptions and decisions around those reports. You know, cause we’re all busy. I think what’s truly unique here is that Otsuka has decided to have their team do it. And I’ll tell you, from my experience – just my past in marketing – having your own hands-on, you’re going to see things, ask things, question things more deeply than you ever could coming from a report. I think that’s a really interesting aspect of this where companies really do roll up their sleeves to understand what it is they’re evaluating.

Kelly Roland: (13:01)
So, Tom, we talked a little bit about the Otsuka focus group and the program that we’ve developed, and the partnership that we have. From your perspective, was creating the focus group program the same as launching into a new clinical trial? You know, were there any differences or any similarities you could speak to?

Tom Rhoads: (13:21)
Well, overall it was a terrific experience for us. I guess on the firsthand we followed the same procedural pathway that we would use for a clinical trial: treating it as a protocol and really following the regimen and structure and review process with very deep collaboration across the teams. By approaching it in this manner, I think we were better aligned with your team, certainly, with the expectations and the outcomes that you were seeking. I think the difference for us in this way that the focus group program really centered on feedback and modification to best support your long-term needs. And so for us, it was very refreshing, maybe not as nerve-wracking either – given that we had opportunities to modify and change – but being able to go in with a mandate to learn and collaborate was really critical, I think to the teams to provide honest feedback, questions, and have the necessary dialogue and how we can make things better overall, from an onboarding, management, you know, site management, and general support throughout the entire trial. It was a great experience for us, for sure.

Kelly Roland: (14:25)
Thank you for that. And I agree, I think that some of the ease of the focus group was really around being able to be creative and work together in that kind of creative fashion, where if something didn’t work or we wanted to pilot something different or add this or switch that, we had the flexibility to be able to do that. So I agree. I think that this was refreshing from all angles – ours as well. So definitely appreciate that. One other question for you. What do you think, again from your perspective, is an important thing that clients, pharma companies in particular or researchers, need to experience when working with new technology?

Tom Rhoads: (15:07)
You know, digital health has been around for gosh, a decade now, I guess we’ve been talking about it materially, and I think clients, or really anyone looking at technology really needs to understand how to best apply the technology, kind of what the upper and lower limits of the technology are. You know, where is it best used? Who best responds to it? How is it supported? Does it work for their needs or not?

And you know, I think one of the things that Otsuka did such a really refreshing kind of remarkable job of is rolling up their sleeves and experiencing it themselves. I think too often clients look to third parties to evaluate technology and give them condensed reports on it. And it’s hard to make decisions from that. But when you experience a technology firsthand, you’re going to have a really insightful and deep understanding of the good and the bad, and be able to make decisions – and I think more informed decisions – and directionally support your strategy long term. That was something that as we move forward, we’ll certainly be sharing that as an important aspect to evaluating new technology.

Kelly Roland: (16:15)
Perfect. Thank you.

Well, thank you for having us and allowing us to present at SCOPE. We certainly hope you come and visit us in the virtual trade show hall. And it’s really exciting to be able to share our focus group study. We very much look forward to sharing the findings that come out of this, maybe in the next SCOPE.

Kelly Roland: (16:35)
Thanks, Tom. I appreciate being here and agreed. I think we look forward to sharing our learnings in the future.