Digital therapeutics are growing in popularity for patients. Combining science and technology creates a double-edge sword including one how to best establish quality and trust in the safety and efficacy of patients.
In this podcast, Maria Palombini, Director of Emerging Communities & Opportunities Development and Healthcare & Life Sciences (HLS) Practice Lead at the IEEE Standards Association (IEEE SA), interviews Michael Ambrose, Director of Product Quality and Analytical Process at USP about establishing standards in digital therapeutics to assure quality and build trust with patients — the core of the healthcare ecosystem.
Re-Think Health Podcast Series is part of the IEEE SA Voice program. IEEE SA Voice shares insights and perspectives from the IEEE SA community, subject matter experts, and industry leaders that are working to raise the world’s standards, drive market solutions, and much more, keeping you at the forefront of technological innovation for the benefit of humanity.
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About This Episode’s Guests
Michael Ambrose
Michael Ambrose, PhD., is the Director of Product Quality & Analytical Methods Incubation, Digital and Innovation Division at the United States Pharmacopeia. Dr. Ambrose has been with the USP for over 14 years, serving as the Director of the Biologics and Biotechnology Laboratory for over 10 years before moving to the Digital and Innovation Division. The mission of Division is to explore and incubate emerging technologies and trends that may impact USP, the way we work or in the way our standards are used or produced. This includes advancing digital fluency and applications of digital technologies and solutions throughout the organization and to our stakeholders. In the Division, Dr. Ambrose has been involved in various technologies including qNMR, Digital Therapeutics and DNA Methods for the Identification of Botanicals.
Follow Michael Ambrose on LinkedIn or get in touch.
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Maria Palombini:
Welcome to the Rethink Health Podcast Series. I’m your host, Maria Palombini, leader of the IEEE Standards Association Healthcare and Life Science Practice. You may wonder why we’re doing this podcast series. So much is changing in the world of health. We have new technologies, tools, applications, all of which should make us think, how can we rethink the approach to health so that we have patients, like you and me, end up with better health. We bring you experts, advocates, researchers looking at rethink the process anywhere in the healthcare ecosystem from bench to bedside to get to where we need to be healthy. So I’m delighted to bring you one of these experts. Michael Ambrose, director at USP is an exciting organization. You know, when we think of quality, we think of USP in the scientific standards world. So Michael, why can’t you tell us a little bit about what USP does and the great work you’re doing there with them.
Michael Ambrose:
Thank you very much for this opportunity and good afternoon, everybody. I am the director of product quality and analytical methods within the digital innovation division. Our group explores and evaluates emerging technologies and trends that impact public health, especially in terms of medicine and therapies. We begin to really work together with the intersection of therapies and technology. USP is a global leader in building trust in medicines like patients and healthcare providers, industry, regulators, and such. We do this by setting standards, that ensure the quality, safety and promote public trust in these medicines, USP, is that doing this for just over 200 years? We started in 1820. Today we are in use in over 150 different countries throughout the world.
Maria Palombini:
Excellent. A fascinating organization. Now we’re in the world of COVID and everybody’s in a virtual environment and I’d like to humanize the experience. So for our audience, let’s hear a little fun fact about you, something that you do in your downtime or nice, interesting place you’ve traveled before, something that you would like to impart with our audience.
Michael Ambrose:
Besides science and technology, I actually have a number of different hobbies. One of the ones, the longest ones I’ve had so far is I am a guitarist. I’ve been playing guitar and blues for about 40 years now. I’ve also recently got a 3d printer and I’ve been having a lot of fun printing things and designing my own jewelry and such. So we also have fun outside of work as well.
Maria Palombini:
So we have a little garage biotech type of situation going on now. All right. So why don’t we get to the core, what do we really need to rethink with digital therapeutics? People talk about them, or people don’t even understand when I say people – patients, doctors, clinicians, we hear anything from an app to be a digital therapeutic or some other application of a technology, which gives us a bit of concern. From your point of view, how would you define a digital therapeutic?
Michael Ambrose:
Digital therapeutics and digital health in general is, as you just stated is a multifaceted area. Uh, we do concentrate on digital therapeutics and we’ve kind of defined it as a modality that uses high quality software programs that provide an evidence-based therapeutic intervention. This is to prevent, manage or treat a medical disorder or disease. These digital therapeutics can actually be the therapy in and of itself, or it can be in conjunction with other therapies as well.
Maria Palombini:
It’s a fascinating area that seems to be growing very rapidly. You know, what are some of the trends in the use of digital therapeutics? You know, we’ve seen the new norm, a lot of conversation about using them for mental wellness due to a lot of emotional distress, but also in pain management. So we’re seeing quite a different use cases for them from your side. What do you see them as a growing trend?
Michael Ambrose:
I see the trend as continuing where it is now to some degree in that the different types of applications for these digital therapy, therapeutic products continue to grow. This is both in areas where the digital product itself is the therapy. And I think that’s one of the weak aspects of it, where the software is therapy. We also continue to see the growth in digital therapeutics in conjunction with not only the therapeutic itself, but in areas where patient and doctor actually develop a different type of relationship outside of just the office visit with the change we’ve had with the COVID-19 the areas of mental health and such is an area where the ability to use digital therapeutic products is really starting to emerge the ability for the patient and the doctor to interact again, outside of the office. Some of the other areas that we’re starting to see is, is in areas of augmented reality and virtual reality applications as well. I think that is one of the larger areas that of study starting to actually trend down.
Maria Palombini:
We’re seeing something very similar as well obviously through the, IEEE standards association, the rise in augmented realities of Fidessa applications. So do you think the best use cases, just from a point of view of industry and patients and doctors and consumers is the best use cases for a digital therapeutic on the commercial side, or maybe from an FDA regulated application kind of thing?
Michael Ambrose:
That’s a tough question to ask because we’re really not in a position to say one way or the other newest. USP is for the quality of medicine that public trust and such. The applications, I think it’s between the patients, the doctor, the healthcare provider, the regulatory agencies, and such. I think there are a couple of different examples, where we can talk about the different types of digital therapeutics companies, such as well doc, there we star products for diabetes, intervention, and interactive. They just got their digital therapeutic endeavor cleared for the treatment of ADHD in children. And that’s an example where the therapy itself is the software or the others such as care therapeutics. They recently had reset, all clear. And that’s an example where the digital therapeutic is used in conjunction with an ongoing outpatient treatment of opioid addiction. Again, that’s where we’ve actually combined both the counseling aspects, as well as traditional therapy with this new digital therapeutic product as well.
Maria Palombini:
Definitely. I think it’s, it is a hard question, but we have to ask. We’re getting to the good part. Now the call to action, right? There’s a great new opportunity in the market for health digital therapeutics mischief makes us rethink a therapy. But now with the rise of something new, we always have to ask questions. There’s always a challenge. So what are you finding with the rise of these therapeutics to be some of the more concerning issues then perhaps need to be a little viewed closer or need a little more attention?
Michael Ambrose:
Sure. I’m not sure one would call it an issue, but it’s something that is extremely important that I think we all have to keep in mind in this new modality, digital therapeutics, these products treat people. We need to keep in mind that in the end, the patients is coming to a healthcare provider or a medical condition. And the provider is trying to treat that patient, that patient can be treated in the number of different modalities. The newest one will be emerging. One we’re talking today, digital therapeutics, it’s still treating patients. And so we have to keep in mind that these are there to alleviate discomfort they’re there to treat the patient. I think that’s one of the things we have to continue keep in mind. Sometimes when you talk about all of the different aspects, it doesn’t always come through, but I think it’s back of everybody’s mind, but the agencies, the FDA, the doctors, the manufacturers, that is the key aspect. I think we also need to make sure we keep that in mind.
Maria Palombini:
I’m so glad you mentioned that because in the world of new technologies applications, we’re so focused on the tool working. Sometimes we forget who the tool is for, and the patient is definitely the center of the healthcare ecosystem. So we must never lose sight of that. And I’m so glad you brought that up. So I think maybe the question, like what adjustments or what really needs to be considered when you think meaning a practitioner or someone who says you should be using this digital therapeutic needs to evaluate and assess it for its patients, what are maybe some considerations you all feel that that would be there?
Michael Ambrose:
Sure. I think if we go back to the premise that we’re treating patients, we start looking at it from the point of view of a patient where again, the patient has to have this trust. So it does have this trust in that this therapy either prescribed or recommended by that healthcare provider is going to have a positive effect on whatever condition they are being treated for the patient, just as in any other therapy has no way of knowing the quality or whether or not that product is going to do anything or do anything positive. And therefore, I think what we need to do is continually to evolve the ability to assess and evaluate the quality of that therapeutic product from the manufacturing, make sure that they have their quality management systems in place that they do the proper testing and evaluation. The regulatory agencies evaluate that product, not only from a software point of view, but this, but from the actual point of view of it being a therapeutic, there are a number of different quality management systems and quality standards out there for a software. But I don’t see many of them talking about the quality needed for actual therapeutics. I think that’s one of the areas that, that, that continues to be addressed. When we talk about software, we talk about security, data management, privacy ownership, we build into the hat and such. So I think all of those areas need to really to be considered even more importantly again, because these are treating patients first.
Maria Palombini:
So speaking of quality, how does USP see its role in helping to establish some sort of standard quote unquote equality for digital therapeutics?
Michael Ambrose:
Really good question. And I’m going to address that by going back a little bit of time, USP’s again, been around for 200 years. Through those 200 years, USP has evolved along with all the different modalities to continue to work with those industries to create the standards needed to assess quality. So we’ve gone from recipes and tinctures back in the 1820s and such to advance chemical medicines and the use of analytical technologies to evaluate quality to today with a complex biologics and such. USP is our ability to convene the appropriate stakeholders, industry leaders, thought leaders, academia, regulatory agencies, and such to convene and work together to try to understand what the quality measurements are for these different modalities and working together to create what those standards are and how to assess them. So I see USP, looking at this, not as a revolution of therapy, but just as the next evolution. Again, as we move from botanicals to typical medicines to biologics now to digital therapy, it is the evolution of the therapeutics and USP has, is continuing to want to do a history of addressing those in bridging technologies, working with the industries to actually create them.
Maria Palombini:
I think that’s really important and a fun fact for our audience out there. IEEE is a little over a 100 years old. And as Michael said, USP is 200 years old. So we are talking to a company who’s a hundred years older than us right now. So that’s awesome that we have some sustainability going on. Okay. So how did I come to learn about USP’s involvement in digital therapeutics is when one of Michael’s colleagues showed me this great paper that they’ve developed. So, Michael, do you want to talk a little bit about the paper you did and how maybe people can find out about it?
Michael Ambrose:
Sure. We just recently published a white paper on digital therapeutics where we go into a lot more detail about, our approach not just to digital therapeutics, but are the USP for appeal approach to reference standards and to the use of quality standards overall, and the value. We do this by first addressing the typical quality parameters that we have in more traditional therapies, such as identity, strength, purity, performance. And also, the question is, are these the correct terms? Do we need to adapt the definition? How do we determine identity and the software or the string, or do we to get, do we need to have a different set of terms that measure the quality of the software? Again, not just as a software, but as a therapeutic software. The paper can be found at http://www.usp.org/dtx . And in that paper, we actually address what your comments, comments, and the industry comments. Everybody’s reading the paper as well. Anybody listening to this podcast, maybe we’ve set up a special dedicated email just for that site, just so that you can submit your comments and thoughts. And that is at [email protected] We look forward to hearing your comments and thoughts.
Maria Palombini:
And we will be sure to put both links. We’re going to write a blog about this podcast, and we’ll put both links on the blog post as well. So people can find it from there as well off the IEE SA beyond standards blog site, we make sure people have access to that. For sure. So everyone out there listening digital therapeutics are here. They’ve been here, they’re growing. I definitely think you should check them out, read this white paper, do a little research. We they’re helping us rethink the healthcare system. So if you want to get involved in some of the work we’re doing, um, at the IEEE SA, we’re doing, we’re talking digital therapeutics and clinical research. We’re looking at it from a point of view of wearables in our, you know, whammy certification program, many different applications and areas. Michael, I want to thank you for being a part of this podcast for sharing your insight and time with me.
Michael Ambrose:
Thank you very much. Appreciate that.
Maria Palombini:
And you know, it’s been a great collaboration. We’ve been collaborating with USP on some of these unique applications, such as smart pills, and now we’re talking together on digital therapeutics, and I think it’s a great collaboration between science and tech.
Michael Ambrose:
Thank you very much. And just one last statement for those that want to learn more about you to learn more about USP and standards setting such. So you please visit us at www.usp.org. You can see what we do with food and dietary supplements, biologics medicines, global public health, and such, and learn how you can, you can work with us as well.
Maria Palombini:
Yes, definitely. Uh, if you’re into this area of quality, definitely you want to talk to USP and for everyone out there, thank you again for joining us. We look forward. We have our next podcast next week coming up on artificial intelligence and blockchain in the world of epidemiology, which is another application of how we really need to rethink epidemiological research. But for now, thank you again for listening and we look forward to your participation and engagement in helping us to bring new solutions to drive adoption in the market.
Michael Ambrose:
Thank you very much. Bye bye.
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