Dr Shawn Davis is a passionate advocate for patients interacting less with their disease. In this interview, he talks about how that passion guides his work.
How does your background in startups and digital innovation influence the way you work today?
When I was in graduate school, I did a minor in business with a focus on maintaining creativity and innovation within organization. I wondered what made inventors and creators good at what they do? I have to admit, I never liked the idea of the lone genius coming up with all of these things. I was trying to figure out if there was a system we can use to make it a little more consistent and reproducible.
When I went into the startup world, I thought it was a great chance to build a team and have more control over their environment, to try to foster that innovation and creativity. When you’re in an organization with 50,000 people, it’s pretty tough to shift that culture or thinking. But if you have 5 or 15 people, you can have a little bit more influence.
As I evolved over my career and I found myself doing some work in the digital health space. I was focused on innovation in general and particularly innovation in large pharma as it involved medical devices and that eventually started overlapping with digital health. It took me a while to appreciate what I was seeing as I reviewed the landscape and I was blown away on multiple levels.
There are so many opportunities in the digital health space presenting themselves right now, but it’s also a challenging space. That’s because there’s all this promise and potential, but people don’t fully understand how to realize it and they’re just started to appreciate how regulated our industry is, and how entrenched a lot of the players are.
I firmly believe digital health is going to play a major role in our healthcare system in the future, and in all of our health in the long run. But how it gets there, and how long it’s going to take, that’s the tricky part.
"The best thing I can do for most patients, it’s to make them forget that they’re patients."
Could you see any intersections between digital health and drug delivery?
To me, one of the challenges is figuring out where to do that smartly and effectively, and where it will drive the biggest benefit for your patients. There are opportunities where it’s going hand-in-hand with drug delivery. But really, I see it as complementary technology to the drug product in many cases.
So from the standpoint that both digital and drug delivery technologies offer an opportunity to improve things for a patient, there are opportunities where they are combined. I tend to think about it more as “What is the problem I’m trying to solve for the patient? What are all the tools at my disposal to solve that problem?” Maybe it’s a digital tool. Maybe it’s a drug delivery tool. Maybe it’s a better diagnostic or a better molecule. It could be any of them or some combination. It’s up to the inventors and creators and scientists at these companies to thoughtfully combine those things in a way that drives the greatest benefit for the patients but also does it in a timely fashion.
People often forget that, yes, you can create some amazingly complex solution, but if you don’t get it to your patients for another decade, there’s a decade’s worth of patients who have been ill this entire time. Speed-to-market really is a key benefit that inventors may want to ignore, but it can’t be. And it certainly won’t be in most pharma companies, because speed-to-market is a big driver.
What are the areas or frontiers in drug delivery that are notable for you?
The revolution in gene therapy – particularly delivery of nucleic acids – is a really important space. It’s a bit of niche space right now, so it’s a little hard for me to say it’s incredibly important because it’s such a small slice of the industry, but it’s going to be growing, and I think the potential benefits are going to be huge. From a drug delivery standpoint, it’s one of the few areas where delivery technology is holding it back to a large degree. This is really the only nucleic acid therapy in a lipid nanoparticle that has actually been approved, on-market and is benefitting patients.
Most people in the space will tell you that delivery is what’s holding this space back. When the delivery technology is needed for the success of a product, and not just a “nice to have” then it’s easy to see that as a critical area for us to focus on.
What’s a little bit less obvious is this interplay between the time-to-market and the benefit to the patient.
In many cases, drug delivery technologies can improve things for patients but they typically are more complex and require more time and cost to develop; they don’t always get on the critical path for launch. That means that products are coming to market unoptimized for the patient, and so my question remains, “If we know how to make it better for the patient, when are we going to do it and why haven’t we already started?”
Lifecycle management for products is probably one of the big untapped areas for drug delivery, where we’ll be able to dramatically improve things for patients through drug delivery technology. It may not be on the first launch of the product, but over the life of the product, you have a lot of opportunities to improve things and drive significant value to the patient and to the company.
Are there any products that are being optimized for patient experience in a new launch or coming down the pike that are interesting to you?
When I think about what the best thing I can do for most patients, it’s to make them forget that they’re patients. They want to go back to being regular people that don’t have a disease. And so to me, that means engaging with my disease as little as I possibly can. Minimizing the dosing frequency is a really big deal for patients. You could be going from taking a pill every day to doing an injection every six months to doing an implant every three years. Those are three really different burdens on a patient. Now what the tradeoffs are, and how you develop the technologies to do those things, is a separate issue.
I think that’s a really interesting area, and we do have ongoing efforts, whether that’s just through delivering higher doses or controlled release technologies, long-acting injectables, that will reduce the frequency of dosing.
To me, those types of things get you further and further away from the idea of having to do something on a regular basis to manage a disease and closer and closer to an actual cure. Am I officially cured? Well, if I never have to deal with my disease and I’m perfectly healthy and everything is managed – that’s pretty close to a cure.
There are also the gene-therapy approaches. Before I came to the company, the team was already focused on using gene therapy for the prevention of pandemics, in collaboration with DARPA.
Obviously, never a more timely issue, but what I try to explain to people is that it’s been a timely issue for a century. It was really exciting work long before COVID-19 came about, and with COVID-19 now upon us, it’s more and more relevant.
"To me, one of the challenges is figuring out where to do that smartly and effectively, and where it will drive the biggest benefit for your patients. There are opportunities where it’s going hand-in-hand with drug delivery. But really, I see it as complementary technology to the drug product in many cases."
You were an early author in microneedles and transdermal research. How did you get started in that, and where is the field today?
It was a little bit of lucky timing that when I started doing my graduate work at Georgia Tech my advisor, Mark Prausnitz, was a new professor. Prior to my arrival I had little to no exposure to the field. He and a few of my prior labmates had just started the work and published some of the first papers in the space.
People were recognizing that by combining microelectronics with biomedical technology, we could achieve this. What really interested me was the cross-fertilization of ideas from a completely different industry. You had people making microchips and then you had people trying to deliver drugs. Figuring out how to take the best tools from one space and using them to benefit another has been a common theme throughout most of my work.
In terms of where it’s most applicable, I have to admit that microneedles have fallen prey to the same problems that many drug delivery technologies have fallen to: promising to do anything and everything for everybody. Unfortunately, that’s rarely a path to success.
Instead, understanding where the limitations of this technology are and where the benefits that match up with those limitations are – it might be a fairly small slice of pie, but that’s where the value is.
For me, microneedles and transdermal delivery in general – you’re getting privileged access to the skin tissue. One benefit of that is delivery to a lot of immune-active cells; so the delivery of vaccines is an important space that’s becoming more and more relevant. People are seeing the benefit, especially from a dose-sparing effect.
The benefits of alternative routes of administration – whether that’s oral, nasal or pulmonary or transdermal – is always about the therapeutic benefit. Don’t tell me that I’m going to inhale something just because inhaling is nicer than a shot. I don’t know if that’s enough to make people switch to your drug. On the other hand, if you tell me that because I’m inhaling it, it’s delivering directly to my lungs and you’re trying to solve a problem with the tissue of my lungs, that makes sense to me.
That’s a key element for all drug delivery, and frankly
one of the challenges for the industry as a whole is
recognizing the technical limitations of these different
technologies and being disciplined enough to focus on
those areas.