In this episode of the MM&M Podcast, Amy West, whose pharma career has taken her from brand manager to head of US digital health strategy for Novo Nordisk (and was a member of MM&M’s 2018 class of Healthcare Transformers), shared her take with MM&M’s Marc Iskowitz on three areas where marketers are wading deeper into the tech space: clinical trials, partnering with startups and data privacy. 

Iskowitz: In the clinical trials area, when you appeared at our Transforming Healthcare Conference, you interviewed a couple of executives of startups in the clinical trial space, Laurent Schockmel, CEO of Antidote, and Mikki Nasch, co-founder and VP of business development at Evidation Health. You discussed things like process and efficiency improvements that the startups have brought to the space. As we hear about pharma breaking down the silos, how are these things being integrated into clinical trials? Is it working, and what’s the proof?  

West: I think it’s a really important area for pharmaceuticals, drug development and discovery. The clinical trial setting is really important for us to be able to get our drugs approved and into the market, into the hands of people that can benefit from them. But as we know, the clinical trial development process is very long and very expensive, and it’s met with some challenges related to finding enough people to include in a trial and then obviously keeping the people that have been recruited for the length of the initiative to get to an outcome. 

And the advancements that we’re seeing with technology and digital health interventions have really provided a way to expedite and create more efficiency in that process and hopefully get a clinical trial to fruition faster. The ability to leverage sensors and wearables is a component of clinical trials. To keep track of the participants helps keep the adherence going much more smoothly. It creates an ability to create a remote clinical trial setting. 

People don’t necessarily have to go into their doctors’ office because they have access to these remote tools and internet-of-things types of data-collection components. The other piece is the opportunity to leverage artificial intelligence when it comes to recruiting people for these trials. It enables the technology to take a very labor-intensive role to try and go and find people and also provides an opportunity to include a wider, more diverse population. I think in a lot of clinical trials, you tend to see a lot of white populations because of what we’ve been able to recruit from traditional means. 

But by leveraging technology and leveraging AI to get in and look at EHR data, it allows us to find people from a broader, diverse population to include in these trials. And, then again, through leveraging the opportunities that we have with remote tracking and monitoring, we can keep the people in the trial longer. We don’t have to get them to come into clinics, so it really helps with that aspect, as well. 

By leveraging technology and leveraging AI to get in and look at EHR data, it allows us to find people from a broader, diverse population to include in these trials.

Amy West, Novo Nordisk

Iskowitz: In terms of using synthetic trials — trials based on real-world evidence — for instance to secure label extensions for on-market drugs, is that practice proliferating? Do you see it happening in a bigger way?

West: I definitely think we’re going to continue to see that trend. That’s really a lot of what we’re hearing from our other customers in the healthcare space, the payer side of things. I think most of them would agree that the products that we have in the market, they’ve been FDA-approved, they’re efficacious, they’re very good at helping people. But the challenges that we see a lot of times is, just because a medication is good and it works, doesn’t mean that the individual is going to take it the way they’re supposed to. So we don’t see that compliance and adherence benefit.

Therefore, we have a lot of pressure on us to be able to prove — outside a clinical, controlled setting — that our products do deliver the outcome that we say they’re going to, and help that person have a better quality of life, and also impact the total cost of care down the road. 

So, real-world evidence is important to bridge that gap that we see from the clinical, controlled setting to what really is happening in the real world. And being able to monitor with a frictionless, digital collection means — with sensors and wearables — that’s becoming a part of clinical trials and marrying up that more traditional trial side with the real-world evidence collection based on the sensor data and the frictionless data collection. 

So we’re going to continue to see that come together, and the more we can leverage those frictionless ways that can keep people engaged, the better off we’re going to be to get to better real-world outcomes and hopefully better overall outcomes for the individual patient, because they’ll stay engaged longer. 

Iskowitz: When it comes to the Aetion model, that synthetic clinical trial model, I wonder whether payers are going to really be skeptical of that kind of data or if, like you say, they’re going to really embrace it.

West: Well, I think the proof at the end of the day is going to be in the outcomes, and we have to have the clinical trials to prove the efficacy and the safety of the product, but how do we keep the person engaged and adherent to the therapy to have that truly optimized benefit and outcome that they need?

Iskowitz: So the reason why I was pushing around the synthetic clinical trials area, and also in terms of other process improvements, is that we’ve seen this take hold in biotech first, but can it really take hold in big pharma, given there may be reluctance to accept something other than a randomized control clinical trial as the gold standard, as well as the traditional difficulty of adopting new practices?

West: I don’t think we have a choice, I think we’re going to get there. With the rapid pace of technology changing, creating more efficiency and opportunity, and the ability to cut down on time to market, total cost of care — that’s really what everybody’s trying to figure out, so it’s not going to go away. It’s just a matter of how we get it figured out. 

There are going to be some hiccups along the way. A lot of it is also going to be tied to what the FDA is comfortable with, as well; it’s very new for them, too. So we’re all kind of learning as we go in this process, but suffice it to say that the technological advancements are not going to go away. There is a lot of efficiency there; we just need to figure out how to harness it in the most effective and safe way. Safety is at the core of all of this, so we have to make sure that we’re comfortable with using these technologies to get us to a safe outcome.

Iskowitz: How else is commercial embracing clinical? 

West: Well, I would say that we’re definitely seeing a lot more earlier partnership from the commercial side and the R&D side. What was more traditional was that R&D was in sort of a silo developing novel solutions and drug discovery, and different approaches to healthcare from the clinical, molecular side. And the commercial arm would then pull that through once it had been approved, and then they would market it and scale it from that point. 

But now, as the offerings that we have in healthcare are more sophisticated, are really good, and the clinical differentiation is not as broad as it might have been in the past, it’s important that as R&D’s investing the dollars early on, that they’re paving a way that is truly going to provide a valued solution for the end user — that we’re not off creating something that’s really great but [for which] there’s no market. So the more that R&D and commercial can come together earlier to really understand the unmet needs of the market; the user preferences; how to approach a solution from a truly empathetic point of view, from the customer, across the entire value chain [the better].

It’s really important that both the commercial and the R&D side come together early on and play together so that, as we bring this solution to market, it truly has a value and need in the market.

Amy West, Novo Nordisk

The healthcare system is so interconnected with the patient, the provider and the payer, [that] it’s really difficult to find a solution for only one of those stakeholders. It really needs to be through the whole value chain. So it’s really important that both the commercial and the R&D side come together early on and play together so that, as we bring this solution to market, it truly has a value and need in the market.

Iskowitz: And a lot of research goes into [identifying] consumer needs and preferences. Speaking of that, the second area that I wanted to ask you about is startups. A lot of them have succeeded, where big pharma sometimes has not, by having their finger on the pulse of what patients need to change behavior, by tapping into that insight. Big pharma, wisely, is moving more to partner with those companies that have figured it out, as a way to stay closer to patient demand. How is that going from your perspective? Give me your take on the state of pharma partnering with startups, circa mid-2019. 

West: Sure. I think it’s undeniable, we need to be focused on these opportunities, and the traditional pharma company — we have amazing innovation in the drug discovery, molecule development, device development space, but we’re not technology companies. So, our subject matter expertise is in that clinical side, but there are so many startups out there that are experts in the technical side and also organizations that are steeped in the consumer experience, outside of the medical, healthcare perspective. 

It’s important for us to bring these [startup- and pharma-based] subject experts together to find a solution that has a good outcome from a medical standpoint, but also is something that engages the person and is easy to use and has that convenience factor that [patients] are looking for. So those are coming from different areas in the industry, so we need to bring these together. 

I can speak from my own experience. At NovoNordisk we have a partnership with Glooko, a Silicon Valley technology company which offers a diabetes management application. We partnered with them to customize one for our Cornerstones4Care patient support program. The key in partnering with them is really making sure that we had aligned objectives, [and] we were both really dedicated to helping people with diabetes better manage their disease state and making it easier for them and more convenient and less burdensome — and hopefully making it something that they don’t have to think about quite so much [as they] improve how they understand and take care of themselves. 

With that aligned objective, we were able to also appreciate the fact that we’re coming from the pharma space, with our clinical side of things [and] they’re coming [from] the technology and the application space, bring those things together and create a solution that was going to deliver for our customers at the end of the day in a collective way. 

And it’s been great because we’ve learned a lot from them, and I’d say vice versa (although I don’t want to speak for them). But being a big corporation in the drug development space, we’re not the most agile organization when it comes to bringing things to market, piloting and testing. We just aren’t structured that way. Drug development takes a long time. Whereas, they’re coming to the table with that very agile, software-development mindset. So really learning from their iterative process, how they test, learn, gain insights from the user experience and move forward quickly and make decisions that are smart, doesn’t always have to be 100% right, but you can make those adjustments as you go forward. Whereas, on the pharma side, we’re not always comfortable moving forward unless we’re 100% right! 

But there are certain things where … it’s okay to not be 100% correct in some instances, as long as there’s no risk to the patient’s safety involved. It’s kind of managing that and learning from their processes how we can pull that agility into the work that we’re doing.

Iskowitz: I had wanted to ask you about that, actually. There were some shared learnings there in terms of adopting some of their agile processes. Can you elaborate on that? 

West: Sure, it’s really around how do you keep a very quick, rapid pulse on your customer: How are they engaging with you, what are you learning from them? Because it’s digital and data-driven, we are actually able to see in a real-time way who’s using it, where are they stumbling in the user interface, how can we make corrections there quickly, and really be able to monitor on a regular basis, almost in a real-time way, and then make adjustments … in a much more rapid way. 

And then if something’s not working, it isn’t a failure, it’s a learning — we just adjust it, we fix it and we move forward; we don’t just throw it all out. It’s a good learning and a different approach to how we think about user needs and how we pull the end-user point of view and interface into what we are doing.       

Iskowitz: Which is something, perhaps, that was lacking before, pulling in that user’s point of view.

West: Yes, and then trying also to triangulate that back to the R&D side of our business. So, “This is what our learnings are,” and speaking to the R&D teams in those terms, as well. 

Iskowitz: How do you balance revenue targets with these new pilots and partnerships with digital health?  

West: At the end of the day, our core commitment is about how do we help people better manage their diabetes, or whatever their chronic disease state is. And we have medications to do that, but again we have the challenges we see with adherence and people staying on therapy the way they’re supposed to or optimizing their therapy. So by leveraging these partnerships with a tech company with our Cornerstones4Care app, if the person has a better understanding of why they’re taking the medicine, what’s happening in their body as they’re taking the medicine, they’re able to track it and see visualizations of the impact. They’re now getting more engaged, they’re being more informed and they’re now able to see the benefits of what they’re doing. And they’re more invested and more engaged, and they’re staying on therapy longer.

Iskowitz: You have data to show that?

West: Well, the trend is that they’re becoming more educated and they’re better able to stay in control, and the thought would be that by staying in control, they’re adhering to their therapy, they’re adhering to the other aspects of managing diabetes: their nutrition, their activity levels, potentially managing stress better. But those are all things that we can look at and if we can actually quantify it in some sort of a data-driven way and get that data back to the end user, if it’s the patient, they can better understand how to self-manage. That’s really the key of it. 

And if they’re better self-managing, the hypothesis is that they are also taking their medication as their doctor has prescribed. So from a pharmaceutical business standpoint, we’re [seeing] extended length of therapy and utilization of the product, so we’re seeing a benefit from a revenue standpoint there.

Iskowitz: And I’m sure that’s a lot easier to track now, with all the wearables, sensors and devices in diabetes.

West: It’s getting there. Speaking in general, everybody is making inroads. I don’t think anyone has it figured out yet. I think data at times can be overwhelming. You’re capturing data from all these different sources, how do you bring it all together? What’s the interoperability? How do you make sense of it? 

Because, at the end of the day, if you don’t figure out how to make sense of the data, then it has no value. So, that’s going to be really critical as a next step, to really understand how we can take this information and use it to make improvements, get it to the end user — whether it’s the patient, the provider or the payer — for better decision-making on their end. 

Iskowitz: Now, you were part of the team that originally built Cornerstones4Care. I’ve been here at the publication long enough to remember when that first came out, and I believe you were on the cover of that issue. We’ll pull that one out before you leave! So, how did that feel to kind of bring a Glooko in, when you already had a patient support program. Did that require coming to grips with the fact that “Look, we can always get better, and these guys are closer to the diabetes patient than we are?” 

West: It’s a couple of different things. The concept behind Cornerstones4Care has always been about how do we get support for people dealing with chronic disease management, particularly diabetes? How do we get it to them in as personalized and as individualized a way as possible, and in a way that is via their channel of preference? How do we make it as seamless and integrated as possible? And, obviously, it’s a challenge because we’re a pharma company and we have a lot of rules and regulations around how we can engage and what we can do, and we’re always striving to get better. 

But knowing that the majority of people have mobile smartphones now, that’s how they want to access information. A lot of people that come to Cornerstones4Care are accessing it through the mobile site. We wanted to make sure that we were there for them through that channel. And so that was really important for us.

Iskowitz: They had a little more traction in the mobile channel.

West: Yeah, and that’s the trend that is going to continue, so we want to make sure that we are where [patients] are and where they want to be engaged, also pulling it through from a text-messaging standpoint. 

Also, [we] recently launched Sophia, which is our virtual concierge leveraging artificial intelligence and natural language processing for people who are searching for information. using her as that almost human element to that digital experience, to engage people and get them to the answers that they’re looking for as quickly as possible. 

[We’re] also pulling her through with voice technology, much like with Alexa. So again, it’s really trying to understand what are the needs and preferences of the people who are engaging with us, and how do we make it easy for them to leverage whatever channel that they want to engage with. It shouldn’t just be us pushing out information based on whatever works for us. 

Iskowitz: So it was a mobile channel play as much as anything else, because from what I recall, Cornerstones is a pretty robust CRM tool. Speaking of how startups have tapped into what motivates patients to change behavior … Google and Amazon have been pushing deeper into the health space. You made the comment to me about a year ago that when people go on Google, they’re focusing on things that they want to be focused on. When they land on a pharma website, they’re focused on things that they don’t want to be focused on, but have to. That’s one reason the tech companies have been very successful. And pharma is trying to learn from that. As patients share more information with Google, however, we’re seeing privacy implications. On the one hand, it reduces friction in the healthcare system, and that could be beneficial from a transaction standpoint. But data-sharing also has some pitfalls, namely for privacy, for instance the recent lawsuit involving an academic medical center and Google. The lawsuit revolved around whether you can really de-identify data when Google is involved, because data can be triangulated in so many different ways. As pharma becomes more patient-facing, as it’s partnering with startups to get that user insight, how are you modernizing your own data protection standards? 

West: It’s definitely being discussed quite a bit. The work that we do at the organization and the data we’ve collected is so sensitive and we’re so dedicated to protecting that. I think most pharma companies are. It’s just that we simply can’t afford any breaches, we can’t afford to not be clear about what the intended use is. There’s just no margin for error there. We take that very seriously, and in order to move that forward, it’s going to take some thought, and working with experts in this space to make sure that, as we make decisions around data strategy, that we’re doing so in a way that’s protecting everybody whose information we have. It’s not going to be easy.

It’s probably one of the reasons why healthcare and pharma in general have been laggards in the technology space. It’s very scary and it’s very difficult to manage data. Even when you have an intended use today, it could change tomorrow. And how people are engaging with those data sets, the interoperability of it, all those considerations. And as we’re collecting more information from different sources, as you create more partnerships with third parties, you’re creating another way to collect information and data, how does that get co-mingled with everything else and how do you protect and manage all of that together? I don’t have any good answers for you today because it’s in discussions, other than to say  we are committed to making sure that every protection is in place as it always has been, and ensuring that, as we evolve in our ability to bring solutions to people, we’re able to harness that data in a way that is going to benefit them, but keeping that data safe and protecting it.

We just can’t afford to have a data breach like some of the financial services companies, like credit card companies and Facebook. Some of those organizations that have been challenged lately and are in the news. And we don’t want any trust issues with our customers. If we don’t have trust with our customers, we’re in a lot of trouble. So that trust and safety are at the core of what we do.

Iskowitz: And we’re also seeing this whole burgeoning area of health data as a business and organizations like 23andMe, which was just in the news today regarding GlaxoSmithKline’s $300M stake in the genetic-testing company, both from the perspective of drug targets but also privacy concerns. If you feel that more data is good for the health system in general, then you’re for that, but the cynic worries about something like that. Where do you come out?

West: I think it’s like you just said. It depends on the individual and how they view data, how comfortable they are with sharing it. It’s going to take a lot of convincing with some groups of people. It’s somewhat individualized based on what your level of comfort is, so I think time will tell. If we’re going to see a true benefit to the health of the individual at the end of the day, there’s going to be a lot more comfort and trust in that. But if we start to see data breaches and these types of things happen, it’s going to create a lot of scrutiny and concern. I still think it’s early days in the healthcare space with these types of things, so it’s hard to say right now because I don’t have a crystal ball. I will say that the stringent nature of what we have to do in the pharma space, the need to protect data and the commitment to protect it is what has made us slower into this technology and use of data optimally.

Iskowitz: The historic reluctance is born out of an abundance of caution?

West: Yes, and I think that even in the FDA, there’s clearly a lot of conversation going on from a legislative standpoint about how does this information need to be protected We’re seeing a lot of things coming out of California around the CCPA [California Consumer Privacy Act] and their rules, and we’re just trying to interpret what all of that means for the data that we currently have, what we’re going to collect in the future, what are the consents that we need and it’s really evolving very rapidly. I don’t think there are any answers for it right now, but we are definitely looking at it very, very carefully and trying to figure out how best do we ensure that we are leveraging this data in a way that’s going to benefit our customers, but keeping it protected, safe and secure. 

Leonardo Lopez-Carreno contributed to this report.

This transcript has been edited for length and clarity. To listen to this episode of the podcast, which aired July 17, 2019, click here.