Future clinical trial paradigms: Improving the Patient Experience

Jake LaPorte, The BIOME by Novartis

Part one of our discussion about extending and improving the lives of patients from the People First, Patients Sometimes podcast.

Jake LaPorte, the leader and founder at BIOME by Novartis joins the People First, Patients Sometimes podcast to discuss future clinical trial paradigms aimed to produce better experiences for patients and the healthcare providers.

Hi, I’m Tom Rhoads, CEO of Spencer Health Solutions.

Our podcast “People Always, Patients Sometimes” was created to feature innovators, disruptors, and patients driving new ways of doing things in clinical trials. Little do we know that the coronavirus would escalate the need for transformation and demonstrate which organizations were prepared to move ahead more quickly. Today we’ve invited Jake LaPorte, co-founder and global head of The BIOME by Novartis. Jake has spoken on the topic of digital innovation and health tech startups, and impacting patient’s lives. We enjoyed our conversation with Jake so much that we have a second episode with him on the schedule. Join us for this episode of People Always, Patients Sometimes as we listen to Jake’s insights on The BIOME by Novartis in digital health and clinical trial innovation.

Janet Kennedy (00:52):

Hi, my name is Janet Kennedy and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. Today we have invited Jake LaPorte to join us. He founded and leads The BIOME by Novartis, also known as Novartis BIOME, the company’s first ever externally branded innovation lab. The BIOME has garnered global recognition for supporting innovative tech and digital health companies and connecting them to Novartis’s vast network of expertise and resources to accelerate solutions that improve and extend patients’ lives. I really love that and I can’t wait to find out more about it. Jake, welcome to the podcast.

Jake LaPorte (01:32):

Thank you so much, Janet, for having me. I appreciate it.

Janet Kennedy (01:35):

You know, you’ve had a very interesting back from before you got to Novartis. So do you mind bringing us up to speed and telling us how you ended up where you are?

Jake LaPorte (01:43):

I started off my career as a scientist. I was actually an organic chemist. I did a little bit of medicinal chemistry, but early on, I sort of learned that while I loved talking about and learning about science, I didn’t necessarily love the bench work. So after graduate school, in order to get a different experience and try to figure out what I wanted to do with the rest of my life, I joined a global consulting firm, McKinsey and company, but there I focus primarily on the pharmaceutical industry and even within the pharmaceutical industry, primarily on R&D. And I got really obsessed with trying to make a contribution to what was starting to be discovered at the time as the R&D productivity problem, right in pharma. And now obviously there was data suggesting that we were on an unsustainable path and I generally believe in bringing technology and science to society to improve human health. So I want to make a contribution to solve the R&D productivity problem. During my time at McKinsey, I sort of learned a tremendous amount, but at some point I got tired of kind of talking about it and wanting to try to do something about it. So that led me on a journey to work at a global CRO called PPD with one of the clients that I had at McKinsey. Her name is Christine Dingivan. She was the Chief Medical Officer at PPD at the time. We learned a tremendous amount from her. She ultimately was hired at, into Novartis to lead a big part of their global drug development organization. And I followed her there to Novartis, to lead digital strategy and innovation for our global drug development organization. And then ultimately then created The BIOME within that. And now we’re trying to grow The BIOME into an enterprise wide solution for all of Novartis. So that’s, that’s sort of my snapshot of my journey to where I’m at today.

Janet Kennedy (03:33):

Okay. So I want to talk about the good old days of 2017 and digital development. What did that mean in 2017?

Jake LaPorte (03:44):

Digital development meant to us, which was the name of my organization was really thinking about how to harness these digital technologies and solutions that were starting to arise and incorporate them into future clinical trial paradigms that made them that made clinical trial is a better experience for patients and the healthcare providers that were participating in our trials and frankly, as well as to make them more efficient and effective and faster so that we could more effectively develop our portfolio of medicines just to make a concrete, right. We were looking at paradigms like decentralized trials, for instance. And how do we bring those about in a scaled way into our portfolio? We were looking at things like digital end points and evidence, and how do we incorporate digital technologies to capture new information in trials to make the development of our medicines more effective.

Janet Kennedy (04:41):

And tell me a little bit about the sense of urgency then versus now, was it something that like this was on our five-year plan or were you really trying to focus on things that, how can we get some tests going sooner?

Jake LaPorte (04:55):

So I’m sort of where we’re at today. Obviously we’ve had a huge catalyst in this area also known as COVID 19, which has obviously challenged the conventional way to do clinical trials pretty significantly. So I think the urgency to do something in this area is unparalleled now compared to where were at 2017. However, we, you know, as Novartis, we had a pretty aggressive schedule to transform the way we did trials back in 2017. And it was more about how do we do some of these digital solutions at scale versus continuing to do them in pilots. But of course the urgency, now that folks have to transform as a matched, due to this new challenge in health.

Janet Kennedy (05:42):

Now, when you were looking at digital platforms in 2017, 2018, even early 2019, were you looking at things that you would absorb within your ecosystem or were these more partnership opportunities?

Jake LaPorte (05:58):

So I think most of the time, what we were looking at is for partnership opportunities. So many of these solutions and digital, and by the way, I think this also applies to the broader part of the enterprise are not things that are naturally owned by a specific pharmaceutical company, because most of the time for digital solutions to be meaningful, they need to be adopted at scale within the healthcare sector, right? Which necessarily requires that multiple pharmaceutical companies are using these things as a standard that multiple healthcare systems are using these things as a standard. So oftentimes that almost suggests that there’s a partnership that needs to happen.

Janet Kennedy (06:40):

So what made you decide that the work you were doing in general needed this big investment of time and effort and physical location in creating The BIOME.

Jake LaPorte (06:53):

What it ultimately came down to is a little bit of what I said before that that partnerships are often so critical to building meaningful digital solutions that solve complex healthcare problems. And if you really reflect on where we’re at as an industry, the pharmaceutical industry is not digitally native, but obviously we need to transform. And so we almost always require a partner to some extent, to help us build a digital solution. The complication is that we have just never, as an industry, built a capability to partner with the external digital health ecosystem effectively. And so there tends to be these barriers or this friction that naturally exists between a major multinational pharmaceutical company and the digital health and tech ecosystems. And The BIOME is really a focus on how do we break down those barriers and allow our internal teams to more fluently partner. And co-create with the digital health and tech ecosystems. That’s really what The BIOME is about. We knew we needed to get better at partnering and that’s what The BIOME is focused on.

Janet Kennedy (08:03):

So I’m really envisioning here, you have the big giant pharma company, and then you’ve got the fly by the seat of their pants startup. Those don’t seem like they would mesh very well?

Jake LaPorte (08:14):

Perhaps not, but in a lot of instances, if you partner with younger companies that are maturing in the right ways, they can bring about beautiful solutions that can really have an impact on healthcare, but it’s the key, the devil’s in the details. How do you partner with them in the right way? A lot of the expectation tends to be that that partners are going to come with a fully baked solution that can easily be plugged in to an environment and deployed at scale. In the reality, what we found is that you need to be able to be committed and make an investment in these companies to really adapt their solution and help them co-create their solution so that it can be adapted into our, the context of the pharmaceutical industry. So let me give you an example of what I mean by that, that we’ve come out with publicly. And we talked about right, is a BIOME project that we did in support of our global health organization. And they had already launched an initiative to increase access to medicines for sickle cell disease patients in Sub-Saharan Africa. What we did is we helped them find a technology that by the way existed in Portland, Oregon, with this company called Hemex Health, that would allow them to identify patients in Sub-Saharan Africa, more effectively, diagnose them more effectively, and therefore allow them to get medicines to these patients more effectively. But that of course required that we make an investment in this company. They weren’t for instance, approved by the FDA in Ghana, which is where we were launching this initiative. So we put some regulatory resources around this company to accelerate the regulatory approval onto the Ghana market to allow them to participate in this initiative. And now they’re involved in this initiative and hopefully through this partnership, we’re going to be able to get more medicines to the patients that need them faster with regards to sickle cell disease. So again, when you partner and you think about how to partner in an effective way, it can really, really increase your ability to extend and improve patient’s lives.

Janet Kennedy (10:28):

And in that example, it really sounds like you were utilizing skillsets, experience, existing departments within Novartis to help advance. So you were giving really a helping hand to a company who maybe didn’t have that deep experience or capabilities. Does that sound right?

Jake LaPorte (10:44):

Yes. That’s a fantastic observation, Janet. That’s exactly right. And I think that you can extend that to a more general Axiom that as a pharmaceutical company, you need to think about the complimentary resources and expertise that you have, that you can bring to bear and how to connect that effectively to the partners that you’re working with and be able to make that investment in them in order to co-create solutions that are really going to have an impact.

Janet Kennedy (11:10):

Alright now, I want to talk about culture and mindset a little bit. Yes. We’ve been talking about digital for a long time. How long has telehealth been in the market, 20 years? And we are just now due to, COVID seeing this exponentially explode. Well, it’s about time, but too bad. It took a global pandemic to change our mindset in working with a large company that has, I’m using my little air quotes here, always done it that way before, have you had to work with your internal existing team about helping them be more flexible in their mindset and think about not solving the one problem, but solving the multiple problems, looking for the multiple right answers. Has that been a challenge?

Jake LaPorte (11:54):

So culture and mindset are so fundamental to any kind of transformation that one undergoes, whether it’s a digital transformation or some other transformation we’ve placed a big emphasis in Novartis on the appropriate cultural transformation that we need to undergo in order to successfully transform into a company that’s driven by data and digital. We thought a lot about that. We’re making a lot of investments in that space. In fact, we have a whole learning organization that is focused on how we upskill our organization with regards to digital skillsets and a mindset, right. That needs to be accompanied with that. When you say it’s a challenge, I think, yes, it is a challenge. It’s more of a journey that we need to go on. We see it as a journey that we’re on in order to up-skill and change the mindset of all of our associates within Novartis to embrace data and digital, and be able to think about how to take smart risks with how they implement digital solutions to really improve the way they do their work.

Janet Kennedy (13:04):

What about the speed of drug development? And maybe that’s an oxymoron right there versus digital tools. Digital is advancing at exponential rates and yet protocol design isn’t there yet. Where does digital come into play? Are you trying to work at it from the very base level, or is there a way even with an existing protocol, you can find ways to bring digital tools in?

Jake LaPorte (13:29):

I think it kind of requires both approaches really Janet. So I think there’s ways right now that you can have an impact on the way you design trials from a conventional standpoint, by being able to bring in more meaningful datasets and really think about, and challenge how you did design inclusion, exclusion criteria, right? To make your trial more amenable to a broader population without sacrificing the scientific objectives you have, and the questions that you need to answer that certainly can be done today. I think going forward, there’s an opportunity to reimagine how one, for instance, designs a trial, and frankly how one acquires the data needed to answer their scientific questions. There’s been discussion in the community around some people call them digital twins, other people roughly allude to the same concept as in silico trials and our ability to acquire more sophisticated information, either through just tapping into existing populations, without them being in a trial, for instance, like in real-world evidence or even using new systems like organoids that can replicate the functionality of complex human systems will only grow over time. And you can start to imagine where some of the stuff we do in trials today with human patients will not need to be done in the future because that data can be acquired by different means.

Janet Kennedy (15:01):

So using simulation technology?

Jake LaPorte (15:03):

For instance, yes. So you can imagine we’ll get more sophisticated over time with how we acquire and our ability to acquire real world evidence, and then how to translate that into meaningful ways in which we can simulate pieces of a trial or pieces of a development program. So it doesn’t burden the ecosystem as much. And we’re starting to see this happen already. This happens already with virtual control arms, for instance, and people have been applying this successfully in the oncology space already, right? So not having to stand up an entire control arm for studies can reduce the burden on the healthcare sector in a pretty significant way.

Janet Kennedy (15:46):

I’m curious about the ‘I don’t know what I don’t know’ issue. Are you finding that your data scientists are coming to you saying, man, wouldn’t it be nice if we knew this next level of information and let’s go find a digital platform that’s building that, or are you finding that the digital folks are coming to you with, “Hey, but if you had this kind of information, you could do even more with it?”

Jake LaPorte (16:11):

Yeah. I think there’s always a tension, right? I think it kind of happens both ways in different scenarios. I think there’s what we try to do is we try to work with our business teams to understand what their challenges are and the questions they’re trying to answer and try to take more of our activity based off of solving those challenges. But there’s always that dynamic as you alluded to, you don’t know what you don’t know. So we also make an investment in trying to understand what is happening in the digital health and tech ecosystems and make our associates within Novartis, more aware of what’s going on so that they’re able to have a better understanding of how those new things could be applied to how they work. It happens in both directions I would say.

Janet Kennedy (16:59):

Are you finding that patients are embracing digital and I’m thinking more specifically of more mature patients that aren’t necessarily still smartphone enabled, et cetera, et cetera. How does that impact some of the decisions you’re making? And again, you mentioned going to Ghana where I actually imagined cell phone adoption is relatively good because it serves as the primary computer for those that have it. But I’m curious about the disparity between the patient’s ability to utilize digital tools.

Jake LaPorte (17:31):

Yeah. So this brings up a fantastic point that I think the overall sector needs to think more about, and that’s building digital literacy across the entire population in order for us to use these healthcare technologies more effectively. And that not only includes patients by the way, but it also includes healthcare providers. So how do we build that literacy? How do we build into the natural way in which people experience their lives and practice medicine, that ability to really select the right tools for them that work that makes sense for their lives. You can almost think about it as an analogy of how do you build the app store for digital health solutions, right? Because that’s a great analogy where it’s very customer centric. You go in with a particular need, you’re able to search the solution set pretty quickly. You’re able to download and try a solution. If that doesn’t work, you’re able to kind of find another solution. And so how do we get to that point? It’s a tougher question, obviously in healthcare and as an entire sector, including the payers and providers, as well as pharma, I think we need to think more about how do we build this literacy within different populations. You mentioned Ghana, for instance, as a perfect example, there is a huge adoption of cell phones, but they’re not necessarily state of the art smartphone. So you have to think about building digital solutions that work on more basic flip phones, for instance, and think about there, there that there might be different partners that are needed to build those solutions. And in fact, we have a very good partner called Dimagi, who thinks a lot about how to build data architecture and solutions that allow people to capture healthcare data on a more basic cell phone so that you can really take advantage of the technology that exists in an area. Thinking about that in a meaningful way is important. Thinking about how to increase the digital literacy within populations that are older, that may not have kind of grown up with technology is important. So all of these things factor into how we increase the impact of digital health. And frankly, that I think boils down to culture and mindset shift, not only within companies, but within the broader population as well.

Janet Kennedy (19:51):

So who has that responsibility then? Drives from pharma primary care providers from the patients themselves advocating?

Jake LaPorte (19:59):

I think we need to find a way to work together as a community to bear that responsibility. I think it’s a shared responsibility amongst everyone that participates in healthcare. I think it’s a responsibility of the payers. It’s a responsibility of the healthcare professionals and the providers and the organizations that focus on them. It’s a responsibility of pharma, for sure. It’s a responsibility of patients and patient advocacy groups to be thinking about that. And the only thing I can say, and I hope people could take away from this podcast is if we can find more ways to work together as a community to advance digital health, I think we’ll all be better off for it.

Janet Kennedy (20:41):

Well, I couldn’t agree more. Let’s focus back on The BIOME for instance, if I’m a digital health startup and I was involved in startup weekend for health a few times in the Raleigh Durham area. Very exciting. Sometimes people came in with ideas that they felt very strongly about and they just needed tech teams to help them develop them. Others were just throwing spaghetti up on the wall, but ended up with something kind of solid. When you have people come into The BIOME, are they literally coming into a working space?

Jake LaPorte (21:11):

In some cases they can be, but we actually are trying to really think about models, which really are accessible to everyone and anyone in the world, because really what The BIOME focuses on is how do we help companies, external partners work with our internal teams to build solutions. And so a lot of that work can frankly be done virtually. And a lot of the support that we give companies can be done virtually. We certainly have physical locations and certainly companies that are local to our physical locations can take advantage of them to the extent that they want to or need to. But the nature of us focusing on digital technologies suggests that there’s certainly a lot that can be done virtually as well. And so we’re adapting our model to take that into account. One thing that you asked about was how do companies really engage and get involved with Novartis and the Novartis BIOME? And we certainly recognize as a company that the journey for an external partner to find the right people within Novartis to support them and match what they’re trying to do can be chaotic. We’re on a journey as a company to make that faster and more effective and a better experience for our external partners. And one of the things that we’re developing actually frankly, has been developed already is called the Novartis digital brain. The easiest way to explain is it’s a partner relationship management platform so much like customer relationship management. We want to have a way to track all the interactions we’re having with our external partners, for the purposes of trying to understand how we match the right internal teams with the right external partners. Ultimately, we want to open this platform up so that it’s accessible to any external partner in the world that can update and manage their profile on the Novartis digital brain. And tell us all of the great things that they’re doing potentially within Novartis or outside of Novartis and help us match them to a team in Novartis. That’s trying to do something where their solution makes sense to be matched to, and therefore kind of cut through all of the arduous process of trying to knock on 20 different doors and figure out the right person to work with within a large complex organization.

Janet Kennedy (23:42):

Well, that’s exciting. Is it by invitation only right now, or how do companies get to your attention? Get to the platform?

Jake LaPorte (23:50):

We don’t have the module yet where external companies can access the Novartis digital brain. It’s definitely on our product roadmap right now. We’re building profiles of all the companies we already work with through a combination of third-party external databases like tech crunch or health Excel, as well as internal inputs into those profiles that have been already developed through teams that are working with these partners. But over time we have the aspiration of inviting partners onto this platform, and it’s not going to be something that’s exclusive where we only invite a select few people. We, again, we really want to democratize access to this platform as a way to cultivate the best relationships with our external partners and match them to the right scenarios in order to work with teams and develop solutions that make sense.

Janet Kennedy (24:40):

Okay. So right now it’s still door knocking for some folks, but you are systematizing and organizing companies you are currently in partnership with.

Jake LaPorte (24:49):

Yeah, that’s right. I mean, we’re on a journey. So certainly I don’t want to give the impression that we solved all of these problems in The BIOME yet we’re on a journey. And frankly, we always like to talk to external partners and understand the challenges that they’re having. As we really seek to build out our services and products, we eat our own dog food, if you will. And that we’re trying to really become more customer centric and get feedback from our external partners and therefore use that feedback to inform the next series of products that we develop. But we’re definitely on a journey.

Janet Kennedy (25:25):

Alright. Well, I know that we’ll have your contact information in the show notes of this podcast episode. So I’m sure you don’t mind if people reach out to you via LinkedIn and get to know you there.

Jake LaPorte (25:35):

I do not mind. No.

Janet Kennedy (25:37):

Well, I can’t thank you enough for being here. We have a lot more to talk about. So I give the audience a heads up that there’s going to be a part two conversation, when we talk more specifically about COVID-19 and the acceleration of digital trial initiatives. So for now, Jake, thank you so much for joining me and I thank everyone for downloading this episode of People Always, Patients Sometimes. If you enjoyed the conversation, a review and rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions. Thanks again, Jake.

Jake LaPorte (26:09):

Thank you. It was a pleasure being here and I look forward to part two.