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Jake LaPorte, Clinical Trial Innovation

Clinical Trial Innovation

Jake LaPorte, Clinical Trial Innovation

Clinical Trial Innovation

Part two of our conversation with Jake LaPorte

Hi, I’m Tom Rhoads, CEO of Spencer Health Solutions. Today we have invited Jake LaPorte co-founder and global head of The BIOME by Novartis to return for a second conversation on the People Always, Patients Sometimes podcast. On the previous episode, Jake spoke about The BIOME by Novartis and digital health innovation in clinical trials today, Jake shares his thoughts with our host Janet Kennedy on COVID-19 innovation, digital health, and more. I hope you enjoy their conversation on People Always, Patient Sometimes.
Janet Kennedy (00:36):
Hi, my name’s 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 again for part two of a podcast episode, where we are discussing The BIOME by Novartis as well as patient centricity in clinical trials. Jake, welcome back to the podcast.
Jake LaPorte (00:57):
Thank you, Janet. It’s great to be back.
Janet Kennedy (01:00):
So for the folks that might not have caught the previous episode, can you give us your elevator pitch on what The BIOME project is?
Jake LaPorte (01:08):
I’ll do my best. So the thesis behind The BIOME is that Novartis has made a big commitment to become a company powered by data and digital, but yet we’re not digitally native. So we almost always rely on an external partner to some extent, to help us build digital solutions. And we recognize we need to get a lot better at partnering with companies in the digital and tech ecosystems. And so The BIOME was developed to break down the natural friction that exists between a large multinational pharmaceutical company and the data and tech ecosystems and help us partner with those companies more effectively to develop digital health solutions that have an impact on patient’s lives.
Janet Kennedy (01:54):
You know, there are a lot – like a lot – of digital tools out there. How do you even sift through and figure out who is a good potential partner?
Jake LaPorte (02:04):
Yeah, that’s a great question, Janet. And that’s frankly, what our process is all about, to be honest, because what is not often acknowledged in digital health is there’s a scarcity of evidence that is available to understand whether a specific digital solution is going to be scalable if that’s even feasible. And that it’s going to have a meaningful impact if it is scaled. And so The BIOME is really an evidence generating mechanism so that we can make better more data-driven decisions about how we allocate our resources within Novartis to make sure that we’re allocating more resources to those things that are more likely to be successful and have an impact on patient’s lives. So for instance, we’re doing a lot of work to figure out how we can sift through this complex ecosystem more effectively and more systematically to even surface the right partners. We’re doing a lot of work to think about how then we onboard those partners more quickly and how we do what I call healthy proof of concept work with them. So we’re really thinking about what are the real meaningful hypotheses, the questions that we really need to answer so that we can get more comfortable, that we need to put more resource behind certain companies and solutions in order to scale them a lot of that discipline. And I think this is true of most of the industry did not exist in the digital space. And frankly, it was a paradox, right? Because we have a very healthy innovation management process when it comes to developing medicines, we certainly just don’t plunk a tremendous amount of resource into medicines that haven’t gone through certain stages of trials. And we certainly know about our portfolio of trials and allocating resources to those ones that have gone through certain milestones, like stage one, stage two and stage three of clinical trials. However, we weren’t doing that as systematically with our digital solutions and The BIOME is really that innovation management process. That’s helping us do that with external partners.
Janet Kennedy (04:13):
All right. So one of the pushbacks that so many young new startups get is how many clinical trials have you done? Well, you know, none because we need you to try us take a risk believe in us. Is that something that’s hard to overcome internally?
Jake LaPorte (04:33):
There are still challenges because there are so many solutions that exist out there. It’s impossible for Novartis to make a bet on every company from the very get-go and be the ones that are really sponsoring their initial work. We’re trying to make as best decisions as possible. So we spread our bets. So there are some that are kind of very early on companies and we have to do our best to figure out if we believe in what they’re doing without the evidence behind them. And that fits well into what we’re trying to achieve. And we make a bet on them. There certainly are companies that we do that with there’s others, where frankly, we might need to see a little bit more evidence behind them before we make a bigger bet. And so it’s a balance that we need to strike as much as we would like to try to support everyone in the very early stages, it’s just not feasible for us to do that.
Janet Kennedy (05:24):
Digital is a pretty broad word. So when you’re talking digital, are you literally talking about apps, platforms, medical devices? What kind of things are you looking at?
Jake LaPorte (05:35):
So for us, we take a fairly loose definition of digital. It could be any and all of those things. Distinctively we don’t play in an area where we’re partnering with conventional biotechnology partners to, for instance, co-develop assets or license, an asset from them. That’s a clear place that we play, but any where there is data to be generated or devices to be tinkered with. I think that’s a natural area where the bio model that we developed can be very effective.
Janet Kennedy (06:11):
Before we jump into the bigger conversation, can you remind folks how they can find out more about The BIOME?
Jake LaPorte (06:17):
Sure. They could probably Google Novartis BIOME, and we have a page that will give you a little bit more information about what The BIOME is, give you links to some of the leadership team, and you can always feel free to reach out to me or others to get more information.
Janet Kennedy (06:36):
Alright. And we will include a link to that in the show notes.
Jake LaPorte (06:39):
Perfect.
Janet Kennedy (06:40):
So Jake, one of the things that I was very curious about is the sea change that has happened and we’re golly, nine months into a COVID process. How has The BIOME changed from this time last year?
Jake LaPorte (06:57):
It’s been a meaningful change, not so much to the operating model that we developed, because we think that’s a good one for us to facilitate digital innovation and meaningful partnerships to create digital solutions that have an impact. But certainly when you factor in COVID-19, which is first and foremost, a human tragedy, it’s also certainly surfaced some of the challenges of the healthcare ecosystem. And we have really focused on helping develop solutions that solve some of the challenges presented by COVID-19. So for instance, we have a big initiative as a company on helping to think about developing telemedicine solutions that improve the continuity of care for folks that now cannot necessarily set up regular doctor’s appointments, right? So there’s a whole second level issue occurring in healthcare, which is that people that normally should be going to the doctor and getting diagnosed with other diseases, simply aren’t going to the doctor or their physician as much and are suffering from diseases that they normally wouldn’t have suffered from. So how do we help patients and physicians connect more effectively? So we’re working a lot on solutions like that, making them scalable and effective and providing more convenience to patients and physicians that are challenged in this new era. We’re also re-diverting some of our resources to focus on specific COVID 19 challenges that have been posed by certain government. So for instance, we have a BIOME in the UK located in London and they work with the NHS and the NHS has defined some specific challenges that they wanted to try and solve. And so our entire innovation program that we have in the UK this year was diverted to helping solve some of the challenges that the NHS has presented. So I think COVID-19 has given us a new problem set if you will, to focus on. And it certainly accelerated a lot of people to really think about how to use digital solutions creatively to overcome some of these challenges.
Janet Kennedy (09:20):
Well, I think that’s really exciting because in many cases we think about pharma as being the big engine. That’s only rolling forward at a certain pace and suddenly the flywheel of COVID-19 has accelerated that. And I think it might be really exciting to be working in a company to know that this is not a solution five years down the road. We’re solving something today.
Jake LaPorte (09:45):
Yeah, certainly. I think again, although it’s first and foremost, a human tragedy, it’s sad that this is the catalyst behind some of this digital transformation. I think the solutions that are being developed are solving some more fundamental challenges in healthcare that will have longer term benefits after we get to a better place with COVID-19.
Janet Kennedy (10:05):
I agree. Totally. And I think telemedicine, which has been in development for over 20 years is finally seeing its day. Do you see any other type of digital health solutions that we’re going to be treating more as an everyday use that might not have been accelerated so quickly?
Jake LaPorte (10:25):
Yes, certainly the biggie out there is telemedicine, as you already alluded to Janet. But I think that frankly opens up a platform for a lot of other digital solutions to be incorporated into a telemedicine backbone. I think as telemedicine gets more widely adopted it’s, there will be ecosystems of digital devices that collected data that can be used in a telemedicine forum to make better more data-driven decisions by a physician remotely. I think you’ll see these ecosystems of devices spring up that are expressly designed to fit within telemedicine scenarios. So almost like a virtual checkup room, for instance, that the doctor can use to deliver care more effectively. And in remote scenarios, I think we’ll also see more creative ways to do digital clinical trials. For instance, I think we’ll be using data more often as telemedicine kind of increases. So does the data that’s being collected. And as the data improves that we have on patients, the smarter we can be around developing hypotheses for clinical trials that make them more honed and more focused on answering the questions we need to answer and nothing more than that. So I think we’ll see trials get more effective. So I think there will be a number of knock on effects that we’ll see as this increase happens.
Janet Kennedy (11:55):
Do you see personalized medicine becoming something much more central to our healthcare system?
Jake LaPorte (12:01):
Certainly over time. You know, I think there’ll be a certain amount of catalytic event that happens through COVID-19 with personalized medicine. But I think that will generally occur over time with more development. One of the things with personalized medicine is that we’ve often looked at what we’ve can do on the molecular level with the evolution of Omix. And we’ve seen that as a flagship for what we’re going to be able to do with personalized medicine, but the conversation is often not focused on the other part of personalized medicine. What we really need is that really well, curated longitudinal data set of healthcare outcomes across a population that allows us to really link up what it means on the molecular level, to what it means for healthcare outcomes. And I think once we start getting these more curated longitudinal healthcare outcomes, datasets, possibly through digital technologies and starting to make those links back to the Omix, we’ll be able to make greater strides in personalized medicine. So I’m very optimistic about the future of personalized medicine. I don’t know if COVID 19 per se is going to accelerate a lot of that right now.
Janet Kennedy (13:17):
Alright, now understand that I’m speaking to a PhD in chemistry, which is not the degree that I have. So I’m going to ask a little bit of a 101 level question here. When you talk about getting more data, are you looking at beyond adherence and persistence? This is really digging a little bit deeper and how can patients be involved in providing that kind of information?
Jake LaPorte (13:41):
So if I relate it back to the question posed around personalized medicine, I think, again, this is something where the healthcare community could really come together and make great strides in how we advance personalized medicine. So personalized medicine has been a concept that’s been around almost since we started the human genome project, right? The aspiration of course, is that we can deliver therapeutics and interventions that are personalized to a person’s genetic makeup. But what we’ve realized over time is that we need more information to really interpret different gene sequences that people have and be able to better predict what that actually means for their health and how they will actually experience a particular therapeutic or intervention. And then more over, we have to also incorporate environmental effects that those people experience because different environmental effects obviously have different impacts on patient’s health. So therefore the grand challenge, I think in personal health is to create a large dataset across a wide population of folks that is able to basically detail what their health care experience and outcomes have been over a long period of time, as well as their genetic makeup and their proteomic signatures and sequences to them be able to make that Rosetta stone translation, if you will, between certain sequences of DNA that might exist with one person and not the other, certain protein expressions at one person as versus the other, certain environmental effects that a person experiences versus the other, and then say, Oh, this is what that means in terms of how their health care and their outcomes have been. Right. And so this is where actually patients can make a tremendous contribution, right? And the amazing thing about it is there’s long been this concern about privacy, right, privacy, around the types of data people are sharing. And that is a very big concern and people are very right to have that. But now with the advent of some of these newer technology paradigms, like blockchain technology, and distributed ledgers, there now becomes an opportunity for patients to own their data, their healthcare data, and share what they want when they want with whom they want and revoke access when they want. And not only that, it then becomes possible for this learning technique machine learning technique called federated learning, which allows you to kind of anonymously sample data from patients that may be on part of a distributed ledger and not have to take a lot of their personal healthcare information, but just take the information they’ve generated health and therefore anonymize that, and still be as effective in developing new, more sophisticated algorithms. So again, this is more of a grand challenge, but I think it’s something that the community is the answer is how do we develop technology platforms that allow patients to be involved in contributing data throughout their lifetime, in a safe and effective way where they’re recognized for their contribution, right? Cause that’s another piece of it. They need to be recognized for the contribution that they’re making, but it allows us to advance medicine and ultimately get better at treating people.
Janet Kennedy (17:14):
In the rare disease community – and I am not familiar with everything you all are developing – but are you working in rare diseases at all?
Jake LaPorte (17:21):
So we don’t have a big focus on rare diseases per se. I think what you’ll find is we work in rare diseases in a targeted way, and it’s more platform driven. Like we have a cell and gene therapy business unit. And so one of our major products that we just got approved last year is Zolgensma, which is a gene therapy to treat spinal muscular atrophy – SMA – it’s miracle, right? Because if you are able to get a treatment to a patient within a certain amount of time, it pretty much cures them from a disease where they would definitely die. So we work in rare disease, but we don’t have like a rare disease business unit per se.
Janet Kennedy (18:02):
So one of the things that we’re hearing from people who have COVID-19 is there long-term health concerns that may be a result, whether it’s heart impact on lungs, et cetera. So co-morbidities become a much more important part of understanding how the data works together and then it gets really complex. So are you finding in The BIOME or in the industry at large, this awareness of the importance of pulling together very disparate pieces of data to try and understand health issues?
Jake LaPorte (18:34):
Yeah, so I think this conversation is starting to become more prominent throughout the entire healthcare sector. The understanding that we need to be able to have more datasets, talk to each other and be joined together in order to power things like machine learning and AI, right. We often talk a lot about the promise of AI and machine learning in healthcare. And it turns out that one of the biggest barriers to seeing more impact from this very impressive technology paradigm is just being able to have the structured datasets to train these algorithms. And so I think there’s more recognition that number one, the healthcare data that we do have tends to be very fragmented and incomplete and that we need to as a community come together and be able to do something about that. So what that means is we need to come together and develop data standards and an ontology, which is basically a language or a way to relate data sets together in order to join datasets that we already have. And then in the future, we need to think about ways in order to collect data more effectively to sort of power some of these powerful technology paradigms like AI and ML.
Janet Kennedy (19:54):
And I think as you said earlier, digital health literacy is essential. Helping patients understand that their data is really needed to help themselves and others.
Jake LaPorte (20:05):
That’s exactly right. It really boils down to ultimately increasing digital literacy, but also developing solutions that make sense, right? So I think we need to be very focused on the patient, what their problem is, how do we solve that problem and how do we protect their privacy? And then how do we communicate that to them to help them understand that that’s what we’re trying to do.
Janet Kennedy (20:30):
Well, and that’s what should always be right? Focused on the patient for the patient, because that’s what we’re trying to do.
Jake LaPorte (20:36):
Exactly.
Janet Kennedy (20:37):
Well, Jake, what a fascinating conversation. And I appreciate your spending the extra time to do a part two episode of our conversation. I appreciate your being here very much.
Jake LaPorte (20:48):
My pleasure, it was fantastic conversation for me and I hope you and the audience enjoys it. And again, if there is any questions about the bio that folks want to follow up, please feel free to do so.
Janet Kennedy (20:58):
Thank you for downloading this episode of People Always, Patients Sometimes if you enjoyed our conversation, a review and a rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions.