The rise of research entrepreneurs and why it matters

How can an extensive collection of real-world data help find more diverse and better participants for clinical trials? How do we create a continuously learning ecosystem that helps bridge the gap between clinical research and clinical care? And what are the biggest challenges to patient record standardization and personalized healthcare? We will learn that and more in this episode with Dr. Lu de Souza, Vice President and Executive Medical Officer of the Learning Health Network, which is a division of Oracle. Dr. de Souza leads a team that seeks to help health organizations integrate clinical research into everyday care. That means addressing clinical discovery cost, time, and patient inequities. She’s also a huge advocate for real-world data and bringing technology to bear for true healthcare advancements. Dr. de Souza has years of experience in health informatics and was the most recent CMO of Cerner in North America. She practiced pediatric hospital and emergency medicine until 2020 and has held multiple leadership and teaching positions. 

--------------------------------------------------------

Episode Transcript:

Research reveals that 95% of patients do not participate in clinical trials. How do we find better ways to connect willing and qualified participants to clinical trials? How do we ensure diversity in participant populations? And how can we make access to clinical trials more patient-friendly? We will get those answers and more in this episode with Brandon Li, Co-Founder at Power. Power is a fast-growing startup building a patient-friendly way to get access to clinical trials and is working to increase the diversity in clinical trials.

--------------------------------------------------------

Episode Transcript:

00;00;00;03 - 00;00;17;02 

Are there better ways to connect willing and qualified participants to clinical trials? How do you ensure diversity in participant populations? And why do 97% of patients not participate in clinical trials? We'll get those answers and more on this episode of Research in Action. 

00;00;18;07 - 00;00;19;19 

The need to. 

00;00;21;14 - 00;00;41;18 

Build the Hello and welcome to Research and Action, brought to you by Oracle Life Sciences. I'm Mike Stiles, and our guest today is Brandon Lee, co-founder at Power. Power is building a patient friendly way to get access to clinical trials, and they're working on increasing the diversity in clinical trials. Brandon, thanks for taking the time to be with us today. 

00;00;41;28 - 00;00;42;27 

Yeah, it's my pleasure. 

00;00;44;06 - 00;01;03;27 

Great. Well, looking forward to it. And we are going to be talking about some amazing stuff as always. But we also always like to get a feel for the person behind that amazing stuff. So what did you want to be when you grew up and how did you get from there to the field of clinical trials and technology and the kind of things you're doing now? 

00;01;04;06 - 00;01;13;12 

It depends on how far back you want to go, but I think that through most of my childhood, I probably wanted to be a like a professional trading card game player as. 

00;01;16;03 - 00;01;17;28 

Are you a Pokemon man or. 

00;01;18;11 - 00;01;29;24 

It was it was all of the above, right? It was like a Pokemon journey. Then there was like a, you know, journey. Then there was a magic. The Gathering journey. I kind of cycled through all of them, but I ended up landing on magic, I think, for most of it. 

00;01;30;15 - 00;01;32;25 

Well, check those old cards. You could be a millionaire. 

00;01;33;01 - 00;01;39;12 

I've been. I've been watching the the price of Charizard skyrocket with a lot of energy. You remember having plenty of money? 

00;01;39;23 - 00;01;43;08 

Well, great. Yeah, but obviously that's not what you wound up doing full on. 

00;01;43;23 - 00;02;12;07 

No, not at all. Yeah, I think the kind of journey here was. Well, at some point I became a consumer internet. Consumer marketplace person sometime between my my kind of professional trading card game times and and kind of coming out of college, I started thinking a lot more about consumer tech. So I spent a handful of years just doing things that look a lot like classic consumer marketplace work. 

00;02;12;07 - 00;02;33;14 

Thumbtack, Airbnb, Zillow, all kinds of kinds of products. And at one point I had a close friend of mine diagnosed with a brain tumor who had to go looking for a clinical trial on her own and, you know, that journey was brutal for her. She did everything that patients basically go and do today, which is backchannel the heck out of every doctor that she knows. 

00;02;33;14 - 00;02;55;08 

And eventually all roads ended up leading to clinicaltrials.gov. So she spent weeks there trying to figure out, okay, is there a trial that could make sense for me? Eventually, she finds one and the contact information is like the front desk of the hospital. So she's cold calling the hospital. The hospital's routing her internally. She's trying to find a way to get an appointment and eventually she gets in front of a study, she gets in. 

00;02;55;08 - 00;03;17;26 

And that's what they had a positive readout earlier this year, which is probably the happiest journey somebody could have gone through. But it was through that kind of experience that I realized a few things. The first one is that she can't be the only person out there who is sitting in front of clinicaltrials.gov, sitting in this kind of situation trying to answer the question, are there leading medical researchers that can help me? 

00;03;18;13 - 00;03;42;10 

And the second thing we realized was, while that journey is way too difficult today, right. Everything from even discovering trials in the first place to evaluating your options to figure out what you could be qualified for, what looks really promising through to even contacting the research sites. So we just put put our heads together and realize, well, I think that we can actually bring a lot from this consumer into that space and hopefully, hopefully help a lot more people in need. 

00;03;42;22 - 00;03;48;09 

So tell me what power was founded to do the problems that it specifically seeks to solve? 

00;03;48;29 - 00;04;14;24 

It's pretty straightforward, and I like to look at it through a couple of different lenses. So through the lens of the patient, it's exactly this kind of dream that I just described, right? It's helping individuals find and get access to leading medical researchers that could help them from the perspective of the sites. It's how do you connect with as many patients that are potentially interested in your study but not established at your site? 

00;04;14;24 - 00;04;31;25 

So maybe you don't have a relationship with them yet, but we help you kind of like widen that catchment area as a site and then as a sponsor. It's well, we give superpowers to your sites and we help elevate the kind of the reach of your studies to the patients that are using our platform. And we have hundreds of thousands of them now. 

00;04;31;25 - 00;04;37;05 

So plenty of folks on, on the website looking, looking around for trials and trial information. 

00;04;37;28 - 00;04;55;04 

So the people who want to be in clinical trials would find useful connections to those doing the research. And what's the level of the research world? How is it embracing the platform? Is it eagerly seeking to connect with these people who want to do clinical trials? 

00;04;55;20 - 00;05;17;25 

I think this this kind of touches on an age old problem, right where everybody I'm sure the kind of guest are. The the audience of your podcasts knows these stats, but we didn't coming in certainly turns out that finding patients to participate in trials is one of the biggest problems in life. Science, R&D, right? 86% of trials being delayed because they couldn't find the patients to participate. 

00;05;17;25 - 00;05;46;23 

So what we found is that we've had north of a thousand like research sites already, like just sign up to start connecting with our patients from the kind of ground ground up. And that's led to a movement that we can then point to some really interesting data and say things like, Wow, actually turns out that the the the research sites that are using power or connecting with patients like ten times more than if they weren't they weren't using patients. 

00;05;46;23 - 00;05;49;19 

And that data has been really meaningful for us to see. 

00;05;49;19 - 00;06;09;20 

Well, is it a database of willing participants that the researchers can go look at and find? Because it seems to me most patients, they are totally taking the guidance of their doctor, you know, and so is the doctor playing a role in connecting these people with these research projects? 

00;06;09;20 - 00;06;27;25 

There's kind of two things here. The first one is, yeah, we've got a registry where patients sign up and they say, Yeah, admitted registry. The registry experience from the the site's perspective is kind of like a LinkedIn for patients, if you can imagine it. It's like, Oh, there's these patient profiles, they've created a profile. I can see them. 

00;06;28;04 - 00;06;51;27 

They might have answered some prescreening questions at some point. So I'm starting to paint a picture of, you know, medical history and I can invite them to connect if it makes sense. So there's kind of like this LinkedIn for patients. And then on the other side, there's also, you know, new patients signing up every month. And I think that's where a lot of the impact is, because our view is that the patients that are most recently active and interested are the patients that are most likely to actually take action. 

00;06;52;24 - 00;06;59;22 

So it's all about new flow of patients in our mind, even more so than the the kind of depth of of the database or the registry. 

00;07;00;07 - 00;07;11;17 

And then what about that Dr. element? Are doctors aware that this tool is available and are they eager or reluctant to get their patients involved in clinical trials? 

00;07;12;04 - 00;07;30;23 

One of the most interesting things that we've started to see is that doctors are referring their patients to us, right? We're starting to see that in the data where, you know, maybe when we launched, nobody's doing that. And then a year ago, you know, you got a handful of people and that number has actually doubled like year on year of like the number of doctors that are actively referring patients. 

00;07;30;23 - 00;07;55;20 

And it turns out doctors are okay, referring patients to clinical trial resources. It turns out they do that all day long anyways, but they actually send patients to clinicaltrials.gov. And if you talk to any doctor about it, they they kind of look at you like sheepishly and and almost kind of confess that they do it because they hate it, they hate clinicaltrials.gov, and they know it's not going to help the patients that they're working with. 

00;07;55;20 - 00;08;17;26 

And it's going to be a really difficult experience. So one of the things we found is that by building a superior product experience for consumers, for individuals on the Internet to learn about clinical trials, doctors are actually more than happy to send patients to to the website to learn about trials. And that's been, you know, one of the kind of happy byproducts of building the kind of best patient experience possible. 

00;08;18;12 - 00;08;26;11 

So because doctors weren't exactly in love with clinicaltrials.gov, they knew they would be sending their patients kind of down a frustrating rabbit hole. 

00;08;26;12 - 00;08;27;05 

Correct. 

00;08;27;05 - 00;08;53;07 

Now, your friend. Well, you're right in saying that, you know, researchers have a hard time finding participants for clinical trials. Your friend on the flip side was eager to participate in a clinical trial. So what makes her different from a lot of patients who are reluctant to participate? Is it because they don't know about the clinical trials or they're too scared to engage in them? 

00;08;53;07 - 00;08;54;23 

What's what's your view on that? 

00;08;55;05 - 00;09;13;29 

Yeah, I think it's actually about evaluation. I think evaluation is a key step. If we think about kind of the journey in three phases, there's like discovery, even learning about clinical trials and seeing the trials in the first place. That's difficult. You know, in clinical trials that is rather hard to do properly. Discovery or even your option search. 

00;09;14;10 - 00;09;32;29 

Then there's the second stage of evaluation. What could be good for me? What am I actually qualified for, and why should I be excited about this relative to status quo? And then there's the kind of participation experience of connecting with the right sites. Right? But I think that, like the second stage of evaluation is really, really the the kind of one of the missing pieces here. 

00;09;32;29 - 00;10;00;15 

All three are difficult, but evaluations of missing piece, oftentimes when we speak to patients and we speak to patients every week, the key question is, well, how should I be thinking about this trial relative to my current my current care? And is there a reason to believe that this is really exciting or meaningful and I think it's on are kind of like partners in the life science space to properly lay that out for patients. 

00;10;00;15 - 00;10;12;10 

What is the driving hypothesis that makes you excited enough to put your your capital behind this, this study? And I think patients are looking for that with probably less of a clinical expert explanation of it, though. 

00;10;12;21 - 00;10;26;13 

Your friend, you mentioned that the outcome was positive, So I'm assuming she got into a clinical trial. She participated. She was not one that got the placebo. She actually got a new drug that helped. 

00;10;26;24 - 00;10;27;05 

Correct. 

00;10;27;16 - 00;10;40;19 

Well, let's talk about a lack of diversity and the things that make clinical trials, not that user friendly for everyone. Why is diversity a hard problem to solve and what makes the reward well worth the effort? 

00;10;41;01 - 00;11;01;23 

You know, we if we look at the stats, it's pretty obvious that clinical trials aren't representative of the population. I think the kind of problem here, let's sit with the problem and talk about kind of like the root cause here. I think the problem here, the problem with it is that it kind of poses a broader public health challenge. 

00;11;02;21 - 00;11;25;22 

Let's imagine everything goes well and we end up getting new treatments through there. Phase three in front of the FDA approved and we start launching them, but we haven't properly ran these trials with a diverse group of patients. We don't actually know how some how some treatments might affect different different populations and that's why I call it a public health challenge, right? 

00;11;25;22 - 00;11;46;14 

Because all of a sudden now something becomes standard of care. But we don't know how it affects East Asian, how it affects East Asians and that's and that's the kind of root cause problem. It's it's not a I think, a performative point that diversity, it's really kind of like a downstream potential public health challenge. So that's why it's so important. 

00;11;46;14 - 00;12;07;12 

And then I think, B, the question of why is it the way it is today is an interesting one. And I think it has to do with the history of clinical research sites that that we choose to partner with. Typically, you know, you partner with a handful of clinical research sites. Those research sites are tasked with recruiting patients from their existing populations. 

00;12;08;06 - 00;12;29;05 

And then, you know, the kind of set of patients you end up seeing on the set of patients that those sites have established. And it just so happens that the sites that we typically work with in research have a largely white existing patients and that that that ends up skewing the kind of population because you've got a bit of a sampling bias at that point. 

00;12;29;25 - 00;12;47;21 

Right. So obviously research is not a one size fits all proposition. That's it's amazing that things have been passed that have not been tested on all types of people, all demographics, different patient sets. There's kind of assumption that, well, if it worked with this group, it's going to work with everybody. 

00;12;48;05 - 00;13;09;07 

Yeah, yeah. I mean, certainly I think the the approach thus far. But you know, I think the the industry is making incredible strides here in raising awareness of this challenge. And then certainly with the recent FDA guidance starting to lean in more to understanding that, oh yeah, there is a potential health care challenge that comes with this that we need to be solving for. 

00;13;09;07 - 00;13;12;03 

And that's been very inspirational. Watch. 

00;13;12;03 - 00;13;32;10 

So you did form power to address all this. What does it do in terms of actively recruiting to solve the diverse party problem? In other words, increasing that pool of minority candidates, people that traditionally have not been participating in clinical trials? 

00;13;32;24 - 00;13;57;20 

You know, we think of ourselves as a a source of unique patients that are interested in trials, Right. So we we help improve access for patients that may not be currently established at the at the research sites. So when we when we think about our role in diversity, what matters to us the most is, is our source of patients more diverse, right, than the other kind of status quo. 

00;13;58;03 - 00;14;23;13 

And turns out when you look at our data, 40% of the patients who sign up and are actively participating on our platform are nonwhite. And that's right in line with what the US Census and what you would expect in a in a representative sample of of the US population. So I'm we're excited that we're able to hold true to that mission of improving access and that as a result of improving access, actually being a representative source of patients that are interested in research. 

00;14;23;29 - 00;14;39;01 

Well, you're tackling a tough space because there's so much regulation and the practices are absolutely entrenched. So what's been the rudest surprise you've encountered in your mission so far or the toughest hurdle you had to overcome? 

00;14;39;17 - 00;15;11;16 

Not not rude surprise, but I think one of the the challenges that, you know, I think everybody can empathize with is that our research sites are incredible busy, busy and often overburdened. So sometimes what is potentially easiest for the patient isn't easiest for the research site. And when you when you think about solving this problem of improving access, if you haven't also solved the problem at the research sites, at the end of the day, you can't close the loop, right? 

00;15;11;18 - 00;15;30;03 

You can't kind of make the kind of transaction complete, so to speak. Right? So one of the kind of hurdles that we need to we need to overcome and we're constantly kind of like balancing is the line between what is best and easiest for patients and then what is best and easiest for the researchers that they actually need to connect with. 

00;15;30;03 - 00;15;39;17 

And it has to be, you know, a little bit of give and take and easy for both, Easy enough for both the they that they both can take action because ultimately if if one of them doesn't take action, nothing happens. 

00;15;39;27 - 00;16;03;05 

Right. So ease of use is definitely a factor. Trust is probably the other factor we kind of touched on this, but we're used to things like control groups and devices to make sure that bias and inaccuracies don't enter the clinical research picture. It seems like if there's underrepresentation and trials, the best results you're going to get are cloudy at best. 

00;16;03;16 - 00;16;42;10 

Yeah. Yeah. You know, trust is an interesting one, right? One thing that we've experienced with the patients on our platform is that once they've if they if they're coming through our platform, it's because they're almost predisposed to be interested in research. Right. If you think about the kind of factors that have to be true for somebody to be predisposed to be interested in research, one of the factors is that they've they've probably considered it a little bit and are coming in with a higher baseline level of trust, which is not to say that you don't have to continue to build trust. 

00;16;42;10 - 00;16;59;15 

As a as a researcher, I think everybody has to continue to build trust and it's easy to erode it, especially in a in a clinical setting. But what we're seeing is that the folks are looking around on our website and poking around and reading about different studies there and and then ultimately choosing to connect with it with a researcher. 

00;17;00;05 - 00;17;04;02 

It's because they've built up a requisite amount of trust already. 

00;17;04;21 - 00;17;22;12 

Well, let's say I'm someone with an understudied disease and I really want to participate in a clinical trial. How does someone go about that? I mean, obviously going to power and being registered and in the database, but what are the odds that I would get accepted? What factors come into play? 

00;17;22;27 - 00;17;51;22 

I mean, I think the kind of standard factors come into play at that point, right? So a patient kind of comes through the journey on the website, finds a trial and connects with a with a study, then I think the standard kind of factors come into play around eligibility. How qualified are we and can we prove our qualification as a part of connecting with the research sites in order to get the research site excited to kind of bring you in and kind of work with you? 

00;17;51;22 - 00;18;12;12 

Right. So some of that is on us as a platform to help help patients maybe put together what we call a dossier or an application packet that helps them get quickly considered and screened for a study. Part of that is the kind of nature of how the protocol is written, and I really think we can influence and that's okay. 

00;18;12;12 - 00;18;17;28 

And that's kind of par for the course. And just the way that research is structured, not everybody is qualified for every study. 

00;18;18;13 - 00;18;30;24 

Well, I was looking over the notes and, you know, one figure really jumped out at me. And, you know, correct me if this figure is wrong, 97% of U.S. patients and providers don't participate in trials. 

00;18;31;14 - 00;18;55;27 

Yeah, it's something like that. I think roughly 3% of of patients as the stat that I've seen, 3 to 5% of patients participate in trials, which is which is amazing when you think about the kind of opportunity to develop improve visibility of research. Research is such an important part of our system and oftentimes should be considered as a part of the the kind of treatment journey like for for an individual. 

00;18;56;01 - 00;19;18;04 

And I think that's part of actually solving this and increasing that percentage of want to think about that is like the end goal. Part of solving this, I think, is building a relationship with patients through their treatment journey and helping them understand, okay, I'm at this point and I'm on this, you know, potential treatment path and there are some trials that are available on and make sense right now. 

00;19;18;13 - 00;19;33;24 

But then there are also some trials that could make sense a year from now based on how these kind of treatments progress and based on how I react to them. And I think part of what we want to do as a platform is build that relationship and help be a part of that that journey in that planning for individuals. 

00;19;34;17 - 00;20;05;11 

Well, 97% is huge. And you said earlier 86% of clinical trials are delayed because they can't recruit enough patients. Is it that people and providers are not participating because trials are so hard to stand up and run? Or, you know, we've talked to other people before, you know, on the podcast and previous interviews and and a big problem is participants in clinical trials kind of don't really know what they're getting into in terms of the level of monitoring that's needed. 

00;20;05;11 - 00;20;19;19 

And, you know, it becomes very difficult to incorporate the clinical trial into their lifestyles. And are those some of the issues that are just preventing 97% from leaning into research? 

00;20;20;12 - 00;20;43;24 

You know, I go back to this evaluation question like, are we are we properly are we properly conveying to patients like the reasons to believe if there's a compelling reason to believe that this is a like the best kind of like path forward, I think that that's is kind of like a like put into context of the burden of, of participation. 

00;20;43;24 - 00;21;05;28 

And I think oftentimes from the patients experience, all they kind of like get exposed to really is the burden of participation without the, you know, the requisite amount of exposure to, you know, why is this the best path forward for me or the best option available right now? I think about it in terms of balancing these two things. 

00;21;06;17 - 00;21;38;22 

Yeah, there's an increased ask and burden on behalf of the patients and there's also potentially a really compelling reason why this is exciting. And those two things have to be put into a kind of like proverbial pros and cons list that individuals can kind of trade off as they as they think about about research, but not no, I don't think that's the kind of question of burden is excluding 97% of of patients, I think that there are patients that that will be turned off by the burden. 

00;21;38;22 - 00;21;41;01 

But I don't think it's 97% of people. 

00;21;41;20 - 00;22;06;23 

And for the general public, you know, getting excited about research, how do you think the amount of time that it takes to do good and qualified research, you know, and get all the way through to FDA approval? It just seems like it takes years and years and years. So it's it's hard to get excited about something that may not yield results for anyone until well into the future. 

00;22;07;08 - 00;22;22;27 

I think if you put yourself into the shoes of the individual participating, right, it's it's not typically a question of, okay, like what is the impact ten years from now? I think it's a question of, you know, what am I experiencing in the here and now? Does that make sense? 

00;22;23;13 - 00;22;39;23 

Yeah, absolutely. Is control of the major clinical trials in the hands of too few facilities and researchers, or do you feel it's pretty much properly democratized? You're seeing a lot of clinical research opportunities available. 

00;22;40;09 - 00;23;16;16 

Yeah, control is an interesting question, right? So certainly clinical trials are concentrated to a group of providers, sites that are familiar and let's say have a track record of doing research. And I think there are like very reasonable rationales for that. I would even argue, you know, probably okay with that, there's a little bit of concentration, right? Because the kind of bigger a trial gets, the more people that are or the more providers that are participating, the more noise and variance kind of gets introduced and gets introduced to the system. 

00;23;16;16 - 00;23;38;20 

And that's not always a good thing. Our perspective here is that we do need to increase access, but the way to increase access is not necessarily to get to 100% of providers participating in in every study. I think the way to increase access is actually to help individuals and patients learn about studies that are happening in their in their geography, and they get properly connected with those sites. 

00;23;38;29 - 00;24;00;02 

And to make that that kind of journey easier, rights for patients have more visibility to what's available and then getting connected with the right person in the city. It doesn't really make sense to have, you know, a hundred providers in Cincinnati doing a doing a study right is just about funneling patients to the to the right locations and improving kind of like access and transparency. 

00;24;00;02 - 00;24;00;26 

Those opportunities. 

00;24;01;17 - 00;24;17;01 

Well, you do have primarily a technology product. You're connecting people to clinical trials. Technology is going to play a role in that. But it's not like this is tender, right? Me So what what kind of tech and guidelines does power use to make these connections? 

00;24;17;01 - 00;24;38;00 

We think of the our, you know, our publicly facing platform and that's that's what most people see when they kind of engage with us as like an Airbnb like interface for individuals who are looking for trial. So it's really on the on the patients side, right? It's like a discovery and evaluation product and we do a bunch of things that are interesting there. 

00;24;38;05 - 00;24;59;26 

But one of the things we do that's interesting is we actually have one of the best structured data sets on eligibility criteria that is out there and then as a result, we can have patients now start to do their search on the basis of, for example, like their genetic biomarkers, and they can do filtering on genetic biomarkers relative or relevant to their their kind of condition that's not available anywhere, anywhere else. 

00;24;59;26 - 00;25;31;04 

Right. From a patient facing perspective, that's that level of kind of like of detailed search experience actually makes the discovery and evaluation process way easier on from a patient's perspective. Then on the flip side, you know, let's use that as continue the Airbnb analogy research sites get access to. Well, we like to think of as, you know, like a referral management or a recruitment management platform that they can use to see all the patients that are interested in their trial on our website, on our platform. 

00;25;32;14 - 00;25;53;09 

So it's kind of a workflow management tool that that sites can use to kind of connect those patients that are on our website and expressing interest in their studies. And then somewhere in between we've got a kind of like matching algorithm. So we're I'm sure everybody who's who's kind of come through here and is working on technology is thinking about ways that you can use A.I. rights to improve workflows. 

00;25;53;09 - 00;26;25;05 

Our view is that A.I. is an interface is not the end game, but as a as a component to kind of like your tech stack is really compelling. So we're looking at ways to use AI to improve match rates, improve kind of screening qualification, and in doing so, reduce some of the burden on the on the patient side for identifying what could be a good trial, but also reducing burden on the site's perspective and having to screen that these patients from from scratch every single time. 

00;26;25;27 - 00;26;38;10 

So it sounds like the databases, the processing power required for that would be pretty intensive. Is all of that being run smoothly and securely in the cloud? Is that a hybrid approach? Is it on premises? What do you have? 

00;26;38;17 - 00;26;46;12 

Yeah, it's all in the cloud and it's not a you know, we're not making our own A.I. models, right? So it's it's not nearly as intense as maybe it sounds. 

00;26;46;29 - 00;27;03;24 

So it sounds like the proposition is just that there are the ability to run filters and eliminate mismatches to get to good results better. And that a superior, I would assume, to what clinicaltrials.gov have offers. 

00;27;04;10 - 00;27;23;18 

Oh, yeah, certainly right. For if we're going to both sides of the equation, patients can more quickly figure out what trials they should actually be considering. Right. Like if you if your patient search on clinicaltrials.gov, you get thrown 150 different options that you need to track in a spreadsheet and try to whittle down towards five or ten that are a good fit. 

00;27;23;18 - 00;27;39;06 

So patients can very quickly do that. It takes them a minute on our platform and then on the researchers side, they can double click into the patient's profile, the medical history, all this kind of stuff in order to quickly make an assessment about whether this patient is qualified enough to kind of come in and screen. 

00;27;39;29 - 00;28;08;20 

So what we've been talking about is bridging the gap and making the connections between patients and clinical research. And Oracle Life Sciences mission is kind of bridge the gap between clinical research and then clinical care. So kind of in the connecting business as well. But if power is successful and we're running diverse clinical trials, what are your thoughts on how those learnings can then be made actionable in the point of care and patient portals area? 

00;28;09;08 - 00;28;37;02 

I think that, you know, and this is kind of early in and the way that we're thinking about it, but I think that providers have a really important role here and consideration and the consideration process of clinical trials. And one thing that we would love to to see more is for us to have broken down the barriers for providers to understand and what trials are currently running in their specialty and stay on top of the best options. 

00;28;37;02 - 00;29;00;12 

Right Today, you know, providers in the community have to stay on top of reams of information. It's really quite a difficult journey for them as well to stay on top of the kind of latest research in their in their category. So one thing we would love to see is for those providers to be able to leverage power to, you know, just stay smart on the kind of latest in a medical research. 

00;29;00;17 - 00;29;05;14 

That way when they do have a patient comes through, they have the information they need at their fingertips as well. 

00;29;06;04 - 00;29;26;29 

Are doctors reluctant to give patients? I don't want to say false hope because the hope is genuine, but it's almost like they don't want to get their hopes up by saying, hey, this clinical trial is likely to give you a solution where today we don't have a solution for you. 

00;29;27;17 - 00;29;50;09 

I think providers are are really the experts at navigating that that conversation. And I don't know any providers who I think misrepresent the the opportunities present in clinical trials. But I think really providers are quite thoughtful about how they present research as an option. 

00;29;50;09 - 00;30;08;06 

Well, we talked about your tech stack. And when you think about your tech stack and you look over all the tools that you have, is there anything on your wish list or is there anything you know, you touched on I a little bit that you see coming in the future that's going to really kick power up a notch? 

00;30;08;26 - 00;30;11;27 

Yeah. I mean, if somebody could just solve this medical record thing, I'd be nice. 

00;30;13;11 - 00;30;29;07 

Well, you've brought up an area of mass chaos, but kind of expand on that. You know, what's what's the problem? Is it just like incoherent, inconsistent, not interconnected methods for keeping medical records for Americans and others? 

00;30;29;19 - 00;31;07;23 

Yeah, all of the above. Right. And, you know, patients might want to get access to their medical records. How do they get those records? You know, the new clinical trial inevitably is going to want the medical records as well. How do how does the trial get access to those medical records, the kind of like general mosaic of different set ups and different communication norms and different like ways to share the records, I think introduces a lot of inconsistency into the space, which makes it difficult for everybody from providers to researchers to patients, and certainly for the life science companies that are pulling their hair out and looking at everything, trying to figure out is there 

00;31;07;25 - 00;31;09;09 

is there a good way through this mess? 

00;31;09;27 - 00;31;12;25 

Turns out a little standardization isn't a bad thing. 

00;31;13;02 - 00;31;38;28 

No, it could be really helpful. I don't know. You know, I think a little bit of the the kind of banking and finance stuff where Clyde has really solved this inter connectivity problem for our intraoperative interoperability problem for financial services institutions to allow fintech at some point. It'd be nice if somebody does that on the medical record side, and there are a lot of really great teams sprinting at this. 

00;31;38;28 - 00;31;47;18 

So, you know, I'm I'm cheering them on. Waiting for the day when collecting a medical record is as easy as connecting my bank account to a new app. 

00;31;48;10 - 00;32;07;28 

Well, if you were to assess where we are today in terms of bringing more participation and diversity into clinical trials and where we might be, say, five years from now, can you change mindsets and the culture around clinical trials in that period of time? Where do you see this going in, say, the next five years? 

00;32;08;15 - 00;32;36;24 

I think it's it's interesting. I think there's a ton of runway ahead of us for impact. Or let's go back to one of the stats that you brought up. 97% do not participate in trials. 3% do getting 1% more of the kind of population to be excited about research. And depending on research, just 1% increases. The overall the overall participate participation rates of the population by 33%. 

00;32;36;24 - 00;32;56;25 

That's massive, right? So can we go from 3% to 5% in the next five years, almost doubling the kind of participation rate? That's huge impact, a huge impact on on our industry. It's not yet broad population adoption. And I think that's okay. When you're starting from a small base, you kind of have to stack up the the wins and think about them economies relative terms. 

00;32;57;14 - 00;33;03;15 

Well, we'll look forward to watching the progress in the space and we'll let you know when that medical records thing gets sort of shorter. 

00;33;05;01 - 00;33;05;03 

So. 

00;33;05;04 - 00;33;15;11 

You can be on your way. Well, Brandon, thanks again for being with us today. If someone wants to get in touch with you or learn more about what power does, what's the best way to do that? 

00;33;15;20 - 00;33;39;28 

Yeah, you know, I think that get in touch with me. I probably shouldn't do this, but my email is Brandon up with power dot com. Feel free to send me an email. Always happy to chat and share. Share what we're up to. And then if you want to take a look at our website, it's it's free and public so it's with power dot com pretty easy to go find and take a look at the kind of experience that we're trying to build for for people who are learning about research. 

00;33;40;11 - 00;34;12;22 

Fantastic. And we appreciate it. If you are interested in how Oracle can simplify and accelerate your life sciences research, we invite you to check out Oracle dot com slash life sciences and also be sure to subscribe to the show because there's more genius ahead and join us next time on Research and Action. 

What does a data hippie believe about the democratization of data? What role do technology companies, government, academia, industry, and other stakeholders play in life sciences and discovery? And how might walking clinical trials lead to improved precision medicine? We will get the answers to those questions and more in this episode with Dr. Chris Boone, the GVP of Research Services at Oracle Life Sciences. Chris has held some prominent roles at AbbVie and Pfizer, influencing health economics, medical epidemiology, and real-world data and evidence. He is an adjunct assistant professor at NYU, engaged in national health data committees, and serves on several boards including the American Heart Association.

--------------------------------------------------------

Episode Transcript:

What is the rare Gaucher disease and how does it impact patients, families, and life sciences? Is enough emphasis being placed on research and discovery for rare diseases? And what are the patient-centered approaches that best serve those battling rare diseases? We will get those answers and more in this episode with Tanya Collin-Histed, CEO of the International Gaucher Alliance. Tanya has been a longtime driving force in supporting patients with rare diseases and advocating for world-class healthcare. Her work has been nothing short of groundbreaking and she’s become the go-to person for patients, medical practitioners, industry, and governing bodies. As a mother of a child with Gaucher disease, she brings a unique, first-hand, and compassionate approach.  

--------------------------------------------------------

Episode Transcript: 

00;00;00;00 - 00;00;25;09 

What is the rare gosh disease? Is enough emphasis being placed on rare diseases? And what are the patient centered approaches that best serve those battling rare diseases? We'll get those answers and more on research in action in the lead to the world. Hello and welcome to another episode of Research and Action, brought to you by Oracle Life Sciences. 

00;00;25;09 - 00;00;49;25 

I'm Mike Stiles. And today we have a truly inspiring guest. Tanya calling his dad, CEO of the International Gosh Alliance, has been a long time driving force in supporting patients with rare diseases and advocating for world class health care. Our work has been nothing short of groundbreaking. She's actually become quite the go to person for patients, medical practitioners, industry governing bodies. 

00;00;50;03 - 00;00;52;01 

Tanya, thanks so much for being with us today. 

00;00;52;14 - 00;00;55;04 

Thanks, Mike. It's an absolute pleasure to be here. 

00;00;55;19 - 00;01;05;11 

Well, before we get into the incredible work you're doing, let's get a baseline understanding of exactly what Gaucher disease is and just how rare it is. 

00;01;06;00 - 00;01;37;11 

Okay. Well, as a caregiver, I'll give a lay lay version to you. So it's a genetic condition and it's inherited. It's caused by a storage disorder. And that is because people with Gaucher have a deficiency in an enzyme. And the function of that enzyme is that it's in the body to break down substances. And because there isn't enough of that enzyme, the substances store in different parts of the body. 

00;01;37;25 - 00;02;05;17 

And it really does depend on what type of disease you have to how the disease affects you. But all patients can have a large liver and spleen. They get anemia, they get bruising where the blood doesn't clot properly and bone pain and bone damage due to the cells being in their bone marrow where which is where the blood cells are made. 

00;02;06;02 - 00;02;42;09 

Now, for patients who have type two and type three, there's also brain involvement and that really ranges from patient to patient. But that can include things like cognitive impairment, seizures, hearing and sight loss, unsteadiness in their movements and tremors. Now, it's it's a rare disease, as you say, and roughly it's around one in 100,000. However, this will different differ from region to region and also from type to type. 

00;02;42;21 - 00;03;11;18 

So historically, type one cases, disease is the most prevalent. Then we go into type three and then type two is like what we would call ultra ultra. However, as we become a much more globally connected community, we are seeing that there are many more patients with type two and Type three in Asia, whereas in sort of Europe and the West, we see more Type one patients. 

00;03;12;05 - 00;03;27;29 

Yeah, well it sounds like just that one issue, the the deficiency of that enzyme can cause countless problems all over the body. It already makes it obvious why this is such a difficult disease to get a handle on. 

00;03;28;17 - 00;04;03;25 

Yeah, absolutely. And I think the thing is, is that often when patients become ill and they go to maybe their general practitioner, you know, and they describe the, you know, how they feel that there are lots of things that could be wrong with patients. And therefore often patients have what we call a sort of diagnostic journey, a diagnostic odyssey where it will take a long period of time for them to actually get diagnosed. 

00;04;04;12 - 00;04;12;04 

If someone is diagnosed and they do get a correct diagnosis for, gosh, what are the typical outcomes? 

00;04;12;20 - 00;04;38;28 

Wow, that's a good question. So again, this goes back to whether or not you have type one, Type two or type three as a rare disease. We are incredibly lucky. So over 30 years ago, there was a medicine developed called enzyme replacement therapy, and this was developed and it what it does is it puts the deficient enzyme back into the patient's body. 

00;04;39;06 - 00;05;00;14 

So it's a bit like, you know, when you've been men. Tom So you've been, you know, you start up or your waist and, you know, you put it to one side and then the binmen come and they empty it, and then you start to store it up again. Well, of course, it's a bit man dotcom, you know, that storage gets more and more and more and starts to affect the average around it. 

00;05;00;20 - 00;05;34;04 

So that that's a sort of good analogy for go phase disease. But because this enzyme replacement therapy was developed and it was it's like an infusion. So patients either have it once a week or once a fortnight, it puts the enzyme back into the body, gets rid of all the storage and a significant proportion of patients. If they get treatment early on and they get the right dose of treatment, then they can actually live really good lives with great outcomes. 

00;05;34;10 - 00;06;05;22 

Now here it's important to say that enzyme replacement therapy is for the non neurological aspects of the disease. So that is your liver, your spleen, your bones. Now it doesn't cross the blood brain barrier. So the type for patients with type two and type three, they still have the all the neurological aspects of of the disease. So if you're type one, it will depend on where you live in the world, whether or not you get treatment. 

00;06;05;22 - 00;06;13;28 

And that's some issue. But if you do get treatment and you get good clinical care, then you can expect to have a relative normal life. 

00;06;14;18 - 00;06;31;20 

Well, and unfortunately, the reason the world has you as such a strong advocate is that this is a disease faced by your own daughter. Tell us about her, what her symptoms were when they started showing up and that journey that you mentioned of getting properly diagnosed and treated. 

00;06;32;10 - 00;07;01;05 

Of course, yeah. This is this is going back a few years ago now. So in 1995, Maddie was my daughter, Maddie was 15 months old. And it was towards the end of the year and we just noticed that she just wasn't that well. And she had quite a low mood and a cold. And, you know, like many pet parents, you know, she was was still quite young. 

00;07;01;05 - 00;07;29;11 

So we took her to the doctors and they were like, yeah, she's got a you know, she's got a throat infection, She's got ear infection. You know, hear the antibiotics go away If she doesn't get any better, come back. So a week goes by, ten days go by. She's she's not any better. So we took her back and at that point, the general practitioner said she's very pale, if you notice that she's very pale. 

00;07;29;25 - 00;07;47;12 

And we was like, Well, yeah, we have noticed, but that's why we just thought it was part of her not not feeling great. So he said, I'll tell you what he said, I think we should you should go to the local doctor, local hospital and they'll do a hemoglobin C what her, her blood types are, and we'll take it from there. 

00;07;48;13 - 00;08;20;01 

Well, that from that morning, basically, we went on a three month journey to the local hospital. Her hemoglobin was 6.4, where it should be around 12. She was admitted she had a number of blood transfusions. On examination, they found out she had a large liver and spleen. We were given the diagnosis of leukemia. So that was obviously very, very challenging for us as a family. 

00;08;20;02 - 00;08;55;05 

She was our first born. Now, at this point in time, we lived not far from London, and the local hospital had shared care for pediatric pediatric oncology with Great Ormond Street Hospital, who most people would have heard of. So we were taken by ambulance to Great Ormond Street Hospital. We were admitted onto the oncology ward and it was like a little conveyor belt of all these little children going through for Beaumaris to aspirations so that they could give her a final diagnosis. 

00;08;56;05 - 00;09;23;16 

Actually, after waiting a number of hours, we were told that she didn't have leukemia, but they suspected that she had something called Go Shay's Disease, which was a very rare disease. Now, you will remember I previously set about this diagnostic journey and diagnostic odyssey, and it takes a long time to be diagnosed. Now, ours was not a typical one for a patient with rare disease. 

00;09;24;02 - 00;09;56;11 

And it goes back to what I said about there being that new medicine in the early 1990s. And because it was approved, the company put investment into awareness and actually Great Ormond Street Hospital had become a center of excellence for Go Shay's Disease. And they had a very, very good doctor there. And actually that doctor cared for Maddie until she was 18 years old at Great Ormond Street when she transferred to the adult hospital at the Royal Free. 

00;09;57;23 - 00;10;27;19 

Now, you know, we were lucky because when they did that bone aspiration for leukemia, because of their expertise, they noticed the sort of shape and the pattern of the cell and that's why she was diagnosed with Go Shay's Disease. And actually from the first visit to the doctor at the end of 1995 to her first infusion of the new medicine to help with her liver and spleen, it was only actually approximately six weeks. 

00;10;28;04 - 00;10;59;20 

So we were, you know, we were very lucky. We did stay in Great Ormond Street for three months because her liver and spleen were so large. She underwent a what we call a partial splenectomy. So she had most of her spleen removed. She was severely underweight and her breathing was very shallow at the time of of admission. So we were in Great Ormond Street for a long time when she when she was first diagnosed. 

00;10;59;20 - 00;11;15;06 

And actually she was on a feeding tube for about a year afterwards just to build her back up. But, you know, if you can have a great diagnosis, then I think we were extremely lucky. In that case. 

00;11;15;23 - 00;11;37;28 

I would absolutely have to agree. I mean, what a horrible thing for Maddie to have to go through and for your family to have to go through. But, you know, it sounds like you landed in exactly the right place to be with the right people. And then based on my own experience, you know, it's not uncommon to go beyond just caring for your loved one and want to make a bigger impact to help others like them. 

00;11;37;28 - 00;11;48;05 

So walk me through your own thought process. What did you see the need was and how did you first go about exploring what role you could play in it beyond Maddie? 

00;11;48;15 - 00;12;17;11 

Yeah. So, you know, when Maddie was first diagnosed, I, you know, it took me almost a year really, to be strong enough to do more than just survive. To be honest, My, my, my, my marriage failed, and I actually became a single mum, which is not uncommon for patients or families that have children with with chronic conditions. But I did have a good job and a great family and friends who were there for me. 

00;12;17;11 - 00;12;47;18 

So when Maddie was diagnosed with type three, Go Shay's Disease, it's obviously have has neurological involvement. There was literally no information out there for me as a parent. And when I went to the library, it said Death within a year. And nobody had ever heard about it. So for me, you know, I set out to develop information for patients and parents so that they wouldn't be in that situation. 

00;12;47;28 - 00;13;16;19 

But also I set out to sort of develop and build a community in the UK, and that was really for support, for support for me, support for Maddie and support for others. Now, around five years before Maddie was diagnosed, that was the UK and Shay's Association was actually set up. Now it was set up because of this new medicine that had come up for type one Gaucher disease. 

00;13;17;12 - 00;13;41;20 

And as patients were going to the hospital and having treatment, they were talking to each other. And this organization set up. So there was already an established group in the UK and I decided to join them and then they invited me to sit on the board as a sort of representative for patients with type two and Type three. 

00;13;42;09 - 00;14;04;10 

And they asked me to do that really, because everybody else on the board had type one Gaucher disease. And if you're a patient or caregiver with a with type two or type three, it really is it's almost like a completely different disease. So I think they saw the benefits of me having the benefits of of having me on the on the board. 

00;14;04;10 - 00;14;31;16 

I did have a lot of support from the founders of the UK Association, Susan Lewis and Jeremy Emmanuel, and also Maddie's consultant doctor Elodie, who was really great in terms of educating me about the disease, what was going on in research, who the the doctors were, where the other patients were. So it was really a sort of collaborative effort. 

00;14;32;13 - 00;15;02;29 

And, you know, I started to bring patients and parents together on family days out and conferences and sort of listened to the challenges. And then we write books on education, trying to find out what was going on in research, the developments, and really how best to go about sort of trying to improve patient outcomes, whatever that looks like, to to to to a patient. 

00;15;02;29 - 00;15;27;05 

You know, were there any new treatments? Was there ever going to be a cure? And it was really about putting information, you know, putting my feelers out there, getting known, getting people to talk to me and, you know, feeding all that back to to the community. I became a board member of the UK Association in 2005, and I started working for them then. 

00;15;27;25 - 00;16;03;01 

And actually I remained working in the UK as well as sort of then going into the European and global state until about 2018. And in terms of my work, European and internationally, again before my time actually back in 1994, again because of this new treatment, seven patient advocates for this disease invited themselves to a European meeting where doctors and researchers were talking about this disease. 

00;16;03;21 - 00;16;31;07 

And these advocates sort of formed an anarchy of of patient of a patient group, because they you know, they saw they had common interests and goals. And by working together, they could see that they would have a much, much stronger voice. And that European sort of group of patients soon turned into a sort of international group of patients. 

00;16;31;07 - 00;16;57;11 

And today that's nine is the international alliance. We'll be celebrating 30 years next year. And I am the CEO of the International Gaucher Alliance and have been involved, you know, since 2008. Really, I sort of got my foot in the door in the UK and then slowly learned a lot and then sort of started to get my foot in the door in Europe and internationally. 

00;16;57;29 - 00;17;24;24 

But I think when I when I really think about why I did what I did and why I became a patient advocate, it really does go back to Maddie being born in the UK, you know, and she had access to treatment and good clinical care. And to me I wanted to try and make sure that wherever other patients lived in the world, that they too could have this. 

00;17;25;12 - 00;18;02;06 

And because treatments were so successful for many patients that, you know, there was a hope for those patients to have a future, but also that they didn't feel alone. Having a rare disease can be very lonely. And for many patients that I work with, I will never, ever meet them. But they know that there is somebody out there who's advocating on their behalf and the if they're feeling down or helpless and have nowhere to go in their own community, then actually there is somebody who does care. 

00;18;02;28 - 00;18;31;19 

Yeah, it is a tremendous resource and sorely needed, not just for Gaucher disease but for others. Actually, the challenges faced by those battling Gaucher disease are so similar to those overall who have or are caregiving. For someone who has a rare disease, as you just touched on it a little bit, but talk to me about what it's like to live in that world where you have something very serious, but because it's rare, you kind of feel emphasis isn't being placed on it. 

00;18;31;28 - 00;18;35;00 

And it can it can feel quite isolating, right? 

00;18;35;08 - 00;19;00;15 

Yeah. So I think I would start by saying people say you've got what I've never heard of. What is it? What is it? And, you know, this is the reality for patients and their and their caregivers, because you absolutely have to become your own advocate or the advocate of your your child. And you have to fight for everything. 

00;19;00;24 - 00;19;29;01 

And every time you go for an appointment, you have to again, go through what it is, how it affects. And then they're interested. You are an interesting case and that in itself is is is very, very challenging. And I think, you know, this is why patient organizations are so important because they provide the support that patients need, that, you know, that pastoral or support that time. 

00;19;29;01 - 00;19;58;11 

Somebody to talk to who knows how you feel and has often been through that situation. But they also provide information and advice so that they can empower you and patients and, you know, for better outcomes. But, you know, I rare diseases don't have the coverage of of more common diseases. And you may live in a country where they're just really on any other patients. 

00;19;58;11 - 00;20;22;18 

Speaker 2 

So it can be really, really lonely. I went to Ireland many years ago with a member of our board from the UK and we actually have met a couple of patients now in Ireland and there was a gentleman there and he was in his fifties, so he'd had chase disease for 30 odd years and he had never met another patient. 

00;20;23;05 - 00;20;47;25 

Wow. You know, that is in a place like Ireland. So you can see how how lonely and isolating it can be not only for the patient but also for their family. I think you hear when we think about, you know, the environment we live in now, you know, social media like Facebook can be very important. Linking patients and families. 

00;20;47;25 - 00;21;18;05 

And often they become, you know, online communities sharing stories and advice. And we see that a lot in negotiate community. You know, type three that my daughter has many years ago there was one type three patient in in Lithuania. So, you know, by using things like social media that that parent could come into a community and sort of be part of a wider family. 

00;21;18;21 - 00;21;39;27 

One of the biggest things that affected us many other patients is that, you know, because it is a rare disease and people don't know a lot about it, it means that people have an unknown future. You know, when Mary was diagnosed, we read death. We knew within a year and we were told not to make any future plans. 

00;21;40;14 - 00;22;10;10 

Parents are told to take their children home and just enjoy life. You know, it's a physical and real emotional rollercoaster. And the thing is, you can't get out of it. It's exhausting. It's not something you can, you know, you can sort of just put to one side. It's part of everything you do. And the thing is, is reality is, is that if you don't fight as a family, nobody will fight for you. 

00;22;11;01 - 00;22;57;05 

And I think like many rare diseases, you know, mental health is a massive challenge for patient and caregiver community. And, you know, we are seeing much more attention being given to this topic, which is good. But like anything in life, it's patchy and not available to all. So importantly, you know, I see my role as sort of being that people often spend a lot of time, you know, just WhatsApp, a new families or people sending little videos and just having a chat and that enables me to sort of hopefully help them make them not feel so alone, but also enables me to sort of link them up with other people that I might know that, you know, they may get support from. 

00;22;59;25 - 00;23;28;06 

Yeah, it sounds like what families need most is connection information and ongoing research. But have you found that the perception isn't necessarily true, that there are actually medical practitioners who are working on and who are captivated by finding solutions to rare diseases? Because that sounds like what you've found. And specifically, have we gotten anywhere in terms of advanced treatments since the early nineties? 

00;23;28;23 - 00;23;29;01 

So. You know, I think, you know, we are really lucky and go chase disease. You know, we we work in an environment where, you know, our doctors and researchers are really committed to improve patient lives and together as a community, you know, physicians and patients, we've really developed a great global community. You've got the international Law Alliance, which is an umbrella organization, and we have 58 member countries, plus we work in another 25 or 30 countries with patients. 

00;24;06;13 - 00;24;46;09 

And then you have the International Working Group on Disease, which is a sort of platform for clinicians and research is globally who are interested in in Gaucher disease. And actually we do a lot of work together on things like guidelines, consensuses, meetings, and we often body doctors are who are new in go chase disease with, you know, people from the Iwg day, for instance, there was a doctor in Kenya who'd got a new patients, had never treated a patient before. 

00;24;46;15 - 00;25;19;27 

So we were able to, you know, buddy them up with somebody from the UK who had a lot of experience. We there is a lack of like diagnostic testing in Zambia. So we know doctors in Brazil that would do testing free of charge for patients. So we link those those doctors up and you know, there's we're working a lot in Africa at the moment and there's a lot of education to be done. 

00;25;20;07 - 00;25;58;00 

So we recently did a online educational session which actually got 1200 doctors from Kenya and the surrounding countries that are interested in pediatric medicine. And one of our doctors from the Iwg today did that educational session for us. So there's a lot of of volunteering, there's a lot of joint working, there's a lot of preceptorship. And, you know, it's really a great collaborative environment now, you know, that's 30 years in the making. 

00;25;58;16 - 00;26;30;25 

But, you know, over the last few years we've seen a real acceleration, you know, in reaching areas of the world that maybe before were cut off. You know, we didn't know that there were patients there. So that's all really positive. And, you know, we patients disease is a is a bit of a success story really in some ways because for type one patients, enzyme replacement therapy has just completely changed the patient, a patient's life. 

00;26;31;13 - 00;27;04;14 

You know, they have been able to get access to treatment. They have been able to get access to, you know, doctors that are very knowledgeable. And, you know, they've been able to get on with their lives, to have families, to have careers, to run marathons. And, you know, enzyme replacement therapy that came on over 30 years ago has been followed for type one Déchets disease, an oral therapy called substrate reduction therapy. 

00;27;04;14 - 00;27;35;16 

So we've gone from, you know, weekly or fortnightly infusions to taking a pill once or twice a day, which has transformed patients lives. And actually at the moment where we are again mostly for type one, there are a number of clinical trials for gene therapy for type one. So, you know, we've gone the real sort of like infusion pill and now we're potentially looking at a one off treatment for Gay Shea's disease. 

00;27;35;25 - 00;28;07;06 

Now most of that is for type one. There is currently one study for type two and one study for type three. So, you know, that's an area still where we are trying to find out how to address the neurological involvement in patients. And there's still a long way to go to go for that. I think the other thing I would say is that one of the challenges for us as a global community is that, yes, we are 30 years down the road from that first enzyme replacement therapy. 

00;28;07;19 - 00;29;01;05 

But if you are born in Kenya or Zambia or Cuba or Pakistan or Jordan, treatment is not available through reimbursement. So that is where there is still a lot of work to do. Now, there are opportunities for patients to get treatments, and that's through charitable access programs. And that's one of the things that we as an organization, the International Gateway Alliance, do a lot with the companies who manufacture these therapies is that we work with them and they have a number of slots for charitable access where patients can be given treatment, a lifelong treatment where there's no river reimbursement in their countries so that they can have that future and that life. 

00;29;01;05 - 00;29;25;05 

You know, we've talked to guests several times on this podcast about patient centered research and citizen science. And it feels like, especially with rare diseases, there needs to be a tighter collaboration where patients and their families are more involved and work more closely and directly with researchers. Are you seeing that happening and is the research side leaning into it? 

00;29;25;16 - 00;30;04;07 

So I think the this is an area that we have been really strong on in as I described earlier, you have the patient community and you have the clinical community who have sort of grown up together and are working very, very closely together. And then you've got the research community and the sort of pharma community who, you know, are not big pharma, they are small pharma, and they recognize that patient centered research and and patient centered support needs to run through everything they do. 

00;30;04;23 - 00;30;36;06 

And what we see is that we see that we are invited to have a seat at the table from very, very early on to really understand the condition, to understand the challenges that patients and their families face, to understand what's important to patients and what areas they're still very little known about. And we can we deliver that to the different stakeholders. 

00;30;36;21 - 00;31;17;10 

And basically we are seen as an equal partner and, you know, things like the development of research projects, the development of clinical trial design, the patient community are really co-creators in this. I think this is an area where we have had a lot of success. So I think generally in rare diseases that you see that there is a real recognition of the value of having patients and patient advocates at the table from the very beginning, because ultimately whatever you're doing, you want it to go as smoothly as possible and you want it to have the biggest effect. 

00;31;17;22 - 00;31;39;11 

Now, if you get everybody around the table at the very beginning, you're more likely to see that happen. Whereas if you get to a point and then you say, Oh, actually maybe we should invite a few patients or patient caregivers or advocates around, see what they think, and then you're having to go back or you're not actually doing that. 

00;31;39;24 - 00;32;07;23 

And then I think, you know, we're seeing more encouragement and necessity by health technology assessments and marketing for licensing like the FDA and EMA to say, you know, where is your involvement from your patient community? How did you know your patient? How did you work with your patient community? What is important to patients? What do they want you to address? 

00;32;07;23 - 00;32;16;03 

Well, in fact, I think you've partnered with Cerner and Visa, which is now part of Oracle Life Sciences, for some research efforts. What does that partnership look like? 

00;32;16;21 - 00;32;43;08 

Yeah, so this is really, really exciting. So as I've said, you know, a lot of work in progress has been done for patients with type one diabetes disease, not so much for type two and Type three. And I've been in this community for 26 years and I've sadly seen many of our patients lose their lives to type two and type ricochets disease now because it is very rare. 

00;32;43;27 - 00;33;20;12 

No single center has enough patients to study. There is a real lack of natural history data on these patients. And actually when you look at patients, even when they have like the same genotype, they have completely different phenotypes. You know, they the way that the disease presents itself in them is completely different. And therefore, it's a really, really challenging disease to really understand and see how you could potentially develop a therapy that is safe and effective. 

00;33;20;21 - 00;33;54;03 

But also, you know, how should we be managing these patients clinically and what are the care and support do these patients need to function in society? So what we did as an international alliance is that we had an idea to set up a patient led patient owned registry just for type two and three disease. And for the last couple of years, we have been working with what was Sunrun Visa and now Oracle, in setting up a registry called Guardian. 

00;33;54;13 - 00;34;27;07 

And Guardian collects patient reported data from patients and caregivers around the world on the way that Type two and Type three patients disease affect patients in their everyday life. And the way that we set it up was we work collaboratively with interviewing patients, doing focus groups, finding out what was important to them, and then developing the question, as in Guardian and the role of Sutter and Visa. 

00;34;27;07 - 00;34;53;26 

Oracle is that they are the they are the the organization that provide all of that support to us in terms of running the registry as a patient organization. We had a vision, we had an idea, we had the passion, but we didn't have the skills and resources in in-house to run a registry. And that is where Sutter and Visa Oracle have come in and we've developed this partnership. 

00;34;54;11 - 00;35;14;21 

Well. So on the research side, obviously clinical trials are where the rubber meets the road. If I have a rare disease, is it getting easier for me to participate and find a clinical trial if I want to? And how easy is it now for researchers to find the patients willing to participate in these trials? 

00;35;14;21 - 00;35;48;13 

So so we do have some trials for go shows disease, but because it's a rare disease, it's not like working in, you know, oncology or diabetes or anything like that. So, you know, there are not a lot of trials, but there are trials. And, you know, the thing is, is that we have a lot of centers of excellence around where patients go to have their disease managed. 

00;35;49;01 - 00;36;35;17 

So the this is an ideal opportunity where you have cohorts of patients to be able to raise awareness and make patients aware that, you know, there are clinical trials for their type of disease. I've got to say the one of the challenges is that most clinical trials are done in the West, whereas we have huge unmet need in the east of the world and that comes down to expertise, but it also comes down to it's easier to run a clinical trial in Europe than it is in Africa, which is something that we as a patient organization are trying to work with. 

00;36;36;00 - 00;37;22;22 

Those interested in bringing clinical trials to shades disease to try and have a different approach. And I think because we have the International Working Group on disease and we have a very strong patient organization and we have a few really good pharma companies that are interested in Roche's disease, We, you know, we work together. So I think that it's not easy to develop trials, but but actually it's also not easy to recruit for clinical trials because patients have also had enzyme replacement therapy or substrate reduction therapy for a number of years now. 

00;37;22;22 - 00;37;53;04 

And these drugs have been really, really good. They do what they say on the tin and patients are living a really good quality of life. So actually recruiting patients into these clinical trials can be quite challenging, particularly when you're thinking about new technologies and patients want to know about safety and efficacy and the benefits of switching from a a safe therapy, which they've been on for for years into something that is experimental. 

00;37;53;19 - 00;38;08;22 

So as an organization, you know, we are really trying to raise awareness and share information on clinical trials and educate patients on clinical trials, you know, to support their decision making. 

00;38;09;12 - 00;38;33;11 

Well, Tanni, it's been so great hearing your story, hearing Maddie's story. There are real people and human beings behind these rare diseases, and you've done such great work bringing that vibe to health care and the work being done on pragmatic solutions. I'm going to bet that listeners will want to learn more about you and what you're doing. Is there any way they can get more information or get in touch with you and the Alliance? 

00;38;34;00 - 00;39;03;17 

Yeah. So like most organizations, we have a great website which is Geisha Airlines dot org and we can also be found on social media platforms like Facebook and other sorts of Instagram. So we, you know, we do have a really good social media presence for you to do is is is find out where the newsletter is or click on the join us on on Facebook. 

00;39;03;17 - 00;39;13;27 

And you know, we have somebody in our group that works specifically on communication and we try and share not only the work we do, but work that our partners do. 

00;39;14;06 - 00;39;47;16 

Perfect. Well, thank you so much again. And if you faithful listener want to find out how Oracle can simplify and accelerate your life sciences research, just check out Oracle dot com slash Life Sciences. Subscribe to the show so you don't miss anything and we will see you again next time on Research in Action. 

International Data Corporation reports safety caseloads are increasing by 30% to 50% each year, and emerging technology will be the only way to keep up. But how are powerful technologies like generative AI advancing safety and pharmacovigilance? Is touchless case processing a good or bad thing? And how do we balance AI, automation, and the human touch? We will get answers to those questions and more in this episode with Bruce Palsulich, Vice President of Safety Solutions at Oracle Life Sciences. His portfolio includes Argus Safety, the industry-leading adverse event case processing and analytics solution, and Empirica Signal, the standard for signal detection and risk management. He has more than 30 years of experience in the healthcare and life sciences industry, including 25 in pharmacovigilance. 

--------------------------------------------------------

Episode Transcript:

00;00;00;00 - 00;00;13;22
What is pharmacovigilance? How can technology best handle the tracking of adverse drug events? And is touchless case processing a good or a bad idea? We'll get those answers and more on this episode of Research in Action.
 
00;00;15;01 - 00;00;18;28
The lead, the Building.
 
00;00;20;10 - 00;00;48;22
Hello, welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles. Today we are talking with Bruce Palsulich, vice president of Safety Solutions at Oracle Life Sciences. Bruce's portfolio includes Argus Safety, the industry leading adverse event, case processing and analytics solution, and empirical signal, the standard for signal detection and risk management. He's got more than 30 years of experience in the healthcare and life sciences industry, including 25 and pharmacovigilance.
 
00;00;49;02 - 00;01;03;25
Now, why is that important? Well, International Data Corporation reports safety caseloads are increasing 30 to 50% each year. Bruce is intimately involved in tackling that volume. So, Bruce, thanks for thanks for being with us today.
 
00;01;04;05 - 00;01;06;00
Yeah, thanks, Mike. Happy to be here.
 
00;01;06;16 - 00;01;17;04
Yeah. Let's get acquainted with you first. How did Life's path bring you into life sciences technology? How did you kind of wind up at Oracle and what are you tasked with getting done there?
 
00;01;17;29 - 00;01;50;08
You know, back back when I was still in university, I actually started off doing software development and consulting with a medical device company. And so early in my career, it was working on the actual embedded software that controlled medical devices. And early on ended up joining a consulting firm that started off doing engineering, consulting on medical devices, and eventually working towards quality software and regulatory submissions.
 
00;01;50;24 - 00;02;17;04
And so came to Oracle in 2009. So we had acquired a company that was that small engineering startup that I mentioned. And this is the company that originally developed Argus Safety, so I managed the team that developed Argus safety originally and through my time at Oracle, I jumped out of a safety for a little while.
 
00;02;17;04 - 00;02;42;24
For about four years I was running our healthcare strategy. That was when we had a much smaller healthcare footprint than we now have with our acquisition of Cerner. But at the time we did a lot of things in sort of what was called health-information exchange, sort of the foundation for national platforms under Australia and Singapore and multiple provinces in Canada.
 
00;02;43;09 - 00;02;51;18
And after doing that for about four years and then I came back to the safety side of the business about ten years ago or so.
 
00;02;52;03 - 00;03;02;25
Well, did you always see yourself doing something in medicine and life sciences, like when you were younger, or did this was this a life path that kind of surprised you?
 
00;03;03;08 - 00;03;29;12
You know, I ommitted the part where for four years I actually worked in aerospace. So I even though when I was still at university, I started off in medical devices. I did take a job in aerospace for four years. But that's sort of left a hollow feeling and not the same sort of mission driven purpose. When you do have a role that's within the broader health care or clinical development.
 
00;03;29;12 - 00;03;55;04
So, you know, I think many people like myself that, you know, whether you're on the vendor side or whether you're on the the pharma side of drug safety or pharmacovigilance or even broader clinical development, I think you do appreciate that there's there's a calling and you feel more purpose driven life. I suppose working in a field that's helping individuals, helping patients.
 
00;03;55;26 - 00;04;13;27
Well, for our audience, and I'm deflecting because our audience is smart, this is mostly for me. Let's just level set. What's what's the main goal of safety and pharmacovigilance? And I imagine safety standards would apply across every step in that drug development process.
 
00;04;14;10 - 00;04;46;07
Yeah. So drug safety and pharmacovigilance is really trying to understand the safety of drugs that are under both clinical development as well as once they complete their clinical development and are approved for broad market use. And so clinical trials really focus on safety and efficacy, but that's done under controlled conditions with a limited number of patients and and sort of restricted patients as well.
 
00;04;46;07 - 00;05;27;27
And once a marketed drug is approved, it's going to be exposed to significantly more patients. And so during a clinical development, a clinical trial, if you had an adverse event that occurs in one out of 10,000 people, that's that's sort of defined as a rare adverse event or adverse reaction. You can imagine if you gave that to a billion people, maybe, for instance, in the example of the COVID vaccines, Now that rare adverse event that's only occurring in one out of 10,000 people is actually occurring 10,000 times in a billion people.
 
00;05;27;27 - 00;05;42;04
And so so really, you know, pharmacovigilance is looking at and trying to understand that benefit risk and manage that risk when it's being exposed under real world conditions to to actual patients.
 
00;05;42;24 - 00;06;11;20
So the study of a drug is hardly done after it's approved by the FDA and goes out into the public, the public market, that monitoring is still happening while safety is paramount, It can't be easy. I mean, for whatever reason, the public does seem to expect perfection without risk when it comes to their drugs. So, I mean, what are the biggest challenges that Pharmacovigilance and the industry has to deal with currently?
 
00;06;12;04 - 00;06;50;12
So, you know, getting back to sort of those controlled conditions that are under clinical trials, for instance, typically you're not looking at pediatric or children exposure. Quite often you're not dealing with elderly patients or immune compromised patients or patients taking multiple medications. You know, do you have the diversity within your clinical trials such that you're getting genetic differences that might exist within different populations and such?
 
00;06;50;12 - 00;07;21;16
And so so all of those are exposures that are going to occur during broad use of those products once they get approved. And so so pharmacovigilance is really trying to, you know, track that, trying to collect as many adverse reactions that occur. It's trying to evaluate whether or not those events truly are a reaction that's related to the drug that's being studied and the drug of interest.
 
00;07;21;16 - 00;07;46;15
Or is it just occurring, for instance, within the general background rate that you would expect within within a patient population? And so all of that analysis is to try and understand, is it more than correlation that just, you know, we have an adverse event that occurred with a drug? Is that coincidence or is that related to other drugs you're taking?
 
00;07;46;15 - 00;08;13;16
Is that a progression of the disease that the patient is taking a medication for, or is it something that is actually induced by by the drug of interest? And how serious is that reaction? And is that something that should be, you know, updated on the prescribing information that's tracked along with a drug and the, you know, communication and education that's done to the health care community.
 
00;08;13;16 - 00;08;16;08
So they understand the risks associated with the drug.
 
00;08;16;28 - 00;08;46;17
So I get the challenge, which is that in a clinical trial to get a drug approved and on the market, there's no way to cover every possible circumstance and every type of person and every type of situation where, like you said, there are other actions with other drugs. And I already get the enormity of the challenge of keeping track of all of those people, all of those interactions, all of those adverse effects.
 
00;08;46;20 - 00;08;59;13
I imagine technology is tackling those challenges, right, Or at least helping to tackle them. For instance, like how can we better efficiently do data management? How does that play a big role in tackling these problems?
 
00;08;59;28 - 00;09;24;29
Yeah, So the you know, we talked about the increasing volumes somewhat. It's still generally estimated that somewhere on the order of between five and 10% of the actual adverse events that occur are actually reported. And so many people might just say, well, I felt dizzy when I took that and so I stopped taking it. And, you know, did you ever tell your doctor, Well, no, I just manage that on my own.
 
00;09;24;29 - 00;09;56;21
So so really part of the challenge is how can you make it easier to collect a higher number of of these adverse reactions that actually occur? How can you reduce the burden on both the patient and on a health care professional to report those? The other is that, you know, we want to move beyond the handling and the workflow of processing these individual adverse event reports and get to a more of the emphasis being placed on driving or deriving insights from the data itself.
 
00;09;56;21 - 00;10;18;20
So so we want to make, as we deliver our own solutions, we want to make the pharma companies more efficient at being able to handle these sort of transactions. But with the real value out of that of then more, more effort and more value can be derived from the insights. From the data itself.
 
00;10;19;10 - 00;10;37;03
Yeah. I mean, there's a need to track adverse events that are happening all the time. The volume and the sources of that data increases exponentially. So you kind of touched on it there. How do you go about not just effectively managing the data flow but actually making it actionable?
 
00;10;37;14 - 00;11;18;12
So I think part part of this is, is within an ecosystem where perceptions are changing. And I'll say when I entered the field, you know, back in the mid nineties and such, the perception was sort of like an ostrich putting their head in the sand or something. And, and I don't want to know about what hasn't specifically been reported and, and Pharmacovigilance and drug safety was really looked at as sort of a a tax on the business a cost of doing business and wasn't appreciated as a valuable information asset that can be leveraged, you know, within a biopharma organization.
 
00;11;18;12 - 00;12;00;26
And so now I think PV data being an expensively curated data set, is now looked as a valuable information asset within organizations. It can be used to identify new indications, it can be used to inform drug discovery and portfolio prioritization. I think more and more we're seeing safety used as a competitive differentiator and certainly we saw that with the COVID vaccines and those that were commercially successful versus those that perhaps were perceived as having a more risks associated with those.
 
00;12;00;26 - 00;12;26;19
And towards this, I think, you know, we're looking at, you know, how can advances in data science, technology, things like machine learning, predictive models, generative AI, how can they be leveraged in order to process and be able to make use of these increasing volumes of information as well as diverse sources of adverse event information as well?
 
00;12;27;07 - 00;12;42;22
Yeah, that's where I want to go next. Are you seeing cloud based platforms and AI transforming pharmacovigilance? I mean kind of balance the hope and the hype for me. How do you see those technologies changing, how we approach drug safety and in like, say, the next decade or so?
 
00;12;43;05 - 00;13;18;23
So I really think and not not even just in this field, but in all fields, if you look at sort of the proliferation and the scaling of accumulation of data and information, it really requires new methods to approach that. So I do think that things like the large language models like Generative AI, are really going to be transformational into how we leverage this data and information specifically within health care and life science, but but also broader, I think, as a global population.
 
00;13;18;23 - 00;13;50;04
But so you can imagine even things like, you know, querying the data versus the natural language conversation, you know, perhaps you could ask how rare is this actual event or how does the rate of this adverse event compare for my drug versus other drugs within the same therapeutic class or given the volume of adverse events for this drug in 2023, how might how many reports might we expect to receive in in 2024?
 
00;13;50;04 - 00;14;26;08
Or are there clusters of patients that appear to be more likely to have this adverse event than other patients? And could you describe those differences? And so those I think, are all sort of examples that we're going to move from strictly having skills of of a data science list or query builder, a developer and such accessing data to sort of expose those questions of the data closer to the the individuals that are forming the question.
 
00;14;26;08 - 00;15;06;24
And so I think right now, you know, we really don't know what sort of insights or what sort of interactions are going to exist between these diverse data sources that are going to lead towards improved insights, improve patient safety. You know, we really want to, you know, identify what drugs work for, what patients and inversely know which patients shouldn't be exposed to certain drugs and and what characteristics, what scientific information is out there already, both broadly, you know, basic chemistry, genomics, pharmacokinetics, things like that.
 
00;15;07;12 - 00;15;10;29
But then bring that down to the experience of an individual patient.
 
00;15;11;18 - 00;15;24;29
Well, you've talked before about touchless case processing and what that could look like in the future. Tell us what that is and what companies should be doing now to start transitioning to that kind of model.
 
00;15;25;17 - 00;15;55;05
So I think sometimes the the phrase touchless case processing can sound a little scary, you know, that humans are going to be completely out of the loop and such. And I think the industry is generally looking for something a little bit more incremental. So we're not looking to say all cases should now be touchless. We're looking at things like, well, perhaps non-serious cases that don't provide a lot of new scientific information.
 
00;15;55;05 - 00;16;37;28
Perhaps those should be handled automatically by the system, perhaps for drugs that are well understood or have been on the market for a long time. Perhaps those would be better candidates for having automated case processing then things that are going to be a new a new drug on the market with less experience and exposure, perhaps cases that are received electronically and, you know, or cases from partners, you know, quite often they'll be global relationships between one pharma who partners with another pharma to to market that product in another region of the world.
 
00;16;37;28 - 00;17;03;22
And so you're receiving adverse event cases from this partner who who is originating those from patients or health care professionals. But if you're receiving that from a partner, you probably trust that they're sending it to you and maybe you can process that item automatically. The other is, is I think again, people get get a bit concerned if you say, well, this is going to be end to end and no human ever touched it.
 
00;17;03;22 - 00;17;35;06
And now we're going to be reporting this. You know, it doesn't necessarily have to be end to end. It can be the high volume of effort activities like doing the actual data entry. It can be decision support to support perhaps the causal assessments or to assess whether or not this is team serious or to look at is this an adverse event that's already listed on the the product label or prescribing information So it can be, you know, specific work steps are workflow steps.
 
00;17;35;06 - 00;18;15;27
Could be touchless, but overall, you know where it is appropriate. I think we still want humans in the loop to to oversee the process overall. So I think there are tremendous opportunities again, to take repetitive non value added processes out of and automate those from from requiring human effort to process those and allow the humans to focus on, you know, insights and focus on more value rather than these repetitive steps that that computers are well suited to be able to process as well.
 
00;18;15;27 - 00;18;39;08
You said something earlier, and that's very legitimate that, you know, a lot of patients will start taking a drug and experience some kind of adverse reaction to it and then just stop and not even tell their doctor about it. No one's ever going to know about the adverse reaction that they had. So there's even a reliability factor on the part of the patients and their willingness to report.
 
00;18;39;27 - 00;19;05;15
How far away are we from being able to have essentially a digital model of patients that drugs can be tested on? I mean, am I going way far ahead in the world of science fiction where in Silico gets kicked up a notch and safety procedures are tested on not real people, but essentially digital versions of patients?
 
00;19;05;15 - 00;19;35;22
Yeah, I think this whole concept and people may have heard the term digital twin and such is is obviously very interesting and I think we'll have certain benefit. I think, you know, certainly, you know, establishing toxicity and such would much better be supported through some of these models than than experimenting on on animals or on humans in order to establish toxicities and such.
 
00;19;35;22 - 00;20;12;08
And so so I think, you know, it's going to start from sort of the bottoms up that way when you're looking at those types of exposures. And I think as we get again, as we sort of stitch together these diverse data sources and have tools to be able to look for correlations and linkages that that are there, that would be difficult for humans to ascertain, then I think, you know, that will allow us to sort of advance these digital models that that represent a human response to medications and such.
 
00;20;12;08 - 00;20;44;18
So I think that's something that is definitely being advanced and we have pockets of that, and those pockets will ultimately end up being combined into a larger simulation of, you know, humans. So yeah, it's certainly an interesting area. And even myself, you know, it took me a while to sort of get my head around what that concept of digital twin and how that's going to benefit clinical development as well as is health care overall.
 
00;20;45;16 - 00;21;06;07
Well, we touched on the balance of hope and hype, but there's another balance here that you also touched on a bit. It feels like we want every advantage that technologies and automation and machines can bring us, but then we only trust those things up to a point. We do want human experience, human judgment and expertise to kind of have the final word.
 
00;21;06;07 - 00;21;13;22
So how do you view where that balance is now between tech and human? What gets us to the lowest error rates?
 
00;21;14;07 - 00;21;47;22
So I think, you know, one of the perception challenges that exists right now is that people think the humans are probably doing a better job than they really are right now. So if you gave the same health care record source document to five different people and said, you know, take from this piece of paper and enter it into the system, you would probably end up you would not end up with five identical versions of data entry from abstraction from that source medical record.
 
00;21;47;22 - 00;22;15;14
And so, you know, which one of those five is right. And what's the error rate there? And so I think you would normally say that humans are going to be somewhere on the order of six or 7% error rate for that type of work. And so even in manual processing is adverse event cases, typically there's going to be some sort of QC sampling that's trying to keep a handle on detecting errors and keep a handle on the overall process and such.
 
00;22;15;14 - 00;22;43;04
And so looking at how, you know, automation or machine learning is going to apply similar things are going to occur. You still want some checks and balances in order to know that you still have control of the automated process and things that are getting into medical judgment. I still think we we want to stick within what we would say is sort of augmented processing or decision support.
 
00;22;43;04 - 00;23;27;27
Speaker 3
So you want to provide assistance to the person making those judgments and say the system has determined that we think this might be related to this drug and based on these factors, why we think that might lead to that decision. Again, it would be up to the health care professional to make the final judgment there. So I think we are you're trying to bring the facts, bring the the right parameters and such into view so that the human can make the best decision, given the data points and the assessments that are being being suggested by by the system.
 
00;23;28;04 - 00;24;04;15
So I think we're still, you know, I was listening to NPR yesterday and they had a discussion on self-driving cars and there are self-driving cars ever going to get to the same accuracy and insights of of a human. And I think, you know, this is similar here, although probably, you know, certainly a different problem than looking at real time sensors in forming a automated self-driving car, but trying to look at human experience, human judgment, you know, how do we model some of those?
 
00;24;04;26 - 00;24;16;25
I think right now we'll stay in this augmented decision support mode for many of these, you know, clinical medical decisions and certainly leave the final judgment up to a clinician.
 
00;24;16;25 - 00;24;34;24
So, yeah, I remain terrified of human drivers. So in your role at Oracle Life Sciences, how is Oracle specifically leveraging these emerging technologies that we talked about like AI and big data to enhance drug safety and pharmacovigilance?
 
00;24;35;10 - 00;25;15;20
So there's a number of technologies and that's that's one of the benefits of being part of the broader Oracle, is that, you know, you kind of have all of these other areas and big areas of investment in AI and data science and high capacity compute and large language models and generative AI. And so so we get to it's like going to the toy store or something and decide which which things already have been built that you get to pull off the shelf and decide how we could apply those into our area of drug safety and pharmacovigilance.
 
00;25;15;20 - 00;25;45;13
And so, for instance, we just added the translation facility and, you know, out of the box in our Argus Cloud, you now have a translate button and it doesn't sound like a big deal, but if you were using an external tool before and then had to cut and paste and you were doing that 20 or 30 times within an adverse event report case to report it to local regions, just taking out that cut and paste and making it as a button straight in the system.
 
00;25;45;13 - 00;26;07;27
And by default we'll hook it up to the Oracle Cloud Translation Service. But if you wanted to hook it up to Google or you wanted to get up to a life science translation service, you could do that as well. Again, we're trying to look for where there are bottlenecks and we're trying to go out and look at where can we leverage an investment that Oracle's already making and then apply that into our specific field.
 
00;26;07;27 - 00;26;52;00
And, and part of that's what's exciting about our acquisition of Cerner is that, you know, I may have had a use case that sounded interesting in Pharmacovigilance. Maybe it's a case narrative generation or a case narrative is not all that different than a discharge summary for a health care record, or if you're doing a health care referral letter for referring the patient to a specialist and giving a summary of their their specific case and such, that's not that different than perhaps auto generating a letter that is a follow up request for collecting additional information on an adverse event case and so on.
 
00;26;52;00 - 00;27;17;28
Many of these there's there's overlap and we're able to team up with the teams that are focused on the health care use cases and add on our life science use cases and, you know, really benefit both teams or sometimes health care is leading the charge and sometimes life science is leading the charge. But ultimately that power together is like a multiplier, not not addition.
 
00;27;17;28 - 00;27;31;14
And and I think is a big benefit. And one of the big benefits of our of our acquisition of Cerner and the fact that we now are a leading health care company, in addition to, you know, what we've traditionally done in life science.
 
00;27;32;06 - 00;27;48;28
Yeah, there are a lot of industry players in life science. So is is what you describe what makes Oracle a real differentiator in the space when it comes to safety and pharmacovigilance? So things like combined assets and the Cerner acquisition.
 
00;27;49;11 - 00;28;25;29
Yeah I think there's there's a couple of things. One is sort of foundational with our cloud infrastructure and capacity there. For instance, we have high capacity compute and GPUs and just within our drug safety solution area, you know, we have two GP2 cloud instances available, dedicated 100% to our use and that's multimillion dollar worth of compute that we have dedicated to to our team of data scientists working to NPV.
 
00;28;25;29 - 00;28;58;05
And that would be difficult, not impossible, but difficult for a lot of other vendors to sort of dedicate that sort of compute capacity in such just to their life science use cases. Now the other I think is is around, you know, the acquisition of Cerner. So we talked about we now have a point of care footprint. So where, you know, clinicians are using Cerner software as the electronic health record when they're interacting with patients.
 
00;28;58;05 - 00;29;28;19
And so if we want to collect information as part of that point of care relationship, we can do that if we want to leverage, You know, we have something that's called the Learning Health Network that has a electronic health record, real world data asset. And so companies that our health systems sign on to use this because they they want a few benefits, they want access to clinical trials.
 
00;29;28;19 - 00;29;55;07
So they want their their patients and such to be able to be included within cohort selection and recruitment, site selection and recruitment for clinical trials. They also want to understand how they're delivery of care matches against other health systems across the country and eventually across the globe. So that they can sort of benchmark and compare how they're doing.
 
00;29;55;16 - 00;30;23;05
So that ends up creating this research data asset That, for instance, is very important for drug safety and pharmacovigilance, so that if you have a particular risk or an adverse event that's been reported against your drug or therapy, that you can then go out and say, well, is that just a correlation? Is there enough information within these individual cases to establish causality to the drug, actually cause that adverse reaction?
 
00;30;23;18 - 00;31;11;09
Or do I really need to go investigate that and understand its usage within the, you know, electronic health care record or claims data? And so so that's one of the areas that we are really focused on right now of sort of benefiting this better together with with the combined assets of and expertise between Oracle and Cerner is how can we leverage that real world data to understand and investigate risks that have been reported in adverse event reports to be able to go out and and understand real world usage there and and look at and understand how many patients are taking this drug, how many patients potentially had this reaction?
 
00;31;11;25 - 00;31;31;17
How many patients generally have this reaction not taking our drug, you know, understand those background rates and such. And so it's another level of understanding of the benefit risk once you have not only the adverse event reports, but the ability to research these within a real world dataset also.
 
00;31;32;03 - 00;31;38;03
Okay. I've got one more question for you. The all those warnings at the end of the pharma TV ads, is that because of you?
 
00;31;38;24 - 00;32;07;22
Well, ultimately, you know, I feel like sometimes we're plane name that tune or something. So a commercial comes on and I'll say, Oh, that's a pharma access to pharma y company. And you know, I'm usually right on naming the drug to that company. But, but it is, it is vitally important, you know, what is being done and where traditionally pharmacovigilance has sort of been a retrospective.
 
00;32;07;22 - 00;33;02;11
What can we learn after it has occurred? We're really trying to move towards what or labeling as precision pharmacovigilance, which is better understand that safety profile, better understand that risk benefit profile, not at these broad population levels that might be by by gender and age group, but getting down to smaller and smaller subpopulations and ultimately ideally to be able to go back and impact proactively the care of an individual patient where we might be able to identify based on a certain patient characteristics, a patient history, genomic marker, current labs, other concomitant medications they may be on presently, that maybe there is a higher risk to that individual patient of therapy versus therapy and provide that
 
00;33;02;11 - 00;33;39;18
information to the clinician that's treating the patient at that point of care. So so we intend to continue to drive towards that advances in drug safety that can improve overall population level help, but want to drive that down to to the ability to inform care around an individual patient. And thus, you know, when we see and hear those commercials and we hear the list of adverse events that are potentially associated with that drug, to give us better context, to say, well, what does that mean for me as bruise versus what does that mean for Mike?
 
00;33;39;18 - 00;33;51;15
And maybe one of us needs to be concerned and maybe one of us doesn't, and wouldn't that be great rather than just hear the list and and know that randomly that might be meaningful or not so obvious?
 
00;33;51;15 - 00;34;08;19
It's a vital part of drug development. And it's been interesting to hear what approaches are being taken and who's leading them. We appreciate you being on the show. For those who are interested in Pharmacovigilance and their interest has been tweaked, is there any way they can connect with you or get more information on what's going on?
 
00;34;09;09 - 00;34;51;14
So for me, I can be reached at Bruce.Palsulich@oracle.com. If you're on any one of your web search engines, you could just search on Oracle pharmacovigilance. The other is that we do have a community that we call the Oracle Safety Consortium. So if you search on Oracle Safety Consortium, you'll come up with and that's sort of our end user community where we have regular monthly events and such that are discussing industry, but as well as Oracle Solutions and how we're addressing the needs of industry through this sort of peer consortium group as well.
 
00;34;51;14 - 00;35;00;09
So those are sort of three ways that you could either follow up with me individually or learn more what we're doing here in Oracle for drug safety and Pharmacovigilance.
 
00;35;00;24 - 00;35;29;25
All right, we've got it. And if you want to see if Oracle can accelerate your life sciences research, just head over to Oracle dot com slash life dash sciences and you'll probably find out what you need to know. Don't forget to subscribe to this show and join us next time for Research in Action.

How is clinical research becoming more patient-focused and more convenient for patients to participate in clinical trials? Why is a decentralized approach especially important concerning rare diseases? And how will digital innovation advance the way clinical research is conducted? We will learn those answers and more in this episode with Scott Schliebner, an innovative life sciences executive with 30 years of experience across the biopharma, CRO, medtech, and non-profit sectors. With a strategic and consultative approach to building and growing life science businesses, Scott has developed relationships, partnerships and collaborations that have driven commercial success. His vast experience includes leveraging real-world data and real-world evidence (RWE/RWD), leading technological innovation, and driving patient-focused paradigms to accelerate clinical drug development. Scott is an active board member, advisor, and mentor and his passions lie with infusing data and innovation into life sciences organizations—especially where rare diseases are concerned. He is currently the leading executive at Rare Clinical.

--------------------------------------------------------

Episode Transcript:

What are the 17 United Nations Sustainable Development Goals? What are the biggest challenges in pursuing and achieving those goals? How does technology play a role? And what’s the best way for government, academia, and industry to cooperate and collaborate in support of fundamental research? We will learn those answers and more in this episode with Declan Kirrane, the Chairman of the Science Summit at the United Nations General Assembly, and founder and managing director of ISC Intelligence in Science. Declan has more than 25 years of experience as a global senior advisor to governments and industry on science research, science policy and related regulation. He has been actively promoting a more significant role for science within the context of the United Nations General Assembly since 2010. This has culminated in the annual Science Summit within the context of the UN’s General Assembly. The focus of the Summit is on the role and contribution of science to attain the United Nations Sustainable Development Goals – or SDGs. The current edition – UNGA78 - takes place from September 12-29, and will bring together thought leaders, scientists, technologists, policymakers, philanthropists, journalists, and community leaders to increase health science and citizen collaborations to promote the importance of supporting science. And we are thrilled that Oracle will be part of the Science Summit with a few of our executives speaking and attending, including Alison Derbenwick Miller, global head and VP of Oracle for Research.

--------------------------------------------------------

Episode Transcript:

http://traffic.libsyn.com/researchinaction/Research_in_Action_S01_E19.mp3

00;00;00;00 - 00;00;22;29

What are the United Nations Sustainable Development Goals? What are the biggest challenges in pursuing and achieving those goals? And what's the best way for government, academia and industry to cooperate and collaborate in support of basic research? We'll get the answers to all this and more on Research in Action.

00;00;23;02 - 00;00;49;08

Hi, and welcome back to Research and Action, brought to you by Oracle for Research. I'm Mike Stiles and today's distinguished guest is Declan Kirrane, who is the chairman of the Science Summit at the United Nations General Assembly and the founder and managing director of ISC Intelligence and Science. And we're talking to a guy with more than 25 years of experience as a global senior advisor to governments and industry on science research, science policy and regulation around science.

00;00;49;10 - 00;01;17;07

Declan has been promoting a bigger role for science in the context of the U.N. General Assembly since 2010, and that's led to an annual science summit that focuses on the role and contribution of science to reach the United Nations Sustainable Development Goals or SDGs. The current edition UNGA 78 is happening September 12th through 29th and will bring together thought leaders, scientists, technologists, policymakers, philanthropists, journalists and community leaders.

00;01;17;09 - 00;01;37;02

We'll talk about increasing health science and citizen collaborations and why it's important to support science overall. Now, Oracle's actually going to be part of that science summit a few of the executives will be there speaking, including Alison Derbenwick Miller, who's global head and VP of Oracle for Research. Declan, thank you so much for being with us today.

00;01;37;08 - 00;01;58;13

Thanks, Michael. Great to be here. Thank you for the opportunity. Delighted to be here. What we want to hear all about the science summit at the U.N. General Assembly. But before we go there, tell me what got you not just into science, but science policies and your role in creating this summit? Well, first is, I suppose, the simple answer to that is happenstance.

00;01;58;13 - 00;02;21;10

I have to tell you, it was not planned. My primary degree is the history of art. And then I did law and probably needed a job after all of that. And then as a lot of people did in the late, late eighties, emigrated to the U.S. of A and on the basis that there was nothing going on in Ireland.

00;02;21;10 - 00;02;51;23

So opportunity beckoned and therefore from that worked on Wall Street and at a boutique mutual fund company. And then between one thing and another, I ended up in a in a boutique similar boutique company in Paris. And from that to Greece and from that, I got into more consulting side of things and from that started working for global multilateral bodies such as the World Bank and the IMF on a contract basis.

00;02;51;23 - 00;03;23;25

And then from that got more into telecoms and from that into into science coming out. And I suppose from the area of telecoms, infrastructure and data rather than, if you like, a bank scientist. And I suppose my history of art background gave me a wonderful perspective on policy, at least that's what I argue. And, and from that I got very interested and from the insights, but partly because the European Commission invited me and a couple of others to set up a dissemination service.

00;03;23;25 - 00;03;57;19

It's called Cordis. Cordis and the Cordis Information Service was designed by the European Commission to provide information on ongoing collaborative research and to provide information on publicly funded research opportunities in the course. The reason the European Union did that was to was to ensure that the information resulting from funding they're providing reached a very, very wide audience. So my job was to to do that and we built that out and that brought me into the area of science policy.

00;03;57;22 - 00;04;27;19

And I gradually began to understand the huge importance of science policy. And of course, 20 years ago science policy was not a thing, you know, it doesn't really exist in terms of policy making headlines, but it gradually came to be and as you know, it's it's part of the lexicon now. A lot of governments around the world have science policy priorities, and it's recognized as a driver for economic development and global competitiveness and driving solutions to global challenges.

00;04;27;19 - 00;04;51;05

So sciences is a thing, but 20 years ago it wasn't. So it's a relatively recent and I began quickly to appreciate the policy dimension of that, and that led me to work on policy that led me to understand policy mechanisms. And, you know, from my standpoint, I mean, there's no point in looking at some global challenges or many global challenges from a national perspective.

00;04;51;12 - 00;05;21;24

Really, it has to be global, it has to be international. That led me to engage with the United Nations. And from that, we just started to build from, as you say, from 2010, to start to build, engage with nations. And I really want to stress these were designed to be very, very simple to present not to a scientific forum, but to the U.N. for it to the mother ship, to the General Assembly, to diplomats, to policy and political leaders, and show them what science is.

00;05;21;24 - 00;05;43;04

And to give you a practical example, our first meeting was on biobanking. And you know, the main attention, wasn't it? What's biobanking? You see, that's exactly what we want. The want the question we wanted them to ask. And from Matt and that first mission, I think there's about 18 people in the room and we had about four or five diplomats last year at the Science summit.

00;05;43;06 - 00;06;07;02

We had approximately 60,000 participants. We had just under 400 sessions and we had 1600 speakers. So we've come a long way. And that really now is it's it's it's established. But we want to keep promoting. We want to keep science in the eye of the U.N. and we want to ensure that the future recognizes the contribution of science.

00;06;07;05 - 00;06;27;29

That's quite a journey. I think you did just about everything except science. Are you sure you weren't in the circus as well? Yeah, well, it's it's, you know, it's all true, you know, So, yeah, it's it's put a lot of it. Last 20 years has been on primarily on science. Yeah. Well in the intro I mentioned the United Nations Sustainable Development Goals or SDGs.

00;06;27;29 - 00;06;54;00

And our listeners are pretty savvy. They probably know about those, but I'm not savvy. So what are SDGs and how do they speak to global health and humanity in the in the in the mid nineties the the United Nations. And when I say the United Nations, I mean many of the United Nations constituent entities and agencies obviously were very concerned about what we generally call global challenges.

00;06;54;00 - 00;07;18;29

And in the area of health and other forms of well-being, the environment, climate, food security and safety and so on and so forth. And that led to a consensus that there needed to be, quote unquote, you know, how's this for a cliche? We have to do something. So that we have to do something resulted in the Millennium Development Goals, which were, as you can imagine, launched on the year 2000.

00;07;19;02 - 00;07;44;01

And they set forward these goals to to  address challenges. And that that 50 years went by pretty quickly. And that then led on to a similar mechanism where you identify a challenge, you define a response to it, and then you allocate specific targets within that and get everyone to sign up to that and off you go now.

00;07;44;03 - 00;08;12;18

So that then that broad approach was repeated for the United Nations SDGs, the Sustainable Development Goals, of which there are 17. And they cover the headlines that you'd imagine between poverty reduction, hunger reduction, improved health, a life below water, life on land, addressing obviously biodiversity, climate and many other areas. And then we're in the middle of these now.

00;08;12;21 - 00;08;45;10

But already the world is turning its attention to the post SDG agenda. And this is where this probably where we are now. The United Nations is organizing the summit of the future September 2024, and that I suppose you could characterize that meeting rather I do as a a banging of heads together because there is a sense of crisis, there is a sense the SDGs are not being achieved, that progress towards the attainment of the SDGs is insufficient.

00;08;45;12 - 00;09;07;19

It is exclusive. It excludes many constituencies, many countries, and again, I won't enumerate them here, but I just present that as as the scenario. So there's now a lot of momentum behind what we know. What do we do next? Why old humble viewers? I don't think it's going to be a if you like, a goals oriented process. I think that's too simplistic.

00;09;07;19 - 00;09;41;01

The world. I think as we found out, is much, much more complex. And I think the issue of inclusion and equity are issues that are present in a way that they were not when the Millennium Development Goals and the Sustainable Development Goals were designed 30 and 50 years ago, respectively. And I think this equity dimension is going to give a far stronger voice to less developed nations.

00;09;41;01 - 00;10;07;05

And just on the back of an envelope calculation, I think if you take the OECD countries and change, you've probably got 30 nations that we could call a developed. And then I suppose the big questions that what about everybody else? And that is becoming a very stark consideration, which was not there. And this needs to be addressed in terms of inclusion and equity to a much, much greater extent than is currently the case.

00;10;07;05 - 00;10;37;01

And arguably then will lead to a more successful approach to whatever succeeds the SDGs, the SDGs. I'm interested in the mechanics behind that because I'm just kind of reading between the lines of what you're saying and it's like for this thing to have true accountability and for these goals to have any teeth at all. There does need to be a someone accountable, be a very good grasp of who the participants are going to be and some form of deadline.

00;10;37;04 - 00;11;01;19

Absolutely correct. Mike And that that was that the plan A the problem with that in in in in a word is it doesn't really work you've so many moving parts you've so many constituencies that it's you know, having this set table of goals and table of targets and allocating milestones know simply doesn't work. Now, why doesn't it work?

00;11;01;21 - 00;11;29;07

I believe in my view it is that many less developed nations don't have the wherewithal to achieve these SDGs. One needs investment, one needs skills, one needs training, one needs cooperation, one is finance. I mean, these are all requirements to make change it, particularly in the area of or particularly in every area. But if you look at health, if you look at energy transformation, if you look at digital transformation, they don't happen without moolah, without money.

00;11;29;14 - 00;11;48;22

So the question is, well, where's I coming from? The answer, I'm afraid, is it's not. And that leaves a lot of they again, when I say lesser developed nations, I mean that is the majority that's 150 nations on the on the on the on a rough calculation. And they're not they don't feel involved. They don't feel they're taken seriously in terms of support for the investment.

00;11;48;24 - 00;12;13;12

And I think they're looking looking at the developed world and they're saying, well, okay, you benefited from carbonized development then and now we're supposed to do on carbonized development and how is that going to work for us? And there's no answer to that. So I think it's extremely complex. And as you say, trying to build consensus around this is extremely difficult because any move forward does require political consensus as very, very hard to get these days.

00;12;13;12 - 00;12;30;16

I mean, you can you can look at Ukraine, you can look at you can look at the Sahel, you can look at many parts of the world where consensus are at a political level. It's very difficult, if not impossible. And then you factor into that, well, how do you then adopt action plans? How do you adopt roadmaps? Again, extremely difficult.

00;12;30;16 - 00;12;54;14

So I in my view, the the SDGs have come a bit unstuck because of the inability of developed nations to provide the necessary wherewithal, including funding. And therefore, of course, the other side of that coin is the inability of of many, many nations to advance those objectives, to achieve the goals that have been set out to reach those targets.

00;12;54;14 - 00;13;32;09

And that simply is not happening. And on SDG eight in the High-Level Policy Forum in July of this year and the the process of reporting on SDH was abandoned for reasons which I think are quite obvious, and no one had anything to report. So I point to that specifically. And also I was with a number of African nation ambassadors for dinner in Brussels two weeks ago, and they pointed out that they've stopped wearing their SDG lapel pins, you see.

00;13;32;11 - 00;13;56;13

And there's two reasons for that. One is in protest at the slow progress towards the SDGs, and secondly, because of, as they see it, their exclusion from the decision making process associated with the SDGs, which, as you can imagine, has a, you know, an annual review mechanism and and and all that sort of stuff. They feel excluded from that.

00;13;56;13 - 00;14;27;04

And my own view is they are for the reasons I've I think I've mentioned or alluded to and this brings this this promotes exclusion and inequity. And again, to repeat this, this wasn't in fashion 50 years ago to the extent that it is today. Now, it is a very, very strong policy and political force. And the institutions, the multilateral institutions that take leadership on these issues now have to find ways to to address that and to build inclusion in a very, very significant and meaningful way.

00;14;27;04 - 00;14;50;08

It's not just the family photo opportunities. It's making sure that these communities, that the stakeholders feel they're involved and they are involved. They're seeing the benefits. And I suppose to that extent, it's it's you know, it's politics as usual. Boy, those those challenges are just huge. It's it's quite an undertaking to to pursue those. But I guess that's what also makes it exciting as well.

00;14;50;10 - 00;15;11;10

Since this show is called Research and Action, we do talk a lot about the need to knock down barriers and support research, but research has several stages from basic all the way through clinical. What is especially important about supporting basic research and getting that right? What are those benefits? I suppose so. Simply put, you know, that's where it all starts.

00;15;11;10 - 00;15;45;05

And when we talk about basic research, we talk about basic research, but I would also call it pre competitive research. So that's a start for, you know, is everybody's friends and everybody is collaborating before they before they apply for a patent or before they discover discover something they can monetize or exploit or innovation in whichever way. And I think a very important aspect of this is the fact that it's by and large government funded, and this gives it a very important dimension, not to mention is seeding the potential for innovation.

00;15;45;07 - 00;16;08;28

And I often reflect that if you if you the government plays a huge role in science and technology. And now I don't have the details in front of me, but, you know, as far as I understand it, about a Tesla Enterprise wouldn't be where it is today without a small business loan from the US government. And of course, Mr. Gates was a beneficiary of government contracts at a very early stage in the development of Microsoft.

00;16;08;28 - 00;16;30;01

So just to point there to the importance of government funding across the board with respect to the government investment in science and technology in the pre competitive space, there's a clear recognition that without a synchrotron or without the government investing in synchrotron or large scale science facilities, then I think we're not going to have stakeholders who can build those.

00;16;30;03 - 00;16;52;12

So it simply simply won't happen. Many, many outcomes I think are evident in terms of the investment and in science and technology. You know, basically we have an advance in knowledge. Basic research seeks to understand the fundamental principles underlying various phenomena. And I think the curiosity driven research around this then leads to much innovation. But of course you don't know that at the beginning.

00;16;52;12 - 00;17;10;28

So I think there has to be a very strong political commitment to Blue skies research. And again, I stress the word political committee because it is a policy decision for a government, any government to invest in pretty competitive research, in science, capacity building, which is predominantly pre competitive and on in there in basic science. So I think that's that's hugely important.

00;17;10;28 - 00;17;34;11

Just to point to the policy dimension, I think that then leads to various innovations and that that that is applying. So you see a very clear narrative between basic research, innovation and applied research. Many groundbreaking innovations and technological advancements have emerged from the discoveries made in basic research. And I think this needs to be spelt out very often when a policymaker gets up in the morning.

00;17;34;18 - 00;17;56;18

That can be a complicated narrative. You know what I want to be getting from this? Why spend vast sums of money on basic research, blah, blah, blah? But I think when you look at the evidence, I think then the case is is compelling. But of course, that needs to be understood continuously, primarily by policymakers. And it does bring long term benefits, The outcomes of basic research might not lead to immediate benefits or applications.

00;17;56;18 - 00;18;25;27

However, these insights often lay the groundwork for future breakthroughs, which could and very often do have significant societal, economic or technological impacts over time. Problem solving is another reason to fund and do basic research educational value. Basic research plays a critical role in educating the next generation or generations, indeed, of scientists, researchers and thinkers. It provides a training ground for students to learn research methodologies, critical thinking and analytical skills.

00;18;26;00 - 00;18;52;06

And these values have multiple applications, multiple applications. And then we have cross-disciplinary insights. I think this is self evident. Basic research often leads to unexpected connections between different fields of study. These interdisciplinary insights can spark collaborations and innovations that otherwise wouldn't come to the fore. Intellectual curiosity, I think, needs also to be highlighted. Then we have the benefits coming from scientific advancement.

00;18;52;10 - 00;19;26;18

So I think Mike, there are many, many, many benefits in that. And I'd just like to point to really one example of basic research. You may not be a follower of radio astronomy or you might be about South Africa won a global competition to build the square kilometer Array telescope, the SKA, and that was a global competition in 2011 against the UK, against Chile, China, Brazil and Canada.

00;19;26;18 - 00;19;50;25

I believe there may be one or two other countries there as South Africa won the right to host and to build the UK and it is now doing that. It's probably a 30 year project. But here you have an example of of an African nation competing to build a hugely complex scientific instrument in the middle of the Karoo desert.

00;19;50;25 - 00;20;30;21

Now why do that? Many reasons to do it. But one of the compelling reasons that I learned from exposure to the project is the enormous commitment that the South African government and now, of course, to have partner countries, including Australia, that huge commitment they have made to education and training the next generation through the scale. And you will see in the system you'll see that many US multinationals, the Dell Corporation, IBM, Microsoft have very strong project association and collaboration with the UK and South Africa.

00;20;30;24 - 00;21;00;04

When the Economist wrote about the UK in 2016, I believe it was, they said this is the world's largest science project. And I think, you know, just it's worth reflecting on that. And this has enormous, enormous future potential. It has existing benefits to the scientific community and of course it is a huge flagship idea that provides a lightning rod for scientific collaboration across Africa and across the world.

00;21;00;11 - 00;21;26;13

At a very practical level, it brings many scientists to visit the facility to work with African and South African collaborators. So this is an ongoing benefit. I think a wonderful example of what our research infrastructure is, what basic science is, and why it should be funded. Yeah, what you just described is an enormous success story. But, you know, candidly, my optimism is challenged because so much of this does rely on government participation.

00;21;26;19 - 00;21;54;08

Yet it feels like as long as money and politics is in the picture, those are the anchors that can weigh things down. And against that backdrop is the science summit. So how did the science summit become a reality and was there any resistance to it or did anybody think this wasn't a good idea or not worth doing? The as far as I've learned, I mean, the response has been universally very, very positive, extremely positive.

00;21;54;11 - 00;22;26;03

And that's because the science summit is designed aimed to advance a greater awareness of the contribution of science to the SDGs. Now, how do you do that? You do that by bringing folk together. And those folk are not just the scientists. I mean, we're not organizing an ecology conference, we're not organizing a radio astronomy conference, we're organizing a science engagement process with U.N. leadership.

00;22;26;06 - 00;22;54;09

And more than that, we are showing how science needs to be inclusive. So to that end, we have a very strong narrative around inclusion. We have a very strong narrative around development, finance for scientific education, for science, performance and investment in science. And through doing that, we are education policymakers. We are engaging with policy makers. And I need to stress this invariably is it is a process.

00;22;54;16 - 00;23;15;28

But at the end of the day, policymakers that I have engaged with at many levels in Africa, Europe and the United States, they want to make the world a better place. I don't think there's any any doubt about that at very often in that quest, they are very remote from the outputs of science for the evidence that is there that shows that science delivers.

00;23;15;28 - 00;23;38;28

Of course, it's in the system. But very often the political system of political decision making is very human. It's a very natural process. It's not always empirical. And I think as you know, and possibly in in the Western world, we see that policy making is becoming more political with a small P. So it's into that environment that we are going and showing how science makes a difference.

00;23;39;05 - 00;24;08;26

Practically. We're showing how science delivers on the SDGs, we're showing how science delivers on the future challenges. And with reference to a very important aspect, we're also highlighting the the importance of enabling access to data now, and this is you'll probably be familiar with the European Union's General Data Protection Regulation, and there are other regulatory regimes in in the United States and Canada, Japan and Brazil and and elsewhere.

00;24;08;28 - 00;24;33;19

And now we are looking at the evolution of regulation concerning artificial intelligence. Now, these regulatory processes as one outcome have impacts on access to data and the use of data for scientific purposes. There is no global regulator, there's no global policymaker. How do we address a global coordination on these issues? And that's something we want to raise within the context of Science Summit to ensure that science is data enabled.

00;24;33;21 - 00;25;00;25

When we talk about science capacity building, essentially we are talking about improving the flow of data, access to data, use of data from machine learning and AI and other purposes, and extending that capability globally. And when that can happen, then you will see dramatically improved outcomes in terms of health research at the environment, biodiversity, energy and many, many other areas.

00;25;00;29 - 00;25;44;06

But we're not there yet. That very much is in the future. So we're trying to align the debate around the objective of creating these new innovations with the need for aligning energy policy, energy technology and other information technology around alignment on regulations. That's huge, huge importance. So we see that. We see the opportunity after the United Nations General Assembly to talk to governments, to talk to political leaders, to talk to Balsillie was to talk to diplomats, to talk to regulators, to talk to bureaucrats and show them what this is, how this matters, and very importantly, how they can include optimized policies to support science in future policies at the bloc level, at nation level.

00;25;44;06 - 00;26;13;20

And we have many, many meetings bringing forward scientists to show what they do, what's necessary in terms of government regulation and support to enable. So we're talking about creating the enabling policy and regular Tory environment for more and better science. And funnily enough, we don't say that's more that's about more money. We don't feel that. We don't think that what there is, is more opportunity and a great need for alignment at government and policy level.

00;26;13;23 - 00;26;39;06

And if every country in the world goes it alone in terms of creating regulation and creating policies, then we're looking at extreme fragmentation. There is much, much untapped potential for governments to work together, and that's one reason we're very happy to be working with Oracle, because, you know, from there, you know, as a company and, you know, forgive me if this is too simplistic, but they, they they create these machines that can communicate data.

00;26;39;06 - 00;27;07;29

And this is a this is a vital and vital a vital need globally. And how they do that and future, I think, will point to many, many future opportunities, which is a very important consideration, because with the science summit and at the level of the U.N., there's there's a huge recognition of the need to work with industry players and the importance of working with industry to deliver innovations, because it's not going to be a university center in it.

00;27;07;29 - 00;27;33;27

With the greatest respect to Cork University in Ireland, they're not going to be making the mess that's going to come through a company. So and industry. So this collaboration opportunity between academia, between governments and industry, I think is ripe for transformation, I think has enormous potential to address global challenges. So can you give us kind of a feel for what kind of speakers and sessions can be expected at the summit?

00;27;34;04 - 00;28;02;24

Yes, Michael, we've got a very inclusive approach to the summit, so we're covering a lot of things, but I suppose I would accept that we have a bias towards health on the health research. On the 13th of September, we have an all day plenary on on One Health, which is a perspective that brings together planet people and animal health into a, if you like, a one world view.

00;28;02;27 - 00;28;26;10

We have a lot of amazing speakers from the five continents who will be coming to that meeting. And what we want to do then is this is relatively rare. It's a relatively new area. By that I mean it's a relatively new or a policymaking. So where want to advance policymaking in this area? We want to also promote interdisciplinary research and show how research matters across these three areas because they cannot be addressed in isolation.

00;28;26;12 - 00;28;56;06

And we'd argue at the moment, by and large, that they are. If you look at national funding systems and national priorities and all the rest of it, they look at animal health or they look at human health or they look at biodiversity. But looking at all three I think is vital. That's our that's our flagship session on Wednesday the 13th on the 14th, Thursday the 14th, we're going to focus on on pandemic preparedness and we're going to bring together the leadership from the National Research Foundation in South Africa, from the African Union Commission, from the European Union.

00;28;56;06 - 00;29;33;16

Delighted to have Irene North steps. The director for the People Directorate in Brussels is coming to join us. For three days. We have Professor Cortes at Lucca from the Medical University of Graz, who leads many European Union research initiatives. But he was the main instigator of the European Union's biobanking research infrastructure, of biobanking, of molecular resources. We should infrastructure, which does pretty much as it says on the can, and we're looking to create a UN version of that, if you like, And look at how this capacity for biobanking is going to contribute.

00;29;33;16 - 00;29;57;01

So and pandemic burden, it's very, very important that we also have President Biden's science adviser, Dr. Francis Collins, former director of the and I and the in the United States, Then we will also have representatives from Dr. Sao Victor. So from the U.S. Academy for Medicine, National Academy for Medicine. He'll be presenting the US approach to pandemic preparedness, which is called 100 days Mission.

00;29;57;06 - 00;30;22;17

What you Need to Do in the first hundred Days. We're very excited about that and very, very much looking forward to using that as a template for a global approach. And while there's been a lot of focus on global strategies, which we obviously very much support, we want to take that global strategy approach to the level of action in terms of what capacity is needed, where's that capacity needed, How can the capacity be delivered?

00;30;22;19 - 00;31;09;02

So very much looking forward to pandemic preparedness as a highlight of the summit. Then on Friday, Friday the 15th of September would have a one day plenary on genomics capacity building with a focus on Africa. But the approach will be global, But bring it forward. Will How does the capacity work for pandemic? Sorry for genomics and has been led by global industry in terms of Illumina and it's been led again by data experts, and that really looks at a future for genomics capacity building in Africa, without which we are going to be or Africa is going to be extremely hampered in the development of medicine and related therapies.

00;31;09;04 - 00;31;37;12

So there are three of the sessions. We also have the Obama Foundation having a meeting on the on the 17th of September. We're going to bring philanthropic organizations together, are for lunch on the 15th. We are going to have a number of sessions around the Amazon with the Brazilian Fapesp, the Rio National Research Agency, and they'll be looking at the future of Amazon from the perspective of collaborative research and development and science.

00;31;37;15 - 00;32;06;00

We will be working with a number of legal experts with the law firm Ropes and Gray, who will bring together experts to identify scenarios for an enabling regulatory environment for genomics that's going to take place on the afternoon of the 16th. We are going to have a number of focus days. The government of of government of Ethiopia will be joining us and they'll be presenting how the Ethiopian government presents or approaches the SDGs.

00;32;06;00 - 00;32;27;18

From the point of view of enabling science. We have a similar approach from the government of Ghana. We will have the nice people from Mongolia, the government of Mongolia. They will be presenting a regional approach from the roof of the world, and we would have the same from Nepal, from India, from Japan, from Brazil and many other nations.

00;32;27;23 - 00;32;58;22

And that national approach is very, very important because again, we want to highlight the need for synergies, highlight the similarity between national approaches and then how they can be brought together and benefit from one another. We will also have a presentation from the editor of Nature, Magdalena Skipper at They'll be presenting a what they call a storytelling evening, and that's that's designed to inform and show how science careers evolve.

00;32;58;28 - 00;33;27;05

So so the community can get an understanding of of how that has worked in a number of individuals so very much at look at looking forward to that. I think that personal aspect is is very, very important. And we will be having a number of sessions with with investors how they are approaching investing in science and technology, how that investment can be better aligned between governments, industry, not for profits, philanthropy.

00;33;27;05 - 00;33;50;18

And we're feeling we're seeing that a lot of these organizations have similar objectives. So there's enormous potential to see how they can be more aligned, work together for common objectives and thereby increase possible benefits and outputs. So very much look forward to dose those discussions. In terms of our principal outputs, what we want to do really is three levels.

00;33;50;18 - 00;34;12;01

First is we want to increase participation and collaboration. So we want to bring people together. And one of the main outputs of the science summit last year, researchers discovered each other. They went away and they started collaborating. That wouldn't have happened if they hadn't met at the science. So that's one level. Second level is what our agenda is.

00;34;12;04 - 00;34;44;27

So the United Nations will convene the summit of the future in 2024. So the question we're asking everybody is what should the science agenda for that meeting look like? And we want to compile it. And with the 400 odd sessions we're running, we want to work with them and see how can they contribute to that, What priorities can they put forward and how do they look in terms of a specific objective which the United Nations can support in terms of energy attainment or the post SDG agenda?

00;34;44;29 - 00;35;22;06

And the third element we want to advance is better policy making, make better policies. We will have tennis knocked and Dennis is the chair of the Inter-Parliamentary Union Science Committee. The Inter-Parliamentary Union is a global organization and represents 138 parliaments around the world. This dialog is hugely, hugely important. So we're going to be working with Denis to see how his members so those legislators in those 140 odd countries can incorporate better global ideas into policymaking at a local level.

00;35;22;06 - 00;35;52;29

And I'm talking about I'm talking about Nepal, I'm talking about Ghana, I'm talking about Kenya, I'm talking about many, many countries. And then what we what we hope that that will achieve is real sustained change. And as we move towards the end of this decade, that's going to be hugely, hugely demanding. But I think if we build this global momentum and we drive this cooperation and instill a sense of cooperation among scientists globally, and also we say that, you know, scientists in fact, are policy policymakers.

00;35;52;29 - 00;36;10;12

I don't see this divide between policymakers and scientists. I think scientists have a huge amount to contribute to policymaking. So, in fact, they're the policymakers. They know a lot about health, They know a lot about what policies are needed to deliver better health. And we want to give them a voice. Well, as I mentioned, Oracle will be speaking and participating at the summit.

00;36;10;12 - 00;36;37;01

And you touched on it a little bit. But when you think about the role for industry players, especially technology giants like Oracle and what's needed to pursue the SDGs, we've talked on the show a good bit about the concept of open science and increasing access to scientific data. It feels like big advances in global health can't happen if those developing or lower middle income countries are kept at arm's length from data.

00;36;37;04 - 00;37;00;02

Absolutely, Mike. Absolutely. Very, very well said. And as I've outlined, is that one of the main impediments potentially to this is regulation by advanced nations, which impacts on less developed nations. So I think an industry has a huge role to play in that because, you know, industry and providing the wherewithal to to advance this data exchange. So we very much look to industry leadership.

00;37;00;02 - 00;37;16;20

And I think Oracle is going to be very instrumental there in showing and leading the way in terms of how data is enabled and how data systems can allow access to data use of data, and of course the use of data for machine learning. And I think that's something we need to learn a lot about, particularly in developing nations.

00;37;16;23 - 00;37;35;25

I also think that the United Nations Global Sustainability Report, the latest version of which is available in draft, and I think the final version will be published at the end of this month. Points to a huge role for for industry. My own view is that I think industry need to be much more at the table at this U.N. table.

00;37;35;25 - 00;37;56;24

I'm delighted to see that Oracle is joining us in this quest, because I think we need to build a narrative and I think it'll be for industry are going to be a very credible partner in terms of telling governments what is necessary, what's needed in terms of creating the space for data to do what data needs. And again, in particular in the countries that are going to be challenged in their quest for access to data.

00;37;56;27 - 00;38;33;03

And that presumes that they have the capacity to have the infrastructure. Many don't, but they're going to need to have that and the industry going to be critical in delivering that. And I think that's that's terribly, terribly clear. So that role for industry in delivering, I think, spans the optimization of policy, the optimization of regulation, the deployment of technology, the maintenance and sustainability of that technology, and of course for the advancement of that technology into different areas in its application, particularly in ICT application, in the areas health and energy and the environment, biodiversity, climate and so forth.

00;38;33;06 - 00;38;55;25

And I think this is something that provides a gives me a lot of optimism in future. And I think also almost we're looking at a, if you like, a post, arguably a post regulatory model where where technology will allow us to define the the remit of Data Act access. I don't think we're there yet, but I think this is this is possibly in future.

00;38;55;27 - 00;39;16;01

And again, Oracle and the colleagues from Oracle will be engaging in a number of discussions on the regulatory side, on the technical side, on the access to data side that's going to help the communities understand not necessarily the solution, but at least define the questions. I think define the questions. Then we have a much greater opportunity in obtaining the answers.

00;39;16;03 - 00;39;39;17

Well, also in my intro, I mentioned that you are founder and managing director of ISC Intelligence and Science. Tell us about that endeavor. What does that do? Well, that that mainly is devoted towards building body types, capacity and advising governments on science. Capacity Building that many faces is based around scientific infrastructures. And of course they come in in many, many flavors.

00;39;39;22 - 00;39;59;29

But ours really is around the design of research infrastructures that that tends to be quite a long, competitive, drawn out, complicated process. Of course, for any funding, there is a there is a competitive process. This takes a a number a number of years, very often for an award, then a subsequent number of years for a design phase to be completed.

00;40;00;05 - 00;40;21;02

Before then you move into construction and operation. Our primary focus is on the design phase and we've done that in in Africa. We do it in India, in in North America, Latin America. And one of our main reasons for focusing on this area is because it means the capacity is there to to allow science to do what it does.

00;40;21;02 - 00;40;46;01

I've mentioned the case of the SKA and in Africa there are many others. But I would say hitherto there's been a lot of differentiation between science capacity. And of course this is this is quite understandable. But I think increasingly in future that capacity will be effectively one big data machine. It won't matter what flavor of science you're doing, you're going to be dipping into a common data reserves.

00;40;46;01 - 00;41;23;05

Now, there's some caveats around that, such as a a synchrotron, for example, or a light source. I think these are, as you can imagine, specific unique instruments. But we're looking forward very much to have the director of the Office of Science in the United States, Dr. Esmond Barrett, talk to us about how this can work on a global level and what are the challenges and how the US experience in building these science infrastructures and capacities can then help many, many other countries to to advance towards not net, not necessary do the same, but at least be on a path to access such capacity.

00;41;23;05 - 00;41;52;08

So ESI has been very, very involved in that and also involved in the regulatory aspects of the impact of updated regulation on science is something we're very exercised about. If we feel that the scientific community historically, by which I mean maybe over the last 15 years have been very slow to understand the implications of regulation of science, but equally the regulatory bodies at national level, equally have been very slow to understand the impacts of science because their primary concerns are not science.

00;41;52;13 - 00;42;23;27

The primary concerns are as they see them is the protection of individual data, etc., etc., etc. and that's very worthy and noble. But then once you pull the thread, you see that that has aspects and implications for scientific endeavor. So we're working in that interface, ensuring or trying to ensure or trying to increase respective awareness and visibility. And now this is has a very sharp focus in the advent of a EIA, the Artificial Intelligence Act in the European Union, which will be defining for reasons we mentioned earlier.

00;42;23;27 - 00;42;43;12

Also, we are very active in that space and we're very particularly active and, and how this seen, how this impacts on less developed nations. Well, Declan, again, we appreciate you being on the show today. If people wanted to learn more about the science Summit or ISC intelligence and science, how can they do that? Main ways. The website for the Science Summit is Science Summit.

00;42;43;15 - 00;45;13;24

It is sciencesummitunga.com the company website is ISC intelligence dot com and then you'll find the usual links to Twitter and all the rest there. Very good. We've got it. And if you listen are are interested in how Oracle can simplify and accelerate your own scientific research. Just take a look at Oracle dot com slash research and see what you think and of course join us again next time for research and action.

How do the latest technologies impact epidemiology, clinical research, and public health? What kind of progress has there been in collaboration, open data, and citizen science? And in what ways can digital health appropriately supplement healthcare with the human touch? We will get the answers to these questions and more in this episode with Christine Ballard, a professionally trained epidemiologist specializing in clinical research and a Research Advocate at Oracle for Research. Christine has her Master of Public Health and is currently pursuing her Ph.D. in pharmacoepidemiology at UNC Chapel Hill. Her vast experience includes stints as an assistant professor and clinical research roles at Wake Forest Baptist Health, the University of Rochester Medical Center, and the New York State Department of Public Health. You can learn more about Oracle for Research here: http://www.oracle.com/research

--------------------------------------------------------

Episode Transcript:

00;00;00;00 - 00;00;24;21

What challenges do epidemiology researchers face in getting solutions to the public? What kind of progress has there been in collaboration, open data and citizen science? And in what ways can digital health appropriately supplement health care with the human touch? We'll get the answers to these questions and more on this episode of Research in Action, brought to you by Oracle for Research.

00;00;24;23 - 00;00;57;18

Hello. Welcome back to another episode of Research in Action, brought to you by Oracle for Research. I'm Mike Stiles, and today we have Christine Ballard with us. Christine is a professionally trained epidemiologist, specialized in clinical research. She has her master of public health and is working on her Ph.D. and pharmacoepidemiology at UNC-Chapel Hill. Her rather vast background includes stints as an assistant professor and clinical research roles at Wake Forest Baptist Health, University of Rochester Medical Center, and the New York State Department of Public Health.

00;00;57;20 - 00;01;26;08

She's currently a research advocate at Oracle for Research. And we're going to learn what those research advocates do and get into a lot more. Thanks for being with us, Christine. Thank you so much, Mike. I can't wait to dive into this. Oh, yeah. I'm looking forward to it as well. And I am going to ping you with questions about clinical research, epidemiology, pharmacoepidemiology as I keep tripping over that word, probably where is what kind of shape health care is in.

00;01;26;09 - 00;01;48;12

We're going to talk about that and some other stuff. But first, what got you as a person interested in this line of work? Kind of give us a little history lesson on Christine. You know, growing up, I lived in rural upstate New York, so I lived right outside of Rochester, right up on Lake Ontario, in a really small town of Albion, New York.

00;01;48;14 - 00;02;17;09

And, you know, there really wasn't a lot there in terms of researchers and health care access, to be quite frank. And, you know, I was diagnosed with type one diabetes at a really young age. I was diagnosed at eight and it I had a couple options When I got diagnosed, I could either face it head on or I could kind of sorrow in getting diagnosed and, you know, kind of letting it take over my life.

00;02;17;09 - 00;03;05;17

And I chose truly to jump two feet in. And I was so interested in being kind of up to date with all of the newest, latest, greatest technology and research updates. And I would find myself as a young kid trying to Google once Google became available, what certain words meant and really kind of educating myself about it. But quickly, growing up in a small town, not having that research access and really not having access to health care providers that even necessarily were familiar with that technology, my parents got me connected with the University of Rochester, and that's where I had a lot of my care growing up.

00;03;05;20 - 00;03;34;21

And really got to to learn and grow as as a kid alongside some of the brightest scientists in the field and it truly inspired where I wanted to go and was so excited when I entered college at the University of Rochester and really getting to work more hands on than you would as an eight year old kid and really just fell in love with the field.

00;03;34;21 - 00;04;06;24

And so I didn't know what epidemiology was even entering college and quickly kind of figured it out. During my studies. You know, like a lot of kids at the University of Rochester, you kind of go in premed, everyone's going to med school. And unfortunately I got rejected many times. And so when I got my MPH, I really fell in love with that and really getting the opportunity to dive into AP research.

00;04;06;24 - 00;04;59;01

And I did a little bit of that at the New York State Department of Health, but really got to spread my wings at the University of Rochester in the Department of Neurosurgery, really exploring health outcomes for patients and really understanding how do we make patients first in research and it kind of set me on this journey. So this past year, I got accepted into UMC Chapel Hill's PHARMACOEPIDEMIOLOGY program, where I get the opportunity to start to understand how pharmacy or pharmacology so all of the treatments that patients are receiving impact their care in certainly looking for ways to continue to always drive patient care and continuing to accelerate new discoveries.

00;04;59;03 - 00;05;23;28

And I absolutely love it and love that. Oracle's giving me the opportunity to do both things, work full time, and also be a full time PhD student. Yeah, I think that's kind of common. I've known several friends from high school who, you know, their path into medicine was a result of something that they experienced themselves, whether it was getting put back together after a car wreck or a disease that they have.

00;05;24;01 - 00;05;50;24

How does your personal health journey with Type one diabetes influence the way you approach research and your job at Oracle now? Because it is kind of a different lens than someone who's just coming at it. Purely academic, purely scientific. Yeah, I think I kind of have to wear both hats to be totally honest, but I think the way that I approach clinical research is really with patients in mind.

00;05;50;29 - 00;06;32;17

Patients have so much knowledge and experience that they can kind of engage in that research process and really understanding how to combine the patient perspective with the traditional research perspective has really been super rewarding and really engaging and allows me to bring my experience as a patient and certainly as a patient advocate forward. And now with Oracle get diving headfirst into the health care space, it really allows me to kind of bring a bit of that perspective to our researchers as well.

00;06;32;19 - 00;07;05;27

And always talking about the new discoveries that they're doing. But how can we relate it back to improving patient care and accelerating discoveries, understanding really how digital health can also revolutionize the way that we've been doing that versus I was that kid that would always bring Excel sheets to doctor's appointments. But I think, you know, I think digital health really is the opportunity to combine new technologies with accelerating the way that we're doing research, which I'm really excited about.

00;07;06;04 - 00;07;30;22

Well, you were talking about how when you were younger, you were making yourself an expert in your condition and probably, you know, seeking answers rather aggressively. Were you happy with the degree to which you were being listened to or did you just keep running up against a brick wall? MM That's a really good question. I have to say I was so lucky as a kid.

00;07;30;26 - 00;08;05;09

My physician was or I should say my nurse practitioner was a type one diabetic herself, which honestly gave me a completely new perspective on life and on the trajectory of the disease. To have somebody who's treating your condition, who is super busy as all of our advanced care practitioners and our MDs are so busy all the time, to see her living a life like that truly impacted where I wanted to go.

00;08;05;13 - 00;08;41;06

Going forward, I will say there were times where I felt like it would not just with my diabetes care, but, you know, with health care in general where you're experiencing something or feeling something and you're like, just listen. And I think that's really where being able to have that patient interaction and research is going to be really critical to understand the unique nuances of health things present in individuals because everybody is different, which I think is really going to help accelerate discovery a lot a lot more as well.

00;08;41;09 - 00;09;11;01

Well, what exactly is a research advocate, especially as it relates to being one for a company like Oracle? Why? Why is that important to advancing research? I think each one of us take on a slightly different role, but really the research advocate is to work alongside researchers to help them navigate huge corporations. And, you know, a lot of us are used to navigating the academic setting because that's what we're familiar with.

00;09;11;01 - 00;09;45;22

That's what we've experienced. But when you throw in a huge company like Oracle, you kind of get a little overwhelmed. And so as a research advocates role, I can I've got the research experience and have navigated the academic setting, but I also have the experience navigating industry through Oracle and so it's really helping the researchers translate what they're doing for their research and how that translate in the academic or nonprofit setting to the industry setting and helping them.

00;09;45;22 - 00;10;14;15

If there is projects that I can help with, we do everything from digital humanities to quantum physics and everything in between. And I am certainly not an expert in everything, but in the health care and the clinical research in the epidemiology space. If there are research areas that I can really work alongside researchers and help them accelerate what they're doing, that's really my role with Oracle for Research.

00;10;14;17 - 00;10;49;10

What attracted me to Oracle for Research was that ability to have that collegiate experience and also provide that researcher to researcher experience as well. A lot of times you get assigned somebody that may not have a research experience or may have heard the word research, but really hadn't lived it with their career. And so I was so excited to be able to kind of bridge that gap, especially coming from academia into Oracle, which was a bit of a learning curve for me.

00;10;49;10 - 00;11;16;23

But to really help, help the researchers get what they want done for their projects and be able to help make really impactful changes to their given fields. But even though you have plenty of laurels to rest on, like you said, you're at the same time getting your PhD and Pharmacoepidemiology at USC. Not an easy thing to do. What is that and what kind of research are you doing?

00;11;16;23 - 00;11;47;04

And and how is that? How does that help us get toward something we can bring the public health as a whole? And so if any of you ask that I or Mike, I feel like I talk to my my parents, they're like, what is it that you do? My dad's just like, I don't know. She's in school. So Pharmacoepidemiology is really the the marrying of pharmacology and pharmaceutical science with epidemiology.

00;11;47;04 - 00;12;31;23

So looking at how patient treatment impacts their overall health outcomes. And so really with that, I've been excited to explore different types of therapy is that are already available on the market to really look at how can we use or repurpose drugs for treating rare diseases and in my focus has been in brain tumors. And so not only with UNC-Chapel Hill and doing all of my PhD work, but I've really been able to dive in with a lab in focus on my own research, looking at how do we improve patient outcomes with brain tumors.

00;12;31;26 - 00;13;09;07

And we do that through a whole host of different tools. Some of it is real world data, and that could be real world data from registries like the Medicare SEER Registry, as an example, where we look at brain tumors or any sort of cancers, and then also be able to take a look at prevalence, meaning the number of cases in total of a certain cancer or looking at incidence, the number of new cases of a certain type of cancer or utilizing other electronic health record data.

00;13;09;08 - 00;13;36;17

So look at continuum of care for health and then also doing firsthand collection of data through clinical trials or clinical research studies that are initiated either by industry or by clinicians. And so really the field of clinical research is is huge. My PhD touches a little bit on that when we take a look at just the treatment side of it.

00;13;36;20 - 00;14;26;05

But my hope ultimately coming out of this Ph.D., I guess what I dream to do is really be able to marry some of my genomic experience using genomic data to also drive precision medicine with our pharmacology, to really be able to start to make an impactful transition for patient care. And my specialty and my focus has really been brain tumors to date, but certainly really interested in the rare disease in oncology space because I think there's a lot of a lot more work that we can do to be able to continue to spread awareness about these different types of cancers, but also a ton of headway to really improve patient care.

00;14;26;07 - 00;14;52;04

Yeah, and you touched on the fact that, you know, the health care overall seems to be driving toward more personalized approaches to treating people. We are all individuals, like you said, Lord knows I like to think I'm special. I don't know. But there are so many environmental and biological variables in the research equation. The kind of research you're talking about sounds incredibly complex to me.

00;14;52;04 - 00;15;20;07

So what epidemiologists have to deal with in terms of procedure and ethics as they do research and try to get something usable out there for the public. That's a loaded question. So with epidemiology, there's a whole host of things to look at. You know, growing up in undergrad and certainly in my graduate studies, the focus has really been on the bio psycho social model, really looking at all effects that could impact a person's health.

00;15;20;07 - 00;16;02;13

So as you touched on environmental, biological, psychological effects, mental health, all of these really contribute to an overall person's wellness. And so epidemiologists have to look across a multitude of different factors to really understand the certain disease that they're studying. I can tell you in the brain tumor space, we've looked at across a multitude of factors, including environmental, including pharmaceutical, including biological, including mental health, to really understand where we can make the biggest impacts.

00;16;02;15 - 00;16;40;14

And then thinking about the ethics associated with research, everything has to be done in certain there's all sorts of procedures that you have to follow. But thinking about our clinical research and our clinical trial data, where we're collecting real world data from patients, it's incredibly important to make sure that the patients are in agreement with sharing their data with the researchers and really understand what the study is looking at and what the benefits or maybe no benefits may be for their particular care.

00;16;40;16 - 00;17;08;02

And so I think, you know, having those procedures in place ensure that the patients are protected, which is truly key. But it certainly is something that I think all of us really strive to hold ourselves accountable for is making sure that patients are front and center as they are truly the ones that are contributing this data. And in allowing us to do the work that we're doing.

00;17;08;05 - 00;17;35;01

Well, I do want to ask about clinical trials because modern medicine means, I assume, collaboration across a range of medical professionals. So how does an epidemiologist work, supplement or partner in clinical trials? What does that interplay usually look like? You know, I've been so fortunate in my career to have supportive physicians and clinicians to work alongside with, but I am not a medical professional.

00;17;35;01 - 00;18;05;19

I don't have my my M.D., I don't have my R.N., I don't have my my degree and physician assistant. So I don't have the firsthand knowledge of treating patients. And so really, epidemiologists are in that supportive role to help drive research. But allowing us to have that interaction with clinicians is key to be able to make sure that the questions we're asking are relevant to patient care.

00;18;05;21 - 00;18;41;05

And what we're finding also is relevant to patient care, because really that's ultimately what we're all trying to do is is improve patient care. So depending on the setting that you're in depends on what your team may look like. But I can say that a lot of times as part of my research teams, we have a physician or some sort of clinician on our team alongside an epidemiologist, a biostatistician who is far better at doing statistical analysis than me.

00;18;41;07 - 00;19;18;06

Sometimes computer scientists who may be helping with the coding, although I do a lot of my own statistical programing myself, but sometimes we'll have the luxury of having a computer scientist on there and then obviously having an IRP that oversees it. An IRP is an institutional review board that makes sure the decisions that we're making in terms of the design of the study and how we're conducting a study is done in an incredibly ethical manner and meets all of the standards that we should.

00;19;18;09 - 00;19;39;22

And so having that oversight is also really helpful to make sure that, again, patients are front and center and we're we're doing the best science we can for regular listeners. I know I keep bringing up Amy Docs or Marcus on the show. She's a Pulitzer Prize winning journalist from the Wall Street Journal and she was a guest. We talked about her book, We, The Scientists.

00;19;39;28 - 00;20;07;16

But it's such a compelling look at patients, scientists, doctor collaboration and how that citizen science is being used in the fight against rare diseases. It's a truly new way of thinking that still honors scientific rigor. What are your thoughts on citizen science and is it gaining traction? I mean, we talked a little bit about it earlier about patients being listened to more, but this kind of kicks it up a notch.

00;20;07;19 - 00;21;01;02

Yeah, her book was fantastic and certainly very insightful of how citizens science should be done in the health care space. In this day and age, all of us have all sorts of devices that are collecting data about all of our lives. I know I'm wearing an Apple Watch and I'm sure many of our listeners are as well. And what I think is interesting is, you know, several years ago, before citizen science in health care really became a thing in the diabetes landscape, folks were using technology to continuously record their glucose readings to be able to get more of a handle on avoiding hypoglycemia, meaning high blood sugar or hypoglycemia, meaning a low blood sugar level

00;21;01;04 - 00;21;45;00

to really help improve their overall care and improve their health outcomes. And so thinking of citizen science, it makes sense to make that leap from what a lot of folks are already doing by tracking their steps or tracking their EKG monitors, tracking their blood glucose level, etc. to be able to incorporate that into that holistic picture of what their daily lives look like from a care standpoint, it certainly helps give physicians a clearer picture of their life, of what they're doing in their day to day life, but also be able to provide more, more personalized care.

00;21;45;03 - 00;22;20;13

But in the research space, it gives you a multitude of data points that otherwise wouldn't have been able to be collected without a huge burden on the patient. And so one of the things I think we have to consider with citizen science is how do we make citizen science approachable for everybody that wants to engage, to engage, and then also be able to allow patients an easy time to find those engagements if they can.

00;22;20;15 - 00;22;48;14

And so when I was at Wake Forest Baptist Health, one of the interesting studies that they did in partnership with Oracle was the Community Research Partnership for COVID 19. And so it really provided patients who, during the heart of the COVID pandemic, maybe at home, working from home to collect data and let us know how they're feeling about everything.

00;22;48;14 - 00;23;12;15

So how are they feeling about the Thanksgiving holiday? How are they feeling about seeing people? When it came time for that Thanksgiving holiday, what were their daily symptoms? Did they receive a vaccine? If they didn't, Why? If they were comfortable sharing that, to be able to understand how do we start delivering care that fits a multitude of different needs?

00;23;12;18 - 00;23;45;18

We were so fortunate with that study to have thousands of patients that were so diligently collecting those pieces of data or sharing those pieces of data with us on a daily basis for over two years. And so seeing that sort of project really starts to open up your mind to what else can we do in the rare disease space in particular, I think that patients are so eager to be able to make advances.

00;23;45;20 - 00;24;19;20

But also if you take a look at traditional data sets that we may use to do analysis for rare diseases, the data is so small that it makes it really difficult to make meaningful discoveries. And so by having patients that are eager to engage, that are advocating on behalf of themselves, or a lot of times others that they're caring for, it provides a whole new perspective that as a researcher I may not have even considered.

00;24;19;23 - 00;24;53;22

And so I think it's really exciting to see how do we start to bridge that gap between patients and scientists. I think we've done a start with that. I think the Robert Wood Johnson Foundation has started to do some of this or other phenomenal grant organizations that have bridged the gap between traditional research grants by having a focus with patient advocates on those particular grants committees or their project committees to really start to bring that in.

00;24;53;22 - 00;25;32;04

And we're starting to see health care bridged the gap as well by creating patient advocacy groups and patient support groups to be able to do that. But I think, again, digital technology is really making that difference and providing apps that can provide that support in a positive manner to patients wide and far. So you may not have your next door neighbor who may be in the same boat, but you can log on to your phone and have somebody who at a couple clicks of a button that may be able to be there to support and really create those those communities for years.

00;25;32;04 - 00;26;02;06

I can say in the diabetes space, we certainly have done that successfully. But being able to bring that to research I think is really making a difference, but also making an option for treatments to truly develop an unapproachable manner for patients. Because if I have to tell you, you've got to do these 35 steps to get to what what would improve your health, you'd probably look at me and go, When do I have time to do all of that?

00;26;02;06 - 00;26;33;06

And so really taking that into consideration and having that first hand patient knowledge is truly going to be key, I think, for continuing to improve our health overall. Well, it is actually technology that's enabling these types of new interactions, especially cloud technologies. You went through a lot of the main benefits of digital health. I know I'm going to floor everybody with this statement, but technology has its drawbacks too, so we can't lose sight of ethics, safety, efficacy.

00;26;33;06 - 00;27;19;01

And I think people still see health care as an in-person human engage. But so in what ways can or does digital supplement that human touch without replacing it? What's the right balance? I think technology has the ability to bridge the gap between inpatient care in not inpatient care, especially in situations where obtaining inpatient care is incredibly difficult. Growing up in a rural, underserved community, my parents would take half a day or full days off of work to take me to Rochester for care, and I was so fortunate that my parents had the ability to do that with their jobs.

00;27;19;04 - 00;27;57;28

But not everybody does. And so really having an opportunity to provide high touch care in a digital setting allows for folks to get access to care that they may not have. It also allows for huge improvements in care. I know in Rochester, for instance, they've got a mobile stroke unit that was having the ability for paramedics to connect with neurologists in the field to be able to reduce the door to needle time with stroke patients, which is critical because time is brain.

00;27;58;01 - 00;28;22;00

And so instead of having to get carted from your house to the emergency room and then do diagnostics to determine if you're having a stroke, that could all be done in the field. And so, yes, there needs to be oversight. Yes, there needs to be some some sort of standards. And yes, there needs to be ethical reviewing of this technology.

00;28;22;00 - 00;28;57;08

But the huge advancements that technology is is truly making for folks is is phenomenal in certainly making health care a bit more approachable. I've always struggled with the whole concept, especially coming from a middle class, underserved health care, almost health care desert in some aspects. It's so nice to be able to make that connection for patients that may have that specialty care offer without having to take hours or days off of work to get it.

00;28;57;13 - 00;29;28;28

And so being able to connect physicians to physicians or patients to physicians outside of their typical catchment area, I think is what's driving improvements in health overall as well. Well, every research, discipline and project is unique, but aren't there some commonalities when it comes to okay, pretty much everybody can use a technology like this. What are some of the biggest technology roadblocks and benefits that you see today's researchers dealing with?

00;29;29;01 - 00;29;58;25

MM I think one of the biggest blocks for research is truly getting access to high powered computing resources that they that they now need because we're collecting data and more and more and more data, it's important to have high powered computing resources to analyze it. I often joke with with researchers when I first started out, I remember getting what we called big data back then.

00;29;58;27 - 00;30;33;17

You know, it was a couple million lines of rows and my poor little laptop that was probably, you know, five years old just could not handle that. But those few million rows now are few billion rows and so it's important to have those high power computing resources to truly be able to analyze the data effectively and efficiently. And that's what I've loved about my role is really being told to give out those resources to help researchers at least break down that barrier.

00;30;33;19 - 00;31;13;05

I think some of the other barriers from a patient perspective is the multitude of different apps that are out there, the multitude of different like telehealth platforms, you name it, you know, we've got it. And how many times have we had to say to somebody, unmute yourself on Zoom as an example, over the last three years? And so I think one of the things that we've kind of got to start putting our heads around is how do we create a fully immersive research platform and what does that look like for patients, I think is I can't even tell you if you told me today, I have to download these five apps and then do this

00;31;13;05 - 00;31;31;08

and that, you're going to lose me. And I'm in the in the field, right? So think about our everyday patients that you're having to say download these five apps and click this and log stuff here. It would be nice if it was all at one click of a button, and I think we're probably not far off from that.

00;31;31;10 - 00;31;58;16

I would say I hope that we're all thinking about that in the same way, but I think that's truly going to make at least getting access as a patient to participating in research a bit more accessible, especially in the technology space. And then for researchers thinking about how can we accelerate the collaboration beyond our typical walls of our institution is also going to be key.

00;31;58;16 - 00;32;21;17

And I think technology getting away from having to share data sets on prem to being able to put things in cloud is really the wave of the future to allow researchers from around the world to collaborate, to really drive change together as well. Well, I know Oracle's been thinking a lot about research data. Like you said, it's a ton of data already.

00;32;21;17 - 00;32;41;27

It's only going to grow exponentially. That's great. We can do a lot with that data, but there is the complexity of it and regulations. So how do you see the data landscape for health care and clinical research? Are we more than we can handle or are we at just right? Hmm. I don't think we're at more than we can handle.

00;32;42;00 - 00;33;29;14

I think what's going to be really key and I think Oracle is certainly becoming a leader in this space is really to connect with the industry standards in working together with researchers to define what those standards should be as we continue to accelerate more and more data growth. I think that with all of our wearables and with all of the multitude of ways that citizens science projects can can continue to grow, we've got a lot of data, but there's also a lot more that we can collect and a lot more that we can continue to grow both both as researchers and as as patients and research participants.

00;33;29;17 - 00;33;58;11

And so I think together with patients and with industry standards and with ethics review boards, everybody can come together as to really define what those standards should look like, both within our own countries as well as internationally, so that we can all start to really make progress together. I can say, I think in the research space and this is one of the things I love the most is, you know, research doesn't really happen in a box.

00;33;58;13 - 00;34;35;19

You certainly can sit in for all room and talk to nobody and you make some small progress. But I think really benefit to research is truly through those collaborations. And so I think as industry continues to dive into this and we get new industry partners like Oracle for the cloud, you know, having them be able to be front and center in helping to learn about what needs to be done in the data space to ensure we're keeping patient data secure is in mind is incredibly important.

00;34;35;19 - 00;35;05;28

And so I, I think we can see that through some of Oracle for research is partnerships with like the Research Data Alliance as an example of really wanting to extend working groups to figure out how do we best treat genomic data, which is something that the industry is just starting to get into. Genomic data is a whole host of tons of data, but truly something that standards haven't been fully developed yet for that.

00;35;05;28 - 00;35;30;23

And Oracle's leading the charge with the research data alliance at trying to define what those standards could and should be. And I think that's going to be where we need to continue to go in the future. So closed data and open data are different things. Thus the two different names, Discovery Research thrives on open data for Explorer and reproducibility.

00;35;30;23 - 00;35;59;28

But for whatever list of reasons, data sharing in the research community is still kind of limited. Why is data sharing important for things like aligning with you? Say the fair principles, all these new NIH policies that are coming out? Yeah, so let me kind of define pain in the health care space or what allows data to be open and what allows data to be closed, because I think that's really important for listeners.

00;36;00;05 - 00;36;46;00

So open data is totally de-identified data. And what I mean by that is in the United States, we've got a principle called Hippo, and there's a, I believe, 20 some odd identifiers that include names, date of birth addresses, dates of service, etc. that can be used to identify patients. And with that, because we want to keep patient identity incredibly secure, because we don't want to share personal data when data is shared in an open space, all sorts of identifiers are stripped from the data so that you cannot track a patient back.

00;36;46;00 - 00;37;13;00

So I can't look at a data set and go, Yeah, that's me, you know. And so that is one data set includes data that is some in-between of that. And that's really defined by an individual institution or organization of what they feel their standard should be. And there's use cases for both for open data and for close data.

00;37;13;02 - 00;37;38;26

Open data is so important for reproducibility because I should be able to take a data set that Mike, you've ran an analysis on and be able to use it to repeat it so that I can say, Yep. Mike, you're your results are right and I'm going to take this algorithm and I'm going to now apply it to a new data set, and it should function the same way.

00;37;38;28 - 00;38;08;02

And that's where I think NIH is really getting at, is to be able to ensure that the research that's being done is done in an open manner so that folks can truly be able to collaborate and grow from what folks have already done. You can continue to accelerate that forward. Closed data is also super important depending on what the researcher is, is trying to determine.

00;38;08;05 - 00;38;35;15

So for instance, if we want to look at a health exposure in a given area, we may need to use closed data to look at a patient's zip code or a patient's census track to really hone in on environmental factors, for instance, in a given vicinity to be able to determine what do we need to do from a public health intervention to reduce that particular exposure.

00;38;35;18 - 00;39;18;08

So really, depending on the institution, will define what may be in that closed data set for that particular research question. We would have to have zip code, but that's something that we probably don't want to share as part of open data. So I think that's where the nuances are going to be. I think we have a lot to figure out in terms of what those standards are for open and closed and how we can come together as researchers and industry to be able to make continue make data open and accessible to people, but also keeping security and patients rights and wants protected as well.

00;39;18;08 - 00;39;41;21

And so I think that's something that Oracle is certainly exploring. And I know a multitude of folks are also exploring. And I think NIH, by putting in these new principles, are truly is truly taking a step in this direction as well. And it'll be interesting to see how we can kind of grow from there over the next couple of years.

00;39;41;24 - 00;40;02;27

Well, I can't let you go without asking about A.I. and the use of these large language models For all the accompanying caution and fear they do show promise you've probably been thinking about, okay, what does this mean for scientific research? What excites you about AI and what makes you a little nervous? Well, I'll start with what makes me nervous.

00;40;02;27 - 00;40;32;20

I think I can do a lot of things and I think we've seen I do a lot of things. And I think one of the the thing that makes me the most nervous about AI is some of the assumptions that can be inherently baked into AI models that are unintentional consequences of a particular model that may have folks come to the wrong conclusion about a certain disease or a certain entity.

00;40;32;22 - 00;41;15;10

But I certainly think AI has a whole of use cases in the health care space that can truly start to add a little new element of precision medicine to given patient care. We've got researchers that are using AI to improve image detection in colonoscopy, in MRI's, to really start to take some of the nuances which radiologists do an incredible job, but to be able to give them another tool to help them as they're reviewing more and more MRI's and all sorts of radiography in a given day.

00;41;15;13 - 00;41;43;16

And so I think AI is going to have a new set of tools for us to be able to do that from the research space. I am excited about AI being able to provide a standardized way of, for instance, analyzing tumor volumes on based on MRI's and looking at time series progression, some tumor volumes to be able to understand how a particular treatment is improving or not.

00;41;43;18 - 00;42;07;27

Particular tumor growth. So I think there's a whole host of of use cases, but I think we all need to be a little cautious and certainly look into the nuances of particular models and algorithms before we we kind of jump to fit in to make sure that we're not inadvertently making assumptions that may not be great for research overall.

00;42;07;29 - 00;42;33;02

Well, Christine, thanks so much for taking the time to be with us. Really good stuff. And what we've talked about is write down our listeners, Ali, But if they want to learn more about what you're doing or get in touch with you, can they do that? Absolutely. So folks can certainly reach out to me on LinkedIn. I’m Christine Pittman Ballard on LinkedIn, and I look forward to connecting with you all as well.

00;42;33;04 - 00;44;44;10

Very good. Well, if you are interested in how Oracle can simplify and accelerate your research, check out Oracle dot com slash research and join us again next time on Research in Action.