Research in Action

"Research in Action" explores the dynamic world of life sciences, covering drug discovery, clinical trials, therapeutic development, and the pivotal role of real-world data and technology in connecting clinical research with patient care. Hear insightful conversations with scientists, clinicians, and leaders from pharma, biotech, and health.

Exploring New Frontiers in Pharma: Mindsets, Data, AI, and Oracle 04/30/2024

Exploring New Frontiers in Pharma: Mindsets, Data, AI, and Oracle How can shifting mindsets fuel the next wave of innovation in the pharmaceutical and life sciences industry? In what ways can we ensure the vast amounts of health data are utilized securely and effectively to foster groundbreaking medical advancements? And how is Oracle's new Health Data Intelligence poised to transform the industry in an unprecedented manner? You’ll learn all that and more with our guest Michael Fronstin, Vice President and Chief Commercial Officer at Oracle Life Sciences, who has worked across nearly every area of the industry from positions at Merck to J&J to Kantar Health and now at Oracle. -------------------------------------------------------- Episode Transcript: 00;00;00;04 - 00;00;26;25 In what ways do the mindsets in the pharma industry need to change? How can we make sure massive amounts of health data is applied to practical effect? And how might Oracle's new Health Data Intelligence platform be an unprecedented game changer? We'll find all that out and more on Research in Action. Hello, welcome to Research in Action, brought to you by Oracle Life Sciences. 00;00;26;25 - 00;00;49;15 I'm Mike Stiles. And today we've got a guest who's been a veteran in the life sciences industry and who knows Oracle Life Sciences quite intimately because the guest is Michael Fronstin, vice president and chief commercial officer at Oracle Life Sciences. He's worked across nearly every area of life sciences, from positions at Merck to J&J to Kantar Health and now at Oracle. 00;00;49;15 - 00;01;11;25 So, Michael, thanks for being here. Thanks, Mike. Happy to be here and thank you so much for hosting this session. Really appreciate it. Great. Well, you know, you're the perfect person to talk to about what I want to talk about, which is changing people's minds and changing how we even approach and think about life sciences. So you've got that to look forward to. 00;01;11;25 - 00;01;34;28 But first, let's learn a little bit more about you. How did your interests and opportunities in life take you down the path that led you to where you are now? Yeah, thanks for that question. That's that's a great question to start out with. I'll tell you that as human beings, we all have something going on in terms of health care, whether it's impacting ourselves or friends or family, everyone's going through something. 00;01;34;28 - 00;01;56;25 At some point. You just don't know what the magnitude is or how long lasting, right? So having patience and empathy is so important. And of course myself, I've gone through things and unfortunately starting at a very early age of 12, I lost my best friend to the brain cancer and from the time I was 12 to the time I was 21, unfortunately, I lost a lot of people to different health ailments. 00;01;57;11 - 00;02;17;10 I guess, climaxing with losing my father when I was 21 years old. During that time, I always thought about health care and how it was impacting the people around me and wondering what could I do? And I felt pretty helpless, to be honest with you during those times, because some young boy don't there and there really wasn't anything I can do. 00;02;17;10 - 00;02;35;01 But as I got older and I went into college, I realized I could make a difference in health care. And that was going to be the industry that I was going to focus on. So I went into social sciences, became a sociologist with a business math background, and went to graduate school for an MBA in health care arbitration. 00;02;35;10 - 00;02;56;07 And that's when really things opened up to me where I started saying, okay, what aspect do I like? Where can I make a scalable impact? And I ended up joining Humana A down in Florida for a year or so, realizing that I can make a difference there and get people enrolled, help them get claims processed and paid. And from there my career took off. 00;02;56;07 - 00;03;21;02 I end up going to Merck, carried the bag and really experience the in office experience back in the days of the early nineties in terms of what patients were experiencing, seeing doctors who were really, really good and so much good at diagnosing patients and treating them in a time where most of the chronic conditions didn't have treatments available and new ones were coming out. 00;03;21;16 - 00;03;53;06 And I'll tell you, it was pretty exciting during these times being at Merck and seeing all these innovations. But I'll tell you, during that time I was really able to focus on one therapeutic area and it wasn't very scalable. It wasn't really having the impact it wanted. And it wasn't until I came to the consulting side of the business, you know, working with dozens of customers and maybe hundreds of brands over the past 20 plus years where I really felt like maybe a direct and indirect impact on people's lives around the globe. 00;03;53;28 - 00;04;16;02 So that's that brings me to today. And now I'm with Oracle Life Sciences, where I feel like it's even bigger and broader and better. So I'm excited about the present. I'm excited about the future. Yeah. You mentioned you kept repeating a phrase that kind of struck stuck with me, which is that you wanted to make a difference. Is that hard to do in the health care space? 00;04;16;02 - 00;04;39;12 I mean, have you been gratified by your ability to do that or has it always been a push and pull? Oh, interesting question. Definitely a push. And so, you know, sometimes you can you can make decisions and get them executed very quickly. Other times, it takes a while to do. You know, you have regulatory bodies that you have to deal with different types of payers around the world. 00;04;39;22 - 00;05;04;19 Decisions are always made quickly. And if it's the right decision because of various reasons, whether it's bureaucracy or internal or external, or you need to generate real world evidence modeling or even publications, we have more than 2000, maybe 3000 publications, and you develop the evidence, you submit the publication. It could take, you know, six months, a year, two years to get it published right? 00;05;04;19 - 00;05;24;14 So things just take time, unfortunately. But yeah, you can make a difference. I feel like I've made a difference. I feel pretty gratified about what I've done. And in the areas of the impact that I've made. So and a lot of it is just make an impact within your world and hoping that you can expand it beyond to make a broader impact. 00;05;24;14 - 00;05;59;11 You were at Kantar Health for like 17 years or so. How did what Kantar does align with Oracle Life Sciences and the idea behind just leveraging technology to benefit customers and partners? I'm actually coming on 19 years since we think about it and you mention it. So when I step back and think about my time at Bert or Change in Merck and the broader industry, life science clients need to accomplish three things in order to get their compound, whether new or existing compound, really the new compounds into the hands of the appropriate patients. 00;05;59;11 - 00;06;24;18 They need to get their drugs approved right by some regulatory authority. They need to get them reimbursed and they need to have a strong launch to drive awareness. Otherwise no one's going to prescribe it or patients. People aren't going to request it, right. So those three things need to need to occur. Kanter Health is really focused on the second and third in terms of the research services and expertise. 00;06;25;00 - 00;07;10;02 So the types of people are. Kanter Help are methodologies, social scientists like epidemiologists, psycho nutrition, these these are the folks that know how to design and conduct research, how to consult on the research from a Real-World evidence perspective and driving insights, evidence from a commercial planning perspective, prioritization, things like that. Where is the Oracle Life Sciences group? The other side of the group is really all about technology and applications predominantly focused on driving clinical trials for regulatory approval, of course, and in the area of pharmacovigilance during those trials and tracking them when those products are in the real world. 00;07;10;06 - 00;07;38;08 Right. Post-marketing authorization. So when you bring these two groups together and these types of people together, the technology, the medical intelligence, the scientific, methodological experience of the cancer health folks, have you got the best of all worlds, right? Technology, data experience combined. You take these wraparound services with the technology in and now our clients are able to see a much higher level of value, if you will. 00;07;38;23 - 00;08;02;25 Well, you've actually been anything but shy in the past about saying how the mindsets in the pharma industry really need to change. So what is the current mindset? And in what ways is it limiting? I'll tell you, the health care industry, including life sciences, has always been a little bit of a laggard in terms of of our movement. 00;08;03;11 - 00;08;30;15 Part of that issue is that we we operate in silos, right? And even within our life science clients or customers, the different cross-functional teams don't always come together. They don't know each other. Sometimes they buy the same data, right? So the inefficiencies of spending more budget than they need to, we're not leveraging the same data for different purposes, and we really need to break down the silos. 00;08;30;29 - 00;08;53;15 I think that from a mindset perspective, individuals on every side of the business really need to step back and pick up their heads and look around, see the big picture, understand where are we going? The data is critically important. Big data was becoming the buzzword ten, 15 years ago, but no one really knew what that B meant. Well, now it's here. 00;08;53;22 - 00;09;14;06 We could do something with big data, right? Is sort of on the fringe. Some people are using it, some people aren't, there hasn't. So this is a time where you could either bury your head in the sand because you don't understand it or you're afraid of it, or you can lean in and figure it out. And if you don't lean in, you're going to be left behind. 00;09;14;06 - 00;09;45;01 So I think we need to break down the silos. People need to step back and see the big picture. And I think they need to take risks and and lean in and it Oracle, that's what we're doing. We're committed to helping, you know, through creating open ecosystems, to breaking down barriers across teams, using our teams. And, you know, hopefully everybody will wind up picking your head up and looking at the big picture and caring more about collaboration and how these things can improve so that innovation moves forward faster. 00;09;45;17 - 00;10;06;25 Is that a realistic ask? I mean, I assume researchers are very busy with their heads down working on what they're working on. Can they can they expand and broaden their view? They have that luxury, Absolutely. It's like anything else, you just have to make the time. You got to take the time to make the time, invest the time to figure it out. 00;10;06;25 - 00;10;26;26 It's not easy. And I'm not saying it's easy by any means, but it's worth it to do. And I remember when I was a rep with Merck, you know, moving to Pennsylvania, the Home Office, the analysis, one of my problems that you get there and if you want pieces of advice when you get there, keep your head up. 00;10;27;13 - 00;10;51;11 And I said, I'm always positive. He said, that's not what he said. Look around, understand what's around you, incorporate it, immerse yourself in things you don't understand. You know, be comfortable being uncomfortable and again, new job, new new house placeholders. How do we find the time, how to figure it out? Right. And I see the people around me and our clients. 00;10;51;11 - 00;11;18;18 I see the people around me at Oracle Life Sciences. The ones who are doing that are the ones that are being most successful. Yeah, I love that. Get, get comfortable being uncomfortable. That's not something people dive into, as is uncomfortableness. But, you know, I don't care if it's industry, politics or even favorite flavor of ice cream. Getting anyone these days to change their mind or change their mindset is really hard. 00;11;18;18 - 00;11;49;09 So getting an industry to collectively think differently, that can't be easy. So what do you see as the biggest challenges to that? And is it that there needs to be some driving force for that? And is that the role Oracle's trying to play? Yeah, it's not easy for sure. All right. So some of the biggest challenges are really the cultures that are existing within and across the industry where people are so busy, right? 00;11;49;11 - 00;12;16;11 They're not set up to work. Cross-functionally The siloed nature that's that's occurring across our industry, even in between clinical care and clinical research, there are gaps. So I think all these different places are causing, you know, challenges in terms of making a difference, getting immersed and taking those risks. People aren't always rewarded for taking risks. So let's say it happens. 00;12;16;11 - 00;12;40;29 Let's say there's a shift in mindset and we're thinking more about leading with knowledge and information and looking at that big picture. What opportunities does that present for both the industry and for me when I get sick? Yeah, no, that's a great question as well. So for the industry, I think we'll be able to actually bring compounds to the to the marketplace more quickly. 00;12;41;10 - 00;13;30;00 Right. For you as an individual or us as individuals, all of us will be able to have more options, both clinical research as a care option. Right? Right now, only 3% of eligible patients participate in a clinical trial. Right. If we're able to take information and put it back in the electronic health record or h.r. System so that doctors can look at it at the point of care and make decisions whether it's about what is your care that they want to prescribe or it's about how are these products impacting you as a patient from a pharmacovigilance or really a tolerability or safety perspective, they're able to adjust very quickly right there on the fly, right? 00;13;30;00 - 00;13;51;29 They'll have more data at their fingertips, as we put it in. And that also could be recruiting patients into clinical trials. Right. So they don't know what's the inclusion exclusion criteria. Look it up. So how can you at their fingertips and knowing that this patient can just walk in the door for these patients scheduled to walk in this week, they're eligible. 00;13;52;00 - 00;14;12;02 Let me make sure that I talk to them about that so that they have other options that will help them get well. Yeah, So it's a good payoff. Your answer to this can be Mike, why don't you just mind your own business, but ask Oracle recently combined their Oracle Health and their Oracle Life Sciences divisions. Why did they do that? 00;14;12;11 - 00;14;37;06 Well, I'll tell you, I won't tell you to mind your own business. This is sort of the the biggest payoff I think we're seeing is movement that we've seen in health care. So the acquisition of Cerner by Oracle was just enormous. And it Cerner, these are your cancer health group is part of it really also was a big deal, right? 00;14;37;12 - 00;15;06;10 Because now we can take what's happening in health, in the clinic, in the hospital, in the offices and combine it with life sciences. Everybody has the same goal, which is to save lives or to increase quality of life of patients. But both of these groups, the hospital systems around the world and the life science companies around the world, they're not connected, right? 00;15;06;10 - 00;15;40;22 They want to be connected. They want to intersect, but they're working in silos, trying to influence each other when they both have the same goals, which is to save lives or help people. And now with Oracle Health and Oracle Life Sciences being under not only the same umbrella of Oracle, but under the same leadership in terms of team of firms, we're able to break down the silos so that we're able to share the appropriate data and information in an open equal ecosystem in bi directional way. 00;15;41;11 - 00;16;09;04 And while these two groups are deeply intertwined, yet this distinct, if you will, there are innovations there that we're looking at that will help everybody that some of the migrations celebrate recruitment, sharing of data, point of care decisions, things of that nature. So it's about turning data into information, that information into insights with some kind of open, intelligent, cloud based platform. 00;16;09;27 - 00;16;39;24 There is the problem, though, of drowning in data, but starving for insight that's applicable to so many businesses across so many industries. How would the ecosystem that you just described keep life sciences customers from drowning in data that is never used for practical effect? They're absolutely drowning in data. There are more data sources existing secondary data sources in the industry and across the world today. 00;16;40;05 - 00;17;12;02 The majority of these like probably 98% of them are not unified, they're not connected, and interoperability is lacking. Credit card companies figured it out a long time ago when healthcare has and we're starting to get there. Training unified platform of data Health data intelligence platform is what we call it in Oracle, backed by the Oracle cloud infrastructure. So you have data that's very sensitive sovereignty of nations, you're using it. 00;17;13;04 - 00;17;58;11 And of course OCI, Oracle Cloud Infrastructure affords the opportunity for security and speed and all these other benefits. So the more of tokenization we could do to connect the charged with other h.r. Claims with patient reported outcomes survey. The more we can do that in standardized ways with the right governance will help our clients sort through this sea of information so that we can and will help them, of course, you know, focus on what's important, you know, and use A.I. to define the trends in predictive analysis, what predicts better or worse outcomes. 00;17;59;01 - 00;18;21;22 So it's going to take time. We're getting there. We're already making a lot of progress, but I think that's now how we're going to help our clients get there. Well, I did ask about the obstacles of changing overall mindsets, but what are the remaining obstacles to actually building and implementing this eco system that you're talking about? Are there remaining tech obstacles? 00;18;21;22 - 00;18;50;01 Are there privacy issues? I mean, what's what's there that's making this a tough job? Not only we drowning in data, we're drowning in obstacles like that. So certainly you know, that's an obstacle of legalities around the world. Cultural changes and mindsets. Like we mentioned, there's governance. Who owns the data? We get data right to the data technology. Then we go back to that for a second. 00;18;50;11 - 00;19;13;28 You know, how do we connect from one system to the other? I do believe there's still 300 EHR systems out there. The interoperability, governance image. I mean, we're just not sure about. Also, we got to kick them off one at a time. And you know what we're doing at Oracle and Oracle Life Sciences is we're partnering with a lot of different organizing that's out there. 00;19;14;06 - 00;19;50;17 You might have seen our partnerships with the video code here. Johnson Labs, from algorithms, Perspectives. We're partnering with a lot of other organizations to help chip away at these... /episode/index/show/researchinaction/id/30767298

Unlocking Innovation Through Public, Private, and Academic Partnerships 04/16/2024

Unlocking Innovation Through Public, Private, and Academic Partnerships What are the best ways to set up public, private, and academic clinical research partnerships? How do we get these public-private partnerships (PPP) to work most effectively? And who should be in charge of what in multistakeholder research collaborations? We will get those answers in more in this episode of Research in Action with our guests Rob King, President and CEO of FHI Clinical; and Dr. Kristen Lewis, Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH. --------------------------------------------------------- Episode Transcript: 00;00;00;01 - 00;00;22;22 What are the best ways to set up public-private clinical research projects? Where does and should the money for such research come from and who should be in charge of what? We'll get those answers and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences. 00;00;22;22 - 00;00;50;05 I'm Mike Stiles. And today we're just trying to outdo ourselves by talking to not one, but two very interesting people. First is Rob King, president and CEO of FHI Clinical. FHI uses Oracle's clinical trial software for their clinical operations and partner with public entities like PATH, which brings me to Dr. Kristen Lewis, who is Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH. 00;00;50;26 - 00;01;29;23 I could go through what each of these organizations do just to hear myself talk, But why do that when I have both of you here? So, Rob, tell us what FHI Clinical does. Yeah, I think Mike, so clinical in a contract, they were actually for profit and hearing of a large nonprofit called F8 had three ethically and while we are for profit empathy, our mission is to address unmet research needs and maximum social impact pouring into development of medical treatment around the world. 00;01;30;04 - 00;01;58;20 While we work globally, we tend to focus on the low and middle income country on the whole pharma and biotech client are also include nonprofits and government. Empathy. Well with biotech receive public funding and path having him be one of our client. Appreciate Kristen being here arguing that four years ago and I'm currently the CEO and I'm happy to be here. 00;01;58;20 - 00;02;22;19 Well great. Kristen what about PATH? Yeah, thanks for the introduction, Mike. It's a pleasure to speak with you and Rob today and have the opportunity to contribute to this discussion. So most people listening to this podcast may not be familiar with PATH. We're a nonprofit global public health organization with approximately 1600 employees worldwide. Our headquarters are in Seattle, Washington, and we have offices across the African and Asian continents and Europe. 00;02;22;19 - 00;02;53;00 Some of the locations we have offices in include Kenya, Ethiopia, Senegal, Uganda, Zambia, India, Vietnam, Ukraine. And I could go on, but I'll I'll hold hold it there. Our mission is to advance health equity through innovation and partnerships. We do this with the help of local and global partners by generating evidence, advancing innovation and strengthening local capacity to improve health in countries and communities that are experiencing disproportionate burdens of disease and barriers to well-being, specifically in low and middle income countries. 00;02;53;11 - 00;03;26;01 This includes working in over 70 countries across the African, Asian, Latin American, European and North American regions. Within Paths Center for Vaccine Innovation and Access, we drive the mission of achieving health equity using a three-pronged approach, including developing, facilitating and implementing global market and policy solutions to ensure sustainable supply and equitable access to vaccines. Supporting country led efforts to advance national health equity priorities, and to strengthen immunization system resilience and driving innovation and technological advances. 00;03;26;01 - 00;03;50;20 To accelerate and optimize access to vaccines. Now, this last point is where my work is focus. Thus, during today's discussion, I'll be speaking with the lens of developing vaccines for disease indications benefiting low and middle income countries, and the importance of public private partnerships in achieving that goal. And just to note, you'll note a common thread there in the introductions from both Rob and myself, and that's the low and middle income country focus. 00;03;50;20 - 00;04;15;17 And I think that you'll start to hear some commonalities come into play as we go further into this session. Great. Well, I think what I want to get into here is kind of what you talked about is the value of public private partnerships in clinical research. Rob, give me the honest first reaction that a lot of private companies have when it is suggested that they partner with a public or a government organization. 00;04;15;17 - 00;04;45;18 Is that something that they jump at with open arms or is there any hesitancy? How does that go down? You know, with recently reading an article about one of the first public private partnerships and it was how mail really hit home, like, you know, for most of our listener, what most people won't be familiar with are the initiative around vaccination for diseases like polio and Spanish flu, MENA and rubella. 00;04;46;00 - 00;05;33;19 And we tend to have short memories. And they and the devastating impact they've had on society prior to vaccination and treatment options or with also that treatment developed over HIV and AIDS and then most recently the COVID pandemic. So with that said, you know, private companies maintain the shy away from what we call the triple P public private partnership in the funding limitations that my, you know, government based funding required a lot of compliance when the whole myriad of regulations and public kind of activity may have restricting how and where or how and when fund your, you know, without experience are now horsepower in the public private partnership. 00;05;34;07 - 00;06;09;21 It creates see private companies to engage and may see growth for example will not serve as a prime contractor on government funding work because when you're in the accounting and you're when the regulatory compliance and you'll only see those of normal commercial contracts, therefore they can turn them and be overly burdensome for those companies to pay. And public private partnerships, you have to have an operational model that meets the unique need of that partnership. 00;06;10;03 - 00;06;36;15 And at the end of the day, you really can't you can't get value for society that public private partnerships have contributed to. And Kristen, from the nonprofit or public side, what what is the benefit of partnering with private companies? Yeah, that's a great question. And I think to answer that, I'd first like to highlight some of the major successes when these partnerships have come together. 00;06;37;04 - 00;07;05;23 PATH has played through public private partnerships. PATH has played a critical role in some of immunizations, created successes over the past 30 years in lmics low and middle income countries. This includes developing the world's first malaria vaccine, which has now reached more than 2 million children, eliminating meningitis epidemics in Africa following introduction of the A4 backed vaccine protecting over 300 million children from Japanese encephalitis, vaccinating millions of girls against HPV. 00;07;06;06 - 00;07;33;20 And I could go on. But those are some some highlights. Path has not achieved these accomplishments in isolation. These successes have been catalyzed via public private partnerships models, and they're examples of which the private sector alone may not have been interested in developing these indications. These vaccine indications for low and middle income country use due to financing or budget considerations or constraints or some of the points that Rob made earlier. 00;07;34;00 - 00;08;03;13 However, with partnerships between PATH and private entities, including finance mechanisms for rollout and use of the vaccines in the regions following development, we've been able to champion development and introduction of vaccines that might not usually have generated sufficient interest for the investment that's required for full development. So in a nutshell, public private partnerships are the bread and butter of our work and integral to the goal of achieving improvements in global public health among populations facing economic challenges worldwide. 00;08;03;24 - 00;08;43;19 Well, so it feels like these partnerships would automatically create multiple stakeholders. So, Rob, how hard is it to make sure that the goals and priorities are aligned amongst all these people and stay aligned? First, I think I have a, you know, expectation and the goals are higher for public private partnership and for commercial initiative. You know, eight you public five, there is an expectation that you're going to achieve the goal or outcome and you're held accountable for how those on her spent. 00;08;44;11 - 00;09;27;10 You're not accountable to a or stockholder, but general public. And you know, public funds are unlimited and there are every dollar may account for whatever goal they're trying to achieve. And we're spending public funds a buying or accounting of how this on her being spent and her limitation on this on and how there may not be extra funds or reserve goes back to if those funds start to run low and usually the public entity defines the impact and the work that has to be completed in ensuring that the funding is in place. 00;09;28;01 - 00;09;53;24 And they then tracking the work that the private company may have contractually in their you mean clear terms on what's being delivered and the restrictions that may or may not be around the funding for that deliverable. So I you agree that saying, though, priorities are paramount because of the fact that we're accountable to the end of the day, to the general public. 00;09;54;09 - 00;10;29;01 And Kristen, is there anything on the public or nonprofit side that's done to kind of make sure that projects aren't subjected to red tape or bureaucracies? I mean, I guess there's always going to be some of that, but to the extent that would might slow things down. Yeah, it's a great question, an interesting and insightful one. So Path we work as a clinical development partner and hold sponsor sponsor roles to implement clinical trials and generate evidence to support vaccine licensure, W.H.O., Prequalification and decision making for vaccine Introduction. 00;10;29;11 - 00;10;51;09 And our work spans the entire vaccine development and delivery lifecycle. And with this broad set of objectives, in order to achieve the aforementioned successes, we have worked with the same urgencies and efficiencies as our private counterparts. From a private lens, there seems to be a perception that the public sector does not come with the same development pressures as the private sector. 00;10;51;19 - 00;11;22;13 In other words, there seems to be a perception that the public sector works slow due to many policies or rules or paperwork, or is generally lacking a sense of urgency, if you will. Now, I don't have that experience working in government, so I can't comment on that side of things. However, in my experience working in vaccine development with a non governmental nonprofit for the majority of my career as well as a few years working for a for profit entity, I can comment that the intensity of work at a nonprofit has been similar to the intensity at a private entity. 00;11;22;26 - 00;11;46;09 While the root of the development pressures may be slightly different. The goal is to develop products as efficiently as possible, while also retaining high quality remain in both sectors. For private entities, I believe the term may be, quote, time as money and quote as a driving consideration. While for my work in the nonprofit space, what drives us is, quote, time is lives, unquote. 00;11;46;14 - 00;12;17;20 And that is really the driving consideration. But regardless of those driving considerations, there's still urgency and sense that we need to be as efficient as possible and ensure that we aren't were removing blockages, red tape, bureaucracy as much as possible. So, Kristen, I'm curious, just from your point of view, when the pandemic came down, that was an entirely different animal in terms and the need to get something done and get something done rapidly. 00;12;17;25 - 00;12;48;23 Just how different a process was that? Yes. So I wouldn't say that the process was necessarily different between the public and private side. I would say that we did things across both sectors in a a new way. So the COVID pandemic really brought home how there are many similarities between the public and the private sectors. Not everything differs according to operating model. 00;12;49;01 - 00;13;14;16 In fact, during the pandemic, the global public health and product development safe spaces, regardless of the type of sector, were going through the same waves of initial shock and uncertainty and how to continue the trials during the very initial stages of the pandemic considerations in terms of the risk benefit tradeoffs of operating non-covid interventional trials during that time, and depending on the type of trial availability of remote technologies and a product's importance to saving lives. 00;13;14;27 - 00;13;38;24 We had to take into consideration different ways and methods for making sure that those Non-covid interventional trials were completed. We also were involved with needing to identify new ways of getting the work done, which included catalyzing a more definitive shift towards identification of local partners that were in close proximity to the trial locations for ease and trial oversight and management. 00;13;38;24 - 00;14;04;12 Implementing remote solution for activities such as source, document verification, remote training, remote site assessments and other types of remote activities, identifying how to get supplies or equipment to the sites ahead of study. Start with supply chains being disrupted and finally determining how to maintain the trials and keep them running once up and going while continuing to deliver with with high quality and ensuring participant safety. 00;14;04;24 - 00;14;30;10 So from Passent, given our work is primarily focused in low and middle income countries, many of the challenges faced in the private sector high income market were further exacerbated due to the relatively slower adoption or uptake of technology surgical clinical trial advances. And this experience was important as it pushed for adoption of technologies that had been previously questioned due to fear of loss of data or other concerns, as with other areas of our lives. 00;14;30;11 - 00;14;56;28 COVID really helped to push the envelope in terms of finding new efficiencies and ways of getting things done. Rob When a partnership like this comes together, I guess this goes along with the expectation setting side that you touched on earlier. How are the roles and responsibilities assigned? I say that in the triple P or public private partnership it really different in that respect as compared to commercial partnership. 00;14;57;25 - 00;15;41;11 You know, the earlier the public finds an objective and a private is to execute that. Now the public entity may only outsource part of the work because they already have the skills and knowledge and the resources themselves. And then they will only outsource the pieces that they can't do themselves. But I think the main thing to keep in mind when a public private partnership is that the public entity, a steward of the public interest and liability and accountability for that public interest lies with them regardless of whether they outsource or not to a private company. 00;15;41;11 - 00;16;05;12 So I feel bad for Kristin and the pressure that they have on them as a public entity compared to myself and her private empathy, where I don't necessarily feel the same pressure we have. Some people might think that the role of public funding is just to get the project more money. You know, we tell you what we need, you go get it for us, and that's your role. 00;16;05;12 - 00;16;28;04 How true or not true is that, Kristin? Yeah. You point out an important consideration for pairing public funding with private resources. There is the potential that private entities may believe that we, the nonprofit, will help bring in key funder resources to augment a development program regardless of their development goals, in alignment with the use of the product in low and middle income countries. 00;16;28;13 - 00;16;54;25 However, in order to mitigate the potential for this misalignment within PATH, we focus on partnering with private entities. When there's clear alignment between Path's mission and the mission of the private entity. Additionally, this alignment has to be in writing agreed to via contract. It includes global access agreements for product availability and use. And so in summary, my experience has been that it's not true that the goal of public funding is to get the project more money. 00;16;54;25 - 00;17;16;10 The goal of public funding is to achieve an outcome that might not otherwise be achievable, given lack of private interest without the public funding to come in and co-fund an objective that benefits low and middle income countries. So we've got public and private represented on this episode with the two of you. What we don't have is someone representing the academic side. 00;17;16;10 - 00;17;45;27 Rob, do you have any thoughts on the role that that third leg of the stool plays or should play? Yeah, you know, there are academic institutions that also have private public anything in and out where I have a lot of admiration for the role of peer academia, Both public and private institutions rely on academia being a catalyst for innovation and providing health very specific areas of research. 00;17;46;24 - 00;18;13;00 There are a lot of academics out there. They're doing very research and I never know when that point of time in in hand. So at every level we rely on our advisory or academic consultant to keep us informed on very specific events or therapeutic topics. And this plays into whether the research into them or not that we intend to do. 00;18;13;10 - 00;18;51;08 And there's a large portion of investigator and key opinion leaders involved in research actually come from academia. On the flip side, academia also relies on public private partnership to bring their ideas into the research environment because they lack the funding to paint the vision or the technical knowledge on how to bring that idea to the next step. You know, I think the example that perhaps a lot of people have heard of are the bar industry days and Loreal, which is the Biomedical Advanced Research and Development Authority. 00;18;51;24 - 00;19;35;13 They host annually this event where people come in for ideas, for collaboration in partnership with US funding, and so they have it. So for them, the novel idea that aligns with the interests of the US government and they get the opportunity to collaborate with other companies that can bring that into fruition as well with funding behind it. So I think there are a lot of opportunities out there for academics to bring the right into fruition, but we have a great job of sort of pulling them in the right direction. 00;19;35;28 - 00;19;58;14 Kristen, I have to tell you, as a as a layperson, I kind of... /episode/index/show/researchinaction/id/30767178

Advancing scientific discovery with patient-led research 03/19/2024

Advancing scientific discovery with patient-led research How can patients and their families become more integral in the clinical research process? How can patient-led research become more accepted in the scientific community? How are inspiring groups forging new, collaborative paths for science and medicine, and reshaping how medical research is conducted? We will tackle those questions and much more in this episode with Amy Dockser Marcus, a Pulitzer Prize-winning journalist and author of the recently published book, “We the Scientists: How a daring team of parents and doctors forged a new path for medicine.” Amy is a veteran reporter at the Wall Street Journal and won her Pulitzer Prize for Beat Reporting in 2005 for her series of stories about cancer survivors and the social, economic, and health challenges they faced living with the disease. She has covered science and health at the Journal for years, and she also earned a Masters of Bioethics from Harvard Medical School. -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;24;19 How can patients and their families become the centers of research? What is open science and who are citizen scientists? We'll explore those questions and more on this episode of Research and Action in the lead in. Hello and welcome back to Research and Action, brought to you by Oracle Life Sciences. I'm your host, Mike Stiles, and our guest is Amy. 00;00;24;19 - 00;00;48;22 Dr. Marcus That's right, that Amy Marcus, the Pulitzer Prize winning journalist, reporter at the Wall Street Journal, a Pulitzer Prize, was won for her series of stories in 2005 about cancer survivors and the social and financial challenges of living with cancer. Her beat, as you would imagine, has long been science and health. And she holds a master's of bioethics from Harvard Medical School, and she's an author. 00;00;48;22 - 00;01;04;26 Her book is We The Scientists How a Daring Team of Parents and Doctors Forged a New Path for Medicine. So this should be interesting as we talk about collaborative, open science and the rise of citizen scientists and patient led research. So thanks for being with us, Amy. 00;01;05;01 - 00;01;06;22 I'm happy to speak with you today. 00;01;06;22 - 00;01;26;29 Great to have you. In your new book, you take readers through some really, frankly, heart wrenching experiences that patients and their families have gone through with a rare and devastating disease called Niemann-pick. Hopefully I'm pronouncing that correctly. Tell us about the book and that disease and what fascinated you about this story. 00;01;27;14 - 00;02;01;21 The origin of the book really is a personal story, which is my mother got diagnosed with a rare type of cancer. And when I tried to do research on her behalf, I started to learn how challenging it is to develop drugs for rare diseases. After she passed away, I took some time off from the Journal. I had a research grant from the Robert Wood Johnson Foundation and I started traveling around the country looking to see if there were new models that might accelerate drug discovery. 00;02;01;29 - 00;02;25;21 And during the course of that research, I was introduced to a group of parents whose children have this rare and fatal genetic disorder, NIEMANN-PICK type C disease. It's a cholesterol metabolism disorder, so the cholesterol doesn't get out of the lysosome and that compartment in the cell and it starts to build up and it causes all kinds of problems. 00;02;25;21 - 00;02;52;12 And the children eventually lose the ability to walk and to talk and to feed themselves. But the parents that I met wanted to do something novel. They had found a group of scientists and researchers and clinicians and even some policymakers in the government that wanted to work together as partners and to see if they could accelerate the search for a cure or an effective therapy for an epic disease. 00;02;52;19 - 00;02;58;11 And they let me follow along during the course of that partnership for over ten years. 00;02;58;24 - 00;03;05;24 That's amazing that you got that kind of insight. And what did you learn over the course of that ten years? 00;03;06;22 - 00;03;34;15 Well, I was really interested in how they saw the production of science in a different way. They all wanted to try to save or extend the children's lives The disagreements lay in. How do you go about prioritizing drugs? What amount of risk is a patient or a patient's family willing to take compared to the level of risk that a doctor or scientist wants the patients to take? 00;03;34;15 - 00;03;54;14 These sorts of tensions arose, I think, in part because they were modeling a new method of where the patients expertise was considered as valuable or even at the center of this of this project. And that's not usually how it is. 00;03;54;14 - 00;04;09;09 But that's rare, right? I mean, in our in the culture of our health care system, it's not really common that the patients input or the patients families input is invited at all. 00;04;09;19 - 00;04;34;11 Yeah, I think that that you're right about that. I mean, the traditional way of setting things up is that the scientists devise the hypotheses and they then construct trials in conjunction with clinicians and sometimes with pharmaceutical companies, of course. But in this particular collaboration that I was describing, the drug was not in the hands of a pharmaceutical company. 00;04;34;11 - 00;04;59;06 It was widely available. And so the partnership was truly about, you know, going to be conducted at the NIH. And therefore it gave the parent and the families, I think, more leeway to do this experimental idea. What if we all recognized each other's expertise? What if we all saw each other as equal partners? What if we got to weigh in? 00;04;59;13 - 00;05;20;24 Not in once. You've already set up the clinical trial, but at the very, very outset, when you're simply going through the scientific literature to come up with potential compounds, when you're thinking about what might work, when you're trying to prioritize what to do first, second and third, all of those things where patients don't always have a voice. But in this case they really did. 00;05;21;07 - 00;05;43;16 You know, we just had Hilary Hannah Ho on the show. She's secretary general of the Research Data Alliance, and we talked about open science and open data and how important all that is to getting the scientific breakthroughs that will actually help people and get to those breakthroughs faster. But open science can kind of be polarizing. There's some confusion around what exactly it means. 00;05;43;23 - 00;05;48;14 How would you define or describe open science and citizen scientists? 00;05;48;27 - 00;06;34;22 Yeah, I think that's a really good point, that there isn't one sort of accepted name and that there are many names and people use different phrases when they're thinking about different things. For me, I used the term patient LED research and I often use the term citizen science. And what I meant by that was, again, what we've been talking about from the outset, which is a recognition that the patient, the patient experience should be at the center of everything, a recognition that the patient and the families are experts, that they have the ability not only to be beneficiaries of scientific knowledge, but also creators of scientific knowledge. 00;06;34;27 - 00;06;46;15 And to me, that shift the idea that you can be a creator of scientific knowledge is the fundamental one that needs to happen if we're going to really reach the goals that I think we all want to reach. 00;06;46;29 - 00;07;11;10 So here's something we highlighted in your book. Quoting here Science is inherently a social enterprise. Yet too often scientists operate behind closed doors, removed from the very people they intend to help. That's struck me as kind of a mike drop statement with a lot of truth to it. But did the pandemic change anything? Was the work still removed from those patients on ventilators and ICU? 00;07;11;20 - 00;07;52;04 So I do make a point in the book to draw some parallels between the various patient led research movement experiences that I describe and the COVID 19 pandemic, and in particular the group of patients that call themselves long COVID patients, where they're suffering symptoms for many, many months. I argue that COVID allowed us in real time to to recognize that anyone can be an expert and that now that is something that it was easier to see during the pandemic because there was a novel virus, there weren't established experts yet. 00;07;52;14 - 00;08;25;28 And so while doctors and scientists and the government were scrambling to try to help patients, I think they also saw themselves for the first time as part of this effort to understand the disease. Together, there wasn't already an understanding of COVID 19. And so what I say in the book is that we can draw from from that experience and sort of take that part of it forward where we say patients should be at the center of things. 00;08;26;06 - 00;09;07;01 Patients are experts. Patients are able to identify things that many scientists or doctors didn't have time to recognize because they were they had to focus on trying to save lives and, you know, working in a vacuum at that point. So there also was a sense of urgency. Like one of the things that I was struck by during the pandemic as a as a science reporter was that scientists were able to put their papers online right away on these websites before it had gone through the full peer review process because it was recognized is so essential to get this information out there as quickly as possible. 00;09;07;09 - 00;09;29;16 And everyone understood that maybe there were going to be some mistakes. It wasn't fully vetted, but it was out there. Not only was it publicly available to the doctors and scientists who are also studying it, it was publicly available to patients and people who are simply interested. And long COVID patients organized themselves, did research on themselves, and they also published their papers on these websites. 00;09;29;16 - 00;09;43;22 I think those types of models where patient researchers can be contributors and can benefit from the information to fuel their own research, I think that should move forward and is it shouldn't be just a relic of the COVID 19 pandemic. 00;09;44;07 - 00;10;05;03 But what isn't there a risk of chaos a little bit? Because we're always told, hey, whatever condition you have, don't go Googling it on the Internet. You'll just go down a rabbit hole and, you know, worry about all these conditions that you may or may not have. So what is the risk of, like you said, mistakes and wrong information being published? 00;10;05;13 - 00;10;27;11 Well, even the traditional peer review process in science publishes papers that turn out to have mistakes in them. Papers are retracted all the time. And there is a well-known phenomenon that peer reviewed papers sometimes the results can't be replicated. I mean, that's the problem for science. I don't think that's a problem just for having patient researchers get involved. 00;10;27;28 - 00;10;54;27 I also think that the advice not to Google something is both old fashioned at this point and probably unrealistic given that almost all of us are connected in some way through the Internet. My sort of idea, rather, is that let's use the Internet and other methods to become better partners. Let's share good quality information online that people have access to. 00;10;55;06 - 00;11;20;20 Let's form partnerships where we can collaborate, where among experts, the people that I was talking to and interviewing and spending time with the parents, they weren't saying, Hey, we're trying to go it alone. We know everything. No, the opposite. What they were saying is we have very relevant and valuable information. We are experts because we live with this disease and we know what level of risk we're willing to tolerate. 00;11;20;20 - 00;11;43;28 And we do our own research. But we need partners who can also help us fill the gaps where we don't have knowledge. We want to collaborate with scientists, we want to collaborate with clinicians treating our children. We want to collaborate with government scientists who have access to data and and robots and things that we're not going to have in lab equipment that we don't have access to. 00;11;44;06 - 00;12;02;19 So no one's saying, go down a rabbit hole by yourself. What people are arguing is let's find ways to pool information, and by pooling everyone's information, we can sort through more quickly what's good, what we think is good, but might turn out not to be good later. And what can benefit all of us. 00;12;03;04 - 00;12;20;02 Yeah, and from a technology standpoint, gathering that data and organizing it and working with it is becoming more possible than ever. COVID should have scared our health system out of its mind. Did it? And is that leading to any systemic changes in science and health? 00;12;20;15 - 00;12;46;19 Well, I'd like to focus on what my book was focusing on, which is can a group of patient activists and scientists and clinicians and government policymakers working together make changes to the system? And I think the answer is yes. You can make changes to the system. The patient researchers that I was talking to and the families I was talking to, they built on activist patient work that had gone before. 00;12;46;19 - 00;13;10;06 And there have been responses in the past. HIV activists were able to influence the FDA to pass the accelerated approval rule that now allows drugs to be approved more quickly. And I think that, you know, compassionate use program that FDA has the patients in my family, the patients in my book and the families benefited from that as well. 00;13;10;17 - 00;13;48;01 So there have been changes along the way. But I think what my book is arguing for, and I think this message came out of the COVID 19 pandemic as well, is that even with all the changes that have been made in the past, the patient experience is still not at the heart of the system. And I think that's the message that all of these families are saying put the patient experience at the heart of things, and then you will see that the system, when you configure the system around the patient centric experience, you'll see that it will work in a different way and an I think, a better way. 00;13;48;02 - 00;13;50;02 But we need to run that experiment. 00;13;50;17 - 00;14;12;20 So we mentioned the concept of citizen scientists. That's what we've been talking about. These are people that pursue what they pursue, driven by mostly love and urgency for their kids, which is just a whole different level of motivation than most researchers have. I think you have a few stories about, you know, people like Chris and Hugh Hempel and and some others that went through this experience. 00;14;13;02 - 00;14;34;21 I want to make a point here that I think also is really important for people to understand who are listening to this. The parents in my book and you know, you cited Chris and Hugh, they were definitely among the pioneers who did this. And there was Phil and Andrea Morella, and there were also Darrel and Mark Poppea who are who are part of this, too. 00;14;34;21 - 00;14;57;29 And many, many other parents. I mean, the Parseghian Research Foundation and the National Niemann-pick Disease Foundation, all family driven. The people who are doing this. Yes, they are driven by their love of their children. They are driven by a sense of urgency. But they're not going to the FDA and saying, Hey, please pass and approve a drug because we love our children. 00;14;58;05 - 00;15;24;05 Please pass and approve a drug based on our emotion. No, not at all. They want to give effective drugs to their children. What they are saying is we are creating scientific knowledge and we think that that should be part of this approval process, that should be part of the drug development process. I just want to give some examples that I cite in the book where the parents were creators of scientific knowledge. 00;15;24;24 - 00;16;07;11 You had parents who read the scientific literature, published scientific literature, called up. The scientists interviewed the scientists came up with hypotheses themselves that they proposed to scientists, contributed to the two scientific experiments, coauthored papers that were published in the peer reviewed scientific literature. You know, went to the NIH regularly to have meetings where they helped contribute to assessing and prioritizing which compounds should go first in terms of advancing them into clinical trials, contributed their thoughts on the risk benefit analysis in devising the clinical trials. 00;16;07;22 - 00;16;34;28 One of the parents went to an FDA sponsored workshop for how to file an orphan drug designation, which is part of the approval process and the long process to getting approval for rare disease drugs. And went to the workshop, participated in the workshop, presented scientific data to the regulators, met with the regulators, and earned an orphan drug designation for one of the compound Cyclodextrin that got moved forward. 00;16;35;07 - 00;16;46;24 So yeah, they have a sense of urgency and yes, they love their children and want to save their lives, but they're producing real scientific knowledge and I really hope that that people take that message away from reading the book. 00;16;47;10 - 00;17;08;15 So those are great examples of exactly what citizen scientists do that sets them apart from just patients who are not doing that level of research, that depth of research. You talk about Chris Austin and the book, and I'm going to read another quick excerpt here, The Promise of Genetics to Deliver new interventions, new drugs and new treatments for patients is not going to happen. 00;17;08;15 - 00;17;27;28 Chris told his boss, unless there's some way to get through the valley of death. Francis gave Chris a green light to pursue his vision. So the boss in that excerpt is former National Institutes of Health director Francis Collins. What is the Valley of Death and Chris's role in citizen led research? 00;17;28;06 - 00;17;54;21 Great. No, that's a great question. So Chris Austin is a Harvard Medical School trained neurologist, also with a background in genetics who worked at pharmaceutical companies as well, and then found his way to the niche where he worked for Dr. Collins and became also a... /episode/index/show/researchinaction/id/30084543

Bringing clinical research into everyday patient care 03/05/2024

Bringing clinical research into everyday patient care 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: 00;00;00;01 - 00;00;25;21 How can an extensive collection of real-world data help find diverse participants for clinical trials? Are some organizations already using the concepts of a continuously learning ecosystem. And what are the biggest remaining challenges to patient record standardization and personalized health care? We'll find all that out and more on today's Research in Action episode. 00;00;27;05 - 00;00;47;23 Hello and welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles and our guest today is Dr. Lu de Souza, vice president and executive medical officer of the Learning Health Network, which is a division of Oracle Life Sciences. In a nutshell, Dr. de Souza leads a team that seeks to help health organizations integrate clinical research into everyday care. 00;00;48;03 - 00;01;11;28 That means addressing clinical discovery, cost time and patient inequities. She's also a huge advocate for real-world data, 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. 00;01;12;12 - 00;01;16;03 Dr. de 'Souza, thank you so much for taking the time to be our guest today. 00;01;16;14 - 00;01;20;12 Now Thank you, Mike. It's really a pleasure to be here. And please feel free to call me Lu. 00;01;21;02 - 00;01;29;21 There's a lot of ground to cover here. But first, let's just find out about you. What was the life path that brought you to where you are today and doing what you're doing today? 00;01;30;15 - 00;01;55;05 You know, as you mentioned, I am a pediatrician who focused on taking care of sick kids in the hospital and the emergency department. And I really loved my job. But like many doctors, I felt frustrated by the inefficiencies of health care. And I felt very frustrated with the limitations of time and data that we suffer both of those things are super essential to make the fast decisions that we need to make. 00;01;55;23 - 00;02;16;20 So I started thinking about technology and the role that it could play in solving some of these foundational issues. And also, you know, we always want to see how many more patients we can help. So I felt like the pivot would allow me to take care of patients in a different way, but at higher numbers. It was not easy decision. 00;02;16;20 - 00;02;41;20 It was very hard for me to leave full time pediatrics, so much so that I stubbornly continue to practice for the first ten years that I was full time at Cerner. But at the time that I was considering joining Cerner, my mother's breast cancer was misdiagnosed and that happened because of inequities, fragmentation in care and a lack of standardization that exists today. 00;02;42;00 - 00;03;08;03 Eventually, she turned out okay with that. But these missteps and delays in diagnosis led to a much more aggressive course of treatment and the complications that came with it. But this experience really sealed the deal for me. I felt like there was a lot of work that I could contribute to so that led me to my career in informatics that started with EMR implementations and technology enabled process improvement. 00;03;08;28 - 00;03;30;25 Then ten years later, my cancer warrior mom was diagnosed with a different cancer. This one was rather rare and aggressive, and we quickly found that there was not enough research to support any specific type of treatment for her and that the survival rate for anything that they could try was pretty low. And that was not good enough for her. 00;03;31;07 - 00;03;57;05 She decided to forego treatment and instead focus on having better quality of life for the remainder of the year that she was with us all of nine months. In stories like that, Mike, are super common. Many of our listeners, I'm sure, have gone through something like it and as devastating as it is, these life experiences also help shape us and they bring these opportunities that we hadn't considered. 00;03;57;19 - 00;04;25;17 And sure enough, only a few months after her passing, the Learning Health Network was founded and I was asked to help out and I was immediately drawn to its mission and vision and the impact that it could have in cases like my mom's. So it took a little bit of time to get here. But last year I was able to take on a full time role with Learning Health Network, and I'm just super excited to be a part of this awesome team that brings transformation to research. 00;04;26;07 - 00;04;29;03 Okay. And tell us what the Learning Health Network is. 00;04;29;09 - 00;05;01;06 All right. So I'm going to start with the why and why it was created and paint this picture for for everyone to understand how important this is today. Clinical discovery. So how we get to medicines and treatments and different diagnostics is still a major challenge for life sciences and health care organizations. And because these two sectors of our industry are mostly siloed from one another, it's a very onerous process for patients and providers to participate in clinical trials. 00;05;02;01 - 00;05;27;13 Even myself as a doctor who understands the language of medicine had a really hard time finding out what types of trials were available to my mom, just as an example. So for context here, when we're bringing a new drug to market, it takes approximately 17 years and it costs an average of $2.5 billion. That those are crazy numbers, right? 00;05;27;22 - 00;05;59;13 And the biggest driver of that time and cost is getting to the patients, identifying the right patients, recruiting them and enrolling them into these trials. And about 20% of these clinical trials fail because they cannot recruit enough patients. And overall, only 3% of our population participates in these studies. Of course, 3% of the population cannot be representative of the diversity that we have here in United States or across the globe. 00;06;00;02 - 00;06;30;04 So the Learning Health Network was created to help solve these problems with the concept of these patients are in everyday care, and that's where trials need to go. We need to bring research into everyday practice. The Learning Health Support Network is a partnership between Oracle and health systems that we serve, and these organizations contribute their de-identified data to serve as the fuel for research and clinical discovery. 00;06;30;18 - 00;06;59;09 So this data set is called the Oracle Real World Data, and I'll call it our RWD from now on to to make it easier. And it's one of the largest datasets in the world like this in exchange for that data contribution, which we're immensely grateful for, Oracle provides these organizations the access to the data set so that they conduct they can conduct their own research, and we provide that at no cost. 00;06;59;21 - 00;07;22;05 We also do all of the heavy lifting for them, so it doesn't take any effort on their side to get the data there to make it de-identified and normalized. We do all of that work and then we offer a variety of benefits for them depending on where they are in the course of doing research, whether it's data science or clinical trials and so on. 00;07;22;22 - 00;07;58;05 So the Oracle Real World Data is home of about 108 million active longitudinal records from all over the United States, covering about 2600 facilities. And this membership comes from a variety of organizations. These whole systems can be large, multistate and academic centers all the way down to critical access hospitals. And this combination, this this composition of membership is intentionally done and balanced by us. 00;07;58;05 - 00;08;37;11 So they're very similar in numbers. And that becomes our superpower by having data from such a wide range of facilities and such diverse communities, and means that people who never had access to clinical research near their homes can now be represented in this dataset and represented in a lot of research that gets done. And it also means that this research, a big data set, matches fairly well to the US Census and brings that much needed diversity that we're lacking in clinical trials today, and that helps decrease the the health and research inequities. 00;08;38;01 - 00;09;03;26 How we do this is again, by using the dataset to find the patients. So we find patients that are good matches for trials, and then we find trials that are good matches for those sites and for that community. And the data can also be leveraged like I said before, by organizations to drive or derive clinical insights by using data science and the tools that Oracle provides. 00;09;03;26 - 00;09;05;10 That is us in a nutshell. 00;09;05;28 - 00;09;28;17 I think there's a lot of people listening that would be really surprised to find out the thing that slows down getting new drugs and new treatments to market isn't necessarily like bureaucracy or red tape or lack of scientific knowledge. I think people would be surprised to find out the real problem is being able to find and get people and a diverse group of people to participate in these clinical trials. 00;09;28;17 - 00;09;32;09 So that's probably what adds great value to this dataset, right? 00;09;32;29 - 00;09;54;27 Yeah, I mean, the things that you mentioned definitely are barriers that we have to cross as well. But it was surprising to me as well as I entered into this space. Just as an aside. One of the reasons it's so important for clinical research to be embedded into care is because we people, patients, we trust our health care providers. 00;09;55;10 - 00;10;09;15 You know, these are the people that we listen to and take advice from. So the studies have shown that the majority of patients that enter clinical trials or accept to participate are because those trials were discussed by their providers. 00;10;10;05 - 00;10;15;00 And what's your role in it? What what constitutes a really good week or a month for you? 00;10;15;15 - 00;10;47;21 As the executive medical director, my main responsibility is really to the health system. Members. I have a team, a super awesome team of clinical researchers that ensures these members gain value from their incredible data contribution and also know how to leverage it. We provide programing around them so that they can learn, collaborate, network and so on, and I also lead our clinical research strategy and operations, which is focused on two major components. 00;10;48;03 - 00;11;26;12 One is bringing the funded research opportunities to the members that want to have clinical research research programs, funded opportunities, meaning they come from life sciences organizations and cross, and also helping these organizations that are smaller to become research ready. So these are organizations that don't today have a program or are beginning and they need more support. The second major focus is breaking down the silos that exist today between clinical research and care delivery, and that will help drive the awareness, the efficiencies, the safety. 00;11;26;21 - 00;11;46;12 It will help us improve that patient recruitment into trials and so on. Now, boy, my my day to day changes quite a bit. So a good week or a month is hard to describe, but I would tell you that a really good day is when one of our community, Rural Health Hospitals, is awarded a study that we facilitated. 00;11;46;23 - 00;12;10;29 And because we know that those patients will be represented, that community will be represented in research and they will gain access to cutting edge medical interventions. It feels really good to know that we played a part in that and another really good day is also when our members use this data set to gain insights that lead to positive patient outcomes and that we're blessed to hear about that quite often. 00;12;11;01 - 00;12;19;04 Our Learning Health Network members have published over 500 peer review articles using this data set. 00;12;19;17 - 00;12;32;11 Best case scenario if the Learning Health Network gets its job right, how can that change how health care data, The gathering and use of real world data is used to improve patient outcomes and health care policy? 00;12;32;23 - 00;13;19;26 Yeah, I would just reiterate a couple of things. With the Learning Health Network and its real world data, we'll have real data in real time deriving insights to lead to better care and better outcomes in the continuously learning ecosystem. We'll be able to quickly restudy and improve upon those longstanding medical practices we have today. So the word restudy is really important because we do have a lot of medical practices today that are gold standard and they're based on old research or based on research that didn't include certain populations, didn't include the necessary diversity or, you know, certainly the composition of us as human beings has changed. 00;13;19;26 - 00;13;43;22 So it is very important to ensure that we're still providing the best care and we can use the data for that. And that also will decrease these existing disparities and drive us closer to personalized care. The future also would look like we no longer will take so many years to complete clinical trials because we're going to know where the patients are for specific studies. 00;13;44;01 - 00;14;11;18 We're all going to know what those studies are more important to take to specific communities and patient populations. And and I think that is going to alleviate a lot of that, not just the time, but also the cost, because these costs are, you know, also what driving the cost of medications for our patients or interventions. Let's see, we'll be able to get to a more predictive and prescriptive models of care. 00;14;12;04 - 00;14;37;24 So understanding not just what happens with an individual now and how to take care of that problem, but also understanding what's likely to happen to Mike based on data points that we have on you today and behaviors. And this way we're able to intervene in the product in a proactive way. Imagine being able to predict and prevent a heart attack from happening three years from now. 00;14;38;05 - 00;15;10;24 All of these things are in our reach today. And the good news is that we're not too far from them. In fact, our our member organizations, the ones that are using the the real world data, are already experiencing practice and research transformation. But we certainly need to scale this up, scale this approach, and hopefully we'll get to a point in which the medical community will trust more on approaching research in this way and it becomes more the standard of care of how we discover and apply changes. 00;15;11;11 - 00;15;18;04 And I also think there is going to be a lot of other possibilities of this data set brings that we haven't necessarily conceptualized yet. 00;15;18;23 - 00;15;23;23 So follow up question You mentioned that organizations are already doing this. Can you give us an example or two? 00;15;24;19 - 00;15;50;12 Sure, sure. I'll give you two of my favorite examples, not just because I'm a pediatrician, but also because less than 20% of all U.S. research funding is dedicated to children. This is a highly underrepresented population in research, just by sheer numbers, which means that patient recruitment in trials is even harder. And conducting those trials in the traditional way is much more challenging. 00;15;50;28 - 00;16;24;20 So these two examples come from very proliferates users of real world data. And in these are pediatric hospitals. The first example comes from children's health of Orange County in California, where they have used RWD and machine learning to create what is the first published pediatric readmissions algorithm. So it's an algorithm that gives us a risk of readmissions for patients that were in the hospital or presented to the hospital, and they were able to accomplish that in the matter of months. 00;16;25;03 - 00;16;51;14 They then incorporated this risk score into the clinical workflows. They put it right inside of their Oracle, Cerner EMR, and they saw a 10% decrease in readmissions in the first two years, which is just commendable. You know, it doesn't just improve the quality of of these kids, but in today's healthcare, this change also amounted to $2.7 million in cost avoidance. 00;16;51;28 - 00;17;18;23 Everyone knows how expensive it is for hospitals when a patient is readmitted. The other example is Children's Mercy Hospital. Their research team leverages the rural data for a lot of projects, and this one is really near and dear to me because I worked in the E.R. with children. They looked at adolescents with migraine headaches that were presenting to the emergency department with these headaches and how they were being treated. 00;17;19;03 - 00;17;44;29 And what they found is that 23% of these kids across 180 AEDs were receiving opioids. I want to repeat that because that's really important to us. 23% of these children were repeating were receiving opioids as the first line of treatment, and that is not necessarily the best treatment for them. It is a misuse of the medication. And it's very aggressive. 00;17;44;29 - 00;18;23;20 And, you know, we're having already opioid crisis in this country. So then they they took that learning. They... /episode/index/show/researchinaction/id/30085288

Building patient-friendly access to clinical trials 02/20/2024

Building patient-friendly access to clinical trials 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... /episode/index/show/researchinaction/id/29344248

Data hippies, real-world evidence, and precision medicine 02/06/2024

Data hippies, real-world evidence, and precision medicine 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: 00;00;00;03 - 00;00;22;00 What does a data hippie believe about the democratization of data? What role should tech companies, government and other stakeholders play in life sciences? Discoveries? And how might walking clinical trials lead to improved precision medicine? We'll get those answers and more on this episode of Research and Action in the lead. 00;00;24;03 - 00;00;43;21 Hello and welcome to Research and Action, brought to you by Oracle Life Sciences. I'm Mike Stiles. And today we're going right to the source when it comes to finding out what Oracle is doing in the life sciences space, what does a company like Oracle have to contribute? Why is it in the space? What does it and the rest of us have to gain from its involvement? 00;00;43;21 - 00;01;09;03 Those are the kinds of questions will be throwing at Dr. Chris Boon, newly appointed EVP 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. 00;01;09;03 - 00;01;14;18 So Chris, you're obviously a very busy person, so we really appreciate your time today. 00;01;15;21 - 00;01;17;02 Thanks, Mike. I'm happy to be here. 00;01;17;11 - 00;01;30;01 Before we get started, tell us about your new role at Oracle and how you see scientific and industry expertise as kind of a winning combination with technology. 00;01;30;01 - 00;01;50;15 Yeah, that's a great question. And I think this is a very fascinating point in our health care and life sciences history. I mean, it's about but I'll start a bit with who I am and what exactly I do as the group vice President of Research Services. I get the great honor and privilege of leading our research services organization formerly known as Cerner. 00;01;50;15 - 00;02;17;14 And these are within the Hawk Oracle Life Sciences Organization. This particular organization has been primarily focused on data analytics and research, right? So in many respects it represents the convergence, if you will, of scientific clinical industry and technology expertise, which I think is pretty much nirvana for where we are with the future of evidence generation in our industry. 00;02;17;14 - 00;02;35;06 And so I'm extremely excited and honored to be able to sort of usher this organization and Oracle into this new realm and fully integrate all the great technologies that Oracle has with all the expertise and expertise and capabilities that that we've had in this R&D as a team. 00;02;35;26 - 00;02;53;21 Yeah, it sounds like there's a lot of people involved and buy in as necessary from a lot of different areas, from researchers to academia to technology. How are you finding the the openness and the willingness to include Oracle in these major efforts? 00;02;54;07 - 00;03;22;05 You know, it's interesting because I feel that the industry is very, very, very hungry for and interested even and curious. Maybe that's a better term for what Oracle will do in this space. I mean, I mean, I think after the Cerner acquisition, people became very intrigued of what Oracle could do, right? Because they sort of they think about the technologies, the advanced technologies that Oracle has, whether it be in a cloud computing automation and these great things. 00;03;22;28 - 00;03;54;26 They think about the clinical trial management platforms that it has. And now you have an electronic health record organization, a capability in addition to a research organization. So it does put Oracle at it's sort of an end of one really. I mean, there's no other company in industry that can can can make those sort of claims and to be true, but also have the ability to sort of drive transformation and how we think about clinical care as well as clinical research with all of the technologies we have at our disposal. 00;03;54;26 - 00;04;03;12 So I think it's a it's a very exciting time and I think that, you know, there's no better place to be right now than Oracle as it pertains to what we can do. 00;04;03;27 - 00;04;18;06 Well, there's no question how large a role data has played in your life and career, But you don't even call yourself a data nerd. Like most folks, you've actually referred to yourself as a data hippie. So what does that mean? Do you live in a van or something? 00;04;18;06 - 00;04;43;03 I think you're right about everything except the van part. But now the term data hippie, you know, it resonates pretty much with my career journey. You know, specifically going back to I first adopted the name back in 2014. I was leading a public private partnership called Health Data Consortium in D.C. but we were really focused on advocating for it and pushing this whole concept of open data and health care, I think. 00;04;43;11 - 00;05;04;19 And really which is sort of the genesis of this idea of the democratization of health data, really. And it was supposed to drive, obviously, innovation that would lead to higher quality patient care and making it more accessible and doing all these other things. In a modern times, though, I think we've sort of we've sort of moved past that a bit, right? 00;05;05;09 - 00;05;29;27 So I think now if I if I think about my, you know, current vision, it's just really about creating a system where you have the use of open, accessible data as a transformative force for the greater good of patients and ultimately the entire global health care system. So, I mean, I hope that there are more people I know that there are more people out there that share this vision, too. 00;05;29;27 - 00;05;37;01 So technically their data hit these just like I am, and we all are champions for this idea of the open exchange of health data. 00;05;37;01 - 00;05;51;04 Well, so if you're a proponent for data hippies, are you up against the man, the man being those who want more siloed proprietary data management? Why or why would anybody be resistant to this open access to data for all that you're talking about? 00;05;51;23 - 00;06;16;09 I think we sort of created a system that sort of has perverse incentives and, you know, and granted, I do believe that there are certain situations that warrant protecting the data privacy for individuals. So I'm not saying that everybody's data should be accessible to the masses for whatever they wanted to do with it. But I also think, too, that there is an opportunity to make data accessible for the public good. 00;06;16;09 - 00;06;34;29 I mean, if you go back to the pandemic, one of the one of the and there weren't very many, but one of the silver linings during the pandemic was this idea of global data sharing in order to sort of move faster with what would be the development of the vaccines, as well as treatment and therapies for for COVID, right? 00;06;35;00 - 00;07;03;18 I mean, that was only made possible by the free flow of data, right? So I think that what we have to do is create an incentive structure. We have to make people understand the value of data. I think you'll find that many folks became extremely educated on how the clinical trial process works and life sciences, but also the idea that using their data can actually be contributory to something that affects all of humanity. 00;07;03;18 - 00;07;25;09 And I think that and that's really where we are. So this whole that fragmented proprietary data, siloed nature that we existed in had, you know, has actually worked against us in many respects. And I think we're at a place in time where history will define what we do, what we've done, and the free flow of health data so critical to human health to be opposed to it. 00;07;25;27 - 00;07;49;14 Well, you mentioned that the the pandemic, what very few things good came out of it. But one of those good things is a more open approach to data and data sharing. What had to happen to make those walls come down that quickly was that a government instituted thing or did the industry itself decide we can't operate status quo and get a vaccine out there? 00;07;50;00 - 00;08;08;02 I think it was all of the above. I mean, but really I think it was more a genuine concern from all parties to really address this pandemic head on. And we knew that not one sector could could address it by themselves. Right. So you knew the public sector can do it by itself. Perhaps the private sector couldn't do it by itself. 00;08;08;02 - 00;08;33;12 So this idea of forming these collaborations, these partnerships, was was critical to sort of advancing science in the way that we knew it and that the way that we'll continue to practice it today, but also in a way that you know, we also had to engage even the community, the broader community, you had to educate people on what on public health matters that some may or may not have been concerned about in the past. 00;08;33;12 - 00;08;56;20 So you have this idea of engaging the private sector, the private sector engaged in a public sector, the public sector and the private sector engaging the public at large. And those are the things that were necessary to make this happen. I mean, and then it makes issues such as what you talk about data sharing a bit easier for people when they understand what the clear purpose is behind the sharing of their health data. 00;08;57;07 - 00;09;08;15 Well, obviously, you wound up at Oracle. How did that come about? What did you see out Oracle that presented great opportunities for what you want to accomplish, both personally and professionally in life sciences? 00;09;09;02 - 00;09;35;27 You know, it's interesting, and I would say that there is a short and a long answer to that question. But but but the short answer is, is that I actually didn't know much about what Oracle was doing and the health care and life sciences space prior to the Oracle Health Conference that I attended in September. And I was invited out to be part of the panel to sort of discuss the future of clinical trials and some innovations that we've seen. 00;09;36;09 - 00;09;57;28 And then I got an opportunity to listen to my Sicilian and Sima and a number of folks really talk about what their perspective, their world view on the future of health care life sciences looked like and what Oracle was actually doing to advance it. Right. And so, you know, you couldn't help but walk away feeling inspired by what this organization was seeking to do. 00;09;57;28 - 00;10;27;26 And so I had a bit of an epiphany while attending this meeting. And and just the idea of joining an organization that sort of shared my my sort of personal vision and values around the industry. And it's aligned with my professional goals. It only makes sense. Right. And it didn't it didn't hurt that the organization sort of believes in fostering innovation and and driving meaningful change and utilizing data and digital technologies to create a better world. 00;10;27;26 - 00;10;53;11 And and that that is what resonated with me. And the other pieces of that that I would say is that you know, I mentioned Mike Mike earlier but and Sima but you know, another person that I would add into that Ms.. Mix is David Fineberg. And I think that having inspirational leadership who have who are very passionate and committed about addressing these tough challenges that we have within the health care industry, I think is critical. 00;10;53;28 - 00;11;10;15 It makes all of our work feel more meaningful. Right? And so as a person who prides himself on being passionate about this industry and passionate about its transformation, it was it's great to partner up with with senior leaders who share that same passion and that same vision. 00;11;11;04 - 00;11;37;03 Well, it seems like technology is playing a bigger and bigger role as a solution to so many of the problems the world has and that we as a people have. Is it that the path to more, better and more accessible health care data is more likely to come from the private tech industry like the oracles of the world, than from some of the other traditional players like academia and government? 00;11;37;18 - 00;12;03;06 Again, I still think it's a multistakeholder approach that's necessary. I mean, you could you can point to the significance of academia. What we've seen with some of the peer reviewed journals and how they thought about the idea of of incentivizing folks to share their data with their publications. Right. And, you know, and sort of a de-emphasized in this need to say that you need to you need to keep your data proprietary. 00;12;03;06 - 00;12;24;15 It's your intellectual property and therefore, you know, it sort of affects their their ability to to move up in the ranks and their universities. But I also think the private sector, we've been at an interesting time the last decade where there's been a tremendous amount of focus on how to monetize data, which is sort of a disincentive for the free flow of data, which is sort of where I end with it. 00;12;24;15 - 00;12;51;24 Right. And I think that, you know, just by a lot of the things that we've seen even from a public sector perspective and regulators and the 21st Century Cures Act, for example, is a way that, you know, you've seen how the impact of working together and collaborating with both regulators, industry and academic researchers and how it essentially facilitates that necessary cooperation that we need. 00;12;52;03 - 00;12;59;17 And that's just one example of how I think that we've seen progression in this particular space. 00;13;00;07 - 00;13;15;15 Well, you brought up something kind of interesting. How do you work through the balance of the need to monetize on the part of private industry versus if that element weren't there, how far we could get, how fast with data sharing? 00;13;16;02 - 00;13;37;27 You know, it's interesting, a few several years ago I was I was quoted in one of the periodicals where I said that we were at a farm. I was at a in a data arms race and essentially what I was meaning by that is that we were looking to amass as many datasets as we possibly got. Granted, we weren't going to use all this data, nor could we even make sense of all the data that we were accumulating. 00;13;38;06 - 00;13;57;09 So what you're hearing, my personal belief is that people pay for insights, noxious, raw data, right? I think that it seems, you know, that that the raw data is the valued asset. And it could be if you actually know what to do with it. But I think that what people are looking for is insights to really drive decision making, right. 00;13;57;15 - 00;14;14;02 Whether that be at the policy level, whether it be at the clinical care level, whether it be at the research level, whether it be in the investment level. However you want to think about it. And I think that there's still the monetization of valuable insights is still there and that still should be very much a part of it. 00;14;14;09 - 00;14;32;07 And it doesn't mean that I'm opposed to the idea of monetizing raw data. I don't want that that belief to be out there. It's just that I believe that there is a greater good that we're all striving for and the more that we can get to an interoperable state within our industry, the better off patients will be in the long run. 00;14;32;10 - 00;14;35;16 And that's really sort of my core belief. 00;14;35;16 - 00;14;41;00 So you've talked in the past sometimes about a walking clinical trial. What do you mean by that? 00;14;41;19 - 00;15;04;11 Yeah, I mean, so the walk in clinical trial is sort of synonymous in my mind, at least with this concept of an app one trials that we've heard or some people refer to it, a single patient trials. And really what we're I think we are is that we're at a space where, you know, digital technologies have advanced and have been adopted and they're rather ubiquitous, you know, in our society as we think about it. 00;15;04;11 - 00;15;40;21 And so we're constantly accumulating data passively about patients and their environments and their lifestyles and their health conditions and even their medical histories. And we now have the ability to better understand and maybe in many ways be preventative with how we think about personal care. Right? I mean, so you get to understand quickly, which gets into this this this sort of world of precision medicine, where essentially treatment approaches are personalized to that individual based on their genes or their environment or lifestyle. 00;15;41;10 - 00;16;00;03 And I think this idea of being a walk, a walk in clinical trial, which is for all intents and purposes, is a paradigm shift from the way we thought about clinical trials in the past. But I think we now have all the technologies there to be able to embrace this concept. Does it apply in every single situation? Absolutely not. 00;16;00;12 - 00;16;12;26 Right. But I do think, and especially in the rare diseases space, there is a tremendous opportunity to do an app. One trials are walking clinical trials as often as I would describe it. 00;16;12;26 - 00;16;25;00 You mentioned precision medicine. What's your vision of precision medicine and how close or far away are we from it? What remains to be done to get us significantly closer to that vision? 00;16;25;23 - 00;16;42;17 I think we're a lot closer than we were, say, even five years ago. Right. And I think one of the biggest drivers for that has to be that direct to consumer genetic testing that folks are able to get. I mean, and the fact that the cost of doing that is much less. We've... /episode/index/show/researchinaction/id/29344013

Advancing rare disease research with a patient-centered approach 01/24/2024

Advancing rare disease research with a patient-centered approach 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... /episode/index/show/researchinaction/id/29636828

Automation, innovation, and the future of drug safety 01/09/2024

Automation, innovation, and the future of drug safety 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... /episode/index/show/researchinaction/id/29343893

Patient empowerment, digital innovation, and rare diseases 10/05/2023

Patient empowerment, digital innovation, and rare diseases 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: 00;00;00;07 - 00;00;24;21 How is clinical research becoming more patient focused and more convenient for patients to participate in? Why is a decentralized approach especially important when researching rare diseases? And what is the most likely future for how clinical research is conducted? We'll get the answers to all that and more on Research in Action. 00;00;24;23 - 00;00;48;24 Hello and welcome back to Research in Action, brought to you by Oracle. I'm Mike Stiles and our guest today is Scott Schliebner. Scott is a leader and innovative life sciences executive with 30 years experience across biopharma, CROs, medtech, and nonprofit. He's developed relationships, partnerships and collaborations that have driven commercial success with a strategic and consultative approach to building and growing life science businesses. 00;00;48;27 - 00;01;16;06 Scott got a lot of experience, including leveraging real-world data and real-world evidence, leading technological innovation and driving patient focused paradigms to accelerate clinical drug development. And he's an active board member, advisor and mentor, and he's all about infusing data and innovation into life sciences organizations, especially where rare disease is are concerned. And last but certainly not least, Scott is the leading executive at Rare Clinical. 00;01;16;09 - 00;01;35;01 Scott, we're glad to have you with us. Thanks for letting me grill you with all these questions. Thank you, Mike. My pleasure to be here with you. Well, let's start at the beginning. A fine place to start. What got you into the field of clinical research and drug discovery and why this special focus on rare diseases? Yeah, great. 00;01;35;01 - 00;02;04;13 It's a great place to start. I think, like a lot of my colleagues in this clinical research, clinical drug development profession, a lot of us sort of find our way into this field as there aren't necessarily a lot of like formal training programs or pathways necessarily. So for me, I was in graduate school, I was doing some more like I would call more basic science, more basic research that I found my one day struggling to. 00;02;04;16 - 00;02;22;00 As I was writing a grant for a professor, I found myself struggling to justify why, why this was really important. I kept saying to myself, Yeah, this doesn't really seem very applied. Is this really make a big difference? I, I can't convince myself this is critical. How am I going to convince a funder of our grant that this is really important? 00;02;22;00 - 00;02;44;17 And it kind of was a little bit of a light bulb moment for me that made me realize while I loved the field of research, I needed to be doing something that was more applied and could have a little bit more of a direct impact upon people. So it sort of led me to the clinical drug development space and clinical trials, and I got started back. 00;02;44;17 - 00;03;12;21 It's been a couple of decades now as I've been around for a little while, but it got started in a sort of like a biotech clinical research setting, helping to design and manage clinical trials and have been sort of engaged and passionate about this industry ever said. So it's been it's been a fun ride. But again, like a lot of people in this space, I think I stumbled into clinical research, maybe not accidentally, but, but, but there's not an obvious clear entry point for some of us. 00;03;12;23 - 00;03;33;25 Yeah. So I get that you, you got into the bio research space and drug development and those kind of things develop that interest. And I get that you wanted to make a real impact that you could feel like you were making a difference. Is that where the focus on rare diseases came into play or when did that? Yeah, thanks for following up on that part of the question. 00;03;33;25 - 00;04;12;02 I think that, yeah, after having been in the industry for a little while, you know, about, I don't know, this was probably like 12 years ago or something. Rare diseases at that time were really still a little bit. They weren't certainly a hot and sexy topic like they are today in 2023. But I came across some patients, I came across some patient groups, and I also came across a couple of clinical trials and I realized that what we were trying to do and what was required really to function and develop drugs in the space of rare diseases really required, honestly, a completely different, really way of operating a completely different paradigm than what we 00;04;12;02 - 00;04;48;16 were doing in most of clinical drug development. And with, you know, with our biopharma industry being pretty risk averse. That's a theme I think you'll hear come up probably a lot today. In our conversation. There hadn't been a lot of appetite or initiative around trying different approaches or looking at things differently. And these rare disease studies for sort of a countless sort of logistical and medical and scientific reasons really require a very different approach of, you know, you're talking about small populations that are geographically dispersed. 00;04;48;16 - 00;05;23;21 You're talking about patients that may have they may have to go through a diagnostic odyssey. A lot of people don't know about these disease states. There's a host of challenges that kind of come together and create a scenario that is even more complicated than your average challenging clinical trial. So also, when you look at the fact that there's something like 10,000 individual rare diseases individually, they're all rare little sub populations, but taken together they make up about 10% of the U.S. population and about 10% of the global population. 00;05;23;21 - 00;05;50;24 So it's it's a big area of unmet medical need. When you look at it from a big picture perspective, when you drill down into individual disease states, individual patient populations, you notice that these patients and families don't have any therapies, they don't have any treatments, they don't have a lot of hope sometimes. And clinical trials. And this world is really their only source of hope at times. 00;05;50;24 - 00;06;10;22 It's less of an experiment and more of a care or treatment option for rare disease patients. And so I found myself really immersed and passionate about this area and felt like it was a space that really needed new approaches. And I've been happy to kind of delve into that and try to make a difference there. And what is the state of that research like? 00;06;10;24 - 00;06;39;24 Is there reason for people with rare diseases to have hope? For instance, there are people in my family who have ankylosing spondylitis, which is a relatively rare form of arthritis. Is it appropriate for them to have hope that in their lifetime something's going to happen? Or are these populations so small and the research to develop drugs for it's so difficult that, you know, we're looking at 50, 60 years in the future before we make any progress. 00;06;39;25 - 00;06;55;20 Yeah, it's a great question. I mean, there really is a really broad spectrum here when we talk about rare diseases. We have such a such a large number of them. I think that the short answer is there is hope. And in a lot of cases that hope is in front of us or is on the very near horizon. 00;06;55;22 - 00;07;18;09 There certainly are other scenarios where another disease states where it's going to take a while and that hope is a little further out to be seen. But the good news is that we've well, there's been a lot of mobilization, there's been a lot of innovation and a lot of attention devoted to rare diseases over the last decade, 15 years, we've seen a lot of drug approvals. 00;07;18;11 - 00;07;39;24 We've seen a lot of companies, we've seen a lot of investment in biopharma biotech firms come into the rare disease space, whether they are small little biotech startups or whether they're the big pharma of the world. Everyone sees this as an opportunity to help develop drugs and help people. And in an area that really needs as much help as we can provide. 00;07;39;24 - 00;08;15;29 So there's a lot of hope. Some of these disease states are a little more clear than others. We understand the biology and the genetics, and maybe we can develop targeted therapies that help these patients some of these other more obscure, ultra rare or nano rare diseases. We're still learning who the patients are and how do we diagnose them and before we can develop a drug and show that it works and that it's safe in those populations, we need to first even understand a little bit about the natural history of some of these diseases and how they progressed kind of on their own and what kind of end points we would want to choose and some 00;08;15;29 - 00;08;37;27 things like that. But the bottom line is that there's a lot of hope, there's a lot of progress, there's a lot of activity, there's a lot of investment. I think there's a fair amount of awareness. We've seen a lot of progress here with people, with people and organizations and industry really getting into the space. Of course. With that said, there's a lot more that we can be doing. 00;08;37;27 - 00;09;02;21 There are a lot of disease states that really need some more attention and more funding and more research. But from where I sit, we've made some great strides and I hope to kind of keep accelerating that progress. Well, science is kind of inherently a social enterprise, but despite that, scientists and clinicians seem to work mostly behind closed doors, maybe even a little too far removed from the people they're actually working to help. 00;09;02;23 - 00;09;24;27 The pandemic changed a lot of things, but for one thing, Big pharma got kind of pushed out of its risk averse comfort zone because they had to speed the science and adopt more openness. So what do you think COVID did to innovation in the clinical research space? What changes are permanent and which ones aren't? Yeah, this is a fantastic topic. 00;09;24;27 - 00;09;57;11 We could we could spend a lot of time on those, I think. Well, necessity being the mother of invention, I think that COVID presented a lot of unique challenges and picking on my risk averse colleagues who may not want to necessarily try something new or go out on a limb with some sort of more risky, unproven approach. COVID forced us to reconsider how we were doing things, and it forced us to keep clinical trials going in a in a manner and keep them operating. 00;09;57;11 - 00;10;32;15 When we couldn't go to clinics or go to hospitals or when we had to social distance. And it forced us to really rethink a paradigm that had not really changed in many decades. So if you rewind a little bit to pre-COVID, there was several movements out there around creating more patient focused approaches. So this idea that you mentioned science being inherently a social enterprise, I envision a lot of clinical protocols and clinical trials being they're often developed in a little bit of a bubble. 00;10;32;18 - 00;11;01;01 Sometimes I'll joke and say in a conference room in New Jersey, right, these clinical trials come to life and are sketched out and designed in a little bit of an insulated bubble of sorts that don't really take into account the perspective and the input and the needs and the voice of the end users, namely the patients themselves. So similarly to the fact that, you know, you may have an iPhone sitting there on your desk next to you. 00;11;01;04 - 00;11;26;27 Apple, of course, didn't design a camera to put on their phone and say, let's see if people want to use a camera. The camera was designed, of course, by consumer demand and designed for the people using it. Ironically, even though science and even though clinical drug development is completely dependent upon patients participating in clinical trials, we rely on them and their data to move things forward. 00;11;26;29 - 00;12;06;22 They're very rarely considered actually, in the design process. Right. That's the irony, is that we rely on them. We must have their participation, but they're kind of an afterthought historically when it comes to designing a clinical trial and thinking about how to implement it. So that being sort of the baseline of how we've operated COVID hits and all of a sudden our world is interrupted and some of these novel approaches that had been being developed, these mobile health platforms, early COVID, we were talking about how can we make clinical trials, quote unquote virtual or hybrid with some of the language we were using. 00;12;06;24 - 00;12;35;18 How do we instead of requiring patients to maybe travel long distances to a clinical site or an academic medical center? Sometimes it could be a weekly visit for 52 weeks. A lot of times that's not going down to your neighborhood primary care physician. It might be driving into Manhattan and going to Memorial Sloan-Kettering every Friday afternoon and taking time off of work and away from your family and your children to participate in the clinical trial. 00;12;35;21 - 00;13;02;09 The bottom line, clinical trials were really not designed for patients, often not realistic and often not feasible. So when we ran into COVID and the challenges that kind of shutting down hospitals sort of created, it forced us to adopt this what we ended up naming decentralized clinical trial paradigm, and it forced us to think through, well, how do we bring clinical trials to patients themselves? 00;13;02;11 - 00;13;25;15 So this was a long, long overdue need that was out there. Again, we've been operating in a little bit of an archaic fashion for quite a while, putting out studies that were not realistic for patients. But when the world around us sort of crashed down and we needed a new approach, we adopted this more patient focused paradigm simply out of need, I think. 00;13;25;18 - 00;14;05;21 So there's been some traction with this. Decentralized clinical trials have become a common term in this industry. We have the Decentralized Trials and Research Alliance that was formed in 2020. There's a lot of companies on investment that have come up to develop this new paradigm of, instead of these critical end users, patients, instead of having them have to travel long distances and inconvenience themselves and for a scenario to be very hard for them, let's create something that revolves around them, that's create a patient centered, patient focused approach where we bring trials to patients in their homes. 00;14;05;21 - 00;14;28;07 And so we do this via some tools like apps on our phone and a mobile health platforms. We do this, of course, now via telehealth and things like that that have become much more routine and regular. We're able to collect data remotely. We're able to push out sort of questionnaires and quality of life and clinical outcome assessments to patients wherever they are. 00;14;28;11 - 00;14;53;23 We're able to send nurses to their home to help them administer drug or check on how they're doing or evaluate their symptoms. So this transition that COVID has sort of forced us into, again, necessity being the mother of invention has forced a more patient focused approach that I personally think we've been really long overdue. So I think of that as a little bit of a silver lining of the pandemic. 00;14;53;25 - 00;15;24;08 There's been some good progress, I think, made as a result of that. But these technologies that you're talking about that are used to monitor these patients in these trials, like maybe wearable technologies or whatever, what's the reliability level of that? Does a lot of this rely on the patient just reporting accurately what's going on? Well, as we've come out of the pandemic now, the interesting sort of dynamic is does this new model really stick around when it's not as needed as it was during COVID? 00;15;24;11 - 00;16;06;16 Do we continue to move forward in this new innovative approach, or do we revert back to the way it was? And along with that, are these sort of challenges maybe, and complications that come along with this decentralized approach, like remote data capture, lots of data sources coming from various areas, various directions, wearables, as you've said. And there's also this kind of push also to not only engage patients where they are, but also to collect data in a little bit of a real world setting in this, you know, real world evidence, real world data, you know, kind of concept around, you know, we're conducting clinical trials that are controlled and we're we're looking at specific variables 00;16;06;16 - 00;16;25;12 and we're looking to evaluate safety and efficacy. But at some point, if this new therapy is going to be approved and patients are are using this in their daily regular life, how it's better for us to also know what that's going to be like, like to study that real world experience now even in the context of a clinical trial. 00;16;25;12 - 00;16;44;27 And so you are even seeing regulators like the FDA encourage the collection of more real world data for that to be used to supplement more controlled clinical trial data. So you're having a little bit of a mixture here and a little bit of an evolution, I would say, in terms of the data and evidence that we're bringing in. 00;16;44;29 - 00;17;12;08 But your point, there's there's lots of challenges with that as well. Now we have a lot of different technology platforms. We have a lot of data sources that need to interface and communicate and integrate. There can be complexities with having lots of different technology platforms for clinical sites and patients to use. You... /episode/index/show/researchinaction/id/28215158

Biotech startup working with Oracle to innovate for pharma 09/20/2023

Biotech startup working with Oracle to innovate for pharma How is academia fostering research that later turns into startup companies? What are new computational powers bringing to in silico drug design? And what is MoveableType methodology and why should pharma be excited about it? We will learn those answers and more in this episode with Lance Westerhoff, President and General Manager of QuantumBio. QuantumBio is a biotech startup operating in the vast field of drug discovery and molecular design. As President and GM, Lance oversees QuantumBio’s day-to-day management including the research, development, and deployment of advanced technology, as well as strategic partnerships and business development. Lance earned his PhD in Chemistry at Penn State University, and he is an entrepreneur, computational biochemist, and published scientist with projects involving the synergistic application of quantum mechanics and molecular mechanics in the life and pharmaceutical sciences. QuantumBio recently earned a Small Business Innovation Research (SBIR) grant from the NIH to run calculations for their MovableType methodology research, which they will be working with Oracle on that research project, and we talk about that and much more in this episode. -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;26;06 How was academia fostering research that later turns into startup companies? What are new computational powers bringing to in Silico drug design and what is moveable type methods? And why should pharma be excited about it? We'll get those answers and more on research and action in the lead. The leading scene. Hello and welcome to Research and Action, brought to you by Oracle for Research. 00;00;26;06 - 00;01;00;18 I'm Mike Stiles. And today our guest is Lance Wester Hof, who is president and general manager of Quantum Bio. That's a biotech startup that operates in the field of drug discovery and molecular design. Lance oversees day to day management, including the research, development and deployment of advanced technology, as well as strategic partnerships and business development. He earned his Ph.D. in chemistry at Penn State, and he's an entrepreneur, a computational biochemist and published scientist with projects involving the synergistic application of quantum mechanics and molecular mechanics in the life and pharmaceutical sciences. 00;01;00;20 - 00;01;24;09 In fact, Quantum Bio earned a small business innovation research grant from the NIH to run calculations for their movable type methodology. Research. They'll be working with Oracle on that project. So, Lance, we're really glad to have you with us. Certainly. Well, thank you for having me. I look forward to the discussion. Well, listeners, I hope you're ready to get into the weeds because we're going to get into chemistry quantum and all the exciting things that are becoming possible. 00;01;24;12 - 00;01;44;12 And it's all emerging science and technology. So keep listening. You'll be well caught up. But to start, we're always interested in what got you, Lance, and what you're doing. What was that professional and personal journey like? Certainly. Yeah, well, and actually, I when I first started things out or I just started really putting my head around what I wanted to do for a living. 00;01;44;15 - 00;02;06;22 Science was actually pretty far from from the discussion or my thought process I'd actually started is as a semiprofessional professional amateur theater geek, doing a lot of five local theater, that sort of thing. I worked at a local Renaissance fair, you know, those sorts of things that that that people that wanted to go more into the the arts. 00;02;06;22 - 00;02;24;22 If you will, you're really wanted to do. And then one day I was when I was in high school and starting to think about what I wanted to do for a living, it just kind of dawned on me that, you know, you could be the best actor in the world and be very successful as a and have a lot of a lot of great enjoyment. 00;02;24;24 - 00;02;46;20 But if you don't catch a break, you can have all sorts of professional and financial difficulties throughout life. And so I started looking at what classes I did well in in high school or what I was doing well. And at that time I was in 10th grade and of course it was the sciences biology at the time. And at the same time I was I had always been into computers. 00;02;46;23 - 00;03;09;06 And so I think my first computer was a Vic 20, which I believe as I, as I looked up, just came out in 1980. So so that kind of puts it perspective that I was about six years old, and so I knew that I would want to do something with computers, something with biology. So then I started really setting up my my high school career for that, for that sort of background. 00;03;09;06 - 00;03;36;13 I studied some theater on the side. Theater is always fun, but, you know, that was where I focused my energy. Then I went to college. I ended up majoring in biochemistry and computer science with an eye towards doing exactly what I'm doing now. And so my wife always jokes with me that and she knew me then too, that, you know, I wanted to do something that most people, including her at the time, had never heard of before, and that was computational biochemistry or computational chemistry. 00;03;36;18 - 00;03;54;15 And so I spent my years in college, you know, certainly learned a lot in biology. I was I was more focused on the biology versus the chemistry side of things, you know, And of course, like I said, with the comp sci. But then when I went, when I started looking at grad school, I had already met my future advisor at the time. 00;03;54;15 - 00;04;18;14 His name is Kenny Myers began at Penn State at the time and now he's he's moved on as well. But I actually had met him a couple of years before I graduated from college and, you know, started talking to him. And then we ended up I decided that was the lab that I wanted to work in. You know, once I went to Penn State and so as I settled in into graduate school again, that would have been in 1998 when I had started grad school. 00;04;18;16 - 00;04;45;15 By about 2000, 2001, you know, I was really starting to think about and talking to him, of course, at the same time about the possibility of starting a company. And I had already done started some companies back then, back in, I guess you could say the the college years doing, you know, web design for people you know back when the web was very, very young and and just getting started those sorts of jobs. 00;04;45;15 - 00;05;15;02 And so I had already had an understanding of of the basics of of getting a business started. And so at that time, then, you know, Katie and myself and then another person began the companies really to focus on commercializing the linear scaling semi semi empirical quantum mechanics technology from from his lab and spinning that out again as as a company that's really focused on applying these methods to drug discovery working in the pharmaceutical space. 00;05;15;05 - 00;05;42;13 Yeah, I've been calling quantum bio a startup, but it's actually pretty established. It's spun out of Penn State in 2002. How did the company come to be and what does it aim to do? What were your highest aspirations for it? Well, I'll tell you, when you're around that long and you've done, you know, a lot of say, ups and downs, we we we always joke with our investors and everything else on the topic that you're really you know, there's a lot of trial by fire when it comes to entrepreneurship and that is part of the process. 00;05;42;13 - 00;06;07;00 And so you become very comfort, comfortable with trying different things, seeing what works, what doesn't work, and learning from mistakes and moving forward. And so when we first spun out the company, it was very focused on a we have a patent that's associated with it, which was a quantum scoring based methodology that again was published probably about that same time frame. 00;06;07;00 - 00;06;28;09 You know, you know, early 2000s. We thought this was going to be the greatest technology that was going to be known to man or whatever and was going to be very successful in pharma. And I think what we learned was that, you know, trying to just develop a academic software package and commercialize it, it's well, it takes a lot more than just a good idea. 00;06;28;10 - 00;06;50;22 You know, you really need to understand, you know, how software is put together. You need to not necessarily focus on it from an academic perspective, answering academic questions, if you will, and really focus more on your client is what the client really needs to do and how much time and effort they're willing to spend on that. And so that's how we learned. 00;06;50;22 - 00;07;10;11 We had a couple of hard lessons along the way, you know, that, you know, these things had to evolve a little bit more, so on and so forth. And so, you know, we certainly but the good news was at the same time we were bringing on clients and, you know, we've we've had made a lot of friends, you know, a lot of folks that we could work with, collaborators, so on and so forth. 00;07;10;13 - 00;07;41;25 And then over the years as we really put our heads around this and understand how things had to progress, I begun to work with the the National Institutes of Health, and I took over the general management of the company at that time and then really focused on raising funding specifically for development of new technologies. And so we've been able to raise probably on the order of about 8 million or so dollars from the Spire program over the over the last several years. 00;07;41;27 - 00;08;12;12 And again, that is focused very specifically on development of new technologies for pharmaceutical research. And we also then at the same time, we expanded beyond just the scoring methodology that we had done, and now we're in the free energy space, the X-ray crystallography space, the nuclear magnetic resonance space. So we've been able to, you could say, grow that that nugget or completely redevelop that nugget and then now expand to into a different lot of different applications. 00;08;12;20 - 00;08;36;05 And that then becomes our key. Then for from a business perspective is now we're focused very much on applications of these technologies. And in order to solve problems, you know, the more interviews we do on the show, the more I'm seeing startups come out of academia as some kind of deliberate ecosystem that's been set up where colleges are basically incubating research startups that then go on to take off. 00;08;36;05 - 00;09;00;08 What what are the universities get out of that? Well, I mean, I think it obviously depends on on a case by case. You know, there's but but in terms of the generalities, those sorts of deals can take a lot of different looks, I guess you could say. So in our case, you know, most of the focus was that you would be bringing out a technology that was developed in the lab. 00;09;00;10 - 00;09;23;08 Again, as I already mentioned, an academic way to solve a problem is oftentimes different than a industrial way to solve a problem. So there's a lot of that R&D that needs to go into developing a technology. And so that's that's one aspect. Certainly the and so therefore, getting that technology out to more people, you know, tends to be a key benefit for universities. 00;09;23;11 - 00;09;48;14 I think the other, of course, you know, is it comes down to a monetary, you know, very oftentimes thanks to the by double act and so on and so forth, there is a requirement that they take this technology and put it out to the world and actually take some sort of monetary value. And so you get a certain amount of of ownership in that in whatever downstream company comes about. 00;09;48;16 - 00;10;18;25 And so that's how generally universities, you know, develop, they pay for their intellectual property offices and so on and so forth by actually investing in those companies. And usually not necessarily, again, invest in cash as much as investing technology into those companies. And then they get they get a certain percentage of the ownership. And so as we as we move forward, then the the certainly it's oftentimes students, grad students, postdocs, faculty, they get the experience and enjoyment of spinning out of business. 00;10;18;25 - 00;10;41;11 So therefore they get some of that training that goes along with it. But then I think also the university gets some some financial benefit then as well. Well, how do you think that relationship is working? Because entrepreneurs are very unique creatures who put it that way. And a lot of PhDs aren't really entrepreneur material. Or better to say, it's not something that comes naturally to them or that they aspire to be. 00;10;41;13 - 00;11;04;08 That's got to be hard. Throwing themselves into business, especially in something like pharma, which is really regulated and competitive. Right, Right. Well, it actually it's interesting. I would actually argue that actually very oftentimes PhDs, especially in the sciences, I again, I can't really speak for, you know, the humanities, but in the sciences very often they are actually entrepreneurial in terms of their spirit. 00;11;04;08 - 00;11;26;04 Now, again, that might manifest itself in different ways. So a great example of that is a professor at a research university. They generally need to raise their own funding to support their labs. They are extremely it's really important that they go out and do quote unquote marketing in the form of going to conferences and conventions and and writing papers and so on and so forth. 00;11;26;06 - 00;11;50;15 And so that that entrepreneurial spirit, I think, is actually pretty strong. And certainly anybody that's in the sciences and, you know, using the scientific method is, you know, already pretty comfortable with risk and uncertainty because, of course, a lot of what we do stems from hypotheses that some of them don't work out. And so, again, that's something that, you know, a lot of entrepreneurs, you know, would be would understand very well. 00;11;50;17 - 00;12;15;02 And so I think that there is a lot of that spirit. I think the difference then oftentimes is, you know, a lot of folks maybe don't necessarily understand a priori or at the beginning of, well, how do I actually raise funding, raise my own capital in order to develop a new a new company out of that? And so it's those aspects that I think where the university can be a really big benefit. 00;12;15;04 - 00;12;38;27 You know, they they kind of provide that little that little test bed or that little seed bed, if you will. They allow that the people to take risks, that it's a little harder to do if, again, you're out on your own. And so I think that that ends up being where a lot of the benefit comes from. And I think that therefore, then they can really kind of play to those strengths and then grow from there and build out from there. 00;12;39;00 - 00;13;04;29 In terms of the pharmaceutical space, absolutely, very highly regulated. That tends to be a an impediment often. I mean, I think it certainly has benefits, but I think the the, the minus of it is you generally have to have a lot more infrastructure that can support understanding of those regulations, understanding of how those those regulations work, how that game is played, quote unquote. 00;13;05;01 - 00;13;24;28 And so I think that part does tend to be a little more difficult. And again, that is where, you know, a university or even just a corporate partner can take a lot of that push, a lot of that heft in terms of competition. You know, I think that's something that I think we we all like and appreciate. These things should be highly competitive. 00;13;25;00 - 00;13;48;26 But the regulation is something that, you know, like I said, there's always this expense that goes along with it and legal fees and so on and so forth. Computational drug design or in silico has shown promise in enhancing the success rates of drug candidates and saving time and money. Now, of course, it can't replace experimental bench work, but in silico platforms like Quantum Bio, they're starting to be seen even by regulators as having a lot of potential. 00;13;48;28 - 00;14;13;21 I mean, the NIH is even funding you. What is so exciting about in Silico drug discovery and design and and why are folks excited about quantum bio? That's a really you know, I think it goes to a core question or a core core benefit that you're absolutely right. I mean, in Silico back, as I mentioned at the beginning, that back in the day was really not something that people fully understood. 00;14;13;28 - 00;14;39;17 They saw maybe a lot of promise there, but there was a lot of concern, you know, is the are the computational methods just going to replace all all lab bench work? And of course, that's nonsense. Of course, lab bench work is is is critical as well. And at the same time, there's a lot of evolution still going on in the field where we were still trying to fully understand how to. 00;14;39;17 - 00;15;11;12 And I think we're still fully trying to fully understand how proteins and ligands interact with each other, how all these different molecules interact with each other. And by expanding that or as that continue to evolve, if you will, and mature, then it really has now become a core aspect of the of any pretty much any pharmaceutical company out there is likely going to have, you know, a number of computational chemists that are working on projects on a day to day basis. 00;15;11;15 - 00;15;32;16 You know, this is now a critical part, a core part of the drug discovery process where again, back back before it was probably more something that folks kept an eye on. They they wanted to see what sort of ideas would be coming out of it. But oftentimes is that as the saying would go, you know, you're you're only going to give them a certain amount of time to give a result. 00;15;32;16 - 00;15;59;02 And if if not, I'm just going to go ahead and go to the lab and make it anyway. And so methods like the ones that we work with and and develop have now, really, like I said, they've become ubiquitous. You know, they are something that's that's part of the drug discovery or pharmaceutical space. And now then where we focus them is laser on very specific specific solutions to very specific types of problems. 00;15;59;04 - 00;16;19;03 And so and so therefore, we play to our strengths and then we very oftentimes then partner with other software companies that then are applying to theirs. And so in in our world, collaboration between pharma, between other software companies is is just part of the day to day. You know, we need to make sure that our software works well with theirs. 00;16;19;03 - 00;16;43;08 They're doing what they do really, really well, and we're doing what we do really, really well. Then that then provides a solution or a set of solutions that really gets added into a toolbox for the pharmaceutical space. And so a firm before and so a practitioner in the pharmaceutical world will have any number of tools. Ours is one of them that that would be solving the types of problems that they need to solve on a day to day basis. 00;16;43;11 - 00;17;10;10 Pharma, it seems to me, moves really slowly and cautiously, sometimes frustratingly slow toward emerging innovations. And silica has been around a long time, so they got used to that. But now computational power has made it a real for something with enormous potential. So how is pharma acting now? Are they do they get it? Are they fully adopting it to modernize... /episode/index/show/researchinaction/id/28066800

Science, Research, and Reaching the UN SDGs 09/06/2023

Science, Research, and Reaching the UN SDGs 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.... /episode/index/show/researchinaction/id/27881970

Talking AI, Computer Vision, Autism, and Small Data Problems 08/16/2023

Talking AI, Computer Vision, Autism, and Small Data Problems How is computer vision being used to spot autism symptoms much earlier in children? What is augmented cognition? And how can you use AI to make data models work even with small data sets? We will learn those answers and more in this episode with Dr. Sarah Ostadabbas. Dr. Ostadabbas is an associate professor in Electrical and Computer Engineering at Northeastern University, where she is also the director of the Augmented Cognition Laboratory (ACLab), which works at the intersection of computer vision, pattern recognition, and machine learning. Before joining Northeastern, she was a post-doctoral researcher at Georgia Tech and earned her Ph.D. at the University of Texas at Dallas. A renowned expert in the field, her research focuses on the goal of enhancing human information-processing capabilities through the design of adaptive interfaces based on rigorous models using machine learning and computer vision algorithms. With over 100 peer-reviewed publications, Professor Ostadabbas has received recognition and awards from prestigious government agencies such as the National Science Foundation (NSF), the Department of Defense (DoD) as well as several private industries. In 2022, she received an NSF CAREER award to use artificial intelligence for the early detection of autism, which she is working on with Oracle for Research. --------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;26;15 How are computer vision and contactless techniques spotting signs of autism much earlier in children? What is augmented cognition and how can you use AI to make data models work, even with small datasets? We'll find all that out and more in this episode of Research in Action. Hello and welcome back to Research in Action, brought to you by Oracle for Research. 00;00;26;15 - 00;00;50;10 I'm Mike Stiles, and today we have with us Dr. Sarah Ostadabbas, an Associate Professor in the Electrical & Computer Engineering Department Northeastern University, where she's also director of the Augmented Cognition Laboratory (ACLab), which works at the intersection of computer vision, pattern recognition and machine learning. Before joining Northeastern, she was a postdoctoral researcher at Georgia Tech and got her Ph.D. at the University of Texas at Dallas. 00;00;50;13 - 00;01;24;04 Her research looks at how we can enhance human information processing capabilities by designing adaptive interfaces based on rigorous models using machine learning and computer vision algorithms. With over 100 peer reviewed publications. Professor Ostadabbas has received recognition and awards from government agencies like the National Science Foundation, the Department of Defense and several private industries. In 2022, she received an NSF career award to use AI for early detection of autism, and she's working on that with Oracle for Research. 00;01;24;04 - 00;01;43;26 Dr. Ostadabbas, thank you so much for being with us today. Thanks for having me. I'm excited to be here and feel free to call me Sarah. Well, listeners, get ready because we're going to get all into computer vision, machine learning, augmented cognition and wherever else I can get nosy about. But first, let's hear about you, Sarah, and your background. 00;01;43;26 - 00;02;12;08 Your passion for technology and physics kind of started back in childhood, right? Yes, that's correct. Actually, physics was my favorite subject in middle school and high school. I was so passionate about it that I even went through the whole volume of Fundamentals of Physics by David Halliday and Robert Resnick in I believe it was in 10th year of my high school, and I was seriously considering to pursue the continuous PhD in physics even before graduating from high school. 00;02;12;10 - 00;02;39;09 And alongside my love for physics, I was always also fascinated by technology, especially computers and programing. I started coding in a language called Basic, which some of your audience may not even heard about that. Why I was in middle school and loved it. Data Analytics capabilities of computer and how computers are giving advanced processing power to human no matter where they are. 00;02;39;11 - 00;03;12;14 I was still living in Iran at the time and experiencing technological advances at that time, such as Internet and cell phone, and they were all very much interesting. And fast forward, all of this led me to pursue a natural combination of my interests, which was an electrical and computer engineering degree with a double majoring in biomedical engineering. And now when I look back, it's actually heartwarming to see one that one seemed to be diverse. 00;03;12;14 - 00;03;41;17 Interesting collection of interests now have shaped my academic journey so far. Was it unusual for someone, you know, at your age, at that early age of middle school, to be coding and thinking about technology and physics and looking that far into the future? I was actually going to date if school, middle school and high school at that time was designed for for math and science. 00;03;41;17 - 00;04;06;00 So no, I had a lot of of my classmates going and exploring different science topics. So it wasn't unusual. I mean, it was unusual when I was taking these heavy books to my gathering at parties, at my family, but not at the school. So I'm glad. And it was 200 of us, 200 girls at and now all of us are all around the world. 00;04;06;06 - 00;04;28;02 Most of us have PhDs. And yeah, it wasn't unusual, but it, it was something that I cherish. Yeah, it's great that you had a school that focused on things like that. So let's kick things off with your NSF CAREER Award focused on developing machine learning algorithms towards the early detection of autism. Tell me if I get this wrong. 00;04;28;02 - 00;04;53;08 But this is about using computer vision to predict autism a lot earlier in children. And what does what does that research involve and what does Oracle for Research have to do with it? You're certainly right. As I mentioned, my academic background revolves around electrical and computer engineering, focusing on data processing. And these data sources can be signals, images and videos. 00;04;53;11 - 00;05;21;06 How might a specific focus a work on computer vision began when I joined Northeastern University as an assistant professor in 2016. As you may know and have heard of over the past decade, deep learning models have been driving advancements in many AI topics, including computer vision. But these algorithms often require a large amount of training data. They are very data hungry. 00;05;21;08 - 00;05;48;24 So my National Science Foundation CAREER Award aims to leverage this advancement in computer vision for a specific health related domain that suffera from limited data. And I'm in particularly focusing on detecting autism in infant even before the first birthday. And this is true processing videos that is collected from them when they are doing daily activities, which is not a lot of things that they do. 00;05;49;01 - 00;06;16;13 They are sleeping, playing or eating. And as I mentioned, my algorithm, they are designed to be data deficient because I'm working on the area that the there are not a lot of data due to this privacy and security reason, but adapting these complex networks, these complex neural networks which are which are building blocks of deep learning necessitates powerful computing resources. 00;06;16;20 - 00;06;44;25 And that's where our collaboration with Oracle become highly valuable, allows me to make this model adapted to this specific application. So you have videos, video cameras, monitoring the kids and kind of like an in the wild get capturing of data. And then the computing power is needed to crunch all that video and that pulls out certain patterns that reveal autism earlier. 00;06;44;25 - 00;07;07;14 Is that how it works? Yeah. I mean, you can say that you put that on the simpler words. Yes, exactly. I'm a simple man. No, no, no. I'm just it's a good I mean, it's a good, good way to describe that. Yes, that's correct. So what we do, we actually leverage these computer vision techniques and contactless video processing algorithm to predict autism, as I mentioned, from daily activities. 00;07;07;19 - 00;07;35;17 And these are daily activities captured by commercial video recording messages. Imagine like a baby monitor or even parent's cell phone cameras. Every parent's love to record videos from the day of their child. So they focus on this specific developmental sign. How will that that relates to motor function, which means that relates to infants posture, muscle tone, body symmetry, and they balance and range of movement. 00;07;35;18 - 00;08;04;05 So these are specific markers that actually has been shown to be early visible warning signs of more developmental disorders such as autism. And they appear actually interestingly, long before the core feature of autism that you may have heard of and these are actually very known, such as social or communication difficulties as well as repetitive behavior. So we are focusing on these early signs. 00;08;04;08 - 00;08;29;11 However, currently the standard approach to monitor this motor function is through visits to child doctor, pediatrician and how is it, unfortunately, over half of these visits are missed. You could imagine often due to the lack of transportation, for parents, it's hard to take time off from work and also lack of child care for other other kids set at home. 00;08;29;13 - 00;09;12;29 So half of these visits are missed and a lot of this early sign has been overlooked. So to address this in equitable access to actually to clinical assessment and a lot of practical constraints, we are trying to to make a home based a I guided in monitoring tools that can track early motor function development very unobtrusively, like just a video that is watching like a baby monitor is rolling and then be the process this video on the back end and track this specific developmental sign and hopefully be we help for the early detection of autism. 00;09;13;02 - 00;09;40;15 I want to also point the fact that it's actually important, very important and crucial to have timely detection in the autism case, because early intervention, it's actually shown that is most effective before the age of four. Yet the average age of autism diagnosis is still around four and a half. So we are hoping to make a clear detection tools better intervention outcome. 00;09;40;18 - 00;10;00;06 It's really interesting to me that body symmetry is a hallmark of development. I guess my question is why would that be and how is Body Cemetery being addressed in your research? That's a very good question. So we are as I mentioned, a motor development is very important. If early signs offer any visible sign of something that may not working out right. 00;10;00;09 - 00;10;32;14 So one interesting aspects of motor function that has been identified as an indicator of neurodevelopmental health is body symmetry. You can imagine that symmetrical movements and posture are crucial for supporting independent movements such as sitting, crawling and walking, especially infant. Then an infant is typically developing movement posture. Actually, you start asymmetric and then gradually they become more symmetrical as our sensorimotor coordination develops. 00;10;32;16 - 00;11;05;06 And during the first year of life, infants could go through the various milestones, such as days rolling over, sitting up, standing so little by little watching, and all of these movement progressed from less symmetric to more symmetric movement and then also study, they have been looking at the infant movement. They have a map showing that the position is symmetry in their movement can be indication of disorders like autism. 00;11;05;09 - 00;11;28;09 However, if we want to have motor functional function assessment in infant, especially body symmetry in larger scale for a long period of time, our for health care provider is going to be very expensive. I mean, somehow impossible and very challenging because imagine if you have 10 hours of videos, how long does it take for you to watch that? 00;11;28;09 - 00;11;54;10 10 hours. I mean, it's going to take 10 hours. But what we want to do, we want to have these computer vision tools apply on these videos to automatically evaluate them all to a function and is start having something in home that people can use and start escorting to one of the mutual developmental indicators, escorting them the symmetry. 00;11;54;12 - 00;12;23;06 So the idea is that we are actually using infant pose estimation algorithms that we have already developed in the lab to assess postural asymmetry based on differences in joint angle between opposing the arms, between the left side and right side. So the effect the the difference is more than 45 degrees, which has been suggested by Esposito in this study in 2009, in the we can call it asymmetric. 00;12;23;12 - 00;12;50;15 We have also come up with our own measure, which is a data learned based assessment on using Bayesian assets to collect aggregation that we could actually come up with two different angles. But how that these are all allows us to do to process the beat you automatically. And then the video is called the whole movement of the infants based based on all of this processing symmetric or asymmetry. 00;12;50;15 - 00;13;12;01 And then physicians can look at that and see that it is something alarming or not. And then as the process of the science and research goes on, well, I've talked to enough researchers to know that recruiting is usually a challenge for any experiment. But with this, the target population is children like babies. How did you manage to get your patient population? 00;13;12;01 - 00;13;39;15 Were there any privacy, access or ethical concerns? It's a very good question and also absolutely an important matter. When recruiting for our experiment, we noticed that the challenge of targeting infants subject under the age of one, parents are already overworked, sleep deprived, and imagine asking them to to be part of yet another task. So it's very hard, however, to be able to overcome this this problem. 00;13;39;18 - 00;14;16;20 We leverage the fact that many parents already are using baby monitoring systems, so they just want to wash them. I mean, a lot of these baby monitors, even the one that they call smart, they don't do anything. It's just a trigger. If the mat the baby's crying or they are moving. So we are aiming to develop this normal system that not only allow the parents to observe the child, but also offers this long term monitoring capability to track the child's developmental process and provides alert if some abnormalities are detected. 00;14;16;26 - 00;14;38;14 So this may be a good incentive for for parents to take part in our study. And as one of the points that you mention about the privacy and ethical concern, we have taken several measures to make sure to address these concerns. We are collaborating with health care professional that they are more familiar with to dealing with the human subject. 00;14;38;17 - 00;15;15;14 And also we are working closely with a Northeastern Institutional Review board known as IAB to make sure our data collection protocol has strict security and privacy standard. We make sure that the parents that they are participating in our study are fully informed about the purpose of the research. And also we get they consent to to use some some part of these data for public use and public release for scientific and technological advancement, because a lot of them these days, how to win is shared in other a study can be built on top of that. 00;15;15;14 - 00;15;37;19 So but we make sure that parents are that the parents that they are part of this study, they are they are aware, fully aware of that. And I want to emphasize that our priority is to preserve the privacy and confidentiality of them, the participant to out the whole process, although they are looking and working on very important and impactful research. 00;15;37;19 - 00;16;05;12 QUESTION But this is also very important at the top of our list. Yes, security and privacy data for data that is important. Is that why a tech concern like Oracle Cloud that obsesses over things like privacy and security kind of speeds up the research? That's very good. Good point that you brought up. That's true. As I mentioned, security and privacy of the data, especially in our field based on the sensitive nature of data that we are collecting, is important. 00;16;05;16 - 00;16;50;21 We are working with them with personal health related information. So we required some sort of robust measure to to protect confidentiality and prevent unauthorized access. And working alongside part industry partners like Oracle ensures that we are actually having a huge safeguard on our sensitive information. The team that I am working with, Oracle has this huge expertise in data management and security practices, and this allows us to then when we are storing, processing and analyzing data in a in a protected environment, we can focus on our research objective while having a partner that gives us confidence in the security and privacy of the data that they are handling. 00;16;50;21 - 00;17;22;04 So it's a very useful and necessary collaboration. So your lab Augmented Cognition Laboratory or the A.C. Lab works with Computer Vision and machine learning. How did that lab come to be and what exactly is augmented cognition? This is actually brings back many fond memories for me, I think. Tell you the story behind the name, Why I was interested in physics, computers, math, and even literature. 00;17;22;04 - 00;17;53;11 I mean, this is specific. Interest by itself can be another podcast session, but not now. I always had a vision of becoming a university professor and leading my own research lab. I remember clearly that I wasn't seen earlier for my Ph.D. when I started to look at look for names for my future lab to reflect the into intersection of engineering inspired artificial intelligence because I was farming, doing school and data analytics. 00;17;53;18 - 00;18;28;25 But also I wanted to emphasize the positive impact of A.I. in human life rather than replacing them. So I came up with the name Augmented Cognition. Augmented Cognition. I actually represent the core idea that I have about enhancing human information processing capability through the design of adaptive interfaces guided by A.I. algorithm, especially machine learning and computer vision. This is specific definition is actually opening of my my web page when I started at my my position at Northeastern University. 00;18;28;28 - 00;18;59;00 This also highlights my focus on utilizing these advanced tools to augment human ability, especially in the data processing domain. Imagine what I'm doing here as part of my NSF CAREER and what I want to to give physician parents the power of processing hours and hours of data and then let them to extract the information that is needed to to make sure to make the informed decisions. 00;18;59;02 - 00;19;23;13 I often have this phrase that at the ACLab we use artificial intelligence or AI to do human intelligence amplification or IEEE. So I do more Iot and A.I.. Your work relies a lot on machine learning and computer vision as tools to generate truly augmented intelligence solutions. How do you leverage the recent advancement of AI in your work? 00;19;23;13 - 00;20;02;06 Because you've probably been watching it for years, but for most of the public, this A.I.... /episode/index/show/researchinaction/id/27564987

Cloud technology’s impact on epidemiology research and public health 07/12/2023

Cloud technology’s impact on epidemiology research and public health 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: -------------------------------------------------------- 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... /episode/index/show/researchinaction/id/27376671

Transforming healthcare research with technology's latest capabilities 06/28/2023

Transforming healthcare research with technology's latest capabilities How do you connect the needs of researchers to the capabilities of technology? What are the main stages of research and the challenges faced at each stage? And will AI and machine learning speed up research and get solutions to market faster? We will learn those answers and more in this episode with Dr. Mark Hoffman, the Chief Research Information officer for Children’s Mercy and the Children’s Mercy Research Institute, a position he has held since 2016. Dr. Hoffman earned his doctorate in Bacteriology from the University of Wisconsin-Madison. He later joined Cerner as a software engineer where he advanced to the role of Vice President for Genomics and Research. Dr. Hoffman was also part of the faculty at the University of Missouri Kansas City (UMKC) in the Departments of Biomedical and Health Informatics and Pediatrics. His formal training in research and experience in software development has prepared him to connect the needs of researchers to the capabilities of technology. His work is focused on identifying the best capabilities possible to meet rapidly changing requirements in genomics, public health, and big data. Dr. Hoffman is an inventor of 22 issued patents, a member of the American Academy of Inventors, a TED talk alumnus, and an award-winning healthcare product developer. You can learn more about Dr. Hoffman and Children’s Mercy here: Learn more about Oracle for Researcher here: ---------------------------------------------------------- Episode Transcript 00;00;00;00 - 00;00;26;02 What are the three main stages of research and the challenges each are facing? How are researchers handling the new federal policies around data sharing? And will AI and machine learning speed research and get solutions to market faster? We'll get those answers and more on this episode of Research in Action. Hello and welcome back to Research in Action, brought to you by Oracle for Research. 00;00;26;02 - 00;00;49;21 I'm Mike Stiles. And today our guest is Dr. Mark Hoffman, who is the Chief Research Information Officer for Children's Mercy and the Children's Mercy Research Institute. That's a position he's held since 2016. Dr. Hoffman earned his doctorate in bacteriology from the University of Wisconsin-Madison and later joined Cerner as a software engineer, where he went on to be Vice President for genomics and research. 00;00;49;24 - 00;01;17;11 Dr. Hoffman was also part of the faculty at the University of Missouri, Kansas City, and the Departments of Biomedical and Health Informatics and Pediatrics. Now, because he's had formal training and research and real-world experience in software development, he's kind of uniquely qualified to talk about what researchers need when it comes to technology. His work focuses on identifying the best capabilities to meet requirements in genomics, public health and big data that are always changing. 00;01;17;14 - 00;01;38;22 He's an inventor of 95 issued patents, a member of the American Academy of Inventors, a TED Talk alumnus, and an award-winning health care product developer. And honest to gosh, that's about the shortest intro I could come up with for someone who is so accomplished. So, we're glad you are with us today, Dr. Hoffman. Well, thanks, Mike. I look forward to talking with you. 00;01;38;24 - 00;02;05;06 Our audience is going to be particularly lucky that they decided to stream this episode because there's a lot to cover. But first of all, what got you into research to begin with? Kind of what led you to each step along the way to where you are now at Children's Mercy? Well, it's a long story, but, you know, I think as a kid, I was always curious and I enjoyed Legos and, you know, taking things apart. 00;02;05;06 - 00;02;36;00 And so, in hindsight, I see all the foundations. And that took me a while to realize that my interests are really split between doing science and building technologies. And so, I see myself as very fortunate to have a role that lets me keep one foot in each of those areas of interest. So, you went when you made the decision to go to Cerner and go into that software development world. 00;02;36;02 - 00;03;05;24 What inspired you to do that? It's interesting. When I was in graduate school studying bacteriology, I was funded by an NIH program that if you're in the life sciences, you were required to take coursework outside the life sciences. I chose to do that in computer science. And then the other requirement was you were required to do an industry internship one summer. 00;03;05;26 - 00;03;31;27 Most of my peers chose to do that in pharma. I chose instead to do my internship at a software development company that does bioinformatics software development. Realized how much I liked that type of work and building things that get used in the real world. It's funny, but to this day, some of the features that I developed are still part of their application suite. 00;03;31;27 - 00;04;04;27 So, I learned from that that I enjoy the software and technology and development process. When there was the opportunity to join Cerner as a software engineer. I jumped at it and happened to be in their microbiology product line, so I was able to talk with the clients about what they were struggling with in the lab, understand that, and then translate that into whatever changes were needed in the software. 00;04;05;00 - 00;04;26;28 Did you expect that to be the case that you would be able to keep a foot in both sides on both the technology and the research side? Or was that something like you never thought that could happen? I didn't plan it this way, but I feel very fortunate that I'm able to exercise so many of my different interests. 00;04;27;00 - 00;05;12;19 So obviously children's mercy benefits from your professional expertise, but behind that you've got a real personal commitment and passion for the work that you're doing that kind of increases your value even more. If you're willing, tell us about that personal connection. And just in general, both Cerner and Children's Mercy are based in Kansas City. And as a parent, while I was working at Cerner, over time, both of our children have needed inpatient care at Children's Mercy Hospital and just the compassion and caring and quality of care and the creativity that we often saw with some of our children's physicians. 00;05;12;22 - 00;05;55;21 The willingness to keep trying things until they could help our kids work through their different health concerns has made a huge impression on me. Now, when I walk through the hospital and see parents with their kids who are going through really some of the most difficult situations you can imagine, I try to take a moment and share a smile or, you know, hold the elevator for a parent. I'm just trying to even though I'm not involved in patient care, I just really am empathetic to those families and see that as really kind of my connection to purpose. 00;05;55;24 - 00;06;35;13 What are the unique differences between a children's centered health care provider like that and, say, a regular adult hospital? What are the biggest differences that the staff has to operate with? I think probably the key difference is with adult medicine, you're really working primarily with the patient and they're making their own decisions. In pediatrics, you're working with children and they're their care providers so that there's more voices involved, you know, with younger children. 00;06;35;14 - 00;07;08;04 It's really is the care providers who are making those decisions with teenagers and adolescents, they certainly will have their own voice into the decision making. So that's really a key difference in pediatrics. I think pediatric medicine is interesting because it's both very cautious but also very willing to innovate. And I find that often to be a really interesting dynamic. 00;07;08;06 - 00;07;33;07 So you were a fan, as it were, of Children's Mercy before you started working there? Absolutely. That was a big part of my decision-making process to come here. So how did that come about that you started working for Children's Mercy? And what exactly do you do there? So, I made the difficult decision to move forward in my career in 2013. 00;07;33;09 - 00;07;58;04 The step that I took was to join the University of Missouri, Kansas City School of Medicine, join the faculty there and form what we called the Center of Health Insights. Through those negotiations, Children's Mercy funded 25% of my role at the university. And so, I already had not quite one foot, but at least a few toes in the door. 00;07;58;06 - 00;08;26;19 And I spent a lot of time building relationships with Children's Mercy. About three years into that, there was some hiring of senior leadership for the Research Institute, and I was involved in that and made the case that I'm seeing other organizations create the Chief Research Information Officer role. That idea stuck and I was hired as our first chief Research Information Officer. 00;08;26;21 - 00;08;50;09 So it sounds like what you want, what you're kind of your North star is to make sure researchers at Children's Mercy can tap into the best technical resources and experts out there, because especially medical researchers, everyone expects them to find answers quickly. You know, there are waiting to be helped. So. What's a typical day like for a chief research information officer? 00;08;50;12 - 00;09;27;09 I tell everybody there really is no typical day. Sometimes I'm down in the weeds talking through technical issues and then in the next meeting can be talking with organizational ownership about high level strategy. Part of what I enjoy is the variety in my role. I don't support any single clinical area of research. So, one meeting just yesterday was with our neurology department, where we're doing research into telemedicine and that can support rural communities where children have epilepsy. 00;09;27;11 - 00;09;55;25 And so there was that meeting and then there was another meeting within the same 24 hours about long read genomic sequencing with our genome center. So just context shifting and you know, always with the theme though, of trying to find ways for technology to be an enabler. All too often my peers in research feel that technology sometimes creates a barrier. 00;09;55;25 - 00;10;25;08 And so, one of my goals is just to try to reduce the barriers and increase the opportunities. And for you, it seems like, you know, you actually see the faces of the people that this research is trying to help. Does that add yet another motivational personal element behind kind of your mission there? Absolutely. I think through the pandemic, the entire work model for people in technology in particular has changed. 00;10;25;10 - 00;10;55;26 I know many of us spent a long time working from home and when I was able to start coming back on site, I just find it very motivating to go to the hospital cafeteria or, you know, get out of my research and technology bubble and be among the patients and families. Well, you've met researchers of every kind all over the world, people just like those who listen to this podcast and you know how they define success and also know what challenges they face. 00;10;55;28 - 00;11;25;06 I'll get to what those are in a second, but let's kind of define research. The stages are basic, translational and clinical. What exactly are those stages and how do you maneuver through those to get to actual innovation? I look at those where I see basic research as working with either molecules, cells or even animal models to understand the biological process. 00;11;25;09 - 00;11;57;14 And then the first level of translational research is taking a subset of those basic findings and exploring whether they may have a role to play in clinical practice. So sometimes that can also be where things start to be defined in an animal model. And then you start when something looks promising, you start working through early-stage clinical trials for safety, and then you start working with patient populations. 00;11;57;17 - 00;12;32;08 And then ultimately, if something's successful and does seem to benefit patients, then it gets rolled into practice and then there's an additional layer that we call outcomes research, where periodically it's important to review whether, you know, those new interventions or new tests really are making a positive difference in patient outcomes. That's kind of how I like to conceptualize the different phases of both basic and translational research. 00;12;32;10 - 00;13;06;17 Well, I'm assuming the challenges and opportunities are different depending on what kind of research we're talking about. So, let's start with your world of clinical research. What makes life unnecessarily harder for clinical researchers and does technology offer any help? I think no matter who I spoke with, recruitment into clinical trials is a continuing challenge. And I do think that data and technology have a helpful role to play in that. 00;13;06;20 - 00;13;37;07 Some of our work, as well as some work within Oracle or Oracle Health, is focused on using large de-identified data sets to evaluate the feasibility of doing research at a particular setting. Do they have enough patients who might meet the inclusion criteria? And so, I do think that data and technology have a role to play in the recruitment challenge. 00;13;37;10 - 00;14;05;23 That's kind of interesting that that recruiting for some of these trials is so difficult. What's the reluctance? You know, people have these conditions, it seems like they would be more than willing to try, you know, something? Why the reluctance? I think there's a number of factors. One is sometimes the designers of a study are maybe overly optimistic about the population. 00;14;05;26 - 00;14;36;01 Sometimes they underestimate the concerns that patients and their families may have. So that's one factor. I think as a scientific community, we need to continue working on how we communicate with the public, especially now, you know, with what I think of as the epidemic of mis- and dis-information. Those may not be preventing people from joining studies, but certainly they impact the willingness to utilize the benefits of research. 00;14;36;04 - 00;15;19;10 Yeah. Do you worry about the level of trust declining in health care researchers? I mean, the pandemic probably we took a hit with that. It's you know, that's a really interesting topic because on the one hand, I often reflect on the pandemic and if it had been ten years ago how different and much worse it would have been, because it really would have been unheard of to have in lab diagnostic tests within weeks, at home, testing within months, and a functional and safe vaccine within a year. 00;15;19;12 - 00;16;16;09 Ten years ago, that would not have been possible. And that's exclusively because of our capacity and in doing clinical research. I think, though, there's a lot of challenging dynamics in play that as a scientific community, we just need to keep getting out into the public, explaining in accessible terms what research is about and why it matters. One thing that we're very intentional about here at Children's Mercy is we have both parent and youth advisory boards, and so we work with them closely as we develop new research initiatives so that they're at the table and they're also out in the community, in the community, sharing the work that's happening here, because that's in so many ways 00;16;16;09 - 00;16;44;18 far more effective to hear from your neighbors, your friends at work than it is to hear from, you know, those of us who are doing the technical work. Well, kind of same question for those at the basic or fundamental research level, what are their biggest headaches? And, you know, is technology being applied to those headaches? Yeah, I think I wouldn't necessarily call them so much headaches. 00;16;44;18 - 00;17;21;07 But, you know, all categories of research, of course, feel that funding is always a challenge. I think for basic research, the volume of data that many techniques, not all, but many generate, creates an exciting opportunity for people who work in data science. For example, genomic sequencing, you know, is highly automated now, but the volume of data that any one genomic evaluation can generate is massive as well as, you know, very complex. 00;17;21;07 - 00;17;48;14 And so, the informatics and data science opportunities to analyze these growing volume of data is really exciting. Yeah, it feels like even though there are different research stages, there's obviously overlap when it comes to some of the roadblocks and opportunities to knock those roadblocks down. I mean, what do you see as kind of the shared pain points? You mentioned funding, I guess that goes across all stages. 00;17;48;17 - 00;18;27;09 Yeah, I think especially in a clinical setting there, there's a very high focus on cybersecurity. So, the research community is not always as involved in that as they probably needed to be. So, you know, we even have a lot of considerations that we incorporate into making sure that our systems, our data are secure to the highest standards. So that also my team tries to insulate the researchers from that type of work because we want them to be focused on doing science. 00;18;27;09 - 00;18;53;28 And in many organizations, we see researchers who have to get their hands in some of these other processes and technology issues. So a key part of what I see as my role and my team's role is insulating the researchers from those types of concerns. Yeah, which I'm sure they greatly appreciate. Obviously, there is a lot of compute resources that are required. 00;18;54;00 - 00;19;28;24 So, I imagine one of your challenges is to make sure these folks have the kind of compute resources they need. Yeah, and that's really an exciting area. We have recently completed the migration for our Genome Center of their bioinformatics pipeline from an on-premise data center to a completely cloud-based system. And we're excited that we're starting to see that gain of efficiencies from that, you know, moving that to a complete cloud model. 00;19;28;24 - 00;20;01;12 We have other projects that are more of a hybrid model. We do have a data center and our new research institute building. So, I'm excited about the new world where we can really offer computational and storage resources at a totally different scale than was needed ten years ago or even five years ago. Well, I know you're part of the Oracle Research Industry Strategy Council, a group that talked about a lot of the same stuff, pretty recently. 00;20;01;12 - 00;20;24;14 Just this May actually. So, one of the topics of discussion was how some researchers who are federally funded are kind of I don't know if struggling is the right word, but dealing with new policies around data storage and data sharing. The NIH has gotten real serious about those policies earlier this year. Why are these policies like FAIR principles coming down now? 00;20;24;17 - 00;20;56;13 And how ready are researchers to cope with those new protocols? Plus, whatever else may pop up in terms of regulation? Yeah, I think the change in policy reflects a realization on the funders that, you know, despite the expectation that researchers would share all of most of their data that was generated with those taxpayer funds, that that wasn't happening at the consistency level that they expected. 00;20;56;14 - 00;21;33;02 So, the major change this year is that that expectation is... /episode/index/show/researchinaction/id/27317634

The rise of research entrepreneurs and why it matters 06/14/2023

The rise of research entrepreneurs and why it matters How can researchers who have developed innovative solutions begin to commercialize? What makes a great research-entrepreneur? And how are universities and organizations helping to bridge the research-to-commercialization gap? We will learn those answers and more in this episode with Laure Haak. A neuroscientist by training, Laure has a BS and MS in Biology and Ph.D. in Neuroscience from Stanford University, and she did postdoctoral work at the National Institutes of Health. Her career includes diverse experiences: serving as founding Executive Director of ORCID; leadership roles at Thomson Reuters, The US National Academies, and Science Magazine. She is currently founder and CEO of Mighty Red Barn, a consultancy that supports impact-based organizations building digital infrastructure, and helping research innovators go from discovery to startup. Laure carries on this work as a Research Scholar at the Ronin Institute, and Board Chair of Phoenix Bioinformatics and the Green Bay Chapter of SCORE. You can learn more about Laure and Mighty Red Barn here: Learn more about Oracle for Research: --------------------------------------------------------- Episode Transcript 00;00;00;00 - 00;00;26;12 How can researchers who have developed innovative products begin to commercialize them? Why are digital persistent identifiers important to researchers? And who are some of the partners that can help researchers get their products to market? We'll get those answers and more on this episode of Research and Action. Hello again. Welcome back to Research in Action, brought to you by Oracle for Research. 00;00;26;12 - 00;00;47;27 I'm Mike Stiles. And our guest today is Laure Haak. Laure is a neuroscientist by training. She has a B.S. and M.S. in Biology and a Ph.D. in neuroscience from Stanford. And she did her postdoctoral work at the National Institutes of Health. She's done a lot over the course of her career, including serving as founding executive director of ORCID leadership roles at Thomson Reuters, 00;00;48;00 - 00;01;14;09 the U.S. National Academies, and Science magazine. She's currently founder and CEO of Mighty Red Barn. That's a consultancy that supports impact-based organizations that are trying to build their digital infrastructure. And it also helps research innovators like many of our listeners, get from discovery to startup. Laure carries on this work as a research scholar at the Ronin Institute and Board chair of Phoenix Bioinformatics and the Green Bay chapter of SCORE. 00;01;14;09 - 00;01;38;01 Laure you're obviously a very busy person, so I'm really glad you're on the show. Well, thank you for the invitation. I'm really looking forward to this conversation. Us as well. So we're going to talk about innovation to commercialization, because we do have listeners who are researchers and PhDs. They've got the research discovery part down. But starting and leading a startup, that's a whole different thing. 00;01;38;02 - 00;02;02;28 But before we do that, what did you want to be when you grew up and what motivated you at each step from Stanford, to ORCID, to Mighty Red Barn? Yeah. And so, I think whenever people ask about careers, it kind of depends on what you had for breakfast, how you answer the question. So, I think the best way to explain my career is that I never grew out of the childhood fascination with how things work. 00;02;02;28 - 00;02;24;19 I never stopped asking why, which has it's endearing and annoying qualities, depending again on what you had for breakfast. I was and still am fascinated with how the brain works. And after college I started graduate school in neuroscience during what was then the decade of the brain. It was a big deal. So I studied hibernation. I studied sleep wake cycles. 00;02;24;19 - 00;02;51;12 I studied how our bodies internal clock responds to light. I was also at the same time involved in the Association for Women in Science as well as Women in Neuroscience, where I managed a quarterly or a quarterly newsletter back in the day when you actually mailed things using stamps in the Postal Service. You know, we couldn’t look at how many people opened, but we had a list of about a thousand people were sending out to. 00;02;51;15 - 00;03;21;14 So during my tenure as president of Women in Neuroscience, that particular group was folded into the Society of Neuroscience. And it is still an active initiative today, which is really awesome to see. So from my postdoc with that portfolio of three years of these newsletters, I joined the Next Wave team at Science Magazine and triple-A US, which is now called Science Careers, and I worked on post-doc policy and career development for science graduate students. 00;03;21;14 - 00;03;39;15 And there's so many really smart people that are so focused on their research, they couldn't see the vast opportunities for applying their passion and skills. I think this gets back to your question, Mike, about, look, there's folks that do research, but how can I be an entrepreneur and start something? And part of it is kind of looking up. 00;03;39;18 - 00;04;04;07 So when I was at the Next Wave team, I helped to support the founding of the National Postdoc Association and then went on to be a study director at the National Academies and working with esteemed scientists to research and produce reports on research workforce issues, including interdisciplinary research, international students. And on the last report I did when I was there was on women in academia. 00;04;04;10 - 00;04;28;15 So from the academies I again moved to something completely different and a tech startup where when I started there was no job description and no job title. It sounds like a tech startup. Yes, but you have to really you know, I came out of academics in that I went to two places where there is a lot of structure, right? 00;04;28;17 - 00;04;53;26 So the tech startup was like, okay. And I was also the only peer there. So I crafted my job and my job title and became the chief science officer. And I help the company build an analytics consultancy that brought the data that they were kind of collecting and munching together to these pressing research policy issues where, you know, you could kind of look at some amount of data. 00;04;53;26 - 00;05;15;07 We didn't have, you know, a lot of it that we needed to really answer these pressing issues. So this was this time was right as compute power was really starting to take off. So I have to admit, during graduate school, we had a computer that took up the size of a room. We had an old one of those things. 00;05;15;09 - 00;05;35;29 And so now a few years later, you can now crunch terabytes of data in hours rather than weeks. And I know these days you can do petabytes in microseconds. But, you know, we're getting there in the machine, sit on a desktop, Right. So this is like this wonderful period of time when people are like, oh, my gosh, what can we do? 00;05;36;01 - 00;05;55;01 And one of the wonderful things we did was work with the National Institutes of Health on a number of program evaluation projects. We had data on grants, we had data on papers, we data on people, we had data on patents. We brought all that together to help the NIH understand what is the impact of their funding in certain portfolio areas. 00;05;55;03 - 00;06;30;27 One of the projects we did was with the NIH leadership, and it was to examine what was thought to be potential bias in the awarding of research grants, a hot button topic and lots of anecdotes. So we were able to bring to bear the compute power and the data that we had to a study which led to a publication of a paper in Science magazine demonstrating a substantial gap in the likelihood of award for black NIH grant applicants, other measures being equal that spurred the NIH to examine their review process. 00;06;30;27 - 00;06;53;26 I'm really, really proud of this work, and I'm proud that the NIH took action, both partnered with us on the work and took action to try to remedy or at least further study and remedy the situation. So some of the stuff I've done, so at the same time all this was happening, startups, right, like to go through and sell and, you know, get money for the investment they've made. 00;06;53;26 - 00;07;24;26 So I was actually part of the startup's management team that was pitching for our acquisition and we were eventually purchased by Thomson Reuters. And overnight we went from a team of about 50 people to a team of about 50,000 people. It is a really big change and I'm the kind of person that really likes the scrappy energy of startups where you can be super nimble and change your mind and oh, maybe we should do this today and started looking for an opportunity to build something new. 00;07;24;26 - 00;07;44;25 So I did the kind of spin in, you know, with the the group. So I did the spin out with the National Post Association. I did the spin in with the evaluation team and analytics team at Discovery Logic, Thomson Reuters. And then it was like, okay, I want to try something else. And this would actually be Let's start a company from the beginning, right? 00;07;44;28 - 00;08;12;29 And I had the phenomenal opportunity to come on board at as ORCID was just starting. And so I became the founding executive director and I was the first staff hire. There was already a board and bylaws and all these other things, but they didn't have any staff. So I became the founding executive director and it was just awesome. I cannot tell you how wonderful that it was, just every day on my hip pinch myself. 00;08;12;29 - 00;08;46;06 I can't believe I have this. Jobs is great. So I helped to. I have to build the operational infrastructure. I built a team and with the team, a globe of community and technology infrastructure for researcher identifiers. So ORCID is essentially a digital name for researchers that connect us with all of our professional activities and contribution. So in eight years we managed to reach financial sustainability is this is a nonprofit and we had over 10 million registered researchers, a thousand members and national consortia in 40 countries. 00;08;46;13 - 00;09;07;28 I was delighted, but it was also time for me to move on because we got where I wanted to get to. It was built and now we had to move into more of a maintenance mode. Then let's build, build, build, right. I was ready for my next build project and I stepped out in 2020 to create Mighty Red Barn, which is, as you said, a consultancy for social impact startups. 00;09;07;28 - 00;09;32;05 So here we are. Well, I'm worried that you're going to go start another company before this podcast is over, but your role at ORCID seems like a pretty big deal when you think about how critical digital persistent identifiers are. Tell me what you're trying to get done at ORCID or what you were working on at ORCID. Why digital identifiers are so important. 00;09;32;08 - 00;09;53;09 Yeah, So I guess the way to explain that is, you know, as you move from print, you know, people going to the library, when I started graduate school, we would go to the library, have a lot of time at the photocopy machine, photocopying stuff from journals. You know, people don't do that anymore. And everyone's looking for stuff on the Internet now. 00;09;53;09 - 00;10;14;06 You can't find things on the Internet unless you have a good key for finding things. Right. And for researchers, anybody with the name notices in my name, I have a fairly unique name, but it's not unique enough to be able to find all of the things that I've done and attach them to me. Even Google still gets me wrong. 00;10;14;06 - 00;10;47;00 I get messages every three weeks saying, Could you please update your record? So what ORCID does is it provides individuals with essentially this digital name, a unique digital persistent identifier that they can use as they're going through their regular workflows. Right. So for example, when you're applying for a grant, when you're registering as a new graduate student, when you're submitting a manuscript or a dataset to a repository, part of that transaction is you including your name and your digital name, your ORCID I.D, as you're going through that workflow process. 00;10;47;06 - 00;11;11;10 So it's not asking you to do any additional work other than basically using ORCID single sign on to go log into these systems, the systems, collect your ID and then attach that ID to the transaction. So now your paper includes your ORCID ID, now your grant includes your ORCID ID, your record at your university, includes your ORCID ID, etc., etc.. 00;11;11;10 - 00;11;34;24 So part of that workflow and one of the things I was really, really big on since graduate school was this idea that research outputs are so much more than just journal articles, right? This huge motivation for me, articles are how we talk about the work we do, right? But there's datasets, there's software code, there's instruments made. This committee is mentoring, teaching. 00;11;34;24 - 00;12;05;14 All of these things are integral parts of the research process. So ORCID was not just about, Here's my ORCID IDs. I publish a paper. It was a way to say to the individual, here you have power in determining what to include in your professional body of work. This is your idea. You decide when and where to use it, and you can also decide what is available on your ORCID profile for public view or sharing with trusted parties. 00;12;05;14 - 00;12;34;03 We were all about providing that power and agency to the individual and based on this presupposition, that individual should control what information is shared publicly regarding their digital reputation. And yeah, so I'm I'm proud that ORCID was has been and continues to be part of the story of providing a way for research as an agency over how they are viewed on the Internet and how people can find and see what they've been doing. 00;12;34;06 - 00;12;58;24 Yeah, it sounds like the way an artist would sign their painting, right? Except providing a digital way, a digital recognition of that. Right. And you started to see more artists using digital identifiers at DMS, things like that, to say, this is my work and essentially coded in the back end. So you can't steal or repurpose the art without some recognition or citation of the artist. 00;12;58;24 - 00;13;22;07 That's all of what this is about. Yeah, the applications go way beyond researchers. Yes. Yes. Now, as promised, we need to get these folks from research to commercialization. I've never seen science and research move so fast as it did during the pandemic, and of course, with good reason, we didn't have a lot of time to putz around with red tape and bureaucracy as we had to get a product to the market. 00;13;22;13 - 00;13;46;22 Now it feels like on university campuses around the world, there's a sense of look up our support and resources because we might have to do that again or produce spin outs. What does that framework look like today and what is the level of support? Yeah, and so I think, you know, part of this is how do folks in academics do commercial work, right? 00;13;46;23 - 00;14;14;22 And so I think starting off with how do we talk about ownership? And one of the big differences between academic and commercial research, of course, is intellectual property rights. Who owns the research output shapes how information is shared and how and what can be moved into a product, right? So for me, during COVID, one of the most impressive demonstrations of the power of open collaboration is the National COVID Cohort Collaborative. 00;14;14;22 - 00;14;46;04 Also known as NC three. And I love identifiers. They used open identifiers including ORCID and dyes and organization identifiers to attribute who made what data contribution, which is really awesome. And they also coupled that with this this really strong metadata framework that enabled the combination and the combination of contributed datasets and components of dataset. Talk about awesome. This is not something you could do in one company. 00;14;46;04 - 00;15;33;05 This requires a collaboration across labs and across corporate. This work was instrumental in driving early data sharing during the pandemic, so you couldn't have gotten the product without that data sharing, right? And part of that data sharing happened, at least in part because everyone who contributed data to the collaborative knew they would get credit, even if another group did the analysis and knew that if some missed study that was contributed or some dataset that was contributed was later withdrawn, that that data could be withdrawn from their analysis as well because of the way that persistent identifiers in metadata had been that that framework had been set up at the get go in NC three. 00;15;33;12 - 00;16;00;12 So the group managing the collaborative actually won the inaugural Data Works and Challenge Prize for data sharing earlier this year, and I encourage you to check it out. Is really phenomenal piece of work. And I personally think that's the way we need to start thinking about getting product to market is the step before that which is how do we enable data sharing that allows people to collaborate on these problems? 00;16;00;14 - 00;16;18;28 Yeah, after this, I think you should go work in Hollywood because, you know, you are you see these screenplays that were written by about 11 or 12 people and it's like, okay, who contributed what? Right now that industry kind of has the same problems of people being, you know, the collaborations and what was mine versus what was else's. 00;16;19;01 - 00;16;58;05 Right. But, you know, the world needs solutions. And the younger you are, the more you've gotten used to near instant gratification. We're used to seeing things happen. So have expectations and research shifted as well, or our research institutions moving as fast to commercialization as they can? What's driving that need to commercialize? Yeah, I mean, you've got the by dual act that shifted everything, at least in the US and there's been a strong push ever since then was in the mid-eighties right of where universities set up tech transfer offices and you know have patent attorneys on staff advising people. 00;16;58;05 - 00;17;23;14 There's a number of universities that have spin out incubators, things like that. If I don't think it's getting faster, if anything, I think some universities are realizing there's a huge amount of effort and money that they're putting into these centers that they may not be recouping there. It hasn't been a fast win for many universities in this space, but it's certainly active. 00;17;23;17 - 00;17;49;08 I think, again, coming back to my previous comment, I think in addition to these spin outs and commercialization, where academic IP intellectual property is acquired by a commercial entity, I think what I would love to see is more people considering this collaborative model, right? One in which there is incentive baked in for data sharing by all parties. 00;17;49;08 - 00;18;16;24 Right. And I like to see this civilly. Is it science fiction? Right. We can look at how high energy physics is done, right? There's this large inter-country collaboration at CERN using shared equipment and management. And, you know, researchers can openly access this facility, you know, by applying to work there. And three, this a covered example I just mentioned proved this concept in biomedical sciences. 00;18;16;24 - 00;18;43;18 Right. What I see that similar in both of these models is both the intent to collaborate on big Thorny and of course, expensive... /episode/index/show/researchinaction/id/27129654