Research in Action

Where are the biggest opportunities to leverage AI in cancer diagnosis and treatment? What are the biggest barriers remaining to move away from a one-treatment-fits-all approach to treating cancer? And how are AI, radiomics, machine learning and deep learning helping to understand which patients will respond best to which treatments?   We will learn all that and more in this episode of Research in Action with Otavio Clark, M.D. Ph.D. and Principal Research Consultant at Oracle Life Sciences.   ---------------------------------------------------------   Episode Transcript:   00;00;00;00 - 00;00;26;16 Where are the biggest opportunities to leverage AI in cancer diagnosis and treatment? What are the biggest barriers remaining to move away from a one treatment fits all approach to treating cancer? And how are ready omics, machine learning and deep learning. Figuring out which patients will respond best to which treatments will learn. All that and more on research and action in the lead in the world.   00;00;26;19 - 00;00;48;02 Hello and welcome to Research and Action, brought to you by Oracle Lifesci Answers. I'm Mike Stiles, and today our guest is Ottavio Clark and Oncology and Specialty Therapeutics executive at Oracle Life Sciences. Now that's a field he's been in his entire career. He has his Ph.D. in oncology and specializes in all things evidence based research, real world data, real world evidence.   00;00;48;02 - 00;01;13;25 And what we're going to be talking about today, AI and the critical field of cancer research. Octavio, thanks a lot for being with us today. I might tinker for the end of the invite. It's a pleasure to be here. And we are really discussing a fascinating issue. That is how the ACA is changing the healthcare landscape. But before we start, I'd like to make a disclaimer.   00;01;13;28 - 00;01;45;27 We would discuss a lot about the study's findings, but we have to to have in our minds that these results that you discuss, they are still early. These findings. We have yet to be validated in prospective longer term studies, but we will discuss the only things that we have a clear direction of the trend. You added that things are going, so it's important for everybody to to think about this product by the cancer, something introductory.   00;01;45;29 - 00;02;10;17 So I think that's pointing towards trends but not about something definitive when you see something moving on in this direction. Okay. Okay. Yeah, that's totally understood and understandable that that would be the case. I do really want to dive right into this so we can make good use of our time. So what are some of the more impressive advancements that we've made in cancer treatment lately?   00;02;10;17 - 00;02;40;18 And does that mean success rates are satisfactory? Has personalized medicine helped to that? Where are those most promising opportunities to improve personalized medicine where cancer is concerned? It's a revolution in personalized medicine. It changes everything in oncology. And honestly, when I was in the medical residence in 1996, 1998, I did not think that we could see these during my lifetime spent This person.   00;02;40;25 - 00;03;15;05 The medicine has changed the way that we practice quality because it's today for many different types of tumors. We can pick treatments that are tailored to read their genetic profiles, and it enhances the precision and the effectiveness of the therapies. We left our scenario before Where do we use the same drug for everything? And now we can get the genetic profile of the patient of the tumor and try to find a targeted therapy that is limited to any specific type of cell.   00;03;15;06 - 00;03;42;03 Sometimes growth genes. This is wonderful. It has improved a lot. The outcomes of the patients have been becoming better and better in the last years, but we still have challenges here. The first one is that we don't have this kind of personalized medicine for all types of tumors, and one very important things. Not all patients respond to the personalized medicine as we would expect.   00;03;42;05 - 00;04;13;05 What it means. We still have patients that do very well, but we still have patients that don't do so well as we would want to to to have it. So the overall success rate in treating cancer with this personalized medicine approach have improved, but they are not yet 653 across all cancer types in demographics. We are still trying to see some improvements in upfront patients elections.   00;04;13;08 - 00;04;39;27 That is, how can I making this personalization even better by selecting out the fraud patients that have a similar genetic profile, but that they can I can identify those that. Do you have a good response to the therapy and those that will not get a good response to the therapy? If we could do this separation based split, we would have a much more effective treatment.   00;04;39;27 - 00;05;10;15 Of course, what are the opportunities and being able to select those patients who are most likely to respond to a particular treatment and identify those who aren't likely to respond? I mean, how might those kind of better patient classifications affect the current staging systems and the epidemiology of cancer? That's a long history. But let's start. If you if you can select patients, we will, of course, be able to do two things.   00;05;10;15 - 00;05;32;29 The first one is offering the patients that whom you will you expect to have a good response to the treatment, to give an effective treatment, and you split the basis that we expect that you not respond to that kind of therapy. To me, you try to offer them some sort of therapy or to select a clinical trial for these patients.   00;05;33;01 - 00;06;06;08 Well, how are we dealing with this? First, there is are there is an artificial intelligence to that we call radio omics today. These are the army is is is a technique that can extract huge quantities of information from medical imaging like key MRI scans and so on. And these really omics can analyze very complex patterns that we human beings can not see and it can give us an additional classification.   00;06;06;08 - 00;06;41;20 And this is something that will help us in dividing this patient, possible responders and possible night responders when we integrated these Arabian Sea tourists in deep learning machine learning technologies, we can identify the subgroups of patients that will really be more beneficial. There is a very interesting study that was recently published this year to the European Studies. This patient included 1300 patients with no small cell lung cancer without early stage disease.   00;06;41;20 - 00;07;17;16 You let these early stage stage one station through this model was able to predict three, six, seven, 6% accuracy. The patients that would be old in not have a nearly relapse just after the treatment. So they analyzed the data from 3000 patients they put inside of these machine learning system. And in this system the tools could be told that around 40% of the patients could have avoided treatment that was not effective for them.   00;07;17;19 - 00;07;44;25 40%. This number is huge and it reflects what we see in practice. Even in this personalized medicine, we still have 46% of patients that would not respond adequately. The problem is we don't know how how to split the patients to be, how to they try to station. So they and these new tools, these artificial intelligence tools, the omics machine learning, deep learning, they are offering the opportunity for this better selection.   00;07;44;28 - 00;08;17;05 And of course it opens huge opportunities for research and development because, okay, we have now these subset of patients that we respond, what do you do with those that don't respond? So it's brought to the need for developing new drugs and new tools that when you get to these subset of patients that are not responding to current treatment into new developments and new new forms of treatment, well, but it is complex and it is still in its infancy.   00;08;17;05 - 00;08;40;27 Everyone's still trying to figure out what it can and can't do best, what the best applications are, What are the complexities of bringing a high end to cancer diagnosis and treatment? And, you know, in what ways do we need to kind of be careful as we start incorporating it? Yeah, we need to be very, very careful with this because we still don't know everything about even the specialists.   00;08;40;28 - 00;09;12;16 They they really don't understand how these tools fully functions. Well, we can really spend a day discussing this topic, but I'd like to call attention to three important feature is here. The first line is we have to care about data, privacy and security because these systems, they use patient data to be treatment. You know, you have to teach the machine about what to do, about what to do, analyze, and we have to have data from real patient.   00;09;12;18 - 00;10;03;21 And often these training data sets that people are using in different approach. So we have to be sure that they have privacy of the data. The security of the data is is assuring and that we have a legal standards like HIPA and that can maintain the confidentiality and the trust of the patient in the system. The second and very important one is the bias in many of these A.I. systems that you see that we have today, because they way that they are trained and again, the machine is learning what we want them to learn and they can sometimes perpetuate or amplify biases if they are trained in data that is not representative of the food   00;10;03;24 - 00;10;32;17 of the food population. One One very good example of these is that the accuracy of some A.I. tools into the noses of a melanoma. Melanoma is that I see that has a black sheet, a black color, and it is very common in people. It can occur in white people and in black people, but they must the A.I. tools, they have a bias for the white people.   0

What is the MOSAIC-NLP project around structured and unstructured EHR data? Why is structured data not really enough for drug safety studies? And to what degree is NLP speeding up access to data and research results? We will learn all that and more in this episode of Research in Action with Dr. Darren Toh, Professor at Harvard Medical School and Principal Investigator at Sentinel Operations Center. www.oracle.com/health www.oracle.com/life  www.sentinelinitiative.org -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;26;14 What is the MOSAIC and LP project around structured and unstructured data? Why is structured data not really enough for drug safety studies? And to what degree is NLP speeding up access to data and research results? We'll find all that out 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;26;14 - 00;00;50;14 I'm Mike Stiles. And today our guest is Dr. Darren Toh, professor at Harvard Medical School and principal investigator at Sentinel Operations Center. He's got a lot of expertise in Pharmacoepidemiology as well as comparative effectiveness research and real-world data. So, Darren, really glad to have you with us today. Thank you. My pleasure to be here. Well, tell us how you wound up where you are today.   00;00;50;14 - 00;01;26;22 What what attracted you in the beginning to public health? Good question. So I trained in pharmacy originally, and I got my Masters degree in Pharmaceutical Outcomes Research at a University of Chicago, Illinois, Chicago. And it's where I first learned about a field called Pharmacoepidemiology, which sort of very interesting to me because I like to solve problems with methods and data and pharmacoepidemiology.   00;01;26;22 - 00;02;00;29 It seems to be able to teach me how to do that. So I got into the program at the Harvard School of Public Health, and when I was finishing up, I was deciding between staying in academia and going somewhere and getting a real job. And that's when I found out about an opportunity within my current organization and I've heard great things about this organization.   00;02;00;29 - 00;02;29;26 So I thought I would give it a try. And the timing turned out to be perfect because when I joined, our group was responding to a request for proposal for what is called a mini sentinel pilot, which ultimately became the sentinel system that we have today. So I've been involved in the Sentinel system since the very beginning or before we began.   00;02;29;28 - 00;03;02;25 And for the past 15 years I've been with the system and the program and because I really like its public health mission and I'm also very drawn to the dedication of FDA, our partners and my colleagues to make this a successful program. Well, so now here you are, a principal investigator. What exactly is the Sentinel Operations Center? What's what's the mission there and what part do you specifically play in it?   00;03;02;27 - 00;03;52;26 Sentinel is a pretty unique system because it is a congressionally mandated system. So the Congress passed what is called the FDA Amendments Act in 2007. And within that FDA, the Congress asked FDA to create a new program to complement FDA existing systems to monitor medical product safety and more specifically, the Congress, US FDA, to create a post-market risk identification and analysis system that will be using data from multiple sources that will cover at least 1 million lives to to look at the safety of medical products after they are approved and marketed.   00;03;52;28 - 00;04;33;07 So in response to this congressional mandate, FDA launched what is called a Sentinel initiative in 2008 and in 2009 as I mentioned, FDA issued its request for proposal to launch the Mini Sentinel Pilot program, and the program grew into the sentinel system that we have today. So it's for my involvement. It sort of grew over time. So when I joined, as I mentioned, we were responding to this request for a proposal and we were very lucky to be awarded the contract.   00;04;33;09 - 00;05;04;05 So when it was starting, I serve as a one of the many epidemiologists on the team and I led several studies and I gradually took on more leadership responsibility and became the principal investigator of the Sentinel Operations Center in 2022. So I've been very fortunate to have a team of very professional and very dedicated colleagues within the operations center.   00;05;04;05 - 00;05;27;26 So on a day to day basis, we work with FDA to make sure that we can help them answer the questions they would like to get addressed. And we also work with our partners to make sure that they have the resources that they need to answer the questions for FDA. And most of the time I'm just the cheerleader in chief just to share my colleagues and our collaborators.   00;05;27;28 - 00;06;11;23 Now that's great. And and then specifically, there's the Mosaic NLP project that you're involved with. What is that trying to achieve and what are the collaborations being leveraged to get that done? So Sentinel Systems has always had access to medical claims data and electronic health record data or year data. One of the main goals for the current sentinel system is to incorporate even more data, both structured and unstructured, into the sentinel system and to combine it with advanced analytic methods so that FDA can answer even more regulatory questions.   00;06;11;25 - 00;06;40;09 So the Mosaic and NLP project was one of the projects that FDA funded to accomplish this goal. So the main goal of this project is to demonstrate how billing claims and data from multiple sources when combined with advanced machine learning and natural language processing methods, could be used to extract useful information from unstructured clinical data to perform a more robust drug safety assessment.   00;06;40;11 - 00;07;21;18 When we tried to launch this project, we decided that we would issue our own request for proposal. So there was an open and competitive process, and Oracle, together with their collaborators, were selected to lead this project. So I want to talk in broad or general terms right now about data sharing, the standards and practices around that. It kind of feels silly for anyone to say it's not needed, that we can get a comprehensive view and analysis of diseases and how they're impacting the population without it.   00;07;21;20 - 00;07;46;15 NIH is on board. It updated the DMS policy to promote data sharing. You know, the FDA obviously is leaning into this. So is data sharing now happening and advancing research as expected, or are there still hang ups? So I think we are making good progress. So I think the good news is data are just being accrued at an unprecedented rate.   00;07;46;17 - 00;08;28;21 So there are just so much data now for us to potentially access and analyze. There's always this concern about proper safeguard of individual privacy. And through our work, we also became very appreciative of other considerations, for example, the fishery responsibilities of the delivery systems and payers to protect patient data and make sure that they are used properly. So you mentioned the recent changes, including in data management, ensuring policy, which I think are moving us in the right direction.   00;08;28;26 - 00;08;56;23 But if you look closer at the NIH policy, it makes special considerations for proprietary data. So I would say that we have made some progress, but access to proprietary data remains very challenging. And the FDA, the NIH policy doesn't actually fully resolve that yet. When you think about the people who do make that argument for limited data sharing, they do mostly talk about what you just said about patient privacy.   00;08;56;23 - 00;09;25;20 IT proprietary data. Pharma is especially sensitive to that, I would imagine. So how do we incentivize the reluctant how can we ease their risks and concerns or can we? Yeah, it's a tough question. I think that this require a multi-pronged approach and I can only comment on some aspects of this. So I would say that at least based on our experience, the willingness or ability to share data often depends on the purpose.   00;09;25;23 - 00;09;55;29 That is, why do we need the data? Many data partners participate in Sentinel because of its public health mission, and our consideration is how would the data be used again, Is there proper safeguard of patient privacy and institutional interest? There are other ways to share data. For example, instead of asking the data to come to us, we can send analysis to where the data is.   00;09;56;06 - 00;10;34;22 And that is actually the principle follow by federated system like Sentinel. So we don't pull the data centrally. We send an analysis to the data partners and only get back what we need it. And it's usually in the summary level format. So that actually encourages more data sharing instead of less sharing. I would say that recent advances in some domains, such as tokenization and encryption, might also reduce some concern about a data sharing, a patient privacy concerns in academic settings.   00;10;34;29 - 00;11;24;26 We've been talking a lot about days, for example, for individual who collect the data and the people I propose to offer them authorship or proper acknowledgment if they are willing to share their data. But that is not sufficient in many cases outside of academic settings. If you look at what is happening in the past ten years or so, there are now a lot of what people call data aggregators that are able to bring together data from multiple delivery systems or health plans, and they seem to be able to develop a pretty effective model to convince the data provider to share that data in some way.   00;11;24;29 - 00;11;55;28 And a way to do that could be to help these data providers to manage their data more efficiently or to help them identify ind

How do clinical research funders operate? Why do patient-centered outcomes matter so much and improve the quality of research? And how is patient-led research being applied to clinical care? We will learn all that and more in this episode of Research in Action with Greg Martin, Chief Officer for Engagement, Dissemination, and Implementation at the Patient-Centered Outcomes Research Institute (PCORI).   www.oracle.com/health www.oracle.com/life  www.pcori.org/   --------------------------------------------------------   Episode Transcript:   00;00;00;00 - 00;00;21;14 How do clinical research funders operate? Why do patient centered outcomes matter so much and improve the quality of research? And how is patient led research being applied to clinical care? We'll find all that out and more on this episode of Research in Action.   00;00;21;16 - 00;00;45;16 Hello and welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles and today our guest is Greg Martin, chief officer for engagement, dissemination and implementation at the Patient Centered Outcomes Research Institute, referred to as PCORI. Greg's been with the organization 12 years or so, and prior to that spent time as manager of State government affairs for the American Academy of Family Physicians.   00;00;45;19 - 00;01;05;09 And we're going to be talking about no big surprise here, patient centered outcomes. So, Greg, we really appreciate you being with us. Well, thank you, Mike. It's a real pleasure and an honor to be here with you. I've listened to some of the podcasts and greatly benefited from the insights and the advice that you're bringing to folks through this, through this series.   00;01;05;09 - 00;01;23;29 So really just a real pleasure to be a part of it. Yeah, the show is really picking up steam and audience and getting some legs under it. All right. I guess let's start off by just having you describe your specific role at PCORI. What's your primary goal every day? And kind of also tell us about the overall purpose of PCORI.   00;01;24;02 - 00;01;46;12 Yeah, that's a great question. You know, and I always kind of joke around with folks that, you know, my mom does the classic two Bobs question from office space here. Remember that movie when I asked you about my job? What what exactly, son, would you say it is that a chief officer for engagement, dissemination and implementation does and it's a limited it's an uncommon title.   00;01;46;12 - 00;02;15;27 But the way I simplify it is that, you know, I get to work with a great team that is focused every day on how it is that people can be involved in the work that PCORI does as a funder, how they can be involved in the work that PCORI has funded and also how they can use in their everyday lives the evidence that property is funded and that last bit they're around evidence that that's why we're here.   00;02;15;28 - 00;02;57;06 PCORI is a clinical research funder. We were authorized by Congress. And interestingly though, even though we were authorized by Congress, we are an independent nonprofit and we're solely federally funded to do one thing, really, which is to fund patient centered comparative clinical effectiveness research or C.R. for short and C.R. as a specific type of research that's looking at intervention and approaches to health and care that are common in practice in the US health care system that stacks those interventions are approaches up against each other to really try and figure out what works best for whom.   00;02;57;08 - 00;03;19;14 But that patient centricity part in our name we take very seriously and we apply that to the C.R. We fund because it's not just about what works best for whom. It's about what works best for home according to their preferences. And that's where you get to the patient centricity. We all want to be healthy. We all want to live well, but we also want to do it in our own way.   00;03;19;14 - 00;03;48;06 We have slightly different definitions and that gets to that, that personalization of care, where we want to understand, given the options, what what should I reasonably expect will happen to me or what can I reasonably expect may come out of this for my loved one? That's the Cory Sweet spot. That's where we sit. And so I work with a great team that finds ways for people to be involved in that work, both again, what we're doing as a funder and the work that we fund.   00;03;48;09 - 00;04;12;23 Where does your passion for this work come from? Was there something you saw long ago in your work at the Academy of Family Physicians that kind of grew your interest in patient centered outcomes and how important that is? Yeah, that that's a great question, Mike. You know, and it's not something that's born from any single source. You know, I think all of us bring different lenses, different perspectives, different experiences to the table.   00;04;12;23 - 00;04;50;07 And one of the reasons why I'm so honored to have this job with PCORI is the fact that we recognize that and we in a way celebrate that and experiences that brought me to this to this point include, you know, that time working for American Academy of Family Physicians. It was a great time with them thinking through and working on issues related to the primary care workforce, health system delivery, health system design, how we pay for health care, how we pay for the myriad of services that make a difference in people's lives.   00;04;50;09 - 00;05;16;14 Prior to that, I've been with the National Conference of State Legislatures and working with state legislators and legislative staff of all stripes, thinking through how it is that we design and arrange systems of care to meet the needs of the people. And then that's the professional lens. But also, candidly, on the on the personal side, we all approach health care as patients, as families, as carers for people.   00;05;16;14 - 00;05;47;17 And we see and we live and we experience the multitude of ways in which our system works or does not. And we see the ways in which questions that we have those dilemmas around the decisions that we're faced with in our health and care and our families. Health and care have answers or don't. Those are the things that really drive me every day when I wake up and I think, okay, how can we advance the ball just a little bit to make life a little bit better for the next person?   00;05;47;19 - 00;06;07;27 Yeah, there's no one that doesn't touch and there's no one who's not affected by the system, the success of it or the shortcomings of it, whichever those may be. But research and especially research that involves the general public, that's not easy. What what does bakery do to create and foster engagement with patients and communities that really work and that matter?   00;06;07;29 - 00;06;41;00 It's no one simple answer. You know, we tend to think of it in terms of recognizing and appreciating the different contexts in which people exist and thinking through, okay, how is it that we can create an approach to engaging individuals from this community or this community itself in a way that's humble, responsive, resonant with the way in which they live their lives and they experience care.   00;06;41;02 - 00;07;14;20 And we also think about it in terms of a few different domains of activities that we can pursue that can foster an environment or an ecosystem where we can start breaking down these silos and breaking down these barriers that may have traditionally existed between research and community, between patients and investigators, between all other members of the health sector payers, insurers, employers, purchasers of care, clinicians of all stripes, hospitals and health systems, etc..   00;07;14;22 - 00;07;46;04 So as we've figured out the array of different tools that we should have at our disposal at the quarry and that we encourage others to develop, we want them into some some domains, some buckets, one of which is you've got to fund the practice of engagement. You know, engagement does require resources. When we first set out at the quarry over a decade ago, we heard clearly from investigators, traditional researchers and enthusiasm for getting closer to community.   00;07;46;04 - 00;08;18;17 But we heard clearly that they didn't have support through their institution and that our requirements may be some sort of unfunded mandate. We also heard clearly from patients and communities a likewise enthusiasm and a likewise concern that they didn't have structural support for their engagement and research. And so you've got to you've got to think about how it is that you are going to resource financially the venues, the forums, etc., for communities to come together with investigators.   00;08;18;19 - 00;08;46;24 You've also got to think through what are the facilitators for driving meaningful and effective engagement. So that's creating different tools and resources. And PCORI has many of these available on our website that we encourage others to use. But also as you look at these, you'll see that many of them are community generated themselves. Sometimes the best and most durable solutions are those that bubble up from the participants themselves.   00;08;46;26 - 00;09;12;04 There's also another domain of work that is really this notion of convening that you really need to think through how it is. We can bring people together because there's no substitution for the human touch, there's no substitution for human interaction and thinking through what are the different modalities that we can support people in bridging diverse perspectives in a complex space.   00;09;12;06 - 00;09;44;12 How can we help them see where it is that they may be using different language to say the same thing or the same language to mean different things? Quite common for us to all just talk past each other when we're really driving towards the same goal, but then also thinking through and this is where we've don

What makes multidisciplinary collaboration the key to health and life sciences research and innovation? What is the impact of bundled, integrated solutions on the patient experience? And how can we invest in what matters most in research while streamlining the entire process? We will learn all that and more in this episode of Research in Action with Frank Baitman, Digital Health, Data, and Technology Executive; and former Chief Information Officer of the US Department of Health and Human Services.   http://www.oracle.com/health http://www.oracle.com/life   -------------------------------------------------------   Episode Transcript:   00;00;00;02 - 00;00;27;22 What makes multidisciplinary collaboration the key to health care innovation? What is the effect of bundled, integrated solutions on the patient experience and how can we invest in what matters most while streamlining the entire process? We'll find all that out and more on Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;27;22 - 00;00;52;08 I'm Mike Stiles. And today our very special guest is Frank Bateman, a digital health data and technology executive. He's currently a senior health IT advisor and was a former chief information officer of the U.S. Department of Health and Human Services. Oracle Life Sciences has an e-book on the next phase of growth for the Life Sciences industry, and Frank was a really valuable resource for that.   00;00;52;08 - 00;01;22;00 He's got a lot of great thoughts on how pharma and biotech are investing in tech to support things like personalized medicine, improved clinical trials and drug safety tracking. That's why we wanted to get him on the podcast. So Frank, thanks so much for joining us. Thanks. It's great to be here, Mike. We appreciate it. Well, we got a lot of ground to cover, but I know you went into corporate strategy in the beginning of your career and through the bulk of your career, but obviously somewhere down the line you started crossing paths with government.   00;01;22;00 - 00;01;42;04 So what did that involve? How did that happen? Well, I've been lucky enough to pursue my interests wherever they took me. I hadn't expected to pursue a career in the life sciences and health care when I started out focused on nuclear arms control. But my interest in technology actually came about from my work on verification measures for a nuclear test ban.   00;01;42;21 - 00;02;09;05 Technology first took me to IBM Research and then under IBM corporate strategy, as you mentioned, when in in corporate, I oversaw the company's ten year outlook. And as a tech company, we saw high performance computing in the life sciences staring us in the face. We needed to be in it. And our chairman at the time, Lou Gerstner, accepted a recommendation that we invest 100 million to launch a business unit focused on the life sciences.   00;02;09;19 - 00;02;36;24 So I love the idea. You were actually serving in the Obama administration. White House Entrepreneur in residence. I love the idea of an entrepreneur in residence because one doesn't quickly equate government with speed, original ideas and innovation. Were you impressed by or frustrated by the speed at which you could bring things to full fruition in government? Impressed? Absolutely frustrated.   00;02;37;00 - 00;03;04;25 Yeah. Our times sometimes there are arcane processes that get in the way of novel solutions, but I always thought that had great admiration for the dedicated dedication the mission demonstrated by civil servants. Doing things differently was really a hallmark of the Obama administration. It wasn't just the Entrepreneur in Residence program you mentioned. Obama appointed the nation's first chief technology officer, the first chief information officer.   00;03;05;06 - 00;03;31;08 He launched the US Digital Service to provide agencies with a different approach to software development. He created challenge that guards as a means for agencies to seek innovations by awarding modest prizes as opposed to large government contracts. It brought new voices to light. I look at our current government a lot, like most governments, it's inherited its structure from the industrial age.   00;03;31;18 - 00;03;58;12 For the most part, it's organized by industry, by vertical. There's an Agriculture Department, energy, health, defense and so on. The congressional appropriations process is what exacerbates the problem in this information age. I really believe that Multi-disc culinary collaboration is what brings about solutions. And I don't have a background in biochemistry, but I worked with biochemists to explore therapies that made effective use in both of our disciplines.   00;03;58;25 - 00;04;23;21 If you think of Tesla for a moment, the company has innovations, it has inventions. But its real success was that of an integrator. It brought together knowhow from battery management, aerodynamics, automobile engineering, software development and legacy. Automakers had been working on these problems in building an EV for years, but their approach failed to deliver a car with mass market appeal.   00;04;24;00 - 00;04;47;06 And I think that's precisely what we need to do in the life sciences now, is bring the disciplines together and organize to solve problems. Now, I think the listeners are starting to see why you're such a fascinating person to have on the show. You've been exposed at high levels to nearly every component of health care, and through most of that you were tasked with being really a futurist and a trend spotter in it.   00;04;47;06 - 00;05;08;17 So just keep my head straight. I'm going to cover things with you in buckets now. The first being what the challenges and opportunities really are in life sciences. Fun fact for our listeners can bring up at their next dinner party. When things get dull, it takes about $2 billion and 10 to 15 years to get a drug to market.   00;05;08;17 - 00;05;30;27 Now, for most people who have gotten used to rapid advancement, getting things they want and need on demand, that sounds absolutely crazy. So can technology kind of change this equation soon? Mike I don't think that's crazy at all, and I really believe that we're on the cusp of change. One of the startups that I worked with, Empower Medicine, is a really great example.   00;05;31;11 - 00;06;04;00 What they're trying to achieve is a complex endeavor. It depends upon bringing together people from different disciplines to work across the universe of stakeholders. And going back to the Tesla example, GM and Ford built highly structured teams in engineering designed propulsion. But Tesla was a software company from the start. So I think the challenge is how do you, as a life sciences company, mimic what Tesla did to bring together the disciplines and focus on the entire process of drug development?   00;06;04;14 - 00;06;33;17 It's almost like if technology isn't the answer, what is? For instance, it's the only way really to capture the volume and sources of adverse events, right? We always look at adverse events and drug discovery thanks to that observation. Technology can do wonders, but it isn't nirvana. I it does great things, but I think it's always important to remember in health care there needs to be a human touch because health care at its core is about people.   00;06;33;28 - 00;07;02;27 Technology is already making waves in clinical trials and there's so much more to come. We're on the early stages witnessing that impact. Things like electronic patient reported outcomes and various sensors are beginning to gather data from patients during trials and during real world use. And this technology facilitates the capture of adverse events actively and passively, leading to just a wealth of data and deeper understanding of therapeutic effects.   00;07;03;19 - 00;07;31;23 This could uncover unexpected drug interactions or shed light and personalize or genomic attributes. Sometimes, though, adverse events are not obvious. And that's that's really another role that technology can play because of its ability to capture so much data, it may find unexpected things to match what's going on in the market. Actually, Oracle just merged its health care and Life sciences organization late last year.   00;07;31;23 - 00;07;55;24 Why do you think those two things are coming together? I know you talk about bringing things together and that's just like one example of it. Yeah, I think that's a really great example. I like to think of health as being all encompassing. The life sciences exist to support health. The same could be said for payors, providers, physicians, health systems, pharmacies, patients, Cros, even employers.   00;07;56;09 - 00;08;24;11 Each has their role to play. The vast majority of companies across the health sector have a mission or model that says something like Patients are the reason we're in business. Well, I'm not questioning it. In fact, I'm pretty confident people are involved, they're sincere. But if serving patients is your mission, I'd ask, when was the last time you took a look at your organization to see if it is optimally designed to address the needs of patients in this information age?   00;08;24;28 - 00;08;54;23 We know that siloed organizations underperform multiple disciplines and experiences are not considered. Information isn't shared in much. The way I spoke about HHS is being a reflection of the health sector by having a research component, by having a regulatory component, by having a provider component. I think that those companies that integrate health disciplines need to step out of their comfort zone in the same way that Oracle combined those pieces.   00;08;55;07 - 00;09;24;18 Now put I want to put that futurist hat on and tell us which innovations you think are going to have the most profound impact. On average, Mike's like me and say the next decade, What do you see coming? So I think it's importa

Why is the confluence of healthcare and life sciences happening? What are the two biggest mistakes of technology in healthcare? And how can research insights be embedded into every care decision? We will find out all that and more with our guest Dr. David Feinberg, a medical professional and healthcare industry executive and current Chairman of Oracle Health.   http://www.oracle.com/health http://www.oracle.com/life    --------------------------------------------------------   Episode Transcript:   00;00;00;02 - 00;00;27;22 What makes multidisciplinary collaboration the key to health care innovation? What is the effect of bundled, integrated solutions on the patient experience and how can we invest in what matters most while streamlining the entire process? We'll find all that out 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;27;22 - 00;00;52;08 I'm Mike Stiles. And today our very special guest is Frank Bateman, a digital health data and technology executive. He's currently a senior advisor to Oakland's De Silva and Phillips and was a former chief information officer of the U.S. Department of Health and Human Services. Oracle Life Sciences has an e-book coming on the next phase of growth for the Life Sciences industry, and Frank was a really valuable resource for that.   00;00;52;08 - 00;01;22;00 He's got a lot of great thoughts on how pharma and biotech are investing in tech to support things like personalized medicine, improved clinical trials and drug safety tracking. That's why we wanted to get him on the podcast. So Frank, thanks so much for joining us. Thanks. It's great to be here, Mike. We appreciate it. Well, we got a lot of ground to cover, but I know you went into corporate strategy in the beginning of your career and through the bulk of your career, but obviously somewhere down the line you started crossing paths with government.   00;01;22;00 - 00;01;42;04 So what did that involve? How did that happen? Well, I've been lucky enough to pursue my interests wherever they took me. I hadn't expected to pursue a career in the life sciences and health care when I started out focused on nuclear arms control. But my interest in technology actually came about from my work on verification measures for a nuclear test ban.   00;01;42;21 - 00;02;09;05 Technology first took me to IBM Research and then under IBM corporate strategy, as you mentioned, when in in corporate, I oversaw the company's ten year outlook. And as a tech company, we saw high performance computing in the life sciences staring us in the face. We needed to be in it. And our chairman at the time, Lou Gerstner, accepted a recommendation that we invest 100 million to launch a business unit focused on the life sciences.   00;02;09;19 - 00;02;36;24 So I love the idea. You were actually serving in the Obama administration. White House Entrepreneur in residence. I love the idea of an entrepreneur in residence because one doesn't quickly equate government with speed, original ideas and innovation. Were you impressed by or frustrated by the speed at which you could bring things to full fruition in government? Impressed? Absolutely frustrated.   00;02;37;00 - 00;03;04;25 Yeah. Our times sometimes there are arcane processes that get in the way of novel solutions, but I always thought that had great admiration for the dedicated dedication the mission demonstrated by civil servants. Doing things differently was really a hallmark of the Obama administration. It wasn't just the Entrepreneur in Residence program you mentioned. Obama appointed the nation's first chief technology officer, the first chief information officer.   00;03;05;06 - 00;03;31;08 He launched the US Digital Service to provide agencies with a different approach to software development. He created challenge that guards as a means for agencies to seek innovations by awarding modest prizes as opposed to large government contracts. It brought new voices to light. I look at our current government a lot, like most governments, it's inherited its structure from the industrial age.   00;03;31;18 - 00;03;58;12 For the most part, it's organized by industry, by vertical. There's an Agriculture Department, energy, health, defense and so on. The congressional appropriations process is what exacerbates the problem in this information age. I really believe that Multi-disc culinary collaboration is what brings about solutions. And I don't have a background in biochemistry, but I worked with biochemists to explore therapies that made effective use in both of our disciplines.   00;03;58;25 - 00;04;23;21 If you think of Tesla for a moment, the company has innovations, it has inventions. But its real success was that of an integrator. It brought together knowhow from battery management, aerodynamics, automobile engineering, software development and legacy. Automakers had been working on these problems in building an EV for years, but their approach failed to deliver a car with mass market appeal.   00;04;24;00 - 00;04;47;06 And I think that's precisely what we need to do in the life sciences now, is bring the disciplines together and organize to solve problems. Now, I think the listeners are starting to see why you're such a fascinating person to have on the show. You've been exposed at high levels to nearly every component of health care, and through most of that you were tasked with being really a futurist and a trend spotter in it.   00;04;47;06 - 00;05;08;17 So just keep my head straight. I'm going to cover things with you in buckets now. The first being what the challenges and opportunities really are in life sciences. Fun fact for our listeners can bring up at their next dinner party. When things get dull, it takes about $2 billion and 10 to 15 years to get a drug to market.   00;05;08;17 - 00;05;30;27 Now, for most people who have gotten used to rapid advancement, getting things they want and need on demand, that sounds absolutely crazy. So can technology kind of change this equation soon? Mike I don't think that's crazy at all, and I really believe that we're on the cusp of change. One of the startups that I worked with, Empower Medicine, is a really great example.   00;05;31;11 - 00;06;04;00 What they're trying to achieve is a complex endeavor. It depends upon bringing together people from different disciplines to work across the universe of stakeholders. And going back to the Tesla example, GM and Ford built highly structured teams in engineering designed propulsion. But Tesla was a software company from the start. So I think the challenge is how do you, as a life sciences company, mimic what Tesla did to bring together the disciplines and focus on the entire process of drug development?   00;06;04;14 - 00;06;33;17 It's almost like if technology isn't the answer, what is? For instance, it's the only way really to capture the volume and sources of adverse events, right? We always look at adverse events and drug discovery thanks to that observation. Technology can do wonders, but it isn't nirvana. I it does great things, but I think it's always important to remember in health care there needs to be a human touch because health care at its core is about people.   00;06;33;28 - 00;07;02;27 Technology is already making waves in clinical trials and there's so much more to come. We're on the early stages witnessing that impact. Things like electronic patient reported outcomes and various sensors are beginning to gather data from patients during trials and during real world use. And this technology facilitates the capture of adverse events actively and passively, leading to just a wealth of data and deeper understanding of therapeutic effects.   00;07;03;19 - 00;07;31;23 This could uncover unexpected drug interactions or shed light and personalize or genomic attributes. Sometimes, though, adverse events are not obvious. And that's that's really another role that technology can play because of its ability to capture so much data, it may find unexpected things to match what's going on in the market. Actually, Oracle just merged its health care and Life sciences organization late last year.   00;07;31;23 - 00;07;55;24 Why do you think those two things are coming together? I know you talk about bringing things together and that's just like one example of it. Yeah, I think that's a really great example. I like to think of health as being all encompassing. The life sciences exist to support health. The same could be said for payors, providers, physicians, health systems, pharmacies, patients, Cros, even employers.   00;07;56;09 - 00;08;24;11 Each has their role to play. The vast majority of companies across the health sector have a mission or model that says something like Patients are the reason we're in business. Well, I'm not questioning it. In fact, I'm pretty confident people are involved, they're sincere. But if serving patients is your mission, I'd ask, when was the last time you took a look at your organization to see if it is optimally designed to address the needs of patients in this information age?   00;08;24;28 - 00;08;54;23 We know that siloed organizations underperform multiple disciplines and experiences are not considered. Information isn't shared in much. The way I spoke about HHS is being a reflection of the health sector by having a research component, by having a regulatory component, by having a provider component. I think that those companies that integrate health disciplines need to step out of their comfort zone in the same way that Oracle combined those pieces.   00;08;55;07 - 00;09;24;18 Now put I want to put that futurist hat on and tell us which innovations you think are going to have the most profound impact. On average, Mike's like me and say the next decade, What do you see coming? So I think it's important to have a framework to think about this. And and I've begun to craft a mind map to ident

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

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 w

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 be

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 w

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

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 f

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 eve

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

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 crystallogra

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

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. http://www.oracle.com/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

How do the latest technologies impact epidemiology, clinical research, and public health? What kind of progress has there been in collaboration, open data, and citizen science? And in what ways can digital health appropriately supplement healthcare with the human touch? We will get the answers to these questions and more in this episode with Christine Ballard, a professionally trained epidemiologist specializing in clinical research and a Research Advocate at Oracle for Research. Christine has her Master of Public Health and is currently pursuing her Ph.D. in pharmacoepidemiology at UNC Chapel Hill. Her vast experience includes stints as an assistant professor and clinical research roles at Wake Forest Baptist Health, the University of Rochester Medical Center, and the New York State Department of Public Health. You can learn more about Oracle for Research here: http://www.oracle.com/research   --------------------------------------------------------   Episode Transcript: 00;00;00;00 - 00;00;24;21 What challenges do epidemiology researchers face in getting solutions to the public? What kind of progress has there been in collaboration, open data and citizen science? And in what ways can digital health appropriately supplement health care with the human touch? We'll get the answers to these questions and more on this episode of Research in Action, brought to you by Oracle for Research.   00;00;24;23 - 00;00;57;18 Hello. Welcome back to another episode of Research in Action, brought to you by Oracle for Research. I'm Mike Stiles, and today we have Christine Ballard with us. Christine is a professionally trained epidemiologist, specialized in clinical research. She has her master of public health and is working on her Ph.D. and pharmacoepidemiology at UNC-Chapel Hill. Her rather vast background includes stints as an assistant professor and clinical research roles at Wake Forest Baptist Health, University of Rochester Medical Center, and the New York State Department of Public Health.   00;00;57;20 - 00;01;26;08 She's currently a research advocate at Oracle for Research. And we're going to learn what those research advocates do and get into a lot more. Thanks for being with us, Christine. Thank you so much, Mike. I can't wait to dive into this. Oh, yeah. I'm looking forward to it as well. And I am going to ping you with questions about clinical research, epidemiology, pharmacoepidemiology as I keep tripping over that word, probably where is what kind of shape health care is in.   00;01;26;09 - 00;01;48;12 We're going to talk about that and some other stuff. But first, what got you as a person interested in this line of work? Kind of give us a little history lesson on Christine. You know, growing up, I lived in rural upstate New York, so I lived right outside of Rochester, right up on Lake Ontario, in a really small town of Albion, New York.   00;01;48;14 - 00;02;17;09 And, you know, there really wasn't a lot there in terms of researchers and health care access, to be quite frank. And, you know, I was diagnosed with type one diabetes at a really young age. I was diagnosed at eight and it I had a couple options When I got diagnosed, I could either face it head on or I could kind of sorrow in getting diagnosed and, you know, kind of letting it take over my life.   00;02;17;09 - 00;03;05;17 And I chose truly to jump two feet in. And I was so interested in being kind of up to date with all of the newest, latest, greatest technology and research updates. And I would find myself as a young kid trying to Google once Google became available, what certain words meant and really kind of educating myself about it. But quickly, growing up in a small town, not having that research access and really not having access to health care providers that even necessarily were familiar with that technology, my parents got me connected with the University of Rochester, and that's where I had a lot of my care growing up.   00;03;05;20 - 00;03;34;21 And really got to to learn and grow as as a kid alongside some of the brightest scientists in the field and it truly inspired where I wanted to go and was so excited when I entered college at the University of Rochester and really getting to work more hands on than you would as an eight year old kid and really just fell in love with the field.   00;03;34;21 - 00;04;06;24 And so I didn't know what epidemiology was even entering college and quickly kind of figured it out. During my studies. You know, like a lot of kids at the University of Rochester, you kind of go in premed, everyone's going to med school. And unfortunately I got rejected many times. And so when I got my MPH, I really fell in love with that and really getting the opportunity to dive into AP research.   00;04;06;24 - 00;04;59;01 And I did a little bit of that at the New York State Department of Health, but really got to spread my wings at the University of Rochester in the Department of Neurosurgery, really exploring health outcomes for patients and really understanding how do we make patients first in research and it kind of set me on this journey. So this past year, I got accepted into UMC Chapel Hill's PHARMACOEPIDEMIOLOGY program, where I get the opportunity to start to understand how pharmacy or pharmacology so all of the treatments that patients are receiving impact their care in certainly looking for ways to continue to always drive patient care and continuing to accelerate new discoveries.   00;04;59;03 - 00;05;23;28 And I absolutely love it and love that. Oracle's giving me the opportunity to do both things, work full time, and also be a full time PhD student. Yeah, I think that's kind of common. I've known several friends from high school who, you know, their path into medicine was a result of something that they experienced themselves, whether it was getting put back together after a car wreck or a disease that they have.   00;05;24;01 - 00;05;50;24 How does your personal health journey with Type one diabetes influence the way you approach research and your job at Oracle now? Because it is kind of a different lens than someone who's just coming at it. Purely academic, purely scientific. Yeah, I think I kind of have to wear both hats to be totally honest, but I think the way that I approach clinical research is really with patients in mind.   00;05;50;29 - 00;06;32;17 Patients have so much knowledge and experience that they can kind of engage in that research process and really understanding how to combine the patient perspective with the traditional research perspective has really been super rewarding and really engaging and allows me to bring my experience as a patient and certainly as a patient advocate forward. And now with Oracle get diving headfirst into the health care space, it really allows me to kind of bring a bit of that perspective to our researchers as well.   00;06;32;19 - 00;07;05;27 And always talking about the new discoveries that they're doing. But how can we relate it back to improving patient care and accelerating discoveries, understanding really how digital health can also revolutionize the way that we've been doing that versus I was that kid that would always bring Excel sheets to doctor's appointments. But I think, you know, I think digital health really is the opportunity to combine new technologies with accelerating the way that we're doing research, which I'm really excited about.   00;07;06;04 - 00;07;30;22 Well, you were talking about how when you were younger, you were making yourself an expert in your condition and probably, you know, seeking answers rather aggressively. Were you happy with the degree to which you were being listened to or did you just keep running up against a brick wall? MM That's a really good question. I have to say I was so lucky as a kid.   00;07;30;26 - 00;08;05;09 My physician was or I should say my nurse practitioner was a type one diabetic herself, which honestly gave me a completely new perspective on life and on the trajectory of the disease. To have somebody who's treating your condition, who is super busy as all of our advanced care practitioners and our MDs are so busy all the time, to see her living a life like that truly impacted where I wanted to go.   00;08;05;13 - 00;08;41;06 Going forward, I will say there were times where I felt like it would not just with my diabetes care, but, you know, with health care in general where you're experiencing something or feeling something and you're like, just listen. And I think that's really where being able to have that patient interaction and research is going to be really critical to understand the unique nuances of health things present in individuals because everybody is different, which I think is really going to help accelerate discovery a lot a lot more as well.   00;08;41;09 - 00;09;11;01 Well, what exactly is a research advocate, especially as it relates to being one for a company like Oracle? Why? Why is that important to advancing research? I think each one of us take on a slightly different role, but really the research advocate is to work alongside researchers to help them navigate huge corporations. And, you know, a lot of us are used to navigating the academic setting because that's what we're familiar with.   00;09;11;01 - 00;09;45;22 That's what we've experienced. But when you throw in a huge company like Oracle, you kind of get a little overwhelmed. And so as a research advocates role, I can I've got the research experience and have navigated the academic setting, but I also have the experience navigating industry through Oracle and so it's really helping the researchers translate what they're doing for their research and how that translate in the academic or nonprofit setting to the industry setting and helping them.   00;09;45;22 - 00;10;14;15 If there is projects that I can help with, we do everything from digital humanities to quantum physics and everything in between. And I am certainly not a

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: https://www.childrensmercy.org Learn more about Oracle for Researcher here: http://www.oracle.com/research ---------------------------------------------------------- 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

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: https://www.mightyredbarn.com Learn more about Oracle for Research: http://www.oracle.com/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

What is in silico drug design? And what role is it playing in drug discovery? How is cloud computing removing the limitations for in silico screening? We will learn those answers and more in this week’s episode with Dr. John Bruning, a Senior Lecturer in the School of Biological Sciences at the University of Adelaide in Southern Australia, where he also founded the University’s laboratory of protein crystallography. Dr. Bruning is also an Oracle for Research Fellow and was named a finalist for the 2022 Oracle Excellence Award in the Eureka Award category. Dr. Bruning received his Bachelor of Science from Texas A&M University and his PhD from Rice University. He has completed two post-doctoral research positions in structure guided drug design at the Scripps Research Institute and the Texas A&M Health Science Center in the Houston Medical Center. His research has been cited in numerous peer-reviewed journals. You can learn more about Dr. Bruning and his work here: https://researchers.adelaide.edu.au/profile/john.bruning Learn more about Oracle for Research: http://www.oracle.com/research