Research in Action

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Research in Action

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

  1. AUG 20

    AI's Role in Cancer Care Today and Tomorrow

    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.

    39 min
  2. Transforming public health with unstructured data and NLP in FDA's Sentinel Initiative

    JUL 23

    Transforming public health with unstructured data and NLP in FDA's Sentinel Initiative

    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 h

    35 min
  3. Empowering Patient-Centered Research Through Technology and Engagement

    JUL 9

    Empowering Patient-Centered Research Through Technology and Engagement

    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'

    39 min

  4. JUN 4

    Advancing clinical research through tech and teamwork

    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

    32 min

  5. MAY 22

    How Innovation is Redefining Health and Life Sciences

    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

    32 min

  6. APR 30

    Exploring New Frontiers in Pharma: Mindsets, Data, AI, and Oracle

    How can shifting mindsets fuel the next wave of innovation in the pharmaceutical and life sciences industry? In what ways can we ensure the vast amounts of health data are utilized securely and effectively to foster groundbreaking medical advancements? And how is Oracle's new Health Data Intelligence poised to transform the industry in an unprecedented manner? You’ll learn all that and more with our guest Michael Fronstin, Vice President and Chief Commercial Officer at Oracle Life Sciences, who has worked across nearly every area of the industry from positions at Merck to J&J to Kantar Health and now at Oracle.   --------------------------------------------------------   Episode Transcript:   00;00;00;04 - 00;00;26;25 In what ways do the mindsets in the pharma industry need to change? How can we make sure massive amounts of health data is applied to practical effect? And how might Oracle's new Health Data Intelligence platform be an unprecedented game changer? We'll find all that out and more on Research in Action. Hello, welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;26;25 - 00;00;49;15 I'm Mike Stiles. And today we've got a guest who's been a veteran in the life sciences industry and who knows Oracle Life Sciences quite intimately because the guest is Michael Fronstin, vice president and chief commercial officer at Oracle Life Sciences. He's worked across nearly every area of life sciences, from positions at Merck to J&J to Kantar Health and now at Oracle.   00;00;49;15 - 00;01;11;25 So, Michael, thanks for being here. Thanks, Mike. Happy to be here and thank you so much for hosting this session. Really appreciate it. Great. Well, you know, you're the perfect person to talk to about what I want to talk about, which is changing people's minds and changing how we even approach and think about life sciences. So you've got that to look forward to.   00;01;11;25 - 00;01;34;28 But first, let's learn a little bit more about you. How did your interests and opportunities in life take you down the path that led you to where you are now? Yeah, thanks for that question. That's that's a great question to start out with. I'll tell you that as human beings, we all have something going on in terms of health care, whether it's impacting ourselves or friends or family, everyone's going through something.   00;01;34;28 - 00;01;56;25 At some point. You just don't know what the magnitude is or how long lasting, right? So having patience and empathy is so important. And of course myself, I've gone through things and unfortunately starting at a very early age of 12, I lost my best friend to the brain cancer and from the time I was 12 to the time I was 21, unfortunately, I lost a lot of people to different health ailments.   00;01;57;11 - 00;02;17;10 I guess, climaxing with losing my father when I was 21 years old. During that time, I always thought about health care and how it was impacting the people around me and wondering what could I do? And I felt pretty helpless, to be honest with you during those times, because some young boy don't there and there really wasn't anything I can do.   00;02;17;10 - 00;02;35;01 But as I got older and I went into college, I realized I could make a difference in health care. And that was going to be the industry that I was going to focus on. So I went into social sciences, became a sociologist with a business math background, and went to graduate school for an MBA in health care arbitration.   00;02;35;10 - 00;02;56;07 And that's when really things opened up to me where I started saying, okay, what aspect do I like? Where can I make a scalable impact? And I ended up joining Humana A down in Florida for a year or so, realizing that I can make a difference there and get people enrolled, help them get claims processed and paid. And from there my career took off.   00;02;56;07 - 00;03;21;02 I end up going to Merck, carried the bag and really experience the in office experience back in the days of the early nineties in terms of what patients were experiencing, seeing doctors who were really, really good and so much good at diagnosing patients and treating them in a time where most of the chronic conditions didn't have treatments available and new ones were coming out.   00;03;21;16 - 00;03;53;06 And I'll tell you, it was pretty exciting during these times being at Merck and seeing all these innovations. But I'll tell you, during that time I was really able to focus on one therapeutic area and it wasn't very scalable. It wasn't really having the impact it wanted. And it wasn't until I came to the consulting side of the business, you know, working with dozens of customers and maybe hundreds of brands over the past 20 plus years where I really felt like maybe a direct and indirect impact on people's lives around the globe.   00;03;53;28 - 00;04;16;02 So that's that brings me to today. And now I'm with Oracle Life Sciences, where I feel like it's even bigger and broader and better. So I'm excited about the present. I'm excited about the future. Yeah. You mentioned you kept repeating a phrase that kind of struck stuck with me, which is that you wanted to make a difference. Is that hard to do in the health care space?   00;04;16;02 - 00;04;39;12 I mean, have you been gratified by your ability to do that or has it always been a push and pull? Oh, interesting question. Definitely a push. And so, you know, sometimes you can you can make decisions and get them executed very quickly. Other times, it takes a while to do. You know, you have regulatory bodies that you have to deal with different types of payers around the world.   00;04;39;22 - 00;05;04;19 Decisions are always made quickly. And if it's the right decision because of various reasons, whether it's bureaucracy or internal or external, or you need to generate real world evidence modeling or even publications, we have more than 2000, maybe 3000 publications, and you develop the evidence, you submit the publication. It could take, you know, six months, a year, two years to get it published right?   00;05;04;19 - 00;05;24;14 So things just take time, unfortunately. But yeah, you can make a difference. I feel like I've made a difference. I feel pretty gratified about what I've done. And in the areas of the impact that I've made. So and a lot of it is just make an impact within your world and hoping that you can expand it beyond to make a broader impact.   00;05;24;14 - 00;05;59;11 You were at Kantar Health for like 17 years or so. How did what Kantar does align with Oracle Life Sciences and the idea behind just leveraging technology to benefit customers and partners? I'm actually coming on 19 years since we think about it and you mention it. So when I step back and think about my time at Bert or Change in Merck and the broader industry, life science clients need to accomplish three things in order to get their compound, whether new or existing compound, really the new compounds into the hands of the appropriate patients.   00;05;59;11 - 00;06;24;18 They need to get their drugs approved right by some regulatory authority. They need to get them reimbursed and they need to have a strong launch to drive awareness. Otherwise no one's going to prescribe it or patients. People aren't going to request it, right. So those three things need to need to occur. Kanter Health is really focused on the second and third in terms of the research services and expertise.   00;06;25;00 - 00;07;10;02 So the types of people are. Kanter Help are methodologies, social scientists like epidemiologists, psycho nutrition, these these are the folks that know how to design and conduct research, how to consult on the research from a Real-World evidence perspective and driving insights, evidence from a commercial planning perspective, prioritization, things like that. Where is the Oracle Life Sciences group? The other side of the group is really all about technology and applications predominantly focused on driving clinical trials for regulatory approval, of course, and in the area of pharmacovigilance during those trials and tracking them when those products are in the real world.   00;07;10;06 - 00;07;38;08 Right. Post-marketing authorization. So when you bring these two groups together and these types of people together, the technology, the medical intelligence, the scientific, methodological experience of the cancer health folks, have you got the best of all worlds, right? Technology, data experience combined. You take these wraparound services with the technology in and now our clients are able to see a much higher level of value, if you will.   00;07;38;23 - 00;08;02;25 Well, you've actually been anything but shy in the past about saying how the mindsets in the pharma industry really need to change. So what is the current mindset? And in what ways is it limiting? I'll tell you, the health care industry, including life sciences, has always been a little bit of a laggard in terms of of our movement.   00;08;03;11 - 00;08;30;15 Part of that issue is that we we operate in silos, right? And even within our life science clients or customers, the different cross-functional teams don't always come together. They don't know each other. Sometimes they buy the same data, right? So the inefficiencies of spending more budget than they need to, we're not leveraging the same data for different purposes, and we really need to break down the silos.   00;08;30;29 - 00;08;53;15 I think that from a mindset perspective, individuals on every side of the business really need to step back and pick up their heads and look around, see the big picture, understand where are we going? The data is critically important. Big data was becoming the buzzword ten, 15 years ago, but no one really knew what that B meant. Well, now it's here.   00;08;53;22 - 00;09;14;06 We could do something

    37 min

  7. APR 16

    Unlocking Innovation Through Public, Private, and Academic Partnerships

    What are the best ways to set up public, private, and academic clinical research partnerships? How do we get these public-private partnerships (PPP) to work most effectively? And who should be in charge of what in multistakeholder research collaborations? We will get those answers in more in this episode of Research in Action with our guests Rob King, President and CEO of FHI Clinical; and Dr. Kristen Lewis, Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.   ---------------------------------------------------------   Episode Transcript:   00;00;00;01 - 00;00;22;22 What are the best ways to set up public-private clinical research projects? Where does and should the money for such research come from and who should be in charge of what? We'll get those answers and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;22;22 - 00;00;50;05 I'm Mike Stiles. And today we're just trying to outdo ourselves by talking to not one, but two very interesting people. First is Rob King, president and CEO of FHI Clinical. FHI uses Oracle's clinical trial software for their clinical operations and partner with public entities like PATH, which brings me to Dr. Kristen Lewis, who is Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.   00;00;50;26 - 00;01;29;23 I could go through what each of these organizations do just to hear myself talk, But why do that when I have both of you here? So, Rob, tell us what FHI Clinical does. Yeah, I think Mike, so clinical in a contract, they were actually for profit and hearing of a large nonprofit called F8 had three ethically and while we are for profit empathy, our mission is to address unmet research needs and maximum social impact pouring into development of medical treatment around the world.   00;01;30;04 - 00;01;58;20 While we work globally, we tend to focus on the low and middle income country on the whole pharma and biotech client are also include nonprofits and government. Empathy. Well with biotech receive public funding and path having him be one of our client. Appreciate Kristen being here arguing that four years ago and I'm currently the CEO and I'm happy to be here.   00;01;58;20 - 00;02;22;19 Well great. Kristen what about PATH? Yeah, thanks for the introduction, Mike. It's a pleasure to speak with you and Rob today and have the opportunity to contribute to this discussion. So most people listening to this podcast may not be familiar with PATH. We're a nonprofit global public health organization with approximately 1600 employees worldwide. Our headquarters are in Seattle, Washington, and we have offices across the African and Asian continents and Europe.   00;02;22;19 - 00;02;53;00 Some of the locations we have offices in include Kenya, Ethiopia, Senegal, Uganda, Zambia, India, Vietnam, Ukraine. And I could go on, but I'll I'll hold hold it there. Our mission is to advance health equity through innovation and partnerships. We do this with the help of local and global partners by generating evidence, advancing innovation and strengthening local capacity to improve health in countries and communities that are experiencing disproportionate burdens of disease and barriers to well-being, specifically in low and middle income countries.   00;02;53;11 - 00;03;26;01 This includes working in over 70 countries across the African, Asian, Latin American, European and North American regions. Within Paths Center for Vaccine Innovation and Access, we drive the mission of achieving health equity using a three-pronged approach, including developing, facilitating and implementing global market and policy solutions to ensure sustainable supply and equitable access to vaccines. Supporting country led efforts to advance national health equity priorities, and to strengthen immunization system resilience and driving innovation and technological advances.   00;03;26;01 - 00;03;50;20 To accelerate and optimize access to vaccines. Now, this last point is where my work is focus. Thus, during today's discussion, I'll be speaking with the lens of developing vaccines for disease indications benefiting low and middle income countries, and the importance of public private partnerships in achieving that goal. And just to note, you'll note a common thread there in the introductions from both Rob and myself, and that's the low and middle income country focus.   00;03;50;20 - 00;04;15;17 And I think that you'll start to hear some commonalities come into play as we go further into this session. Great. Well, I think what I want to get into here is kind of what you talked about is the value of public private partnerships in clinical research. Rob, give me the honest first reaction that a lot of private companies have when it is suggested that they partner with a public or a government organization.   00;04;15;17 - 00;04;45;18 Is that something that they jump at with open arms or is there any hesitancy? How does that go down? You know, with recently reading an article about one of the first public private partnerships and it was how mail really hit home, like, you know, for most of our listener, what most people won't be familiar with are the initiative around vaccination for diseases like polio and Spanish flu, MENA and rubella.   00;04;46;00 - 00;05;33;19 And we tend to have short memories. And they and the devastating impact they've had on society prior to vaccination and treatment options or with also that treatment developed over HIV and AIDS and then most recently the COVID pandemic. So with that said, you know, private companies maintain the shy away from what we call the triple P public private partnership in the funding limitations that my, you know, government based funding required a lot of compliance when the whole myriad of regulations and public kind of activity may have restricting how and where or how and when fund your, you know, without experience are now horsepower in the public private partnership.   00;05;34;07 - 00;06;09;21 It creates see private companies to engage and may see growth for example will not serve as a prime contractor on government funding work because when you're in the accounting and you're when the regulatory compliance and you'll only see those of normal commercial contracts, therefore they can turn them and be overly burdensome for those companies to pay. And public private partnerships, you have to have an operational model that meets the unique need of that partnership.   00;06;10;03 - 00;06;36;15 And at the end of the day, you really can't you can't get value for society that public private partnerships have contributed to. And Kristen, from the nonprofit or public side, what what is the benefit of partnering with private companies? Yeah, that's a great question. And I think to answer that, I'd first like to highlight some of the major successes when these partnerships have come together.   00;06;37;04 - 00;07;05;23 PATH has played through public private partnerships. PATH has played a critical role in some of immunizations, created successes over the past 30 years in lmics low and middle income countries. This includes developing the world's first malaria vaccine, which has now reached more than 2 million children, eliminating meningitis epidemics in Africa following introduction of the A4 backed vaccine protecting over 300 million children from Japanese encephalitis, vaccinating millions of girls against HPV.   00;07;06;06 - 00;07;33;20 And I could go on. But those are some some highlights. Path has not achieved these accomplishments in isolation. These successes have been catalyzed via public private partnerships models, and they're examples of which the private sector alone may not have been interested in developing these indications. These vaccine indications for low and middle income country use due to financing or budget considerations or constraints or some of the points that Rob made earlier.   00;07;34;00 - 00;08;03;13 However, with partnerships between PATH and private entities, including finance mechanisms for rollout and use of the vaccines in the regions following development, we've been able to champion development and introduction of vaccines that might not usually have generated sufficient interest for the investment that's required for full development. So in a nutshell, public private partnerships are the bread and butter of our work and integral to the goal of achieving improvements in global public health among populations facing economic challenges worldwide.   00;08;03;24 - 00;08;43;19 Well, so it feels like these partnerships would automatically create multiple stakeholders. So, Rob, how hard is it to make sure that the goals and priorities are aligned amongst all these people and stay aligned? First, I think I have a, you know, expectation and the goals are higher for public private partnership and for commercial initiative. You know, eight you public five, there is an expectation that you're going to achieve the goal or outcome and you're held accountable for how those on her spent.   00;08;44;11 - 00;09;27;10 You're not accountable to a or stockholder, but general public. And you know, public funds are unlimited and there are every dollar may account for whatever goal they're trying to achieve. And we're spending public funds a buying or accounting of how this on her being spent and her limitation on this on and how there may not be extra funds or reserve goes back to if those funds start to run low and usually the public entity defines the impact and the work that has to be completed in ensuring that the funding is in place.   00;09;28;01 - 00;09;53;24 And they then tracking the work that the private company may have contractually in their you mean clear terms on what's being delivered and the restrictions that may

    34 min

  8. MAR 19

    Advancing scientific discovery with patient-led research

    How can patients and their families become more integral in the clinical research process? How can patient-led research become more accepted in the scientific community? How are inspiring groups forging new, collaborative paths for science and medicine, and reshaping how medical research is conducted?  We will tackle those questions and much more in this episode with Amy Dockser Marcus, a Pulitzer Prize-winning journalist and author of the recently published book, “We the Scientists: How a daring team of parents and doctors forged a new path for medicine.” Amy is a veteran reporter at the Wall Street Journal and won her Pulitzer Prize for Beat Reporting in 2005 for her series of stories about cancer survivors and the social, economic, and health challenges they faced living with the disease. She has covered science and health at the Journal for years, and she also earned a Masters of Bioethics from Harvard Medical School.  -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;24;19  How can patients and their families become the centers of research? What is open science and who are citizen scientists? We'll explore those questions and more on this episode of Research and Action in the lead in. Hello and welcome back to Research and Action, brought to you by Oracle Life Sciences. I'm your host, Mike Stiles, and our guest is Amy.     00;00;24;19 - 00;00;48;22  Dr. Marcus That's right, that Amy Marcus, the Pulitzer Prize winning journalist, reporter at the Wall Street Journal, a Pulitzer Prize, was won for her series of stories in 2005 about cancer survivors and the social and financial challenges of living with cancer. Her beat, as you would imagine, has long been science and health. And she holds a master's of bioethics from Harvard Medical School, and she's an author.     00;00;48;22 - 00;01;04;26  Her book is We The Scientists How a Daring Team of Parents and Doctors Forged a New Path for Medicine. So this should be interesting as we talk about collaborative, open science and the rise of citizen scientists and patient led research. So thanks for being with us, Amy.     00;01;05;01 - 00;01;06;22  I'm happy to speak with you today.     00;01;06;22 - 00;01;26;29  Great to have you. In your new book, you take readers through some really, frankly, heart wrenching experiences that patients and their families have gone through with a rare and devastating disease called Niemann-pick. Hopefully I'm pronouncing that correctly. Tell us about the book and that disease and what fascinated you about this story.     00;01;27;14 - 00;02;01;21  The origin of the book really is a personal story, which is my mother got diagnosed with a rare type of cancer. And when I tried to do research on her behalf, I started to learn how challenging it is to develop drugs for rare diseases. After she passed away, I took some time off from the Journal. I had a research grant from the Robert Wood Johnson Foundation and I started traveling around the country looking to see if there were new models that might accelerate drug discovery.     00;02;01;29 - 00;02;25;21  And during the course of that research, I was introduced to a group of parents whose children have this rare and fatal genetic disorder, NIEMANN-PICK type C disease. It's a cholesterol metabolism disorder, so the cholesterol doesn't get out of the lysosome and that compartment in the cell and it starts to build up and it causes all kinds of problems.     00;02;25;21 - 00;02;52;12  And the children eventually lose the ability to walk and to talk and to feed themselves. But the parents that I met wanted to do something novel. They had found a group of scientists and researchers and clinicians and even some policymakers in the government that wanted to work together as partners and to see if they could accelerate the search for a cure or an effective therapy for an epic disease.     00;02;52;19 - 00;02;58;11  And they let me follow along during the course of that partnership for over ten years.     00;02;58;24 - 00;03;05;24  That's amazing that you got that kind of insight. And what did you learn over the course of that ten years?     00;03;06;22 - 00;03;34;15  Well, I was really interested in how they saw the production of science in a different way. They all wanted to try to save or extend the children's lives The disagreements lay in. How do you go about prioritizing drugs? What amount of risk is a patient or a patient's family willing to take compared to the level of risk that a doctor or scientist wants the patients to take?     00;03;34;15 - 00;03;54;14  These sorts of tensions arose, I think, in part because they were modeling a new method of where the patients expertise was considered as valuable or even at the center of this of this project. And that's not usually how it is.     00;03;54;14 - 00;04;09;09  But that's rare, right? I mean, in our in the culture of our health care system, it's not really common that the patients input or the patients families input is invited at all.     00;04;09;19 - 00;04;34;11  Yeah, I think that that you're right about that. I mean, the traditional way of setting things up is that the scientists devise the hypotheses and they then construct trials in conjunction with clinicians and sometimes with pharmaceutical companies, of course. But in this particular collaboration that I was describing, the drug was not in the hands of a pharmaceutical company.     00;04;34;11 - 00;04;59;06  It was widely available. And so the partnership was truly about, you know, going to be conducted at the NIH. And therefore it gave the parent and the families, I think, more leeway to do this experimental idea. What if we all recognized each other's expertise? What if we all saw each other as equal partners? What if we got to weigh in?     00;04;59;13 - 00;05;20;24  Not in once. You've already set up the clinical trial, but at the very, very outset, when you're simply going through the scientific literature to come up with potential compounds, when you're thinking about what might work, when you're trying to prioritize what to do first, second and third, all of those things where patients don't always have a voice. But in this case they really did.     00;05;21;07 - 00;05;43;16  You know, we just had Hilary Hannah Ho on the show. She's secretary general of the Research Data Alliance, and we talked about open science and open data and how important all that is to getting the scientific breakthroughs that will actually help people and get to those breakthroughs faster. But open science can kind of be polarizing. There's some confusion around what exactly it means.     00;05;43;23 - 00;05;48;14  How would you define or describe open science and citizen scientists?     00;05;48;27 - 00;06;34;22  Yeah, I think that's a really good point, that there isn't one sort of accepted name and that there are many names and people use different phrases when they're thinking about different things. For me, I used the term patient LED research and I often use the term citizen science. And what I meant by that was, again, what we've been talking about from the outset, which is a recognition that the patient, the patient experience should be at the center of everything, a recognition that the patient and the families are experts, that they have the ability not only to be beneficiaries of scientific knowledge, but also creators of scientific knowledge.     00;06;34;27 - 00;06;46;15  And to me, that shift the idea that you can be a creator of scientific knowledge is the fundamental one that needs to happen if we're going to really reach the goals that I think we all want to reach.     00;06;46;29 - 00;07;11;10  So here's something we highlighted in your book. Quoting here Science is inherently a social enterprise. Yet too often scientists operate behind closed doors, removed from the very people they intend to help. That's struck me as kind of a mike drop statement with a lot of truth to it. But did the pandemic change anything? Was the work still removed from those patients on ventilators and ICU?     00;07;11;20 - 00;07;52;04  So I do make a point in the book to draw some parallels between the various patient led research movement experiences that I describe and the COVID 19 pandemic, and in particular the group of patients that call themselves long COVID patients, where they're suffering symptoms for many, many months. I argue that COVID allowed us in real time to to recognize that anyone can be an expert and that now that is something that it was easier to see during the pandemic because there was a novel virus, there weren't established experts yet.     00;07;52;14 - 00;08;25;28  And so while doctors and scientists and the government were scrambling to try to help patients, I think they also saw themselves for the first time as part of this effort to understand the disease. Together, there wasn't already an understanding of COVID 19. And so what I say in the book is that we can draw from from that experience and sort of take that part of it forward where we say patients should be at the center of things.     00;08;26;06 - 00;09;07;01  Patients are experts. Patients are able to identify things that many scientists or doctors didn't have time to recognize because they were they had to focus on trying to save lives and, you know, working in a vacuum at that point. So there also was a sense of urgency. Like one of the things that I was struck by during the pandemic as a as a science reporter was that scientists were able to put their papers online right away on these

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4.7
out of 5
3 Ratings

About

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

Information

  • Creator
    Oracle Corporation
  • Years Active
    2022 - 2024
  • Episodes
    31
  • Rating
    Clean
  • Copyright
    © 2023
  • Show Website
    Research in Action

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