>>Welcome to this exclusive discussion. IBM, the next three years of life sciences, innovation, precision medicine, advanced clinical data management and beyond. My name is Dave Volante from the Cuban today, we're going to take a deep dive into some of the most important trends impacting the life sciences industry in the next 60 minutes. Yeah, of course. We're going to hear how IBM is utilizing Watson and some really important in life impacting ways, but we'll also bring in real world perspectives from industry and the independent analyst view to better understand how technology and data are changing the nature of precision medicine. Now, the pandemic has created a new reality for everyone, but especially for life sciences companies, one where digital transformation is no longer an option, but a necessity. Now the upside is the events of the past 22 months have presented an accelerated opportunity for innovation technology and real world data are coming together and being applied to support life science, industry trends and improve drug discovery, clinical development, and treatment commercialization throughout the product life cycle cycle. Now I'd like to introduce our esteemed panel. Let me first introduce Lorraine Marshawn, who is general manager of life sciences at IBM Watson health. Lorraine leads the organization dedicated to improving clinical development research, showing greater treatment value in getting treatments to patients faster with differentiated solutions. Welcome Lorraine. Great to see you. >>Dr. Namita LeMay is the research vice-president of IDC, where she leads the life sciences R and D strategy and technology program, which provides research based advisory and consulting services as well as market analysis. The loan to meta thanks for joining us today. And our third panelist is Greg Cunningham. Who's the director of the RWE center of excellence at Eli Lilly and company. Welcome, Greg, you guys are doing some great work. Thanks for being here. Thanks >>Dave. >>Now today's panelists are very passionate about their work. If you'd like to ask them a question, please add it to the chat box located near the bottom of your screen, and we'll do our best to answer them all at the end of the panel. Let's get started. Okay, Greg, and then Lorraine and meta feel free to chime in after one of the game-changers that you're seeing, which are advancing precision medicine. And how do you see this evolving in 2022 and into the next decade? >>I'll give my answer from a life science research perspective. The game changer I see in advancing precision medicine is moving from doing research using kind of a single gene mutation or kind of a single to look at to doing this research using combinations of genes and the potential that this brings is to bring better drug targets forward, but also get the best product to a patient faster. Um, I can give, uh, an example how I see it playing out in the last decade. Non-oncology real-world evidence. We've seen an evolution in precision medicine as we've built out the patient record. Um, as we've done that, uh, the marketplace has evolved rapidly, uh, with, particularly for electronic medical record data and genomic data. And we were pretty happy to get our hands on electronic medical record data in the early days. And then later the genetic test results were combined with this data and we could do research looking at a single mutation leading to better patient outcomes. But I think where we're going to evolve in 2022 and beyond is with genetic testing, growing and oncology, providing us more data about that patient. More genes to look at, uh, researchers can look at groups of genes to analyze, to look at that complex combination of gene mutations. And I think it'll open the door for things like using artificial intelligence to help researchers plow through the complex number of permutations. When you think about all those genes you can look at in combination, right? Lorraine yes. Data and machine intelligence coming together, anything you would add. >>Yeah. Thank you very much. Well, I think that Greg's response really sets us up nicely, particularly when we think about the ability to utilize real-world data in the farm industry across a number of use cases from discovery to development to commercial, and, you know, in particular, I think with real world data and the comments that Greg just made about clinical EMR data linked with genetic or genomic data, a real area of interest in one that, uh, Watson health in particular is focused on the idea of being able to create a data exchange so that we can bring together claims clinical EMR data, genomics data, increasingly wearables and data directly from patients in order to create a digital health record that we like to call an intelligent patient health record that basically gives us the digital equivalent of a real life patient. And these can be used in use cases in randomized controlled clinical trials for synthetic control arms or natural history. They can be used in order to track patients' response to drugs and look at outcomes after they've been on various therapies as, as Greg is speaking to. And so I think that, you know, the promise of data and technology, the AI that we can apply on that is really helping us advance, getting therapies to market faster, with better information, lower sample sizes, and just a much more efficient way to do drug development and to track and monitor outcomes in patients. >>Great. Thank you for that now to meta, when I joined IDC many, many years ago, I really didn't know much about the industry that I was covering, but it's great to see you as a former practitioner now bringing in your views. What do you see as the big game-changers? >>So, um, I would, I would agree with what both Lorraine and Greg said. Um, but one thing that I'd just like to call out is that, you know, everyone's talking about big data, the volume of data is growing. It's growing exponentially actually about, I think 30% of data that exists today is healthcare data. And it's growing at a rate of 36%. That's huge, but then it's not just about the big, it's also about the broad, I think, um, you know, I think great points that, uh, Lorraine and Greg brought out that it's, it's not just specifically genomic data, it's multi omic data. And it's also about things like medical history, social determinants of health, behavioral data. Um, and why, because when you're talking about precision medicine and we know that we moved away from the, the terminology of personalized to position, because you want to talk about disease stratification and you can, it's really about convergence. >>Um, if you look at a recent JAMA paper in 2021, only 1% of EHS actually included genomic data. So you really need to have that ability to look at data holistically and IDC prediction is seeing that investments in AI to fuel in silico, silicone drug discovery will double by 20, 24, but how are you actually going to integrate all the different types of data? Just look at, for example, diabetes, you're on type two diabetes, 40 to 70% of it is genetically inherited and you have over 500 different, uh, genetic low side, which could be involved in playing into causing diabetes. So the earlier strategy, when you are looking at, you know, genetic risk scoring was really single trait. Now it's transitioning to multi rate. And when you say multi trade, you really need to get that integrated view that converging for you to, to be able to drive a precision medicine strategy. So to me, it's a very interesting contrast on one side, you're really trying to make it specific and focused towards an individual. And on the other side, you really have to go wider and bigger as well. >>Uh, great. I mean, the technology is enabling that convergence and the conditions are almost mandating it. Let's talk about some more about data that the data exchange and building an intelligent health record, as it relates to precision medicine, how will the interoperability of real-world data, you know, create that more cohesive picture for the, for the patient maybe Greg, you want to start, or anybody else wants to chime in? >>I think, um, the, the exciting thing from, from my perspective is the potential to gain access to data. You may be weren't aware of an exchange in implies that, uh, some kind of cataloging, so I can see, uh, maybe things that might, I just had no idea and, uh, bringing my own data and maybe linking data. These are concepts that I think are starting to take off in our field, but it, it really opens up those avenues to when you, you were talking about data, the robustness and richness volume isn't, uh, the only thing is Namita said, I think really getting to a rich high-quality data and, and an exchange offers a far bigger, uh, range for all of us to, to use, to get our work done. >>Yeah. And I think, um, just to chime, chime into that, uh, response from Greg, you know, what we hear increasingly, and it's pretty pervasive across the industry right now, because this ability to create an exchange or the intelligent, uh, patient health record, these are new ideas, you know, they're still rather nascent and it always is the operating model. Uh, that, that is the, uh, the difficult challenge here. And certainly that is the case. So we do have data in various silos. Uh, they're in patient claims, they're in electronic medical records, they might be in labs, images, genetic files on your smartphone. And so one of the challenges with this interoperability is being able to tap into these various sources of data, trying to identify quality data, as Greg has said, and the meta is underscoring as well. Uh, we've gotta be able to get to the depth of data that's really meaningful to us, but then we have to have technology that allows us to pull this data together. >>First of all, it has to be de-identified because of security and patient related needs. And then we've gotta be able to link it so that you can create that likeness in terms of the record, it has to be what we call cleaned or curated so that you get the noise and all the missing this out of it, that's a big step. And then it needs to be enriched, which means that the various components that are going to be meaningful, you know, again, are brought together so that you can create that cohort of patients, that individual patient record that now is useful in so many instances across farm, again, from development, all the way through commercial. So the idea of this exchange is to enable that exact process that I just described to have a, a place, a platform where various entities can bring their data in order to have it linked and integrated and cleaned and enriched so that they get something that is a package like a data package that they can actually use. >>And it's easy to plug into their, into their studies or into their use cases. And I think a really important component of this is that it's gotta be a place where various third parties can feel comfortable bringing their data together in order to match it with other third parties. That is a, a real value, uh, that the industry is increasingly saying would be important to them is, is the ability to bring in those third-party data sets and be able to link them and create these, these various data products. So that's really the idea of the data exchange is that you can benefit from accessing data, as Greg mentioned in catalogs that maybe are across these various silos so that you can do the kind of work that you need. And that we take a lot of the hard work out of it. I like to give an example. >>We spoke with one of our clients at one of the large pharma companies. And, uh, I think he expressed it very well. He said, what I'd like to do is have like a complete dataset of lupus. Lupus is an autoimmune condition. And I've just like to have like the quintessential lupus dataset that I can use to run any number of use cases across it. You know, whether it's looking at my phase one trial, whether it's selecting patients and enriching for later stage trials, whether it's understanding patient responses to different therapies as I designed my studies. And so, you know, this idea of adding in therapeutic area indication, specific data sets and being able to create that for the industry in the meta mentioned, being able to do that, for example, in diabetes, that's how pharma clients need to have their needs met is through taking the hard workout, bringing the data together, having it very therapeutically enriched so that they can use it very easily. >>Thank you for that detail and the meta. I mean, you can't do this with humans at scale in technology of all the things that Lorraine was talking about, the enrichment, the provenance, the quality, and of course, it's got to be governed. You've got to protect the privacy privacy humans just can't do all that at massive scale. Can it really tech that's where technology comes in? Doesn't it and automation. >>Absolutely. >>I, couldn't more, I think the biggest, you know, whether you talk about precision medicine or you talk about decentralized trials, I think there's been a lot of hype around these terms, but what is really important to remember is technology is the game changer and bringing all that data together is really going to be the key enabler. So multimodal data integration, looking at things like security or federated learning, or also when you're talking about leveraging AI, you're not talking about things like bias or other aspects around that are, are critical components that need to be addressed. I think the industry is, uh, it's partly, still trying to figure out the right use cases. So it's one part is getting together the data, but also getting together the right data. Um, I think data interoperability is going to be the absolute game changer for enabling this. Uh, but yes, um, absolutely. I can, I can really couldn't agree more with what Lorraine just said, that it's bringing all those different aspects of data together to really drive that precision medicine strategy. >>Excellent. Hey Greg, let's talk about protocols decentralized clinical trials. You know, they're not new to life silences, but, but the adoption of DCTs is of course sped up due to the pandemic we've had to make trade-offs obviously, and the risk is clearly worth it, but you're going to continue to be a primary approach as we enter 2022. What are the opportunities that you see to improve? How DCTs are designed and executed? >>I see a couple opportunities to improve in this area. The first is, uh, back to technology. The infrastructure around clinical trials has, has evolved over the years. Uh, but now you're talking about moving away from kind of site focus to the patient focus. Uh, so with that, you have to build out a new set of tools that would help. So for example, one would be novel trial, recruitment, and screening, you know, how do you, how do you find patients and how do you screen them to see if are they, are they really a fit for, for this protocol? Another example, uh, very important documents that we have to get is, uh, you know, the e-consent that someone's says, yes, I'm, well, I understand this study and I'm willing to do it, have to do that in a more remote way than, than we've done in the past. >>Um, the exciting area, I think, is the use of, uh, eco, uh, E-Pro where we capture data from the patient using apps, devices, sensors. And I think all of these capabilities will bring a new way of, of getting data faster, uh, in, in this kind of model. But the exciting thing from, uh, our perspective at Lily is it's going to bring more data about the patient from the patient, not just from the healthcare provider side, it's going to bring real data from these apps, devices and sensors. The second thing I think is using real-world data to identify patients, to also improve protocols. We run scenarios today, looking at what's the impact. If you change a cut point on a, a lab or a biomarker to see how that would affect, uh, potential enrollment of patients. So it, it definitely the real-world data can be used to, to make decisions, you know, how you improve these protocols. >>But the thing that we've been at the challenge we've been after that this probably offers the biggest is using real-world data to identify patients as we move away from large academic centers that we've used for years as our sites. Um, you can maybe get more patients who are from the rural areas of our countries or not near these large, uh, uh, academic centers. And we think it'll bring a little more diversity to the population, uh, who who's, uh, eligible, but also we have their data, so we can see if they really fit the criteria and the probability they are a fit for the trial is much higher than >>Right. Lorraine. I mean, your clients must be really pushing you to help them improve DCTs what are you seeing in the field? >>Yes, in fact, we just attended the inaugural meeting of the de-central trials research Alliance in, uh, in Boston about two weeks ago where, uh, all of the industry came together, pharma companies, uh, consulting vendors, just everyone who's been in this industry working to help define de-central trials and, um, think through what its potential is. Think through various models in order to enable it, because again, a nascent concept that I think COVID has spurred into action. Um, but it is important to take a look at the definition of DCT. I think there are those entities that describe it as accessing data directly from the patient. I think that is a component of it, but I think it's much broader than that. To me, it's about really looking at workflows and processes of bringing data in from various remote locations and enabling the whole ecosystem to work much more effectively along the data continuum. >>So a DCT is all around being able to make a site more effective, whether it's being able to administer a tele visit or the way that they're getting data into the electronic data captures. So I think we have to take a look at the, the workflows and the operating models for enabling de-central trials and a lot of what we're doing with our own technology. Greg mentioned the idea of electronic consent of being able to do electronic patient reported outcomes, other collection of data directly from the patient wearables tele-health. So these are all data acquisition, methodologies, and technologies that, that we are enabling in order to get the best of the data into the electronic data capture system. So edit can be put together and processed and submitted to the FDA for regulatory use for clinical trial type submission. So we're working on that. I think the other thing that's happening is the ability to be much more flexible and be able to have more cloud-based storage allows you to be much more inter-operable to allow API APIs in order to bring in the various types of data. >>So we're really looking at technology that can make us much more fluid and flexible and accommodating to all the ways that people live and work and manage their health, because we have to reflect that in the way we collect those data types. So that's a lot of what we're, what we're focused on. And in talking with our clients, we spend also a lot of time trying to understand along the, let's say de-central clinical trials continuum, you know, w where are they? And I know Namita is going to talk a little bit about research that they've done in terms of that adoption curve, but because COVID sort of forced us into being able to collect data in more remote fashion in order to allow some of these clinical trials to continue during COVID when a lot of them had to stop. What we want to make sure is that we understand and can codify some of those best practices and that we can help our clients enable that because the worst thing that would happen would be to have made some of that progress in that direction. >>But then when COVID is over to go back to the old ways of doing things and not bring some of those best practices forward, and we actually hear from some of our clients in the pharma industry, that they worry about that as well, because we don't yet have a system for operationalizing a de-central trial. And so we really have to think about the protocol it's designed, the indication, the types of patients, what makes sense to decentralize, what makes sense to still continue to collect data in a more traditional fashion. So we're spending a lot of time advising and consulting with our patients, as well as, I mean, with our clients, as well as CRS, um, on what the best model is in terms of their, their portfolio of studies. And I think that's a really important aspect of trying to accelerate the adoption is making sure that what we're doing is fit for purpose, just because you can use technology doesn't mean you should, it really still does require human beings to think about the problem and solve them in a very practical way. >>Great, thank you for that. Lorraine. I want to pick up on some things that Lorraine was just saying. And then back to what Greg was saying about, uh, uh, DCTs becoming more patient centric, you had a prediction or IDC, did I presume your fingerprints were on it? Uh, that by 20 25, 70 5% of trials will be patient-centric decentralized clinical trials, 90% will be hybrid. So maybe you could help us understand that relationship and what types of innovations are going to be needed to support that evolution of DCT. >>Thanks, Dave. Yeah. Um, you know, sorry, I, I certainly believe that, uh, you know, uh, Lorraine was pointing out of bringing up a very important point. It's about being able to continue what you have learned in over the past two years, I feel this, you know, it was not really a digital revolution. It was an attitude. The revolution that this industry underwent, um, technology existed just as clinical trials exist as drugs exist, but there was a proof of concept that technology works that this model is working. So I think that what, for example, telehealth, um, did for, for healthcare, you know, transition from, from care, anywhere care, anytime, anywhere, and even becoming predictive. That's what the decentralized clinical trials model is doing for clinical trials today. Great points again, that you have to really look at where it's being applied. You just can't randomly apply it across clinical trials. >>And this is where the industry is maturing the complexity. Um, you know, some people think decentralized trials are very simple. You just go and implement these centralized clinical trials, but it's not that simple as it it's being able to define, which are the right technologies for that specific, um, therapeutic area for that specific phase of the study. It's being also a very important point is bringing in the patient's voice into the process. Hey, I had my first telehealth visit sometime last year and I was absolutely thrilled about it. I said, no time wasted. I mean, everything's done in half an hour, but not all patients want that. Some want to consider going back and you, again, need to customize your de-centralized trials model to, to the, to the type of patient population, the demographics that you're dealing with. So there are multiple factors. Um, also stepping back, you know, Lorraine mentioned they're consulting with, uh, with their clients, advising them. >>And I think a lot of, um, a lot of companies are still evolving in their maturity in DCTs though. There's a lot of boys about it. Not everyone is very mature in it. So it's, I think it, one thing everyone's kind of agreeing with is yes, we want to do it, but it's really about how do we go about it? How do we make this a flexible and scalable modern model? How do we integrate the patient's voice into the process? What are the KPIs that we define the key performance indicators that we define? Do we have a playbook to implement this model to make it a scalable model? And, you know, finally, I think what organizations really need to look at is kind of developing a de-centralized mature maturity scoring model, so that I assess where I am today and use that playbook to define, how am I going to move down the line to me reach the next level of maturity. Those were some of my thoughts. Right? >>Excellent. And now remember you, if you have any questions, use the chat box below to submit those questions. We have some questions coming in from the audience. >>At one point to that, I think one common thread between the earlier discussion around precision medicine and around decentralized trials really is data interoperability. It is going to be a big game changer to, to enable both of these pieces. Sorry. Thanks, Dave. >>Yeah. Thank you. Yeah. So again, put your questions in the chat box. I'm actually going to go to one of the questions from the audience. I get some other questions as well, but when you think about all the new data types that are coming in from social media, omics wearables. So the question is with greater access to these new types of data, what trends are you seeing from pharma device as far as developing capabilities to effectively manage and analyze these novel data types? Is there anything that you guys are seeing, um, that you can share in terms of best practice or advice >>I'll offer up? One thing, I think the interoperability isn't quite there today. So, so what's that mean you can take some of those data sources. You mentioned, uh, some Omix data with, uh, some health claims data and it's the, we spend too much time and in our space putting data to gather the behind the scenes, I think the stat is 80% of the time is assembling the data 20% analyzing. And we've had conversations here at Lilly about how do we get to 80% of the time is doing analysis. And it really requires us to think, take a step back and think about when you create a, uh, a health record, you really have to be, have the same plugins so that, you know, data can be put together very easily, like Lorraine mentioned earlier. And that comes back to investing in as an industry and standards so that, you know, you have some of data standard, we all can agree upon. And then those plugs get a lot easier and we can spend our time figuring out how to make, uh, people's lives better with healthcare analysis versus putting data together, which is not a lot of fun behind the scenes. >>Other thoughts on, um, on, on how to take advantage of sort of novel data coming from things like devices in the nose that you guys are seeing. >>I could jump in there on your end. Did you want to go ahead? Okay. So, uh, I mean, I think there's huge value that's being seen, uh, in leveraging those multiple data types. I think one area you're seeing is the growth of prescription digital therapeutics and, um, using those to support, uh, you know, things like behavioral health issues and a lot of other critical conditions it's really taking you again, it is interlinking real-world data cause it's really taking you to the patient's home. Um, and it's, it's, there's a lot of patients in the city out here cause you can really monitor the patient real-time um, without the patient having coming, you know, coming and doing a site visit once in say four weeks or six weeks. So, um, I, and, uh, for example, uh, suicidal behavior and just to take an example, if you can predict well in advance, based on those behavioral parameters, that this is likely to trigger that, uh, the value of it is enormous. Um, again, I think, uh, Greg made a valid point about the industry still trying to deal with resolving the data interoperability issue. And there are so many players that are coming in the industry right now. There are really few that have the maturity and the capability to address these challenges and provide intelligence solutions. >>Yeah. Maybe I'll just, uh, go ahead and, uh, and chime into Nikita's last comment there. I think that's what we're seeing as well. And it's very common, you know, from an innovation standpoint that you have, uh, a nascent industry or a nascent innovation sort of situation that we have right now where it's very fragmented. You have a lot of small players, you have some larger entrenched players that have the capability, um, to help to solve the interoperability challenge, the standards challenge. I mean, I think IBM Watson health is certainly one of the entities that has that ability and is taking a stand in the industry, uh, in order to, to help lead in that way. Others are too. And, uh, but with, with all of the small companies that are trying to find interesting and creative ways to gather that data, it does create a very fragmented, uh, type of environment and ecosystem that we're in. >>And I think as we mature, as we do come forward with the KPIs, the operating models, um, because you know, the devil's in the detail in terms of the operating models, it's really exciting to talk these trends and think about the future state. But as Greg pointed out, if you're spending 80% of your time just under the hood, you know, trying to get the engine, all the spark plugs to line up, um, that's, that's just hard grunt work that has to be done. So I think that's where we need to be focused. And I think bringing all the data in from these disparate tools, you know, that's fine, we need, uh, a platform or the API APIs that can enable that. But I think as we, as we progress, we'll see more consolidation, uh, more standards coming into play, solving the interoperability types of challenges. >>And, um, so I think that's where we should, we should focus on what it's going to take and in three years to really codify this and make it, so it's a, it's a well hum humming machine. And, you know, I do know having also been in pharma that, uh, there's a very pilot oriented approach to this thing, which I think is really healthy. I think large pharma companies tend to place a lot of bets with different programs on different tools and technologies, to some extent to see what's gonna stick and, you know, kind of with an innovation mindset. And I think that's good. I think that's kind of part of the process of figuring out what is going to work and, and helping us when we get to that point of consolidating our model and the technologies going forward. So I think all of the efforts today are definitely driving us to something that feels much more codified in the next three to five years. >>Excellent. We have another question from the audience it's sort of related to the theme of this discussion, given the FDA's recent guidance on using claims and electronic health records, data to support regulatory decision-making what advancements do you think we can expect with regards to regulatory use of real-world data in the coming years? It's kind of a two-parter so maybe you guys can collaborate on this one. What role that, and then what role do you think industry plays in influencing innovation within the regulatory space? >>All right. Well, it looks like you've stumped the panel there. Uh, Dave, >>It's okay to take some time to think about it, right? You want me to repeat it? You guys, >>I, you know, I I'm sure that the group is going to chime into this. I, so the FDA has issued a guidance. Um, it's just, it's, it's exactly that the FDA issues guidances and says that, you know, it's aware and supportive of the fact that we need to be using real-world data. We need to create the interoperability, the standards, the ways to make sure that we can include it in regulatory submissions and the like, um, and, and I sort of think about it akin to the critical path initiative, probably, I don't know, 10 or 12 years ago in pharma, uh, when the FDA also embrace this idea of the critical path and being able to allow more in silico modeling of clinical trial, design and development. And it really took the industry a good 10 years, um, you know, before they were able to actually adopt and apply and take that sort of guidance or openness from the FDA and actually apply it in a way that started to influence the way clinical trials were designed or the in silico modeling. >>So I think the second part of the question is really important because while I think the FDA is saying, yes, we recognize it's important. Uh, we want to be able to encourage and support it. You know, when you look for example, at synthetic control arms, right? The use of real-world data in regulatory submissions over the last five or six years, all of the use cases have been in oncology. I think there've been about maybe somewhere between eight to 10 submissions. And I think only one actually was a successful submission, uh, in all those situations, the real-world data arm of that oncology trial that synthetic control arm was actually rejected by the FDA because of lack of completeness or, you know, equalness in terms of the data. So the FDA is not going to tell us how to do this. So I think the second part of the question, which is what's the role of industry, it's absolutely on industry in order to figure out exactly what we're talking about, how do we figure out the interoperability, how do we apply the standards? >>How do we ensure good quality data? How do we enrich it and create the cohort that is going to be equivalent to the patient in the real world, uh, in the end that would otherwise be in the clinical trial and how do we create something that the FDA can agree with? And we'll certainly we'll want to work with the FDA in order to figure out this model. And I think companies are already doing that, but I think that the onus is going to be on industry in order to figure out how you actually operationalize this and make it real. >>Excellent. Thank you. Um, question on what's the most common misconception that clinical research stakeholders with sites or participants, et cetera might have about DCTs? >>Um, I could jump in there. Right. So, sure. So, um, I think in terms of misconceptions, um, I think the communist misconceptions that sites are going away forever, which I do not think is really happening today. Then the second, second part of it is that, um, I think also the perspective that patients are potentially neglected because they're moving away. So we'll pay when I, when I, what I mean by that neglected, perhaps it was not the appropriate term, but the fact that, uh, will patients will, will, will patient engagement continue, will retention be strong since the patients are not interacting in person with the investigator quite as much. Um, so site retention and patient retention or engagement from both perspectives, I think remains a concern. Um, but actually if you look at, uh, look at, uh, assessments that have been done, I think patients are more than happy. >>Majority of the patients have been really happy about, about the new model. And in fact, sites are, seem to increase, have increased investments in technology by 50% to support this kind of a model. So, and the last thing is that, you know, decentralized trials is a great model and it can be applied to every possible clinical trial. And in another couple of weeks, the whole industry will be implementing only decentralized trials. I think we are far away from that. It's just not something that you would implement across every trial. And we discussed that already. So you have to find the right use cases for that. So I think those were some of the key misconceptions I'd say in the industry right now. Yeah. >>Yeah. And I would add that the misconception I hear the most about is, uh, the, the similar to what Namita said about the sites and healthcare professionals, not being involved to the level that they are today. Uh, when I mentioned earlier in our conversation about being excited about capturing more data, uh, from the patient that was always in context of, in addition to, you know, healthcare professional opinion, because I think both of them bring that enrichment and a broader perspective of that patient experience, whatever disease they're faced with. So I, I think some people think is just an all internet trial with just someone, uh, putting out there their own perspective. And, and it's, it's a combination of both to, to deliver a robust data set. >>Yeah. Maybe I'll just comment on, it reminds me of probably 10 or 15 years ago, maybe even more when, um, really remote monitoring was enabled, right? So you didn't have to have the study coordinator traveled to the investigative site in order to check the temperature of the freezer and make sure that patient records were being completed appropriately because they could have a remote visit and they could, they could send the data in a via electronic data and do the monitoring visit, you know, in real time, just the way we're having this kind of communication here. And there was just so much fear that you were going to replace or supplant the personal relationship between the sites between the study coordinators that you were going to, you know, have to supplant the role of the monitor, which was always a very important role in clinical trials. >>And I think people that really want to do embrace the technology and the advantages that it provided quickly saw that what it allowed was the monitor to do higher value work, you know, instead of going in and checking the temperature on a freezer, when they did have their visit, they were able to sit and have a quality discussion for example, about how patient recruitment was going or what was coming up in terms of the consent. And so it created a much more high touch, high quality type of interaction between the monitor and the investigative site. And I think we should be looking for the same advantages from DCT. We shouldn't fear it. We shouldn't think that it's going to supplant the site or the investigator or the relationship. It's our job to figure out where the technology fits and clinical sciences always got to be high touch combined with high-tech, but the high touch has to lead. And so getting that balance right? And so that's going to happen here as well. We will figure out other high value work, meaningful work for the site staff to do while they let the technology take care of the lower quality work, if you will, or the lower value work, >>That's not an, or it's an, and, and you're talking about the higher value work. And it, it leads me to something that Greg said earlier about the 80, 20, 80% is assembly. 20% is actually doing the analysis and that's not unique to, to, to life sciences, but, but sort of question is it's an organizational question in terms of how we think about data and how we approach data in the future. So Bamyan historically big data in life sciences in any industry really is required highly centralized and specialized teams to do things that the rain was talking about, the enrichment, the provenance, the data quality, the governance, the PR highly hyper specialized teams to do that. And they serve different constituencies. You know, not necessarily with that, with, with context, they're just kind of data people. Um, so they have responsibility for doing all those things. Greg, for instance, within literally, are you seeing a move to, to, to democratize data access? We've talked about data interoperability, part of that state of sharing, um, that kind of breaks that centralized hold, or is that just too far in the future? It's too risky in this industry? >>Uh, it's actually happening now. Uh, it's a great point. We, we try to classify what people can do. And, uh, the example would be you give someone who's less analytically qualified, uh, give them a dashboard, let them interact with the data, let them better understand, uh, what, what we're seeing out in the real world. Uh, there's a middle user, someone who you could give them, they can do some analysis with the tool. And the nice thing with that is you have some guardrails around that and you keep them in their lane, but it allows them to do some of their work without having to go ask those centralized experts that, that you mentioned their precious resources. And that's the third group is those, uh, highly analytical folks that can, can really deliver, uh, just value beyond. But when they're doing all those other things, uh, it really hinders them from doing what we've been talking about is the high value stuff. So we've, we've kind of split into those. We look at people using data in one of those three lanes and it, and it has helped I think, uh, us better not try to make a one fit solution for, for how we deliver data and analytic tools for people. Right. >>Okay. I mean, DCT hot topic with the, the, the audience here. Another question, um, what capabilities do sponsors and CRS need to develop in-house to pivot toward DCT? >>Should I jump in here? Yeah, I mean, um, I think, you know, when, when we speak about DCTs and when I speak with, uh, folks around in the industry, I, it takes me back to the days of risk-based monitoring. When it was first being implemented, it was a huge organizational change from the conventional monitoring models to centralize monitoring and risk-based monitoring, it needs a mental reset. It needs as Lorraine had pointed out a little while ago, restructuring workflows, re redefining processes. And I think that is one big piece. That is, I think the first piece, when, you know, when you're implementing a new model, I think organizational change management is a big piece of it because you are disturbing existing structures, existing methods. So getting that buy-in across the organization towards the new model, seeing what the value add in it. And where do you personally fit into that story? >>How do your workflows change, or how was your role impacted? I think without that this industry will struggle. So I see organizations, I think, first trying to work on that piece to build that in. And then of course, I also want to step back for the second to the, uh, to the point that you brought out about data democratization. And I think Greg Greg gave an excellent point, uh, input about how it's happening in the industry. But I would also say that the data democratization really empowerment of, of, of the stakeholders also includes the sites, the investigators. So what is the level of access to data that you know, that they have now, and is it, uh, as well as patients? So see increasingly more and more companies trying to provide access to patients finally, it's their data. So why shouldn't they have some insights to it, right. So access to patients and, uh, you know, the 80, 20 part of it. Uh, yes, he's absolutely right that, uh, we want to see that flip from, uh, 20%, um, you know, focusing on, on actually integrating the data 80% of analytics, but the real future will be coming in when actually the 20 and 18 has gone. And you actually have analysts the insights out on a silver platter. That's kind of wishful thinking, some of the industries is getting there in small pieces, but yeah, then that's just why I should, why we share >>Great points. >>And I think that we're, we're there in terms that like, I really appreciate the point around democratizing the data and giving the patient access ownership and control over their own data. I mean, you know, we see the health portals that are now available for patients to view their own records, images, and labs, and claims and EMR. We have blockchain technology, which is really critical here in terms of the patient, being able to pull all of their own data together, you know, in the blockchain and immutable record that they can own and control if they want to use that to transact clinical trial types of opportunities based on their data, they can, or other real world scenarios. But if they want to just manage their own data because they're traveling and if they're in a risky health situation, they've got their own record of their health, their health history, uh, which can avoid, you know, medical errors occurring. So, you know, even going beyond life sciences, I think this idea of democratizing data is just good for health. It's just good for people. And we definitely have the technology that can make it a reality. Now >>You're here. We have just about 10 minutes left and now of course, now all the questions are rolling in like crazy from the crowd. Would it be curious to know if there would be any comments from the panel on cost comparison analysis between traditional clinical trials in DCTs and how could the outcome effect the implementation of DCTs any sort of high-level framework you can share? >>I would say these are still early days to, to drive that analysis because I think many companies are, um, are still in the early stages of implementation. They've done a couple of trials. The other part of it that's important to keep in mind is, um, is for organizations it's, they're at a stage of, uh, of being on the learning curve. So when you're, you're calculating the cost efficiencies, if ideally you should have had two stakeholders involved, you could have potentially 20 stakeholders involved because everyone's trying to learn the process and see how it's going to be implemented. So, um, I don't think, and the third part of it, I think is organizations are still defining their KPIs. How do you measure it? What do you measure? So, um, and even still plugging in the pieces of technology that they need to fit in, who are they partnering with? >>What are the pieces of technology they're implementing? So I don't think there is a clear cut as answered at this stage. I think as you scale this model, the efficiencies will be seen. It's like any new technology or any new solution that's implemented in the first stages. It's always a little more complex and in fact sometimes costs extra. But as, as you start scaling it, as you establish your workflows, as you streamline it, the cost efficiencies will start becoming evident. That's why the industry is moving there. And I think that's how it turned out on the long run. >>Yeah. Just make it maybe out a comment. If you don't mind, the clinical trials are, have traditionally been costed are budgeted is on a per patient basis. And so, you know, based on the difficulty of the therapeutic area to recruit a rare oncology or neuromuscular disease, there's an average that it costs in order to find that patient and then execute the various procedures throughout the clinical trial on that patient. And so the difficulty of reaching the patient and then the complexity of the trial has led to what we might call a per patient stipend, which is just the metric that we use to sort of figure out what the average cost of a trial will be. So I think to point, we're going to have to see where the ability to adjust workflows, get to patients faster, collect data more easily in order to make the burden on the site, less onerous. I think once we start to see that work eases up because of technology, then I think we'll start to see those cost equations change. But I think right now the system isn't designed in order to really measure the economic benefit of de-central models. And I think we're going to have to sort of figure out what that looks like as we go along and since it's patient oriented right now, we'll have to say, well, you know, how does that work, ease up? And to those costs actually come down and then >>Just scale, it's going to be more, more clear as the media was saying, next question from the audiences, it's kind of a best fit question. You all have touched on this, but let me just ask it is what examples in which, in which phases suit DCT in its current form, be it fully DCT or hybrid models, none of our horses for courses question. >>Well, I think it's kind of, uh, it's, it's it's has its efficiencies, obviously on the later phases, then the absolute early phase trials, those are not the ideal models for DCTs I would say so. And again, the logic is also the fact that, you know, when you're, you're going into the later phase trials, the volume of number of patients is increasing considerably to the point that Lorraine brought up about access to the patients about patient selection. The fact, I think what one should look at is really the advantages that it brings in, in terms of, you know, patient access in terms of patient diversity, which is a big piece that, um, the cities are enabling. So, um, if you, if, if you, if you look at the spectrum of, of these advantages and, and just to step back for a moment, if you, if you're looking at costs, like you're looking at things like remote site monitoring, um, is, is a big, big plus, right? >>I mean, uh, site monitoring alone accounts for around a third of the trial costs. So there are so many pieces that fall in together. The challenge actually that comes when you're in defining DCTs and there are, as Rick pointed out multiple definitions of DCTs that are existing, uh, you know, in the industry right now, whether you're talking of what Detroit is doing, or you're talking about acro or Citi or others. But the point is it's a continuum, it's a continuum of different pieces that have been woven together. And so how do you decide which pieces you're plugging in and how does that impact the total cost or the solution that you're implementing? >>Great, thank you. Last question we have in the audience, excuse me. What changes have you seen? Are there others that you can share from the FDA EU APAC, regulators and supporting DCTs precision medicine for approval processes, anything you guys would highlight that we should be aware of? >>Um, I could quickly just add that. I think, um, I'm just publishing a report on de-centralized clinical trials should be published shortly, uh, perspective on that. But I would say that right now, um, there, there was a, in the FDA agenda, there was a plan for a decentralized clinical trials guidance, as far as I'm aware, one has not yet been published. There have been significant guidances that have been published both by email and by, uh, the FDA that, um, you know, around the implementation of clinical trials during the COVID pandemic, which incorporate various technology pieces, which support the DCD model. Um, but I, and again, I think one of the reasons why it's not easy to publish a well-defined guidance on that is because there are so many moving pieces in it. I think it's the Danish, uh, regulatory agency, which has per se published a guidance and revised it as well on decentralized clinical trials. >>Right. Okay. Uh, we're pretty much out of time, but I, I wonder Lorraine, if you could give us some, some final thoughts and bring us home things that we should be watching or how you see the future. >>Well, I think first of all, let me, let me thank the panel. Uh, we really appreciate Greg from Lily and the meta from IDC bringing their perspectives to this conversation. And, uh, I hope that the audience has enjoyed the, uh, the discussion that we've had around the future state of real world data as, as well as DCT. And I think, you know, some of the themes that we've talked about, number one, I think we have a vision and I think we have the right strategies in terms of the future promise of real-world data in any number of different applications. We certainly have talked about the promise of DCT to be more efficient, to get us closer to the patient. I think that what we have to focus on is how we come together as an industry to really work through these very vexing operational issues, because those are always the things that hang us up and whether it's clinical research or whether it's later stage, uh, applications of data. >>We, the healthcare system is still very fragmented, particularly in the us. Um, it's still very, state-based, uh, you know, different states can have different kinds of, uh, of, of cultures and geographic, uh, delineations. And so I think that, you know, figuring out a way that we can sort of harmonize and bring all of the data together, bring some of the models together. I think that's what you need to look to us to do both industry consulting organizations, such as IBM Watson health. And we are, you know, through DTRA and, and other, uh, consortia and different bodies. I think we're all identifying what the challenges are in terms of making this a reality and working systematically on those. >>It's always a pleasure to work with such great panelists. Thank you, Lorraine Marshawn, Dr. Namita LeMay, and Greg Cunningham really appreciate your participation today and your insights. The next three years of life sciences, innovation, precision medicine, advanced clinical data management and beyond has been brought to you by IBM in the cube. You're a global leader in high tech coverage. And while this discussion has concluded, the conversation continues. So please take a moment to answer a few questions about today's panel on behalf of the entire IBM life sciences team and the cube decks for your time and your feedback. And we'll see you next time.

>>from around the globe. It's the Cube presenting Cuban cloud brought to you by silicon angle in 2000 >>nine. Hal Varian, Google's chief economist, said that statisticians would be the sexiest job in the coming decade. The modern big data movement >>really >>took off later in the following year. After the Second Hadoop World, which was hosted by Claudette Cloudera in New York City. Jeff Ham Abakar famously declared to me and John further in the Cube that the best minds of his generation, we're trying to figure out how to get people to click on ads. And he said that sucks. The industry was abuzz with the realization that data was the new competitive weapon. Hadoop was heralded as the new data management paradigm. Now, what actually transpired Over the next 10 years on Lee, a small handful of companies could really master the complexities of big data and attract the data science talent really necessary to realize massive returns as well. Back then, Cloud was in the early stages of its adoption. When you think about it at the beginning of the last decade and as the years passed, Maurin Mawr data got moved to the cloud and the number of data sources absolutely exploded. Experimentation accelerated, as did the pace of change. Complexity just overwhelmed big data infrastructures and data teams, leading to a continuous stream of incremental technical improvements designed to try and keep pace things like data Lakes, data hubs, new open source projects, new tools which piled on even Mawr complexity. And as we reported, we believe what's needed is a comm pleat bit flip and how we approach data architectures. Our next guest is Jean Marc de Connie, who is the director of emerging technologies That thought works. John Mark is a software engineer, architect, thought leader and adviser to some of the world's most prominent enterprises. She's, in my view, one of the foremost advocates for rethinking and changing the way we create and manage data architectures. Favoring a decentralized over monolithic structure and elevating domain knowledge is a primary criterion. And how we organize so called big data teams and platforms. Chamakh. Welcome to the Cube. It's a pleasure to have you on the program. >>Hi, David. This wonderful to be here. >>Well, okay, so >>you're >>pretty outspoken about the need for a paradigm shift in how we manage our data and our platforms that scale. Why do you feel we need such a radical change? What's your thoughts there? >>Well, I think if you just look back over the last decades you gave us, you know, a summary of what happened since 2000 and 10. But if even if we go before then what we have done over the last few decades is basically repeating and, as you mentioned, incrementally improving how we've managed data based on a certain assumptions around. As you mentioned, centralization data has to be in one place so we can get value from it. But if you look at the parallel movement off our industry in general since the birth of Internet, we are actually moving towards decentralization. If we think today, like if this move data side, if he said the only way Web would work the only way we get access to you know various applications on the Web pages is to centralize it. We would laugh at that idea, but for some reason we don't. We don't question that when it comes to data, right? So I think it's time to embrace the complexity that comes with the growth of number of sources, the proliferation of sources and consumptions models, you know, embrace the distribution of sources of data that they're not just within one part of organization. They're not just within even bounds of organization there beyond the bounds of organization. And then look back and say Okay, if that's the trend off our industry in general, Um, given the fabric of computation and data that we put in, you know globally in place, then how the architecture and technology and organizational structure incentives need to move to embrace that complexity. And to me, that requires a paradigm shift, a full stack from how we organize our organizations, how we organize our teams, how we, you know, put a technology in place, um, to to look at it from a decentralized angle. >>Okay, so let's let's unpack that a little bit. I mean, you've spoken about and written that today's big architecture and you basically just mentioned that it's flawed, So I wanna bring up. I love your diagrams of a simple diagram, guys, if you could bring up ah, figure one. So on the left here we're adjusting data from the operational systems and other enterprise data sets and, of course, external data. We cleanse it, you know, you've gotta do the do the quality thing and then serve them up to the business. So So what's wrong with that picture that we just described and give granted? It's a simplified form. >>Yeah, quite a few things. So, yeah, I would flip the question may be back to you or the audience if we said that. You know, there are so many sources off the data on the Actually, the data comes from systems and from teams that are very diverse in terms off domains. Right? Domain. If if you just think about, I don't know retail, Uh, the the E Commerce versus Order Management versus customer This is a very diverse domains. The data comes from many different diverse domains. And then we expect to put them under the control off a centralized team, a centralized system. And I know that centralization. Probably if you zoom out, it's centralized. If you zoom in it z compartmentalized based on functions that we can talk about that and we assume that the centralized model will be served, you know, getting that data, making sense of it, cleansing and transforming it then to satisfy in need of very diverse set of consumers without really understanding the domains, because the teams responsible for it or not close to the source of the data. So there is a bit of it, um, cognitive gap and domain understanding Gap, um, you know, without really understanding of how the data is going to be used, I've talked to numerous. When we came to this, I came up with the idea. I talked to a lot of data teams globally just to see, you know, what are the pain points? How are they doing it? And one thing that was evident in all of those conversations that they actually didn't know after they built these pipelines and put the data in whether the data warehouse tables or like, they didn't know how the data was being used. But yet the responsible for making the data available for these diverse set of these cases, So s centralized system. A monolithic system often is a bottleneck. So what you find is, a lot of the teams are struggling with satisfying the needs of the consumers, the struggling with really understanding the data. The domain knowledge is lost there is a los off understanding and kind of in that in that transformation. Often, you know, we end up training machine learning models on data that is not really representative off the reality off the business. And then we put them to production and they don't work because the semantic and the same tax off the data gets lost within that translation. So we're struggling with finding people thio, you know, to manage a centralized system because there's still the technology is fairly, in my opinion, fairly low level and exposes the users of those technologies. I said, Let's say warehouse a lot off, you know, complexity. So in summary, I think it's a bottleneck is not gonna, you know, satisfy the pace of change, of pace, of innovation and the pace of, you know, availability of sources. Um, it's disconnected and fragmented, even though the centralizes disconnected and fragmented from where the data comes from and where the data gets used on is managed by, you know, a team off hyper specialized people that you know, they're struggling to understand the actual value of the data, the actual format of the data, so it's not gonna get us where our aspirations and ambitions need to be. >>Yes. So the big data platform is essentially I think you call it, uh, context agnostic. And so is data becomes, you know, more important, our lives. You've got all these new data sources, you know, injected into the system. Experimentation as we said it with the cloud becomes much, much easier. So one of the blockers that you've started, you just mentioned it is you've got these hyper specialized roles the data engineer, the quality engineer, data scientists and and the It's illusory. I mean, it's like an illusion. These guys air, they seemingly they're independent and in scale independently. But I think you've made the point that in fact, they can't that a change in the data source has an effect across the entire data lifecycle entire data pipeline. So maybe you could maybe you could add some color to why that's problematic for some of the organizations that you work with and maybe give some examples. >>Yeah, absolutely so in fact, that initially the hypothesis around that image came from a Siris of requests that we received from our both large scale and progressive clients and progressive in terms of their investment in data architectures. So this is where clients that they were there were larger scale. They had divers and reached out of domains. Some of them were big technology tech companies. Some of them were retail companies, big health care companies. So they had that diversity off the data and the number off. You know, the sources of the domains they had invested for quite a few years in, you know, generations. If they had multi generations of proprietary data warehouses on print that they were moving to cloud, they had moved to the barriers, you know, revisions of the Hadoop clusters and they were moving to the cloud. And they the challenges that they were facing were simply there were not like, if I want to just, like, you know, simplifying in one phrase, they were not getting value from the data that they were collecting. There were continuously struggling Thio shift the culture because there was so much friction between all of these three phases of both consumption of the data and transformation and making it available consumption from sources and then providing it and serving it to the consumer. So that whole process was full of friction. Everybody was unhappy. So its bottom line is that you're collecting all this data. There is delay. There is lack of trust in the data itself because the data is not representative of the reality has gone through a transformation. But people that didn't understand really what the data was got delayed on bond. So there is no trust. It's hard to get to the data. It's hard to create. Ultimately, it's hard to create value from the data, and people are working really hard and under a lot of pressure. But it's still, you know, struggling. So we often you know, our solutions like we are. You know, Technologies will often pointed to technology. So we go. Okay, This this version of you know, some some proprietary data warehouse we're using is not the right thing. We should go to the cloud, and that certainly will solve our problems. Right? Or warehouse wasn't a good one. Let's make a deal Lake version. So instead of you know, extracting and then transforming and loading into the little bits. And that transformation is that, you know, heavy process, because you fundamentally made an assumption using warehouses that if I transform this data into this multi dimensional, perfectly designed schema that then everybody can run whatever choir they want that's gonna solve. You know everybody's problem, but in reality it doesn't because you you are delayed and there is no universal model that serves everybody's need. Everybody that needs the divers data scientists necessarily don't don't like the perfectly modeled data. They're looking for both signals and the noise. So then, you know, we've We've just gone from, uh, et elles to let's say now to Lake, which is okay, let's move the transformation to the to the last mile. Let's just get load the data into, uh into the object stores into semi structured files and get the data. Scientists use it, but they're still struggling because the problems that we mentioned eso then with the solution. What is the solution? Well, next generation data platform, let's put it on the cloud, and we sell clients that actually had gone through, you know, a year or multiple years of migration to the cloud. But with it was great. 18 months I've seen, you know, nine months migrations of the warehouse versus two year migrations of the various data sources to the clubhouse. But ultimately, the result is the same on satisfy frustrated data users, data providers, um, you know, with lack of ability to innovate quickly on relevant data and have have have an experience that they deserve toe have have a delightful experience off discovering and exploring data that they trust. And all of that was still a missed so something something else more fundamentally needed to change than just the technology. >>So then the linchpin to your scenario is this notion of context and you you pointed out you made the other observation that look, we've made our operational systems context aware. But our data platforms are not on bond like CRM system sales guys very comfortable with what's in the CRM system. They own the data. So let's talk about the answer that you and your colleagues are proposing. You're essentially flipping the architecture whereby those domain knowledge workers, the builders, if you will, of data products or data services there now, first class citizens in the data flow and they're injecting by design domain knowledge into the system. So So I wanna put up another one of your charts. Guys, bring up the figure to their, um it talks about, you know, convergence. You showed data distributed domain, dream and architecture. Er this self serve platform design and this notion of product thinking. So maybe you could explain why this approach is is so desirable, in your view, >>sure. The motivation and inspiration for the approach came from studying what has happened over the last few decades in operational systems. We had a very similar problem prior to micro services with monolithic systems, monolithic systems where you know the bottleneck. Um, the changes we needed to make was always, you know, our fellow Noto, how the architecture was centralized and we found a nice nation. I'm not saying this is the perfect way of decoupling a monolith, but it's a way that currently where we are in our journey to become data driven, um is a nice place to be, um, which is distribution or decomposition off your system as well as organization. I think when we whenever we talk about systems, we've got to talk about people and teams that's responsible for managing those systems. So the decomposition off the systems and the teams on the data around domains because that's how today we are decoupling our business, right? We're decoupling our businesses around domains, and that's a that's a good thing and that What does that do really for us? What it does? Is it localizes change to the bounded context of fact business. It creates clear boundary and interfaces and contracts between the rest of the universe of the organization on that particular team, so removes the friction that often we have for both managing the change and both serving data or capability. So it's the first principle of data meshes. Let's decouple this world off analytical data the same to mirror the same way we have to couple their systems and teams and business why data is any different. And the moment you do that, So you, the moment you bring the ownership to people who understands the data best, then you get questions that well, how is that any different from silence that's connected databases that we have today and nobody can get to the data? So then the rest of the principles is really to address all of the challenges that comes with this first principle of decomposition around domain Context on the second principle is well, we have to expect a certain level off quality and accountability and responsibility for the teams that provide the data. So let's bring product thinking and treating data as a product to the data that these teams now, um share and let's put accountability around. And we need a new set of incentives and metrics for domain teams to share the data. We need to have a new set off kind of quality metrics that define what it means for the data to be a product. And we can go through that conversation perhaps later eso then the second principle is okay. The teams now that are responsible, the domain teams responsible for the analytical data need to provide that data with a certain level of quality and assurance. Let's call that a product and bring products thinking to that. And then the next question you get asked off by C. E. O s or city or the people who build the infrastructure and, you know, spend the money. They said, Well, it's actually quite complex to manage big data, and now we're We want everybody, every independent team to manage the full stack of, you know, storage and computation and pipelines and, you know, access, control and all of that. And that's well, we have solved that problem in operational world. And that requires really a new level of platform thinking toe provide infrastructure and tooling to the domain teams to now be able to manage and serve their big data. And that I think that requires reimagining the world of our tooling and technology. But for now, let's just assume that we need a new level of abstraction to hide away ton of complexity that unnecessarily people get exposed to and that that's the third principle of creating Selves of infrastructure, um, to allow autonomous teams to build their domains. But then the last pillar, the last you know, fundamental pillar is okay. Once you distributed problem into a smaller problems that you found yourself with another set of problems, which is how I'm gonna connect this data, how I'm gonna you know, that the insights happens and emerges from the interconnection of the data domains right? It does not necessarily locked into one domain. So the concerns around interoperability and standardization and getting value as a result of composition and interconnection of these domains requires a new approach to governance. And we have to think about governance very differently based on a Federated model and based on a computational model. Like once we have this powerful self serve platform, we can computational e automate a lot of governance decisions. Um, that security decisions and policy decisions that applies to you know, this fabric of mesh not just a single domain or not in a centralized. Also, really. As you mentioned that the most important component of the emissions distribution of ownership and distribution of architecture and data the rest of them is to solve all the problems that come with that. >>So very powerful guys. We actually have a picture of what Jamaat just described. Bring up, bring up figure three, if you would tell me it. Essentially, you're advocating for the pushing of the pipeline and all its various functions into the lines of business and abstracting that complexity of the underlying infrastructure, which you kind of show here in this figure, data infrastructure is a platform down below. And you know what I love about this Jama is it to me, it underscores the data is not the new oil because I could put oil in my car I can put in my house, but I can't put the same court in both places. But I think you call it polyglot data, which is really different forms, batch or whatever. But the same data data doesn't follow the laws of scarcity. I can use the same data for many, many uses, and that's what this sort of graphic shows. And then you brought in the really important, you know, sticking problem, which is that you know the governance which is now not a command and control. It's it's Federated governance. So maybe you could add some thoughts on that. >>Sure, absolutely. It's one of those I think I keep referring to data much as a paradigm shift. And it's not just to make it sound ground and, you know, like, kind of ground and exciting or in court. And it's really because I want to point out, we need to question every moment when we make a decision around how we're going to design security or governance or modeling off the data, we need to reflect and go back and say, um, I applying some of my cognitive biases around how I have worked for the last 40 years, I have seen it work. Or do I do I really need to question. And we do need to question the way we have applied governance. I think at the end of the day, the rule of the data governance and objective remains the same. I mean, we all want quality data accessible to a diverse set of users. And these users now have different personas, like David, Personal data, analyst data, scientists, data application, Um, you know, user, very diverse personal. So at the end of the day, we want quality data accessible to them, um, trustworthy in in an easy consumable way. Um, however, how we get there looks very different in as you mentioned that the governance model in the old world has been very commander control, very centralized. Um, you know, they were responsible for quality. They were responsible for certification off the data, you know, applying making sure the data complies. But also such regulations Make sure you know, data gets discovered and made available in the world of the data mesh. Really. The job of the data governance as a function becomes finding that equilibrium between what decisions need to be um, you know, made and enforced globally. And what decisions need to be made locally so that we can have an interoperable measure. If data sets that can move fast and can change fast like it's really about instead of hardest, you know, kind of putting the putting those systems in a straitjacket of being constant and don't change, embrace, change and continuous change of landscape because that's that's just the reality we can't escape. So the role of governance really the governance model called Federated and Computational. And by that I mean, um, every domain needs to have a representative in the governance team. So the role of the data or domain data product owner who really were understand the data that domain really well but also wears that hacks of a product owner. It is an important role that had has to have a representation in the governance. So it's a federation off domains coming together, plus the SMEs and people have, you know, subject matter. Experts who understands the regulations in that environmental understands the data security concerns, but instead off trying to enforce and do this as a central team. They make decisions as what need to be standardized, what need to be enforced. And let's push that into that computational E and in an automated fashion into the into the camp platform itself. For example, instead of trying to do that, you know, be part of the data quality pipeline and inject ourselves as people in that process, let's actually, as a group, define what constitutes quality, like, how do we measure quality? And then let's automate that and let Z codify that into the platform so that every native products will have a C I City pipeline on as part of that pipeline. Those quality metrics gets validated and every day to product needs to publish those SLOC or service level objectives. So you know, whatever we choose as a measure of quality, maybe it's the, you know, the integrity of the data, the delay in the data, the liveliness of it, whatever the are the decisions that you're making, let's codify that. So it's, um, it's really, um, the role of the governance. The objectives of the governance team tried to satisfies the same, but how they do it. It is very, very different. I wrote a new article recently trying to explain the logical architecture that would emerge from applying these principles. And I put a kind of light table to compare and contrast the roll off the You know how we do governance today versus how we will do it differently to just give people a flavor of what does it mean to embrace the centralization? And what does it mean to embrace change and continuous change? Eso hopefully that that that could be helpful. >>Yes, very so many questions I haven't but the point you make it to data quality. Sometimes I feel like quality is the end game. Where is the end game? Should be how fast you could go from idea to monetization with the data service. What happens again? You sort of address this, but what happens to the underlying infrastructure? I mean, spinning a PC to S and S three buckets and my pie torches and tensor flows. And where does that that lives in the business? And who's responsible for that? >>Yeah, that's I'm glad you're asking this question. Maybe because, um, I truly believe we need to re imagine that world. I think there are many pieces that we can use Aziz utilities on foundational pieces, but I but I can see for myself a 5 to 7 year roadmap of building this new tooling. I think, in terms of the ownership, the question around ownership, if that would remains with the platform team, but and perhaps the domain agnostic, technology focused team right that there are providing instead of products themselves. And but the products are the users off those products are data product developers, right? Data domain teams that now have really high expectations in terms of low friction in terms of lead time to create a new data product. Eso We need a new set off tooling, and I think with the language needs to shift from, You know, I need a storage buckets. So I need a storage account. So I need a cluster to run my, you know, spark jobs, too. Here's the declaration of my data products. This is where the data for it will come from. This is the data that I want to serve. These are the policies that I need toe apply in terms of perhaps encryption or access control. Um, go make it happen. Platform, go provision, Everything that I mean so that as a data product developer. All I can focus on is the data itself, representation of semantic and representation of the syntax. And make sure that data meets the quality that I have that I have to assure and it's available. The rest of provisioning of everything that sits underneath will have to get taken care of by the platform. And that's what I mean by requires a re imagination and in fact, Andi, there will be a data platform team, the data platform teams that we set up for our clients. In fact, themselves have a favorite of complexity. Internally, they divide into multiple teams multiple planes, eso there would be a plane, as in a group of capabilities that satisfied that data product developer experience, there would be a set of capabilities that deal with those need a greatly underlying utilities. I call it at this point, utilities, because to me that the level of abstraction of the platform is to go higher than where it is. So what we call platform today are a set of utilities will be continuing to using will be continuing to using object storage, will continue using relation of databases and so on so there will be a plane and a group of people responsible for that. There will be a group of people responsible for capabilities that you know enable the mesh level functionality, for example, be able to correlate and connects. And query data from multiple knows. That's a measure level capability to be able to discover and explore the measure data products as a measure of capability. So it would be set of teams as part of platforms with a strong again platform product thinking embedded and product ownership embedded into that. To satisfy the experience of this now business oriented domain data team teams s way have a lot of work to do. >>I could go on. Unfortunately, we're out of time. But I guess my first I want to tell people there's two pieces that you put out so far. One is, uh, how to move beyond a monolithic data lake to a distributed data mesh. You guys should read that in a data mesh principles and logical architectures kind of part two. I guess my last question in the very limited time we have is our organization is ready for this. >>E think the desire is there I've bean overwhelmed with number off large and medium and small and private and public governments and federal, you know, organizations that reached out to us globally. I mean, it's not This is this is a global movement and I'm humbled by the response of the industry. I think they're the desire is there. The pains are really people acknowledge that something needs to change. Here s so that's the first step. I think that awareness isa spreading organizations. They're more and more becoming aware. In fact, many technology providers are reach out to us asking what you know, what shall we do? Because our clients are asking us, You know, people are already asking We need the data vision. We need the tooling to support. It s oh, that awareness is there In terms of the first step of being ready, However, the ingredients of a successful transformation requires top down and bottom up support. So it requires, you know, support from Chief Data Analytics officers or above the most successful clients that we have with data. Make sure the ones that you know the CEOs have made a statement that, you know, we want to change the experience of every single customer using data and we're going to do, we're going to commit to this. So the investment and support, you know, exists from top to all layers. The engineers are excited that maybe perhaps the traditional data teams are open to change. So there are a lot of ingredients. Substance to transformation is to come together. Um, are we really ready for it? I think I think the pioneers, perhaps the innovators. If you think about that innovation, careful. My doctors, probably pioneers and innovators and leaders. Doctors are making making move towards it. And hopefully, as the technology becomes more available, organizations that are less or in, you know, engineering oriented, they don't have the capability in house today, but they can buy it. They would come next. Maybe those are not the ones who aren't quite ready for it because the technology is not readily available. Requires, you know, internal investment today. >>I think you're right on. I think the leaders are gonna lead in hard, and they're gonna show us the path over the next several years. And I think the the end of this decade is gonna be defined a lot differently than the beginning. Jammeh. Thanks so much for coming in. The Cuban. Participate in the >>program. Pleasure head. >>Alright, Keep it right. Everybody went back right after this short break.