From around the globe, it's theCUBE with digital coverage of Dell Technologies World, digital experience brought to you by Dell Technologies. Hello everyone and welcome back to theCUBE's continuing coverage of Dell Tech World 2020. This is Dave Vellante and I'm here with Sam Grocott who is the Senior Vice President of Product Marketing at Dell Technologies. Sam, great to see you, welcome. Great to be here Dave. All right, we're going to talk generally about cloud in the coming decade, but in really how the cloud model is evolving. But I want to specifically ask Sam about the as a service news that Dell is making at DTW. You know, what those solutions look like, how they're going to evolve. Maybe Sam, we can hit on some of the customer uptake and the feedback as well. Does that sound good? Yeah, sounds great. Let's dive right in. All right, let's do that. So look, you've come from the world of Disruptor. You know, when you joined Isilon, they got acquired by EMC and then Dell. So you've been on both sides of the competitive table and cloud is obviously a major force. Actually, you know, I'd say the major disruptive force in our industry. So let's talk about how Dell's responding to the cloud trend generally, then we'll get into the announcements. Yeah, certainly. And you're right, I've been on both sides of this and there's no doubt if you look at just over the last decade or so, how customers and partners are really looking at evaluating how they can take advantage of the value of moving workloads to the cloud. And we've seen it happen over the last decade or so and it's happening at a more frequent pace. And there's no doubt that is really what planted the seed of this new operating experience. You know, kind of a new lifestyle, so to speak, around as a service. Because when you go to the cloud, that's the only way they roll is you get an as a service experience. So that really has started to come into the data center as organizations are moving specific workloads through applications to the cloud of, hey, how do I get that in an on-premise experience? And I think throwing gasoline on that is certainly the pandemic and COVID-19 has really made organizations evaluate how to move much quicker and more agilely by moving some applications to the cloud. Because frankly, on-prem just wasn't able to move as fast as they'd like to see. So we're seeing that macro trend accelerate. And I think we're in good shape to take advantage of that as we go forward. Well, that brings us to the hard news of what you're calling Project Apex, i.e. your as a service initiative. What specifically are you announcing this week? Yeah, so Project Apex is one of our big announcements and that's really where we're targeting how we're bringing together and unifying our product development, our sales go to market, our marketing go to market, everything coming together underneath Project Apex which is our as a service and cloud-like experience. Look, we know in that world where customers were constantly evaluating which applications stay on-prem, which applications and workloads should go to the cloud. I think the market has certainly voted clearly that it's gonna be both, it's gonna be a hybrid multi-cloud world. But what they absolutely are clear that they want is a simple, easy use as a service experience regardless of if they're on-prem or off-prem. And that's where really the traditional on-premise solutions fall down because it's just too darn complex still. They've got many different tools managing many different applications that oversee their cloud operations, their various infrastructure, whether it's server or compute or networking, they all run different tools. So it gets very, very complex. It also is very rigid to scale. You can't move as fast as the cloud. It can't deploy as fast. It requires manual intervention to buy more.  And then of course, the traditional method is it's very capex heavy in a world where organizations are really trying to preserve cash, cash is king. It doesn't really give them the flexibility traditionally are going forward that they'd like to see on that front. So what they wanna see is a consistent operating experience for their on and off-prem environments. They wanna see a single tool that can manage and report and grow and do commerce across that environment, regardless of if it's on or off-prem. They want something that can scale quickly. Now look, when you're moving equipment on-prem, it's not gonna be a click of a button, but you should be able to buy and procure that with a click of a button. And then very quickly within less than a handful of days, that equipment should be stood up deployed and running in their environment. And then finally, it's gotta deliver this more flexible finance model, whether it's leveraging flexible subscription models or OPEX-friendly models, customers are really looking for that more OPEX-friendly approach, which we're gonna be providing with Project APEX. So very, very excited about kind of the goals and the aspirations of Project APEX. We're gonna see a lot of it come to market early next year, but I think we're well situated, as I said, to take advantage of this opportunity. So when I was looking through the announcement and sort of squinting through it, the three things jumped out and you've definitely hit on those. One is choice, but sometimes you don't want to give customers too much choice, so it's got to be simple and it's got to be consistent. So it feels like you're putting this abstraction layer over your entire portfolio and trying to hit on those three items, which is somewhat of a balancing act, but is that right? Yeah, no, you're exactly right. The pillars of the Project APEX value proposition, so to speak, is simplicity, choice, and consistency. So we've got to deliver that simple kind of end-to-end journey view of their entire cloud and as is for this experience, that needs to span our entire portfolio. So whether it's servers or storage or networking or PCs or cloud, all of that needs to be integrated into essentially a large single web interface that gives you visibility across all of that. And of course, the ease of scale up and frankly scale down, you should be able to do that in real time through the system. Choice is a big, big factor for us. We've got the broadest portfolio in the industry. We want to provide customers the ability to consume infrastructure anyway they want. Clearly they can consume it the traditional way, but this more as a service flexible consumption approach is fundamental to making sure customers only pay for what they use, so a highly metered environment, pay as they go, leverage subscriptions, essentially give them that OPEX flexibility that they've been looking for. And then finally, I think the real key differentiator is that consistent operating experience. So whether you move workloads on or off-prem, it's got to be in a single environment that doesn't require you to jump around between different application and management experiences. All right, so I got to ask you the tough question and I want to hear your answer to it. I mean, we've seen the cloud model, everybody knows it very well, but why now people are going to say, okay, you're just responding to HPE. But what's different between what you're doing and what some of your competitors are doing? Yeah, so I think it really comes down to the choice and breadth of what we're bringing to the table. So we're not going to force our customers to go down one of these routes, we're going to provide that ultimate flexibility. And I think what we'll really define ourselves against them and shine ourselves against them is that consistent operating experience. We've got that opportunity to provide both an on-prem edge and cloud experience that doesn't require them to move out of that operating experience to jump between different tools. So whether you're running a storage as a service environment, which we'll have in the first half of next year, looking through our new cloud console that is coming out early next year as well, you're going to be able to have that single view of everything that's going on across your environment and also be able to move workloads from on-prem and off-prem without breaking that consistent experience. I think that is probably the biggest differentiator we're going to have. When you ladder that onto just the general Dell Technologies value of being able to meet and deliver our solutions anywhere in the world at any point of the data center at the edge or even cloud native, we've got the broadest portfolio to meet our customer needs wherever we need to go. So my understanding is the offerings, it's designed to encompass the entire Dell Technologies portfolio from client solutions, ISG, et cetera, not VMware specifically, but it's really that whole Dell Technologies portfolio, correct? Yeah, and look, over time we totally expect to be able to transact VMware through this. So we do expect that to be part of the solution eventually. So yeah, it is across PC as a service, storage as a service, infrastructure as a service, our cloud offers all of our services, traditional services that are helping to deliver this as a service experience. And even our traditional financial flexible consumption models will be included in this because again, we want to offer ultimate choice and flexibility. We're not going to force our customers to go down any of these paths, but we want to do is present these paths and go wherever they want to go. And we've got the breadth of the portfolio and the offers to get them there. Okay, so it's really his journey. You mentioned storage as a service coming out first. And then as well, if I understand it, the idea is that I'm going to have visibility and control over my entire state on Prem, cloud edge, kind of the whole enchilada, maybe not right out of the chute, but that's the vision. Absolutely, you've got to be able to see all of that. And we'll continue to iterate over time and bring more environments, more applications, more cloud environments into this. But that is absolutely the vision of Project Apex is to deliver that fully integrated core edge, cloud partner experience to all of the environments our customers can be running in. I want to put my customer hat on, my CFO, CIO hat. Okay, what's the fine print? What are the minimum bars to get in? What's the minimum commitment I need to make? What are some of those nuances? Yeah, so both the storage as a service, which will be our first offer of many in our portfolio and the cloud console, which will give you that single web interface to kind of manage report and kind of thrive in this as a service experience. All that will be released in the first half of the next year. So we're still, frankly, defining what that will look like, but we want to make sure that we deliver a solution that can span all segments from small business to medium business to the biggest enterprises out there. Globally, goal expansion through our channel partners, we're going to have GEOs and channel partners fully integrated as well as service providers as well as a fundamental important piece of our delivery model and delivering this experience to our customers. So the fine print day will be out early next year as we GA these releases and bring into market but ultimate flexibility and choice up and down the stack and geographically wide is the goal and the intent we plan to deliver that. Can you add any color to the sort of product journey? If you will, I even hesitate, Sam, to use the word product because you're really sort of transferring your mindset into a platform mindset and a services mindset as opposed to bolting services on top of a prior, you sell a product is okay, service guys, you take it from here. It's really, you have to sort of rethink how you deliver. And so you say, you start with storage and then so what can we expect over the next midterm, longterm? Yeah, I'll give you an example. Look, we sell a ton of as a service and flexible consumption today. We've been at it for 10 years. In fact, in Q2, we sold our annual recurring revenue rate is 1.3 billion growing at 30%. Very, very pleased. So this is not new to us but how you described to Dave is right. We adopt products, customers then pick their product, they pick their service that they wanna bolt on then they pick their financial payment model and they bolt it on. So it's a very good customized way to build it. That's great. And customers are gonna continue to want that we'll continue to deliver that but there is an emerging segment that wants more just kind of think of it as the big easy button. They wanna focus on an outcome. Storage as a service is a great, great example where they're less concerned about what individual product element is part of that. They want it fully managed by Dell Technologies or one of our partners. They don't wanna manage it themselves. And of course they want it to be pay for use on an OPEX plan that works for their business and gives them that flexibility. So when customers going forward want to go down this as a service outcome driven path, they're simply gonna say, hey, what data service do I want? I want file or block unified object. They pick their data service based on their workload. They pick their performance and capacity tier. There is a term limit of, you know, right now we're planning one, one to five years depending on the amount of terms you wanna do. And then that's it. It's managed by Dell Technologies. It's on our books from Dell Technologies. And it's of course leveraging our great technology portfolio to bring that service and that experience to our customers. So the service is the product now. It's, it really is making that shift that we are moving into a services driven services outcome driven set of portfolio and solutions for our customers. So you actually have a lot of data on this. I mean, you talk about a billion dollar business, maybe talk a little bit about customer uptake. I don't know what you can share in terms of numbers and a number of subscription customers but I'm really interested in the learnings and the feedback and how that's informed your strategy. Yeah, I mean, you're right. Again, we've been at this for many, many years. We have over 2,000 customers today that have chosen to take advantage of our flexible consumption and as a service offers that we have today. Nevermind kind of as we move into these kind of turnkey, easy button as a service offers that are to come that early next year. So we've leveraged all of that learnings and we've heard all of that feedback. And it's why it's really important that choice and flexibility is fundamental to the project APEC strategy. There are some of those customers that they want to build their own. They wanna make sure they're running the latest PowerMax or the latest PowerStore. They wanna choose their network, they wanna choose how they protect it. They wanna choose what type of service they're, they wanna cover some of the services they may want very little from us or vice versa. And then they wanna maybe leverage an additional more traditional means to acquire that based on their business goals. That feedback has been a lot of fair but there is that segment that is like, no, no, no. I need to focus more on my business and not my infrastructure. And that's where you're gonna see these more turnkey as a service solutions fit that need where they wanna just define SLAs, outcomes. They want us to take on the burden of managing it for them so they can really focus on their applications and their business, not their infrastructure. So things like metering, tons of feedback on how we'll wanna meter this, tons of feedback on the types of configurations and scale they're looking for. The applications and workloads that they're targeting for this world is very different than the more traditional world. So we're leveraging all of that information to make sure we deliver our infrastructure as a service and then eventually solutions as a service. You think about SAP as a service, VDI as a service, AI and machine learning as a service. We'll be moving up the stack as well to meet more of a application integrated as a service experience as well. So I wanna ask you. So I mean, you've given us a couple of data points there, you know, billion dollar plus business, a couple of thousand customers. It is this, I mean, you got decent average contract values if I do my math right. So it's not just the little guys.  Is that fair to say? Totally. I mean, I would say frankly, you know, in the enterprise space, it's the mid to larger sides of historically and we expect they'll continue to wanna kind of choose their best of breed of products, best of breed services, best of breed, financial consumption, great. And we're in great shape to there. We're very competitive, very, very confident or competitive in competing in that space today. I think going into the turnkey as a service space, that will play up market, but it will really play down market, mid-market, smaller businesses. It gives us the opportunity to really drive a solution there where they don't have the resources to maybe manage a large storage infrastructure or backup infrastructure or compute infrastructure. They're gonna frankly look to us to provide that experience for them. I think our as a service offers will really play stronger in that mid and kind of lower end of the market. So tell us again, the sort of availability of the actual, like the console, for example, when can I actually get, I mean, I can do as a service today. I can buy subscriptions from you. This is where it all comes together. What's the availability and rollout details? Sure, so as we look to move to our integrated kind of turnkey as a service offers, the console we're announcing at Dell Technologies World as it's in public preview now. So for organizations and customers that wanna start using it, they can start using it now. The storage as a service offer is gonna be available in the first half of next year. So we're rapidly kind of working on that now, looking to early next year to bring that to market. So you'll see the console and the first as a service offer with storage as a service available in the first half of next year, readily available to any and everyone that wants to deploy it. So we're not that far off right now, but we felt it was really, really important to make sure our customers, our partners, and the industry really understands how important this transformation to as a service and cloud is for Dell Technologies. That's why, frankly, externally and internally, Project Apex will be that North Star to bring our end-to-end value together across the business, across our customers, across our teams. And that's why we're really making sure that everybody understands Project Apex and as a service is the future for Dell and we're very much focused on that. So I mean, as the head of product marketing, this is really a mindset, a cultural change really. You're really becoming the head of service marketing in a way. How are you guys thinking about that mindset shift? Well, really, it's how am I thinking about it? How is the broader marketing organization thinking about it? How is engineering clearly thinking about it? How is finance thinking about it? How is sales? This is transformative across every single function within Dell Technologies has a role to play to do things very differently. Now, it's gonna take time. It's not gonna happen overnight. Various estimates have this as a fairly small percentage of business today in our segments, but we do expect that to start to, and it has started to accelerate and ramp. We're preparing for a large percentage of our business to be consumed this way very, very soon. That requires changes in how we sell, changes in how we market clearly, changes in how we build products and so forth. And then ultimately how we account for this has to change. We're approaching, and I think the right way, Dave, where we're looking at this truly end-to-end. This isn't a tweak in how we do things or an evolution. This is a revolution for us to move faster to this model. Again, building on the learnings that we have today with our strong customer base and experience we've built up over the years. But this is a big shift. This isn't an incremental turn of the crank. We know that, I think you expect that, our customers expect that, and that's the mission we're on with Project 8x. Well, I mean, with 30% growth, I mean, that's a clear indicator, and people like growth. No doubt that clients are, that's a clear indicator that customers are glomming onto this, and I think many folks want to buy this way, and I think increasingly that's how they buy SaaS. That's how they buy cloud. Why not buy infrastructure the same way? Give us your closing thoughts, Sam. What are the big takeaways? Yeah, big takeaways is, from a Dell Technologies perspective, Project 8x is that strategic vision of bringing together our as-of-service and cloud capabilities into a easy-to-consume, simple, flexible offer that provides ultimate choice to our customers. Look, the market is spoken. We're going to be living in a hybrid, multi-cloud world. I think the market is also starting to speak that they want that to be an as-of-service experience, regardless if it's on or off-prem. It's our job, it's our responsibility to bring that ease, that simplicity and elegance to the on-prem world. It's certainly not going anywhere. So that's the mission that we're on with Project 8x, and I like the hand we've been dealt. I like the infrastructure and the solutions that we have across our portfolio, and we're going to be after this for the next couple of years to refine this and build this out for our customers. This is just the beginning. Well, it's awesome. Thank you so much for coming on theCUBE. I mean, we're seeing the cloud model. I mean, it's extending on-prem, cloud, multi-clouds, going to the edge, and the way in which customers want to transact business is moving at the same direction. So, Sam, good luck with this, and thanks so much. We appreciate your time. Yeah, thanks, Dave. Thanks, everyone. Take care. All right, and thank you for watching. This is Dave Vellante for theCUBE and our continuing coverage of Dell Tech World 2020. The Virtual Cube, we'll be right back right after this short break.


appreciate y'all being here. It's good to see everybody in person outside of virtual. I know usually we have a few technical difficulties when we go virtual, so it's good to see you guys in person. Hope everybody's doing well. We want to start out by acknowledging and thanking some people in the building as we prepare for this process. We start off the offseason and we had a goal to add competition to the roster to add quality men and players into the building. And we believe our pro staff working along with the coaches and football administration have done a really good job working to do that. We're obviously not finished. The roster building process is 24 7365, so we're continuing to work through that. We'll turn over every stone yet. We appreciate the work that's gone into it up to this point as Thursday approaches. There's a lot of people that have worked hard to get us prepared for the draft. We feel very confident, excited and prepared and we're excited about what we're going to be able to do day one, two and three. And that's because of a lot of people that have had their hands in it, starting with the college scouting department who they've grinded through this process for a long time. The coaches as soon as the season ends, they turn into scouts. We have a very inclusive process and so they're very involved. They're on the road. They're they're writing up a lot of players and they do a lot of work and so and also opening their door to scouts and spending time with scouts is so we can have a cohesive staff. So we appreciate the coaches, um, it analytics, the video department, the training room, the doctors. A lot of people have put their put a lot of work into this. So I would say we're very thankful and excited as we approach the draft and just to follow up on what Terry spoke about. I'm very thankful. We have a very collaborative staff and a tremendous job. We're excited to be a couple days away from the draft. We feel like we've had a really productive spring. So that will open up questions. Well, I would say one of the main differences is not being under the covert restrictions that we had last year. So all the different exposures that we get with the players having unlimited access at the pro days, been able to go out and do personal workouts, being able to bring players in for the 30 visits, being able to be in person at the combine, being able to look the local pro day is something we didn't have last year. And there's obviously a lot of homegrown talent here that we're able to see. And so that was exciting. So I would say one of the big parts is just not having all those restrictions that we had last year. And the other part is, Hey, we have been together this entire staff for over a calendar year. And so the cohesiveness and building those relationships. That's important. And so us being together, living together really helps in the process as well. Um, I don't think it's that simple as a look. We evaluate. We spend a lot of time with this quarterback draft class this year. We spent a lot of time with the draft class last year. Did a lot of work and we could obviously we're not going to give away what we're going to do at eight or any other pick, but we could come out of this draft for the quarterback. Um, we want to add to that room and we'll see what happens, but we do a lot of work on this class. We did a lot of work on this class just like we did last year. Well, we have until until next week. And so we're working through that, but we'll communicate directly with the players and their agents once we make those decisions. And we'll just keep that internal and private for right now. What is that like? We'll start. Sure. There's a lot of holes that happens. Why guys are successful while they're not a lot of it's fit. You know, when you're taking a player, especially taking a quarterback, it really any any portion of the draft to make sure you have a plan. And so I'm surprised you only you only went to 88. Thought you go earlier. There's some pretty good early 80s classes too, but I'm a little disappointed you didn't go back that far. Could be Jimmy Hay. Jimmy Hay is the story. So Jimmy would know. Yeah, it certainly helps. Yeah, you look at why why certain players were successful. Why they weren't what you could possibly controlled. Yeah, I mean, you take it. I don't think you ever dismiss a class year after year. I think you need to understand quarterback talent that's coming into the league. If you don't take one who you potentially would have to see you have to face off against. So that goes into it. But you certainly study history and why guys are successful. Why guys on it? That your mind drifts more toward what's this war or what's this Yeah, I think sometimes it probably more the floor. You know, I think anything else you get you're certainly trying to enhance and develop. But that's certainly where mine goes doesn't say it's right or wrong. But that's just how my mind operates. It depends what you're looking for the certain position. Like what's the job description? What's your vision for the player? How do you think he fits?  So when you when you put a pick in, you've got a plan for the guy and you can follow through with it like here's here's what I know he can do. Here's what you're trying to enhance. Certainly, it's all kind of different skill players, right? There are a lot of guys that have different abilities that can be successful and depends what you're looking for and who's available when you pick. And when you take that player, do you have the vision? You're gonna try to enhance that and play them in the right spot. So certainly you look at all that stuff. No, I'd say it's the same. And I would say usually we want to bring in players that have a high floor because we're focusing on the makeup and bringing in the right human beings. And so usually if you have players that have the right makeup, they're wired the right way, and they're gonna work and and and they're gonna they're gonna get obviously the coaching here and they're gonna get all the resources here. So they're gonna they're gonna have that high floor because of their makeup and because of their intangibles. And yet obviously we want players with high ceilings, but you'd rather like this, you don't want it to be like this, you know? So I think when we focus on the makeup, then we usually get players that that'll have high floors. What it definitely helps, we always want that's the first part of the process in the offseason. And we want to bring in as as much as you can in every phase at every position. And when you add, we always want to take the best players off the board in the draft. But when you're adding to those positions, you're adding competition, I think that helps going into the draft. So that's that's really important. That's something we prioritize. So yeah, that helps a lot. Yeah, well, you know, last year, everyone was playing under the same rules. And so we had to and we got everything accomplished that we needed to. But I think it is different when you actually get people in the building and you're getting up, you're able to be around them a lot more as opposed to being on a zoom. I think there is a difference being in person and spending more time with them. I don't know if I could put one specific thing on it and why it's important. But I think being being in person and getting that time up close. I think that's valuable. Charles, the widespread reception is that there's more uncertainty from folks trying to project the first few picks in the draft. Would you agree with that? And if you do, how does that impact your maneuvering? You're, you're trying to get a graph on your board and what you expect to see in number eight? I agree. I agree. When's the last time we sat here and everyone doesn't know who the first and second pick are. It's unique, especially last year. We were sitting here. We were like the first pick of the draft last year, because especially once San Francisco traded up, we basically knew the first three players that were going to come off the board. And now this year, that's not the case. And we're sitting at eight. And so we try our best to anticipate what's going to go in front of us. But we have to be prepared for a lot of different variables and a lot of different scenarios, whether we have to stack the players and be prepared to take them off how we see them. But we also have to be prepared to have those conversations about moving up, about moving down. And so I would say yes, there's so many more variables. But we just have to be prepared for every scenario. In fact, public lemonade talks you may have to keep doors open on what calls you may want to receive from folks who might be interested in talking to you before your day. I would say we still go through the same process. We're always going to talk to the teams ahead of us and the teams behind us. And we're going to talk to the other 31 teams and communicate. And so we're going to have those conversations anyway, regardless. And same way, we're going to stack the board. So I think it doesn't it doesn't affect your process. We just have to make sure we're intentional and we know exactly we go through every every single scenario and to determine what we're going to do. Yeah. So what he wants me to do is repeat his question and say, you know, that's what you're talking about. Savvy, right? I got to watch him too. It's not just D lead. I got Jeff. No, I'm not going to give you a chance back. Look, I'll say this. We were always we're trying to add competition at every position and constantly and trying to bring in players that are going to compete. And this is week two of the all season program. And obviously players choose if they want to come or not. And that's their prerogative. But I'll say we have a lot of guys out there competing and working to get better. And we appreciate that we're excited about that. So we saw improvement in areas throughout the year. We'll see improvement throughout the soft season. We're going to keep bringing in competition. That's our charge. That's our goal at every single position and bringing competition and continuing to improve. We we're always looking we always have a yeah, we always have an after action report. We're going to always look at with a critical eye, look at everything we do, whether we're talking about last year's draft or or the way we approach every single decision, every single transaction we make, we're going to look at it with a critical eye and we're going to always evolve and improve the process. We're focusing more on the process, Jeff, as opposed to focusing on exactly what the result is. We're looking at the process and we're going to always constantly improve and evolve in every single area. So so yes, we look back at last year. We're going to look at every single the detail of everything we did every decision we made and look at ways that we could have improved. I think that's where you have to have humility in these roles and and we both have that and we both do that. Like your story is already written on some of the players. Is that what you're asking? We got all the way to go. We got a lot of guys that are take take on bigger roles and be a fool to look back at history after one year and say, I know exactly what this guy's career is going to look like. We got a lot of guys that we feel good about that played different roles and roles will expand this year. That's part of our job as coaches develop and still feel pretty good. I think I don't know if there's a specific player or position you're talking about. No, no, no, you're just talking about just a general catch on. Yeah, I think you could continue to evaluate, develop. I think the, you know, over time made a mistake. You got to be realistic about it if you need to move on. And but we feel pretty good about where our guys are at. A lot of guys that were drafted last year and they're expected to have bigger roles for us this year. For you guys, when you evaluate the draft class, some teams do it differently, but do you guys have like a tier aim or a lot of lead prospects that you say, hey, there's four, five, six hours in a period. How does that impact you guys at eight? Yeah, good question. We do. We'll evaluate the class and we'll we have certain categories that would put players historically in the first round. So and we're not going to grade on the curve, so we're not going to have 32 first round picks every year. We might have 21st round picks, 18 first round picks. And so and so when you're making those decisions, you do look at, okay, this is this is an impact. We can get an impact player up to this point. So if we discuss the trade back, then we don't want to go below this area or you're weighing out the pros and the cons of it. So we do. We evaluate the players, put them in certain categories, and and that's how we can make decisions to know where you can still get impact players or what area you are in the draft. Well, we're gonna live in the moment right now. Obviously, we we know that we have such a good scouting department.  And so when we're watching crossover tape, you see the players and you know what's coming up next. But that being said, I think you always have to live in the moment and do its best for your team. We're thinking big picture. But we're not going to say, Hey, we might get this player next year. So we don't want to get this player this year because there's so much that comes between and you think about the time and it's funny when you'll see a mock draft right after this draft for next year, take one of those and then put it up next to the real draft and it's comical, you know. So we again, we have an excellent scouting staff that makes us aware of everything that's coming in the future. But we had to live in the moment and do its best for our team right now. He's worse than a man right here. Yeah, again, without giving giving anything away, it's a it's a good class. I think throughout there are players at the top in that elite level. There are players throughout the draft and even down at the bottom. So in that such a unique position in that it doesn't have to be one flavor. If you're a pressure player, you know, you can come different ways. And so but I would say it's a it's a strong class. Yeah, well, it's kind of like the question that was posed earlier that at eight right now where last year we had a at this time as we're sitting here, we had a pretty good feeling about a renew who we're drafting in less. Obviously something would happen trade wiser. But now it's completely different. We have our board set. But to know who's going to be there at eight, or if we're going to stay at eight, move up or move down. There are so many variables. I would say right now our board is set. But the hay is never in the barn. We're continuing to work through things all the way up until and throughout the draft, we're constantly working on it. So our board is set. We got the players up where we have them stacked, but we're always gathering information and always working through it. I think there's starters at every single position. And that's a great question in the way you proposed it. And you could I love it, man, some savvy, these experience, right? But there's starters at every position. And and to look at to right now we evaluate the players. And of course, there's going to be starters that come out of this class. We won't know that until three, four years from now with some of the players. But but at every position, there's starters, there's backups at every position. There's some guys that aren't going to make it at every position. No, we could we could draft a quarterback in any of the rounds or there's multiple ways to acquire a quarterback. We want to add to our room and we will. But so it could be in the draft. It could be after the draft. It could be via trade. We're not going to limit ourselves to any possibility. We're going to turn over every stone. So whether it's in the draft or not, we'll add to that room. Thank you. Where do you stand on that? And is there ever any push and pull between the I don't know what that was microphone. So I thought I was on the question. Push and pull between the guy who's sitting at the top of the board and someone else who might be at a position of what you guys view as a more immediate need. I think when you get yourself in trouble, I mean, if things are even, I think contingencies to go, you want to say need, but the way you got to trust the process and the way your board says so, if it's even, yeah, there's certainly a tendency to go more of a need, but you don't want to sit there and you got to trust your evaluation process, your scouts and everything you always weren't put in because the pressure of the clock is to overdraft some money and bring them up. I think you get yourself in trouble. So that's why I think you get best player available. There's always exceptions, but that you try to stay consistent that way. Yeah, there's not a there's not one room that we don't want to add to. And so and that's why we have needs in every area of the roster and even places we might feel better about. We're thinking big pictures so there could be players that won't be under contract in a couple years or something. So we're always there's not one position that we don't need to add competition to, which makes this process very easy for us because we can we want to add quality players and human beings into this this team and into this locker room. And and so we're going to be able to do that. So I wouldn't say there's one position where we'd say, hey, we're all set. We don't need to add a player there. Not a not a great strategy. So I think the more we can continue to add at every position creates a competition, improve the roster. I mean, that's what we'll do. I mean, you saw how many transactions we made last year. No different. I think what you're seeing now, there's a lot more avenues and people more willing to make those trades or however, however your process goes. But I think that's what you're seeing around the league as well. Mm hmm. Well, I think you do what's best for the team. And if you can consider that, I think you'll be in good shape. I'm also the heck. I'm the head coach first. And I think you know that. And I spent a couple years on defense, sad enough, special teams, you understand that you need to improve your team in all three phases. And and we you can look at it and I'm sure we got needs everywhere. You're going to have needs everywhere every year. I mean, you want to continue to improve and enhance and evolve. So I feel good about where we're at where our process is at right now. And we're excited about this draft coming up. Josh. So so when we talk about the players, the the categories that puts a player in the first round, it's going to be an impact player, right? So so he's going to be a major impact. And as we go through the draft, OK, there's the solid starters and contributors and developmental. So there are categories in each area. Now, what is an impact player? Is is there we don't have it's not like we have a certain he has to right, these statistics six, we evaluate the players. And so as you grade the draft classes three years down the road, then you evaluate the players regardless of their statistics or their specific play time, you'll just evaluate the players and what they were. But as we set the board, we have the if you fit in this impact category, you fit in the first round and and like I said, we're never going to grade on the curve. Yeah, it's an impact, Josh, the winning coming in the impact of winning what the role is.  Yeah, if you overdraft somebody, I've seen this happen for you may say, OK, he's a step around big, started 50 games, but he also went to three positions before realizing I couldn't play. So I've seen that too. So it's hard. I mean, that's what makes this sport hard. I mean, so many variables you can make an argument for or against in a day to have an impact and help this team win. And comes to making the pick, whatever the pick may be down the road this year or next. And you're looking at the quarterback position. Is your influence or input whatever the word is, any different with that position of positions? Sure. I mean, that's, you know, that's the one thing most important position. Yes, we get you're going to be judged on the decisions we make.  Hey, yes, yes, it's good to have conviction. But Friday night, Saturday, off season, the trade 23, you know, I'm so you hope to have a long career here. But it won't just be like, Hey, this is my guy. I got picked on them. There's a lot of things that that always that always makes me laugh a little bit too is like you draft a player instead. I found them. What about the thousands guys the Scouts went through team from the training staff to the weight staff to make sure that you're all on the same page. You have a role for that player, a lot to go into for just sit there and say Pat my son back say I'm that transaction for the quarterback. It'll be a collaborative effort. And it's it's it's it is funny when you see I don't know how some other they're I didn't want and that that's just false. And if anyone has been around us at all, they understand the way our process works. We're going through it together. We're on the same page. Are we always going to agree in every moment? Of course not. But we both have humility and have mutual respect that we're going to talk through things, communicate through things. Obviously, the coaches, Scouts, we're going to take all the information and find the right player for the Falcons in every process or hadn't been a decision that we haven't made like that and there won't be one. So in our process, it is truly an inclusive process and we're going to be on the same page with every decision we make. How does that affect what you want or where we end up picking? Yeah, it's a weighing process. We actually had our second medical meeting yesterday afternoon and we went through every prospect and where they are in the rehab and there's different ones or some players that you're not going to see work out. Some players are able to see work out and we really lean on our doctors and our training staff to tell us, OK, this is where the player is now. This is the expectation based off where they are in their rehab and we expect the full recovery at this point. And so we lean on them a lot in that process and it's basically weighing. OK, this player might be a red shirt or this player is PUP or and we weigh the player's talent compared to what we're going to get on the back end and how long he's going to be out for. So it's really leaning on. We're not doctors. We're not experts in that area, but we lean on. The doc, I guess you might and you read a book about me and you think. So but we really lean on them in that process and we wait out the player, the talent level of the player and the medical what we expect on the other end of it. So I like to suede you for taking no not at all. You mentioned before. I won't give you the exact number. He's looking for the headline. It's not. Yeah, he's looking for. It's not necessary. Thirty three. OK, I'll go. First one was one of us to say something. He can put on PFT. One of the, you know, I'm Michael Rostin's. But they're going to give you the, you know, so. But I won't tell you the first round, but usually there's rarely thirty two first round picks. So you always know at what point are you not going to get what you deem a first time first round pick talent. But but there's never usually not thirty two. Well, we'll keep that private. All those communications between us and and Todd and Grady. And we'll keep those private and direct with them and keep that in house. But we've been clear with how we feel about Grady and the person, the player, all those things. Love Grady, but we'll keep that in house. It's a good question. It's a really good question because when you're looking at with different positions and when you stack the value of positions and you look at how much they cost, all those things, they all mean something. And that being said, I would say for us when we're valuing when we want to know what positions are important, it's more so what's important to author and offensive staff and and in that way what's important for our team in the way you value it. But you always have to think about those things, those numbers at all the what people get paid and all those things are important. But I would say we lean more towards what's important us in this building. I think there's a lot of different variables. And the one thing I think you can't be too critical on them and people play offense a lot of different ways, right? That's the town pool coming through. And and so, you know, certainly you want to evaluate the decision making. And I was accuracy is a big part. And then you evaluate the arm strength and how he fits and what you could do with them. So obviously, decision making accuracy is a big part of it.  And the rest of it, you know, you see what's what's the best fit. What he's doing and is all what's he's being asked to do. I think that's one thing that gets overlooked. I think it's it's easy just to criticize a guy. Well, I don't see him throw these routes. Well, they may never ask him to do that. But can he does he have a pocket feel? Is he a good decision maker? And is he accurate? I think you go from there. Then you evaluate the arm strength and there's a lot of other factors. But that's kind of where you start. Yeah, is there any way to point the roster of the franchise to be at a certain point by the end of the day? Yeah. The simplest way I could figure out how to get a question and how to be judge. Oh, come on. You're supposed to be here to judge me. I'm not supposed to judge you, right? You want to start? Explain a little more. Yeah, I mean, you're asking if we're like... Well, I think... Sure. So, obviously, it's really important.  So, we really need to be at this point this upcoming season? I'm not even going to talk about terms of wins and losses, I'm talking about terms of roster and having pieces to build on. There's no way to bring your mind. Because obviously, you can't... You're not going to go on next summer and buy seven players. Right. Yeah, and I would say we have a plan and we're working to execute that plan. And regardless of the dead money this year and all those things, we're excited about the players are in this building right now and we need to go in this draft and add some... add pieces and add... Again, we have five picks over Thursday and Friday and then nine total picks. And so, we got to hit on those players even after the draft. There's a bigger pool with COVID and the way everything happens so there's a bigger pool here. So there's going to be some players that we signed after the draft that could have would have been drafted in another year and I have confidence in our scouting staff and our coaches in developing those players that we're going to be able to bring in a lot of impact players, a lot of good players this year. Even the players that we sign, regardless of whether... regardless of how much we spend on players, we have confidence in our scouts and our coaches. So we see that even despite the challenges we had this year, Jeff, we're going to like where we are as a team as we step into the year and we're going to continue to improve and there's never going to be a time that we have a lot of money and we're going to go out and be reckless and we're still going to have a process and have discipline and do things the right way. So it's tough to... I feel like we want to have a smart, tough, competitive team and we want to continue to improve every day and that's how... I think that's how I would judge it with the way we're competing and what we have in the building. Sounds good. Terry just answered it. And one more question. What surprised you given how... Man, it's... this draft is... I'm having trouble predicting it, Jeff. It really is tough to anticipate the draft. Right now, what's going to happen in the first 10 picks or the first 15 picks. So it's tough, man.  And it's funny, my phone is... I got a million calls because everyone wants to talk through the draft and wants to gather information. But I don't have the answers right now. That's why we got to be so prepared for a lot of different variables. So it's tough. It really is difficult to predict. This is a very unique draft. We are. You can tell us the story, by the way. No. Is that what I'm looking at? It's a... Terry got a sponsorship. You can't say that. Maybe they sent an extra one. Maybe. We'll show it to you afterwards to see if we can get Terry to send us more watches. There you go. Again, that's what keeps those in-house. Keep those in-house. Keep it in-house. Well, keep it... Well, no, we're just... Keep that private. Yeah, keep it private. We don't want to offend anybody. And Terry didn't... You're already throughout this time. Terry didn't... That's not good. The watches that were sent to everybody. Tim Z is going to give you a call about the sponsorship. Well, I didn't say who it was. So I'm not getting myself in trouble. But there was a select few that Terry handed him out to. Oh, goodness. Here we go. There we go. I didn't get one, so you wrap it up. I actually liked it. It's funny because a couple years ago when you had the COVID draft and it was really efficient. And I remember sitting in my living room and I had the little ones tugging on me. And it was very efficient and it worked. Last year, we had a smaller, not as many people in the draft room. And it was outstanding. I think there's too many chairs and tables in our ward, a draft room right now. I would say that. So I liked it when it was not as many people. Well, I think, you know, the easiest thing, we've got a lot of we've got a lot of draft picks this year. And you liked it. Hit on the majority of those. I mean, you got younger players that are probably on more team-friendly deals, especially with the current cap situation. So in the short term, and I think every year you don't want to dismiss it. I know that's kind of a dependent where teams are at. They're just living through for agency. I think you get the point where you can definitely supplement for agency. But you've got enough. You've hit on enough draft picks that you keep replenishing. And you've got guys you're developing. So if you do lose a guy that, you know, it makes a lot of money as for agency. You've got another guy. And so I think you could have a good balance. But what we're at currently is from last year to this year and where a cap issue is like draft picks, whether some of them are ready or not, they're going to have to play. So that last year was some of them. We had a plan and injuries come up and you got to play a guy earlier or you're able to be disciplined in certain spots, maybe on the back end. But so what we're at current for 22 of them, those drafts obviously big for us. Sure. Yeah, but I think you have a good balance. And again, there's always a great unknown for agency when you go out there and you obviously got to fill your, the cap space, but you'd like to be able to resign some of your own players and then supplement it where you're not just relying on one big for agency dump. That helped. Cool. Can I ask a quick follow-up to the follow-up? Sure. Is that why it's my favorite sort of judge? I think so. I mean, I've seen it both ways. Guys, if that's success year one and maybe they get comfortable and their habits change or they get content. And I think that's the hardest thing is for guys that are rare ones that stay motivated and they continue to do it year after year after year. And then I've seen it the other way. Guys may struggle, come from a completely foreign system. You believe in the player, hey, we're bringing you along and then they really take off year two, year three. But some of them when we had a plan, maybe not to play them as early as we had to, well, somebody had to play, right? So that's why you just, it's hard to say, hey, we're exactly, this is what we're gonna be in a year, Jeff, so you can use Terry's words against them. We're not gonna give you that satisfaction, but there's a lot of variables that happen. And that's why not being evasive, but it's not fair to somebody's player after year one to say that they're, oh, this guy's riding off and already getting his bus ready and can't, or this guy can't play. That fair? Absolutely. And especially about the last year, but you anticipate in that place to the dual role this year? D-Led's got him at wide receiver, so. Is that where he's got him in his depth chart? D-Led's got him at wide receiver, so I didn't know that's news to me. We just hopefully to expand on it and we'll have to see. I mean, again, if you, we feel good and we have a running back that's a rookie that's gonna be, we feel good about going into the season, his role may evolve back on the perimeter. It just depends. You know, you may have weeks where we got a plan and give him more carries. We obviously like the football player. We appreciate what CP did for us last year and what he's gonna do for us in the future. But that's what's fun about coaching the guy like CP because you can move him around a lot of different spots. You still got him at wide receiver? Are you gonna? Is that what you're gonna go with? Yeah, I'm gonna stay with him. All right. Interesting. It's gonna be Sunday night. We'll see. We'll see you there. You still got the safety's wrong. Not to say I'm auditing you or anything, but to ahead your bet. All right, anything else? Good. All right. All right. Thank you guys. Thanks guys.


couldn't put this book down. I loved every page of it and I'll tell you why in just a second. Okay the quick description of this book the title diabolic refers to a genetically engineered humanoid that is created to act as a bodyguard for a specific person that is mentally and emotionally bonded to a specific person and their only goal in life is to protect that person. This takes place in the distant distant future untold thousands of years in the future when the human race has settled and overtaken countless star systems all over the galaxy. It's a future dark ages time. The the ruling family has maintained control by conducting all-out war against education and science. All of the space faring technology and genetic technology and everything that they use to travel their empire and control their empire is in decline and falling apart. Because nobody is left who knows how anything's anything works or can rebuild anything so it really is a dark ages. The empire is in its heyday but it's going to fall soon and everybody knows it and that's the setting of this book. From the description in the the dust jacket here which I'll let you read you can pause that and read it while I'm talking. I got the impression that the diabolic that had been created for this little girl named Sidonia was going to be kidnapped with the kidnappers thinking that the diabolic was Sidonia. That is not at all what happened. I was surprised at every turn by this book. I never knew where it was going to go and I loved everywhere it went. This author S.J. Kincaid pulled no punches. She held nothing back. She considered nothing sacred. These characters are not her precious babies. There is nothing about this that could be called a Mary Sue story. I would say that if you enjoyed the Hunger Games you will enjoy this. I would also say that if you hated the Hunger Games you would also enjoy this because it's so much more than that. It's like great YA fiction combined with Game of Thrones or with Dune. The galaxy spanning decadent royal empire was very reminiscent of the complexities of the royal families of Dune. I just can't recommend this enough. I do want to add that I learned about this book from another YouTuber called One Minute Books. She is a librarian who reviews exclusively children's books and because her area is so different than mine she always comes up with books that I've not seen or heard of and every once in a while she'll review a really nice YA piece of fiction like this and I've learned about a number of books through her so give her a look and get this book. Please remember to press that like button. It helps my videos get seen and then subscribe so you can come back next time. I do science fiction book TV and movie reviews all the time and please consider becoming a patron. There's a link in the description below.


But I decided to go the casual way and talk about stuff that might help in getting genomic medicine moving. This is from the point of view of where I sit at FDA, which is as the director of the personalized medicine staff, which resides in the office that regulates laboratory tests. It's now called OIR. It's got a much longer name, but a shorter acronym. And that's in the Center for Devices at FDA. We do do a lot of work with other centers as well. So I put together what I'd like to think is a short but profound list of things that might help in getting this to work and to work well for patients, and that is we need standards for genomics. We don't have standards, and this is a tremendous amount of information that's being churned out at many centers around the United States and the world, and we don't know if it's comparable one to another. We need quality systems and the things that are used to generate the information. And that means you actually have a plan. I'll talk about that in a little bit more. We actually would benefit hugely from curated databases of evidence, and that means when you have a finding in a whole genome that it actually gets into a database and outcomes and management and so on are recorded. Because if it's something that's rare or newly encountered, it's the only way other people are going to know, other than publishing a case study, that that even exists. And a lot of the databases that exist now are in fact fairly well populated, but mostly not curated. They're more like repositories. People just submit information. There's not necessarily a lot of control on what actually gets in there or the quality of what gets in there. So I'll talk about that a little bit more in a minute. And I think most of all, we need evidence to put in the databases. A lot of people are wanting evidence, but it doesn't seem like a lot of people are putting together programs to get evidence. So I think we would benefit a lot from that. I always hear it. I've been on these federal committees since 2001, and we've been talking about evidence for clinical utility since then, and I'm sure people talked about it for years before then, but I still haven't seen very many studies set up to actually create high quality evidence. So where are we now? FDA is working with the National Institute of Standards and Technology, and who is running the Genome in a Bottle Consortium, and we are creating standard reference materials for human genomes and microbial genomes. These will be materials that are highly characterized, and will continue to be characterized over time with new technologies and new information that we can gain. And these will be materials that can be purchased by anyone, and we'll have standard methods that go with them. So we're hoping that we're going to get at having the standards problem partially addressed, but we don't expect to have anything available for another year or so. We need to think about rational regulation of how these genomic systems should, and well how they should be regulated, and when I say genomics, I'm not just talking about sequencing, I'm talking about anything in genomics. I think a week or two ago there was a meeting that used to be called ISCA, it's now called ICCG or something like that, which started off around looking for copy number variations, I believe, in the human genome to look at underlying disease that can be detected by copy number variations. We need to think about rational regulation, what FDA can contribute, and what the clinical community can contribute. Because in my personal opinion, having 100 different labs all around the country, all doing their own thing, all spending their own money to validate their own system is probably not the most economical way to get at good testing, and it's probably got some holes in it that could be fixed with the right level of regulation. We need to look at databases and how we'll get at having high quality curated clinical databases, and we've kicked off a project at FDA where we've gotten funding from our critical path funders to actually contract out looking at all the databases in what the United States are everywhere, everywhere in the world to see, we're going to use people who actually do this for a living to find out who has what and how it operates and so on to see, we don't want to build a database, we want to help other people's databases be improved to the highest quality possible. So we're going to do a survey to see what's out there, and we've been working with NHGRI on this to try to work towards something that not only will inform, I think, patients and providers, but will inform the regulatory mechanism, you know, if it's in the curated database then it's probably right and we accept that kind of thing. So we're working towards that, and then we're following a lot what's being offered out there, and I don't know about if any of you are in the oncology field, but the area of testing for gene variants in oncology is absolutely exploded. There are, I don't know how many different companies that will test your somatic genome and tell you whether you have a K-RAS mutation and B-RAS mutation and so on, and then some of them provide you advice, some of them just provide you results, but we're following what's going on, and some of it's a bit unsettling, I can tell you. So we are hoping that the clinical community will help us to weed out the lousy players and not order things from them, but I'm telling you there are some lousy players out there. So what are our goals? We want widely available standards materials and standard methodology and welcome the participation. I think the genome and a bottle consortium, you can find it online, is working well together and lots of people are contributing towards building the kind of information we need to have to have good standards materials. What I would especially like and I think the FDA would especially like is instrumentation and software systems that are built under quality systems, and what does that mean? What are quality metrics? It means that you start out saying, what do I want to build? What do I want it to do? And then you say, how should I design it to do that? And how will I test it? So I can show that it does what I say it does. And you would be surprised, probably some of you, that almost anything you buy from a life sciences type company that provides instrumentation does not go through this process. They might go through it informally, but there will be in most cases no formal design control and they will have no way to show that they built, that they can routinely build what they think they're building or that it meets their needs. And I'm not knocking that, that's not a bad thing. In life science, you may want to rev a lot, you may want to do a lot of things in life science, but for clinical use, it's my view and the view of the FDA that a little more control is warranted. We really, really are, want to move towards the goal of useful databases so that we can build information and disseminate information that's actually based on real evidence that's been curated by people who know what they're doing. We want evidence to drive care and we need to define what actionable evidence is. In the case of cancer, actionable mutations has become the new buzzword, but nobody agrees on what that means and we need to define it. So to actually design studies that are intended to generate high quality evidence and not necessarily just a publication or something like that would be extremely, extremely welcome. I don't know how hard that is to get funded. We need education, really seriously education for interpreting the data that comes out of this and I'm sure everybody knows that decision support is included in this, how physicians will use this information and we did find on a website of a company who's offering stuff, you know, the question and answer for physicians about their genetic testing and the question from the physician was do I need to know about genetics and the answer is not really. I'm not sure that's true or advisable, but it does demonstrate sort of the direction some people are going is that the physician who's ordering this doesn't really need to know anything about it. We'll just give you the answer. Trust me, it's got to be right. It's genomics. So I think I don't know how education and good interpretation will happen, but it's pretty clear that we'll need it and I'll stop there. And as you'll notice, I didn't say anything about LDTs and I, so don't ask. No, the guidance is not, yeah, the guidance has not been published. Okay, let's see, we have many. So we have I think Brad, Mark, there was one behind Dan and Dan. I'm a little surprised you're getting into evidence and discussion of action ability and that sort of thing. That's part of our main mission at NIH as well. But can you expand on that a little bit? Yeah, from the regulatory viewpoint, if you say something's actionable, if you make a claim about it, then we need you to tell us what does that mean? It's very, very simple. I mean, we're not trying to establish what's actionable. We just need to know what do you mean when you say something is actionable? Do you mean there's a drug out there that may be targeted to that mutation? Do you mean? Yeah, I wanted to come back to a question that had come up earlier, which you didn't specifically discuss, which is also related to anticipated guidance from FDA related to clinical decision support related to their use as a device or their definitions of device. Could you update where that discussion is? I think the guidance is being drafted. I personally have run screaming away from clinical decisions of work, but David Litwak, my colleague, is working on that and on drafting that, so it's coming. And I can pretty much assure you that it's going to tell you what we think requires a submission, and what doesn't, and what we really don't even think is a device. I did a site visit review of FDA a year ago, and I know you guys have scientists who are sort of half scientists and half reviewers. I would imagine you'd need a huge army of people to handle this, to tackle this. Do you have expertise in place to sort of handle every gene or the whole genome? So the way regulation works is you don't really need expertise for every gene or genome, because regulation, while we deal with particular genes and genomes, it's not terribly different from one to the rest. The way we regulate IVDs is you look at analytical validity. That is how well does the system measure what it's intended to measure, and you look at clinical validity. Does the answer actually correlate well with the disease state or condition that you're looking at? And that's actually fairly easy to do in many cases without extensive knowledge, but you would be surprised. We do have a small army, and many of them are PhD-level scientists from the genetics field. Many of them are laboratorians who've come out of clinical laboratories and so on. So, yeah, and I mean, not to say the LDT word, but we actually don't get that many genetic tests come into FDA for regulation. So, and in fact, our scientific in CDRH, our scientists are not reviewers in most cases. That's more classical of the Center for Biologics. Mark Ritane, University of Chicago. I am an oncologist, and I share your concerns, and I do need to mention the LDT word. And so I think that there's different kinds of LDTs, obviously. There's the LDTs that a hospital will develop for its own patients and for which it may or may not get reimbursed on a piecemeal basis, and then we have LDTs being developed by companies, and many of which despite not bearing any resemblance to the safety and efficacy threshold of FDA have been deemed reasonable and necessary by CMS and therefore are being reimbursed and are being utilized by oncologists. And so the real problem out there is there's virtually no incentive for a company to seek FDA approval when they can make the same amount of money without FDA approval. And since oncologists are happy to order any tests that justifies treating a patient with a drug. And so I think that's the crux of the issue. And so somehow we need to create a system where maybe CMS would pay more when it's been deemed safe and effective, and so that you could still get, you know, if it's truly reasonable and necessary, that's fine, but safe and effective somehow should warrant a higher payment.  How you resolve that, there's probably multiple different paths, but I don't know that you want, that anybody really wants something that isn't safe and effective. Which I don't think is what you're saying, but... Well, no, I think patients don't know and physicians often don't care. Well, you probably know we've been working on this for a long time and have lots of ideas about it, but I couldn't agree more. There are perverse incentives for lots of things out there and not a lot of good incentives for people to sort of prove that their device does what it says it does. I wanted to just sort of highlight what I think is sort of a schizophrenia from where I sit when I look at the great mass that is the federal government and I understand that everybody at this table is part of that and you don't view yourself all as one part of one mass. But FDA labels for drugs include pharmacogenetic advice for dozens, I've lost count, in the germline and in the somatic genome. So I want to ask you and Steve to sort of comment on the schizophrenia that that creates on the part of practitioners who were told on the one hand the FDA label says that you should think about this or you should do it and it's always couched in sort of never completely coercive language and the fact that when people want to do that or when people want to act on it, there's this barrier. And I'm not saying that one, you know, there shouldn't be a barrier, but it does create this sort of how do you deal with that? How do you reconcile what it is you're putting in the label with what it is that those guys down the street are willing to pay for? You'll be surprised to hear, but we don't. No, I'm not surprised. Our directive is to determine safety and efficacy in the case of drugs without regard and safety and effectiveness in the case of devices without regard to who will pay for what when. So we actually cannot consider whether it will be paid for or what the price is. That is not part of our remit. So do we try to work together with CMS? We do. The statutory, it's not conflict, but differences make it so that it's not easy for us in reviewing safety and efficacy to provide all the information that would be required for a CMS reasonable and necessary decision. Thank you. You put you in. Can I just have quickly? For most of those particular issues where FDA has within a drug language this particular test is required, I think a huge portion of those are tier one codes and even if they're not, they're paid for. It is some of the newer codes where there is, we're now working through the contractors to see how we're going to pay for those. It may be an issue. But for most of the genomic testing that are being used to determine whether a particular drug is going to be effective or not in the oncology space in particular, most of those tests are paid for. Things like warfarin testing and so on, maybe what you're moving to. There is significant concern that those tests are being paid for and physicians are ignoring them. You do a HER2 test and you ignore the results.   Those are all oncology tests. None of those are in the germline genome. The germline genome has 58 the last time I looked and I'm sure it's more than that now. CYP2D6, CYP2C19 and you don't pay for those. I'm just sort of highlighting the schizophrenia and trying to sort of get a handle on how maybe it's just that FDA has its own mandate and you have your mandate and that's the way things should be. That's pretty much what it is. They could be, you know, Congress would have, again, it's who's the Board of Directors. We have to operate under the laws that we have because our lawyers get really, really nervous when we step outside of that. I think you put your finger on the pulse here. I'm going to describe this a little bit more in the afternoon, but I think the discrepancies between the CMS approaches and the FDA approaches and other people approaches can be looked at as a discrepancy between clinical validity and utility. So for example, some of the gene drug labels that you have, I think the last time we checked there's more than 100 of these. There is no evidence of clinical utility. There are described gene disease associations and the FDA thought to put that as a service to the, you know, practitioners and the public. Whereas CMS uses a higher level of sort of evidence in terms of utility for reimbursement. So validity versus utility. Actionability sometimes falls in between and sometimes when we define actionability, we define it as only validity whereas actionability may be also viewed as utility. I think, you know, Blue Cross Blue Shield has their own processes. So I think a little bit of harmonization can go a long way in terms of understanding each other's definitions. Naomi, really the last word. So Liz, my understanding of how the FDA views drugs as being useful is something like it's likely to help a physician make a better decision as opposed to a more specific and definition of utility. Is that correct or is that change? You're talking about companion diagnostic? For diagnostics, I'm sorry if I misspoke. Whether this be imaging or laboratory, et cetera. I guess I would fall back on a recent guidance in which we talk about benefit risk, that the benefits of using the test should outweigh the risks of using the test. And because my group only really looks at IVDs, there are lots of tests that aren't IVDs, imaging and so on. And that's all in there is that there's some benefit that outweighs the risk. So that is a bit of evolution in the concept? That's always been there. That's always been the underlying thinking process, but we just published a guidance to sort of more formalize it in people's thinking. It's how do you know that something's safe and effective while you look at all the data and you determine that the benefit outweighs the risk. So a test, for example, could be not that great, but the benefit of using it might outweigh the risk of using it or outweigh the risk of not having a test at all. And there's a huge spectrum in that benefit risk assessment. Some things have to be really good, some things don't have to be that great. Okay, great. We ought to move on. Thank you very much, Liz. And I would just remind everyone that the purpose of bringing these groups together is really to find commonalities and ways in which the federal agencies and the various ones we've heard about before the break can work together to address some of the challenges that we're seeing in implementing genomic medicine. So we all recognize we've got a very challenging healthcare system. Some would say we don't have one. Until you try to change it, then you realize we do. But at any rate, let's try and keep the focus of the discussion on that if we can. Dr. Clancy.


Hello people of the internet, my name is Johnny, welcome back to yet another FNAF news video. Hope your day is going good, the weekend is almost here. And in today's video we got a whole bunch of amazing news to talk about, ranging from brand new merchandise to security breach actually coming to the Switch, who could have seen that coming? As well as a whole bunch of movie news including some brand new pictures of the entity known as Scott Cawthon. So if you're excited for all this brand new FNAF news, don't forget to scroll down there, give the sub button a little tickle so you don't miss out on any more future FNAF news. And without further ado, BOOM! Balloon Foxy Jump Scare. Did that getcha? This is the brand new Flocked Balloon Foxy Pop and Tea Bundle from Funko. This was leaked all the way back when the Balloon Circus characters were first getting revealed. It's a bundle that includes this T-shirt of Balloon Foxy on it as well as a Flocked variant of the Pop version of Balloon Foxy. I think both items look absolutely adorable. I absolutely will be picking this up. Currently, I believe the only way to get your hands on this is to pre-order it on Amazon UK for a May 14th release. And speaking of merchandise, we've got Bio World releasing a couple brand new products recently. First up is a security breach five piece backpack set. As you can see it comes with all the essentials, the main backpack, a pencil case as well as a little key chain with the security breach logo on it. A lunch box as well, honestly I feel like everything you need possibly for school is available in the set. You've also got this strange 3D youth cosplay zip up hoodie of Freddy Fazbear. It looks pretty goofy, especially how gigantic the FNAF logo is on the front. Lastly, Bio World also released some brand new socks themed around security breach. Moving on to what is my most anticipated brand new FNAF book coming up, the FNAF Cookbook. Because a while back we got the full table of contents revealed for the Cookbook. And as you can see, there is a whole bunch of recipes. I believe based off the description, there's about over 40. But for categories, you've got Freddy Fazbear's pizza, Roxanne Wolf's burgers and subs, Chica's chicken, maybe a little cannibalistic, but certainly an interesting category Chica. Gregory's pulled pork, Freddy's Five Nights classics, Bonnie's breakfast, Monti Gator's sweet things and dancing rabbit drinks. And speaking of drinks, we got a brand new recipe revealed to us, the Monti Gator's green with envy. Now I don't know about you, I'm always a little hesitant with the recipes when they don't have what the item is in its title, but based off the picture, it looks to be some sort of smoothie or a shake. And interestingly enough, there's a little note on the bottom of one of the pages from Gregory saying, look out for Monti Gator. Monti Mystery Mix is a strange green pizza topping glue, which I used to lure and finally destroy Chica, mean and green from Gregory. So who knows, maybe after all the Cookbook will have a little bit of lore inside of it. That's pretty interesting, a note from Gregory. Next up, we got some news that I honestly didn't think I'd ever say, but Security Breach is coming to the Nintendo Switch. Yesterday it was revealed from GameXplain that a walk-in-progress build of the Switch port was playable in the halls of the 2023 Game Developers Conference. What you're seeing now is captured footage of the game running on that walk-in-progress build on the Switch. There is no release date for the port just yet, but according to GameXplain, the reflections and graphics look absolutely fantastic, though the game is still a bit choppy in some areas. I'm hoping that since this is still a walk-in-progress build, Steawool is gonna take the time to work through those choppiness and hopefully make the game as smooth as they possibly can on the Switch. So to me at least, the longer it takes for Steawool to acknowledge the existence of this port, the better. So hopefully, like I said, they're taking the time to sort through some of these big issues, the choppiness, but hearing that the reflections and the textures look great on the Switch is very surprising to hear. Maybe I shouldn't be too shocked because the help-wanted Switch port also looked very, very graphically good. I'm just, I'm a little worried about the choppiness and how a massive game like this. And let's also be honest here, also not the most optimized game. I'm just a little worried about how it's gonna run on the Switch. But any and all updates on this port, I'll be sure to let you know. Moving on now to the final topic of today's FNAF News video. The FNAF movie, first up, we've got this picture, which at first you may not recognize what this lot is, but it was where the facade of Freddy Fazbear's Pizza Place was built for the film. But now, since it's been taken down, it appears filming on the facade has concluded, which makes sense. I know a lot of people were like, oh my God, what happened so fast? I mean, keep in mind, it was only the front of the building. I don't imagine they're gonna take that long to film those shots, but I am a little sad that they took it down. It completely makes sense, I'm sure. If they just left it up, it would be vandalized and dangerous stuff like that, but it's an amazing part of the FNAF movie history. And to see it go is a little heartbreaking. And they better hope they don't need to do any reshoots on that set, because, well, I mean, they took it down. Next up, we've got some very exciting news. Two-time Emmy Award-winning composer, Michael Whalen, has joined the crew of the film. Whalen's gonna be acting as the main composer for the score of the film, which is very exciting. He's worked on a whole bunch of stuff. Corgo Veronica decides to die. Two films with absolutely phenomenal scores I've heard. He's also worked on the theme songs for Get This, Good Morning America, and The Oprah Show. What the heck? Absolutely fantastic news. It's amazing to have someone as talented as Whalen. Like I said, two-time Emmy Award-winning composer working on this little FNAF film. Next up for movie news, we've got Kat Connor Sterling, who has officially revealed she's been cast as Max in the movie. We all kind of knew this for a long time, because it got leaked out, but she did officially reveal it exclusively with Deadline a couple of days ago. And over on Twitter, she decided to fancy us by posting a picture of her when she first got the script for the movie. Obviously not showing anything she shouldn't be, just the front of the script, which as you can see, it's a pretty beefy long script. But on the front, it says Five Nights at Freddy's, officially confirming that is the name for the film. A lot of people were thinking, maybe it was gonna have a tagline, maybe it was gonna be called FNAF, the movie, or who knows, some people still thought it was gonna be called Bad Cupcake. But nope, it's just FNAF. The screenplay was written solely by Scott, which is absolutely insane to think about. My man Scott wrote this whole gash dang script. Of course, it did have revisions from Emma, who is the director, as well as Seth, as well as showing off the dates for the white, blue and pink versions of the scripts. Which if you don't know what that is, don't worry, it's nothing too important. It's just kind of what stage of revitalizing the script it's in. And lastly, some of the most exciting news of all, a few YouTubers you may know, Docko, Apeit Ryan, Baz, Razbowski, were flown out to New Orleans by Scott himself to visit the set of the film, shoot some vlogs, take some pictures, watch some behind the scenes for the film. And they've been posting a lot about their trip. As you can see, for the first time in years, some brand new pictures of Scott hanging out with the boys. Fun fact, this is actually Docko's first time actually meeting Scott in person, which just absolutely huge congratulations, Louis, if you're watching this. We also met up with Emma Tammy, who, like I said previously, is the director for the film. And then also teasing us a little bit as they're reacting to presumably one of the sets for the film. Docko tweeting out, the FNAF movie set is beyond incredible and something that I'll never forget. The whole cast, crew, the Jim Henson company, and Scott have put so much love and passion into this movie, it's truly amazing. So some very exciting news.  Baz also tweeted out, it's worth mentioning, I will be able to talk about my experience on the FNAF set when I am back. I won't be able to show any of the set just yet, but would you like to see me share with you what I've seen in a video? So stay on the lookout for Baz's social media as well as all the other boys' social media to see what they're getting up to on their trip on the FNAF movie set. And if there's any more updates, I'll be sure to let you know. But that is gonna do it for this FNAF news video. Thank you so much for watching and I'll see you all on the flip side. Goodbye.


Coppen there and a team sits in Australia car doing another run for VIPs on our Armoural Power Stage and how dramatic was that? We had Brendan Rees and Rhiannon Gelsimino winning the stage by only 0.3 from Eli Evans and Glenn Wessons, our former champions. The big news though was of course Scott Petter just over the rise there had a big moment pirouette of the car. Fortunately for him not a lot of damage but of course that speaks volumes as this afternoon we do our first heat of rally Victoria. The crews have got plenty to do, perfect chance for us to head up the hill, have a chat to them in service. Tony Salons you made it through there, third in the Armoural Power Stage, a good run for you guys. Fantastic yeah we like never done the power stage very happy to do that, I don't know how our times went but you know I actually think we're doing the media stuff and I really think that I'm probably getting faster as the time goes on so good things to happen. I did a local rally in camera a couple weeks ago and then did another tarmac thing up at Easton Creek a few weeks I've been in the car a little bit, the boys gave the car a good haul over, it's feeling really strong so looking forward to it. Steven Kenzie you did a great job on the qualifying but we didn't see you in the final run. No unfortunately we've been to shock on that jumping the power stage there not power stage, qualifying run so we weren't able to run the power stage unfortunately I reckon we would have put in a good time too. You'll have us great to have you back here mate. Yeah it's nice to be back it's uh what was it? Canberra was the last time I competed in ARC so back in the tank formers type R this year it's feeling pretty good we were 0.3 off Brendan on the on the power stage so pretty happy with that the boys have just found that the car wasn't getting 100 throttle as well so we'll keep that one up our sleeve for the forest I think. Yeah don't tell anyone that but you know if you're pretty pleased with that you haven't done a lot of driving this year and I mean those guys have been on the money particularly Scott and Brenda so to come out and be in the mix and nearly take the power stage straight off is pretty pretty good for you. Yeah that's right oh I'm happy I know they're pushing pretty hard and the year I've had off I know they're always improving I can see their stage times from last year so I'm here to win I might be a nuisance to the other guys and well this makes it interesting for the championship as well so but I want to get a win for the type R so let's see how we go. You had a big issue in testing and these guys have been working the midnight oil to get this car right and obviously first run out has won this one the power stage it's pretty good going. Yeah that's great signs because we didn't really get the tests that we wanted Wednesday so to have the car ready we'd lowered it a bit got the good traction and the kumos worked well out there as well so we're really happy with the balance this afternoon's a different story four forest stages and it's really going to be on Scott will be out there trying to win points Eli myself some of the other guys Mackenzie's and the Citroens it's going to be on this afternoon is what you're focused on how are you feeling right now how do you think you're going to go for that first stage?  Yeah look we had a little nudge of that same bank on the first run so um got away with it and and didn't and didn't get away with it second time so uh you know I said but the car feels really good um you know I think it's come up all right after the damage but uh and we'll see we'll see this afternoon