So today we are going to pour into you about nonprofit emeritus boards. Julia Patrick is really going to lead today's discussion. I will add whenever I think you know I have something to add but I'm looking forward to learning.  Just as you do each and every episode as well as right behind Julia and I on every episode. We are just thrilled to have their continued partnership as we continue on into 300 like close to 350 episodes now so so grateful to have their investment, not only in our episodes but truly in our community your community at large so thank you to our presenting sponsors, and thank you to Julia Patrick CEO of the American nonprofit Academy. I'm Jarrett ransom, I get to have fun each and every day except for when I'm not here to to play this fun co hosting role I'm Jarrett ransom the nonprofit nerd CEO of the Raven group. I missed yesterday. I had some power outages in my studio which really just, you know, put a damper on on me being on so I know yesterday went well I'm looking forward to today again today is this master class, really talking about emeritus boards this is a topic that I go to you Julia, since a to learn more about this topic so share with us and and again like unzip that brain and let it all come out because I am looking forward to learning as I'm sure many of you live as well as they're recording. What is the power of emeritus boards how do they work how do you get them started how do you keep them engaged. So Julia, thank you. Hey, thank you, you know it's really an interesting topic we visit this from time to time. We've spoken about this over the past year and a half we've had questions about it for our Friday ask and answer it. Seeing those questions come up more frequently now that people are looking to get back into restructuring your boards or re engaging your boards. So many nonprofits 1.8 million nonprofits in this great nation of ours. They put kind of like a freeze on board movement didn't mean that their boards didn't engage it's that they stopped bringing in new people or letting people go off because you know it was it was such a perilous thing to figure out how are we going to navigate a challenging time for our nonprofit and bring in new people or move off old people so now I see a lot of boards that are ramping up and I'm sure you're seeing this to just a number of inquiries that I'm getting to see what I'd like to be on somebody's board. Which comes in frequently. It's really really have been amplified. I have been seeing this to answer that question and in fact as I look at the evolution of the organization in which I am hearing most of this from come from when it comes to the topic of emeritus board. I'm really looking that evolution of you know they're about 1520 25 years young as an organization and they are evolving those really champion ambassadors, because as I'm sure you're going to share the emeritus board is not where they all go. Right, it is not the succession plan of every board member. Yeah, and it's kind of an interesting thing because it really does have some gravitas. It's not a given so let's start with actually because you know I'm a word geek emeritus comes from the Latin word, word veteran soldier, sometimes you'll see it as old soldier. So, it really is a word that connotes wisdom and age and time served, and maybe a person who doesn't have the full on capacity that they had in their youth doesn't mean that their mind is not as capable. It just might mean that they don't have that vitality that they once had to serve full on with a board. So this is a really interesting way to frame it, because a lot of times emeritus boards we think, oh my gosh they're like super old people and that can be the case. A lot of times it's just people that have moved on to other things. And so my whole deal is, don't lose that institutional knowledge. Don't let it go because it is so incredibly value value oriented for making decisions that could really change the trajectory of your organization. So, one of those things when we talk about board champions, the emeritus board is an actual board, and we'll get into this a little bit more, but they are another if you will subset of the main board the fiduciary board, the board of directors. So they have an actual management situation that allows them to still be a cohort right. The emeritus boards are tasked with leading certain things.  They might work on an archive project. They might work on an anniversary project. Right. So I mean, it does have a piece of it that's pretty important. And one of the things that's really interesting about the emeritus board Jared is that they are actually voted on by the board. Right. By your peers. Absolutely. And like you said, it's not a given that everybody just shuffles off to the emeritus board. So it needs to be something that is recognized as not only an honorific, but an actual piece of business, if you will, right. No, I have a question so when we talk about board service in general we often talk about the expectations of those members. What are the typical if that's even the right word expectation of an emeritus board member. What does that look like really good question that it's going to differ depending upon what your organization sets up. So for example, I worked with groups where they maintain a an amount of money that each emeritus board member is going to pay a and the form of do's they call it that, or an annual gift to the organization. Okay, it can be a little it can be a lot. Right. Because you have to remember, it can be very prestigious for some people to be on an emeritus board of a high profile organization. Right. So there's value going both ways. Oftentimes and we'll get into this a little bit more. They're going to be certain things that are required. So for example, you know, attending one event a year, attending one meeting a year. It might be to provide mentoring. It might be to provide as we open up tours. You know you're going to bring so many people to our campus. Right. And we're going to engage in that so it really is a function of how you want to get that that board to work for you right. You need to be strategic. So with that we have a live question that came in. So I'm going to curve ball get, get ready to or knock it out of the park, whatever. Although I know it's basketball right now but we're going to go there. We're going to stick to baseball. Yes. So the question that came in is how would you handle a board member who rolls off the board thinking they are going to get knighted. I love that word with emeritus status and do not get emeritus status. So essentially how do you handle a board member that assumes that they will be you know really tapped on the shoulder voted into emeritus and they're not. That is a great question and you know, I don't think I've ever been asked that question in that way and I love it. I think this is, and this goes back to one of my main principles that I always address when we're talking about boards. It's all about expectations and understanding the process. And so this is one of those things that you need to be talking about as you go forward. Your existing board members need to know that there is this wonderful opportunity called the emeritus board and not everybody gets to go on it. You know, it's privileged. I'm going to say that word. It's just functional, and you have to still do some things you're not just going to have your name, you know, on the website. And it's something that is studied, meaning the rest of the board needs to look at that and determine if that's going to be a good fit. Oftentimes this would be administrated through the nominations committee. So for those of you who have that nominations committee. Sometimes they call it, they'll call it board HR, you know, board development, that kind of piece. That's that committee so you would go through an actual nomination process. Good question I hope that helps. It's not, it's not an easy thing. I also want to talk really quickly about the, the piece that the dovetails into what we were talking about a little earlier and that is, what are those requirements and you brought that up. There's no fiduciary role, meaning these board members are not the first line of defense on any, any, any legal issues contracting grants. They probably aren't even listed on the 990s IRS 990s. They could be more importantly, they are going to be in a specific. They are usage, if you will, they're going to be prestigious people that you might include when you are applying for a grant to say you have these, you know, community elders or these community supporters, you know, standing at the ready. Oftentimes there is no term that this will be voted on forever, right, or the terms might be long, eight years, 10 years, something like that. A lot of times we will see founders founding board members, really tremendous people of import or impact become lifetime emeritus board members. That means for the duration of their life they're identified, and you obviously with their permission, then they are with that group right so to give you an idea, a lot of times we would see this with maybe governors, state governors, US senators, sometimes even really large funders maybe somebody who's endowed something to a campus, that kind of a thing. Without founding board members are founding founders of the organization, is this a great place to really don't want to use the word but I'm going to house these individuals in perpetuity I'm thinking that would be kind of an infinite emeritus opportunity to really have that institutional knowledge but also to acknowledge and just, you know, recognize them as founding members. Yeah, I mean, I'm thinking of the, you know, the airline stewardess that stands at the end of the cabinet says bye bye, bye bye. I mean, this is one of those things we talked a lot about this founder syndrome on the nonprofit show. And this is one of those places where, you know, we see this a lot in the nonprofit sector where an organization is started with a parameter. There's a lot of community changes, thought leadership changes, maybe the problems change, and yet you still have that cadre that is very passionate. That's very dedicated that was the founding piece, but they're aging, right, and maybe they're not is able to give their full force of effort faith and intellect to that to organization. The Emeritus Board is a graceful way to move people off without losing them as champions. And that might sound a little harsh, but I think you never want to have like a messy situation where you extricate yourself from those founding members in a negative way. Have you seen that Jared, I have seen that now I'm questioning, is there a certain sweet spot or number of Emeritus Board members. It's a really good question and you know we always say 15 to 25 is where a lot of board numbers live. And that's one of the beautiful things is things of the Emeritus Board is that you can keep going up.  Now I have actually seen recently and it was kind of an interesting situation. And I haven't seen this too much, but I saw, and something that was called the Eternal Board, and that was for deceased board members. I have never seen that. Yeah, it was a little shocking. And this was not like a faith based or, you know, anything like that it was just, it was an organization that recognized the August, you know, import of, of their board members. And those that had passed on, and I suspect I do not know, but I suspect it was a board that must have faced probably a sudden loss of a number of people. Right, I'm not saying something like calamitous, but maybe just over a short period of time, they lost some board members maybe young board members who knows and then they wanted to do something that honored them. So basically with the global virus that we've had in that pandemic, this could be an opportunity that has arisen with so many health complications for many vulnerable populations. So, and she's not that far fetched right. Yeah, really, that's, you know, I didn't, I didn't think of it that way. I'm pretty sure they started it before the pandemic. But you know what, I'm sure that is. That's an awesome thing to consider because you're right. I mean the loss in our country that continues. It has been significant, yes, and continues. I was just talking to someone and for those of you that are avid viewers and watchers, you know, I'm sure you know this by now but I also had COVID in December of last year but I was just talking to someone who so graciously brought me chicken noodle soup when I was sick, you know, and he had had it as well and I was like how are you doing how are you feeling is there residuals. So there's a lot of community members a lot of you know our citizens that really are experiencing so many continued complications. I'm very grateful and blessed to really be healthy. But that was just something that came to mind, you know, just really, really natural in today's conversation. Talk to us about, sorry go ahead. Well I was going to move us into the slide that we see here which really is about maintaining connectivity. And my big question is because of COVID because of going through the pandemic and so many pivots right I know we're all tired of hearing that word but let's be honest it's kind of vernacular. I'm so as we move into you know this, this pivot stage, a lot of our, the way we've done business has changed. How does that really impact the maintaining connectivity with our emeritus board, knowing that these might be and I'm going to say, you know, literally older individuals that are not as adept to the newer ways of doing business talk to me about that and what that might look like. You know, I love that you asked this question and that you framed it in this way, because one of the things that, and maybe it's just because I just turned 60, but one of the things that this emeritus board is masterful at is the human connection. Yes, and the connection of people to resources to thoughts to actions to deeds to history. And so that doesn't go away. Right. It just has to be put forth maybe in a different way. So, you know, the zoom concept still works do they may might they need a little, you know, help or instruction on that. Yeah, could be maybe not. But the reality is, this is the group that you can go to when you need that. Hey, does anybody know, you know, so and so from XYZ. This is what you get. This is the power and the magic of the emeritus board, because they are working within many, many layers of their own professional history, their professional connections, and their family connections, right.  But this is the army of leadership that you can access for things you would never imagine. You know, you talk about this a lot. And that is when you're moving forward on a big grant proposal, or a community proposal or, or even an MOU to go to your board and just say hey we're going to be doing this. Do you know anybody.  Yes, yes. Well, and that's the power of connection right and it also takes me back to the word we've been talking so much about is the return on relationship because these individuals really have sunk their teeth into the community. And this is where they have invested their time and additional resources. And so the likelihood of these individuals truly serving as a really well connected ambassador is really strong. Another live, I'm going to say comment that came on during today's episode as you were just sharing Julie about maintaining connectivity, and this individual shares that we only allow past officers to be nominated. Again, not even automatically on but nominated for emeritus so they only allow past officers to be nominated in emeritus role they are called upon to serve on ad hoc committees, but are always kept in the loop on organization activities, and I think that is a perfect comment, especially in this conversation right now where we are on maintaining that connectivity. And I like that and it shows me that this organization is using this the structure, they're using this human capital, if you will, to move through the journey of the organization. Bravo to you. I would challenge you to look at non officers, because if there are, you know, shining stars that could still be in your portfolio, so to speak, you shouldn't let them go and I, you know, when I look at high level boards. Sometimes real power brokers are hesitant to take an officer position, because they're on so many other boards. And so you have to kind of look at that. And if you have an organization that's run tightly and in the separation of an executive committee versus you know full board all that, you need to kind of factor some of those things in, but don't. I think that's a good way from that general general population, because it might be somebody that you're letting go of that you really pull in. But I love that question or comment because that shows to me that they are working this group. Yay team. I mean, yeah. Wow, we should have them on as a guest. Type back to them. Okay, I, you know, we don't have much time. One of the questions that you raised. And even this, this last question is, you know, how are you engaging them. I love having these emeritus board members serve on ad hoc committee as ad hoc committee members mentoring and all that. We've seen a lot of success with an annual event digital or IRL, where there is some sort of component with the existing board and the emeritus board comes together. It might be for a coffee. It might be for heavy orders at somebody's home. It might be a team on the campus of the organization, because a lot of times we see a trajectory of this, the certain board started things, but they weren't always there to finish it. I'm thinking of long term capital campaigns. I'm thinking of construction projects. I'm thinking of the evolution of an organization's physical space right. I'm thinking too as we look and this has been a big conversation during the pandemic Julia has really been about collaborative initiatives right of how organizations might merge or acquire with one another. How the emeritus boards plural of all are any of these organizations coming together could really unify to strengthen the community in this message. And I think that is a wonderful opportunity to really engage your emeritus boards in, you know, that that social event and update. Clearly, I had a question about how might you engage the emeritus board when it comes to these social events updates and whatnot with the current board is there a mentorship opportunity that you've seen work successfully. So a lot of boards and I always, I'm like a big champion of this concept is no matter the age or the sophistication of a new board member. I can compare them with a mentor for one to two years, one to two years. And I think that is where this can come in. Now you might be like, Oh my gosh, you know, Sally Smith, she's been on 25 boards and she knows the process and you know, that's great but she might not know the culture. That's where this emeritus board leadership can come into. And it's really strong. It's really powerful. And you know this from mentoring yourself. I think as a mentor, oftentimes you get more out of things than the mentee. Absolutely. We just started our chitty chat chat today talking about the Mandela scholars how how we've both been a part of mentoring the Mandela scholars at some point in our careers and I personally have received so much out of that as well so it's been it's been really nice. Well, Julia, this has been a very phenomenal emeritus boards masterclass I am so grateful for you opening up and sharing all of that wonderful wisdom that you have collected throughout your community service. Thank you for sharing with us the nonprofit emeritus boards. I want to say there's some other resources in particular on this topic on the American nonprofit Academy so please do check that out American nonprofit Academy calm. This live recording will be on our archives you can find those Roku TV Fire TV YouTube video you name it you just say the words Julia Jarrett nonprofit show and you lo and behold it will show up somewhere in your environment so It is true. We are so grateful of course to our presenting sponsors as well without you we could not continue these robust conversations so thank you to our presenting sponsors that you see here. They also come on make an appearance and share with us their wisdom and experience of many, many years, decades. So each and every one of our presenting sponsors also has an episode each and every month to help you continue the great work that you are doing here in our community. I did not mean to skip us but Julia Patrick of course has joined us today and shared with us in this masterclass Julia is the CEO of the American nonprofit Academy and that is where you can find many more resources on the emeritus board topic, as well as many others.  We know that life is starting to open back up and everyone is starting to fill their schedules with many other activities and events so while you might not be able to join us live. You can always find our recordings and we have actually seen a huge spike in our archive viewership so we know that what we are doing is helpful and supporting you in the good work that you are doing each and every day. Thank you. We do and you know, this before we go we don't have, but just a few, few moments here. We're really excited about our new partnership with fundraising academy. They're now the exclusive sponsor of Friday ask and answer. And so we had our first one with Tony bell last Friday, last Friday and I've got to tell you. It was fascinating, because he totally researched all the questions you know he got the deck before, which you do not. And say that's a little unfair. I know well you know what you're, he's a newbie and I didn't want to like spring it on him, I kind of did but then I was like I can't do that. Holy moly. I'm not saying he was better than you. I'm not saying that at all, but he was better than me on certain things. Because he's a new sponsor I didn't want to do that all like, what are you talking about. I disagree. But we did have some different. Correspondence, which was super cool. And one of the things that I figured out, which was so interesting is that you know we're situated in the West, and he situated in the east. And so some of his, and he's from the east, just like I'm from the West born and raised he's born and raised from the east. Some of our approaches were I thought, very, very cultural. Interesting and I'm bicoastal, born and raised in the east, working professionally in the West so I have a lot of, you know, differing. I want to say like those learned behaviors and the cultural behaviors. I've brought that with me certainly into my, my Western ways. But you know what, I loved it.  Yeah, and this is what we need to think about when we are looking at the operations of successful nonprofits because there is a difference culturally from parts of our country and so it was it was riveting. But yeah, I want to say join us for asking answered on Fridays, he's not going to be with us every Friday he'll be on a couple times a month but it was really fun Jared and when you do it with him you'll really like it. I did. Well tomorrow is Friday and that is our ask and answer so thank you to fundraising Academy, Julia and I will be on tomorrow hope that you will join us as well. And until then, stay well, so you can do well. See you later.


Hello everyone, I'm John Furrier with theCUBE. We are here in Palo Alto at VMware's headquarters for a special CUBE on the ground. We're covering the latest updates from VMware. End of year predictions, or end of year commentary and predictions for next year. I'm here with Sumit Dewan, who's the Senior Vice President General Manager and user computing business taken over for Sanjay Bhutanen. Welcome to theCUBE on the ground. Great to be here. So end of year, you know, December our last CUBE event was Amazon re-invent, which was, I think we had 90 events that we went to this year. And, you know, the one pattern we saw was the shift towards, you know, a user-centric, data-centric kind of computing environment where Yasi Mobile's on the front burner on that one, but more cloud powering, all that innovation. Give us the update from your perspective. You guys had a lot going on. Sanjay was leading it now as a COO for VMware. But you guys had a robust year. You had a great ecosystem that developed. We covered the DocuSign Box, your partner event San Francisco earlier. What's the update? Well, first of all, congratulations to Sanjay. You know, always tough shoes to fill, if any of you know Sanjay. So, but excited because the market has become really, really interesting. You know, started out with the products being highly around management and security. And that was sort of the value proposition as people were just bringing on these mobile devices. But now it's become how people are going to be using the power of these mobile technologies and get their work done better, faster, easier in a simpler way. And that's why we did the announcement with the ecosystem, because the power of working lies in the applications. Talk about the AirWatch acquisition real quick. It was the update. That's been a big lift for VMware, certainly in the business side of the growth and the revenue we've seen that Sanjay's covered that. But where is it today and how does that look for 2017? Well, AirWatch, of course, is the platform that enables us to build what we call digital workspace. You know, the workspace, which is sort of where people access all of their applications from mobile devices is all powered with that AirWatch technology. So AirWatch sort of technology has become a core part of our workspace platform. And it's only going to go further from just mobile and security to now providing an experience across all types of applications. You guys have built a lot of features into that. We saw the announcements, you know, certain features that are unique to the enterprise. This year at Amazon re-invent, we saw the explosion of the enterprise cloud now emerging and VMware had a strategic announcement. We covered that also with Andy Jassy, Matt Gelsinger in San Francisco, where you start to see the cultures of VMware and AWS connect. And Amazon Web Services is still adding more and more services, these building blocks, so to speak. How does that impact your business? Does it accelerate it a bit? Does it change it? How does that, this new enterprise cloud change your business? See, heterogeneity is a good thing. You know, when all the apps were written for a single platform, all on premise, then they could be delivered in a certain way. And people could have been empowered in a certain way. When the applications start exploding, start going to multiple clouds, they still need to be accessed from multiple devices. And that's where our solution comes in. You know, the digital workspace and what we have built with Workspace One provides that experience of connecting all these applications running in all these different clouds to any device. We actually love the fact that there's explosion of applications on the cloud because it only accelerates the need for a digital workspace platform. The digital transformation, the CIOs out through the CXOs and also the architects, the solution architects are out there trying to figure out how to architect on premise and cloud in the digital transformation. Also, you guys are at the center of that with the end user computing group. And you're kind of getting in the weeds too on specific things like identity, for instance, is a big thing. How should CIOs and CXOs figure out the architecture for digital transformation? Because the digital space is one of the things you mentioned, has a lot of identity in it. There's all these nuance features in the enterprise. How should they be thinking about that digital transformation? Now that they have this on-prem and cloud, certainly with Amazon and VMware's relations, what's new, how does it impact? What specifically is the innovation and the enable it for you guys? Well, besides building out the applications that they have to do for digital transformation, you know, I think that every CIO needs to be thinking about three things. First, how are they gonna empower their users using these applications on different types of devices? Second, how are they going to secure the information on the devices because this information is now going to go outside of what their traditional security boundaries have been. And third, how they are going to build a platform so that the next time they're building an application, they're not continuing to reinvent the wheel over and over again. So user experience, having a management and security platform, and building some kind of a platform so that they're not reinventing this over and over again is the three things I would offer to all the CIOs. So business mobility has been a hot topic obviously on the enterprise side with, for the old days of VDI and some of the work space and stuff, but now that the consumer experience is now kind of blending in and converging with business, what are the drivers there that you guys see because mobility is what everyone wants. Yet there's some inhibitors on the adoption side such as, you know, data spoofing, security. We've seen a lot of IoT kind of hacks with DDoS and kind of a pedestrian stuff penetrating into the enterprise.  How do you worry about, was it the right data, real time? These are the new concerns. Yeah, well it's actually quite simple. If you think about what's driving all of these security issues, is actually driven by shadow IT. And who drives shadow IT? And users, right? So it's a fundamental end user computing problem. And the reason why shadow IT is driven is because IT is not able to enable the users and the experience of the users to be able to embrace new applications fast enough. They can go to any kind of a cloud, sign on an application and get onto their device within a matter of seconds. That's clearly going to do what? Lowest common denominator on security. The least possible security of any specific application will drive the security flaw in the entire system. So that's the problem. We're solving with our solution, right? If you think about, if you have a platform that strengthens the security one way for all application and it provides a great experience, then if you are an end user, what would you do? You actually would want the application you want to be delivered through the same platform and increases the overall security. So it becomes a nice virtuous cycle in our assessment. So one of the things that Andy Jassy, the CEO of Amazon Web Services, talked to me about in depth was the old guard versus the new guard. You could argue that VMware's not totally an old guard like company, you've been around for a while, public company, but there is some legacy on-prem from an Amazon perspective. He talks about mostly how customers want to consume services like in the cloud. And Pat Gelsinger was talking to me about the same thing, that the customers are requesting more cloud hence the Amazon. What are the big changes that you see from a business model perspective around consumption of the kinds of services that you're enabling? What's going to change? What are the some areas that you guys are focused on to give customers more choice and more flexibility in how they consume services and how they buy from VMware? Yeah, yeah. Well, first of all, right, I completely agree that customers like consuming new services from the cloud. But that doesn't mean the way the business is getting done today and potentially for years to come, which is from the data and applications that are powering the data centers, going to go away for any sort of foreseeable future. So there is going to be this world where you're going to see combination of both on-premise applications, traditional applications, maybe cloud-based applications, all delivered to a range of devices. And just like in our partnership with Amazon, we sort of tie these worlds together. Similarly, for enterprises on their end user computing side, we tie this complexity together so that people can access the applications from any device. So to me, it's actually a win-win for the enterprise as well as the application providers who are building to the cloud, because now they can tie all of these applications with a single experience to the users using any device and make it mobile. Yeah, I've been bullish on the VMware, Stu Miniman I were talking, he's always more skeptical, but I'm very bullish on the fact that VMware customers now can have a road to the cloud. The question for you is on that point is what is the things that you've heard from customers around this opportunity? Have you heard anything positive? Have you heard concerns? What are some of the key conversations that you've been in around how VMware now has this hybrid, true hybrid path for on-prem and cloud? Well, customers actually really like the fact and they understand now VMware's cloud strategy. If you think about it, VMware started out as a company that provided freedom and flexibility for hardware. That's sort of what virtualization did, right? So they understand, so the value of VMware associated with how it provides freedom of hardware. Now, the next thing we did was we enabled mobility. Mobility is freedom of devices. And now once we are sort of announced this whole partnership with AWS and our hybrid cloud strategy, effectively it's taken the same freedom and now applied to cloud. So it's freedom of hardware, freedom of cloud and freedom of devices. And that sort of fits in what they expect VMware to be able to do because we did that for the hardware for them and we're doing it for devices now. So the nice thing about the end-users is one, it's at the edge of the network, truly with mobile. Summit, talk about the, because you're the general manager and senior vice president. So you hear from customers. And you also have to talk to the product guys. So talk about the roadmap out there and how do you guys look for your priorities for 2017 in terms of looking at balancing the fast pace of customer adoption and also changing the industry with what's on the product roadmap. What's the focus? What's the focus? I think first of all, the market interest that we have seen in our digital workspace solutions has been absolutely amazing. You know, we talk to our customers, we have an advisory board. So we give them $100 bills and every one of them votes on the money and guess what? They all put their money on it. Fantasy VMware, kind of like the project, which projects are gonna work. That's exactly what it is, you know. It's monopoly money, it's not real money. But they get their monopoly money, they put their money on it. And the number one thing that comes in is user experience and enablement of the users. Now you may wonder that people like making users more productive and all that stuff. But at the end of the day, what all of the IT professionals, which is who they are, they're the ones who are consuming our solutions, they care about is how end users perceive the service they're offering to them. And they want to continue to drive that experience up, making their people more and more so that they can work from any device, anywhere. Because when that happens, they actually get a much better life. Not just work experience, but overall experience. Talk about some of the cool things you've seen. Obviously, you see a lot. What are some of the coolest things that you've seen customers do on the end user side? I think a couple of things I'd mention. The first thing I would say is our customer, American Red Cross. So that's cool because our solution is what's powering all the volunteers in the American Red Cross to be able to access their applications anytime. Think about how many volunteers they enroll across the country to help when the problems or crises occurs anywhere in the country. Using our platform, they're able to bring these people, give them access to the applications for just the period of time in any location that they have to be located using any device that they may be accessing. So what's under the hood? What's cool that's under the hood? Under the hood? Unpack that. Under the hood is our mobile technologies because these people are bringing mobile devices, oftentimes their own, either phones or tablets, accessing applications. That's AirWatch. Sometimes they're also accessing applications that are not designed for mobile devices, but are designed for the current data center. So in the background, there is our virtual applications technology that's delivering applications from the data center onto these mobile devices. And of course, the great experience that puts all of these applications in a very easy to access with a single identity-based framework that provides a single sign-on experience to all these applications. To me, enabling something like American Red Cross who's involved in saving lives. How many people are involved in this power? You're talking about 200,000 plus volunteers that come in and out every given year. You get to manage those services at the edge of the devices, phones and what not, iPads and mobile devices. That's right. You're doing much more than that. You're empowering and enabling them for not just managing the devices, but also enabling them to be able to access applications instantly. So predictions 2017. Give us some predictions for what's going to happen this year. First of all, I think 2017 to me is what I call Act Two of Mobile Innovation. Act One, if you think about it, was all about, hey, I've got these BlackBerry devices that are going away. They're being replaced with smartphones. How do I get them embraced in a secure fashion? We've had great success in it. We have clearly become a dominant player. Act Two. So to me, Act Two is all about enabling people to be able to access the information and applications from any device in a secure fashion. This whole concept of workspace, which is all driven by mobile, by cloud, like you mentioned, in a heterogeneous world that we live in, is going to be the foundation for 2017. And what are we doing about it? I think you'll see us do some interesting things because this world requires a lot of connectedness of application, just like in a consumer world.  Why can't we do that across our mail and sales force? Or as you were coming in with a calendar invite that you knew you were going to be talking to me and I was going to be talking to you, why didn't we have information about LinkedIn, about us, just in our fingers? The joke on theCUBE is I'm going to be replaced by a bot here, so, you know. Certainly a mobile device. But I could have had push notifications saying, hey, you know, there's some cutting edge news and I want to ask about, what about competition? How are you guys going to compete? What's the competitive strategy? Obviously, IBM has been talking about their new workspaces as well.  How are you guys going to compete? The red gorilla, huh? Anyways, so. I don't want to say 800 pound gorilla, but the red stack, but they're very good Oracle on Oracle. I mean, we're, they have some success there. Yeah, I think when I look at our digital workspace solution, I think I'd say the, you know, the, right now, the market is in a still a state where there's not that many solutions that are truly defined as digital workspace. So, actually, we would welcome a little bit more of companies coming up with solutions that are similar to them, because then the market starts developing and starts growing from just a management and security to more and more workspace solution. Having said that, I think in terms of competition, the competition space is very siloed. There are either players that offer VDI solution, or there are players that offer mobile management solution, or they are offering identity solution. No one's really put them together into a solution like what we have done.  So, we think it's not going to be trivial in 2017. What's the identity strategy? Talk about identity, because that's a hot button. People want to know, how do I federate identity, because that's, no one wants to have 10 different versions of an identity platform within there. Yeah, I mean, if you think about what's happened, right?  Cloud applications came along. Well, what happened? Salesforce is not building their application on Active Directory, or on Azure AD, or in Google Directory, or Amazon Directory, they built it themselves. You know, worked it at the same thing. So, to me, the directory concept of all cloud applications being written on a single directory is no longer going to be the case. Instead, what you need is to have a platform that puts users identity in the center of defining the user's workspace, okay? Which is based on who you are, what applications you can access, and the context that you're coming on should be able to define an experience for you. So, if you're coming in from a mobile device, and let's say you're from VMware, hey, it's a trusted friendly network, you can get access to the applications. But if you went to any other of networks that are not trusted, or on a device that's not trusted, maybe you have restricted access. To me, that's the change in identity. Identity is no longer just a single entity buried in a directory. Instead, it's the foundation of how the workspace is defined. Because the users are in control in that environment. That's right. Now, also, as a result, what ends up happening is it provides a little bit more self-service experience. Now, you can decide, on this device, I want to access applications that you need for doing the interviews. Whereas, on the personal device, you only need some other corporate applications that you use for mobile access. So, soon we'll have our AI and machine learning, all the good stuff, and augmented reality into the queue. That's my final question, is VMware is a very geeky culture. It always has been. It is. We're proud to be geeks. It's true. That's why Amazon, that's why I like the Amazon relationship, too, as Sanjay pointed out. Yeah, it's the geeks meeting each other. This good culture, there's not a collision, it's some synergy. But you guys must talk about some of the geeky cool things that are happening, like AI, augmented reality, virtual reality. Yes. That's right. Your thoughts on where that is, half-baked. You guys see some promise? What's your thoughts on that? Well, I think in general, the space is still half-baked in my assessment, even though there are some really cool and compelling products now. I mean, at the Connect conference in September, we announced partnerships with some of the key players who are creating these AR and VR-based devices that are coming in to the workforce for doing things that are in the shop floors and manufacturing to some of the back-office functions in the warehouses. So there are some interesting devices coming in, and we, of course, secure them and manage them. There's also some interesting sort of technology that you can use for, again, accessing your workspace. In our labs, we have some of these people walking around with AR and VR devices and clicking on the AR. Clicking on the AR. Clicking on the AR. Accessing their applications. But I do think that the technology is in development. I think 2017, we're going to start seeing that come into the workforce because these devices that are very sort of, at this point in time, defined as rugged devices for back-office or for warehouse functions, they all have a reason to go to AR, VR. Just the form factors and the cost and the pricing will go down over the course of next 12 months. And when it does, it's going to be great because we already have solutions that enable and empower these devices very well. In 2017, what's your thoughts on where data will be stored? Obviously, customers want to protect their data and trim as where people are, but some are saying cloud could be. So now this goes from AR, VR, to more of AI. I think the data plays a big role because at the end of the day, if you think about the problems with this secure shadow IT, one of the issues is there's just so much information. I call it DD, BD, it's data data and big data. The reason is because there's so much data out there, eventually it becomes a big data problem with this mobility. If people are accessing these applications from all the places, if they all have self-service access to the applications, there's no way anyone who's running IT can manage and control the environment. All of it has to be done through analytics, through intelligence, through self-learning of the platform. And that's what the role of data is going to play in this workspace. Exciting, very exciting stuff. So Ma, thanks so much for coming and chatting with theCUBE here on the ground. We are on the ground at VMware's corporate headquarters in beautiful Palo Alto, amazing campus. And we'll be back with more coverage of theCUBE on the ground at VMware. Special presentation of theCUBE, I'm John Furrier, thanks for watching.


The series is part of the R Fund Learning Resource website. The website is sponsored by the Center for Data and Visualization Sciences, part of the Duke University Libraries. Today we're going to talk about library packages, why you would use them, what they are, or else we're going to talk about the tidyverse, and we're going to talk about other sources for library packages. First of all, why would you use packages? Packages extend the functionality of your base R programming kernel. So if you have a particular subject domain that you're an expert in, you probably want to use packages that other subject domain developers have developed to make that world easier to analyze. You may want to write a package of your own that makes your subject area easier to analyze. A good example of library packages is the tidyverse. The tidyverse, by their own definition, is an opinionated collection of packages. What do they say? An opinionated collection of packages with consistent web-based documentation and a supportive community. But there's an important stuff there. Opinionated means they have a sense that this is the best or easiest way to use R. I happen to think more than nine times out of ten, they're correct. But that's what they mean by opinionated. They have a sense that there's a right way to use R or an easier way to use R. Easier than base R. I think that's correct. The other thing that tidyverse is, is a meta package that loads eight helper packages. It actually, when you install tidyverse, it installs tens of packages. Maybe 40 takes about five minutes to install. But the meta package, when you load it, only loads eight. So let's talk about that. When you install packages, you install them only once. You only need to install it once. It's always there. The next time you open up RStudio, that package is available to you. But in order to use that package, you have to load that package with the library function and to do that at every session. So let's take a look at that and see what it looks like. Here in a blank RStudio at the base, if I wanted to install a package, I could go over here to package and click install. If I want to install the tidyverse, I can just start typing tidyverse. And click on this install button right here. It will choose a default place to put those libraries. And it chooses from CRAN or the comprehensive R Archive Network, which are a whole host, thousands of packages, which have been through some rigor to be blessed as good and well-written packages. Packages exist in lots of places, not just on CRAN. There's packages. A lot of packages exist on tidyverse. Sorry, on a lot of packages exist on GitHub. We'll talk about how to install those. Bioconductor, R OpenSci, Metacran, other places to get packages, but a whole bunch of them are on CRAN and they're easy to install this way. Now, again, if I clicked install, I could install that. It would take about five minutes because tidyverse is a big package. Like I said, it installs about 40, I don't know, tens of packages anyway. And I don't need to do it because I've already got it installed. So if I scroll down here, or if I start typing tidyverse, I can actually load this package just by clicking on this check mark. When I do that, you'll see the command over here in the console. So if I type load, that's the command to load a package, library followed by the package name. In the case of tidyverse, like I said, it's a meta package. It loads eight packages. What are those eight packages? Let's have a look. There's ggplot, for plotting, for visualization, ggstand for grammar or graphics. There's tibble, which is for displaying your rectangular grid data, your data frames. There's tidyr, which I use principally for transforming data, pivoting wider, pivoting longer. A lot of data likes to be long. It's a great utility package for that. There's reader. That's for importing data, mostly text data, CSV data. There's purr. That's for iterating over your data frame or iterating over your list. That's an advanced topic. But purr is really handy. It basically modernizes and or replaces sapply, lapply, mapply, things like that. There's the plier. That's for transforming your data. That's a handy set of five, at least five verbs that are easier to remember than some of the code in base r. There's stringer. That's for manipulating natural language, for finding patterns in languages, for using regular expressions or regex. And there's four cats. That's for managing or manipulating categorical data. The other thing that when I loaded that library, it told me is that there are some conflicts, right? And the other filter, the filter function of the, of the deployer library is masking the stats, the filter function in the stats library. I can still run the stats filter function. I just have to type out the full reference to it. So stats is the package name or library name. And then filter is the filter function within stats. Conversely, by just type filter, the default, and you saw it there, that default is going to be the plier. Okay. The other thing it tells me then, of course, is that the lag function in the plier is masking the lag function in stats. All right.  I might create a second level heading here and say load library packages and then say tidyverse is really great and opinionated. Now I can make that work hotlink by using my Markdown. Then I can insert a code chunk and type in my library code chunk. If I want this code to be available to my technical audience, I'm going to leave it as is, but I might turn off the warnings because I don't want it to necessarily spit back that it loaded whatever the console is telling me. So I can load more than one library. And now that I have these warnings turned off, the console won't say anything below here, but it may say something, right? No, it turns it off in both places. Console won't say anything right here. The other thing I might do if I have a technical audience, if I have a non-technical audience, is I might choose to change this to show output only. In other words, to not show the code because maybe my non-technical audience doesn't care what packages I'm loading. Remember, install a package once, load it every time.


I recently attended the Discovery Institute event at Southern Methodist University in Dallas, Texas. It was titled Four Nails in Darwin's Coffin. What follows is the audio only of the question I asked of the panel and the answers they gave. If you're hoping to see blood or a shouting match or a witty retort, you're out of luck. I actually had some questions prepared specifically about the evolution of Wales, but since they'd addressed that point already, I ad-libbed a question that had really been bothering me. It concerns the limitation they placed on evolutionary change in development. Before I play the clip, let me set the scene. For those of you unfamiliar with SMU's reputation, it's affiliated with the United Methodist Church, but not overtly religious. It's a very prestigious business school, very conservative, and the students have a reputation for coming from wealthy families. The event was planned to start at 7 p.m., but they were 45 minutes late.  Nothing new was presented. The most humorous comment was John Wells saying that we have no idea how long the explosion took. It might have happened overnight. Such comments are obvious pandering to the young Earth creationists who fund the Discovery Institute. No mention was made of the fact that the Cambrian radiation did not give rise to a single vertebrate vascular plant or insect. So it's almost 9 p.m. when they start the sessions, which lasted for about an hour. Stephen Myers was the emcee, Jonathan Wells was there, along with Doug Axe from the Biologic Institute, a wholly-owned subsidiary of DI, Paul Nelson and Richard Sternberg. Myers is a philosopher. Wells has PhDs in biology and theology, but has never published a research paper. Paul Nelson is a philosopher of biology. Sternberg is a theoretical biologist, which leaves only Doug Axe as an actual research biologist. Doug has nine papers in Medline, and Sternberg has exactly one. So the total number of peer-reviewed science papers published by the entire panel is 10. That's about half of what Thunderfoot has published, and a little less than I managed before I went to industry. I'm not talking to equals, in other words. The impression I got from the crowd is that many of them were part of youth groups or campus groups of local churches. They moved in large crowds and knew the sponsor well enough to call them by first name. Here's the clip. I'll pause it at several points to explain the questions and responses. So this relates, I think, to several of the areas you talked about today. But one concept I didn't hear discuss was gene duplication. Specifically, how that relates to mutations resulting in lethality early in development. If there are multiple copies of a gene and they're less constrained, does that change your assessment of the possibility of mutations during development? Or the probabilities. Good question. The topic of gene duplication relates to the model of the resumption model that I presented. Certainly, if you have extra copies of genes within the genotype, within the genome, in theory, this provides the substrate for all kinds of innovative changes. And in theory, you should be able to relate gene duplications to innovations that have occurred either within laboratory populations or along an evolutionary tree. The problem is that whereas you find a number of gene duplicates that are around, many of them are sub-functional. Those that we know in plants, those that we know in animals. So it's still another question of whether or not they do provide that substratum. But there's another aspect to it, and it relates to a figure that I showed. After a rather small number of changes, you've got this extra gene out there. Presumably, it's not being... changes aren't being said by natural selection. After four, five, six substitutions, it drifts into non-functionality. More often than not, it becomes a pseudo-gene. So it remains a tantalizing hypothesis that's constantly presented as a... covers, if you will, a multitude of theoretical reasons. But it's yet to be demonstrated that you really can tie an innovation to it. I want to pause here because I want to summarize what he just said. Gene duplications have never been shown to generate new functions, and pseudo-genes are irrelevant for evolution. Remember that he just said that. He's also said that we aren't able to place gene duplications on a phylogenetic tree, and I've been showing you papers published just in the last three months that put the light of that statement. It's well known that some plants are polyploid, which means they have more than the standard number of chromosomes. These duplications change the way the plant grows and what soil it can grow in. So that's a gain of function from gene duplication in a laboratory model. For example, the human tumor necrosis factor receptor is part of a superfamily of over 34 genes in our genome, each with different function, but only relatively minor differences in protein sequence. This is a recurring theme in biology. A useful gene is co-opted for many different functions. The way this happens is that the gene is duplicated, drifts, and is activated with a new purpose. Watch in the next clip as Richard Sternberg, Discovery Institute fellow, confirms that this is the case in contrast to where he just said that gene duplication is not a source of new functions. Well, specifically on what you just said, pseudogenes can also be reactivated. That's true. Well, pseudogenes, it depends. Often when they're reactivated, I do not know of an instance. I mean, there may be one. The pseudogenes that have supposedly adopted functionality are often performing a role in the cell in development that is different from the putative ancestral sequence. So if you have, like, a protein-coding gene, and you've got an extra copy, and it became a pseudogene, then the new role is often something else. It does not go back to what it was doing. But, nevertheless, it's very hard to pin down a specific innovation where you say, aha, at this point, give you an example of bony fishes. You have anywhere from 22,000 plus species of bony fishes. A compelling idea is that what happened is the genome was duplicated. I mean, the whole genome was duplicated. They became effectively tetraploids for a while, or at least part of their genome became, instead of two copies of each gene, you have four copies, and that you can explain, you know, puffer fishes, sea horses, flounders, etc., from this. But the problem is that when you actually look at the many innovations you have, it's very difficult to tie them to any of these extra copies that are lying around. I'm going to pause again and spare Rick his misery. Steven Meyer is about to step in to stop the travesty. Did you follow where we've gone from? We started at gene duplications don't produce innovation. We passed through pseudo genes producing new functions, and now we're at the point where Rick admits he's observed developmental gene duplication in the evolutionary history of his bony fish. But it's just really hard to tie the gene duplication to the innovation, except in flounder and sea horses. Feel free to go back and see where he realizes his error and starts correcting. No wonder Steven is going to stop this and pass the ball to Doug Axe. Oh, what fun I was having at this point. Rick, could I get Doug to speak to that as well in just a sec? Because I'd like to point out that whereas the gene duplication, operating as Rick is in his critique, still within the neo-Darwinian framework, accepting all the assumptions that neo-Darwinism asked you to assume, you could entertain the gene duplication hypothesis as a way of solving some of these problems. But when you get to the kind of thing that Jonathan and Paul are talking about, the problem of developing innovations at the body plan level, simply having extra copies of DNA is going to help you. But even at the level that Doug is addressing, I don't think it solves the problem, because you still have this huge combinatorial space to search. I just wondered if you could speak to that, Doug? Can I restate the question for Dr. Axe? Is the combinatorial space really all possible proteins that could be formed, or is it the current complement of proteins that exist? In other words, do cells try to invent new proteins by randomly jamming the amino acids together, or do they modify existing ones? So you're talking about new protein structures. New protein functions, I thought was the issue. Well, the fact is there are 2,000 fundamentally different protein structures, so a Darwinist has to explain how you get to different structures. So often new functions seem to require new structures, because that's what we see. When we see new structures, they're often performing new functions. There are 55,000 proteins in the Protein Data Bank. There are only 80 fold families known, usually called domains. Three of those folds, SH2, TIM, and B3, B4 account for a high percent of all functional fold domains. We call these the super families, or the super folds. In other words, most proteins reuse what already works. They don't go searching for new ways to fold proteins very often. So Doug made a terrible analogy of optimal fitness searches in protein domains to Google queries. I'd like to modify it. Suppose you wanted to generate functional web pages that would draw visitors. Would you have to invent fantastical animals and clever stories? Or would you just cut and paste porn, fail jokes and pictures of cute cats into a random generator, and spit out 90% of the internet? Here on YouTube, you just need a steady stream of makeup advice, licensed music videos, and cute things sneezing. Proteins are more like the internet than a well-written novel. The same motifs are reused over and over, and only sometimes do we see the emergence of some new successful meme, which is quickly seized upon and adapted into thousands of other crossover innovations. An example is the ABC transporter, which is shorter for ATP binding cassette transporter. It's a modular unit. Recombination can plop down into any gene and turn it into something that moves molecules in and out of the cell against a gradient. It's part of everything, from antibiotic resistance in bacteria to human cystic fibrosis. We call it a cassette because it's more or less self-contained information about how to do something. We know it's ancient because it's highly conserved. I'll deal with where domains come from in just a minute after Doug has a chance to be interrupted by Steve Meyer yet again. But a space that has to be searched isn't just 2,000 possibilities. Those are the things that we see out there doing the job. How that happens, nobody has a clue, but presumably it would have to involve extensive cutting and pasting and mutating. And effectively, if you look at the sequence difference between a novel structure and the closest sequence you can find, the sequences are so wildly different that you're effectively, as I tried to give in my simple example, having to search the whole space. You basically have to be able to pull things out that are so remote in the space that it makes no difference what you started with. So effectively, in that case, having a second copy of the same gene isn't going to help you solve the problem? Let me clarify that. When I say search the whole space, I do not mean you have to have tried all possibilities. What I mean is you have to wander so far in the space that the starting point is irrelevant. New folds and therefore new domains arise very rarely, but they aren't impossible, as Doug thinks. That's because to get from A to B, as I show in the diagram on the right, you have to have a version of A that is pretty bad at its job. That's only possible if there's a duplicate copy that's good. Or if A isn't a critical fold, then the bad form of A finds that it can do the job of fold B, but only very poorly. But that poor version that can do both A and B has a selective advantage. Further evolution will result in stepwise movements up that shallow hill to the fitness peak for fold B. What Doug has done is to imagine a fitness landscape where there can be no overlap between A and B, no gentle slope to climb between them. The good news, at least for me, is that several papers in the last few years have shown that the model on the right is more accurate. My message to Doug is that whenever you and the rest of the scientific world disagree, sometimes it's healthy to question your own conclusions rather than everyone else's. So I don't mean to monopolize time, but I know that there are literally hundreds of thousands of different sequences that all do the same function in different organisms. Right, for example, a jellyfish, adenine, whatever, reductase. Homologous. Homologous, right, but doing the same function. So there must be hundreds of thousands of possible functional proteins accomplishing the same purpose in different organisms. Is that true? Sure, and you could go a lot higher than that. But if the JNB 2004 paper, which I can give you the reference for, carefully examined the prevalence of those functional variants, and there's trillions of them, but the thing is you have to divide by 20 raised to the 150th power, which is stalking the enlarge. So it doesn't matter that you have trillions of functional sequences, the denominator is so large it becomes impossible. I'd say of the three people I interacted with, Doug gets a small measure of grudging respect. Sternberg was a buffoon, and Meyer was a slimy weasel who could only recite mantras. To all of the panelists, I want to say thank you for being such good sports and providing us with such great entertainment. Thanks for watching.


Thanks for having me here today. I'm a pathologist. I've been at the FDA in OIR for three years And today I'm going to try to help you understand When you need an IDE? How do you know when you need an IDE? I think the rules for that are relatively simple Sometimes they're easy to apply. Sometimes they're not and we'll get into that so from our Code of Federal Regulations a significant risk device is defined as an Investigational device that and we for in vitro diagnostic devices. We use really parts three and four of this definition So it's for use of substantial importance in diagnosing curing mitigating or treating disease or otherwise preventing impairment of Human health and presents a potential for serious risk to the health safety or welfare of a subject Or otherwise presents a potential for serious risk to the health safety or welfare of the subject now There are different types of devices and We want to make a clear distinction here between in vitro diagnostic devices Which is what we deal with and what we're talking about today versus implanted devices Now in an implanted device, it's very simple if you have a prosthetic heart valve The risk of the trial is the same as the risk of the device. It's very easy It's different for in vitro diagnostic devices the risk of the trial depends on how the information generated by the device is used so there's a Distinction that doesn't really have to be made between the device and the trial because the determination is really based on both The risk determination question for in vitro diagnostic devices is what is the risk of the use of this device in this specific trial? So the use of the identical device one device can be either significant risk or non-significant risk Depending on how it's used in the trial and you can have two trials using the same device One would be an SR trial. The other would be an NSR trial I want to bring up something that dr. Khan raised earlier. He mentioned a device master file If you show us a device and you give us all possible information about it We can't tell you if it's SR or NSR unless you tell us how it's being used in a trial But if you're using a single device in multiple trials You can make it easier on yourself and on us if you submit a device master file and then trial by trial if you need an IDE for a trial you can Send in that IDE and reference the the analytical validation data in the master file That's just one way of sort of simplifying the process if you're in that situation Now, I'm a pathologist as I said I deal mainly with companion diagnostic devices for oncology trials I'm not a molecular biologist But the general principles that I'm going to give you any oncology and drug examples The same general principles apply to genomics devices We use the same rules There may be some Finer points that some of the other people today can get into But I'm going to give you the basic rules that we use in the oncology trial and there are basically four questions Four key questions with respect to risk First will the results from the device be used for enrollment? Second will the results from the device cause patients to forego known effective or approved therapy Third will the results from the device cause patients to be subjected to unacceptable Toxicities and fourth will the results from the device cause patients to undergo a pet potentially high-risk biopsy There's one additional question that we usually don't have to address because there's usually not enough data from drug trials, but sometimes there is and Based on available data. Is there a known biomarker effect with respect to either toxicity or effectiveness? If there is a known effect then the use of the device could Be of risk by increasing toxicity or diverting a patient for more effective therapy Well, there are certain things that we don't consider at all in a risk determination. We don't consider benefit We only look at risk now as David indicated earlier in the evaluation of an IDE We do look at risk and benefit But the question of whether you need an IDE a potential benefit is not part of that equation. It's only risk Another thing we don't consider is the number of patients at risk If you have a trial with three patients in it It's not NSR just because you have three patients that we We undergo the same decision-making process regardless of the number of patients in the trial Incorrect exclusion from a trial Would not be considered a risk because we would expect management of that patient to revert to standard of care So what do you need for risk determination for an in vitro diagnostic device? Well, we like to see a complete clinical trial protocol This would of course include the inclusion and exclusion criteria Proposed interventions based on the device. How is the in vitro diagnostic device used to make decisions about treatment? or enrollment We'd like a general understanding of the device and sampling requirements Now I have a black box here and I use that black box intentionally When I downloaded this presentation last night onto my iPhone this box was green. I'm glad that it's it's black right now But you know, it's a black box because we you know, the truth is we don't really look much at the details of the device In this risk determination. We look at the device output And how the information is being used so very simply a device will give you a Say a marker negative or a marker positive result If that result is used for enrollment or arm assignment or stratification or other purposes that will determine the level of risk and whether the Study is significant or non-significant risk The most the simplest Example of an NSR trial is a device where the output is used purely for exploratory purposes the information is not being used to drive anything and Is not being used to put patients in a particular arm of the trial or drive treatment So if it's purely for explore exploratory Most likely a trial like that would be an NSR trial Now if the device output is used as a criterion of enrollment Then the device exposes the patient to all the risks of being in the trial and these risks could include Forgoing known effective therapy drug toxicities or new biopsies performed solely for trial purposes a Trial might be stratified using known or suspected prognostic indicators For example age gender or smoking history and if the device output is used purely for stratification within trial arms Then this would not change the risks to which the patient is exposed and that would generally Be an NSR trial however Sometimes You have for example a trial where subjects are accrued without respect to device results Until let's say 50 marker negatives are enrolled and subsequent to that point only marker positives will be enrolled Well that the determination with that would be the same as a marker based enrollment that and that would determine that the risk of that would Be determined by what happens to the patient based on the test So let's say you have a trial where patient everybody's enrolled But arm a Put marker positives and arm be you have marker negatives. Well, this would be an NSR trial But only if there's equipoise ie if the arms are both equal or of unknown risk And that's sometimes true, but it's often not true for example, if you have arm a and arm be where arm a is an experimental agent and R&B's Patients get standard of care treatment which is known to be effective Anybody who's enrolled in arm a is going to forego known effective therapy Therefore an incorrect test result will potentially deprive a patient of alternative effective therapy and this would generally be classified as a significant risk trial Yeah, the experimental agent might prove to be better than the standard of care, but it might be worse We just don't know so it's it's clearly a risk Now there's a situation where sometimes everybody in a trial gets standard of care But the experimental agent is an add-on to standard of care And in many situations we we consider this non-significant risk because everybody is getting standard of care But there is an exception to this With regard to drug trials There are some situations where there's usually not a lot of information available about toxicity of experimental drugs, but sometimes we have enough information to know that That an agent is particularly toxic or more toxic than what the patient would have otherwise received so An arm a study where everybody gets standard of care, but in one arm the experimental agent has expected severe toxicity if the Arms are divided by a marker positive marker negative in other words if the test Determines which arm the patients go into this would be an SR trial Because the patients Would be going Undergoing added toxicity beyond that expected with standard of care agents Okay, now I've used that phrase standard of care. We could probably Talk all day long about what is standard of care? we In oncology and drug trials and companion diagnostic devices for Those trials we find NCCN guidelines very useful They're not carved in stone. We know that standard of care does change, but they are used useful and we use them frequently There are two things I'd like to point out about NCCN NCCN guidelines They do use the phrase clinical trial In in various parts of the guidelines Now you'll note that on the bottom of every page of every guideline in every edition You will see this statement clinical trials and CC believe NCCN believes that the best management of any cancer patient And it is in a clinical trial Participation in clinical trials is especially encouraged Well, that's fine, and I'm not sure if everybody agrees with this, but this does not affect our risk determination This Does not mean the trial all trials are safe or there is no risk However elsewhere in the NCCN guidelines appear for example for patients with renal cell carcinoma if they have stage 4 surgically unrespectable renal cell carcinoma First-line therapy there are several options one of which is clinical trial and we take this to mean that That there really is no really good therapy that the patient is going to forego so So So that again, that's that's sort of one of the ways that we use the NCCN guidelines Okay biopsy risk this this is sometimes considered a and can be a complicated question But it's important to recognize that If enrolled patients in a trial will undergo a biopsy beyond what would be considered standard of care For the sole purpose of development of the test of the device Then the risks of the biopsy are attributed to the device So accordingly a high-risk biopsy in this setting would generally warrant a significant risk determination now Every patient is different and biopsy risk varies widely and it depends on a lot of factors These include the site of the procedure the type of the procedure patients disease and underlying health and Institutional experience and support capabilities in the in the context of a clinical trial The biopsy risk is controlled according to the clinical judgment of the health care providers Now just as examples of potentially high-risk biopsies. There's lung, medial stynum, brain, pancreas These are generally sites that you don't want a biopsy unless you really have to Examples of biopsies that are likely low-risk are for example skin endoscopic gastrointestinal biopsies and cervix Now we acknowledge that in studies It means oncology studies of recurrent and end stage cancers the site that will need to be biopsied May not be known in advance and it generally is not known in advance when the protocol is written But it's important to keep in mind that a patient on a clinical trial Using an investigational device should not undergo about high-risk biopsy solely device for device development unless there's an approved IDE so In summary It's not the device that's high-risk. It's not the trial that's high-risk It's it depends on the specific use of the device in a specific trial and Again the output of the device How the output of the device is used on up in the trial. Thank you


I'm non-experiment. I'm a real human being. I will no longer allow this board to make decisions for my family. Regardless of your vote today, I am taking back full power and control by withdrawing my healthy children out of BPS. This is what I think about masks. Should kids have to wear masks at school? And for how long? 18 states require kids, some as young as two years old to mask all day in school. Nine states have banned school districts from requiring masks. In Florida, Governor Ron DeSantis issued an executive order in July to stop mask mandates, writing that a right to a normal education is imperative to the growth and development of our children and adolescents. The order came in part thanks to the activism of parents like Tina Discovich. We support parental choice in masking always. We believe a parent has the ultimate authority, the ultimate right to the fundamental right to guide and direct the upbringing, the medical care and the education of their children. Discovich is a former member of the Brevard County School Board and co-founder of Moms for Liberty, which has 160 chapters and more than 70,000 members nationwide and advocates for parental rights. She says mask requirements drove parental engagement like she's never seen before. Annie and all school board members that quote yes on this mandate, you're fired. Masks work and you know that.  Peaceful non-compliance will be our only way forward. If they make the mask mandate where we have to wear a mask, I will not be attending school and be doing FLVS because I cannot breathe. The bottom line is this is wrong and it is illegal. They showed up to talk about the concerns they had for their individual child. They didn't really care or know about the bigger picture, but they knew their student, a mother of a deaf student spoke, parents of students with MRSA on their face, students with Infantigo on their face. My son has a rash all around his mouth and has for three months now. These parents are, you know, they're not out for a crusade. They're not on a big mission. They know their child. They see what's happening.  Discovitch says compulsory masking caused her 13-year-old son to become obsessed with the fear of getting sick, a psychological disorder known as contamination OCD. He's a very shy child. He's very much an introvert. And as COVID was unfolding, he really started experiencing some mental health issues. He would hide behind the mask and I think he would be unseen and he would blend in. And I was watching him closely because the mental health issues were escalating. After the Brevard County School Board voted to extend the mask mandate several months before the DeSantis executive order, Discovitch pulled her son out of public school. I knew at that moment that I lost the vote that I couldn't keep him in our school system. I was a school board member of our public schools. It broke my heart to pull him out of the district. I shed a few tears over it, but it was necessary for his health and well-being. These decisions that parents are making are not necessarily coming from a place of science. It's coming more from just personal preference. Lisa Goyne is the president of the Florida chapter of the American Academy of Pediatrics which supports in-school mask mandates. She testified against the state of Florida in a lawsuit challenging DeSantis' executive order. But the judge in that case sided with the governor stating in his decision that the school boards failed to prove that the state's mask opt-out rules facilitate the spread of COVID-19 in schools. This is why judges should remain in the courtroom and not in the clinic because everything that he said is totally wrong. Goyne acknowledges that COVID-19 poses a low risk of serious illness to young children, but says mask mandates are necessary because they can still spread the disease to adults. A lot of parents that I've heard talk about this feel like there's not a clear end in sight. And in the meantime, their children have to wear these masks six, seven hours every day and that that has its own costs in terms of being able to communicate and socialize with peers during a sensitive developmental period. How do you think about those trade-offs? Wow, have these parents been inside a classroom? Okay, if you ask teachers the same question, you know, kids are adjusting. That's what I love about working with children is they're very resilient. I mean, I get that kids are compliant and a lot of them are resilient, but are there any potential long-term psychological effects that parents should be concerned about? No, not that we've seen. I mean, we look at this, you know, again, we're advocates for the health and wellbeing of children. We would never make recommendations that weren't vetted by experts and the AAP continues to recommend universal masking of kids in the classroom, end of discussion. In early December, the U.S. Surgeon General announced that COVID has added an unprecedented impact on the mental health of America's youth, though it didn't specifically cite mask wearing. The COVID-19 pandemic further altered their experiences at home, school, and in the community it found. Because compulsory all-day masking is a new phenomenon, there are no long-term studies on its effect on childhood mental health and development. So, are the benefits worth the potential costs? The masks, we think of them as a completely benign intervention, but they are not. Jay Bhattacharya is a professor at Stanford and testified as an expert witness on behalf of the state of Florida in the lawsuit over the governor's executive order. We essentially have reorganized our society around the control of a single infectious disease when in fact, health is plural. Health has many, many, many inputs. Public health is therefore going to be complicated. Public action that benefits reduction of one disease might hurt another disease. We have to think about these trade-offs all the time. Bhattacharya pointed out an independent study of Florida's school system showed no statistical differences in the case rate between school districts that required masks and those that didn't. On net masks are probably more harmful than good in schools. I don't believe that there's any evidence that it actually did much as far as COVID-19 spread. For kids to wear masks. The most widely cited study in favor of mask mandates to use data collected in North Carolina schools, which the authors wrote about on the New York Times op-ed page. But that study suffered from a fundamental flaw. As the researchers admitted, because North Carolina had a mask mandate for all K-12 schools, we could not compare mask schools to unmasked schools. CDC director, Rochelle Walensky, recently shared a graphic claiming masks in schools reduced the likelihood of outbreaks by three and a half times. But that study didn't even account for whether schools were open during the period in question. Tracked outbreaks as opposed to cases and didn't control for vaccination status. You can't learn anything about the effects of school mask mandates from the study. Jonathan Ketchum, a public health economist at Arizona State University, told David Zweig of The Atlantic. There's no randomized evidence at all on masking children at zero, like none. No high quality evidence in terms of controlling disease spread. That's what leads to this kind of scientific uncertainty. Badacharya, who's an informal advisor to DeSantis, appeared with the governor on a panel in March that YouTube removed from its platform because they questioned the efficacy of masking children, which contradicted guidance from the Centers for Disease Control. I was stunned in that environment to shut down debate like YouTube did or to attempt to anyways, is absolutely responsible. The CDC has an absolutely extreme position on masks. It recommends masking toddlers two and up. The World Health Organization recommends against that. It says two to five don't mask. And for six to 11, it says, think about it very carefully because there are some harms to them. It depends on sort of the language development and other developmental issues. The European CDC in particular says no masking at all below 12. But some parents of immunocompromised children say that DeSantis infringed on their liberties by making it dangerous for them to come to school. We have a child here in Florida. She was suspended because she wouldn't wear a mask. What about her access? You know, it's really unfortunate that we have to pick and choose. The vaccine is now available and 95 masks are available, which have been proven to keep out a portion of the virus. And so if you are concerned about your child's health, you will probably wanna make sure they're vaccineed if they're high risk and that they are very well masked and that they have a well fitting mask. But the blanket statement of masking on another person's child who may have other issues is unacceptable. And some local officials say that DeSantis' order amounts to executive overreach and undermines local decision making. What do you think about that? Is this setting a bad precedent in terms of what a governor can do? It's an interesting argument. I believe in local control. I'm a champion of local control and I think education needs to have more local control. But on this one issue of government overreach, I think the role of government is to protect its citizens and to defend their individual liberty. And if the governor or a higher level of government needs to step in to protect individuals and their liberty and their ability to raise their children in the way they see fit, I think that's the one instance that it's okay. The Florida Department of Education also made available vouchers for any parent looking for an alternative masking policy then in place at their district school. The Scovitch supports this move but says the state should do even more to accommodate parents looking to exercise choice. I think it's welcomed but there are a lot of problems there. So, especially here in Florida, one of the problems with school choice is transportation. The ability to get from one school to another, if you're a family that can't afford that, that's not a choice for you.  For now, Florida has won its standoff with the federal government, which dropped its cease and desist order against the state for withholding funds from school boards resisting DeSantis' anti-mandate order. No school districts in Florida currently have a mask mandate in place. There's this tension that has come to the fore between personal choice and bodily autonomy and public health. How do you think about those questions, especially when they come into conflict? Okay, if we're gonna just toss out public health measures, where do we start? Where do we go from here? Do we start allowing people to not wear our seat belts? If you wanna do whatever you wanna do with, you know, in the privacy of your own home, that's one thing. But if your behavior affects somebody else, we as public health professionals have to make those decisions to do what's best for the entire community, not just for that one individual's rights. Long term. This isn't about masks. This isn't about vaccine mandates. This isn't about COVID policies. This is about the role of the parents in a child's public education. It's fundamentally a complicated thing. And so to turn into a morality tale of you must stop the spread of this disease at the expense of all else in life, I think was an enormous mistake.