Ahoy, ahoy, and welcome to the channel. I'm Dr. Sumerian, not a real doctor. And today we are going to talk about the top SCP-6000 contest entries. I'm going to go over each of them in a little bit of a summation and give you kind of my own personal evaluation of the ones I've read so far. I haven't read them all. There's about a hundred of them. Probably won't read more than 10 at most, depending on if they come up later. But for this, I've read about six. I want to say six of them. Today's video is also sponsored by the SCP Foundation Wall Art by Vermillion Creative Kickstarter. But I'll talk more about it at the end of the video. But there will be a link at the top, near the top of the description, that will send you to their Kickstarter page, and you can pledge. But we'll talk about it a little bit later. For now, let's go over the CP's. So what I've done so far is, I probably will read some of the future ones a little bit down the line. But my plan right now is to read anything that's higher rated than the 6000 contest hub. That feels like a good cutoff point. If you can't get a higher rating than a hub with no content, I feel like you've probably, I should say no creative content, then I feel like you've done something wrong. Now, out of the current seven, yes, seven SCPs that meet that requirement, I've read all of them, except for one. And that's because it is 30,000 words long, which ironically is probably the one you would need the most, the one you would most need a summary of. But we'll get to that at some point in the future. I'm planning on reading it. I guess it's inevitable that I have to. But not there yet. I know it's multiple choice endings, which is why it's so long, but I wouldn't feel comfortable reviewing it without seeing all of the content. So anyway, we'll start with the one that is maybe going to win. It's complicated. Looks like this one is solely written by Rounder House. Yeah, it looks like it. Okay. So let's grab the licensing information. SCP, it's not SCP 6000. This is the problem. Licensing information is technically correct for the moment, but it's not. We're just going to call it the serpent, the moose, and the wanderers library by Rounder House from the SCP Wiki is licensed under a Creative Commons share alike attribution license. So what is this about? Well, as the name might suggest, this is a serpent's hand focused SCP, specifically the wanderers library. It strongly involves an author avatar of there's a character, there's a person, there's an author. Let's do it that way. There's an author on the SCP most notably, probably the author of SCP 1000 named The Deadly Moose, and their author avatar is an odd name, Tilda Swinton Moose. But that character shows up quite a lot in this article. And what is happening is that the wanderers library in exists and is spreading from some sort of portal in the Amazon rainforest. It is a very interview heavy SCP. Most of the important stuff happens in conversations between Moose and one of the entities that was recovered from the anomaly. But in the end, the wanderers library basically is taking over the entire world. That's that one. And it's likely going to be the one to win, though the next one is making a bit of a what's the word I'm looking for here. Reach for number one. It's DJ cactus is and we're going to go down and see if this has licensing information at the end. It doesn't. But regardless, let's double check and make sure that it isn't co authored. And it doesn't look like it is. This article is called the Demon Hector and the dread titania. And it is about it's a lot of things. Ironically enough, it is said in the Amazon and Creek. It is said in the Amazon and it is also involves SCP 1000. And by extension, Tilda Swinton Moose, the author avatar of the. So the top two articles in this contest, both are set in the Amazon and heavily involve the author avatar of Moose, which is an odd coincidence. This one may run ahead, but I understand cactus has decided. Oh, I don't know this for sure. I shouldn't say this out loud if I don't know for sure. But I have heard some rumors that cactus is planning on giving the 6000 slot to round our house, even if he manages to beat him in the contest, which is, you know, because he's won what he won 3000. And he's and he does pretty well in the other contests as well, because he's cactus. All these are really long, by the way, not just that's not true. One of them isn't. But most of these SCPs are also very long. And this one's no exception. It is about Oh, man, this is hard to summarize. So the fairies from taboo have long, long time ago created SCP 1000, the Bigfoot Monsters in an effort to fight back against humanity. And ended up creating something that was weirder and more terrifying than humanity was.  No, I think about it. It's very similar in that kind of way. Children of the forest and the white walkers have this have a similar origin to this. But what and same reasons even that they wanted to fight back against humanity. So they created these monsters and these monsters, then became their own sort of plague and problem. But what happens is, SCP 1000 is still exists in sort of ways they took on a David Empire. There's a whole bunch of stuff happening in this SCP. The important parts, though, is that it involves SCP 1000, SCP 4000, and moose. You have to read it to understand. It's a lot of exploration. And it also, you know, there's this underground cave underneath the Amazon rainforest that basically is there's corpses of like, I don't know, it's hundreds of thousands of people or entities, I should say, 100,000 of entities, some of them fairy, some of them human, some of them the monsters, I believe that are Bigfoot. The reason why this seems a little bit rambly is that the article itself isn't rambly. I'm not saying that. The reason why this is rambly is the article is just complicated as heck. And I recommend it as well as I recommend the other one as well. I'd be surprised if Cactus actually overtakes Rounder House, but he might.  The third in the list is Nearer My God to Thee. We're going to look at this real quick. Make sure we get the crediting in properly. By the way, hold on. The demon hector and the dread titana was written by DJ Cactus and is under a Creative Commons share alike attribution license. We're going to say these out loud. We're also going to have links in the description to all of these. Nearer My God to Thee was written, oh it actually has this licensing citation that makes it a little easier, was written by Elegy Fishtruck. It is licensed under a Creative Commons share alike attribution license. And it's just Elegy Fishtruck again. I think one of these is co-authored by a little bunch of people. And this one's pretty simple. There are a number of end-of-the-world broadcasts in reserve at a lot of major networks. On the off chance, it's something were to happen. Then the world were to be ending. They're supposed to play these things. I believe one of the more famous ones is the Turner Broadcasting's version where they basically have an orchestral version of Nearer My God to Thee. In this version, in the SCP universe, this is actually quite short, the SCP foundation has laced these broadcasts with something that will make people calm down and just accept the end. That's it. That's the whole article. It's the shortest of all of these entries. Then we have The True Empire. And we're going to scroll down again. There is a licensing citation which is good. Okay, by Ace Millard, I could be, I've never had to say that out loud before, but I'm hoping I got it right. Ace Mallard or Ace Millard and Storm Breath, a licensed, it's called The True Empire, and licensed under a Creative Commons share-like attribution license. And this one is kind of a two-parter. See, let's grab the article's description. All right, SCP-140 is the old Dayvite book where if it gets completed, the Dayvite Empire comes back. And in any fluids that are allowed near it will cause it to write more and the Dayvite Empire comes closer and closer to modern day. Someone steals the book and finishes it. And the SCP foundation has just a few months to figure out what to do about it, and eventually they decide they're just going to have a broken masquerade because the Dayvite Empire, as described, is this terrible blood worship, or should I say scarlet, king-worshipping blood magic empire that stretches back into antiquity, and if it exists in modern day, things are going to get real bad real quick. But then it happens and it turns out that none of that is true, and that the Dayvite Empire of today is fairly mundane. There's still some stuff like they were still not a great empire. They owned more slaves than any other empire on earth has ever owned, but, this is important, a slave uprising took them out at some point. And the book was just written by some dude who thought it made up a whole bunch of stuff and thought it would be cool if the Dayvite Empire was just like eldritch abomination of an empire that could come back at any time and be just was terrible. But what he ended up doing by creating it was he wiped the Dayvites who still existed off the map. And so what comes back is Davisstan, which is essentially just a no different than the basic, what's the word I'm looking for here, Central Asian states, maybe a little bit more advanced, but not by much. And a former Soviet Republic as well. So it was under the Soviets for the longest time. And that's it. That's the article. The next one is All Creatures Great and Small by Big Sloth on My Face, License Center Creative Commons Share Like Attribution. This one is, I'm not sure if I'd say it's my favorite. It was my favorite until I read the next one, which I actually enjoyed more. I also have problems with all of these. None of them are as I particularly impressed with, but they're all right. And some of them, if you really enjoy the content, like you're super into the Dayvites or you're super into the Serpent's Hand or if like the lore of 4000 and the fairies, which I wasn't particular fan of in the first place, or Bigfoot, which I'm not a particular fan of in the first place, interest you, then those could interest you as well. But this one in particular is sort of more original, doesn't rely on much of anything that I can think of. And it's essentially a tree of life. But in that tree of life is housed the genetic material for all living things. And if you modify the stuff on the tree, you also modify stuff in real life. And I actually quite like it. I think it's worth reading. And I'm not going to spoil it for you more than that. But yeah. And then finally, the one I read just this morning, which I think may be my favorite, there is one problem I have with it. I'll say this. It definitely reads more as a tale than an SCP. And that is, I guess, probably my worst, yeah, that's probably my worst problem with it. But other than that, I think it's I think it's probably my favorite article in the SCP 6000 contest. It's also on the list of articles I've given you so far, the lowest rated. So this is by T. Rutherford. Nope. Nope. I don't want to click through that is licensed under a creative common share like attribution license. Again, links to all of these will be in the description below. And Amelon is about an alternate universe, which I love the alternate universe, SCPs, that's it's right in my wheelhouse. It's about an alternate universe basically where the SCP foundation of their world united with all the other anomalous groups and brought about world peace and world order and magic and everything is like omnipresent, but in sort of a way that you would think of as technological at the same time. And yeah, there's just a long discussion. I mean, it's a it's a good story. That's important to remember. It is a very good story. It's just not a I don't think it's a good but I liked it more than all of the other ones. So if I had to recommend one, I'd probably recommend that it's also the lowest rated among all it's only just made it was yesterday when I looked it wasn't even above the contest of it's only just now raised above the contest hub in rating. There are more below the contest hub and rating that I'm probably going to go over. I might actually make a new cutoff as anything plus 100 or or lower. I'll probably do one more video, maybe two, depending on how much time it's going to take me to sum up inevitable, but regardless, that's it for today. We're going to talk a little bit about this foundation SCP foundation wall art. Actually, I'm going to put this stuff up on the screen right now. So I mean, this this piece of wall art is going to have so many characters from the SCP foundation in it. It's got Dr. Sumerian. It's got Dr. Sumerian. It's not listed on the on the thing here, but it is it is I've seen the art, so it is in there. But there's Dr. Kleft, Dr. Kondracki, Gears, Bright, Glass, Sumerian, Iceberg, Kane, Tallerin, Wondertainment, Max Lombardi, Diogenes, Emma, I, and photosynthetic Elliott, Chelsea photosynthetic Elliott, I guess it's the name, and then just tons of SCPs in here. Most of these SCPs are series one. So if that's your thing, you might like this a little bit more. But I think regardless of SCP, regardless of if series one is your thing or not, this is a beautiful piece of art, I think. And yeah, you can see it on the screen right now. I highly suggest you go over. The link will be in the description below. And it helps me out a little bit to help them out. So I really believe in the content in the work. And yeah, that's it. Thank you very much for watching. If you enjoyed the video, head on over to patreon.com forward slash de Sumerian and Pledge at any level, like everybody here on the screen already has, including Dr. Jay Redacted and Synderiki, both Pledge at $100. And for God's sakes, hit the subscribe button. My God. My last month was only on plus 127 subscribers. I have had not even particularly impressive days last year, not this year, but last year, over 127 subscribers. At this rate, it's going to take me 30, what, 30 more years to get, not 30 more years, 30 more months to get to 100,000. I want that silver play button, bitches. Anyway, thank you very much for watching. And thank you for letting me know that I'm not alone out here. I will see you all again on Thursday.


Did we decide, oh, are these working? All right. Hey. How you doing? Hi. This has been really great and really inspiring. We did our little prep and we have a couple questions to ask ourselves. We're gonna talk about independence and interdependence. And I'm gonna ask Tempest the first question. By the way, my name's Amar. And Tempest, what are you in your practice independent of? Martin, I have to start, well, thank you for the question, but before I start, I just have to say that I'm suddenly in here feeling a little tender because there are some people in the room that I haven't seen in a really long time. So bear with me as I collect myself and try to answer this question without just wanting to hug all the people. So my name's Tempest Hazel. I am a writer, curator, one of the co-founders of 60 Interstrom Center. And the very quick version of what 60 is, 60 is a publishing platform and archiving initiative an advocacy organization that really focuses on queer, diasporic, indigenous trans and disability communities and artists in the Midwest. And so when I think about this question, it goes back to the, for me, it goes back to the origins of 60. When we originally started, I think what we were hoping to do as writers and documenters and folks who were really deeply interested in the archives was to look outside of the mainstream institutions and look at more of like the independent spaces within Chicago and do a lot of archiving and documenting around that. And that was really based on, in a lot of ways, our education and going through having a curriculum that really just didn't reflect us in our communities. I can say that for myself. 2010 wasn't that long ago, but it feels like very long ago when it comes to that conversation. There is a lot that has changed, a lot that has remained the same when it comes to education, what we understand cultural canons to be, how art history is taught, what is valued and prioritized. So 60 was definitely created as a reaction to that. And because we are art historians, we're thinking the important piece is to get to the heart of how knowledge is created. So we couldn't just be writers, we also had to engage with archivists and librarians and the people doing that documenting. But we initially thought about ourselves as being kind of reactionary and resisting and independent of certain institutions or these spaces that we didn't feel held us or reflected us. But over the years, I think we've gotten a much more maybe complex understanding of the work that we do. In that, as much as we're in the business of thinking about and building future cultural canons that more reflect our communities or better reflect our communities, it's not independent of the spaces that also were harmful to us in a lot of ways or didn't reflect us. There is a relationship that we have with that because history, the archives exist. So we're thinking about the ways that we respond to the knowledge and the material and the ephemera that does exist as we build, as we kind of like working on this, on the side to think about envision future canons, like canons that are more representative of us. So there's that simultaneous, I think we've already felt that those thoughts and that energy in the room this morning of like building the future we want to see. But I think that there's a simultaneous thing that happens where as you're building something new, you're also working within the things that exist. So in a lot of ways, we're really interested in how we relate to, well, I will say, I think the way we think about our relationship to institutions and the institutions of history and culture and archives and all of those things, that has changed in that we understand that these institutions are also made up of people. And a lot of those people are co-conspirators with us. So thinking about being independent of those institutions isn't quite accurate. We're more in relationship with the people who we're aligned with and who have a similar vision as we do and are working within as we're building outside. Yeah, because those people are also trying to be independent of their institutions, right? They're trying to not be of the institution, but actually of something that they themselves value. And these institutions, just to clarify, like universities, galleries, museums, these are the kinds of things. Libraries, yeah, it's interesting because everything you're saying, even though you work in completely different spaces than I do in some ways, is completely resonant at the same time. Just the origin, the arc of the narrative is like almost the exact same for me because, while I don't think about Canon because I co-founded this platform with Elijah McKinnon called OTV Open Television, which is a kind of anti-Netflix, if you will. It's an app that you can download on your phone right now, support queer independent art. I thought of it, yes, anti-Netflix. I'm independent of Hollywood, right? We developed all of our stories in Chicago where almost every TV show you see is developed in Los Angeles. And there were a lot of ways in which, yeah, we were bucking the system. We were local instead of global. The focus was intersectionality, similar kinds of communities, right? Queer, trans, women of color, disabled folks, undocumented folks, and those companies don't really think about identity in their programming decisions except to extract from our communities versus with OTV we wanted to invest in our communities. If, and I took a meeting with everyone who emailed me whereas to get a meeting with Netflix, you need an agent, you need a manager, you need connections, all these things. So thinking about being independent of Hollywood is not about the Canon because TV is in a lot of ways disposable. Like people, they're not archived often. A lot of old TV shows are missing but there is this question of value, right? That I think connects us that in art, the Canon is what ascribes value to stories, to artists. In television, it's access to this distribution, right? The money, the glamour. And we just very much wanted to be independent of that whole system because I think it's neocolonial, it's extractive. My lab actually did a study recently where we analyzed the black playlist on these platforms and found that overwhelmingly they represent trauma.  And when you look at OTV, our stories aren't traumatic. Many of the stories are actually connected. They're about solidarity between different types of people. They're joyful, but they're also complicated. It's not just like this hokey capitalist joy, it's like the joy that's won from real struggle. So there's a lot of ways in which we're independent of it, but very quickly I realized we're not independent of these systems. In 2017, we released a show from Sambalian Fatima Askar called Brown Girls that sold HBO. I love that. You should all check it out. It's a beautiful show. Amazing. And I was like, oh, that's interesting. HBO is checking for Chicago like this. And it just kept happening actually. By the time I handed the platform ownership over to Elijah in 2020, we had like, I was throwing brunches in LA and I could invite like 20, 30 people who were working for Netflix and Disney and all these places. And it was complicated for me because I was like, on the one hand, that's what these artists wanted, right? There was these migration from Chicago to LA because that's where the money is and people wanted to work as an artist. And I imagine you found the same thing too that like artists wanted to be in some institutions or recognized by these institutions in order to survive, in order to thrive, in order to be remembered. And so I think about, when we were after this conversation, I was like, oh, Tempest and I, we're the independent people. We were like, created independent institutions. And then we started talking and we're like, but are we though? Right, right. So maybe I wanna ask you then, who are you interdependent with? What does interdependence mean to you? Like, do you view yourself as interdependent with these institutions or other people or things or people, you know, spaces, places? Yes. Yeah, I mean, I think I'll echo again or just talk more about what I said before of, and to what you're saying, we're all, especially as artists, we're all moving in so many different ways and move through the world and change roles and positions and end up in different places for periods of time. And a lot of that has relationship to these places, but I think the more, for 60 at least, the more we understand ourselves as an organization that is interested in people and communities that automatically means just because of how we live our lives and how we move through the world that we're interdependent with all of it because we're all part of all of it. So it's, the separation is perhaps maybe more so in somewhat in ethos and philosophy and ideology in some ways and maybe in methodology in some ways, but understanding that the community archive, for instance, or an archive that like your personal archive or like somebody's or OTV's archive that might be held with OTV is just as important as the special collections that have a public library or the collections at Northwestern, you know, being able to, and to understand that the work that we do has to address it all and has to be in relationship to it all in order to have the type of like building a cannon or trying to push or shift or change or mold or feel the agency to be able to change a cannon is like a big, you know, it's a big question or it's a big tap. So for us, we see working in a lot of different ways in a lot of different places, it's really important. So that interdependence is everything. It's, yeah, it's, I mean, it's really the basis of the work is understanding our relationship to each other, to our communities, to our city or region, our country, the world and, you know, we have to, as an organization, kind of reflect the complexity of that so that, and acknowledge that we're connected to everything. It sounds like a lot of work for you. It sounds like you're in a lot of different kinds of people. Yes. But I mean, that's what we do, you know, like I look in this room and I'm just like, think about the work and I think about the work in this room, we're all doing a lot of work. And it's also because I think to your question again, to the interdependence piece, this is our lives. You know, I think part of what's 60, what's important to 60 is that we, what's important to 60 is that we understand that the art world isn't isolated. And I think we all know that it's not in a vacuum. It is very much so affected by everything that's happening in the world.  We strive to create something that is a reflection of the way we live our lives. And our lives are a lot of work. To live in this world is a lot of work. Yeah, I'm just, when you're talking, it's like I'm thinking about the ways in which I'm interdependent with just the team, the people around me, you know, and first and foremost, I prioritize them and care for them and supporting them. And then the artists and their communities and the deep relational work that that requires the dinners, the meetings, the parties, the seeing people around town, right? The like way in which I'm interdependent with Chicago and this ecosystem and everyone here and everyone I meet. And how surprising that is, you know, just thinking, even looking at the room and seeing that like we livestreamed Martin's opera, you know, and like- You did? Yeah, I think it's not on the platform. You had to be there. But it was brilliant. And looking at Angelique and like Field was our first funder. Like before Field, I didn't know if we would exist as an organization, you know? And how there's just all these like diverse relationships that have taken cultivation.  How much time do we have? Yeah, Max says we got, we had to- Oh no! Oh, okay. Well, it was great to talk to you, Tephas. We just distilled about a three hour long tea time together into 15 minutes, so. Yeah. Thank you, Max. It's great to spend time with you. We'll pick it up over tea. Yeah, indeed. Okay, we'll invite you all to take a little break, get some sunshine outside. We'll take 20 minutes, stretch your legs, have some tea and coffee and chat, please. We also are really thinking about the coffee breaks and our lunch as the moment for you to share with each other, a hug also. So we will come back together about 10 to noon. Thank you.


Great. Thank you. So, first of all, I want to thank, reiterate a big thank you to Rebecca Hong, who really did a lot of work that made this day possible, as well as Christina and Laura Rodriguez and Dr. Green. As he mentioned, this is part of a larger effort, which has been really helpful for us, and we hope for NHGRI as well, and we look forward to continued activities like this and in other realms as we work together to move genomic medicine forward. So, what I'm going to do right now is to talk about, just give a general overview of IDEs, why are we here, why are we talking about genomics, and sort of set the scene for the rest of the day.  Certainly, drugs, traditional devices like, you know, heart valves or new implantable devices have always been regulated, but just because of the nature of the technology and how it was used and the focus on basic research, it's not something anybody really had to think about in the sort of academic, basic science research world. But today we're seeing much more of an intersection, and this is because of the promise of the technologies that all this basic research has led to, and as a result, the emphasis, the increasing emphasis on translation and on moving these technologies into the clinic so that they benefit patients. This is something that we all support. We all benefit from, and it is part of FDA's mission to get new, innovative technologies to patients. So we want to support NIH, and HGRI, and other institutes at NIH in this effort. However, one of the challenges has been the increasing, this increasing overlap with clinical, with regulations that govern clinical use, and for tests like genomic tests and other types of tests, as they move into the clinic, they are falling under the scope of the investigational device exemption regulation, which regulates investigational use of in vitro diagnostics and other devices. And we'll talk a little more what we mean by investigation because this is one of these terms that we have a very precise meaning, but you could think of it more or less as human subjects research. The change in scope has not really been an issue because, and I think naturally so, people have not been aware that this regulation even existed or that it applied to the sort of research that people who have been not just funded by NIH, but in other spheres have been doing. And one of the examples and one of the reasons we're here is from an incident that occurred, you know, several years ago now where an investigational test at an academic medical center was used without complying with the IDE regulations, without all the oversight that would have been required. And it was used in a, it would turn out to be a test that had, that did not work, that was based on false and maybe even falsified results. And it was used in the setting of oncology and harm patients. Patients sued the institution. It also led to an IOM report, which I list here, and they had a number of recommendations, and this is back in 2011 or 2012, as we were beginning to see this explosion of omics moving into the clinic. Couple of those recommendations were that FDA needed to step up its efforts to communicate what these requirements were and how they applied to omics. And also to engage in a dialogue with the community to develop, not just to educate, but also to help develop better ways to provide oversight for this technology. So this conversation is very much in that vein. This is something we've been working on for several years. We believe that education and dialogue is the best way to make sure that everybody not just meets the regulatory requirements, but that we apply those requirements in a way that makes sense and that benefits everybody, including the researchers and the scientists who are developing these technologies. So we are here to tell you about the regulations, what our thought processes are, how those apply to genomics. But at the same time, hearing from you is very important because like everybody else, we rely on the latest science and we apply the knowledge that is available. And as knowledge changes, we need to change. We need to update our thinking as well. We also feel that speaking with NIH is incredibly important because we recognize that academic researchers, NIH-funded researchers often face special challenges. Many most have not had prior interaction with the FDA, or even if they have, they haven't had prior experience with IDs. Most of the people, most of the academics who have interacted with FDA have done so in terms of either traditional devices or more commonly with drug regulations, which are in fact rather different. This means that people don't know what to do, but it also leads to communication gaps where it becomes difficult for us to even communicate what the requirements are or for you to understand them. And so one of the things we want to do as an outcome from this workshop and from future conversations is to develop better ways of explaining this and outlining what the pathway is. Many people who are in academic settings don't really have adequate regulatory support and I don't mean that institutions are doing anything wrong, but this lack of experience extends to the institution and we recognize that many NIH-funded researchers are not in industry where you have a regulatory staff that will take care of all of this. And there's also the time-limited nature of NIH-funded research. When you get a grant, when you have a grant or when you award a grant, this is for four years or five years, you're under the gun. I think most of us all know what that's like, what that time pressure is like. So having an additional regulatory step to undergo can have a significant impact and we want to minimize that impact. It's important to point out that when we say, when we talk about applying to ID regulation, we're not saying the research shouldn't go forward. We're not saying that people are doing anything wrong. This is a part of our legal system of oversight for patient protection in the United States. So the purpose of this workshop is from, at least from our standpoint, is first to help you understand the ID regulation because understanding it will allow people to be prepared ahead of time. The best time to know what you have to do is as you're planning your initial study. Planning ahead will make the entire process easier. You'll have every, you will be much closer to having everything you need at the beginning of the process and we don't want to disrupt research or research projects. So we want to have people understand this at the beginning. And then, you know, in having this conversation to identify barriers to meeting ID requirements is important to us because we want to help people overcome them. And so understanding those barriers will help us, help us do our job in helping you, you know, follow the ID regulation. So just a few points about the ID regulation. This is a quote from the Code of Federal, this is text from the Code of Federal Regulations, which is defines what the ID regulation is. And the purpose is to allow investigational devices, including IVDs, to be used in research by exempting those devices from all the requirements that a normally marketed device would have. So, you know, if you're going to sell something, you have to get an FDA approval and meet all these requirements. And the point is, at the research stage, that doesn't make sense. But we also want to make sure that those investigations are conducted in a way that protects public health and safety. And that is ethical, meets ethical standards. And so we have that goal as we look at IDEs. Now, we can talk about IDEs as an exemption, but we also refer to IDEs as a regulatory submission that permits clinical investigation of devices and IVDs. And as I said, this allows, you know, you to use a device in an investigation without complying with other requirements that you would for marketing. It's focused on risk and they are delegated responsibilities, which means that a lot of the responsibilities for making sure there's compliance with ID do not lie actually initially with FDA, but they lie with the investigator or the sponsor and their IRBs. And you'll see a little more during the day how that works out. But getting an IDE approval when you do have to make an ID submission, you know, when we're looking at an investigation, we are trying to ensure that risks are out, you know, outweighed by anticipated benefits to subjects, that the informed consent is adequate. Again, this is the ethical oversight. And that the investigational device plausibly is effective, you know, so that you're not using something crazy on people and somehow posing risk to unnecessary risk to them. And so that third point really will get into one of our topics today, which is analytical validation, that when we are reviewing an investigational device, including an IVD, we need data on how that device performs. Now, how much we need will depend, as you will see, but that's sort of one of our major questions in one of the ways in which we primarily look at safety. Now, a few points about FDA review, because I think often we're viewed as a monolith, a black box. And I think it's sort of scary to people, but we're actually very friendly. We're fun to talk to, as you will see today. But there are aspects of FDA review that I think people would appreciate, and I think would be a value add. So first of all, it's highly interactive. So this is, you know, during the course of a review of any submission, there are many opportunities for informal or formal conversations between an FDA and a sponsor, i.e., the person who's submitting whatever the application is. You know, if information is missing, you may get an email saying, I need to know this. Or if there are questions, you can contact the reviewer. It's not a black box. You know, there are many opportunities for communication, which makes the process be more effective, and helps get people to approval. We also have a more formal pre-submission process that you'll hear about, which allows conversations before submissions, which allows you to answer some basic regulatory conversations. And this is a huge benefit to people, because you can determine exactly what you need to send in, if it's worth sending something in, or if you even need to send something in. Also, the important thing to know is we don't apply a single standard to all of each of our diagnostics. The review really happens, and the details of that review happen on a case-by-case basis. So what is required will depend on a number of factors. What is the actual test? What is its intended use? How is it going to be used in the investigation? What's the design of the study and other factors? So we aren't going to apply or, you know, we don't apply requirements to IVDs, or we try not to when it's not required, when it wouldn't make sense for that IVD or that technology. And so we really often times, the IDE review process worth tailoring the review to the way the different risks can be mitigated in an investigation. The last thing I want to point out is that this is really a different focus than peer review, and it's different. First of all, we're not looking primarily at the science of your study. We're not making a comment on whether the study, what the value is, if it's worth doing, how much it's going to contribute to general scientific knowledge. We're primarily evaluating safety and ethics. And so even to the degree that we overlap, we're sort of looking at it through a different lens. And part of that is analytical validation, and one of the things we want to address today and in the future is what that means in a really detailed way so that people can understand. Because our review of analytical validation is very detailed, or can be very detailed. It depends again on the context. And it can even include evaluation of lying data. So you would send in all the numbers that have been accumulated. It's more true with pre-market submissions for marketing approval, but nevertheless it is something we do look at. Now, we're spending a whole day talking about the IDE, but I do want to point out the good news, which is that most studies of the feature of diagnostics will not require an IDE and will actually be exempt from the regulation. This is, you know, given, so an example would be a very common study, use of archived, de-identified specimens is almost always exempt from the IDE regulations, which means, you know, if you don't even have to worry about the entire process, then if you are in a situation, and this is just one example of how something can be exempt from the IDE regulation, some of the studies we see are really exempt. Some studies aren't, and then we have to make a determination of whether the risk posed to patients is significant enough to require an IDE submission. And you'll hear about that process. But even in the realm of studies that aren't exempt, most studies do not reach that bar of being significant risk. We actually receive very few IDEs, and I'll also say of those, almost all of them are approved. I would say, though, that this is something that could change as more technologies move into the clinic and more people use them to take, you know, even in an investigation to take potential actions about their health. And that's something we can discuss later. Now finally, I just want to say a little bit about our office, because this is, you know, if you were to submit an IDE or to deal with us in some way, this is who you'd be dealing with. For in vitro diagnostics, we have, so we're the office of vitro diagnostics and radiological health. So that second part, radiological health, we actually have two divisions within this office. Radiological health and mammography, you can ignore those for today. We don't, I don't even know who's in that of those divisions. But the four that deal with in vitro diagnostics are DIHD, so this is immunology and hematological devices, molecular genetics and pathology or GMGP, microbiology devices, DMD, and division of chemistry and toxicology devices, DCTD. So today when we're talking about the IDEs, we're going to be talking about a range of types of studies. So not just genomics and the sort of, you know, whole genome sequencing and returning results sense, but also in the context of, you know, specific types of diagnoses or specific trials of investigational drugs, where we see probably most the bulk of our IDEs at this point. The other thing I want to point out is that the people who work in this office come from a range of backgrounds. They, almost all of them have advanced degrees, PhDs or MDs. Most of our medical officers still do some practice, so they're not, you know, they still are, you know, involved in the medical community. They come from clinical labs that some of them have run clinical labs. Some of them come from a more pure research. So we have a range of experience and expertise. We have software experts. There are statistical experts. We can, we, when we review something, we assemble a review team as necessary to address all the things and we actually can access anybody in the FDA. So even for ethical review, we can, we have people we can call on. The other point I want to make is that the people who do review, and you'll hear from some of them, from them today, are experts at reviewing in vitro diagnostics. So somebody who focuses on a specific type of test or technology has seen every variation. They know every way in which that test can go wrong as well as anybody. And they're used to reviewing tests, I mean, really, if you think about a test going into the clinic, that test has to be reproducible. It has to be able to generate correct, accurate and reproducible. It has to be able to consistently generate correct results because with a patient, you have one shot in most cases. So as we talk, as the field talks about reproducibility, designing better research for clinical work particularly, I would hope that, you know, the field can leverage the expertise that sits in OIR. I think because of the lack of interaction in the past, because there hasn't been this intersection, people may not realize that, I think FDA is not just, is sitting on a resource and that's one of the discussions I also hope we can have in the future. I know the reviewers are thrilled that I'm committing them permission. Even more work. So just to end with sort of an overview of a day, the day, this is sort of a very general flowchart of the thought process. What we want to communicate to you today, there's too much, there are too many variations and details to even cover in the course of one day. But if you walk away with anything, it's the thought process you should be applying. And you want to know when and how to come to FDA for help. So you're going to start with some sort of clinical protocol that has an investigational device or a clinical protocol and you're going to just ask, is there a device? And if so, is that device investigational? I mean, would it even be subject to the IDE regulation? And if it is investigational, if it's exempt or not? And I can see on my yes and no backwards here, because if you're not exempt, then you move on to determining what the risk is of that investigational device, including IVD in the trial. If it does not rise to a level of significant risk, you have a limited set of requirements, what we call the abbreviated requirements that you comply with and you're considered to have an investigational device exemption and you can proceed with your investigation. And this all assumes, of course, IRB approval and all the other regulations, you know, meeting all the other requirements. If you do rise to a level of significant risk, you also have to submit an IDE and get that approved by FDA, which happens is by law, a decision has to be made within 30 days. So it can be a very, you know, the review itself is fairly rapid. Once that's approved, you can proceed with the investigation. If for some reason it were to be disapproved, you just address the issues that will be laid out in any sort of disapproval, submit an IDE, the second IDE, and proceed. There's no limit to the number of times you can submit and there's no equivalent to a paid line. We aim to approve IDs. That is our goal and we approve almost all of them. So with that, I'll end and we can move on, I guess, to addressing some of the details. Thank you. Thank you, David. Our first session is aimed to address the question of what an investigational device is in the context of genomics research. And as you can see on your agenda, the questions we would like to get is for our community who are relatively new to this, what is the definition of a device in general? What types of technologies used in genomics research could qualify as a device? A lot of these questions on the agenda today were developed from experienced researchers had, so we're hoping to elucidate those a little further. Our first presenter is Dr. Stephen Kingsmore, who is President and CEO of the Rady Pediatric Genomic and Systems Medicine Institute at Rady's Children Hospital in San Diego. He's part of the Newborn Sequencing and Genomic Medicine and Public Health or Insight Research Consortium. Thank you for joining us today, Stephen.


Everybody force and Jay here. We got 20 23 boomer draft baseball choice and jumbo seven box mixture number nine pick your team style Got Chad s with the Braves Chris B. Phillies Chris s Royals Cody W. Cardinals David W. Rockies Duke has the Reds Gabriel Tigers a's Giants Harper Rangers Yoomitsu Red Sox Jeffrey H. Cubs Mets Mariners Jeremy H. Diamondbacks Guardians John s twins Josh and Nationals Justin K Dodgers Keith J. Orioles Kyle B. Brewer's Matt s Padres Matthew B. Marlins Morgan L Ray's Noah G. Astros Olivier with the Angels and the Jays Peter with the Pirates Tom Yankees Travis White Sox Good luck guys mixer number nine here paper-based donated everything else ships People abroad has half the drive of what MJ or Kobe had I don't know if that's true at all. Oh, I don't know. I mean, that's an opinion. I guess I don't agree with that Wow That's I think that's kind of he's I mean he's playing at 39 years old Yeah, I don't agree with that Anyway, let's see a monster super here last bowman break of the daytime We'll see a super in top scrim on the last or something First auto is gonna be Guardian CJ Kafis CJ Kafis practice of Rada and O'Donnell Lunar glow we've got Walton for the Phillies refractors of Carlson Reed and Connor Burns Come on Penn State Come on Penn State Transformative talent refractor to 250 is white Langford for Texas 210 to 250 Langford got refractors of Williams and Baton T light blue paper here is bow for the Brewers out of 499 glass Langford Rangers Fractor is Savakul and Jake Cunningham Can't do the past when I beat the Broncos Come on, dude. First bowman auto Maui Ohuna Giants Fractors of Meyer and Alderman. Yeah, the more we talk about the worse it gets That's exactly what that is How much better is OG than RJ? Light blue is solace for the Padres refractors of Brian Acuna and Colton led better Yes, but still I feel like the Knicks are gonna regret it if I was a Knicks man I would just I burned my jersey green grass the 99 TJ Nichols for the Rays Solace got Max Clark. Yeah, but it's a tip. It's a tip of no coach team So it's been there was a refractor Braden Taylor.  It gets better doesn't it fractures of Kravi and move just gets better. That's Raptors And I'd be a great team, but you're making the right moves for a player that you're probably not gonna pay true Montgomery Jase Barofin Blue refractor first bowman auto true blue here Quinn McDaniel Giants 121 of 150 Fractors of O'Halloran and Cade Morris Interfractors of Woodward and a Mahoney, okay, let's see a big-time case of choice here Brady told the 50 Brady told 50. Let's go. Come on. It's pretty cool. It's pretty cool. Pretty much That's probably the the shortest and sweetest way to get to the point lane is say it just like that Nick's the next thing that makes sense. Hey, the magic used to be that team signed business act beyond over a bunch of money and draft Mario his own yeah, and Where are they now? Yeah, only took us like eight years to get to where we are Got lucky to win the lottery Alfred Payton, okay Payton wasn't a terrible one. He was a late Late lottery right was he number eight pick nine pick that one wasn't as bad as some at least He was a serviceable NBA player for quite a few years Actually, wasn't there somebody like numerous players better behind them that turned out better There's also a lot of bad players ahead of them. This is you're always gonna find that but now pain was okay I wasn't like a total swim. That was not a hit, but definitely not a Gigantin I wasn't like a Hezonia type pick. Yeah, James Barofa and first woman auto for the Blue Jays Who was the who was the player the magic drafted ahead of Peyton? Obama's the tough one. That was the fifth pick first auto Tommy Hawk for the Guardians I was the pick behind Luca too, wasn't it? Yeah, I'm a hot guardians first woman auto. Yeah, orange. No class of 2023 calling how caught up for the Mets Colin Howe commets auto Yeah, don't look at pissing graphics last 20 years One of the things that stunk is I know the magic didn't make the pick because it was a traded pick But the Demona subbonus and they traded subbonus and all the depot The thunder for a surgery pocket that one that one stings, dude That one stings worse. I would say that's probably like one of the worst Drafting a player like late lottery and not hitting is like, okay But when you like right away your future, that's that's when it gets tough green lava first auto max Anderson tigers Number 72 of 99. That's rough Okay, see we got Aaron Gordon the senior guy Peyton. So that's like that's a that's a good one. Yeah He was a good player We traded him got some good picks and all ended out well with the Aaron Gordon saga We got the right picks in return. It was fine. I'm able to build around him, which is an ideal But yeah, I think you're no wait, you're trying to be right 2013 right 2014 Dario Sarich he's actually a decent pro though, but I think he was immediately. I don't think he was ever a magic I think he was immediately trade to Philly Yes, I think it was a trade to Philly first auto Colin how a lot of howks today. Oh, that's again Gold shimmer first auto Hunter Holland for Cincinnati Number 12 of 50 nice Holland old shema. All right, let's get some bigger names here. Good. How I was gonna say that was like This is bonus where he was never a magic Technically he was traded by the magic and trade it but they didn't make it so can't even take credit that they drafted them and traded It's honestly better if they didn't drive He wasn't drafted by the med. That made me feel better hearing that It was sorry for Peyton. Yeah, gold shimmer tie P here. We go 50 of 50 book and auto Hey Big hard Mariners. That's going to Jeffrey H. Hey, we got one bag for you, sir. Congrats. Thank you for joining Clean signal the p2 some of his autos are kind of in that is great. That's a great hit All right next up. We have a refractor first woman auto Max Anderson Tigers 302 of 499 a lot of book and stay right It's very it's very interesting. It is in choice first auto is gonna be AJ Ewing for the New York Mets 58 of 150 Sarge has been at least the role player. I'm like most of teams he's been on. Let's see. What else the magic do?  Not a total flop out. It's a bust of a pick I'd say but He's still in the league Just thinks it thinks because that draft was actually decent Yeah, that wasn't even behind him to first woman auto is going to be Seth Keener for the White Sox Jet Howard I'd truly to say he was a second. He was a second round or two. So I don't know or no He was a late lottery truly to say for jet Seth Keener first auto Bryson was the only person I'd the only magic fan that I know that like to pick But if he can develop he he's a shooter. Yeah, I think he just needs to probably get better At other parts of his game to be on the court A choice first auto Paul ski Nine of 150 You go skis the 150 for the Pirates That's on that He's dust there. We'll get that back for your pirates and a base first auto is letting him around us for the Jays Great choice case. We got going here. Let's finish strong still two boxes here Still six autos. Come on Brady show you or I go through this box We got to get NT filled up. I think the next one's super close Still Miami Justin Marlin's left an NT next the fish Case of NT 59 bucks Hold a Hanley Ramirez bat barrel last night. That's pretty cool. That's awesome, dude Do the hand ram Red Sox outfield legend It's all I know That's all I know a nice a base auto here for the Orioles gonna be Enrique Bradfield jr. Good hit Baltimore I mean, we're still in Anthony Black's first half of his first season He's been good at spots. He's good at certain things. I think we're okay right now at the Anthony Black pick And a not strong draft after the first few picks. Yeah, we just got unlucky with a lot Well, I mean we were picked where we were slotted to in the lottery. So it's whatever but He's getting minutes in it for for that. It's pretty decent He'll develop he'll develop I say we just trade faults and try to develop him trade faults and Wendell together and get Get something to get anything to get anyone that can shoot the ball a choice first auto is gonna be Grayson hit You know 40 of 150 for his own up. It's you can't jump ship on Anthony Blackburn. There's also what 19 still There you go the way first woman auto Tommy Hawk Guardians numbered 142 of 150 I think you yeah, it's just so early for him. I mean it feels like Confidence which grows over time.  I'm not worried about anything. I'm worried about the jet Howard pick I'm not worried about it to be black refractor a first woman auto cold care for the Rockies Numbered 108 of 499 good hit Colorado.  Honestly It Consistency is his biggest thing, but that's because of the injuries in the past couple seasons Got a choice here Rangers are not Rangers. Sorry twins Luke Kishaw 80 of 151st auto Twins Kishaw is a solid one and last hit of the break is a base auto Adrienne Santana the race first round early first tough centering on that one for you Tampa Let's go ahead and do a recap guys a couple of monsters in that break The Matt I don't think the mad the magic can buy but they can't be like a super aggressive buyers and like overpay for something If they because you could you could you could fall into that let's trade for oji on obi-shrap Dude imagine that I would be so defeated. I would be so sad.  I'm sorry You'll probably never be good again. I'm sorry This is it. That's all like your ceiling is the second round of the playoffs. That's your ceiling. All right numbered cards of both Langford Nichols into the autos now of Santana Bradfield Maraudis Keener hawk Rofan Ahuna Cephas Hauke Hauke on the insert refractor of Colt Carrick Max Anderson choice Grayson hit Luke Kishaw AJ Ewing Blue wave Tommy hawk true blue Quinn McDaniel Green Laba Max Anderson gold shimmer hunter Holland Yeah, if they can move Carter and Fultz for kind of anything Then I think that's that's that's that's good. That's good. We had a choice schemes to 150 Pittsburgh big card there and a gold shimmer type heat Sweet Pete. That's the bookend Pete to 50 to 50. I'll do it. Thanks again everybody moving on now to some NT


You are about to hear a romantic drama, Untamed, adapted from a story in Street and Smith's Love Story magazine and featuring the love story girl in the role of Diane Morley, a wealthy sportsman who is famous for his string of polo ponies and the polo teams that he's developed. Recently, Zachary Morley has organized at the Lanesa Club a girl's polo team with which his daughter Diane has been playing a brilliant if erratic game. Our first scene opens at the polo field. The girl's team is at practice. Suddenly, Diane breaks away from the others and rides imperiously up to Toby Trent, the coach. Yesterday, you let me ride sugar for a while? Well, that horse... You said she was too nervous to be handled by a girl. Yep, that's right.  That will do, Diane. I'll... You'll keep still until I finish. You're letting another girl ride sugar and I consider it an insult.  After all, that horse is mine and I don't intend to lend it to any spoiled, untamed, headstrong... If you mean me, I... I do mean you. You're hot-headed and vile temper.  Sick of trying to cope with a little sap. Oh, you... You could be a brilliant player if you got over some of your conceit and realized that it takes more than one to play polo.  Are you finished? No, I'm not. From now on, the team will dispense with your services until you think of yourself as one of the members instead of Diane Morley. You know what this means. It means you don't play in the midwit game tomorrow unless you apologize to Rochelle and me both. Public... To Rochelle and to you. To Rochelle and to me. Why, you're nothing but a groom around the club doing odd jobs so you can play polo on my father's team. Remember, the La Maiser Club is my father's. His money keeps it going. You're coaching this girl's team just to keep on the right side of him. If it weren't for him, you wouldn't be allowed inside the clubhouse. You'd be down in the stable with the rest of the groom's way you belong. And I forgot to add that you are an insufferable snob. Why, you... Now, are you going to apologize or are you going to clear out of here? I apologize to no one, least of all those who are good. Very well then. Start riding and ride faster. I'll take you off that nag and turn you over my knee. I'm going and when I come back, there'll be a gentleman in your place. Toby Drenth. Why? Can't play in the men's team and he can't coach our team. I won't have it. Well, what's the matter, honey? I thought you were all steamed up about Toby. Oh, he's not a gentleman and he's got to go. Yeah, that's a big ought to die. Toby's a grand player. The men like him. And he comes of good people. Oh, what of it? He's penniless. Living in a shack up in the hills. Hang on to a string of pony so he can have an excuse to play polo. Coaching the girls' polo team to curry favor with the club. Oh, he's impossible. You've been set on the girls' polo team that would make a showing. We hired coaches... Who are fools? All of them. Anyhow, they quit. I guess you made it too hot for them. Now, Toby has a real team. Can't you let well enough alone? No, he insulted me. He's got to go. I hate him. Well, I guess that's that. Only you will have to furnish me a reason. Reason? Well, I've got to have something. I can present to the men at the club. Something other than a whim of my daughter. Well, I'll find something that will knock him off his pedestal with a bang. You got any ideas? Yes. Father, I'm dining with Toby Trent at his shack tonight. Well, of all the... Oh, he doesn't know it yet. It's a surprise to him. I'm going up there and later I'll phone you. I'll be excited, hysterical, and then you'll come running. And then? Then you'll find I've been fighting for my honor all over the place. You'll save me, and you'll have a very good reason to rise up in your fatherly wrath and smack Toby Trent down. My dear, I'm warning you. Young Trent's no weakling. You may come out second best. Oh, I can handle him. He'll end up on his knees. Don't say I didn't warn you. You interrupted your dinner, but I came to say I'm sorry. I told you the apology had to be made in public. And what about Rochelle? Does it mean so much to you, Toby, what I do about Rochelle? Yes, it means a great deal. I couldn't wait until tomorrow. I had to come tonight. Well, now that you've spoken your piece, you can go back. I'm dangerous when I eat. Oh, I'm not afraid. I go to the zoo just to see the animals eat. Besides, I'm starving. What are you cooking, ma'am? Steak. Now, go on. Are you going? Well, it's dark. I'm not sure of the trail. Oh, very well. I'll go with you. Come on. Oh, Toby, I can't go and leave you like this. Angry at me. I'm going to stay. All right. You will stay. You ask for it. Toby, stop, oh. Until you kissed me, I never dreamed it could be like this. You said you were hungry. Toby, do you like living alone like this? Yes, I like living alone. Better than having someone here? A girl like me, Toby? Much better than having a girl like you with me. Suppose you'd rather have Rochelle. Who wouldn't? I'm going to look after the ponies. You wash the dishes. That's more in your line than playing siren. Oh, is that so?  Use your energy on those dishes. You'll find hot water in the kettle. Oh, yes. Take your dishes. Here's another one. Very pretty. Well, have you finished?  When anything goes wrong, you have to break something. That's the way you're made, I guess. It's all you can do. All I can do? Well, you wait and see. Now, that phone isn't working. You can't call your father. Well, he knows I'm here. If he doesn't hear from me, he'll come up. When he sees I'll listen, here's my story. You'll be running out of the country just ahead of me. You came up here to frame me. Yes, well, what are you going to do about it? Just this. We've been meeting since the day you were born. A good, healthy spanking. This is probably the first spanking you've had in your life, and it's just about time. That's Toby. I don't like that nothing to nothing is going to end the second chucker. What do you think their chances are? Oh, pretty fair, Mr. Morley. I'm afraid the girls will have to do better than that, though, if they're going to hold that midweek bunch much longer. I wish Diane were playing. Have you seen her? No, not since last night. Seems to be a very subdued girl this morning.  I notice every time you ride up, you hesitate and lose momentum. You've lost a couple of goals that way. I'm sorry. Hello, Diane. Where have you been all day? Toby. Toby, I want to play. For the first time in my life, I'm really apologizing. To Rochelle and to you, Toby. OK. Go on in there and play. You too, Rochelle, and Diane, for the first time in your life. See if you can play with the team. I'll try, Toby. There's no doubt about it. She's a changed girl. And far be it for me to say, it's not an improvement. Now, the game's pretty near over. The score is tied. We'd have had three more goals if Rochelle hadn't lost those three shots. Oh, why did Diane leave it for her every time? Why didn't she shoot it in herself? She can do it. Yet every time she rides the midway player off and leaves the shot for Rochelle, and she misses every one of them. Well, you told Diane to play as a member of the team and to quit the solo work. Looks to me as if she is. Look, Toby, look where the ball is. Right in front of the midway goal. There goes Diane after her. Or if she only takes it. There's Rochelle right after her. She's going to let Rochelle take it. Not if I can stop her. Take it, Diane! Take it, yourself! She could only hear me. I don't know if she heard you, but she took it. We won the match. Look, that midway player ran in for her. She's down. Knocked out of me when that horse sat on me. Darling, can you ever forgive me? Forgive you for what? Oh, for treating you so cruelly. For fighting against the love that's in my heart. Oh, listen, Toby, I'm the one who needs forgiveness. I was mean and selfish. I'll never be that way again, Toby. I'll be sweet and gentle. And you'll marry me? Any time you say it. Toby, if I'm ever nasty again, just give me another spanking, will you? Maybe you don't think I will. You have been listening to a romantic drama featuring the love story girl and presented with the permission of Street and Smith, publishers of Love Story magazine.