WEBVTT 00:00.000 --> 00:02.000 You 00:30.000 --> 00:32.000 You 01:00.000 --> 01:02.000 You 01:30.000 --> 01:32.000 You 02:00.000 --> 02:02.000 I 02:30.000 --> 02:35.360 Don't want to lie, you know, I don't think I'm a liar. I try not to be a liar. I don't want to be a liar 02:35.360 --> 02:38.720 I think it's like really important not to be a liar 02:38.720 --> 03:06.920 Do we have a new person in the chat for the first time that actually knows why they're here? Well, welcome to the show. Well, great to see you 03:06.920 --> 03:11.420 Tall trees catch a lot of wind get ready for some wind 03:12.420 --> 03:19.500 It's about all I can say thanks. Thanks for showing up though, man. I'm really happy you're here 1313 Pam trying to hit it 03:20.140 --> 03:22.140 Trying to hit it 03:36.920 --> 03:50.680 That's a good question. I did not turn on YouTube. I'm sorry 03:50.680 --> 03:53.400 I didn't that I won't be able to do it now. I would have to do too much 03:53.400 --> 03:58.320 I'm just gonna leave it off a YouTube is not streaming right now. Sorry about that Schumer, but thanks for checking 04:06.920 --> 04:08.920 I 04:22.680 --> 04:30.840 Am very excited to be here today. I've got some actual work to do and this work allows me to also share it with you 04:31.620 --> 04:39.840 And so I've got a little work to do on a consulting basis where one of the things that I need to do is take a look at a video 04:41.080 --> 04:47.400 That is stored on the FDA website and so rather than just watch this video on my own 04:48.000 --> 04:53.100 Without any fun help or commentary in the background. I thought I would share it with you 04:54.000 --> 04:57.460 And yeah, let's let's see if this works 04:57.460 --> 05:02.620 If you've been here for a while, then you know where you are if not 05:03.460 --> 05:09.220 Welcome to the welcome to the show. We have at least one person here who may be a recovering skilled TV watch 05:09.220 --> 05:12.500 You're finding us for the first time where we stay focused on the biology 05:12.500 --> 05:15.780 We don't take debate on TV and we love our neighbors. Welcome 05:19.140 --> 05:22.220 This is how it works people just keep sharing my work 05:22.220 --> 05:26.820 So if you're here for the first time, please understand that if you enjoy it the best way that you think 05:27.460 --> 05:33.140 You can help is not necessarily to send coin but to actually share it with people that you know haven't seen it 05:33.700 --> 05:39.620 Because there's a lot of people out there that have not seen it and need to be exposed to this biology 05:39.620 --> 05:42.420 But if you've been here a while and you think you can support please 05:42.420 --> 05:48.660 I'm not I'm not telling you not to because there's a family of five that is trying very hard to support me 05:49.380 --> 05:51.380 I mean, I'm part of that family of five 05:52.100 --> 05:55.260 And so all of this is really a family effort 05:55.260 --> 06:02.180 And it's not without the support of my family that would happen. And so you can support us at Giga on biological calm 06:02.420 --> 06:06.820 You can also find all different ways to share us there and ways to connect with me, etc 06:06.820 --> 06:12.460 I do play this list every morning and every afternoon although it's not complete right now 06:13.300 --> 06:17.340 Some people don't want their name on it, but it is not as large as it needs to be 06:17.740 --> 06:19.740 and so all 06:20.940 --> 06:22.940 subscribers are welcome 06:22.940 --> 06:30.380 That is about 120 people right now, so it's not a very big group of people that's that's coming together 06:30.380 --> 06:32.860 And so each one of these people is a little tiny bit 06:34.620 --> 06:38.140 Part of making this happen. I can't take credit for doing this on my own 06:44.140 --> 06:49.980 The independent bright web is something that we're trying to start here a movement of citizen journalists 06:49.980 --> 06:54.900 citizen archivists citizen historians 06:55.380 --> 07:01.820 That are trying to take back the narrative take back our republic before they teach this mythology 07:02.340 --> 07:07.100 Mythology to our children, and we can no longer get them back. That's really where we are 07:07.540 --> 07:12.620 This illusion is sustained through our active participation and if we can't convince 07:13.300 --> 07:17.060 college age kids and young adults young parents to 07:17.700 --> 07:21.180 Extract themselves from participating in this illusion 07:21.860 --> 07:28.620 We may we may lose what what we now call freedom and sovereignty forever for generations to come 07:29.780 --> 07:32.340 And so the way we do that is united non-compliance 07:33.260 --> 07:35.260 We don't participate 07:35.940 --> 07:41.300 We may really need to do something as drastic as not send our kids to university for a few years 07:42.500 --> 07:44.500 That wouldn't be an impossible movement 07:45.100 --> 07:51.540 especially with people like myself and others who can provide the learning online and 07:51.820 --> 07:53.820 provide the network of 07:54.740 --> 07:57.740 activity and and and learning online the 07:58.020 --> 08:04.420 Substitute for for that university system, which is right now just one giant grift where they pay 08:05.940 --> 08:07.940 Where they pay 08:08.940 --> 08:15.060 Deans and and and associate deans and and and assistant deans and 08:15.540 --> 08:21.060 And football coaches and football staff more than they pay their faculty and their working postdocs 08:22.020 --> 08:24.260 And it's a real it's real terrible 08:24.260 --> 08:30.020 So I do think giggle and biological is one of the safest ways to get biology in your head. Hello Jeff if you're out there 08:30.020 --> 08:32.020 Hello, good to see you 08:32.500 --> 08:37.860 This is giggle and biological high-resistance low-noise information brief brought to you by a biologist 08:37.940 --> 08:42.820 That biologist's name is Jonathan Cooey. That's me. I'm coming to you live from Pittsburgh, Pennsylvania 08:43.300 --> 08:45.300 the back of my garage 08:45.300 --> 08:46.500 and 08:46.500 --> 08:48.500 Thank you very much for coming 08:48.940 --> 08:55.620 Today we are still trying to penetrate this conscious and intelligent manipulation of our organized habits and opinions 08:57.620 --> 09:00.340 The way that this has been accomplished is 09:01.620 --> 09:03.620 over decades and 09:03.620 --> 09:05.620 if you want to get a glimpse 09:06.100 --> 09:07.220 into 09:07.220 --> 09:08.420 how 09:08.420 --> 09:09.940 ready 09:09.940 --> 09:14.660 How the dominoes were all lined up from the beginning of the pandemic 09:14.660 --> 09:20.740 I think it's really instructive to go back to the beginning and look at what people were saying how scared they were not scared 09:21.140 --> 09:27.940 What concerns they really had what priorities they had what part of the train they wanted to grab onto and pretend they were stopping 09:27.940 --> 09:31.540 What part of the train did they want to push on to say that they were helping 09:32.020 --> 09:36.660 These people were orchestrating a theater and I think if you see 09:37.460 --> 09:39.540 And if we take a look at some of these 09:40.020 --> 09:44.660 Mashingations early in the pandemic we're going to see something that we never thought we would see 09:45.060 --> 09:48.180 And so i'm excited to bring you this possible 09:49.140 --> 09:50.420 insight 09:50.420 --> 09:55.460 And so i'm just going to start with it right away because it is a little bit of a long video and I do want to complete the work 09:56.100 --> 09:58.100 and so 09:58.100 --> 10:00.100 I am going to watch the whole video 10:00.260 --> 10:06.020 So and i'm not going to watch it at too much speed mostly because I don't think I can adjust that 10:06.900 --> 10:08.900 because the player 10:08.900 --> 10:11.060 That the hold on let me go down here 10:12.820 --> 10:14.820 The player that the 10:18.100 --> 10:20.260 Sorry that the 10:20.260 --> 10:22.980 I don't think I can adjust it so you're just going to have to deal with it 10:23.860 --> 10:28.580 And it's a weird recording. I couldn't download it. It's like broken up into two screens for a while 10:29.220 --> 10:31.220 We're just going to have to cope 10:31.220 --> 10:33.620 What this is and I think we'll get an exact 10:34.260 --> 10:38.900 Read on what it is if I click play that i'm just going to try to preface it first a little bit 10:39.620 --> 10:46.740 Um, if you wouldn't mind go check on on stream dot giga ohm dot bio and just see if everything is going okay 10:47.460 --> 10:51.700 Um, and if you notice, um, if you leave a comment in 10:53.220 --> 10:55.700 Oops not that one if you leave a comment on 10:56.100 --> 10:58.100 Um 10:58.100 --> 11:00.740 On the stream dot giga ohm dot bio 11:01.860 --> 11:06.660 Chat then I can put it up here on the screen and we can we can answer questions that are in that chat 11:06.740 --> 11:11.220 I'm trying to encourage people to use that because I want to see how much traffic it can handle 11:11.220 --> 11:14.580 I wanted to see if for example, I was kicked off of twitch 11:15.220 --> 11:19.300 And I primarily streamed on peer tube how many people can it handle that kind of thing 11:19.780 --> 11:23.060 So I understand it's a little annoying to go over there or to click on that 11:23.060 --> 11:27.300 But um, anybody that does have the bandwidth and wouldn't mind doing it. I would really appreciate it 11:27.380 --> 11:29.380 So I'll go back over here to this thing 11:30.500 --> 11:35.780 So I want to watch this video again. It's from the fda. I think it's from around february 2020 and what it is 11:36.180 --> 11:38.180 Is it's a room full of people? 11:38.500 --> 11:40.500 Who are going to get euas 11:41.300 --> 11:42.500 Maybe even 11:42.500 --> 11:47.620 Like robert melon and steve kirsch are sitting in the audience waiting to figure out how they can get an eua for from 11:47.620 --> 11:51.620 Monoten from ota dean or selek oxib or whatever other things they were interested in 11:52.100 --> 11:54.100 I find it very interesting that I think 11:55.380 --> 12:02.980 I think steve kirsch was pushing something else other than ivermectin on brett wine steins podcast 12:03.780 --> 12:06.180 and I think it was also a 12:07.060 --> 12:11.540 substance that was identified by the domain server, although i'm going to have to go and check all these things 12:12.500 --> 12:15.700 Mark has done a couple really great shows mark husatonic live 12:16.420 --> 12:17.700 Mark hulak 12:17.700 --> 12:19.380 If you're not familiar 12:19.380 --> 12:26.660 Is a good friend of mine and somebody who through the course of the pandemic has become a very good friend of mine is also an independent 12:27.140 --> 12:33.700 Archivist one of the best out there and he's been doing a lot of reporting lately brief reports on how 12:34.260 --> 12:35.940 ditra and 12:35.940 --> 12:44.340 and the domain and the domain program and all these things were really integral in in coordinating our perception of 12:44.980 --> 12:46.980 the response and also 12:47.700 --> 12:50.180 sort of seating a number of 12:51.300 --> 12:58.420 What we can now see as narratives which which forward the idea of a novel virus which needs novel solutions 12:58.500 --> 13:05.540 And the domain was this AI program that supposedly ditra ran with the help of robert melones team 13:06.260 --> 13:13.060 Where they scanned all of the known pharmaceutical products on the fda register to see if they would interact with the three lc 13:13.700 --> 13:19.140 three cl protease that robert melones team had made a virtual computer 13:20.660 --> 13:23.060 3d crystallography model of it and then 13:23.540 --> 13:28.980 I don't know he said at some point dontami's podcast that they also use laser scanning confocal microscopy 13:29.060 --> 13:31.860 But I don't know how that interfaces with a 3d 13:32.500 --> 13:36.180 virtual model of a crystal of a of an enzyme but anyway 13:36.580 --> 13:42.900 He purports in three weeks or so to have helped ditra in this program domain or using this program 13:43.940 --> 13:45.460 to have 13:45.460 --> 13:51.380 Scanned all of these things and and predicted which ones would work and it's supposedly it spit out remdesivir 13:51.780 --> 13:53.940 hypermectin cellococcib and 13:54.260 --> 13:56.660 Fomotidine and then they all went to work testing them 13:57.460 --> 14:00.740 And uh, so that's what we're supposed to believe but at the same time 14:01.220 --> 14:06.500 Of course, you know that the fda was interested in giving out euas for testing 14:07.140 --> 14:12.980 And that was one of the biggest, you know kind of the the number of euas that were giving out for testing might have been 14:13.220 --> 14:16.020 More than 250 by the time we got to 14:16.500 --> 14:21.620 2021 so that means roughly 200 give or take different 14:22.820 --> 14:29.220 Methodologies different sets of proprietary variables that were involved in declaring covid or not covid 14:29.620 --> 14:32.980 We're circulating and being spent money on in america 14:33.380 --> 14:39.540 Nevermind the rest of the world and so it's a pretty extraordinary place to go right in front of I think this is in february 14:39.620 --> 14:46.020 Right when they're starting to encourage everybody who has the entrepreneurial skills or resources to go into this and help 14:46.340 --> 14:49.300 The response of the nation so i'm really curious as to how 14:49.940 --> 14:52.980 Morbid this must be because it must have been a very scary time 14:53.300 --> 14:56.660 When they thought they had to have an emergency meeting about emergency use 14:56.820 --> 15:01.380 Authorizing all kinds of things that they otherwise wouldn't have needed if it wasn't such a crisis 15:03.220 --> 15:08.740 I don't think we're going to switch to classic view because the last time I tried that I think it was screwed up and that's why I stopped watching it 15:10.340 --> 15:13.620 There we go. Everybody can take their seats. We'll get started 15:29.220 --> 15:31.700 Like I said, I'm not going to really try to speed it up or anything 15:31.700 --> 15:32.660 You're just gonna have to follow 15:33.220 --> 15:41.300 According to fda's website hhs has declared six emergencies that have authorized fda to issue emergency use authorizations 15:41.860 --> 15:45.620 For unapproved and vitro diagnostic tests to diagnose. Wow. Did you know that? 15:46.180 --> 15:50.180 And those were for america coronavirus and avian influenza in 2013 15:50.740 --> 15:52.740 Abola in 2014 15:53.140 --> 15:57.460 Evie d68 in 2015 and zika in 2016 15:57.780 --> 15:58.340 Wow 15:58.340 --> 16:00.580 Last week the secretary declared an emergency 16:00.580 --> 16:04.660 Wait, wait, wait, wait, wait, wait, wait, wait. I gotta hear that. That's crazy 16:05.060 --> 16:07.060 avian influenza 16:08.580 --> 16:15.380 This website hhs has declared six emergencies that have authorized fda to issue emergency use authorizations 16:16.020 --> 16:19.540 For unapproved and vitro diagnostic tests to diagnose the disease 16:20.340 --> 16:24.340 And those were for america coronavirus and avian influenza in 2013 16:24.980 --> 16:26.980 Abola in 2014 16:27.380 --> 16:31.620 Evie d68 in 2015 and zika in 2016 16:32.260 --> 16:37.380 And last week the secretary declared an emergency for the novel coronavirus some called the wuhan virus 16:38.180 --> 16:43.860 Well, some of the tests authorized under the eua provisions have been cleared or approved by the fda 16:44.500 --> 16:47.540 Many were never submitted to the agency for approval 16:48.500 --> 16:50.820 Good morning. Okay. So 16:50.820 --> 16:55.620 Just just so you're aware already what we just wrote down six emergencies in 16:56.340 --> 16:59.140 2013 it was avian flu 17:00.580 --> 17:02.180 And it was 17:02.180 --> 17:08.500 mares in 2014 it was ebola in 2015 she said evd 68 17:10.420 --> 17:12.820 And in 2016 it was zika so 17:13.860 --> 17:20.260 Six emergencies who were declared where emergency use authorizations were given to things 17:21.700 --> 17:28.500 Do you see what this means already is something that's never been on my radar before that this whole this whole 17:31.380 --> 17:33.940 This whole circus has been fired up before 17:35.700 --> 17:37.460 This whole 17:37.460 --> 17:44.980 Drill has been done before complete with contracts and proposals and money exchanged and paid out 17:46.500 --> 17:48.260 Do you see 17:48.260 --> 17:55.940 Patents made products tested trials run six times since 2013 17:58.900 --> 18:03.140 Why wasn't there why didn't she list sars in 2002 18:05.060 --> 18:11.060 You know what I think that reveals I think that reveals that there was some kind of legislation between the original sars 18:11.620 --> 18:16.260 And whatever happened in 2013 where they did it twice avian flu and mares 18:18.420 --> 18:24.340 That's a pretty extraordinary first 25 seconds of a video. That's pretty badass is what that is 18:25.300 --> 18:26.580 um 18:26.580 --> 18:35.620 Okay, now i'm going to let it go again. Well, and welcome to the mvic fda workshop advancing euahibd products toward full marketing 18:36.100 --> 18:38.100 status 18:38.100 --> 18:44.420 Um, i'm tennel miller chair of the medical device innovation consortium. Okay. So look at that title already 18:44.420 --> 18:47.140 it's advancing euahibd 18:48.660 --> 18:55.300 I guess that's in vitro. I we'll we'll see what ibd is. I'm sure she's going to say it toward full marketing status 18:55.300 --> 18:58.340 So we're talking about getting an euah product 18:59.220 --> 19:01.220 full approval 19:01.700 --> 19:03.700 February 3rd 19:04.260 --> 19:06.260 2020 19:06.820 --> 19:14.500 We're still a whole month away from 15 days to slow the spread and they are already talking about euas 19:14.980 --> 19:16.020 being 19:16.020 --> 19:20.100 a pathway to full marketing status ladies and gentlemen 19:22.500 --> 19:24.820 If you rehearsed it six times in a row 19:25.940 --> 19:27.940 2013 19:28.100 --> 19:30.100 2013 2014 19:30.100 --> 19:35.060 2015 and 2016 it's not really surprising that they fired it up like this now is it 19:36.900 --> 19:40.340 They just did event 201 four months ago 19:45.060 --> 19:49.700 I hope you're starting to see why this is a much more valuable video than I ever thought it would be already 19:50.100 --> 19:53.860 clinical diagnostic steering committee and i'll be your 19:54.500 --> 19:57.060 master of ceremonies for today's workshop 19:57.700 --> 20:04.500 Although the timing is nearly perfect. We plan this workshop long before the wuhan coronavirus made headlines 20:05.060 --> 20:10.020 And today is not specifically about the coronavirus and I wanted to be clear on that 20:10.500 --> 20:14.260 Nonetheless to does today's discussions could color the path forward 20:14.900 --> 20:20.900 This workshop explores the challenges in moving euah products to full marketing status through denogo 20:21.460 --> 20:23.460 fighting k or pma 20:24.100 --> 20:30.020 Or over the course of the day. We'll discuss the issues and consider potential solutions that could apply broadly 20:30.580 --> 20:33.220 Many of which are likely much larger than fda 20:33.780 --> 20:38.580 And require stakeholders of all different viewpoints and backgrounds to come together to collaborate 20:39.060 --> 20:41.780 on finding reasonable solutions 20:43.940 --> 20:49.860 Also, we don't have the experts around to engage in lengthy conversations about certain topics such as patent law 20:49.940 --> 20:52.180 So we won't we're talking about those 20:52.180 --> 20:54.660 Today we'll look forward to learning about lessons learned 20:55.220 --> 21:03.060 And charting the next steps to the use of real world data and real world evidence to help support the advancement of euah ivd products 21:03.540 --> 21:05.540 to full marketing status 21:06.100 --> 21:11.300 But before we get started this workshop is the result of many many people working behind the scenes 21:11.300 --> 21:13.380 And I'd like to thank our fda colleagues 21:13.940 --> 21:18.020 doctors jennifer ross and kim sapsford and mike waters for their assistance 21:18.420 --> 21:23.540 As well as the many other volunteers from various government agencies and the ivd industry 21:24.020 --> 21:32.020 That work to make today's workshop possible to our speakers and panelists in advance who came from literally around the globe 21:32.820 --> 21:37.460 Thank you for generously sharing your time your expertise your slides your information 21:38.340 --> 21:41.780 Now i'd like to introduce our first speaker pamela goldberg 21:42.340 --> 21:47.540 Pamela is just so you know that that overload is in me. It's overloading no matter how loud i put it background 21:47.940 --> 21:51.620 On md. I see the medical device innovation consortium pamela 21:52.980 --> 21:58.580 I agree the vocabulary is incredible. I mean this is shocking to me quite frankly 22:02.660 --> 22:07.620 Thank you dinnell and welcome everyone look at the smile on her. We're really we've been 22:08.260 --> 22:11.300 planning this for a few months and 22:12.740 --> 22:14.740 What couldn't be more timely? 22:14.740 --> 22:19.460 Those of you who don't know md. I see the medical device innovation consortium 22:19.940 --> 22:24.980 We're a public-private partnership that got created a number of years ago 22:26.580 --> 22:31.540 When there were frustrations about the regulatory science process 22:32.180 --> 22:37.300 and um, but we bring together industry and 22:38.260 --> 22:39.780 government 22:39.780 --> 22:41.780 patient advocacy groups 22:42.580 --> 22:44.580 nonprofits and 22:45.700 --> 22:50.100 And academic they have been planning this for months 22:50.820 --> 22:55.060 It's february third. I wonder how long months is 22:56.340 --> 22:58.820 Is that since november or october? 22:59.300 --> 23:02.820 event 201 happened in october 23:04.900 --> 23:08.820 The first uh brat we Weinstein podcast was around that time 23:10.420 --> 23:18.580 The eighth brat Weinstein podcast took place on december in december of 2019 where sam heris was allowed to say that when the next pandemic comes 23:18.580 --> 23:21.140 We won't be able to tolerate any anti-vax views 23:22.100 --> 23:24.100 And brat agreed 23:24.740 --> 23:32.580 Do they not do these people actually believe the lie that they're telling themselves that it just happens to be 23:33.060 --> 23:36.660 That we got told to plan a conference on euas 23:37.460 --> 23:40.420 And it just happens to be arriving at february third 23:40.740 --> 23:47.860 Who it won't be completely about the coronavirus, but it could be that this meeting just happens to determine all we do that 23:48.980 --> 23:52.660 Are you kidding me? Could they possibly be that naive? 23:53.620 --> 23:55.540 I'm afraid it's true 23:55.540 --> 24:00.980 I'm afraid there are a lot of people inside of our bureaucracy that are exactly that naive 24:02.740 --> 24:06.180 Exactly that naive because they have a salary 24:06.980 --> 24:10.900 That makes them comfortable with being exactly that naive 24:11.300 --> 24:17.060 They have a job security that makes them feel comfortable with being exactly that naive 24:18.020 --> 24:22.660 Make no mistake about it ladies and gentlemen. She's smiling because she loves her job 24:25.220 --> 24:30.260 She thinks honestly that she is part of an apparatus that saves lives and she's proud of it 24:30.260 --> 24:36.900 She gets a good salary for it. She's got a great house. She's got she gets prestige and she gets 24:38.100 --> 24:41.620 Reinforcement from her colleagues people look up to her 24:42.500 --> 24:51.140 It's not much different than how a biology professor like myself can be trapped inside of academia and not understand exactly how trapped they are 24:51.540 --> 24:55.860 Exactly how useless what they're doing is or potentially could be 24:59.300 --> 25:01.460 And that's how deep this goes 25:01.460 --> 25:07.860 We must wake people like this up to see that this is possible before they'll ever even believe it's true for them 25:08.180 --> 25:15.060 It is extraordinary to see this. I mean, I need to get through this video. I don't know how I'm going to get through it 25:15.060 --> 25:17.060 It's like an hour and 50 minutes 25:17.060 --> 25:18.500 medical centers all to 25:19.540 --> 25:28.100 Share the story about how do we get patients better products faster safe or cheaper and we do that through a number of pathways 25:28.820 --> 25:30.820 Both in the diagnostics world 25:31.540 --> 25:32.820 but 25:32.900 --> 25:39.540 Throughout the medical device industry and so we're really excited to put today's event together 25:40.260 --> 25:46.820 When we first started talking about this event with the diagnostic steering committee 25:47.460 --> 25:51.700 It was a great idea and who should we bring to the table and 25:52.740 --> 25:56.180 In part because this is such a timely topic today 25:57.460 --> 25:58.980 We have 25:58.980 --> 26:02.340 Over 150 people have signed up to be here in person 26:02.900 --> 26:06.340 More than 90 people are joining us online. So 26:07.700 --> 26:10.420 This is really important and we 26:11.140 --> 26:15.460 Want and need all of your input to make today successful 26:15.860 --> 26:18.500 So I don't want to take up too much of your time 26:18.980 --> 26:22.660 And I don't want to interrupt all the time, but I just want you to know what's on my mind 26:22.740 --> 26:25.780 One of the thing i'm thinking of right now is who's in that audience 26:26.660 --> 26:28.660 And why are they in that audience? 26:29.060 --> 26:31.060 I wasn't in that audience 26:31.300 --> 26:35.860 If somebody at the University of Pittsburgh that was in the department of neurobiology 26:36.420 --> 26:43.060 Was in their office at this time and I just casually walked by their office to ask them how their bike ride into work was 26:43.460 --> 26:46.740 And they were watching this. I would be like, why the hell are you watching this? 26:48.980 --> 26:51.620 And if somebody in the department of neurobiology 26:52.900 --> 26:59.220 Smart enough to know what's going on said, oh, i'm watching this because I think i'm thinking about starting my own pcr testing 26:59.860 --> 27:04.340 Facility in Pittsburgh how it had been like who the hell told you to do that? 27:08.500 --> 27:13.060 Because I was still just going to work, right? We didn't even have a lockdown yet 27:14.100 --> 27:21.700 So think about what it would take for you or your friend or a colleague of yours to have decided to attend this meeting 27:21.940 --> 27:25.220 Why am I giving you this example? 27:25.780 --> 27:31.460 I'm giving you this example because i'm being asked to watch this video as part of a consulting gig that I have 27:32.900 --> 27:36.020 And that consulting gig is looking into 27:36.980 --> 27:38.180 a 27:38.180 --> 27:41.060 testing company or two on the west coast 27:41.860 --> 27:47.060 And the crazy thing about this testing company is that they got a contract to test 27:47.860 --> 27:48.660 uh 27:48.660 --> 27:50.420 municipal employees 27:50.420 --> 27:52.420 Somewhere on the west coast 27:52.420 --> 27:56.980 And that contract was given to them of course very early because they had an EUA 27:57.700 --> 28:03.700 For a pcr test for covid that they could offer to this municipality 28:04.260 --> 28:10.500 The strangest shit though because the guy who started this company decided to buy four 28:11.300 --> 28:13.300 incredibly over 28:13.620 --> 28:19.380 Over budget pcr machines four of them in order to do this 28:20.020 --> 28:23.380 Machines that are capable of doing all kinds of other things 28:23.380 --> 28:28.420 They could have been machines that essentially served as a core facility for a university 28:28.900 --> 28:34.740 But this guy already in I guess march of some time already decided it was time to order 28:35.140 --> 28:41.300 Some pcr machines because it looks like that's going to be needed and I can get this contract and make a lot of money 28:41.940 --> 28:46.580 Because they want to test municipal workers that don't take the vaccine every week 28:48.020 --> 28:50.980 Well, how do you get told how do you get the clue to do that? 28:51.300 --> 28:57.780 If you were a faculty member at a university like I was just explaining and you thought you were going to go into pcr testing 28:58.020 --> 29:01.620 Had in february of 2020. I would have said who the hell called you 29:02.340 --> 29:05.060 Why did you have that idea? I thought you were into your work 29:06.020 --> 29:08.020 And 29:08.020 --> 29:13.380 The guy who started the company that we're looking into was a porn movie producer 29:16.500 --> 29:18.500 Now why in the hell would a porn 29:18.500 --> 29:20.500 Movie producer decide to buy 29:21.380 --> 29:28.180 $400,000 worth of pcr machines and apply for a contract with a new company that he's just starting 29:29.540 --> 29:31.540 And get awarded the contract 29:32.420 --> 29:34.420 It's very strange 29:36.020 --> 29:41.860 And the cool thing is is that in this video somewhere is the person who actually approved the EUA of that company 29:41.860 --> 29:44.420 And so I just want to see what the hell's going on 29:44.420 --> 29:51.940 But I'm already asking this question because the person that I'm looking into it for is a person who had absolutely no business 29:52.020 --> 29:58.420 Going in to the pcr testing business when they did and they had absolutely no business doing so 29:58.820 --> 30:04.820 With the serendipitous chance that they would get a huge contract with a large municipality 30:06.820 --> 30:12.180 Some very shady shit happened in 2020 ladies and gentlemen excuse my language 30:13.460 --> 30:15.300 And we have a lot of work to do 30:15.300 --> 30:20.820 I got a lot more of this video to watch so I got a I got to push play but I got to make sure you understand why we're watching this 30:22.340 --> 30:24.340 And why i'm preserving it 30:24.580 --> 30:29.460 Because we have some great speakers here today and some important issues to discuss 30:30.100 --> 30:36.500 But thank you all for being here dinnell. Thank you for chairing our steering committee and for emceeing today 30:37.140 --> 30:42.180 And uh, I'd like to uh recognize my colleagues from mdic 30:42.660 --> 30:44.820 Um who really put this together? 30:45.620 --> 30:47.620 carolyn hiller 30:47.620 --> 30:51.860 Can you wave your hand in the back of the room for those who don't know carolyn? 30:52.500 --> 30:54.500 She has uh 30:54.500 --> 30:58.900 Has been remarkable in pulling this together and john hunt from mdic john 31:00.900 --> 31:05.300 And uh, thank you all for being here and I look forward 31:05.700 --> 31:08.260 I mean, it's extraordinary. This is really like 31:09.300 --> 31:13.620 Love and and kumbaya and exciting. We're all going to make money 31:14.340 --> 31:20.340 This is like a some kind of pre apple meeting or something like that. Look at the smile on her face 31:20.740 --> 31:24.340 They're all excited. They're proud of the coffee and the donuts that they provided 31:24.580 --> 31:26.660 They're so happy with the chairs they chose 31:26.980 --> 31:34.500 I'm just so glad you guys were able to to get all the the emails out on time and everybody was able to get here and the web link is stable 31:34.500 --> 31:36.500 It's just great. Isn't it? 31:37.380 --> 31:39.940 Holy cow i'm never going to get done so productive day 31:43.620 --> 31:46.340 Oh, I probably do have it a little lower than the video. Sorry 31:47.140 --> 31:48.420 Thank you pamela 31:48.420 --> 31:54.420 Next we'll transition into our opening session that provides an introduction to emergency outbreak 31:55.300 --> 31:57.700 Situations and data collection our first 31:58.980 --> 32:00.980 Is dr. Luciano borio 32:01.380 --> 32:09.380 Dr. Borio is the vice president technical staff at ink utel an independent non-profit strategic investment firm that works to identify 32:09.380 --> 32:11.380 Acutel 32:13.060 --> 32:16.900 Solutions to support the missions of the united states intelligence community 32:17.540 --> 32:21.400 She specializes in biodefense emerging infectious diseases 32:21.860 --> 32:29.540 Medical product development and complex public health emergencies. Dr. Borio earned her MD from george Washington university 32:30.100 --> 32:32.100 I swear I did not know this was in here 32:32.500 --> 32:36.900 And critical care medicine at john's hopkins and the national institutes of health 32:37.540 --> 32:43.380 Prior to joining ink utel. Dr. Borio served in senior positions at the at d. I can't believe it a council 32:44.020 --> 32:49.700 Please welcome dr. Borio who will speak about national preparedness and response in the 21st century 32:50.020 --> 32:55.460 I cannot believe it. I cannot believe it. I did not know this was going to ink utel. Oh my goodness. You don't 32:57.860 --> 32:59.380 Thank you 32:59.380 --> 33:01.380 Oh my gosh 33:01.940 --> 33:03.380 Welcome 33:03.380 --> 33:05.380 Great to have you nice 33:05.860 --> 33:09.700 Is that lavender? Thank you for this kind introduction and good morning everyone 33:10.900 --> 33:15.220 I very much appreciate the invitation to be here with you this morning 33:16.340 --> 33:21.300 As some of you know, I spent almost 10 years working here at fda 33:22.020 --> 33:23.940 and the teams at the commissioner's office 33:24.660 --> 33:32.420 And in the office of in vitro diagnostic test she worked for 10 years for the fda before she went to ink utel 33:33.140 --> 33:38.260 I mean come on. I can't even make this up. You got to be kidding me. I'm never going to finish this video 33:38.260 --> 33:40.260 This is going to be a whole day's work 33:40.580 --> 33:44.900 That organized this event with mdac are very special to me 33:45.780 --> 33:48.180 I have fun memories of our collective work to 33:48.980 --> 33:53.220 Come back many outbreaks and I'm extremely proud of their accomplishments 33:54.260 --> 33:57.620 Which is why i'm deeply grateful for this opportunity to speak with you 33:58.180 --> 34:00.100 today 34:00.100 --> 34:06.900 As we gather here today, the world is experiencing a great threat from the novel coronavirus 34:08.180 --> 34:11.140 That emerged in china at the end of last year. She's reading 34:11.860 --> 34:15.540 Normally we have to remind people that we live in an era of epidemics 34:16.420 --> 34:20.100 We talk about how infectious diseases emerge and re-emerge continuously 34:20.740 --> 34:22.740 most often and predictably 34:23.060 --> 34:25.060 That some can travel the globe quickly 34:26.100 --> 34:28.260 while others devastate regionally 34:29.140 --> 34:35.060 But either way these epidemics can cause havoc to their communities lead to lots of life 34:35.700 --> 34:38.980 Make health care workers vulnerable disrupt economies 34:39.540 --> 34:43.220 And in some instances lead to lots of confidence in our political leaders 34:44.260 --> 34:50.740 We talk about how epidemics fray the she is telling us the story of giordano from another side 34:50.740 --> 34:53.220 She just said sometimes the pandemics even cause 34:53.620 --> 34:56.340 Epidemics even cause people to lose faith in their governments 34:56.740 --> 35:02.660 It is extraordinary. This is the model of the world that they want everyone to assume 35:02.740 --> 35:06.340 It's the model of the world. They always have to introduce to you in the beginning 35:06.740 --> 35:10.660 So that you assume it it's it's the presuppositions of this model 35:11.300 --> 35:16.580 That are going to enslave our children if we don't break it and you can hear her. It's incredible 35:17.060 --> 35:21.060 And this is february 3rd when they're still not very good at it. They still haven't picked 35:21.540 --> 35:22.740 the best 35:22.740 --> 35:24.180 Enchanters 35:24.180 --> 35:30.500 This is like audition days, you know, it's incredible in qtell, but I used to work for the fda 35:32.820 --> 35:34.820 Fabric up society 35:34.820 --> 35:41.540 And we remind folks that it is in our collective interest to contain these outbreaks as soon as possible 35:42.100 --> 35:44.100 no matter where they occur 35:44.580 --> 35:49.940 Today we live in the scenario that we have repeatedly worn one day would come 35:52.020 --> 35:54.020 Look at how she's doing it here today 35:54.980 --> 36:00.100 About 15,000 people mostly in china had been confirmed to be infected with this new virus 36:01.220 --> 36:04.580 And sadly this number represents the very tip of the iceberg 36:05.300 --> 36:09.780 As this virus continues to expand its footprint and spread around the world 36:12.180 --> 36:18.020 And although we have learned from the past and we have made significant progress in combat and epidemics 36:18.980 --> 36:26.020 The world is not prepared to respond to this latest threat. Wow a pandemic may be inevitable. Wow 36:27.860 --> 36:31.380 Given what appears to be a highly transmissible respiratory virus 36:32.180 --> 36:36.420 And much work remains ahead of us and we need to brace ourselves for 36:37.460 --> 36:41.380 Some difficult weeks and months to come. Wow, she knows a lot 36:42.180 --> 36:46.580 So as preceded my remarks this morning, I would like for you to keep in mind one theme 36:47.220 --> 36:51.940 Which is the power of the we of the collective work for one thing I know 36:52.660 --> 36:58.740 Unity's strength and when there's teamwork and collaboration unity is wonderful things can be achieved 36:59.700 --> 37:05.060 These are now my words. These are the words of the child poet Maddie stephanak who died at a young age in my rare disease 37:06.820 --> 37:09.380 And as my wonderful NIH mentor dr. Heron was or 37:10.020 --> 37:15.220 Was one of the leading positions to combat the 8th epidemic in the early 80s 37:15.620 --> 37:19.860 He likes to remind me to this day that yes, the path is difficult because 37:20.420 --> 37:26.420 All of the easy things that could have been done by single individuals or institutions have been done already 37:27.780 --> 37:31.140 So progress will require collective and hard work 37:33.300 --> 37:37.620 In 2003 when the SARS coronavirus took the role by surprise 37:38.180 --> 37:43.380 There were very few tools in place in the United States to rapidly combat emerging infectious diseases 37:44.260 --> 37:45.860 The animal rule 37:45.860 --> 37:54.340 Had been recently created in 2002 to help drug developers test countermeasures in diseases that could not be readily evaluated in people 37:55.300 --> 37:59.380 And later in 2004 FDA was given the authority to issue 38:00.180 --> 38:07.620 Emergency use authorizations or EUAs to authorize the use of unapproved countermeasures doing public health emergencies 38:08.100 --> 38:10.100 And a prospect of benefit 38:10.260 --> 38:15.620 Our way to risks and these were both very important useful and necessary authorities 38:16.740 --> 38:21.060 The EU way in particular has proven to be crucial time and time again 38:21.620 --> 38:27.540 It provided timely access to diagnostic tests during the 2009 H1 and 1 influenza pandemic 38:28.100 --> 38:35.220 The 2014 West African Ebola pandemic the 2016 zik epidemic in the Americas just to name a few 38:36.100 --> 38:39.060 Just to name a few of those of you the first robust reliance 38:39.860 --> 38:42.660 On EU way for diagnostic tests. That's impressive 38:42.660 --> 38:44.900 So we we were talking about this earlier, right? 38:44.900 --> 38:52.820 We were when when we said that the first EUAs were given in 2013 after a declared emergency for MERS 38:53.380 --> 38:57.380 And then also in 2013 for a declared emergency of avian flu 38:57.860 --> 39:02.740 There were EUAs issued she just revealed that EUAs were established in 2004 39:02.820 --> 39:05.060 So after the original SARS pandemic 39:06.660 --> 39:15.140 So you could even imagine a scenario where the original SARS pandemic was made precisely for the establishment of the need for an EUA 39:16.180 --> 39:19.780 And then six or five times six times 39:20.420 --> 39:24.340 One two three four five six avian flu mares Ebola 39:24.900 --> 39:28.020 Evd 68 which i'll look up after the stream and 39:28.660 --> 39:30.420 Zika were all 39:30.420 --> 39:33.860 Emergencies that were declared and EUAs were given out 39:34.260 --> 39:40.260 So we're learning history here that we still really haven't learned at least I haven't in the last four years 39:40.660 --> 39:43.140 So that really shows you how disingenuous the whole 39:43.620 --> 39:46.100 mystery solving exercise has been I mean I 39:47.860 --> 39:49.860 Why why hasn't any 39:49.860 --> 39:55.380 Lawyer ever told me that EUAs were started in 2004 and I still don't know what law that is 39:55.780 --> 40:01.780 And why didn't we talk about the EUAs that were given out in those years and that that precedent had already been established? 40:01.860 --> 40:08.420 It's weird how the nuts and bolts of the cage that we're in are never discussed 40:08.580 --> 40:14.100 We could just elect people that would get rid of the prep act we could just start 40:16.180 --> 40:22.580 Filing suits in 50 different states with single people who are vaccine injured and try to claim 40:23.060 --> 40:28.180 That it's a violation of our seventh amendment right to have to go through this CICP or the VICP 40:28.660 --> 40:30.660 And eventually one federal judge 40:31.460 --> 40:34.660 Sorry one state judge is all state judges have to say well 40:34.660 --> 40:38.500 I can't see your trial because the prep act says that you can't sue 40:38.900 --> 40:42.340 And then you can appeal to a circuit court in the circuit court 40:42.740 --> 40:46.660 You will appeal to as that's a violation of my seventh amendment and one 40:47.380 --> 40:51.700 Federal circuit court in America only one has to say holy shit 40:51.700 --> 40:55.540 You're right the prep act is a violation of your seventh amendment right and 40:56.340 --> 40:58.340 who 41:00.180 --> 41:02.180 Case law 41:02.580 --> 41:04.580 strikes the prep act 41:05.380 --> 41:11.780 And the who has no ability to declare an emergency anymore that the human health and human services 41:12.580 --> 41:14.580 division of the 41:14.580 --> 41:16.340 uh 41:16.340 --> 41:20.020 Of the executive branch can respond with there's no emergency to declare 41:20.820 --> 41:23.380 There will be no EUAs there will be no legal 41:24.100 --> 41:28.500 though will be no legal protection for countermeasure production 41:29.460 --> 41:31.460 Or producers rather 41:32.020 --> 41:34.020 It'll just be gone 41:34.660 --> 41:40.580 That's as simple as it is. It's just one case that goes to one state court and gets denied trial and gets 41:40.900 --> 41:47.300 appealed to a federal circuit and only one federal circuit judge has to say oh yeah, you're right seventh amendment violation doing 41:48.180 --> 41:50.180 And it'll be over 41:50.500 --> 41:54.900 But for some reason there isn't one organization in america that's taken that strategy 41:55.940 --> 42:00.340 Not one organization not one lawyer not one legal fund 42:00.820 --> 42:04.820 Not one nonprofit is taking that strategy, but that's the obvious strategy 42:05.620 --> 42:12.660 It and any lawyer that i've ever talked to about it has had a real hard time explaining to me why it isn't the right strategy 42:12.980 --> 42:20.820 The best response I heard from one time was I shit you not from erin siri who told me that it's not the right time 42:23.140 --> 42:26.340 And there are people who heard him say that because that was in a zoom meeting 42:27.780 --> 42:32.740 So i'm you can confirm it. It's not the right time. That was his that was his 42:33.060 --> 42:36.420 That was his argument his answer 42:38.420 --> 42:44.340 And so I have no answer for this other than to say that I think we are being led by our noses we are being 42:45.140 --> 42:52.980 Trapped inside of a limited spectrum of debate that has no bounds in that sense that all parts of our reality are effectively controlled 42:53.540 --> 42:58.580 Anywhere where there is a possibility of us escaping or a possibility where we could pass on 42:59.220 --> 43:03.300 This freedom to our children and understanding of what really how it's defined 43:04.260 --> 43:06.260 They have attempted to confuse us 43:08.100 --> 43:14.420 And one of the things that you can see here is that this idea of an emergency and the idea of responding to it 43:14.740 --> 43:19.380 Is already built into the the bureaucracy and in fact it almost 43:19.780 --> 43:24.980 The bureaucracy feels better when they're called into action than they do when they're just waiting for it to happen 43:24.980 --> 43:26.980 And that's why you see the smiles on their face 43:27.940 --> 43:31.460 It's it's almost like a fire department that's been doing drills all the time 43:31.460 --> 43:34.500 And now they finally get it to get into their trucks and turn on the sirens 43:34.580 --> 43:37.060 You've got dang right they're going to drive through main street 43:38.260 --> 43:40.500 You're gosh dang right they're going to use the hoses 43:43.540 --> 43:48.820 And in cutel, I mean, I can't even I can't even believe it's in cutel. I don't even know why I stopped talking 43:48.820 --> 43:50.820 I'm just going to keep watching. Sorry guys 43:51.780 --> 43:55.540 In the 2009 flu pandemic was a paradigm shift 43:56.100 --> 44:00.980 And I'm pleased to see that Sally Hui that is here with us today because she really led this effort back in the 44:01.620 --> 44:03.140 2009 44:03.140 --> 44:08.820 The agency worked alongside developers and in real time to get tests validated and authorized 44:09.460 --> 44:12.340 FDA made clear that the data he needed to see 44:12.820 --> 44:14.820 For these tests to be distributed for use 44:15.380 --> 44:17.780 In a way that was responsible with public health 44:18.740 --> 44:21.460 It provided guidance and support to dozens of developers 44:21.940 --> 44:30.020 It showed that fda could serve the dual role as regulator and collaborator doing complex public health emergencies 44:31.140 --> 44:35.940 That was a paradigm shift regulator and these processes are still in place today 44:38.100 --> 44:41.540 This timely access reform regulator and collaborator 44:41.620 --> 44:43.780 It was a major paradigm shift 44:43.780 --> 44:48.580 She said in 2019 because of the flu or something like that of 2009. I don't know 44:49.300 --> 44:52.100 But that's a pretty amazing revelation and also 44:52.820 --> 44:54.820 actually an admission 44:54.900 --> 45:00.420 That the fda sees themselves as a regulator and a collaborator so they're regulating themselves basically 45:01.700 --> 45:04.900 They have a vested interest in things passing 45:05.620 --> 45:07.620 It 45:07.620 --> 45:11.700 Would be like teacher evaluations being filled out by the teacher, right? 45:12.740 --> 45:15.060 That's essentially what we're talking about here. There's no 45:15.780 --> 45:19.380 Advantage for them to evaluate their clients 45:22.180 --> 45:24.820 In an honest way because they win either way 45:26.340 --> 45:28.180 It's it's amazing 45:28.180 --> 45:31.940 And this woman should have practiced her speech a little more because she reads terrible 45:32.420 --> 45:36.100 By the eaway authorities is key since the agnostic tests 45:36.660 --> 45:39.780 Are one of the most critical components of outbreak management and control? 45:40.340 --> 45:42.500 I don't have to remind this audience, but I think I will 45:43.540 --> 45:46.580 Diagnostics allow us to protect the healthy and treat the sick 45:46.980 --> 45:49.140 They allow us identify and isolate the sick 45:49.700 --> 45:53.060 They allow for the efficient allocation of scarce medical resources 45:53.700 --> 45:55.780 They enable fundamental public health measures 45:56.260 --> 46:00.580 They are necessary for the conduct of clinical trials to evaluate vaccines and therapeutics 46:01.060 --> 46:02.020 And they are true 46:02.020 --> 46:08.740 So if you didn't think it was a testing pandemic now you absolutely know it is because she's explaining to you now 46:09.220 --> 46:11.220 the diagnostic testing is key 46:12.500 --> 46:16.180 And in fact, it was very key to deciding between 46:17.140 --> 46:22.580 Before we had diagnostic testing pere Corey says what we had was pulse ox 46:23.860 --> 46:28.500 And so people who had low pulse ox were given supplementary oxygen because that makes sense 46:28.820 --> 46:31.380 But supplementary 46:31.860 --> 46:35.940 Oxygen at 10 liters a minute or 60 liters a minute 46:36.420 --> 46:40.580 According to some crazy medical records that i've seen with my own eyes 46:42.260 --> 46:44.260 That's pretty toxic 46:44.820 --> 46:48.900 But if you use the diagnostics to tell doctors what to do if you tell 46:49.460 --> 46:54.660 Doctors that these diagnostics tell you whether this is a particularly deadly disease or not 46:55.460 --> 47:00.420 That's a pretty crazy rock and a hard place to be tweet be between 47:01.780 --> 47:04.500 And professionally a lot of these were young kids 47:05.460 --> 47:11.460 Residents that were told okay, you're taking over the er because we're sending the old attending physicians home and giving them 47:12.020 --> 47:17.700 Early retirement and you might have to listen to this guy who just came in. He's from the national guard 47:18.500 --> 47:25.060 This is February 3rd before all of that happened before any of that happened 47:27.700 --> 47:34.740 And they have in cutel giving a presentation to fda and their associates 47:37.140 --> 47:41.460 Please understand that this is as close to a smoking gun as we're going to get 47:42.420 --> 47:46.260 To seeing how many of these dominoes were stacked perfectly 47:47.220 --> 47:49.220 And how willingly they were kicked over 47:50.340 --> 47:52.340 And how nobody did anything to stop it 47:53.700 --> 47:54.580 And 47:54.580 --> 48:00.340 That coupled with the fact that a certain number of these people are willing to read whatever is put in front of them or 48:01.220 --> 48:08.180 More importantly willing to teach whatever they're told to teach even if it's just a mythology which gets everybody to conform 48:10.420 --> 48:12.420 Comply 48:13.060 --> 48:17.700 It's amazing. It's amazing. This is going to be one of the best long shows i've ever done 48:18.820 --> 48:23.460 We are first a line of defense and can be read it sooner than any other countermeasure 48:23.540 --> 48:26.980 I'm still stuck on it too. They've been planning this for months 48:27.300 --> 48:35.460 2013 fda sought and was granted new authorities by congress to issue eways when there is potential for an emergency 48:36.180 --> 48:38.180 even before it actually occurs 48:38.500 --> 48:39.780 So that 48:39.780 --> 48:43.620 You would not have to wait for an emergency threat to become an actual emergency 48:44.900 --> 48:52.500 The thought being the diagnostic tests are important to detect outbreaks at the earliest possible timeline point when there is no time to waste 48:53.780 --> 49:00.980 The novel coronavirus that is rapidly making its way around the globe serves as a stark reminder of the importance of diagnostic tests 49:01.860 --> 49:06.020 Any vaccines and therapeutics that might be developed will take some time 49:06.740 --> 49:09.220 Which may limit their impact on outbreak control 49:09.940 --> 49:15.380 Whereas diagnostic tests are already making a difference. Wow and i'll come back to this later 49:17.460 --> 49:22.820 So in addition to new authorities we have seen remarkable progress in what i like to call the response enterprise 49:23.700 --> 49:29.860 So in terms of information sharing china publicly shared a viral sequence of the novel coronavirus early on 49:30.500 --> 49:36.660 Allowing many researchers and developers to begin work and understanding and developing countermeasures for this virus 49:38.020 --> 49:41.940 In terms of support for countermeasure development. There are new players in the mix 49:42.740 --> 49:48.900 The coalition. I know you know, I know i'm stopping it a lot, but keep in mind what what what has she already 49:49.540 --> 49:53.060 Now what part of that enchantment did you just get cast 49:54.580 --> 49:58.260 The part of the enchantment that just got cast was that if they have the sequence 49:58.740 --> 50:04.260 Then we can develop a whole bunch of new countermeasures for it because all we need is the sequence in order to do that 50:04.740 --> 50:10.020 That's us. That's an assumption that is embedded in that's that little bit of the story. She just said 50:10.740 --> 50:16.100 In every person in the room and every person that's online listening to it was already 50:18.580 --> 50:20.340 Confirming their 50:20.340 --> 50:22.340 They're 50:22.340 --> 50:24.340 The narrative in their hand 50:24.900 --> 50:29.380 Otherwise, they wouldn't be here. No, there's nobody in this they they say that this isn't about the coronavirus 50:29.380 --> 50:34.260 They say they've been planning this for months and it's just lucky that we're having you know, so timely 50:35.780 --> 50:37.780 But that's absolutely ridiculous 50:39.140 --> 50:40.660 And 50:40.660 --> 50:43.460 It's crazy. It is crazy what we have here 50:44.100 --> 50:49.380 For epidemic preparedness innovations or sepi for short, which is led by my good friend, Richard hatchet 50:49.860 --> 50:53.700 Is already working with multiple developers to facilitate vaccine development? 50:54.900 --> 50:59.140 In addition, the department of defense has established an office of biotechnology 50:59.700 --> 51:03.300 Led by anyone else finding an odd that she's funny that she has the sniffles 51:03.300 --> 51:08.180 So she's really good friends with the head of sepi. That's great. That's great. Oh, wonderful 51:08.340 --> 51:12.180 Good friend dr. met Hepburn to facilitate countermeasure development 51:14.020 --> 51:20.580 And they're already working with other us government agencies to identify and support some of the most promising products 51:21.460 --> 51:23.460 The 51:23.460 --> 51:26.660 EUA however was never intended to be the end game 51:27.060 --> 51:31.300 It was never intended to replace standard tried and true robust 51:31.860 --> 51:35.060 scientifically and rigorously validated countermeasure development 51:36.660 --> 51:42.740 There was tremendous pressure in 2014 to issue EUA's for investigation of vaccines and therapies 51:43.860 --> 51:49.300 however from the experience that we had of issuing an EUA for permavirus a flu drug 51:49.860 --> 51:51.860 In the 2009 flu pandemic 51:52.500 --> 51:56.500 We knew that we wouldn't learn much about the drugs risks and benefits 51:58.340 --> 52:01.620 We were challenged to do better when faced with Ebola in 2014 52:02.820 --> 52:08.260 The idea that scientifically informative clinical studies were not feasible during public health emergencies 52:08.660 --> 52:11.300 Were put to rest with several studies 52:11.940 --> 52:17.300 Being conducted by the NIH in a series of efforts led by dr. Cliff Lane at NIAID 52:17.860 --> 52:23.220 In collaboration with WHO, NGOs, and other international partners 52:24.740 --> 52:29.620 The clinical studies were conducted under the most difficult conditions 52:30.660 --> 52:34.820 The process was arduous and challenging. It required collaborations 52:35.940 --> 52:37.940 Success was not obvious 52:38.100 --> 52:43.300 Just be sure you understand that I am also very annoyed that she's reading a statement to us right now 52:43.860 --> 52:49.060 I'm incredibly annoyed that she's reading a statement to us and I'm incredibly annoyed that she didn't practice it more 52:49.460 --> 52:51.940 And I know that she probably did not write this 52:53.140 --> 52:58.660 That's what we're dealing with here ladies and gentlemen. These people get paid good money. They have a very comfortable life 53:01.780 --> 53:07.060 And so when they're told to read something they read something they think they are part of a governing apparatus 53:07.140 --> 53:10.020 That's bigger than them and they have they just a part of it 53:10.100 --> 53:13.220 They're happy to be here inside of it that lady is so happy 53:13.620 --> 53:21.860 The lady before her was so happy and so proud that these months have been so productive and successful in organizing this extremely 53:22.980 --> 53:24.980 timely conference 53:27.700 --> 53:29.940 Sorry, I have to keep disappearing the efforts paid off 53:30.900 --> 53:37.700 Today we have a licensed vaccine and clinical data on several several effective therapies for Ebola 53:38.020 --> 53:40.900 That we hope will result in approved therapies 53:42.980 --> 53:45.380 So where does that leave us with diagnostic tests? 53:46.660 --> 53:53.220 Why have we struggled to achieve fd approval for diagnostic tests that are fielded under the eOA authorities 53:54.740 --> 53:59.540 The good news is that the system for developing and validating diagnostic tests during emergencies 53:59.860 --> 54:04.260 And the issuance of eOA's during the emergency is very well established 54:05.060 --> 54:12.020 The bad news is that too few of these tests continue to be validated to the extent necessary to gain fd approval 54:13.060 --> 54:18.100 As a result very few authorized tests are eventually approved 54:19.300 --> 54:24.580 And we are here today to examine this issue and to develop solutions 54:27.460 --> 54:33.540 It is most likely true that some tests when examined more regularly would not meet fd standard for approval 54:34.260 --> 54:38.260 And some developers may choose not to pursue approval for fear of failure 54:39.780 --> 54:43.060 I recognize that market forces play a very significant role here 54:43.780 --> 54:49.700 There's little incentive. So she is more or less admitting that while an eOA exists 54:49.700 --> 54:54.980 We could be using tests that actually aren't aren't good enough for fda approval 54:56.900 --> 54:58.900 She just said that 54:59.620 --> 55:01.620 And that lots of them might be that way 55:02.580 --> 55:08.500 But it's still okay. It's still great. It's a great system. We need these tests in order to know who to treat 55:09.220 --> 55:13.140 But the tests aren't good enough for fda approval. So we've got to fix that problem 55:14.420 --> 55:19.140 So what are we going to do? We're probably going to lower the standards. We're probably going to enable 55:19.860 --> 55:21.300 the 55:21.300 --> 55:25.060 disingenuous data collection during its eOA application to 55:25.700 --> 55:26.820 to 55:26.820 --> 55:29.860 proxy for what would be a a proper 55:30.580 --> 55:34.500 uh evaluation of of the diagnostic as a tool 55:35.140 --> 55:37.940 That's that's what we're going to hear here. I can I can hear it already 55:37.940 --> 55:41.620 But the the extraordinary thing is that she says the words 55:41.700 --> 55:46.420 She read the words that she just read and I guess she must hear the contradiction in her hand 55:46.500 --> 55:50.100 Or she's really just an orator and not really a thinker but just like a 55:50.660 --> 55:55.380 Automaton or something. I mean it's it's absurdly obvious to me that this is 55:56.340 --> 56:00.020 This is borderline criminal evidence of exactly what happened to us 56:02.900 --> 56:11.460 For the commercialization of diagnostic tests for certain emerging infections, especially once the outbreak that drove the initiative development of the test is over 56:12.340 --> 56:15.620 And we cannot ignore these market forces either 56:16.740 --> 56:20.500 And aside from the commercial sector, it is fact that government 56:21.380 --> 56:28.260 Has deprioritized the support for diagnostic tests as a countermeasure over and over again 56:28.900 --> 56:33.540 When a decision is made to spend a dollar on a therapy or diagnostic tests 56:34.260 --> 56:38.260 The therapy usually wins even though these drugs 56:38.980 --> 56:46.660 Are incredibly important. They offer incremental benefit over standard support of medical care whereas diagnostics 56:47.540 --> 56:50.180 Are the backbone of the response 56:53.140 --> 57:00.100 I'm going to go so far as to say that this is her primary message and it's before I'm a I'm a levelate reason 57:01.540 --> 57:08.180 And that malevolent reason is that this is part of the scottop to come of course that they're going to use PCR tests 57:08.900 --> 57:14.500 They're going to sell PCR tests as being highly specific and very accurate so accurate 57:15.220 --> 57:21.140 That they can pick up an asymptomatic infection to allow you to save your grandmother or stay away from her 57:21.940 --> 57:25.700 And they're so accurate and so worth doing that we should line up 57:26.980 --> 57:32.100 All the way around the block to drive through and submit to a swabby 57:35.460 --> 57:38.340 I think that this is incredible because 57:39.140 --> 57:41.140 She is making an absolute 57:42.020 --> 57:44.020 B line hail mary pass 57:44.340 --> 57:50.820 For the idea that diagnostics need to give getting more credit than they deserve and trying to tell a story about how you know 57:51.220 --> 57:58.260 Therapeutics are often given given a lot more leeway than then diagnostics, but diagnostics are actually really important 58:00.020 --> 58:03.620 And we were going to do tracking trace for more than a year to come 58:04.340 --> 58:08.260 After this we were going to spend millions of dollars around the country 58:08.740 --> 58:13.460 To follow up on positive tests by calling people and having them test 58:17.300 --> 58:23.540 In cutel is telling the fda and an audience that's seeking potentially how to get an EUA 58:24.100 --> 58:26.100 Up to full marketing status 58:26.340 --> 58:31.140 The diagnostics are much more important and are going to be much more important in the future 58:31.620 --> 58:33.700 Isn't that what she's saying? 58:33.700 --> 58:35.700 I think she's saying that 58:38.820 --> 58:42.180 And that's why collaboration and funding support by the US government 58:42.580 --> 58:48.660 And other partners becomes important to promote the systematic collection of data from the real world use of these tests 58:49.300 --> 58:52.500 These data could be used to support fda approval 58:53.780 --> 58:57.300 And if that's done developers win because the 58:58.020 --> 59:03.780 Requirements of the emergency create a path for utilization of real world evidence toward approval 59:04.340 --> 59:10.980 This sets very nice precedence. It facilitates the approval pathway for many other diagnostic tests 59:12.980 --> 59:14.980 And the public health and patients win 59:15.620 --> 59:21.220 Because they have the confidence that the tools they're using have been subject to rigorous scientific scrutiny 59:21.620 --> 59:22.340 Wow 59:22.340 --> 59:27.860 But for this collaboration to take place we need to speak frankly about the obstacles to achieve this end goal 59:28.020 --> 59:30.900 What's the option? And I would encourage you to do that today. Okay 59:31.620 --> 59:38.660 We need to understand what capability is each has and we need to develop shared responsibility for making this a success 59:39.620 --> 59:44.740 If we did this for vaccines and therapies, we can certainly do this for diagnostics if there is a will 59:46.260 --> 59:48.260 And let's not stop here since we are 59:48.740 --> 59:55.460 Together let's go further. Let's imagine a world where rapid diagnostic tests are available at the point of care 59:56.820 --> 01:00:00.340 For every future emerging infectious disease epidemic 01:00:01.060 --> 01:00:07.460 Or routine medical care wait, what a world with small handhelds that can one molecular base test what 01:00:08.180 --> 01:00:10.180 I'm sorry. I have 01:00:10.180 --> 01:00:13.060 Diagnostic tests are available at the point of care 01:00:14.420 --> 01:00:18.420 For every future emerging infectious disease epidemic there you go 01:00:18.660 --> 01:00:26.420 It's that there it is a world with small handhelds that can one molecular base tests in local complexity settings 01:00:26.660 --> 01:00:30.260 See imagine how valuable that would be for responding to epidemics 01:00:30.900 --> 01:00:32.900 And for caring for patients on a normal day 01:00:35.220 --> 01:00:39.940 So to think about how amazing it would be if we could sequence your genome with a 01:00:41.700 --> 01:00:43.700 Wow, I mean, wow 01:00:46.180 --> 01:00:49.220 Hey, we come together with a tremendous sense of urgency 01:00:49.700 --> 01:00:54.660 Innovative ideas and a renewed commitment to putting strategies into practice 01:00:55.060 --> 01:00:59.220 Remember the world the words of Maddie step-a-neck 01:00:59.940 --> 01:01:03.140 Unity's strength when there's teamwork and collaboration 01:01:04.020 --> 01:01:06.020 Wonderful things can be achieved 01:01:06.820 --> 01:01:09.780 In this era of order measures, quarantines 01:01:11.620 --> 01:01:17.540 Social distancing, elbow bumps, I wish you a highly productive workshop and discussions. Thank you 01:01:18.420 --> 01:01:20.420 Were we doing that already? Wow 01:01:20.980 --> 01:01:22.980 This 01:01:22.980 --> 01:01:25.620 This era this era she says 01:01:26.580 --> 01:01:28.580 It's gonna be a new thank you dr. Borio 01:01:29.140 --> 01:01:30.340 Wow 01:01:30.340 --> 01:01:35.460 Diagnostics are the backbone of the response. I think that's that says it all. That's awesome. Thank you 01:01:36.340 --> 01:01:40.100 Our keynote speaker today is dr. Neura Pollock. She said that was awesome 01:01:40.100 --> 01:01:46.660 She is the associate medical director of the infectious diseases diagnostic laboratory at Boston Children's Hospital 01:01:47.300 --> 01:01:54.100 As well as a faculty member of the division of infectious diseases at Beth Israel deaconess medical center in boston 01:01:54.740 --> 01:01:59.540 She's an associate professor of pathology at harvard medical school with a joint appointment in medicine 01:02:00.180 --> 01:02:04.100 And she completed her m d pht at the university of california, serencisco 01:02:04.420 --> 01:02:12.180 Her medical residency at brigham and women's hospital in boston and her infectious diseases clinical microbiology fellowships at bid mc 01:02:12.740 --> 01:02:20.820 Dr. Pollock has an active research program focused on the development and evaluation of novel diagnostics for infectious diseases and related applications 01:02:21.300 --> 01:02:28.260 And she'll be speaking about evaluating novel diagnostics in an outbreak setting lessons learned from Ebola 01:02:29.780 --> 01:02:32.260 Oh, man. So she's going to tell us how they 01:02:33.300 --> 01:02:41.460 Tried to diagnose use in vitro diagnostics in the Ebola scenario and how well it worked or what come on you got to be kidding me 01:02:42.820 --> 01:02:44.820 So 01:02:48.180 --> 01:02:53.540 Just so you know, rober melon's not going to step up to the mic even though that wouldn't surprise me i'm pretty sure he doesn't 01:02:57.300 --> 01:03:01.620 But steve kirsch could be in the audience at home i that that wouldn't surprise me 01:03:06.180 --> 01:03:07.380 Uh oh 01:03:07.380 --> 01:03:10.420 It problem all this conference has fallen apart fast 01:03:11.380 --> 01:03:13.780 The coffee and donuts isn't going to make up for this 01:03:20.900 --> 01:03:22.900 Can't find her slides 01:03:24.500 --> 01:03:30.020 I need a head nod carolyn slides looking for my slides looking for slides 01:03:33.060 --> 01:03:37.300 Yes remdesivir was used for Ebola as well, but i don't think it worked very well for Ebola 01:03:41.300 --> 01:03:43.300 I 01:03:47.220 --> 01:03:51.140 Think in today's world, it's a little bit of an assumption to assume that these are all women 01:03:51.140 --> 01:03:54.580 But I think they are indeed female indeed. I do think that's true 01:03:56.020 --> 01:03:58.020 Just want to be careful, you know, you don't want to make any 01:04:02.820 --> 01:04:05.460 Holy shit, what's happening here? This is kind of funny 01:04:06.420 --> 01:04:10.660 What wall I guess we're gonna have to call the it lady. She must be out getting more donuts 01:04:12.660 --> 01:04:14.660 One thing you can never rely on 01:04:15.620 --> 01:04:19.620 By telling you why I was invited i think and I appreciate that you really believe 01:04:19.780 --> 01:04:21.300 um, I 01:04:21.300 --> 01:04:25.460 My research program focuses as she said on the development of novel diagnostics 01:04:26.100 --> 01:04:27.380 and I 01:04:27.380 --> 01:04:30.260 I am here to tell you about the experience that we had 01:04:30.740 --> 01:04:36.340 Evaluating novel diagnostics during the Ebola outbreak in West Africa in 2014-16 01:04:37.060 --> 01:04:40.740 And this is something i'm sure that many of the people in the room were involved in 01:04:41.540 --> 01:04:43.540 And my goal in the talk is actually to 01:04:44.420 --> 01:04:48.420 a sense of what my experience was but as a generalizable 01:04:49.460 --> 01:04:51.700 Topic so that we can pull from that okay 01:04:51.700 --> 01:04:56.260 I'm actually thinking now it wouldn't be crazy if Robert Malone was in this audience as she says that 01:04:56.260 --> 01:04:59.060 I think a lot of us were involved in that Ebola response 01:04:59.060 --> 01:05:02.420 Well, he definitely was so it wouldn't be crazy if he was in in the room 01:05:03.940 --> 01:05:05.940 Shit 01:05:12.260 --> 01:05:16.740 It says it's running but it's not playing oh man did I screw it up please don't 01:05:22.660 --> 01:05:24.660 What's happening 01:05:25.620 --> 01:05:27.620 Shit 01:05:27.700 --> 01:05:32.660 Darn it I might have to refresh it a little bit something why sorry 01:05:41.460 --> 01:05:46.180 I'm still gonna try and keep it skipping forward and see if I can do that. I won't do it anymore. I'll just wait 01:05:48.580 --> 01:05:53.060 So I think it is really interesting right we're talking about people again that have been through the 01:05:53.620 --> 01:05:59.940 Been through it already now. I'll just start by by telling you why I was invited I think and I appreciate this invitation 01:06:00.820 --> 01:06:01.940 I 01:06:01.940 --> 01:06:06.100 My research program focuses as she said on the development of novel diagnostics 01:06:06.740 --> 01:06:08.420 and I 01:06:08.420 --> 01:06:10.900 Am here to tell you about the experience that we had 01:06:11.540 --> 01:06:16.980 Evaluating novel diagnostics during the Ebola outbreak in West Africa in 2014-16 01:06:17.620 --> 01:06:21.300 And this is something i'm sure that many of the people in the room were involved in 01:06:22.100 --> 01:06:29.060 And my goal in the talk is actually to give you a sense of what my experience was but as a generalizable 01:06:30.100 --> 01:06:35.060 Topic so that we can pull from that and take it to a larger level and apply it now 01:06:35.060 --> 01:06:37.060 Um 01:06:50.420 --> 01:06:55.540 I would just start talking there's a whiteboard behind you. I mean come on 01:06:56.660 --> 01:06:59.060 I don't know. I I find this kind of funny 01:06:59.460 --> 01:07:01.460 Um 01:07:01.460 --> 01:07:05.060 Definitely the nqtell lady would have been screwed without her notes, right? 01:07:05.140 --> 01:07:08.740 So I mean, it's not surprising I guess but maybe it's just you know, you want to do it right 01:07:09.300 --> 01:07:11.940 And she knows she has her slides on that laptop somewhere 01:07:16.100 --> 01:07:18.100 She's just gonna pull out her usb 01:07:21.860 --> 01:07:24.180 Wow, I don't know what to say. I think this is uh 01:07:26.020 --> 01:07:28.020 This is gonna be really gold 01:07:29.860 --> 01:07:31.860 I'm gonna risk clicking this button again 01:07:37.860 --> 01:07:40.500 Just gonna keep trying to go forward. Oh it guys here 01:07:45.060 --> 01:07:51.380 Wow, they really had to pull the whole rip cord here after all this planning for months. I mean gee whiz 01:07:52.740 --> 01:07:54.740 Just let the lady hook up her laptop 01:07:59.060 --> 01:08:01.060 I 01:08:07.780 --> 01:08:15.140 Oh now the rickin apologies. It appears we have the technology fixed hopefully the technology she calls it. There you go 01:08:15.700 --> 01:08:17.220 Okay 01:08:17.220 --> 01:08:19.220 All right, here we go. Thank you 01:08:20.020 --> 01:08:21.860 No problem, masa 01:08:21.860 --> 01:08:28.100 Okay, so as I said, we're going to be talking about lessons learned from ebola and with the goal of applying it to 01:08:28.740 --> 01:08:33.300 Today, of course the bullet is still going on today. I know we are all focused on coronavirus, but 01:08:34.420 --> 01:08:38.980 Okay, so as I mentioned my interest is in the development and evaluation of novel diagnostics 01:08:38.980 --> 01:08:44.660 And there are a lot of as an academic coming to this with also a public health perspective 01:08:45.300 --> 01:08:52.180 There are many opportunities and challenges in this area and lots of interesting things to do proof of principal demonstration with novel technologies 01:08:52.740 --> 01:08:58.820 method comparison, which will definitely come up in this talk point of care used how good is the point of care testing to be 01:08:59.380 --> 01:09:03.380 How good is a gold standard and what is clinical validation really involved? 01:09:03.620 --> 01:09:08.820 What does that mean in a controlled setting but particularly in a field setting and particularly during an outbreak? 01:09:09.700 --> 01:09:10.660 Okay 01:09:10.660 --> 01:09:17.620 So the laboratory diagnosis of Ebola virus disease in the 2014 to 16 epidemic had many challenges that i'm sure many of you are available 01:09:18.100 --> 01:09:21.460 But a main problem is that testing if if it was available 01:09:22.100 --> 01:09:29.620 Was standard high complexity real-time PCR that was performed in biocontainment laboratories and biosafety was a very very big issue 01:09:30.020 --> 01:09:31.860 There were specimen collection challenges 01:09:31.860 --> 01:09:36.900 So there were resource limitations that meant that that actual supplies for doing the napuncher packaging 01:09:37.220 --> 01:09:46.020 Transport were often not available and there was inadequate training for actually collecting these samples that compromise safety of the sample and safety of the operator 01:09:46.820 --> 01:09:55.780 There were many logistic challenges that emerged as this rolled out including incomplete specimen submission forms lack of unique identifiers 01:09:56.740 --> 01:09:59.220 Unfortunately, I see someone reading here as well 01:10:00.100 --> 01:10:07.620 Um, I don't I don't know what else to say other than than than she's reading. She's much more rehearsed than the ink util lady 01:10:08.340 --> 01:10:10.340 But this is definitely reading 01:10:10.820 --> 01:10:15.380 It's fine, but i'm just letting you know transport delays results reporting delays 01:10:15.620 --> 01:10:18.740 I'm certain that all of this is being felt right now in china 01:10:19.140 --> 01:10:26.580 There was a big deal at that time. So the reality was it results could take a long time to return to clinical sites and there were many opportunities for error 01:10:28.180 --> 01:10:30.180 So in 2014 01:10:30.180 --> 01:10:38.340 At the beginning, um, the international mobile lab deployment to west africa was robust but there was still inadequate access in many many areas 01:10:38.580 --> 01:10:44.980 And this led to an urgent clinical need for new tests and particularly rapid sample to answer point of care tests 01:10:45.060 --> 01:10:49.940 That could be run by less experienced operators. So again here. She's defining a need 01:10:50.020 --> 01:10:54.580 She's defining a need that wasn't met and so she's defining a new market and she's 01:10:55.460 --> 01:10:59.300 It's really uh, it is a it is an amazing presentation 01:11:00.340 --> 01:11:04.500 And this led to an explosion in test development that I certainly had never seen 01:11:04.980 --> 01:11:07.620 And an acute need for evaluation of these tests 01:11:07.940 --> 01:11:11.860 And so I was drawn in in the winter of 2014 when I was asked to help partners in health 01:11:11.860 --> 01:11:19.140 Which is a Boston based nonprofit urgently developed some field studies and Sierra Leone to try to evaluate the most promising Ebola diagnostics 01:11:19.380 --> 01:11:24.660 In the hopes that they could be used on those patients and we had some available funding from the abundance foundation 01:11:25.460 --> 01:11:32.740 So what I knew before the Ebola outbreak from my experience was a fair amount consider all the variables think about everything sample handling 01:11:32.820 --> 01:11:35.700 Who's the case? What's the reference method? What's the cutoff? 01:11:36.100 --> 01:11:40.900 All of those things and I knew that we should expect the unexpected particularly in a field context 01:11:41.220 --> 01:11:46.980 Lot to lot variability not assume that a fingerstick sample would be the same as a vena puncture sample 01:11:47.540 --> 01:11:52.340 Which reference method gives the right answer? So I was familiar with these challenges up front 01:11:53.220 --> 01:12:00.020 However, what I learned after being involved in this was much larger than that and that is that there are systemic and systematic 01:12:00.100 --> 01:12:04.260 Challenges to evaluating novel diagnostics in an emergency setting in particular 01:12:04.660 --> 01:12:13.060 And then if we don't collectively consider these challenges and find solutions together that development and evaluation of novel diagnostics and future outbreak settings 01:12:13.140 --> 01:12:15.300 As we are in now would be handicapped 01:12:15.300 --> 01:12:22.420 So this leads to the concept of a global emergency diagnostic framework and really a preparation that's diagnostic focused 01:12:22.900 --> 01:12:26.500 To be prepared to act quickly and to succeed 01:12:28.100 --> 01:12:30.100 Okay, so back to winter of 2014 01:12:30.340 --> 01:12:37.380 So i'm i'm i'm immediately drawn to nick hudson statement, which is whenever they say they have a global problem that needs a global solution 01:12:37.380 --> 01:12:45.060 You know that it's bullshit. She just said that we need a global solution to the evaluation of diagnostic tools 01:12:45.620 --> 01:12:47.460 holy cow 01:12:47.460 --> 01:12:49.460 That's pretty impressive 01:12:49.700 --> 01:12:54.340 I mean, this is this is a major. Uh, this is this is impressive 01:12:54.980 --> 01:12:57.140 It was a very confusing and chaotic time 01:12:57.620 --> 01:13:01.700 Uh, there were multiple novel acids under development and it was a big question mark 01:13:01.700 --> 01:13:05.380 Which one should be prioritized? Which of the tests are we going to test the video? 01:13:05.620 --> 01:13:09.700 Should we go after a novel assay and a novel platform or only something that's well-known 01:13:10.020 --> 01:13:15.220 What about platforms that have never been tested in the field before all sorts of developers were throwing their hats in the ring 01:13:15.460 --> 01:13:17.460 There were technologies that had never seen 01:13:18.020 --> 01:13:21.460 Anything outside of a laboratory. What about production capability? 01:13:21.540 --> 01:13:25.700 Should we only go with companies that had the capacity to produce giant numbers of tests? 01:13:26.260 --> 01:13:28.260 What about how do we plan? 01:13:28.260 --> 01:13:28.980 um 01:13:28.980 --> 01:13:34.420 The clinical studies in parallel with the development of the tests themselves. What what sample types are we going to do? 01:13:34.580 --> 01:13:39.140 What should the study look like? How do we design it? It was pretty much chaos at that time 01:13:40.660 --> 01:13:44.420 There were multiple RTPCR assays that were in use in the field 01:13:44.660 --> 01:13:48.180 Which led to the question of which one of these should be choose is a reference method 01:13:48.260 --> 01:13:51.700 Which is obviously extremely important for a test evaluation 01:13:51.940 --> 01:13:58.900 But at the beginning of the outbreak there wasn't an Ebola virus diagnostic evd diagnostic with either fda or who approval 01:13:59.220 --> 01:14:02.740 But there are a lot of laboratory tests out there ldt's lab develop test 01:14:03.220 --> 01:14:07.380 CDC had one dod had one public health england had one there were home brews 01:14:07.860 --> 01:14:11.940 And then it was so it was in the fall of 2014 that the first who 01:14:12.340 --> 01:14:17.060 Emergency use authorization the listing was uh was was approved for a commercial assay 01:14:17.060 --> 01:14:19.620 Which was the eltona real starfire of a file of iris screen? 01:14:19.940 --> 01:14:25.220 And also in november 2014 came the first fda eua for a commercial assay also by 01:14:25.780 --> 01:14:30.580 Interesting that she says the the who also gives out emergency use authorizations 01:14:30.580 --> 01:14:34.500 That's an interesting thing that I didn't know so that's just take notes here 01:14:35.540 --> 01:14:37.140 On a slightly different 01:14:37.140 --> 01:14:41.860 But there were all these assays out there and there was very little sharing of data about how the ass is compared 01:14:41.940 --> 01:14:46.420 So it was very difficult to understand which one of these we should choose as a reference method 01:14:46.500 --> 01:14:50.580 Have which one was the best one to use for novel test comparison 01:14:51.620 --> 01:14:58.340 On top of it. There were multiple people in charge and it was very difficult to understand who who was truly in charge 01:14:58.980 --> 01:15:04.660 Who was there fda was there cdc dod phe department for international development 01:15:05.300 --> 01:15:10.340 That was just the global groups and the us groups and and so on but in uk groups 01:15:10.500 --> 01:15:14.900 But then you had the groups in country serially own what do they need who's in charge there? 01:15:14.900 --> 01:15:20.340 So there were multiple bodies there as I've indicated here all of whom had to be in contact 01:15:20.340 --> 01:15:25.220 And it was very unclear how to do that. There were formal processes for study approval 01:15:25.380 --> 01:15:29.300 There were informal processes which you couldn't know unless you knew the right people to ask 01:15:29.780 --> 01:15:33.940 And then there were unique biosafety considerations for collection and testing of samples 01:15:34.260 --> 01:15:36.820 And then of course we were in an outbreak so speed was essential 01:15:36.900 --> 01:15:40.740 So there were all of these barriers and sources of confusion upfront 01:15:41.700 --> 01:15:45.460 So the first step for me was to learn something about diagnosis of Ebola 01:15:45.540 --> 01:15:50.660 So as an ID clinician, I knew something as a microbiologist. I knew something but not what I needed to know 01:15:51.300 --> 01:15:56.180 So these are the sort of traditional and historical background methods for how you test for Ebola 01:15:56.180 --> 01:15:59.540 I won't spend much time on this other than to say Ebola is an RNA 01:16:00.020 --> 01:16:03.540 I'm super annoyed because I thought that this would be up here, but it's not 01:16:03.620 --> 01:16:06.580 I don't know why this is not working like that, but I can't 01:16:07.380 --> 01:16:12.260 Just so you know, I can't download this video. It's like on only the FDA website. You can see the 01:16:13.060 --> 01:16:16.100 The link up there. Maybe I can copy it for you if you want to 01:16:16.740 --> 01:16:21.460 If you maybe you can figure out how to get this thing off of the internet and onto a hard drive 01:16:21.460 --> 01:16:23.940 I don't know. I can't I'm gonna put this link in the chat 01:16:24.820 --> 01:16:28.820 Maybe someone can try that. Yeah, you could screen record it, but it's really long 01:16:29.540 --> 01:16:31.860 But yes, you could you could screen record it 01:16:32.180 --> 01:16:34.580 Service in code separate viral proteins 01:16:35.380 --> 01:16:40.100 The the stream that has caused the most damage is Ebola's eye ear, but it's not the only one 01:16:40.740 --> 01:16:42.980 So traditionally it was cell culture, which is very slow 01:16:43.380 --> 01:16:48.500 Then serologic tests came along where they didn't work very well because it took too much time to form an antibody 01:16:48.500 --> 01:16:56.340 So it wasn't clinically useful then people realized you could detect proteins by ELISA and that those came up very quickly when someone was symptomatic 01:16:56.580 --> 01:16:59.540 That became an area of use and then finally 01:17:00.260 --> 01:17:04.500 reverse transcription PCR or real-time PCR, which was clearly 01:17:04.820 --> 01:17:07.220 I'm pretty sure that ELISA is the 01:17:07.860 --> 01:17:10.100 the antibody 01:17:10.100 --> 01:17:13.460 Linking tests that is used in a lateral flow test 01:17:14.100 --> 01:17:17.940 So when she says that they were testing for proteins using ELISA, that's 01:17:18.580 --> 01:17:24.340 Would eventually become a lateral flow test. I guess they weren't producing mass producing lateral flow tests for Ebola 01:17:24.820 --> 01:17:28.020 But that's what what an ELISA test would be as far as I know 01:17:28.740 --> 01:17:32.180 I might have to go to the bathroom pretty soon, which is not what I intended, but 01:17:33.380 --> 01:17:36.340 Maybe I'll take a break and and break the video into two. I don't know 01:17:36.580 --> 01:17:40.660 Sensitive then the other methods and people also learn that the CT value 01:17:41.460 --> 01:17:47.780 The psycho threshold could be useful for predicting outcome and then we could use those tests to look at other sample types 01:17:47.860 --> 01:17:49.860 Not just blood but more saliva 01:17:50.820 --> 01:17:52.020 Wow, that's interesting 01:17:52.020 --> 01:17:59.300 So the psycho threshold of our tPCR is already being advocated for as being a useful indicator of infectiousness 01:17:59.380 --> 01:18:01.380 Which we have already 01:18:01.860 --> 01:18:04.980 It's already been shown that that's not really true unless you do a few 01:18:05.780 --> 01:18:07.780 Reads, right? You got to do like three or four 01:18:08.500 --> 01:18:11.060 PCR's and then you take an average of the CT 01:18:11.140 --> 01:18:15.780 But if you just use one CT that will never work. That's an amazing thing to put in here 01:18:16.740 --> 01:18:18.740 Wow, they were really on all of it 01:18:19.060 --> 01:18:21.700 Fluid and so on so that was sort of a history 01:18:22.100 --> 01:18:26.020 This was the figure that we ended up putting together during the work just to understand 01:18:26.580 --> 01:18:28.580 How these different analytes came up over time? 01:18:28.900 --> 01:18:32.980 When did someone have enough RNA in their blood and so on? So I won't dwell on this. This is 01:18:33.700 --> 01:18:37.060 Published in a review that we did in 2016. Well, she did a review 01:18:37.300 --> 01:18:42.660 But the point is that reducing the time to diagnosis is key and for pretty much any outbreak pathogen, that's true 01:18:43.060 --> 01:18:47.620 For Ebola the clinical management and infection control issues were enormous 01:18:48.420 --> 01:18:51.780 The clinical presentation was non-specific. They could have had malaria 01:18:51.860 --> 01:18:58.260 They could have had many of of other things and so separating patients while you're waiting for the test results was a really big challenge 01:18:58.660 --> 01:18:59.380 On top of it 01:18:59.380 --> 01:19:05.380 It was very difficult for the patients themselves to go back to the community if they test until they tested negative 01:19:05.460 --> 01:19:08.820 They needed a negative test to get out of that triage area 01:19:09.540 --> 01:19:11.300 And to get healthcare elsewhere 01:19:11.300 --> 01:19:13.620 There was the problem of testing of dead bodies 01:19:13.620 --> 01:19:19.860 I'm sure you all know this that the that bodies needed to be tested in order to allow families to proceed with aerial practices 01:19:20.180 --> 01:19:24.100 And then of course contact tracing, which is something that's very very 01:19:24.740 --> 01:19:26.740 Important right now in our current outbreak 01:19:27.860 --> 01:19:32.580 Okay, so that was step one to learn and then the second step was trying to design and execute as 01:19:32.580 --> 01:19:38.980 Quickly as possible studies of the most promising diagnostics in the hope that they could actually be useful and be implemented 01:19:39.940 --> 01:19:41.940 So in 2014 in the fall 01:19:41.940 --> 01:19:48.980 What we as a community felt we needed were diagnostics that were safe and rapid and cost effective from the user perspective 01:19:48.980 --> 01:19:56.580 But in particular that were usable at or near the point of care instead of having to go to a centralized laboratory hours over a dirt road 01:19:57.220 --> 01:20:02.820 And they needed to be performable by local laboratory technicians or healthcare workers and ideally the latter 01:20:03.380 --> 01:20:05.060 So it had to be easy 01:20:05.060 --> 01:20:12.340 So the first study that we did was a evaluation of this particular test called the corgenics rebob antigen rapid tested 01:20:12.580 --> 01:20:18.100 And i'm not going to focus so much on the details of this particular study, but just on the generalizable take home points 01:20:18.740 --> 01:20:21.220 How do we pick this one we picked it as a community? 01:20:21.300 --> 01:20:25.700 So in consultation with the WHO find Ebola diagnostics access collaboration 01:20:25.780 --> 01:20:29.700 So it was sort of put up as a possible front runner that met criteria 01:20:30.180 --> 01:20:35.940 We knew it had detected. It was a simple lateral flow immuno assay. It didn't require external instrumentation 01:20:36.100 --> 01:20:40.580 It did require a cold chain, which is not good, but nonetheless, this is the one we did 01:20:41.460 --> 01:20:45.620 And so the kind of study that we designed for this is not rocket science 01:20:45.620 --> 01:20:50.980 But it was actually pretty hard to conceptualize this rapidly because we knew we wanted to test finger sick 01:20:52.420 --> 01:20:57.060 Samples at point of care that in itself is a big deal with Ebola 01:20:57.220 --> 01:21:00.980 Because that means that it needs to be done by someone in full ppe and i'll show you some pictures 01:21:01.380 --> 01:21:04.980 But we that's the point so point of care testing finger sick sample 01:21:05.300 --> 01:21:09.140 Edd suspects at partners and health sites test performed at the bedside 01:21:09.140 --> 01:21:14.580 So done and read by ministry of health technicians in what we call the red zone so full ppe 01:21:15.060 --> 01:21:21.460 But we also wanted to know whether testing in a reference lab would look the same. So we had our our collaborators at public health england 01:21:22.340 --> 01:21:23.540 testing 01:21:23.540 --> 01:21:29.140 consecutive venous whole blood samples as they came into the lab for testing for clinical purposes 01:21:29.300 --> 01:21:31.060 We also tested with the rdt 01:21:31.060 --> 01:21:36.980 So we had our two pongs of testing and then we compared all of the rapid diagnostic test results 01:21:36.980 --> 01:21:44.180 The rdt results blinded to the clinical test results on those same patients from the blood that had been done at drawn at the same time 01:21:45.220 --> 01:21:48.100 And for that our reference method was one called altona 01:21:48.260 --> 01:21:51.380 Which is as I said the one that had emergency use authorization 01:21:51.940 --> 01:21:58.420 We had our visible lines on our lateral flow red by two readers and if they disagreed we had a third reader 01:21:58.500 --> 01:22:01.460 So we were looking at inter operator variability. So we were trying to it 01:22:01.620 --> 01:22:06.020 So you're looking at inter operator availability of lateral flow tests 01:22:06.660 --> 01:22:08.900 Do you agree that there are two lines here? 01:22:09.940 --> 01:22:15.140 I don't know that second line. It looks pretty dim. I don't know what what what would you say? Are you pregnant or not? 01:22:15.300 --> 01:22:17.300 That 01:22:17.300 --> 01:22:19.300 That's her job 01:22:22.340 --> 01:22:26.180 Do you see what's happening here? We are actually witnessing the 01:22:26.980 --> 01:22:28.100 ongoing 01:22:28.100 --> 01:22:31.540 bamboozlement of an entire bureaucracy over the 01:22:32.580 --> 01:22:34.080 primacy of 01:22:34.080 --> 01:22:41.860 Diagnostics the usefulness of lateral flow testing the relevance of a combination of antibodies turning a stripe a different color 01:22:42.820 --> 01:22:48.660 In finding viral particles or viral proteins. This is all part of their worldview 01:22:49.300 --> 01:22:56.580 Most of them are presuppositions which have to be assumed to be true in order for you to even understand what this woman is saying 01:22:58.900 --> 01:23:06.500 If you have any skepticism at all about the danger of RNA spreading around the world in the form of a bleeding sickness 01:23:07.700 --> 01:23:10.260 Then you won't be able to understand a word this woman is saying 01:23:11.060 --> 01:23:14.020 Because you have to assume that Ebola exists that it spreads 01:23:14.500 --> 01:23:20.500 And that it needs to be tested for and so why aren't why wouldn't we evaluate all of these hundreds of tests? 01:23:23.540 --> 01:23:29.140 Why wouldn't we send blood from africa to the UK so that they can verify the tests 01:23:30.580 --> 01:23:32.580 Even though the blood could have Ebola in it 01:23:32.900 --> 01:23:34.900 It's 01:23:36.420 --> 01:23:43.140 It's amazing man. I'm ladies and gentlemen. I'm just having a blast. This is crazy. That's all of these characteristics at the same time 01:23:43.700 --> 01:23:48.820 So this is what the setting looked like you can see colleagues and floral PPE at the partners in health site 01:23:49.940 --> 01:23:53.780 This is to demonstrate how we had to collect our data. So here's a generalizable point 01:23:53.860 --> 01:24:00.020 So we have a highly highly contagious agent and you are not allowed to take your data forms out of the red zone 01:24:00.100 --> 01:24:02.500 So how do you do that? How do you capture the data? 01:24:03.060 --> 01:24:09.460 We ended up there was a triage moment where we could capture clinical data on paper before the person went into the red zone 01:24:09.860 --> 01:24:13.860 Then in the red zone we collected our our assay data on paper 01:24:14.340 --> 01:24:21.940 On forms and we did the test and then we had to document this by please make no mistake about it. This is worst case scenario 01:24:21.940 --> 01:24:31.220 This is just a very simple recitation of what the worst case scenario is and how you handle a worst case scenario 01:24:31.540 --> 01:24:37.220 Her personal experience with executing a plan for worst case scenario 01:24:38.340 --> 01:24:43.380 And why would they have her speak on february 3rd of 2020? 01:24:45.700 --> 01:24:50.020 To a group of people about getting EUAs to full marketing potential 01:24:52.740 --> 01:24:59.540 Man oh man when the people finally wake up. It's going to be one the heck of a barbecue. Holy cow 01:25:00.180 --> 01:25:02.180 I can't wait 01:25:02.420 --> 01:25:04.420 The bourbon is just going to flow 01:25:04.420 --> 01:25:10.740 Bring it up over a fence between the hot zone and the non-hot zone and taking a picture from the other side of our case 01:25:11.140 --> 01:25:14.180 Form so that we can we could record this data 01:25:14.660 --> 01:25:17.620 So just an example of the challenges of data recording and I can 01:25:18.100 --> 01:25:24.660 Imagine what is happening right now in china trying to actually transform transform data from paper to an electronic database and so on 01:25:24.660 --> 01:25:27.620 It's very challenging particularly with biosafety issues in play 01:25:28.740 --> 01:25:35.140 This is the more calm but still brought setting in the public health england lab where they're in the flexible film isolator 01:25:36.500 --> 01:25:38.500 So same idea 01:25:39.060 --> 01:25:43.620 Okay, she's showing pictures of people working in high containment facilities, of course 01:25:43.620 --> 01:25:50.260 You know like the sheng she Lee picture then and then and the picture that we have of of a young Steve Hatfield 01:25:50.740 --> 01:25:53.620 Um when he was working on Ebola you see now 01:25:55.060 --> 01:25:57.620 You see she probably knows Steve Hatfield 01:25:59.860 --> 01:26:06.980 Over our study conclusions we concluded that art that the test actually performed quite well against the compared of the altona as our benchmark 01:26:07.780 --> 01:26:11.300 100 sensitivity and 92 specificity against his benchmark 01:26:11.540 --> 01:26:16.740 We did see that we needed two readers to be able to get that sensitivity because sometimes they disagreed and there were weak bands 01:26:17.220 --> 01:26:23.140 We learned but it was feasible to do this in the red zone that someone could read that one of these things through their foggy mask 01:26:23.620 --> 01:26:28.100 And that um despite patients being dehydrated and we could do finger six and do this 01:26:28.420 --> 01:26:31.940 So we learned that kind of practical stuff inter operator greeting was high 01:26:32.340 --> 01:26:38.740 We detected all the patients with low CT values meeting high amounts of virus in the blood so the most infectious people 01:26:38.900 --> 01:26:41.060 However, and here's a generalizable point 01:26:41.780 --> 01:26:45.380 We learned that the altona assay was an imperfect reference method 01:26:45.860 --> 01:26:46.980 And how did we learn this? 01:26:46.980 --> 01:26:53.780 It's because we tried to do discordant analysis because we had some samples that were positive by the rapid test and negative by the altona 01:26:54.100 --> 01:26:56.100 So we said public health england 01:26:56.420 --> 01:27:02.020 Any other assay we could use and say they had an assay called the trombley assay, which they still use that was their lab develop tests 01:27:02.500 --> 01:27:04.340 And as it turned out 01:27:04.340 --> 01:27:08.900 On one to one comparison the trombley was significantly more sensitive than the altona tests 01:27:09.380 --> 01:27:15.540 And we surmised that the that was probably because when public health england had to implement the altona tests in the field 01:27:15.780 --> 01:27:19.140 They used what they could as an amplification platform. They had a smart cycler 01:27:19.460 --> 01:27:24.740 That's what they use probably not the ideal method for this particular altona assay 01:27:25.060 --> 01:27:27.060 And so the altona assay was actually missing 01:27:27.620 --> 01:27:31.700 Samples that had low amounts of virus in the sample and the trombley detected those 01:27:31.700 --> 01:27:37.460 So I know that fda doesn't like as I understand the fda doesn't like discordant or discrepent 01:27:38.660 --> 01:27:42.420 Analysis, but it was actually critical here for us to understand what was happening 01:27:43.060 --> 01:27:48.340 And what we came away with was that the reference standard actually causes to overestimate the true sense 01:27:50.420 --> 01:27:54.740 It doesn't like as I understand the fda doesn't like discordant or discrepent 01:27:55.940 --> 01:27:58.420 Analysis, but it was actually critical here for us to understand 01:27:59.300 --> 01:28:06.100 She ain't supposed to say that missing samples that had low amounts of virus in the sample and the trombley detected those 01:28:06.100 --> 01:28:07.060 So 01:28:07.060 --> 01:28:11.940 I know that fda doesn't like as I understand the fda doesn't like discordant or discrepent 01:28:13.140 --> 01:28:16.820 Analysis, but it was actually critical here for us to understand what was happening 01:28:17.300 --> 01:28:19.860 The update was at the reference standard 01:28:20.420 --> 01:28:25.940 Actually causes to overestimate the true sensitivity of the rapid test and underestimate its true specificity 01:28:26.020 --> 01:28:28.260 Because it was just not a perfect reference method 01:28:28.740 --> 01:28:33.860 And so we in the end of the day, we didn't really know how the rdt would have performed in a set of samples with lower 01:28:34.340 --> 01:28:37.780 Viral loads or what the significance of such samples and patients would be 01:28:38.340 --> 01:28:42.660 So generalizable the reference method really matters and you can't always know this up front 01:28:43.780 --> 01:28:47.060 Integration and I'll just mention this because it's also I think relevant 01:28:47.860 --> 01:28:51.940 There was a lot of disagreement after our study about how to implement this test or if 01:28:52.580 --> 01:28:56.260 There was concern about the use at point of care of an imperfect 01:28:56.660 --> 01:29:01.300 Test which most point of care tests at this point are how do you do it? How do you implement it? 01:29:01.300 --> 01:29:05.300 How do you teach people there was a lot of discrepancy between what we saw in the field? 01:29:05.300 --> 01:29:11.860 Not a lot, but and unfortunately she's not going to say the simple fact is that these tests become a problem at point of care 01:29:12.420 --> 01:29:14.580 depending on the prevalence of the disease 01:29:15.460 --> 01:29:20.740 if you're doing a PCR test it has a specificity that fluctuates depending on the 01:29:21.620 --> 01:29:23.620 prevalence of the disease 01:29:24.260 --> 01:29:24.820 and 01:29:24.820 --> 01:29:30.100 Thomas binder explained that in our interview about a week ago where he said if you use a PCR test 01:29:30.740 --> 01:29:35.620 To test to see if men are pregnant you will get false positives and none of them will be pregnant 01:29:37.540 --> 01:29:44.900 And that's the specificity if it's 98 percent specific then that that's what you're going to get 2 percent false positives 01:29:45.860 --> 01:29:48.260 in a population who cannot be positive 01:29:49.060 --> 01:29:54.900 And so if you are testing on a background of no Ebola then you're going to get a lot of false positives 01:29:54.900 --> 01:29:57.940 So she's not really telling you the whole story 01:29:58.020 --> 01:30:04.660 But she's trying to give you the impression that there's a job to be done and there's an ideal to be attained 01:30:04.660 --> 01:30:07.060 The ideal would be a hundred percent a hundred percent 01:30:08.580 --> 01:30:15.460 But of course that's not possible and so we need to do all this complicated work and complicated p values 01:30:15.860 --> 01:30:18.900 To understand which one is the best of these imperfect things 01:30:19.220 --> 01:30:23.860 And then we can only deploy it when it's you know needed or useful or appropriate 01:30:25.540 --> 01:30:29.860 It's nothing but an elaborate setup of smoke and mirrors to make sure 01:30:30.420 --> 01:30:34.900 That as the the deck chairs are rearranged and the shells are moved around 01:30:35.300 --> 01:30:38.580 And you're trying to keep track of where the ball is that it's impossible 01:30:39.300 --> 01:30:41.940 She's already telling you why you won't be able to know 01:30:42.340 --> 01:30:48.020 She's already telling you why there will be a lot of false positives when we issue EUAs for testing for a new virus 01:30:48.340 --> 01:30:50.340 That's the problem we had with Ebola 01:30:50.340 --> 01:30:57.220 And in fact the FDA doesn't like you to do the kind of cross across evaluation that in order to show it 01:30:59.220 --> 01:31:01.220 Think about what she just said 01:31:04.500 --> 01:31:06.500 Holy moses creable 01:31:06.820 --> 01:31:12.740 Some discrepancy and what was produced in it by the WHO in a laboratory setting with process and samples 01:31:12.900 --> 01:31:14.260 What does that mean? 01:31:14.260 --> 01:31:18.420 Okay, and then on top of it very importantly, you still need the approval of the in-country 01:31:18.900 --> 01:31:21.620 authorities whether or not you oh man, so the you the 01:31:22.340 --> 01:31:23.940 WHO does 01:31:23.940 --> 01:31:28.900 Makes up their own tests based on frozen samples and then we have to get those tests past 01:31:29.460 --> 01:31:34.500 Individual fda's and cdc's it's awesome. This is the most amazing video ever 01:31:34.980 --> 01:31:41.700 FDA WHO anybody else CE mark the country the one who's decides about whether to use this and it's a whole other level 01:31:41.780 --> 01:31:44.660 So this led to stalemate and a lot of confusion 01:31:45.620 --> 01:31:51.300 Okay, so a moment on the ora quick test another rdt. This is the one that has proceeded to 01:31:51.860 --> 01:31:55.380 Full regulatory approval. It's FDA approved as of october 2019 01:31:56.020 --> 01:31:58.980 And I just put up this detail about what was done in the package insert 01:31:58.980 --> 01:32:02.660 Just so you can see what what it took to get to full regulatory approval 01:32:02.980 --> 01:32:09.220 Well, what ora quick was not able to do was to do a point of care study on real patients in real time because it just wasn't ready 01:32:09.380 --> 01:32:13.860 Then the patients were gone. So the the type of data that we got for the other test 01:32:14.340 --> 01:32:18.740 Is not in here, but they did studies on for example non-human primates in fingers six 01:32:19.300 --> 01:32:24.580 Um, so but you can see what was done here. Um, and she's almost making the argument 01:32:24.580 --> 01:32:27.700 We've got a hurry so that we can test more of these diagnostics 01:32:28.260 --> 01:32:30.180 That's the argument that I hear 01:32:30.180 --> 01:32:36.100 That if we wait too long the disease will be gone and then we won't be able to test any of these diagnostics out on the people who are sick 01:32:36.580 --> 01:32:38.580 It's extraordinary, but I do hear it 01:32:40.580 --> 01:32:43.780 Just there was it was just not ready in time to actually do things like 01:32:44.340 --> 01:32:51.380 Operational inter-feeder variability and so on on this test in real time in a in a keen incentive see 01:32:52.180 --> 01:32:56.260 Okay, it's exactly what so just shifting to the other study we did the gene expert Ebola 01:32:56.260 --> 01:33:02.260 So this is also in use now in the drc outbreak and I meant to say the ora quick is as well 01:33:02.900 --> 01:33:03.860 Um 01:33:03.860 --> 01:33:09.940 So this one also had EUA by both FDA and WHO and was CE March all around the same time 01:33:10.340 --> 01:33:16.340 This you are probably familiar with it's an automated sample to answer system where you in this case put the sample into a 01:33:16.580 --> 01:33:20.420 Inactivating reagent for about 20 minutes and then you transfer it into the cartridge 01:33:20.740 --> 01:33:25.700 And then it goes on to the same expert platform that people are using for lots of things right now 01:33:26.740 --> 01:33:31.380 Has two genetic targets and so on so this is what we chose for our other study 01:33:32.740 --> 01:33:34.740 And what we learned here 01:33:34.900 --> 01:33:41.940 Was that the on both whole blood and buckleswap samples this assay had very very good performance. It's a hundred percent sensitive 01:33:42.740 --> 01:33:44.740 on whole blooded buckleswap 01:33:45.780 --> 01:33:50.420 When compared to the trombly assay I mentioned run by public health English and the specificity 01:33:50.420 --> 01:33:55.460 Here's another point of why I think discordant analysis even though it's complicated is really important 01:33:55.460 --> 01:34:01.860 So what we saw was that the specificity of the expert versus in whole blood was around 96 percent 01:34:02.020 --> 01:34:07.700 Okay, but then we said wait a second some of the ones that are testing expert positive and negative by the trombly assay 01:34:07.860 --> 01:34:10.660 they might be real and we went back and looked at them and 01:34:11.380 --> 01:34:12.340 um like 01:34:12.340 --> 01:34:17.460 Seven out of eight of them were from patients who already had been diagnosed with Ebola and this were being 01:34:17.540 --> 01:34:20.420 Seerily tested just to watch their viral lows fall down 01:34:20.820 --> 01:34:27.940 So they were real and so we feel very confident in converting our our sense of best our specificity to 99.5 01:34:28.580 --> 01:34:31.460 But that was the screpid analysis. So you take relief 01:34:32.580 --> 01:34:33.940 Okay 01:34:33.940 --> 01:34:37.380 point out that um doctor swab order of MSF also did a study 01:34:37.940 --> 01:34:46.900 An operational study had very similar results was doing testing by right in a lab right next to their patients and found extremely similar results 01:34:47.940 --> 01:34:49.060 Okay 01:34:49.060 --> 01:34:51.060 So collective accomplishments 01:34:51.060 --> 01:34:57.380 Um in this outbreak the lab response the deployment of international labs was truly inspiring 01:34:57.940 --> 01:35:03.860 Uh, there were 40 international labs. They were performing real time. RTPCR. They all had rigorous bio containment 01:35:03.860 --> 01:35:05.860 It was truly truly impressive 01:35:05.860 --> 01:35:10.020 And what's also impressive is the fact that at the start of the outbreak there were as I said no 01:35:10.420 --> 01:35:14.340 No diagnostics that had regulatory approval, but by may of 2016 01:35:14.900 --> 01:35:16.900 So a little more than two years later 01:35:17.220 --> 01:35:23.460 Um, a lot of tests were approved and we managed to do a small number of field studies for novel test evaluation 01:35:24.260 --> 01:35:26.020 Not many, but there were a few 01:35:26.020 --> 01:35:30.980 So this is you can't read this, but this is all the tests that got EUA. This is one slide of two 01:35:30.980 --> 01:35:33.220 So we have a bunch of of manual 01:35:34.260 --> 01:35:36.660 Real-time PCR essays in pink 01:35:37.220 --> 01:35:41.460 So non-automated and then the next page we have some some automated 01:35:41.780 --> 01:35:45.860 PCR essays in blue and then we have some rd cheese and green and some compressive, right? 01:35:45.860 --> 01:35:49.300 So it's two slides of of test that got you a approval 01:35:50.740 --> 01:35:56.180 Now tests that got EUA approval for Ebola, so imagine she's got two slides full for that 01:35:56.660 --> 01:36:00.180 It was more than 250 in the united states in the first year and a half 01:36:00.420 --> 01:36:02.660 So we were just over flooded with 01:36:03.380 --> 01:36:06.580 With things that we didn't know worked and nobody gave a shit 01:36:08.020 --> 01:36:10.020 She says this is totally normal 01:36:11.620 --> 01:36:16.420 It's interesting and relevant to this group is sort of what where do they go after that, right? 01:36:16.420 --> 01:36:20.100 And this is again not my area, but just focus of this this group 01:36:20.900 --> 01:36:26.980 And so what I understand is that the WHO once there is no longer a public health emergency of international concern 01:36:27.300 --> 01:36:33.780 They still encourage manufacturers of these products that are listed through their EUAL to apply for full prequalification 01:36:34.180 --> 01:36:38.660 But there aren't any any products that have been fully pre-qualified as I understand it by WHO 01:36:38.900 --> 01:36:41.380 I asked friends couldn't find it. So I 01:36:41.860 --> 01:36:45.700 FDA it's just or a quick as I mentioned that one RGT that is progressed 01:36:46.180 --> 01:36:48.180 Okay, so we'll be talking about that 01:36:48.500 --> 01:36:52.900 There and I will I will not be the one to explain this mechanism 01:36:54.180 --> 01:36:58.980 But I want to meet the point that even if it's approved that doesn't mean that you can get it and there was a useful 01:36:59.620 --> 01:37:01.140 Study that was done 01:37:01.140 --> 01:37:08.020 Recently, it's in common to nature from january 2019 where they this is the group in I believe the UK 01:37:08.500 --> 01:37:12.340 Where they said, you know, we are in international reference laboratory 01:37:12.420 --> 01:37:15.620 Let's see if we can get any of these Ebola diagnostics within two weeks 01:37:15.940 --> 01:37:20.900 And so they emailed all the manufacturers they called everybody they put in all of the requests for tests and 01:37:21.460 --> 01:37:25.860 They found that of all the available tests there were only four of them that they could actually get within two weeks 01:37:26.660 --> 01:37:32.420 Okay, so even if they're approved that doesn't mean a company can just sort of get them to you in the necessary timeframe 01:37:32.420 --> 01:37:34.420 So I think that is a key barrier 01:37:35.460 --> 01:37:36.500 Okay 01:37:36.580 --> 01:37:40.420 All right, so now to the bigger problem and these are the general points that I want to make 01:37:40.900 --> 01:37:45.780 Which is that throughout the outbreak there was just a real lack of clarity regarding the processes 01:37:46.180 --> 01:37:52.740 Certainly the priorities, but also because it was such a strong biosafety consideration for sample testing and and collection 01:37:53.060 --> 01:37:58.660 There were major delays in the diagnostic evaluation process and it just really felt like we couldn't work fast enough 01:37:59.220 --> 01:38:04.580 To develop and evaluate and improve these tests and I do think that we can and should do better 01:38:05.540 --> 01:38:12.420 So I'm going to close by focusing on the specific challenges and questions that I think are quite generalizable and relevant right now 01:38:13.540 --> 01:38:18.900 Okay, so let's start with sample ownership. Okay, so who owns the clinical samples once they're tested 01:38:19.220 --> 01:38:22.340 Um, this is a summary that Betsy Wonderly and I 01:38:23.140 --> 01:38:27.380 Wrote up after our experience. She worked with fine throughout and spent a lot of time on the ground 01:38:27.700 --> 01:38:29.700 We we experienced a lot of the same 01:38:29.860 --> 01:38:32.340 Frustration so we decided to summarize our thoughts together 01:38:32.900 --> 01:38:36.740 So who owns the samples if you're going to make the biobe for example 01:38:36.820 --> 01:38:41.700 Is it the government of the country whose patients were tested or where they were tested? 01:38:41.700 --> 01:38:44.260 So Sierra Leone for example, do they own the samples? 01:38:44.660 --> 01:38:47.540 Does it matter if the patients were searing Sierra Leone? 01:38:48.260 --> 01:38:50.260 Do they own the samples? 01:38:50.420 --> 01:38:53.780 Who owns the samples? What does she really mean there? 01:38:55.300 --> 01:38:57.940 Who owns the data? That's what she means 01:38:58.820 --> 01:39:02.820 Who owns the data? That's what she means. Do you hear it? I hear it 01:39:03.540 --> 01:39:05.540 I hear it plain as day 01:39:06.020 --> 01:39:09.060 Is it the lab who's doing the testing which was public health England? 01:39:09.460 --> 01:39:13.700 Is it the organization that keeps and holds the sample of public health England? Is it? 01:39:14.500 --> 01:39:19.540 Who's the funder the WHO owns the samples and that's very important for biobanking 01:39:19.940 --> 01:39:21.940 And then of course 01:39:21.940 --> 01:39:24.980 Oh my gosh. It's all one big agenda 01:39:25.300 --> 01:39:28.100 Then there's the question. So once you have samples, what can you do with them? 01:39:28.100 --> 01:39:32.420 Can you ship them out of Sierra Leone to someone else or to a company? 01:39:32.420 --> 01:39:36.020 And should who pays for that? Should the company have to pay for it? 01:39:36.020 --> 01:39:38.740 Who decides who gets those samples? Right? 01:39:38.740 --> 01:39:43.300 So they would especially when the outbreak disappeared and there there are no more positives 01:39:43.700 --> 01:39:45.540 Who determines the research priorities? 01:39:46.100 --> 01:39:49.860 Academics companies who she didn't mention the patient exact 01:39:50.660 --> 01:39:53.060 And then when we get to data ownership, it looks busy 01:39:53.060 --> 01:39:58.420 But it's all the same question. Data ownership. So who owns the data that you get from that clinical testing? 01:39:58.740 --> 01:40:02.340 Can you transmit it out of the company? Nice. Who pays for it? Or should you have to pay for it? 01:40:02.340 --> 01:40:05.460 Just to get a clinical data. Oh my gosh. It's brilliant. Laboratory data 01:40:06.340 --> 01:40:11.060 Who pays for the transmission? Who's in who's a prioritized receiver and so on? 01:40:11.060 --> 01:40:16.100 So a lot of questions around data ownership. Oh my gosh. Do you understand the subject? 01:40:16.100 --> 01:40:20.580 So this is a sticky area. So this is essentially what we are investigating 01:40:20.580 --> 01:40:25.140 Because why would a PCR testing company started by a porn producer 01:40:25.860 --> 01:40:31.380 Decide to buy $400,000 worth of core facility level sequencing machines 01:40:31.780 --> 01:40:38.020 That could do a hell of a lot more than amplify a small amplicon on a single flagged PCR test 01:40:38.020 --> 01:40:39.860 That doesn't even use nested primers 01:40:40.660 --> 01:40:48.740 Do you understand how absurd it is the little little tiny little tiny 01:40:49.620 --> 01:40:51.620 Piece of the puzzle that I'm working on 01:40:53.140 --> 01:40:55.140 Right now 01:40:56.020 --> 01:41:03.860 How many other diagnostic testing companies were started by people that weren't even faculty members at a university 01:41:04.340 --> 01:41:05.860 That were tipped off 01:41:05.860 --> 01:41:09.620 weren't even biotech entrepreneurs that were tipped off 01:41:10.100 --> 01:41:11.860 But were just people 01:41:11.860 --> 01:41:18.260 That were too dumb to know what they were being tipped off to do that were too dumb to know what the samples were being done with 01:41:18.340 --> 01:41:20.340 after they took the test 01:41:21.700 --> 01:41:25.940 Too dumb to care about where the data would be sent or who would be 01:41:26.740 --> 01:41:33.860 In charge of the samples after they returned the test data to the municipality that was requiring their employees to take the test 01:41:33.940 --> 01:41:39.700 In the first place did they do a whole genome sequencing and send that digital data to some other country 01:41:40.180 --> 01:41:45.540 Send it to ditra send it to nih send it to some company and in in china 01:41:46.340 --> 01:41:48.180 We don't know 01:41:48.180 --> 01:41:52.820 But they certainly had the equipment in the laboratory that would have been able to do it 01:41:53.620 --> 01:41:57.700 And that equipment was extreme overkill for testing 01:41:58.420 --> 01:42:02.900 Using an EUA approved test with a single amplicon not to 01:42:03.700 --> 01:42:05.220 Just one 01:42:05.220 --> 01:42:07.220 No nested primers 01:42:08.740 --> 01:42:10.740 And the testing supplies 01:42:10.900 --> 01:42:17.060 And the test kit reagents were supplied by a company called bji or bci 01:42:18.500 --> 01:42:20.340 Bci I think 01:42:20.340 --> 01:42:24.340 A major sequencing company in china 01:42:25.380 --> 01:42:30.980 With year long connections years long connections already to the human genome project 01:42:31.380 --> 01:42:33.380 Did you hear what I said? 01:42:36.420 --> 01:42:40.740 There was a diagnostic testing company on the west coast 01:42:41.380 --> 01:42:43.380 That decided to apply for an EUA 01:42:44.420 --> 01:42:48.580 Using a test produced by a chinese company that has a decade long 01:42:49.300 --> 01:42:53.380 Partnership with the human genome project one of the largest 01:42:54.100 --> 01:43:00.820 Genomic companies in china decided to provide the testing materials that we're going to get an EUA approval 01:43:01.460 --> 01:43:08.900 By somebody in this lecture series on this day on february 3rd 2020 01:43:10.020 --> 01:43:13.780 A porn producer started a company using chinese 01:43:14.820 --> 01:43:17.860 provided reagents chinese provided 01:43:18.340 --> 01:43:20.340 Primer sets chinese up 01:43:20.980 --> 01:43:23.540 provided but EUA approved 01:43:24.980 --> 01:43:26.980 PCR testing 01:43:27.060 --> 01:43:29.700 For a single amplicon one target 01:43:31.940 --> 01:43:36.100 And they got a contract that resulted in millions of dollars in profit 01:43:37.540 --> 01:43:39.540 From a municipality 01:43:40.020 --> 01:43:43.220 A porn producer decided that that was what he was going to do 01:43:45.380 --> 01:43:47.460 And as I explained at the beginning of this video 01:43:47.460 --> 01:43:51.940 I would have been suspicious of someone that was my colleague at the university of pittsburgh 01:43:52.260 --> 01:43:55.700 A tenured professor that would have decided to attend this seminar 01:43:56.100 --> 01:44:02.580 And see how they could go about getting an EUA for a PCR test and start a PCR testing company in pittsburgh 01:44:02.900 --> 01:44:05.140 I would have been like who the hell called you? 01:44:08.740 --> 01:44:10.740 We should find out who was in this audience 01:44:10.740 --> 01:44:16.020 We should find out every single person that signed up for this and then figure out why the hell were you there? 01:44:20.340 --> 01:44:22.020 Because there were 01:44:22.020 --> 01:44:28.100 Places and people that were participating in this charade taking millions of dollars 01:44:28.660 --> 01:44:36.500 And likely stealing the genetic data of american college students american police officers american paramedics 01:44:36.900 --> 01:44:41.140 american doctors american health care workers anybody that was forced to test 01:44:44.260 --> 01:44:50.980 Because at least one of these testing companies that got a very lucrative contract that no longer exists anymore that had a 01:44:51.300 --> 01:44:53.540 EUA too early to be explained 01:44:55.540 --> 01:44:57.540 Was set up by a porn producer 01:44:58.500 --> 01:45:00.500 That's simply unexplainable 01:45:05.700 --> 01:45:11.860 The illusion is bending too far. It's brittle. It's breaking. It's cracking and this video is incredible 01:45:12.420 --> 01:45:14.420 February 3rd 2020 01:45:14.500 --> 01:45:19.700 In subject need to provide consent for their wreaths for research testing to be done on their excess clinical sample 01:45:19.860 --> 01:45:24.820 And this is an uh, you know a big area of discussion even in a non-entric setting 01:45:25.300 --> 01:45:27.300 But in this 01:45:27.460 --> 01:45:30.900 I can't believe she's saying this human subject. So this is a sticky area 01:45:30.900 --> 01:45:38.340 So does the human subject need to provide consent for their wreaths for research testing to be done on their excess clinical sample and this is an uh, you know 01:45:39.220 --> 01:45:43.380 Does it do they see her and so on so they need a lot of questions around 01:45:46.100 --> 01:45:48.100 Do they subject so this is a sticky area 01:45:48.100 --> 01:45:53.940 So does the human subject need to provide consent for their wreaths for research testing to be done on their excess clinical sample? 01:45:54.100 --> 01:45:56.100 Do you hear she's asking a question does 01:45:56.820 --> 01:46:05.940 The patient need to provide consent because the the college students of america didn't need to provide consent and the university sold those remnants on 01:46:06.900 --> 01:46:08.900 I guarantee you they did 01:46:09.620 --> 01:46:16.020 They sold those remnants on to sequencing companies that probably sold those sequences to china or whoever wanted them the highest bidder 01:46:18.100 --> 01:46:21.620 They might have even taken those sequences and tried to correlate back to the 01:46:22.340 --> 01:46:24.580 To the epic database if any of those 01:46:25.300 --> 01:46:30.900 Children or college students are in that database so they could correlate the genetic data to the epic database 01:46:31.700 --> 01:46:33.700 So 01:46:35.220 --> 01:46:40.740 That's how dark I think this operation was I think that's what she's basically hinting at right here when she says 01:46:41.620 --> 01:46:46.020 Do do do patients need to give permission for their remnants to be used for other things 01:46:47.380 --> 01:46:51.860 That's at the heart of what we're looking at in in on the west coast right now with this 01:46:52.260 --> 01:46:56.180 Extremely shady. How do you explain this guy decided to buy 01:46:56.980 --> 01:47:02.740 $400,000 worth of sequencing equipment that he didn't need in order to fulfill a contract 01:47:03.300 --> 01:47:05.380 That he apparently already knew he could win 01:47:08.980 --> 01:47:17.140 It's because of the remnants of the testing samples ladies and gentlemen the remnants of the testing samples have your dna in it 01:47:17.140 --> 01:47:19.140 And 01:47:24.420 --> 01:47:29.300 This is a you know a big area of discussion even in a non-out break setting 01:47:29.860 --> 01:47:33.620 But in this context, how do you do this language barriers? 01:47:34.340 --> 01:47:37.300 Patients on death's doors as if they actually 01:47:37.300 --> 01:47:39.300 All the patients as if they can 01:47:39.940 --> 01:47:44.500 And then which bodies in country need to sign off on a human subjects research protocol 01:47:44.580 --> 01:47:47.620 And I think this is really critical. This was a complete black box 01:47:48.100 --> 01:47:53.220 Who do you have to ask for approval who needs to give it how many people what order and so on? 01:47:53.220 --> 01:47:56.020 So that so it's a real barrier to making good progress 01:47:57.220 --> 01:47:59.860 Then there's regulatory authority, right, which is why we're here 01:47:59.860 --> 01:48:05.300 So but in practice the question is even once you have these EUA, what does a country do with that? 01:48:05.300 --> 01:48:13.140 Will they accept WHO emergency approval as justification to purchase and provide the tests in their country or not 01:48:13.700 --> 01:48:19.540 Do you have to generate additional in-country data in order to get the country to approve a test for use? 01:48:19.860 --> 01:48:25.460 And if so, who's in charge of that process who's saying yes, and this has been very slow 01:48:26.580 --> 01:48:29.780 I think in all the countries that were affected in terms of actual in-country 01:48:30.100 --> 01:48:32.820 Independent approval of specific tests for use 01:48:33.620 --> 01:48:36.740 According to the organizers which spoke at the beginning of the video 01:48:36.740 --> 01:48:40.100 You can roll it back and listen to or say it that they have been planning this 01:48:40.660 --> 01:48:44.740 This meeting for months, and they're just really excited that it's going off without a hitch 01:48:47.300 --> 01:48:49.620 List of the large scale of the WHO and FDA 01:48:50.100 --> 01:48:52.100 UAs 01:48:52.500 --> 01:48:59.300 So then regulatory continued how do manufacturers actually validate their system when they have trouble getting access to samples 01:48:59.700 --> 01:49:06.740 And biosafety concerns are big and complicate testing and who should be responsible for organizing test validation 01:49:06.900 --> 01:49:13.060 Should it be the manufacturers themselves or should there be some umbrella group the WHO the CDC because remember 01:49:13.620 --> 01:49:17.140 How would anybody in this audience validate their EUA? 01:49:18.740 --> 01:49:24.740 How would anyone in this audience evaluate their potential EUA test unless they had a sample that they could use? 01:49:26.420 --> 01:49:29.140 It's extraordinary ladies and gentlemen what you're hearing here 01:49:30.020 --> 01:49:34.180 How could anybody these of these people develop a test unless again we talked already 01:49:34.580 --> 01:49:41.460 Half an hour ago an hour ago. She said that the sequence was available so people could already start making shit excuse my language 01:49:42.820 --> 01:49:46.660 So it's it's this is amazing. I'm I am having such a good time with this 01:49:47.140 --> 01:49:48.340 Fine 01:49:48.340 --> 01:49:52.420 And then who decides which tests are prioritized? This was a big deal during Ebola 01:49:52.420 --> 01:49:57.620 There was a lot of discussion about this is your test and this is your test and and who's you know 01:49:58.180 --> 01:50:01.860 My tests and so that kind of stuff just shouldn't be happening 01:50:02.580 --> 01:50:06.980 Then there's what I mentioned about approval. So aside from what what what tests can be done in country 01:50:07.220 --> 01:50:09.140 What sample types are approved? 01:50:09.140 --> 01:50:16.260 So in us labs we take this very seriously in terms of going off label requires a whole validation, right? 01:50:16.580 --> 01:50:19.780 So what if WHO says you can test being this whole blood 01:50:20.180 --> 01:50:26.500 But CE marks is you can do finger stick blood or what if WHO says you can do plasma and 01:50:26.820 --> 01:50:30.020 FDA says you can do finger stick like what's approved? 01:50:30.260 --> 01:50:34.980 What can you do and can you do something else that makes more sense for you and this validated or not? 01:50:36.260 --> 01:50:37.220 Okay 01:50:37.220 --> 01:50:41.940 Then there's this gold standard. So this is what I referred to when I mentioned the altona not being a 01:50:42.580 --> 01:50:44.580 optimal benchmark in our study 01:50:44.580 --> 01:50:46.580 What do you do when a lab develop test? 01:50:47.380 --> 01:50:49.540 Looks like it might be best, right? 01:50:50.100 --> 01:50:56.100 Should a lab develop test even be considered as a reference method for everybody and if so, what do you do? 01:50:56.100 --> 01:51:00.900 What kind of valuations must be done in order to make it the method, right? 01:51:01.540 --> 01:51:06.900 Should efforts be made to take the best looking lab develop tests and give it to everybody and if so, who's paying for that? 01:51:07.460 --> 01:51:15.060 And then one thing we found throughout was was that the you know, even what you test how you call the test positive 01:51:15.620 --> 01:51:21.540 Not consistent from test to test. What's the CT cutoff? These are things that are, you know, very deliberately selected 01:51:21.620 --> 01:51:26.980 But to say a test is positive doesn't have a lot of meaning unless you really know how that test performs against 01:51:27.620 --> 01:51:29.620 other benchmarks and so on 01:51:30.900 --> 01:51:36.420 Communication, how do we communicate findings to clinicians in the field if there are if there isn't good infrastructure? 01:51:36.740 --> 01:51:40.500 They need to know what the results are so that they use the test properly. How do you do that? 01:51:40.580 --> 01:51:43.540 Especially if their decision Wi-Fi everywhere? 01:51:44.420 --> 01:51:50.820 So the vision that we we had was this idea of a global emergency diagnostic framework where this stuff could just be figured out in advance 01:51:51.540 --> 01:51:58.740 frameworks and standards for specifically for diagnostic evaluation or ideally development and evaluation in an outbreak setting 01:51:59.540 --> 01:52:05.380 With ideally the major players and experts developing these standards with international input 01:52:06.820 --> 01:52:13.620 And the goals for this would be to have a system systematic framework for diagnostic evaluation so that in advance you would have prepared templates 01:52:14.180 --> 01:52:20.340 For a diagnostic evaluation and you could give them to a field lab. You could give them to a test developer. Give them to the clinical site 01:52:20.980 --> 01:52:27.380 And you could develop guidelines that would summarize for example, what's the IRB process in this country? 01:52:27.780 --> 01:52:32.660 How do you do it? What does it look like? Have a template know what you need to do know what it needs to say? 01:52:33.220 --> 01:52:39.780 So planning in advance who needs to approve it and so on could be an extreme benefit in these situations 01:52:40.340 --> 01:52:45.700 And we already know how that we need to accommodate lots of different types of evaluations. We need point of care 01:52:45.700 --> 01:52:50.740 We need in lab. We need different sample types all of it. We should we can easily prepare that in advance 01:52:52.420 --> 01:52:57.700 Then we need to optimize collaboration between the global leaders WHO and CDC FDA in particular 01:52:57.940 --> 01:53:01.460 There was a lot of redundancy and lack of synergy during Ebola 01:53:01.620 --> 01:53:07.540 There were controversies about which tests to include in multi-test evaluations tests that were left out of 01:53:08.020 --> 01:53:13.780 Multi-test evaluations just because the form wasn't filled out properly and and things that we can avoid 01:53:14.420 --> 01:53:19.700 So we should be doing collaborative bio banking. We should be synergizing together for test evaluations 01:53:19.700 --> 01:53:23.060 You have a set of samples. Let's test all of these different products together 01:53:23.140 --> 01:53:30.420 So we can really see how they compare no standardized samples for she just said that the FDA doesn't like that earlier 01:53:30.420 --> 01:53:33.060 That's pretty funny that she's advocating for that now. Hey 01:53:33.860 --> 01:53:40.660 And then of course communication and we definitely need increased transparency as much transparency as possible for data sharing 01:53:41.140 --> 01:53:42.660 For EUA 01:53:42.660 --> 01:53:48.820 Valuations we found, you know, sometimes there would be an EUA document and it just didn't have still the information that we needed 01:53:49.300 --> 01:53:53.380 In order to compare between tests. We couldn't do that with the documentation that was there 01:53:54.740 --> 01:53:56.740 So there were some interesting 01:53:57.220 --> 01:54:00.420 Points just from the industry perspective and I know there are many industry people here 01:54:00.420 --> 01:54:06.660 This was sapphire who did the gene expert and the point was made companies need funding to do this 01:54:06.980 --> 01:54:11.700 And what do you do about the fact that if if a test is only going to be used intermittently during an outbreak? 01:54:11.700 --> 01:54:12.900 What do you do the rest of the time? 01:54:12.900 --> 01:54:19.300 Can you just divert sapphire's production line suddenly to Ebola away from MRSA and flu, right? 01:54:19.300 --> 01:54:21.220 So these they need to think about this 01:54:21.700 --> 01:54:27.140 And it's particularly important that the testing is to use in a resource limited setting because then you need to keep the test costs low 01:54:27.940 --> 01:54:29.300 um, so 01:54:29.300 --> 01:54:33.780 Funding is is key can't easily maintain large stocks on the shelf 01:54:34.260 --> 01:54:40.020 And so there's this concept growing I can see of surveillance testing and the utility of that for all the reasons 01:54:40.020 --> 01:54:47.460 You can imagine for catching outbreaks early, but also to keep products in motion and to keep them developed so that nothing is dormant on a shelf 01:54:49.300 --> 01:54:51.300 Um, uh, biomareu 01:54:51.460 --> 01:54:58.980 Marc Miller they developed the biofire for Ebola and had some feedback as well the importance of the biome and the 01:54:59.540 --> 01:55:01.220 biofire 01:55:01.220 --> 01:55:04.580 I think was also is still um one of these large 01:55:05.220 --> 01:55:09.940 Panel diagnostics is also a biofire test now with like 17 different targets 01:55:10.420 --> 01:55:13.060 So that company's been around for a while if i'm not mistaken 01:55:13.540 --> 01:55:17.780 The the video is frozen, but I don't think it's it's it's actually recorded frozen 01:55:17.780 --> 01:55:22.420 So i'm just going to leave it frozen. I'm not going to try and fix it questions around who can access the biobank 01:55:22.500 --> 01:55:28.500 Can anybody or do you have to meet some basic standard of performance before you get those those sa samples? 01:55:29.300 --> 01:55:33.060 What are the requirements for ua? Um, how you know, how do you? 01:55:34.020 --> 01:55:39.140 Uh, what what what rules are specific to a given country as opposed to 01:55:39.620 --> 01:55:47.380 Here and so on and and a plug for common procurement systems to make it easier to actually bring tests into different countries 01:55:48.260 --> 01:55:54.980 Okay, so i'm going to finish up status of biobank. So, um, this this is a actually a 2016 review 01:55:55.060 --> 01:55:56.260 but there are 01:55:56.260 --> 01:55:58.260 Ebola biobanks 01:55:58.260 --> 01:56:05.220 As of 2016, um, this WHO review found 162,000 sample stored 15,000 in which were positive 01:56:05.540 --> 01:56:11.940 But there were concerns about how they were stored 116,000 samples. That's a lot of genomes 01:56:12.580 --> 01:56:14.580 um the you know the 01:56:15.300 --> 01:56:20.100 Tenuous freezer conditions and so on so higher lab capacity needed 01:56:20.900 --> 01:56:25.940 Um, but one biobank i learned about preparing for this talk was a biobank is a collaboration between ministry of health this year 01:56:25.940 --> 01:56:32.980 Early own and public health england and this is the Ebola biobank and so they have there's they wrote a paper and uh welcome open research 01:56:33.140 --> 01:56:40.020 About it so you can read about it there, but it's it's an interesting general concept. It's a shared biobank 57 01:56:41.300 --> 01:56:45.220 41 i'm just going to try and see if i can fix this. Sorry 01:56:45.860 --> 01:56:52.740 I'm just going to 5741 if this doesn't work. I'm going to go to basketball pretty soon anyway 01:56:52.740 --> 01:56:55.220 So i'm going to try and reload the recording 01:56:57.220 --> 01:56:59.220 And then see if we can go forward 01:57:02.340 --> 01:57:07.940 I know this is probably not going to work, but hopefully it will 57 right there 01:57:07.940 --> 01:57:15.380 Open research about it and you can read about it there, but it's it's an interesting general concept 01:57:15.380 --> 01:57:21.220 It's a shared biobank Sierra Leone actually owns the samples if anyone wants to have access to it 01:57:21.220 --> 01:57:25.140 They put in an application. They have to get IRB approval in Sierra Leone 01:57:25.700 --> 01:57:28.420 They have to have an mta. There are some ip issues 01:57:28.420 --> 01:57:32.980 But it's a process that they have worked out and there's access to these samples 01:57:32.980 --> 01:57:36.740 So I find this an impressive biobank that emerged from this 01:57:37.540 --> 01:57:42.420 And finally so progress so there is an R&D blueprint that came out after this 01:57:42.980 --> 01:57:46.100 Called action to prevent epidemics planet of action 01:57:46.580 --> 01:57:53.140 So it came in May 2016 and was updated in 2017 and 2018 and their goal was to create a road map 01:57:53.540 --> 01:58:00.100 To accelerate the development and evaluation of therapeutic vaccines and diagnostics for pathogens without break potential 01:58:00.180 --> 01:58:02.180 So a very laudable goal 01:58:02.500 --> 01:58:04.500 Had the list of priority diseases 01:58:04.580 --> 01:58:14.100 But just as as the the previous speaker said, it's really focused on therapeutics and vaccines and diagnostics are kind of the the lower lower end 01:58:14.660 --> 01:58:20.020 The 2020 website for this does mention biobanking, but it is just really not that focused on diagnostics 01:58:20.820 --> 01:58:26.660 Um, so but we can assume that any elements that are focused on funding data sharing biobanking regulatory approval will have 01:58:26.980 --> 01:58:31.060 You know, so diagnostics and biobanking is what she thinks is most important 01:58:31.060 --> 01:58:37.060 And also what the cue and acute intel person thinks is most important boss relevance, but it's not 01:58:39.300 --> 01:58:45.460 But what it does say is something that I agree with which is that everybody will benefit if if the development effort during outbreaks are 01:58:45.780 --> 01:58:47.780 facilitated by adoption of 01:58:47.780 --> 01:58:51.140 Principles that are fair and transparent and have been negotiated in advance 01:58:51.540 --> 01:58:56.580 And I really strongly think that anything we can do together to develop these principles and in a framework 01:58:57.060 --> 01:59:03.620 For actual development and evaluation and diagnostics in an outbreak setting will be very you a very worth it 01:59:04.500 --> 01:59:06.500 So I'll stop there. Thank you very much 01:59:10.740 --> 01:59:12.740 It's quite a few people 01:59:13.220 --> 01:59:16.500 Thank you very much Dr. Pollock very um thought pervert thing 01:59:17.140 --> 01:59:19.860 Okay, we're going to shift gears just a little bit and 01:59:20.420 --> 01:59:24.820 Here from the fda on the perspective on the ua situations 01:59:25.380 --> 01:59:30.660 So join me in welcoming the following representatives from fda and fda representatives if you would come up 01:59:30.740 --> 01:59:33.140 I can go ahead and and sit down in your 01:59:34.100 --> 01:59:36.260 seats up here. You can see their name tags there 01:59:36.980 --> 01:59:41.140 I have real admiral denise hinton fda chief scientist 01:59:41.940 --> 01:59:43.300 Tim stencil 01:59:43.300 --> 01:59:50.260 Md phd director of o ht seven an office of in vitro diagnostics and radiological health for cdr 01:59:50.900 --> 01:59:56.580 Uve sharp phd director division of microbiology devices for o ht seven 01:59:57.060 --> 01:59:58.420 oir 01:59:58.420 --> 02:00:06.180 Michael waters phd shield team leads cdr h rwe tactical team. Oh, I are representative fda 02:00:06.820 --> 02:00:09.620 Um, I understand some of you may have slides 02:00:10.260 --> 02:00:15.700 So mike if you want to come help me at least pull up the slides. That would be great. Okay. It's 313 02:00:16.020 --> 02:00:20.340 Um, I'm going to my excuses. I'm only one handed and it's my left 02:00:21.380 --> 02:00:25.860 I'm going to call and take a break here. Um, I think it's a good place for me to 02:00:27.220 --> 02:00:29.220 To try and cut it in half 02:00:29.780 --> 02:00:37.780 Um, the fda portion of this presentation will be just as good as the in cutel and uh, n i h portion or n i i d 02:00:37.860 --> 02:00:38.900 Persian 02:00:38.900 --> 02:00:44.660 Um, but I I need to get some ducks in a row and get my stuff together and then i'll be back after dinner 02:00:44.980 --> 02:00:46.980 And i'll try and do this thing 02:00:47.300 --> 02:00:50.180 After dinner around seven thirty or eight o'clock when the boys go to bed 02:00:50.660 --> 02:00:54.820 Um, and then we'll do the last half of this. Um, and I think it's going to be a really good 02:00:55.460 --> 02:00:59.060 Um, I mean it's already been very good. We've learned a lot of things 02:00:59.060 --> 02:01:05.140 We learned the most that I've ever learned in eight minutes of video was the the first eight minutes of this video 02:01:05.140 --> 02:01:06.820 The link is in the chat here 02:01:06.820 --> 02:01:12.980 So you can watch it yourself if you want to or try to download it using the instructions that where I think provided by suit spider 02:01:13.460 --> 02:01:21.380 Had giga ohm dot bio. Um our soapbox over there. So a lot of fun things are happening. Um, uh, we're we're making progress 02:01:21.780 --> 02:01:24.580 I do uh really feel as though we are still 02:01:25.300 --> 02:01:29.860 Um in this state where we are being consciously and intelligently manipulated 02:01:29.860 --> 02:01:35.060 And so we need to start really being um, highly highly aware 02:01:35.700 --> 02:01:41.620 Of the fact that um, there are people who believe that we that it's okay to govern us like this 02:01:41.700 --> 02:01:48.420 There are people who believe that because of the nature of human population and coming generations 02:01:48.500 --> 02:01:53.540 And the imperative to collect this data in order for us to get anywhere before this population is gone 02:01:54.180 --> 02:01:57.300 Um, I think we are being actively bamboozled and so 02:01:57.780 --> 02:02:04.340 Ladies and gentlemen, please stop all transfections and humans because they are trying to eliminate the control group by any means necessary 02:02:04.820 --> 02:02:06.100 and uh 02:02:06.100 --> 02:02:09.700 We will see each other, uh in a few hours. I think if all goes well 02:02:09.700 --> 02:02:15.860 Um, I'll post something on soapbox if i'm gonna cancel on you, but I don't think I will. I'll see you after dinner 02:02:39.700 --> 02:02:41.700 So 02:03:09.700 --> 02:03:11.700 So 02:03:39.700 --> 02:03:41.700 You