From 5e6c2a4b691536dd6c59894403856a4ec8d4586d Mon Sep 17 00:00:00 2001 From: Soothspider Date: Fri, 5 Apr 2024 12:56:26 -0700 Subject: [PATCH] AI Captions. Apr 5. FDA Study Hall --- ... - FDA Study Hall LIVE -- (5 Apr 2024).vtt | 4430 +++++++++++++++++ .../README.md | 6 + 2 files changed, 4436 insertions(+) create mode 100755 twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024).vtt create mode 100644 twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/README.md diff --git a/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024).vtt b/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024).vtt new file mode 100755 index 0000000..7319b44 --- /dev/null +++ b/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024).vtt @@ -0,0 +1,4430 @@ +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 + diff --git a/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/README.md b/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/README.md new file mode 100644 index 0000000..0acb60d --- /dev/null +++ b/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/README.md @@ -0,0 +1,6 @@ +# FDA Study Hall LIVE -- (5 Apr 2024) -- Gigaohm Biological High Resistance Low Noise Information Brief + +## Streams +- https://twitch.tv/videos/2111594956 +- https://stream.gigaohm.bio/w/mSyQpw9gNejxtGVjRjcgmL +