Stream.Transcripts/twitch/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024)/2111594956 (2024-04-05) - FDA Study Hall LIVE -- (5 Apr 2024).vtt

WEBVTT

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You

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You

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You

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You

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I

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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

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I think it's like really important not to be a liar

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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

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Tall trees catch a lot of wind get ready for some wind

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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

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Trying to hit it

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That's a good question. I did not turn on YouTube. I'm sorry

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I didn't that I won't be able to do it now. I would have to do too much

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I'm just gonna leave it off a YouTube is not streaming right now. Sorry about that Schumer, but thanks for checking

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I

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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

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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

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That is stored on the FDA website and so rather than just watch this video on my own

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Without any fun help or commentary in the background. I thought I would share it with you

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And yeah, let's let's see if this works

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If you've been here for a while, then you know where you are if not

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Welcome to the welcome to the show. We have at least one person here who may be a recovering skilled TV watch

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You're finding us for the first time where we stay focused on the biology

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We don't take debate on TV and we love our neighbors. Welcome

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This is how it works people just keep sharing my work

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So if you're here for the first time, please understand that if you enjoy it the best way that you think

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You can help is not necessarily to send coin but to actually share it with people that you know haven't seen it

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Because there's a lot of people out there that have not seen it and need to be exposed to this biology

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But if you've been here a while and you think you can support please

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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

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I mean, I'm part of that family of five

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And so all of this is really a family effort

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And it's not without the support of my family that would happen. And so you can support us at Giga on biological calm

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You can also find all different ways to share us there and ways to connect with me, etc

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I do play this list every morning and every afternoon although it's not complete right now

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Some people don't want their name on it, but it is not as large as it needs to be

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and so all

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subscribers are welcome

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That is about 120 people right now, so it's not a very big group of people that's that's coming together

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And so each one of these people is a little tiny bit

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Part of making this happen. I can't take credit for doing this on my own

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The independent bright web is something that we're trying to start here a movement of citizen journalists

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citizen archivists citizen historians

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That are trying to take back the narrative take back our republic before they teach this mythology

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Mythology to our children, and we can no longer get them back. That's really where we are

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This illusion is sustained through our active participation and if we can't convince

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college age kids and young adults young parents to

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Extract themselves from participating in this illusion

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We may we may lose what what we now call freedom and sovereignty forever for generations to come

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And so the way we do that is united non-compliance

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We don't participate

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We may really need to do something as drastic as not send our kids to university for a few years

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That wouldn't be an impossible movement

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especially with people like myself and others who can provide the learning online and

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provide the network of

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activity and and and learning online the

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Substitute for for that university system, which is right now just one giant grift where they pay

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Where they pay

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Deans and and and associate deans and and and assistant deans and

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And football coaches and football staff more than they pay their faculty and their working postdocs

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And it's a real it's real terrible

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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

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Hello, good to see you

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This is giggle and biological high-resistance low-noise information brief brought to you by a biologist

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That biologist's name is Jonathan Cooey. That's me. I'm coming to you live from Pittsburgh, Pennsylvania

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the back of my garage

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and

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Thank you very much for coming

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Today we are still trying to penetrate this conscious and intelligent manipulation of our organized habits and opinions

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The way that this has been accomplished is

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over decades and

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if you want to get a glimpse

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into

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how

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ready

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How the dominoes were all lined up from the beginning of the pandemic

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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

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What concerns they really had what priorities they had what part of the train they wanted to grab onto and pretend they were stopping

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What part of the train did they want to push on to say that they were helping

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These people were orchestrating a theater and I think if you see

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And if we take a look at some of these

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Mashingations early in the pandemic we're going to see something that we never thought we would see

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And so i'm excited to bring you this possible

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insight

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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

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and so

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I am going to watch the whole video

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So and i'm not going to watch it at too much speed mostly because I don't think I can adjust that

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because the player

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That the hold on let me go down here

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The player that the

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Sorry that the

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I don't think I can adjust it so you're just going to have to deal with it

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And it's a weird recording. I couldn't download it. It's like broken up into two screens for a while

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We're just going to have to cope

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What this is and I think we'll get an exact

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Read on what it is if I click play that i'm just going to try to preface it first a little bit

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Um, if you wouldn't mind go check on on stream dot giga ohm dot bio and just see if everything is going okay

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Um, and if you notice, um, if you leave a comment in

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Oops not that one if you leave a comment on

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Um

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On the stream dot giga ohm dot bio

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Chat then I can put it up here on the screen and we can we can answer questions that are in that chat

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I'm trying to encourage people to use that because I want to see how much traffic it can handle

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I wanted to see if for example, I was kicked off of twitch

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And I primarily streamed on peer tube how many people can it handle that kind of thing

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So I understand it's a little annoying to go over there or to click on that

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But um, anybody that does have the bandwidth and wouldn't mind doing it. I would really appreciate it

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So I'll go back over here to this thing

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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

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Is it's a room full of people?

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Who are going to get euas

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Maybe even

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Like robert melon and steve kirsch are sitting in the audience waiting to figure out how they can get an eua for from

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Monoten from ota dean or selek oxib or whatever other things they were interested in

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I find it very interesting that I think

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I think steve kirsch was pushing something else other than ivermectin on brett wine steins podcast

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and I think it was also a

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substance that was identified by the domain server, although i'm going to have to go and check all these things

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Mark has done a couple really great shows mark husatonic live

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Mark hulak

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If you're not familiar

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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

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Archivist one of the best out there and he's been doing a lot of reporting lately brief reports on how

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ditra and

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and the domain and the domain program and all these things were really integral in in coordinating our perception of

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the response and also

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sort of seating a number of

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What we can now see as narratives which which forward the idea of a novel virus which needs novel solutions

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And the domain was this AI program that supposedly ditra ran with the help of robert melones team

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Where they scanned all of the known pharmaceutical products on the fda register to see if they would interact with the three lc

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three cl protease that robert melones team had made a virtual computer

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3d crystallography model of it and then

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I don't know he said at some point dontami's podcast that they also use laser scanning confocal microscopy

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But I don't know how that interfaces with a 3d

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virtual model of a crystal of a of an enzyme but anyway

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He purports in three weeks or so to have helped ditra in this program domain or using this program

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to have

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Scanned all of these things and and predicted which ones would work and it's supposedly it spit out remdesivir

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hypermectin cellococcib and

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Fomotidine and then they all went to work testing them

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And uh, so that's what we're supposed to believe but at the same time

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Of course, you know that the fda was interested in giving out euas for testing

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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

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More than 250 by the time we got to

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2021 so that means roughly 200 give or take different

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Methodologies different sets of proprietary variables that were involved in declaring covid or not covid

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We're circulating and being spent money on in america

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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

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Right when they're starting to encourage everybody who has the entrepreneurial skills or resources to go into this and help

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The response of the nation so i'm really curious as to how

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Morbid this must be because it must have been a very scary time

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When they thought they had to have an emergency meeting about emergency use

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Authorizing all kinds of things that they otherwise wouldn't have needed if it wasn't such a crisis

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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

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There we go. Everybody can take their seats. We'll get started

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Like I said, I'm not going to really try to speed it up or anything

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You're just gonna have to follow

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According to fda's website hhs has declared six emergencies that have authorized fda to issue emergency use authorizations

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For unapproved and vitro diagnostic tests to diagnose. Wow. Did you know that?

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And those were for america coronavirus and avian influenza in 2013

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Abola in 2014

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Evie d68 in 2015 and zika in 2016

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Wow

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Last week the secretary declared an emergency

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Wait, wait, wait, wait, wait, wait, wait, wait. I gotta hear that. That's crazy

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avian influenza

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This website hhs has declared six emergencies that have authorized fda to issue emergency use authorizations

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For unapproved and vitro diagnostic tests to diagnose the disease

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And those were for america coronavirus and avian influenza in 2013

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Abola in 2014

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Evie d68 in 2015 and zika in 2016

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And last week the secretary declared an emergency for the novel coronavirus some called the wuhan virus

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Well, some of the tests authorized under the eua provisions have been cleared or approved by the fda

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Many were never submitted to the agency for approval

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Good morning. Okay. So

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Just just so you're aware already what we just wrote down six emergencies in

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2013 it was avian flu

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And it was

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mares in 2014 it was ebola in 2015 she said evd 68

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And in 2016 it was zika so

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Six emergencies who were declared where emergency use authorizations were given to things

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Do you see what this means already is something that's never been on my radar before that this whole this whole

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This whole circus has been fired up before

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This whole

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Drill has been done before complete with contracts and proposals and money exchanged and paid out

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Do you see

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Patents made products tested trials run six times since 2013

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Why wasn't there why didn't she list sars in 2002

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You know what I think that reveals I think that reveals that there was some kind of legislation between the original sars

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And whatever happened in 2013 where they did it twice avian flu and mares

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That's a pretty extraordinary first 25 seconds of a video. That's pretty badass is what that is

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um

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Okay, now i'm going to let it go again. Well, and welcome to the mvic fda workshop advancing euahibd products toward full marketing

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status

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Um, i'm tennel miller chair of the medical device innovation consortium. Okay. So look at that title already

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it's advancing euahibd

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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

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So we're talking about getting an euah product

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full approval

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February 3rd

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2020

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We're still a whole month away from 15 days to slow the spread and they are already talking about euas

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being

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a pathway to full marketing status ladies and gentlemen

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If you rehearsed it six times in a row

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2013

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2013 2014

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2015 and 2016 it's not really surprising that they fired it up like this now is it

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They just did event 201 four months ago

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I hope you're starting to see why this is a much more valuable video than I ever thought it would be already

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clinical diagnostic steering committee and i'll be your

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master of ceremonies for today's workshop

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Although the timing is nearly perfect. We plan this workshop long before the wuhan coronavirus made headlines

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And today is not specifically about the coronavirus and I wanted to be clear on that

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Nonetheless to does today's discussions could color the path forward

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This workshop explores the challenges in moving euah products to full marketing status through denogo

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fighting k or pma

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Or over the course of the day. We'll discuss the issues and consider potential solutions that could apply broadly

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Many of which are likely much larger than fda

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And require stakeholders of all different viewpoints and backgrounds to come together to collaborate

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on finding reasonable solutions

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Also, we don't have the experts around to engage in lengthy conversations about certain topics such as patent law

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So we won't we're talking about those

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Today we'll look forward to learning about lessons learned

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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

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to full marketing status

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But before we get started this workshop is the result of many many people working behind the scenes

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And I'd like to thank our fda colleagues

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doctors jennifer ross and kim sapsford and mike waters for their assistance

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As well as the many other volunteers from various government agencies and the ivd industry

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That work to make today's workshop possible to our speakers and panelists in advance who came from literally around the globe

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Thank you for generously sharing your time your expertise your slides your information

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Now i'd like to introduce our first speaker pamela goldberg

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Pamela is just so you know that that overload is in me. It's overloading no matter how loud i put it background

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On md. I see the medical device innovation consortium pamela

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I agree the vocabulary is incredible. I mean this is shocking to me quite frankly

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Thank you dinnell and welcome everyone look at the smile on her. We're really we've been

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planning this for a few months and

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What couldn't be more timely?

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Those of you who don't know md. I see the medical device innovation consortium

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We're a public-private partnership that got created a number of years ago

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When there were frustrations about the regulatory science process

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and um, but we bring together industry and

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government

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patient advocacy groups

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nonprofits and

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And academic they have been planning this for months

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It's february third. I wonder how long months is

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Is that since november or october?

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event 201 happened in october

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The first uh brat we Weinstein podcast was around that time

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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

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We won't be able to tolerate any anti-vax views

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And brat agreed

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Do they not do these people actually believe the lie that they're telling themselves that it just happens to be

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That we got told to plan a conference on euas

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And it just happens to be arriving at february third

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Who it won't be completely about the coronavirus, but it could be that this meeting just happens to determine all we do that

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Are you kidding me? Could they possibly be that naive?

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I'm afraid it's true

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I'm afraid there are a lot of people inside of our bureaucracy that are exactly that naive

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Exactly that naive because they have a salary

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That makes them comfortable with being exactly that naive

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They have a job security that makes them feel comfortable with being exactly that naive

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Make no mistake about it ladies and gentlemen. She's smiling because she loves her job

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She thinks honestly that she is part of an apparatus that saves lives and she's proud of it

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She gets a good salary for it. She's got a great house. She's got she gets prestige and she gets

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Reinforcement from her colleagues people look up to her

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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

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Exactly how useless what they're doing is or potentially could be

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And that's how deep this goes

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We must wake people like this up to see that this is possible before they'll ever even believe it's true for them

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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

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It's like an hour and 50 minutes

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medical centers all to

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Share the story about how do we get patients better products faster safe or cheaper and we do that through a number of pathways

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Both in the diagnostics world

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but

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Throughout the medical device industry and so we're really excited to put today's event together

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When we first started talking about this event with the diagnostic steering committee

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It was a great idea and who should we bring to the table and

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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

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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

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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

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And uh, thank you all for being here and I look forward

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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

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Solutions to support the missions of the united states intelligence community

32:17.540 --> 32:21.400
She specializes in biodefense emerging infectious diseases

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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

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And critical care medicine at john's hopkins and the national institutes of health

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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

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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

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Great to have you nice

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Is that lavender? Thank you for this kind introduction and good morning everyone

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I very much appreciate the invitation to be here with you this morning

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As some of you know, I spent almost 10 years working here at fda

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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

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That emerged in china at the end of last year. She's reading

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Normally we have to remind people that we live in an era of epidemics

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We talk about how infectious diseases emerge and re-emerge continuously

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most often and predictably

34:23.060 --> 34:25.060
That some can travel the globe quickly

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while others devastate regionally

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But either way these epidemics can cause havoc to their communities lead to lots of life

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Make health care workers vulnerable disrupt economies

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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

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Epidemics even cause people to lose faith in their governments

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It is extraordinary. This is the model of the world that they want everyone to assume

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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

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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

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Enchanters

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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

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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

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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

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And sadly this number represents the very tip of the iceberg

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As this virus continues to expand its footprint and spread around the world

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And although we have learned from the past and we have made significant progress in combat and epidemics

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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

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So as preceded my remarks this morning, I would like for you to keep in mind one theme

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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

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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

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All of the easy things that could have been done by single individuals or institutions have been done already

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So progress will require collective and hard work

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In 2003 when the SARS coronavirus took the role by surprise

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There were very few tools in place in the United States to rapidly combat emerging infectious diseases

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The animal rule

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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

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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

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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

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On EU way for diagnostic tests. That's impressive

38:42.660 --> 38:44.900
So we we were talking about this earlier, right?

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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

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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