WEBVTT

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I think we're going to start again because my wife took the kids to the gym and I missed

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the ride by about 30 seconds that's why actually the stream was still on and I was still doodling

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because I was trying to figure out where the car went and then I think I just realized

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that what happened was my wife took the kids to the gym which means that I can finish this

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stream now as a second edition and then do something else after dinner to earn my bread.

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So I'm going to go right away back to this and that means that I'll cut over here, I'll

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put this one up, I'll get over to this one.

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And I will head to the gym after this is over with and meet them after they're done shooting.

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So they have this thing, you can look it up on the internet, it's called shoot 360 and

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it's a little like workout place just for basketball and they get a half an hour of

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shooting on like a rebounding machine and they also get like a half an hour of ball handling

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and so they do that by themselves and then after that we play and so usually during that

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hour I have a podcast in my ears or something like that and I'm shooting around on the big

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gym. So it's a pretty nice place to go because it's also in this giant building that has

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a full-size soccer field inside of it and so you just get this kind of very spacious

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feeling, it's a giant gym with a giant place to shoot buckets and also it has soccer going

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on and stuff so it's kind of like a little funny temple of sport. So that's where they

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are now, I've got about 45 more minutes, I think that's all I need to finish this.

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So I will escape out of here and we'll just let Uve continue to explain the subtleties

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of getting an EUA from the FDA in February of 2020.

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The guidance describes FDA's current thinking on this topic and should be reviewed as a

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recommendation unless specific regulatory or statutory requirements are cited. The guidance

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is applicable to all devices as defined under Section 201 of the Act. As you've seen earlier

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in Dr. Tense's presentation, for the purpose of the guidance, real-world evidence is defined

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as data relating to patient health status and or delivery of healthcare routinely collected

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from a variety of sources. For example, real-world data include data derived from electronic

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health records, claims and billing, data from products and disease registries and data gathered

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from other sources such as mobile devices. For the purpose of the guidance, real-world

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evidence is defined as a clinical evidence regarding the usage and potential benefit

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or risk of a medical product derived from analysis of real-world data.

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The regulatory context in which real-world evidence may be used, FDA will consider the use of real-world

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evidence to support regulatory decision-making for merit devices when it concludes that the data

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used to generate the evidence are sufficient quality to inform a supportive, support a particular

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decision. Real-world data may potentially be used as some or all of the evidence necessary to

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understand medical device performance at different points of the total product life cycle. For

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example, real-world data may be used to generate hypothesis to be tested in appropriate clinical

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study or be used as evidence for expanding the labeling or to include additional indications for

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use. I would like to mention the guidance does not change FDA's standards for regulatory decision

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making and in each context we will evaluate whether the available evidence is of sufficient

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quality to address the specific. So I assume that he's going to be evaluating it when it comes to

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EUAs that he himself has granted and that's where I think this regulatory scheme starts to become

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incredibly sketchy because you might think that there might be an ACIP equivalent here but there

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isn't there's just this one guy who they sheriff and a maybe a couple equivalents that are able to

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give EUAs they make the decision and the context in which that decision could be made is solely

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dependent on what he considers good and if it's all real-world data that he makes that decision on

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all the better clinical studies can now be based on real-world data that includes data from medical

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devices, mobile devices, disease registries and electronic health records. Do you see how a national

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security priority could really streamline the use of an electronic health record to cross-reference

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and verify a disease registry or cross-reference or verify mobile device data? Do you see where

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a national security priority event could put a German-speaking American guy in front of you

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telling you that he is the firewall between you and a wholly fraudulent set of diagnostics being

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used to create the illusion of a pandemic? This is our firewall right here, this guy

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and his angry presentation that he's being seems to be forced to being given right now. It's

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extraordinary regulatory decision being made.

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So what are the characteristics for real-world data to support particular regulatory decisions?

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Please note that the FDA does not endorse one type of real-world data over another.

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They're all the same. They're all great. Assess the reliability and relevance of the source

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and the specific elements to determine whether real-world data sources and the proposed analysis

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can generate evidence that is sufficiently robust to be used for a given regulatory purpose.

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The primary factors FDA considers are assessing the reliability of data include data approval

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that is how the data were collected and data assurance that is whether the people and processes

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in place doing data collection and analysis provide adequate assurance that errors are minimized

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and that the data quality and integrity are sufficient.

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Real-world evidence might be used in support of regulatory decision-making in several situations

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as listed here. For more detail in all of the

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sections, I refer to section six of the guidance.

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So before I end, I have two slides where I want to address a couple of questions,

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common questions from sponsors which plan to transition an EUA IBD product to a full market

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application. The first question is, can I use the analytical and clinical data obtained for an

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EUA authorization? The answer is yes, if new modification to the device has been made since

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the authorization. However, if modifications have been made, then the risk assessment of the

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modification will be required to determine to which extent the changes to the device would

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influence its performance. For clinical data, it's important to assure that the comparator

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method used to determine the truth of the specimen is still viewed as an acceptable

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preference method. And the second question, can I use generated the data outside of the US

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for my FDA submission? The answer here is yes as well provided that the test procedure and

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performance, the test procedure was performed according to the package insert with no deviations.

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We encourage sponsors to contact early, as early in the development for questions

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concerning the use of EUA data to support marketing submissions.

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The last question, can real data be used to help support the advancement of EUIBD products

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through full marketing status? As stated in the guidance, I just reviewed

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under the right conditions, yes. Data derived from real-world sources

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that potentially be used to support regulatory decisions. And under the right conditions,

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real-world data and associated real-world evidence, they constitute valid scientific evidence

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depending on the characteristics of the data. As I mentioned earlier several times,

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we encourage sponsors to contact us early in the development for questions concerning data to support.

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So data derived from real-world sources becomes validation. That's what we're doing here now.

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We're allowing these EUA devices to be rolled out and then for them to collect their own data,

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report their own results, call it real-world data and be a source of validation for a market

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approval submission. And it's as simple as that. He's telling you exactly how it's done. Yes,

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it can happen. This is the way it's done. This is where the reliability has to be feigned.

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This is where these are the benchmarks that you need to meet. That's what he's saying.

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It's extraordinary.

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Marketing market applications. This is my last material slide.

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I want to thank my division, the whole staff of my division of the Division of Microbiology

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Devices. Everybody is one way or the other involved in EUAs. And I would like to especially

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acknowledge the individuals listed here because they have performed the heavy lifting in most of

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the EUAs that we have seen. All those thanks to OC and OCC for their continuous help as well as

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to our colleagues from SIBO who have helped us with standards which you will develop.

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These are the individuals who make EUA happen. They have stand up to any call of an emergency

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and they have worked tirelessly over weekends to make these devices available to the public as

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fast as possible. Thank you.

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Tirelessly over the weekend.

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And so that guy was essentially what he said was that he is the head of all the EUA because

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this whole division of microbiology devices is EUAs, this whole department. So the division

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of microbiology devices, isn't that an interesting division to be the head of for 20 years?

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To get three houses for heading to not lose your accent?

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Really wanted to thank everybody. It's good that we've got incredibly good time

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for making out your critical positions, isn't it?

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As a note to the Office of the Chief Scientist for actually being able to help facilitate a lot

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of this work in the medical device innovation consortium where we could actually get a conference

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together in very short time. So Frank Whitehold in particular has been in short time.

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The ladies that started the conference said that they've been organizing this for months.

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What is he talking about? Is that a short time to him?

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Incredibly important in actually helping do a lot of the background work that is

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helping facilitate hopefully the future for the collection of rural evidence.

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And so to go on with Dr. Shur and Dr. Stenzel we're actually talking about

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just let's drill down just a little bit more in the rural evidence and fundamentally

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while he wants to drill down the real world evidence.

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There was a 21st Century Cures initiative and we had the FDA reauthorization act

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which led to Meduva for commitments actually to help get pre-imposed market information

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to support regulatory decisions across the breadth of which.

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That was a mention of something very important.

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The 21st Century Cures initiative.

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21st Century which led to Meduva for commitments actually to help get pre-imposed market information

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to support regulatory decisions across the breadth of which it could pop.

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A huge amount of real important legislation that underlies the possibility of pandemics.

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Being executed in the way that they were executed this time is found in the 21st Century Cures

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Act and initiative. And I strongly recommend that everybody look into that if you've never

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heard of it before. I am a little bit less informed about this one that I am about prep

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and about the National Vaccines Act but this one is essential and it's a part of this stepwise

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move toward the prep act. And so I need to read into this as well but it's interesting

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that he mentions that one as being pivotal.

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Completely used. And underneath that the medical device innovation consortium has the

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national evaluations system for health technology to help develop a space where real

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evidence could actually fundamentally be used. Now in the Center for Devices and Real Logic Health

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we actually have a strategic priority to do this and part of the strategic priority was

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this guidance that that Uva just talked about which is a cross-center harmonized effort.

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Now again you're probably going to see this many times throughout the day but

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that context of collecting information from a real clean health care setting.

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Obviously that information if it's going to be collected it's going to have to be analyzed to

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be able to be used in the context of valid scientific evidence. Now what are we talking about?

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In the traditional setting you know obviously many of you are familiar with the fact that

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studies are designed and they're conducted and analyzed. And then when those devices go out to

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market I please note the context here that an ID is probably not necessary in every single

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situation. In some cases it might be and I would refer to the Rural Evidence Guidance

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to actually provide the context for that but when those devices actually get to market

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or get to actual use in a health care setting they begin to help generate data.

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Then that data when it's generated is done in a natural health care setting and then the question

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is how can we collect and analyze that information so it can actually be useful. And so this is an

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unprecedented shift in the way we think about medical records and medical data and they are

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shifting it at a very opportune time right before the pandemic starts when we're going to grant 200

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plus EUAs for diagnostics that could actually be the data collection that could be reflected back

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on the nationwide electronic medical records etc. They are talking about a national

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security priority here right this is a national security priority and so all of this talk about

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what to do with the data and how to collect it has built into it these national security priorities

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which may actually lead to them doing things that they wouldn't otherwise do collecting data that

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they wouldn't otherwise do and interfacing with electronic medical records in a way that they

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wouldn't otherwise do in order to facilitate a national security priority of moving more EUA products

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to full market approval I can't write worth a damn when I'm actually talking while I write and

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trying to write what I'm saying because then I try to write too fast so what does this say moving

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more EUA products to full market approval I should write that without so such scribble scratch here

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but that's the national security priority that has been ascribed to the entire seminar

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I'm so glad I got to close this out with a little bit of a of a closer here because it's really

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this is really summarizing the last three the last three so well as we looked at this seminar from

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February 3rd 2020 what we are seeing is that the national security priority is not the safe and

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effective products that are rolled out but it is getting more EUA products to successfully get

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to full market approval using this shift from having to go through a pre-market submission system

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to being able to use real world evidence gathered during the EUA stage to get through the approval

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process without having to go through all this pre-market submission stuff

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replacing what was required in a pre-market submission as outlined by Louvay sheriff that includes things like

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that includes quality control that includes precision that and now can instead be substituted

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within silico evaluation and no full validation is required and and that means that all of these

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things can in theory get through with real world evidence that has been misconstrued as validating

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their effectiveness and that is a very dangerous place to be had February 3rd 2020 February 3rd

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it hasn't even started yet and we're already throwing all regulatory systems out of the out of the

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out of the window and having a german national with a thick accent explained to us how we can

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circumvent the traditional methods of pre-market approval before full market approval of the FDA

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by getting an EUA and doing everything with real world data that can even include things as mundane

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mobile device data never mind data from other EUA products right which could also be used to

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evaluate whether or not the virus was there and so then one EUA product is validating the

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effectiveness of another EUA product don't you see it holy cow it's amazing in that space

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fundamentally we need data quality data quality is a very important key yeah it's all processed

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data quality understand what the information is inside of a health care system exactly how

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are you going to be able to use it now this question is the common question

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that really drives the next statement of what is valid scientific it's fundamentally so per

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our regulations you can submit anything you want to but fundamentally we can only rely on

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valid scientific evidence and to be a little more clear about what valid scientific evidence could

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be it really is a very broad breadth and range um well controlled investigation parcel controlled

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studies objective trials and even reports of significant human experience if it can actually

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be determined that you know by qualified experts that there's reasonable assurance

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of safety and effectiveness that are real world personal experience can also be used to evaluate

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the effectiveness of an FDA device here he just said those words you want to hear him say him again

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I'll roll it back half a second now information

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objective trials and even reports of significant human experience if it can actually be determined

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that you know by qualified experts that's impressive there's reasonable assurance

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to say from the fact that information that's impressive that's impressive and has been used

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support regulatory decisions it doesn't always follow the traditional space but certainly

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it's noted that things that are weird really can't be used as valid scientific evidence is it's not

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logical a rationality section kind of be taken into place so what is not regarded as valid

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scientific evidence is your isolated case reports are random experiences um if you don't have enough

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detail around it how do you actually use utilize that information this is where the key comes in

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so all we care about the end of the day is information that's fit for purpose and the appropriate

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yes he did of a particular setting so we're talking he did he said weird things we don't use

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weird things weird things are not generally scientific but you know it's a individual evaluation

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basis talking about information that's relevant and reliable we have to be able to make a determination

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fundamentally that the benefits outweigh the risks and that we can actually utilize that

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information and throwing in a little extra complexity into that setting of course is that we try to

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make sure that patients information is properly protected so we have harmonization for that

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information it does become a little more understandable at how you can actually navigate patient

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protection information and get high quality information out so in the rural evidence space

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now he's using very big words to describe how they are going to try to protect people's personal

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data while using it to evaluate EUA devices I don't think you can hear it any other way he

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used the phrase here at the bottom information harmonization do you know what that is that's got

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to be the the interface between an electronic medical record database and the database of a

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pharmaceutical company the database of a social media company interfacing with the data from a

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electronic medical medical record database would be information harmonization and talking about

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how to anonymize make all anonymous the data or to protect people's personal data

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is precisely what you would talk about if you intended to use a national security priority

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to allow people to create information harmonization when that would no way shape or form be allowed

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under the normal laws governing medical data and its use

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that's why he has to use these big words and talk with such obfuscating sentences because

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he doesn't tell you want everyone to understand it does become a little more understandable

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at how you can actually navigate patient protection information and get high quality

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information out so in the rural evidence space the HIPAA privacy role is how we operate for

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helping protect that information and the understanding that not everything in the research space is

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covered under under HIPAA that the access and use for the common role helps provide a little

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additional context there but that being said information in the rural setting has been used

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in many different spaces there for indication expansion for new indications for condition of

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approval in both a pre-market and post-market setting and all these slides will be available

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online if you want to do a deep dive but there has certainly been information collected from

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multiple different venues and the point is please be creative and don't limit yourself

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to that information. The perfect example which I think may have a degree of applicability

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in this setting in particular is the note of an ability to actually utilize a publicly maintained

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database when we actually partner together what was able to happen here in the next

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chance sequencey space and I think that something that could be replicated in an EUA space next

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gen sequencing appropriately set up is in lieu of full traditional studies what we're able to use

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is information directly harvested from a publicly retained a publicly maintained database because

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there was collaboration that happened up front between the sponsors between the database folders

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and between FDA and when we actually partner together to get interoperability for that data

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and establish appropriate quality checks which are achievable it was achievable in this case

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and it'll be achievable in the future we can actually work together if you have questions

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about real-world evidence there is actually an email address if you don't want to contact

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the divisions directly you can you can email c3h clinical evidence at fda.h just.gov and if you

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want to learn more about some of the public private partnerships you can contact c3h clinical

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evidence at fda.h just.gov or if you want to learn more about shield in the diagnostic space you can

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contact me thank you so thank you to all of the fda colleagues for sharing the fda perspective

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today I think it sets a wonderful foundation for our discussions today and I look forward to

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your engagement throughout the day as well we're going to take a break now and I'm going to make

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a deal with you you guys silence your phones I'm hearing some phones and I promise we'll work

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on getting those technology smoothing up here how's that for a deal wow so they're done that

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was the end of that one and that's fine I knew it was not the much left because I didn't want to

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leave it till after practice and then have to do that so we are still here ladies and gentlemen

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at the same place where we have been for a very long time

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oh I didn't mean to do that I apologize

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you like that thing though I don't think it's that bad it actually looks pretty good that's also

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render forest you know render forest is kind of fun so that was the last part of the market seminar

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we won't do that one anymore I've taken my notes I've got my stuff I've got a lot more work to do

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on Uve Sheriffs patents and some of the country companies that he worked for and we're going to

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look at I'm going to look at some of his publications and try to decide if it's possible that maybe he

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was doing more than just giving out EUAs maybe he was involved in the Human Genome Project or

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in collaboration with companies that were involved in the Human Genome Project and

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that might give us a clue to why he was in charge of giving away diagnostic EUAs

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and and why it would be that EUAs would be given away by single people or by some weird

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division called microbiome microbiological devices which is a very bizarre thing

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so thanks for coming back for the last half hour if you missed it live thanks for coming back and

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checking it out I will try to be on later this evening and later this evening I've got at least

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a list of 20 or so things that I could cover and so we'll just see which of these pending

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sort of study halls that is necessary to do that I'll do at eight o'clock and I'll see you then

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thanks very much for coming and we'll be back soon

