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# FDA II Study Hall LIVE -- (10 Apr 2024) -- Gigaohm Biological High Resistance Low Noise Information Brief |
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## Streams |
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- https://twitch.tv/videos/2116198929 |
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- https://stream.gigaohm.bio/videos/watch/qZvw7WKaSuUgA3hPAUXV8Z |
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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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19:54.700 --> 20:00.300 |
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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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24:03.980 --> 24:09.260 |
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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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24:09.260 --> 24:15.820 |
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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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25:15.180 --> 25:22.860 |
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he doesn't tell you want everyone to understand it does become a little more understandable |
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25:22.860 --> 25:27.500 |
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at how you can actually navigate patient protection information and get high quality |
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25:27.500 --> 25:36.780 |
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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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25:36.780 --> 25:42.780 |
|||
helping protect that information and the understanding that not everything in the research space is |
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25:42.780 --> 25:49.100 |
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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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25:49.100 --> 25:57.020 |
|||
additional context there but that being said information in the rural setting has been used |
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25:57.020 --> 26:03.420 |
|||
in many different spaces there for indication expansion for new indications for condition of |
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26:03.420 --> 26:07.900 |
|||
approval in both a pre-market and post-market setting and all these slides will be available |
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26:08.300 --> 26:14.620 |
|||
online if you want to do a deep dive but there has certainly been information collected from |
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26:14.620 --> 26:19.820 |
|||
multiple different venues and the point is please be creative and don't limit yourself |
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26:19.820 --> 26:24.140 |
|||
to that information. The perfect example which I think may have a degree of applicability |
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26:24.700 --> 26:33.180 |
|||
in this setting in particular is the note of an ability to actually utilize a publicly maintained |
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|||
26:33.180 --> 26:38.620 |
|||
database when we actually partner together what was able to happen here in the next |
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|||
26:38.620 --> 26:42.780 |
|||
chance sequencey space and I think that something that could be replicated in an EUA space next |
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26:42.780 --> 26:50.620 |
|||
gen sequencing appropriately set up is in lieu of full traditional studies what we're able to use |
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|||
26:51.260 --> 27:00.700 |
|||
is information directly harvested from a publicly retained a publicly maintained database because |
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27:00.780 --> 27:09.020 |
|||
there was collaboration that happened up front between the sponsors between the database folders |
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|||
27:09.660 --> 27:15.180 |
|||
and between FDA and when we actually partner together to get interoperability for that data |
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27:15.740 --> 27:20.860 |
|||
and establish appropriate quality checks which are achievable it was achievable in this case |
|||
|
|||
27:20.860 --> 27:25.740 |
|||
and it'll be achievable in the future we can actually work together if you have questions |
|||
|
|||
27:25.740 --> 27:31.100 |
|||
about real-world evidence there is actually an email address if you don't want to contact |
|||
|
|||
27:31.100 --> 27:36.700 |
|||
the divisions directly you can you can email c3h clinical evidence at fda.h just.gov and if you |
|||
|
|||
27:36.700 --> 27:40.860 |
|||
want to learn more about some of the public private partnerships you can contact c3h clinical |
|||
|
|||
27:40.860 --> 27:47.580 |
|||
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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|
|||
27:47.660 --> 28:01.820 |
|||
contact me thank you so thank you to all of the fda colleagues for sharing the fda perspective |
|||
|
|||
28:01.820 --> 28:07.820 |
|||
today I think it sets a wonderful foundation for our discussions today and I look forward to |
|||
|
|||
28:07.820 --> 28:12.780 |
|||
your engagement throughout the day as well we're going to take a break now and I'm going to make |
|||
|
|||
28:12.780 --> 28:19.020 |
|||
a deal with you you guys silence your phones I'm hearing some phones and I promise we'll work |
|||
|
|||
28:19.020 --> 28:24.380 |
|||
on getting those technology smoothing up here how's that for a deal wow so they're done that |
|||
|
|||
28:24.380 --> 28:30.780 |
|||
was the end of that one and that's fine I knew it was not the much left because I didn't want to |
|||
|
|||
28:30.780 --> 28:37.740 |
|||
leave it till after practice and then have to do that so we are still here ladies and gentlemen |
|||
|
|||
28:37.740 --> 28:40.860 |
|||
at the same place where we have been for a very long time |
|||
|
|||
28:43.340 --> 28:45.660 |
|||
oh I didn't mean to do that I apologize |
|||
|
|||
28:48.460 --> 28:52.380 |
|||
you like that thing though I don't think it's that bad it actually looks pretty good that's also |
|||
|
|||
28:52.380 --> 28:58.220 |
|||
render forest you know render forest is kind of fun so that was the last part of the market seminar |
|||
|
|||
28:58.220 --> 29:03.660 |
|||
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 |
|||
|
|||
29:03.660 --> 29:09.500 |
|||
on Uve Sheriffs patents and some of the country companies that he worked for and we're going to |
|||
|
|||
29:09.500 --> 29:14.700 |
|||
look at I'm going to look at some of his publications and try to decide if it's possible that maybe he |
|||
|
|||
29:14.700 --> 29:22.140 |
|||
was doing more than just giving out EUAs maybe he was involved in the Human Genome Project or |
|||
|
|||
29:22.140 --> 29:26.860 |
|||
in collaboration with companies that were involved in the Human Genome Project and |
|||
|
|||
29:26.860 --> 29:31.420 |
|||
that might give us a clue to why he was in charge of giving away diagnostic EUAs |
|||
|
|||
29:32.060 --> 29:37.820 |
|||
and and why it would be that EUAs would be given away by single people or by some weird |
|||
|
|||
29:40.540 --> 29:47.020 |
|||
division called microbiome microbiological devices which is a very bizarre thing |
|||
|
|||
29:47.900 --> 29:52.940 |
|||
so thanks for coming back for the last half hour if you missed it live thanks for coming back and |
|||
|
|||
29:52.940 --> 29:58.220 |
|||
checking it out I will try to be on later this evening and later this evening I've got at least |
|||
|
|||
29:58.940 --> 30:06.380 |
|||
a list of 20 or so things that I could cover and so we'll just see which of these pending |
|||
|
|||
30:07.020 --> 30:11.740 |
|||
sort of study halls that is necessary to do that I'll do at eight o'clock and I'll see you then |
|||
|
|||
30:11.740 --> 30:19.980 |
|||
thanks very much for coming and we'll be back soon |
|||
|
|||
@ -0,0 +1,6 @@ |
|||
# FDA III Study Hall LIVE -- (10 Apr 2024) -- Gigaohm Biological High Resistance Low Noise Information Brief |
|||
|
|||
## Streams |
|||
- https://twitch.tv/videos/2116298320 |
|||
- https://stream.gigaohm.bio/w/wUwkuujnTJyMYDLMBYcTMy |
|||
|
|||
Loading…
Reference in new issue