Pharma & MedTech Information: Why It Matters More Than Ever

Good.

Let's do it!

For what? Happy Friday. I am Sean Smith. Posture MedTech Leading Voice. And I am super excited today because we have an organization. here represented the Pharma and MedTech Information Group. It's a nonprofit organization of information professionals, and we'll get into who their members are more. But I wanted to give you a little background. Karen, who's on the call, Karen Morabli from Springer Nature and I worked together at InfoDesk many, many years ago. And she was then involved with the Special Libraries Association and went to a number of their events, sponsored a number of their events.

And even spoke at a couple of them. So… She reached out to me about this new organization. And introduce me to Diana and Samantha. So Lisa's not here. But Diana Gao is. and she's the president. I believe he's president of. Yeah. Chair, sorry. And so, yeah, so here we are. Before we get started, I want to drop, one link into the, into the chat, if I can figure out where it is. And that is… For this new thing that I want to try. Oh, we're going to do a poll today, by the way. So, if you're a panelist, you can't, participate in the poll, but everybody else can. And if you're.

Panelists, you can answer the questions in the chat. But no, this first thing that I'm putting into the chat is… a link to a post that I did this morning, and it's… it occurred to me that medical devices come in all different shapes and sizes, so I want to know the biggest device and the smallest device that you've ever worked on. And… but I want to… Yeah. do this experiment and see if anybody will participate. So that's my ask for the morning. Upcoming events next week. David Fillmore is going to be talking about MDUFA. I know you're all excited about MDUFA 6, so I think it's 6, right? And

And Anna has pasted that in. And then the following week, we're gonna have our very own Andre Dimino. Hi, wave hi. And, Andre, is gonna be… speaking about his experience, in contract manufacturing, engineering, design and build, etc. So I'm super excited about that. And. Without further ado, I'm going to introduce the speakers. Today, as I said, we have Diana and Samantha, if you'd like to say hello.

Hello, did you want me to say more than hello?

It's.

Okay.

Sure.

as Sean mentioned earlier, I am the chair for PHMTI. My day job is global lead of competitive intelligence and market research at J&J, but on the pharmaceutical side, not on the med tech side.

Good morning. I'm Sam and Trilligator, and I'm involved with this call. This will be my 3rd year as the planner of Phmti's fall seminar. But my day job is being the librarian at Regeneron pharmaceuticals. So Phmti is just a little extra fun that we get to have together.

Great. So, one thing that we're also gonna try during this call is, to build a list together of, MedTech resources, right? So, I mean, you can use pharma resources if your specialty is pharma, but, we're gonna get to that later on. You know, where encouraging people to participate. If you'd like to be promoted to a panelist, just raise your hand electronically, or send a message in the chat, and my team will monitor that Anna and Francesco and then So…

we hope that you leave with something useful today. I I mean, I I love this group. So You know, tell us who… what pharma and MedTech information is.

So, we are, a community, and we're looking to bring together people who work with publicly available information across pharmaceutical medical technology industries, and really look to help Facilitate, if you will, the exchange of best practices, and advance members' knowledge, experience, values, careers, etc. Whether you are an analyst, a searcher, a librarian, a CI professional. on the publisher or developer side, you know, data science, medical information, you know, regardless of the role, I would say, is more around people who are users of this type of information.

We kicked off our group in July of 2023. This year will be, our fourth Seminar and in a little bit Sam will talk a little bit more about the seminar that we're having and I think one of you know we've been on this mission to really try to build the organization and add folks and I think one area that's in our name is the whole med tech piece and we don't really have. A lot of members, and we're hoping after today that we'll pique enough interest where some of you will either be willing to join the organization, or even attend the fall seminar to see what it is we're all about. Next slide.

And as I mentioned, you know, whether it's finding the right information from a literature searching perspective, you know, there's… especially on the farm side, we have this regu… a body of regulatory intelligence folks that are users of this information, CI for sure. The clinical people, medical people, knowledge management, even on the patent side, are all consumers and users of medical and pharmaceutical med tech information and feel would really benefit by being a member of the organization.

Where do you see the most traffic from users? You know, regulatory probably gets a lot. Literature search probably gets a lot. Competitive intelligence, I would think. You know, What about clinical? What about patents? You know, like, where… What are people doing? You know, how are people using the resources now?

Yeah, I mean, I… and, you know, Sam and Karen certainly jump in. From my perspective, I think, and I can talk about, you know, where I work and the people that I interact with and support, from a clinical… side, you know, one of the roles we have in CI is really to ensure that the studies we're doing, that the studies that are being conducted, are going to differentiate our products enough in order to be competitive in the marketplace. In order to do that. You need to have the right competitive information. Patents, I mean, there's probably a whole legal group across J&J and various Places with regard to patents.

We… I can say from a CI perspective, I don't do a whole lot with patents, to be honest. We get asked more around what's the LOE, you know, so when's a particular drug going off patent, losing exclusivity, so more around that. versus, you know, doing more monitoring. I will say, and I've been a strong believer and try to beat this drum, although I think patents scare people, because it's, you know, the way they're written, and they're not… they're vague on purpose, right? But I think it's a rich source of competitive intelligence, a rich source of information. If you look at what's being patented, what companies are working on, I think it can

point you to a lot. It's just… taking the time to really understand those sources and figure out how you can get out what you want. And I don't know, Sam, if you want to add anything?

Yeah, my day to day is more on the early side of research compared to your clinical side. So I work really closely with scientists that are like just starting out their research, looking deep into the literature. And I will take them through from like very beginning of just running a Boolean search or using a new AI tool, finding that information they need. all the way through looking at the competitive intelligence information. You know, we work with a ton of vendors that make this information available if it's not already publicly available. So we really run the full gamut of the research process.

At the library. And our library at Regeneron is tiny, there's only two of us supporting 17,000 people, so when I say, like, we really go through the whole process, we do, because there's just two of us, so we get to experience it all.

Well, and I think you raise a good point, because you need to really understand whether you're working, and I do work, whether it's early in the pipeline, or in late development, or drugs that are already on the market, you need to understand the competitive landscape. You need to understand not only what it looks like today, but if you're working on early assets, whether it's a drug or a device, what the standard of care looks like today may not be the same in 5, 8, 10 years when your product is gonna be ready to get marketed. So, I don't think I… I would like to say that, how can you do a strategic plan, a business plan, a plan, whether it's a disease area or a product plan, and not have some sort of insights, intelligence factored in?

What about regulatory intelligence? We've got a lot of regulatory people in our group, you know, and the, you know, the value of your organization for regulatory intelligence professionals, you know, I mean, it's the stock and trade of the regulatory groups.

Yeah, I work very closely with our regulatory intelligence team. So we have a whole team for regulatory intelligence here. And my job is to make sure that they have access to the information they need. So I'm managing subscriptions on their behalf. They come to me if they need information. I'll make sure that they have that in the future. But, like you said, incredibly valuable to have our regulatory intelligence team supporting everyone else throughout the company.

And I think the partnership is important as well. You know, our regulatory intelligence folks, yeah, they do a lot of what Sam said, but they also need to understand it's helpful for them, I think, to understand the landscape, the competitive landscape. While they may be monitoring policy and guidance and that type of information, you know, their hands are also in, if we're going to be filing, doing a filing, they need to understand you know, what's… what surrounds that. So, I think where you… the more you can partner with regulatory, and I think they, you know, would certainly benefit from this organization as well.

Now, at this point, I'd like the audience to use the chat function and to talk about where, what. their go-to sources of publicly available MedTech information are. And you can go beyond the list that you see here. You can, you know, what is your most used resource? What is your most dependent upon resource? For, regulatory information. And then, Anna, if you can launch the poll. as well. Then… we can have them multitask. So the first question is, Has anybody ever heard of PHMTI before? That's number one. Fairly easy question. Number two is, how is information research handled in your organization? And it includes, I work by myself, or I'm not sure. And then.

Number three is, where would stronger information support create the most value in your organization? And do you really, you know, if you see a need for stronger information support. Within your organization, you know, we'd love to know what that looks like. And this is really just a poll that I threw together for them so that they leave here with something that can help their planning committee and their team understand the MedTech audience a little bit better and what your needs are. So the more of you that participate in this. question and answer session, the happier I'm going to be, but also I think that, you know, the more useful it is to them.

So, I'm gonna… clip, take that off my screen, and go back to, you know, in terms of publicly informa… publicly available sources for pharma or med tech. Samantha, why don't you start us out? What is your go-to? What does your everyday look like?

Yeah, so, I mean, of course, PubMed is… you know, where we find everything pretty much, although I will say that we do subscribe to a lot of specialty vendors that kind of aggregate this information. So we're not just relying on pubmed. We have, you know, multiple sources integrated. But in terms of getting free information, publicly available information. Yes, pubmedclinicaltrials.gov. These are my top 2. I also am frequently looking for patents. So those are available online for free as well. And then it's what you do with that free information, right? That really counts. and how to

you know, make sure that you're finding what you need. I do find that some of the subscriptions that we rely on are great curators and aggregators of this information, But it is out there for free if you're willing to do the digging on your own.

I'm gonna pick on somebody in the audience for a moment, and I'm just, deciding who to ask. I think it's gonna be Carrie, because I like to pick on Carrie a lot, just because she's a good sport about it, and I don't have to worry about her getting too angry at me. Carrie.

Sean. Haha.

For MedTech.

Yes.

No. Where do you go? Databases? Mod, I don't know, you know, like, what, what, what do you use?

Depends on what I'm looking for.

Yes. Okay. Okay, so… let's assume that you're doing a regulatory pathway assessment. You know, you're just figuring out. I've got this company, and they've come to me. They want to do a class to Medical device. So I don't know.

I would go to the FDA dad, I'd go to FD.

Right? Got.

code database.

product code database. Yeah. So that's that's a big one. Start with the product code. yeah, I'm Then, then where do you go?

I'd have to search all of that, and then I'd look for other 510 s for substantial equivalents. Within those product codes, And what's the other part of your question?

So, what they're talking about, you know, is competitive intelligence. So, do you… do you work with clients in understanding what the playing field is going in to the market, what market access is gonna look like, how… the information sort of carries the product through the entire life cycle.

Yep. So, depending on what I'm finding in there for… and then, depending on what their intended use is, right? So… I mean, it depends on what product we're looking at. So, if it's going to include clinical trials, then we're going to jump over to the clinical trials database, right? We're going to look and see what they're doing there, and that's going to give us all kinds of lovely information. And then from there, we may need to jump to PubMed to get their clinical studies.

Mmhm.

No.

search.

And we're gonna get names of companies, so then we may jump to patents. And then we're gonna get all kinds of lovely details on their design and companies. And then we're gonna jump over to, med device or drug pipe, I mean, depending what we're looking at, and we might need to get some global data. On the companies. Crunchbase, wherever.

Mmhm.

Just depends on what we need to do, and what the client has actually asked us for in the… regulatory clinical strategy.

Thank you. So.

Okay.

Back to Diana and Samantha, you know, that is the typical MedTech workflow in a sense, you know, at least, you know, 80/20 rule. And that's what a lot of our Our, subscribers are interested in that kind of information, you know, and sort of, you know, helping. helping clear away the regulatory hurdles, the business challenges, the various aspects of it, to understand, you know. before I try to bring this product to market, you know, is this even feasible?

And I assume that that's parallel in the pharmaceutical industry.

Yeah, I mean, I don't think it's much different. One thing I will say, and I've heard from colleagues. On the med devices side is that some seem to feel we have a much more. wealth of information available on the pharmaceutical side than on the med tech side. Whether or not people here agree, I don't know. We subscribe to a lot of databases, besides what you have on there, and what I see people putting in the chat. There's a lot of information out there, and, you know, our job is to really cull through that. And it makes sense out of that. and to deliver insights. I mean, the value, and I'll speak as a CI professional, the value that I add are the insights that I provide, the so what, the impact, so what does all of this mean? But the workflows, you know, if you're looking at whether you're working early in the pipeline and we have a new mechanism of action or a new target.

or a drug that's in very early development, you need to continuously monitor the landscape. So, you know, I have tons of alerts that I have set up in various different sources that I read through every morning. For… on the information, on the topics that I'm tracking. So, it's this concept of continuously monitoring whatever that space is, so that you can then add a, you know, really… Be informed but start to see patterns, right? So it's taking disparate pieces of information and putting that pattern together to say, oh, what does this all mean and what should we be doing about this? So I, you know, school and train a lot of the CI folks across pharma that we get.

And it's really going deep in the area that you're monitoring, but that concept of monitoring, it's not one and done. You don't read something today and then don't ever look at it again. It's that continuous monitoring and knowing which sources and understanding you know, what do you get from PubMed versus what do you get from a patent database versus what do you get from clinicaltrials.gov, and making sure that you're setting alerts up in the right place so that you don't miss anything. And while there's a wealth of publicly available information, there's a lot of proprietary databases that we spend a lot of money on, that we subscribe to, because what's out there publicly isn't always enough.

And then you've got your public, you've got your proprietary databases, and then we layer on in CI primary research that we do, where we'll go out and get a vendor to go out and talk to key opinion leaders, or… physicians, or we go to conferences. Scientific conferences is a huge piece of information, and we're, you know. we pull in conference abstracts into our portal that we have, oftentimes the first time something's released, or new science is released, is out of Congress. So I, you know, while the publicly available information is really important. I wouldn't discount what you can do on the primary side as well. And attending conferences, I think, is really critical for the work that we do.

Excellent point. I agree. I like to attend conferences. There's always something valuable. Happening in person. And so the results are in. I just wanna share this. Everyone who participated, thank you. So regulatory information is the winner, followed by competitive and market intelligence. Looks like, scientific literature, app-powered research, not sure. And then this is fairly evenly split. I'm to… as to, how is the information handled. And, you know, you're lucky that there are a lot of people on this call that have not heard of

Phmti before, and hopefully today they'll get to know you a little bit better. Let's let's turn to the elephant in the room. And you know, What impact? Are you seeing with AI in the way that people are accessing information? You know, it's had a tremendous effect on, on, marketing clients are seeing website traffic trailing off. In, in droves. And I think that's because a lot of people are going directly to the LLMs with their questions. And.

You know, how, how do you see the role of AI as helpful and how do you see it as.

Okay.

is detrimental. And then we'll open it up to the audience on this as well, because I'd like to hear Some sassy opinions about, about AI as usual.

I can start with my somewhat sassy opinion of AI. I do think that it's been incredibly helpful in the, you know, simple search tasks that some of us are responsible for, but it's not this information revolution that some are calling it. And… Sorry. Sorry I'm on vacation today. I was just getting housekeeping. Sorry about that. So yeah, I don't think that the return on investment is there in the way that people anticipated that it would be. from the start. However, it can be super helpful for small tasks, but we always need to rely on the human in the middle. Don't trust everything that you receive.

and also make sure that you're being responsible and ethical in the way that you're using it from a knowledge management perspective. I think it's been critical to position Yeah. my department and myself as a leader in the AI transition, helping people figure out how to use this properly, how to use this ethically and efficiently, and not get carried away with the noise around AI, but really be logical and reasonable about the way we're using it and the way the company is using it as a whole.

Yeah, and I'll… I'm gonna… I'll jump in here, Sam. You know, my opinion is let the machine… let the AI… let the machine do what the machine does best, and that is cull through tens of thousands of pieces of information and return to you what's most relevant and then you put your human brain on top of that, to do the insights piece. I mean, we're using AI a lot. We have a portal where we've aggregated several different content sets, good vetted data. So I will say garbage in, garbage out. So if you've got really good data and you're asking questions or you're asking it to do a summary in our application, everything is cited back. So I think it's critical that you can get to the original source of where the information came from.

So that if something doesn't… you're reading a summary and something doesn't sit right, you can get immediately to where it came from to make sure that it's interpreted it correctly. I have to say that I have a lot of people who… I think there's this fear around for the kind of work that we do that AI is going to replace us. And I don't think it is. I think our roles might be a little different. We may be focused on maybe different things. So I say less on the data gathering because the AI does that at least what I'm using and accustomed to the AI does that well. But my brain's better spent on the implications, the strategic impact. What does it mean to the organization? Where do we go now because of whatever this is?

versus spending hours and hours reading through scientific articles, clinical trials, pipeline records. Let the machine do that. Because then I can take that and say what it all means. So we've had good success, I would say, at least for my application of how we're using AI, but I don't ever think we're gonna get rid of the human brain. I think it's essential and critical that the human is in the loop. But… I've gotten… maybe it's made me a little bit lazier? I don't tend to… you know, it's interesting, I had a conversation with somebody on our team, and I said… you know, they said, oh, well, the way we have it set up, it…

it'll summarize up to the top 20 most relevant. And I said, okay, so run a search and you get 325 articles back. How many of those do you go through? Oh, I don't go past the first 5 in the list. So, essentially, the AI summarizing the top 20 most relevant, giving… exposing you to more than you'd ever see if you were doing it yourself anyway. And when I think of some of the tasks that we do, like target product profiles, we're actually using the AI in the portal to run about 110 simultaneous prompts to get me back the information that I need then to put together a target product profile. So… that takes minutes, and then I can take that document and read through that versus spending months going through all of this information. So I see it as an enabler, as a force multiplier, if you will, but I don't see it as a replacement for a human.

Yeah, I agree completely with that statement. It allows me personally to be a lot more productive. to get a lot more done every day. Some people might find that objectionable, and I certainly understand, the sentiment. It's changing the nature of, my role, but… and it's changed the day-to-day substantially. But I have to say that a lot of the stuff it's done away with, I didn't want to do in the first place. And if, anybody remembers, you know,

way, way back when, when I was little, you know, we used to go to the library, and go to the card catalog, and then go to the stacks, and then, you know, go to find the thing, and, and, you know, have rotary phones, and manual typewriters with little erasers and whatnot. And so, if we look at the arc of the story, and we look at, you know, where we've come from and where we're going, then we see that there have been a number of technology changes with, with regard to information retrieval, research, intelligence, and that it just continues to evolve and change. But. into the part about, you know, the human, what I'm, what I started referring to as human experience.

artificial intelligence cannot be a substitute for human experience. And the human experience that I see, just from the people on my screen at the moment. represents hundreds of years of experience, in extremely, specific fields, you know, Daniel at the FDA, Luke with engineering, you know, and, and, and so forth. And, and when you dig deeper beyond. what the AI knows. My favorite new question to ask the LLMs is, what don't you know about the subject? Where is your knowledge gets sketchy? And you get some interesting answers. And the most interesting answer that I got recently is we don't really know what regulatory affairs people do from day to day.

We don't really understand a day in the life of a regulatory affairs professional. You know, and I think that kind of. opening for experience… for… For storytelling, for experience, for… Judgment is… is enormous. Does anybody from the audience have any comment or thoughts on this?

Yeah, this is Dan. I'll just put a little note. I mean, some way, somehow. some people think that using AI is, like, something you shouldn't do, and… and I'm wondering if it's just a fear that some people have about… using AI as a tool to enhance something that you already know, or, like Diana said. when you use… when I use AI, I use it to compress, to synthesize, you know, to… to summarize for me, and to give me a framework from which then I can move on into doing something that is more relevant to, in my case, to the clients that I'm working with.

What? But that's it. I use it as a tool, just so that I can do my job better and faster. And so that I can pick up the details that could've… Been missed for… my human nature. And I think that a lot of people don't really understand. AI is not the future. It is the present. And you really have to appreciate that if you don't jump on the bandwagon, You're gonna be left behind. And 5, 10 years from now, you're going to be regretting. that you did not take advantage of such a great opportunity that we're… To me, it's a technological advancement. And that's all there is to it. If we try to put adjectives to it and to humanize, how do we use it? I know you mentioned ethical, but we still need to understand what ethical means, right?

Because, if I'm using the tool correctly, that's ethical. If I'm using it to do damage, then of course it's not correct, but… You know, but even the framework of what ethical means, I think we've got to put it into context as well. And we're still learning from it. I'm not saying we are there yet.

-H.

Well, and you know, I'm gonna take what Sean said about the experience. And everybody on this call, but I'm also gonna take what Daniel said, you gotta use it as a tool. It's like saying, you know, years ago, I'm not gonna use Google. I'm not gonna use the search engine. I'm gonna go back to an encyclopedia.

Mmh.

You know, you got to use the tools that are at your hand and you got, you have to, you know, my wife is a big on social media. And she can pick out a video any day of the week that is made by AI. So… and it turns a lot of people off when all you're using… sorry, I'm getting an AC unit replaced and my dog's going nuts. But you've got to use the tools properly as opposed to just letting them run amok and replace what the personal experience is. Just my two cents.

Okay.

Teams. Oh, sorry.

Oh. I think a lot of people in medtech, they… it is so… such a wide landscape that in whichever part they're working, they're usually working in a niche. So that, the amount of information that's available For these large language models on these niches is also very much limited. So… In my experience, I use AI for some… language-type tasks, and programming is also with programming languages, so it's heavily used in programming as well. But for… like, I'm the engineer for engineering, I haven't found…

any useful tool yet. It might come, but it's not there yet. And as you say, you need the experience, but you get the experience by Doing the hand work and making mistakes and learning from your mistakes, and I see a lot of young people using AI right now. They make mistakes, and they cannot see where they're missing the point. So I think for young people who want to use the AI as a tool, which they should. There also should be developed something. In which they can learn to use it. As a tool, as it's meant to be, and not as you press a button, you get an answer. I mean, I've met an engineer, and he said… I asked, how much current is here… is there in this device? He said, oh, 10… he took his, his, pocket calculator out. 10 milliamps! Don't you think that's a little bit too much? No, it's 10 milliamps!

because he didn't know knew the the science behind it. It was 10 microamps. So He was a factor about a thousand away from what's… was saved. But it's like he used a tool without knowing what the tool was doing. And I think the same can happen with AI as well. So there should be something that we learn, the young people, how to use it properly when they don't have the experience we have. And that's my two cents.

You know, I like that you said that, because I had this conversation the other day with someone, and I said, I almost feel like we're dumbing down our younger generation. Because we came up through the ranks having to learn how to look for information, having to learn how to synthesize it, making sense of what it means, using our brains to do that. Now everybody wants to press a button. and I, like, you know, I see younger people that I interact with, and I'm like. Where's your ability to problem solve to strategic, you know, think strategically? It's not all about, you know, using AI. So, you know, I worry sometimes what this is going to do to the younger generation because I just feel like they don't.

The ability for them to learn to problem solve and think strategically is almost being hampered because of the use of AI.

Yeah, that started, unfortunately, a long time ago. Remember when you used to find directions by using maps? Yeah. Next one. Now we have GPS. Kids don't know this. So, I mean, and this is, what, more than 30 years that we've been… Doing that transitioning. So, it's been a little by little, I mean, I think that what's going to happen is that eventually they will adapt and transition like all of us have done that. And I agree, the concern is there. But I would be interesting to see how they manage, because every generation Has its own challenges. Otherwise, we as a human race would not grow and progress. Unfortunately, that's our destiny. It's to be…

200 years from now, why we were what we are not today.

So.

Oh, I hear you.

Hey, Se.

Yeah, go.

No, I was just gonna add that I work one of our colleagues. Took the last year and a half to implement an AI tool for.

Okay.

doing test automation on a medical device that's actually on the market. And they took the approach of, we're going to build all the guardrails around it so we can effectively and safely use this tool before just trying to get all the advantages of it. And the guy that I've worked with that's been doing this, he looks at it as just another tool, as if he hired another engineer to take on tasks, so he can kind of double his efforts. But from the beginning, it was how do we build guardrails around it, because we're in this regulated environment, so that we don't pay for it later in a in a negative way.

And so they did it incrementally over about a year and a half, and now he trusts it implicitly, because he's built in the guardrails and the processes, so he can double-check all the results as it goes through, so they continually, in a granular fashion, improve how it works. And I think, Sean, that's the same company I told you, where an engineer decided to use it on his own, no guardrails, and just trusted it, and asked it to check his code to bring it to best practices, and he gave it that instruction on a Friday, came in on a Monday, and reams of code had been deleted. that he's still trying to find. So we've showed, if you do this correctly with the right guardrails, using the right

AI tool that's been AI enabled to make sure it's private so your data is not going out there to be hacked, I mean, there's all these rules and guardrails they put into it before they even used it, and now they're getting productive use out of it in the medical device world without any surprises, and I think that's kind of key. Know what you're doing before you start using it, or at least get somebody that can help you. Before you use it in business, or engineering.

So bringing this back to… PHMTI, you know, and information leaders within the organizations, what role are you guys taking in terms of spearheading training, making sure that the younger people are brought up to speed, that they understand that these are tools and that a hammer is just a hammer. by itself, you know, and it's what you build with it, and the skill with which you build with that tool. So how do you help them understand, you know, what using these tools properly looks like. Do you provide that sort of training or anything like that?

Oh. For where I am in my group, yes. So my… application, my portal application was one of the first ones to go live, with generative AI included in it, so I do a lot… I spend a lot of time on training. I've got some good, you know, we will use examples of, you know, prompts to ask which what's a good prompt, what isn't. I also do a lot of training around the underlying data sources so that people understand what the actual… what the data is that they're asking the tool to interact with, because I think it all… it all starts with the data. I think the foundation is the data, the underlying data, and then the tool that sits on top of that. So I do a lot of training, and I give examples, so…

Question on that, Diana. you take a you have a lot of work in in selecting the right data sources that are of high quality. But a lot of data right now is generated by AI. So it gets into naval stair gazing. How do you prevent… the bad AI data from getting into your sources.

So, the platform that we have, there's 3… types of information. There's our internal insights, so all of the competitive intelligence information in the market research that we do is in the portal. There's all the proprietary databases that we subscribe to, so many I saw in people's chats, Global Data, Sightline, all of that information that's in there. then we have conference abstracts, we have a patent file, we have Cortelis regulatory intelligence. So, you know, I… I have to hope that the data that I'm buying, plus what's, you know, in PubMed, is… is good data, and that, you know, a scientific article wasn't done using generative AI. But, you know.

that's the best that I can do. I mean, we're not pulling in… everything that's out on the internet, everything that's in Google, it's… it's… collections of data that have been vetted that seem to be really good data. Now, if Sightline is doing stuff and using AI to create the data. Honestly, I'm not aware of that.

Yeah, I have a similar experience or. pretty much exactly the same. But one of the most important things, like Diana is saying, is knowing what data you're buying and what's going into your tools. And that's why a lot of companies are working so hard to build internal tools rather than just purchase something externally, so that there are guardrails, and there is protection around what data is there. And and you know what our researchers are discovering through our AI tools. When we have trusted vendors that we work with. We hope that they maintain, as I was saying about being ethical, it really is about the information that goes in and the information that goes out. Are they copyright compliant? Is their information accurate? Is it coming from a good source? These are all really important things when you're thinking about creating or using an AI tool.

So back to the audience, if you could write in the chat what you see. Umm. Being the most strategic, you know, is it more data, better data, you know, regulatory scrutiny, competitive pressure, new tools, where… where do you see things moving? Because this will really help, PHMTI sort of… figure out, you know, what… what you as the audience, information consumers, what do you… what do you want to look to them for? You know, where… where can they be the most, helpful I think, would be an interesting thing to explore.

I do, want to be respectful of time and give them time to, give this pitch. I, live outside of Philadelphia, and so I'm planning on attending, and, very grateful to be asked. Yeah. And, but, you know. Anybody interested in speaking, anybody interested in attending, anybody interested in sponsoring, anybody interested in going to this event, tell us about the event.

Yeah, great. So this is our fourth year with our fall seminar, and this year our focus really is around AI. We have kind of three focus areas, basically staying valuable, like the role of. information professionals staying valuable in this new AI transition. Looking back to talk about AI's impact on your role so far, where has it helped, where has it hurt, and then also looking ahead at what's next. We're looking for speakers to do either presentations, 30 to 45 minutes, to join panels, or we like to call it like a fireside chat, which is just more conversational about your area of expertise. It's 45 to 60 minutes. We also have availability of lightning talks. If there's a topic that you're, like, passionate about but only want to speak on briefly, you can do a 15-minute lightning talk.

Or even a full case study or workshop, a breakout group you can, you know, present on your area of expertise and then break us out into groups and have us do a little bit of work around it. I'm going to drop a link into the chat just so you can actually take a look at our website for the fall seminar. As we mentioned earlier. we feel that we have a lack of med tech experts involved. We have a lot of information professionals, knowledge management, competitive intelligence, and the vendors that we work with, but we're really lacking this med tech expertise. So reaching out to Sean and you know, doing this meeting is our hope to get you guys into the fray, get you involved. We want to hear what you have to say. A lot of us are responsible for

providing the information that you might need. So we'd love to hear from your perspective. If you're not interested in speaking, we'd love to just have you as a member, an attendee. Yeah, if you…

And I understand that if you become a member, you get to attend or something like that. It's like not like like it's almost like break even like the pricing. Karen.

Is that true for this year, Diana? I think if you become a, you can sign up to become a member and attend the seminar in the same, in one fell swoop. Is this true again for this year? I believe so. In any sense, this is not an expensive.

No, it's not.

Society or seminar to attend. It's on the cheaper side. We're pretty small. But we are growing rapidly. I think we've jumped from, like, 60 attendees to now over 150 last year. We're hoping to be bigger this year. We had to change our venue, to accommodate more people attending. So yeah, we would love to have the perspective of some of our Medtech regulatory friends. Just some new topics. And you know our Our topic is around AI this year, but we welcome anything that's adjacent in your area of expertise. It doesn't have to be so focused on AI. If you just want to talk about how you stay valuable and, you know.

bring your expertise, and it's not around AI. That's okay, too. Send in your abstract. We'll take a look, and we'll be happy to have you.

And there's a way, Sam, for them to have your email address they can get right off the website, so that they know how to reach you, or go through Sean. I just wanted to add that, the meeting is going to be held at the Soap Hotel at Rittenhouse Square, which is a lovely hotel And I saw someone put in the chat, they wanted to know if they did speak, is there a way to do it remotely? We don't love that idea, because that costs us a lot more money to make that happen, but I'm not gonna… Say no, I'm actually the event planner, so… but I also have a day job as well, which we all do. So, just let us know if you're interested, and we'll figure it out, if that's something you want to do.

We'll look into it and see what the cost might be for that.

I think the thing that's interesting to me about the MedTech perspective is that a lot of people don't have centralized information resources at the companies that they work at, and so you end up with, a lot… a lot of people being responsible for sourcing their own information, or for using limited company resources that are available. Unless you work at one of the largest MedTech companies, you're not likely to have any sort of library or information services available to you at this point, so it could be interesting to bring that perspective of you know, the regulatory affairs consultant who is doing all this research on their own, and what tools they're using, and what they're not using, and where AI helps, and where it doesn't. I don't know, those are just…

Spit out some ideas.

I also wanted to add, now that you said that, John, that as part of the seminar, of course, there's all the great sessions that Sam and her team are coming up with, and hopefully we'll have a bunch of folks from today that'll be interested, you know, because I've already told Sean he's going to be talking. But, We also have 6… 16… Exhibitors, we'll call them sponsors, that will be there, so you get to engage with them over the The two days, To talk to them about their resources and what they might have. So, you might not have that opportunity at other meetings, so we give you that opportunity here.

To chat with everybody.

So take a look at their website, get to know them, and hopefully, you know, some of you will want to participate in one way or another, attendee, speaker, panelist, lightning round.

Whatever.

Sponsor, member, yeah. And let's… let's support one another, you know? Let's… let's look at… we're all in this together, you know? And, you know, I love bringing new… perspectives to this call. I think that this was an outlier in a way. You know, we get a lot of, you know, information heavy, you know, this is, you know, how you do this particular aspect of risk or recalls, or this, that, or the other thing. But you know, this the session was eye opening for me. I hope you all enjoyed it. Let's see, what do we have in terms of slides left? Let's close the loop.

So I'm going to go through the chat and the survey and pull together our shared source list, ask some questions. with the AI like, you know. to analyze it and try to send a roundup of today's call, and then I'll publish an article. About it, next week. on MedTech Leading Voice. So look, look for that. what's this say? One thing to try. Pick one source or idea from today, and use it this week. Did anybody get any good ideas from this call that you didn't have beforehand, or any additional insights, or… or did you name… but one thing that you…

enjoyed into the chat. Would love to hear that. Let's see, I want to thank the speakers. Diana, do you have any closing words for us?

No, just thank you for the opportunity. It was really nice to be able to interact with a different group of people. And we hope that something we said piqued your interest enough that if not wanting to speak, you'll at least be willing to consider attending the conference to see what it's all about. So thank you.

Very nice. Samantha.

Thanks for the opportunity. It was great to speak and I hope to see many of you at the seminar. And if you have any questions, my email is on the website. Just feel free to email me and I'll be happy to help.

Karen.

I'm going to echo what they've said. Thank you, Sean, because, you know. Sometimes I do come up with a good idea every now and again, right?

I'm gl.

Glad you reached out, you.

I am too, I was like, yay!

And now that we know that we lived like 20 minutes apart, you know.

We do. I'm like, I go down an accident quite a bit sometimes.

We're gonna be at Outback Steakhouse before you know it.

Wherever you want to go, Sean.

Just kidding. Okay. Well, any closing words from the gallery? Oh.

I just have one question. So I'm more on the services side of the med device world. And regulatory meets. Right there, when there's product recalls, when there's field change orders, engineering change orders, all of that, we desperately need you all. We desperately need you all. So, having service people As part of your organization, would that be of any help?

Yeah, okay.

Okay.

We need you too. Yep.

We desperately… because you have all the answers.

Yeah.

Or at least can lead us to, you know, the horse to water. So truly, truly appreciate, this. Did not know your organization existed, and not surprising.

Mmhm.

And it it really helps our side of the world. Having you all. So thank you.

Thank you.

Look forward to seeing you in Philly then.

Yes, thank you.

Thanks everyone for your time today. Really appreciate it. Remember next week, MDUFA 6. with, David Fillmore, from Market Pathways, publication. It's gonna be speaking, that'll be eye-opening, and then in two weeks, Andre Dimino, will be talking about his work. Thank you all. I hope you have fun.

John.

weekend, and I will see you next week.

Thanks again. Bye-bye.

Thank you. Have a good weekend, everybody.

Bye, bye.