Pat, here we go. Hello, everyone. Good afternoon. Thank you for joining. I think we're just going to wait a couple of minutes. We don't want to waste too much of your time. But just waiting for everybody to jump on so we capture everybody from the beginning. Again, thank you all for joining us. We're very excited for this presentation. I'm hopeful that it's the beginning of a series of research, how to build research for our members who have asked questions. So we'll give it just another minute. And then we'll jump on. You're right, Lisa. Yeah, excellent. Good. Hopefully it's not noisy here. All righty, why don't we, why don't we get started. So, again, new year new strategy how to build successful research program. As mentioned, I'm hopeful that this is the beginning of a new series provided by MedAxiom. As you know, all good companies should continue to grow and expand their services and just as that MedAxiom is looking to continue to grow and offer our members more services. And we've heard a lot of chatter amongst our members about building research right how to do that. What's the appropriate infrastructure. So we're hopeful that we can add to our portfolio and help our members to build research and for some of them who are already doing research is to become more efficient. And for those who aren't doing research it's how to start a research program. So I'm incredibly honored to have a special guest with us, Lisa Boyle. I'll have her introduce herself in a minute. Ari, if you don't mind advancing. So really quick some housekeeping. Obviously, the links to the presentation can be found on the left hand side, but more importantly, we're hopeful that you guys ask questions in real time. We really want this to be an engaging active conversation between Lisa, myself, and the audience. This is really an opportunity for all of us to learn together and nothing like the present, you know, to ask your questions. No point in waiting. Please ask freely. And again, if you're thinking it, other people are thinking it also. So please feel free. All right. So really quick, Lisa and I, unfortunately, no disclosures. Sorry, agenda. So obviously, I'm going to have Lisa introduce herself and her vast experience in industry. I'll give you a quick overview from the MedAx perspective, and then we're going to jump right into site selection criteria. And that's actually the meat and potatoes of this conversation, right? We really want to talk about review Lisa's list of what she's looking for. And then I'm going to hopefully add some value by translating that into what that means for the hospital, what that means for your clinical practice. And then hopefully we'll have lots of questions and then we'll wrap it up. Thank you. So quickly again. All right. Thank you. So Lisa. Lisa is currently the vice president of clinical and medical affairs at Geneva. She has vast experience in industry. And actually, she's also has her own company. So Lisa, if you don't mind, I'd love for you to elaborate on all your incredible background and experience. And also tell us why. Like I said, it's a it's a random world that you and I both ended up in. So why? Why? Tell us. Thanks, Anna. Yeah. So my background is computer science. And in 2008, we had an opportunity to move states from Ireland. So that led me into Medtronic. And I always say I grew up in Medtronic. That's where I first discovered clinical. I didn't know it existed. So I was very, very naive. And I got an opportunity there because I was I have project management skills. And they said, hey, you know what I mean? Do you want to stay in R&D or do you want to go into clinical? And I went, oh, clinical sounds fun. It sounds interesting. And they didn't have any understanding of process. And that's what I get, this process. So I grew up in clinical and understood, you know, what takes what it takes to set up a clinical trial. How to be a global, how to have a global presence, how to have, you know, get ready with your data to get a manuscript ready at the same time as your podium presentation. What to look for in a presenter, what that looks like, you know, and what's going to be who's going to be a good presenter who can share the data, who can keep an audience engaged, plus have that scientific value as well. So that's that's where I started. That's where I hone my skills and learned. And I'm very grateful. Then I moved to Becton Dickinson, BD. Very, very different. I moved there for the vice president role. And the global clinical affairs and medical affairs team were the clinical affairs team was responsible for all of the global studies, all of the studies that the nine business units did. So at one point in time, I was responsible for 834 clinical studies not to be sniffed at. And with that, again, it gave me a different viewpoint because in Medtronic, I was in coronary and structural heart. So, you know, I mean, I was very detailed in that area with Becton Dickinson. I was doing everything from vacutainers to the covid vaccination. You know, I mean, how we can get that, how we can we didn't have a flu, if you remember, for a couple of years. So how could we get a flu vaccine and a covid vaccine? So we, again, thought of a strategy to follow the sun. So I started in Australia and said, OK, that's when flu season is going to start first. And we followed the sun over across the globe to try and get the right indications for the covid and flu vaccine. And then I left Becton Dickinson after three years. And I said, I want to get back into, you know, I mean, getting into the clinical teams and being more involved in the doing of the trials. So I set up my own company, which is Clinical Connect. So connecting clinical teams to doing research and helping them understand how to do it in the most efficient way possible. So clinical operations really very powerful for me there. And then thankfully, I got the opportunity because I've been part of a team to join Yenavav and the valve itself. The people there knowing that the data are so good and that that's what helped me quite honestly. So I'm very, very thankful to now be part of that team and start getting ready for our next trials. I mean, I'm really moving the needle, advancing the science and getting this therapy to people that deserve it. Wow, that's amazing. I appreciate your background and how you got there. It's always fascinating to me how we ended up where we are. And it's, you know, I guess quite lucky that you started with that little company Medtronic, right? To really gain a lot of insight to a very big world, although we're so niched in this cardiovascular space. But it's amazing how big it is. Right. But thank you for joining us today. And I look for I look forward to learning from you. And I'm sure our members will also have a lot to learn from you. All right. I'm excited. So quickly, Ari. So, again, I pulled this from the NIH website. This is nothing new. I'm just going to give you quickly from the MedAction perspective where we're coming down on this. So obviously, we across the board, we're looking to diversify. Clinical trials, right. The patients that are enrolled, the populations that are participating. We keep talking about this a lot and everybody's doing something, but we're still not doing enough. Right. To build diversity, inclusion and clinical trials. So knowing that and knowing that our members want to do research and knowing where health care is going, it's kind of this perfect intersection right now for all of us to rethink what we're doing. And if we're not doing, think about doing research. Right. And build on our clinical expertise that a lot of our members already have. Ari. So with that really quick, the future of health care in general. Right. So right now we're predominantly ambulatory. We know that. But we also know with everything that's happened, starting off with how COVID kind of put steroids on everything, on the digital transformation, where we're going to end up. Ambulatory is going to go from 80 percent to 30 percent over the next 10 years. So really, in order to do research well, we really need to figure out how to get to those patients. Right. Those patients are no longer going to be easily, and I say easily as if it's easy to begin with, identified in the clinic. So we need to be more creative. We need to think about how we're following our patients. So, again, although it's kind of a ripe opportunity, in my opinion, to to to jump into research. Right. That being said, infrastructure is critical, from my opinion. So we're going to talk about this, about being creative and how we're all going to move forward in the same direction together. All right. So really quick, Lisa is going to jump into her site selection criteria. And then from my perspective, I'm hoping I can add a perspective. It's how her selection criteria, how that what does that mean for your institution? Right. Whether you're part of a large academic medical center, which is my background, or if you're part of a small private practice, regardless, there's still some basics that you need to have in place to be successful. And obviously, if you're from a larger institution, it looks a little bit different. But we can go into those details if you would like. With that, Lisa, I'd love to hear from you. Oh, yeah. Thank you. So as you guys know, sponsors like in pharma and medical device, they are carefully looking for sites. And I always say site selection is an art form. We're looking for hospitals to participate in our trials. We're looking for them to be sure that they are compliant with the regulatory requirements, that they can actually execute efficiently. And that, you know, I mean, the safety of the patient, they're following good clinical practice is paramount. We want hospitals or research centers with experienced PIs, you know, and the research staff. One of the questions I always ask is, you know, I know the PI or the physician always wants to do the trial. They're very engaged. Do you have a research coordinator that is just as engaged? Do you have a list of trials and where are we on your on your hit list? You know what I mean? Because, again, our team and house is going to be reaching out to the research coordinator saying, hey, did you get patients in? Did you get patients in? And if you're if we're not in your top three, research quarter is not going to be able to give enough time to get our study done. So there are some of the things that, you know what I mean, are practical and operational that we look for. Again, do you have experience? Are you a research naive site? Because that's going to need a lot more handholding in our minds. Then somebody is like, yeah, I've been doing this for years. You know, we've a well-oiled machine going on here that we're good. So that's there's there's some of the things that we look look for from from the hospital initially. So, again, we're looking at expertise and experience of the PI and research, as I said, the guaranteed patient population. Again, if we're looking at, as you can imagine, when you start off a trial, you're either going to start in the highest patient population or nothing and then work your way down to the to the lowest patient population. So what what do you have that patient population that will fulfill that criteria? We want a physician that is collaborative, that is not going to not allow us on site, you know, to do our good clinical practice requirements of monitoring and auditing. And we want to know, hey, if you've not enrolled, get on the phone with us, help us explain what can we do to help you enroll? What barriers, what challenges are you are you seeing, you know, so that we can truly understand and work as a partner? I think the referral pathways are crucial because it's not just, you know, you might have the patient population or you might have the capabilities, but you know that the site, you know, 10 miles away, you can work with that physician and you can refer patients in there. So patient referral pathway is really, really helpful. And if you think about it, it builds up a stronger community as well. And you're going to get a broader breadth of patients then being treated and you will be recognized as, hey, you know, I mean, that that person is really, really good to support us on regulatory compliance. What we're looking for is sites that are demonstrating an adherence to compliance. It's number one, if you think about it as a sponsor, I have to go to FDA and pass the red face test to say, yes, I don't have too many protocol deviations. The PI, you know what I mean, follow this protocol to the nth degree. There is there's no issues. We haven't had a lot of adverse events from the from the procedure as well. Good clinical practice guidelines must be adhered to and the assurance the trial will be conducted ethically. I think that goes without saying, you know, but we also know, you know, I mean, that there's some things to whatever fault things happen, you know what I mean. But again, making sure that we're aware of the guidelines, aware of the protocols. And as I said earlier, just being in collaboration and communication with the sponsor to say if in doubt, reach out and check and call. You know, I mean, there's always somebody that's going to be able to answer your question. The appropriate infrastructure, again, you know what I mean, that you have access to the technology that you need, that you, for example, with Yenabab, we need a cardiac surgeon and an interventional cardiologist, you know what I mean, to be in the line. So do you have that partnership with your peers? Can you, which also helps to add into the patient population. So infrastructure to me means a lot more than just the nuts and bolts. It's it's can you do an echo? Can you get an echo to the core lab? Can you get all the blood draws or, you know what I mean, that we need all basically per protocol? Can you follow up? Can you follow that appropriately? And then I'm going down, I'm going fast, I apologize, but geographic location, you know, it's more than just getting a diverse patient population based on, you know what I mean, our skin color or whatever. It's like. How are we going to socioeconomic areas? If we're in a low income area, can you still incentivize and get these patients to come to your hospital? Can you operate outside of the nine to five? You know, because we all know, again, there's patients out there that are in low paying jobs, but they need to work odd hours. You know what I mean? Can we still get them enrolled in the trial? How can we be innovative in order to get the catchment that we need? And then finally, you know, a lot of things in industry, as you guys know, comes down to cost. You know, so how much is the site willing to negotiate? Definitely fair market value. But is there an exorbitant overhead just to get in and do a clinical study? Because that's going to ultimately come back to the sponsor as part of the study. And should we do it or should we not? So that's a quick download. I appreciate that. That was a lot. And we're going to drill down on each one of those. But thank you for that preliminary some of those preliminary details. That being said, I wanted to we're going to go into expertise and experience. But I want to make sure that our audience, our members aren't intimidated by some of the things that you mentioned. Right. For example, being being an existing PI. Right. Because we want to create opportunity for new PIs. Right. So we want to make sure everybody knows that this is, you know, one on one. Right. We're figuring out what goes on, what that infrastructure necessary to start research. We're not again, we're not looking to be the next DCRI, Timmy, CRF. That's not that's not the intent. If you want to, MedAxiom is here for you and we'll figure out how to help you build that because we all love a good challenge. That being said, everyone should be able to do research. Right. There's a lot of value in having research as part of your organization. Right. Whether you're a big practice or a small practice creates a ton of opportunity. So we want to know that people should consider it. You know, it's I get that there's some folks, you know, we see it all the time with some of our members where there's some of your old school folks. Again, we're creatures of habit. They are clinical and they don't want anything to distract them. And you know what? That's great. We need those folks, too. However, there are always faculty members, clinicians in your practice who are interested, are looking for more intellectual stimulation. You're looking to do something different, looking for publications and just looking to expand their portfolio. And research is a great opportunity to do that. So that's just another reason. And as the business perspective, it's also an alternative revenue stream, right? We're not looking to make a ton of money, but it's alternative revenue stream that allows for creativity. So that's something to think about. So, Lisa, back to you. So when you say experience and expertise. So, again, if you're if you're not an existing PI, I get, you know, hence the problem. We keep going back to the same guys, right? The same institutions, because they're a known entity. We know that they can produce. They're efficient. We get what we need, but we want new people. We want new science. Yes. So how are we going to break through that? I haven't done research again, but I see a ton of patients. How can we work together? What are your what's your advice for that population? I think for physicians that are looking to get into research there, I think they're they're doing a number of things. They're going to conferences. They know they're following trends in industry. They know what's up and coming. And then I would encourage reach out. When in doubt, reach out. So you'll see again, if you're if you're following, if you're following the trend. So Yenneval is right up there. A lot of people know that the data was when your data was presented at TCT. So, again, it's it's reaching out and said, hey, I saw your data. Love to be involved. What are you doing next? Here is what we can do. And just let's engage and have to have a discussion. Ideally, it would be that we have an infrastructure. We have, you know, I have colleagues that are high enrollers that have already been in trials. So I've already spoken with them. I know what the what the expectations are. And then every trial is different. So making yourself approachable, making yourself engaging with the sponsor and just saying, what is it that you're looking for? You know, am I a good fit? If not now, when? What do you need to see from me? You know, so that you're you're you're gaining more information. You're pulling information from that potential sponsor as well. And then quite honestly, if you think about it, if a sponsor is gone, wow, this person, you know, really seems to be on it. I'm very much of the opinion. Work with the willing. If somebody doesn't have the infrastructure, the experience yet. OK, I'm going to work with you and we're going to get there. With Yennebel and with most of the TAVI studies, let's be honest, they have to be proctored. You have to remain proctored. So you're going to be in a safe space as well. What we're really wanting to hear from you is you want it. You can get the infrastructure, you can get the people in to help and support. Or if not, can you work with me to get the people into help and support? And then, you know what I mean? Just give me give me an opportunity. Let me try. And I think that for me goes an awful long way. And I'm also good, but it might not be now. You know, but at least you're going to get honest feedback why it's not now. I love that you said that. Right. That first of all, it's as easy as just making the call and saying I'm interested. But maybe it's not this time, but it's the next trial. Right. Yeah. So let's see it up. So we're ready. So I appreciate that. I see that there's a question. Ari, if you wanted to. Yes. The question is, it seems to take a lot of time to get through IRB and contracting at some hospitals. Is that something you look at? So sure. That's like, yeah, go ahead. I was just gonna say, Dr. Pinto, we will get to your question a little bit later when we talk about some of the institutional obstacles that many people have, right? I think it's a legit question and it's an obstacle and it has been. And I don't know that we have the answer, but we're gonna openly discuss those obstacles. Very good. But yeah, I love that it's as easy as a call. Let's move on to your next slide. So this is, to me, seems obvious, right? A guaranteed patient population from your behalf, Lisa, right? Like you don't even wanna waste your time unless you know there's patients. But how do we know if there's patients? And how do we, you know, is it as easy as a potential PI saying we saw, we had 600 TAVR cases last year. Like, is it that easy? What do you, how do you connect those dots? So I think, then it goes back. There's a little bit of, I won't say manipulation, but there's a little bit of background checking, and fact checking from the sponsor side. So we're gonna see from TBT registry, you know what I mean, how many TAVRs were done. We can always check what regions they were done. You know what I mean? We'll also know, again, from who's up on the podium, who's been talking about it. We'll know from sales, where, from our sales information, where TAVRs were being bought and being done. So we can fact check if you have a patient population. And again, for Yenaval, we're looking for people with aortic regurgitation. So physicians then who have done TAVRs. So it's like, okay, do you have that skillset? And we know, again, that you're, if you're doing TAVRs, then you probably have a relationship with the physician that's going to support you as well in randomizing patients. And then we're going to do some of our own analyses as well and saying, okay, based on where they are in that, you can use, you know, AI, machine learning. You can drill down and do some analysis to say, okay, are they truly seeing that type of patient population? And just get some facts before you believe. So it's listen and verify. If that answers the question. No, absolutely. So out of curiosity though, are you guys always, I mean, this is interesting to me. Are you guys always doing the background checks beforehand before people reach out to you? So do you already know who you want to go after? Or is that still, is there opportunity? Oh, no, I think there's still opportunities. So as you say, yeah, there's, studies are expensive. So a sponsor needs to be very cautious. And you know what I mean? And our dollars need to go, we need to get the biggest bang for our buck. So that's a business decision, right? But I also think that there's always going to be opportunity and if you're, again, willing to say, hey, here's how many TAVRs we're doing per quarter. Here's, so you know that you're getting a patient population coming in. Here's where we can, based on our protocol requirements, we can ask some very, very specific questions, to say, okay, are you seeing then that right patient population for us? And then I also think, sorry, I've lost my train of thought then as well. That's okay, it'll come back to you. Sorry, yeah, it will come back to me. But the, so while we're checking, and while we're doing, checking from both the commercial side and from a clinical side, because I can go on ct.gov, cttrials.gov and see who's doing what. So we can check there. And then if you're also open to being a pathway, you know what I mean, for referrals, I think that's also going to give you a lot of good praise because it allows a site to access a broader pool of patients then as well. You know, and say, hey, yeah, send them on up to me. And if a site can refer patients to other sites within their network and it can help meeting the enrollment targets a lot more efficiently. And again, because we're looking at studies are expensive, I need to know that I'm not going to waste dollars by setting up a study and paying the startup fees and, you know what I mean, getting you all set up and putting time and attention to it when you don't actually have the patient population we need. That's, that looks bad on the sponsor. And it also, I think, looks bad on the site. So I have a follow-up question to that. So you said a referral site, and again, referrals are, you know, are gold. We all need those and love those. But what's in it for the research? What's in it for the site that's the referral site? So one, I'm assuming that they have access to the, you know, the valve in this case, right? That their patients, which again, not all populations have access right now, but what else do they get out of it as being a referral source? I think it's a lot of goodwill in the community and in, for the sponsor to know that somebody's willing to say, hey, I ultimately want to treat this patient. Do you know what I mean? I can't do it here, but I know my colleague down the road can. And I think it adds to the goodwill, which actually means a lot, because again, somebody who's willing to just go to treat that patient. And I think from a sponsor perspective, I would be looking at that person with a lot, very kind eyes and saying, what can we do? What can we do for them? They're willing to move people along just to get the patient the treatment. What can we then do for them? And that's a collaboration and more of a connection. So I, you and I both have put a lot of value in citizenship, right, obviously. And I think that's truly important to our work environment. That being said, batting our eyelashes only takes us so far, right? Exactly. All right, so let's move on to the next slide. Oh, there's some questions, Ari. So we have two questions. So the first one is how can we bring appropriate research to our cardiovascular ASCs? So I think that's an amazing question actually. And I think that's the future, that slide from earlier, the future of cardiovascular care, right? There's a lot, we need to move everything outside of the hospital and ASCs, we know is where they're going to end up. And we know as Medicare continues to expand their portfolio of reimbursement, more and more activity is going to be moving there. And I think that's ultimately where we're going to be, you guys, I say we loosely, are going to be recruiting patients, right? And I think it's a gem of an opportunity to build infrastructure so that, as Dr. Pinto mentioned earlier, the IRBs, right? The large institutional legal systems and IRBs and stuff that we just are, at times difficult to work through and at times opportunity lost, right? We've all, I've been at way too many meetings where a lot of angry PIs because the contract never made it through legal and they've already shut down enrollment, right? So I think ASCs, I appreciate the question, is the future, what do you think, Lisa? No, I agree with you. I totally agree with you. The amount of bureaucracy is tough to get through and every site is very, very different. And we always ask as well, how often do your IRB meet? Do you have a central IRB or do you not? And then again, the contract process, every site is different. So a lot of times, if you've worked with a site before, you already know what their contract is going to be and it can be faster. So it's trying to understand, okay, how can we get to common ground more faster? You know what I mean? In order to do the right thing. Yeah. Yeah, I think ASCs is an exciting opportunity, right? Exactly. From the MedAction perspective, we're excited to help build that infrastructure, right? Because again, it's a different perspective, different clinical pathways, different infrastructure. I think it's an untapped market right now. I see that there's another question and I think this is a great question too. And Lisa, this is definitely from your perspective. I've been a PI in over a hundred CV trials and hope to continue, but I'm now in private practice. Is clinical research actually profitable? What makes sites, which mistakes to sites from a business? So is research profitable? We're never gonna get rich on research unless you own the research company, right? Then that's not the intent. But if you build your infrastructure slowly and appropriately, I think research is profitable. Every single one of these trials, at least from my perspective. And again, I come, you know, I have the luxury of having worked at large academic medical centers in Boston, lots of clinical trials. Again, you're never gonna get rich. You need to have the appropriate cost structure, which means don't overstaff. You need to have a lean quality infrastructure built, right? Which means the right people. But every single one of these trials, you should be able to make a little bit of money, right? And you take those residuals from each project and it's a seed money for future research. And I think that's, you know, the understanding, everyone needs to know that going into it, right? Some of these trials are gonna make a lot of money because you're super efficient and your patients are already there versus others are gonna cost you more. But it's short, but you know, slow, but steady, right? But private practice, I think actually is the untapped opportunity because most places we go to these big hospitals and it's hard. Private practice, you don't have all those layers to work through. So I think that's actually, you know, where I'm hopeful. I'm hoping you agree, Lisa, that these are the places that we need to tap into, right? Oh yeah, no, I totally agree. You shouldn't have the administrative overhead that the big hospitals have if you're going into private practice. You already know, you know what I mean, people that you can lean on, you know what I mean, to keep your costs down. And also there's always an opportunity to do investigator sponsored studies. You know what I mean? So you'll get a grant from the sponsor and say, hey, I have an idea, it aligns with what you, what I believe, you know what I mean, your strategy fits. I can do this. So you get paid to do it. And you know, and that's great from a sponsor perspective because somebody else is taking on the burden. However, we're giving them the money. We're not taking on the sponsor's resources. You can do it, be as lean as you need to be, take your enrollment as long as you want it to be or as short as you want to be, depending on how much effort you want to put in. And then you're guaranteed to get a paper out of it or potentially a podium, or again, moving the needle. So you're getting money plus, you know what I mean, visibility and potentially a manuscript, I think, which is a win. Yeah, I think money and a paper is a win-win, right? I mean, it's, that's exactly what we're trying to do. It would take that. Yeah, right, to fill that. Ari, next slide, please. So PI collaboration and communication. So what are you thinking about this one? So this is a funny one to me. Again, we all know PIs are very, very busy and they also have the best will in the world. They want to be involved in the next shiny new thing or the next potential new thing. And I mean that with the greatest respect. But what I find upsetting and frustrating is when you're trying to engage with them saying, hey, you know what I mean? For example, getting a lot of protocol deviations coming out, like, you know, what's going on? Help me understand. Or as I said earlier, you're not recruiting. What's the barrier? You know, why have you so many screen calls or why are you not even getting people into your pipeline? You know, so that type of, they're the types of communication and collaboration that I want. I want the PI to be my partner. I want to be able to reach out, you know, take up the phone and say, hey, how's it going? Again, what can I do? What do you need from me? As opposed to, you know, the PI just going, no, I can't, I'm too busy to get in on a call. I can't attend investigator meetings. I can't give you a status update because all they want is give me, give me, give me, give me, give me. And I think, you know, that I struggle with that. And I'm going to be very honest, I struggle with that a lot. Whereas it's going to be a much more profitable relationship if, you know what I mean, I can communicate and collaborate with the PI because we're both looking at the end goal. And there's always going to be something in it for both of us. Is there a correlation between patient recruitment and communication and PI communication with the professor? Yes, I would say that we could definitely draw that correlation. Yeah, you don't want people going silent on you. And again, if other sites are struggling, you also want to be able to say, hey, will you reach out to them? You know, peer-to-peer, explain what's working for you and what's not working for them. As I said, I like the physicians I work with to be collaborative and partners in crime because ultimately we want to get this product approved by whatever regulatory body we need to go to, U.S. or U.S. and, you know what I mean, and get patients treated. Yeah, no, that makes sense. And from an institutional perspective, I've worked with many PIs and, you know, all those obstacles we keep talking about, legal, IRB, and from my perspective, incredibly frustrating to work your way through all of those layers and then no recruitment from the PI. You set up the account, you've assigned your staff to work on it and nothing comes about it, right? Yeah. And you created the budget in the system and nothing. And, you know, it's also, you know, when you do, when that activity continues to happen, you lose credibility, right? The PI within the system, right? So the next time you need to get an IRB proposal in and you need to have legal signed off on it, it's not a high priority for the rest of us, right? We've already done this and we see, we see the routine, right? What keeps happening. So from all perspectives, right, it's critical that we, you know, you start it, you finish it, you do it well. Working with you or administration. Yeah, no, you're, listen, you've hit the nail on the head there, Anna. And again, a lot of what we're saying, all is still rooted in, you know, effort and cost. Yeah. On both sides. You know what I mean? So nobody wants to waste their time or waste their money. You know what I mean? So that's why it's just important to be upfront and honest, you know, and actively reaching out and engaged. Yeah, excellent. Ari? There is another question if you'd be open to that. Absolutely, please. I work for an academic slash research facility. I am digressing with this question, but Lisa mentioned core labs in your intro. We are wanting to create an echo core lab. Do we want, do we work with a current research groups PI to determine the best route? Our lab has 10 research studies circulating through and there is a value of a core lab for us. Wow. I think that's a you question. As the administrator, I say, if you want to do it, we'll roll up our sleeves and figure it out and do it. But obviously we need the clinical champion to decide that. What do you think? So I think I'd like to have a conversation, more of a conversation about it. So an echo core lab, obviously I haven't set one up. I know they are extremely effective. They are necessary. Most of the, if not all of TAVR studies are going to need them. So it is a very lucrative business opportunity. And I think quite honestly, the key is getting really good echocardiographers that are willing to look outside the box and say, okay, sponsor or whomever, what is it that you're trying to measure? Where do you want to go? And taking that time to come up with a really important and clear protocol that people can follow. You know what I mean? So that you're getting really, really good images. And you know what I mean? And it's easy to read as well. I think it's a great opportunity if you can do it. Yeah. And from the infrastructure business perspective, I think I've seen a lot of core labs. There's a couple that we've worked, large animal core that we helped run years ago back at the Brigham. Again, they're hard to get off the ground, but once they're up and operational, they can actually be lucrative too, if you do a good job. And the staffing has really been the obstacle in the last few years, right? Across the board. It's obviously not just your echo techs, it's everybody, right? However, a good core creates alternative revenue streams again too, right? So it's a good way to incentivize your existing staff to expand their skillset, to give them almost moonlighting type work. Obviously you don't want to push anybody beyond their bandwidth, but people love opportunity. So it's something to consider if you want to do this, it's figure out who that core team is and everybody loves to make a little bit of extra money, right? Yeah. It's having that engaged team, but it's a great question. Again, from the MedAction perspective, we would love to help in any capacity. Ari? Referral pathways. So yeah, let's chat about this a little bit more. I'm assuming is this the earlier, the referral doc centers? Yeah, exactly. And as I said, a referral pathway in place allows a site to access that just broader pool of potential study participants. I will tell you there's a physician in down South, put Southwest, and they are getting referrals from three states around them. And that is huge. You know what I mean? And it's a small center, but they are out there sharing, hey, here's what I can do. Here's what I can do. Here's what I can do. And people are intrigued and then you have, you're saying what you can do. You're proving you can do it well. You're getting out there. You're actively trying to recruit. Like you're literally trying to become a salesman and saying, here's all the studies I am currently recruiting for. Come, give me your patients if you can't do it. And building those relationships and being credible. So I think that is absolutely huge. And once a sponsor knows a physician can pull in people like that, that's a no brainer. You know what I mean? That truly is a no brainer to be able to say, great. You know what I mean? You have enough contacts. You have enough relationships already built up to ask, hey, do you have these patients? Are you seeing anybody that could meet this criteria? Bring them along. I mean, I guess it's also just better patient care, right? You create opportunity for your patients that others don't have. It's kind of a competitive edge, better patient opportunity and more collaborative, more community, collaborative, community village type of activity, right? Exactly, exactly. Good citizenship as you and I call it, right? That is of high value that there's just not enough about there. Yeah. But no, that makes sense. Yeah. All right. Oh, this is definitely you, but oh, and I guess this is part of the IRB question asked earlier, but yeah, give me your perspective about the regulatory compliance. Yeah. So again, I touched on it, like sites must demonstrate a commitment to adhering to regulatory requirements, including GCP and the local regulatory authorities are regulations. And the reason it seems like a no brainer, like it truly seems like a no brainer, but the sponsor wants the assurance really, like, again, as I said, it's going to come down to cost, credibility. The sponsor is investing a lot in you and your site. And we want to make sure that this trial is going to be conducted with the best quality, because again, ultimately we're going to be submitting it to a regulatory body. It has to pass the red face test. There is no way that, you know what I mean? We can allow constant protocol deviations and there's always going to be a context about, well, we're just, and it's to help the patient. And it's this, that's a pattern of behavior then, you know, that you have to be thinking about. So you always must think with a regulatory, a compliance mindset, good clinical practice, you know what I mean? And say, hey, is everybody on my team doing the right thing for the patient and for, you know what I mean, the sponsor? Yeah, it's, I think from the, you know, hospital perspective, it's having that core team, right? It's really having identified who those folks are. Yeah, right. And that's, it's surrounding yourself, but with that team, that core team that believes in the value of, you know, of clinical research, you know, is doing the right thing all the time. At the same time, when I think of regulatory, I've obviously also think IRB, right? And the institutional obstacles that are, there's no way of hiding it, they suck, right? It's been painful to get through some of this stuff. And I don't know that, I don't know how much, how much ability we have to change the existing infrastructure within some of these large hospitals, but I think the value is the future, right? The, you know, the ASCs, these private practices, I think that's where the research has to go because it's just not cost-effective within these large institutions. We were just visiting a client last week and they were talking about their hurdles and they're an academic institution and, you know, the, how slow the process is and the tax they have to pay to the Dean, the tax they have to pay to the chairman. And again, it's just not cost-effective. So finding more creative outlets, I think the private practices where they can use centralized IRB functions around the country, right? Not their own internal systems. And again, these ASCs, I think they also will, you know, end up using these centralized IRB companies that are way more effective and ultimately faster, quicker and more cost-effective for you guys, right? Yeah, no, I'm glad you got me back on track there, Anna. I'd forgotten, you're so right. The IRB process is quite frustrating. I understand the role, totally understand the role, wouldn't have it any other way. However, you do have to keep asking those questions, like how often are they meeting? Remember going through COVID, if you didn't have COVID on your protocol, you were not even looked at, you know what I mean? They prioritize. So it's understanding as well where that hospital is probably prioritizing what they want to focus on as well, you know, because you don't want to be working and saying, yeah, yeah, yeah, we're all set, we're all set. And it's like, yeah, you're not gonna be on their docket for three months, you know? Like it's very demoralizing again, when you're trying to, you know what I mean, say, hey, you have my full support from the sponsor, we're all in here, and then you just get stopped. Yeah, and it's demoralizing for everybody, right? The PI, the sponsor, incredibly frustrating for everybody. You close doors of opportunity before they even, you know, for truly open, right? Exactly, exactly, exactly. Ari, I see there's another question. Oh, wow. So going off that piggybacking off of sponsors, research has become more and more complex. How do sponsors feel about the rising costs coming from sites? Do they agree that there is an increasing number of resources needed to run trials at sites? Ooh, that's a good question. That is an excellent question. And again, from my perspective- Not good for you. No, not good for you. So I think, let's be honest, Yenaval is the smallest company I've worked in, right? So the burden of proof on the bigger companies is huge. FDA, we talk about FDA, they're not gonna let you get away with anything. And because of that, the bigger companies have more money to throw at it, do you know what I mean? So they don't mind if, I won't say they don't mind, but they can tolerate shifts in costs at the site, because again, their trials are more complex. You know, they're trying to, we're narrowing and narrowing the field, so it's bigger head-to-head trials with bigger patient populations, with more criteria to do. So it is more intensive. And then the sites are constantly bombarded, because again, if you're a good research site, you're doing a lot of research. So you're very, very busy. You're doing clinics however many days then as well, you know what I mean? So there's a lot of burden on the physicians as well at the site. So I get it. You know what I mean? It does take more to probably do less than we used to do five, eight years ago. But from a sponsor perspective, like that is freaking us out, because again, the burden of proof to actually get quality data, engage physicians, you know what I mean? So they're not distracted. Getting the data in, in a timely manner so that we can keep our quality checks up and we can keep our wheels turning and turning. It is, it's costing us a lot more and a lot more people, as I say, to do probably less, you know, than a few years ago. Yeah, I guess I'm, I hadn't thought of it. I mean, it's a great question, but I hadn't thought about it. The cost to run a hospital, right? The cost of nurses, the cost of staff, literally every, you know, every expense within the hospital infrastructure has gone up so that you have to pass that cost on to somebody, right? Yeah. It makes sense that it's passed on to the sponsor, but I am assuming from your perspective, I'm assuming that site has credibility, quality, consistency, that it's worth paying into it, right? But this goes back into that experience, right? If you haven't demonstrated, you know, accountability previously, you know, you're not gonna support it going forward, right? Yeah, it's like, you know, the poor kids, they say, how can they get in the housing market? You know what I mean? If they don't have money and the prices keep going up, that's effectively what it is as well. It's like when you're new to research, how do you get on that wheel? And a lot of it is like try and work with the sponsor to, you know what I mean, especially the smaller sponsors, so that, you know what I mean, it's not cost prohibitive to start a collaboration and research with you. Yeah. And I guess when you do something well, I had a previous conversation from earlier today from one of these outside companies who does echoes and sends the folks to the patient's house to get an echo, right? We won't mention the company. But that being said, how cost, how expensive they are, right, to do this. But if nobody else is doing it, they kind of have an edge right now, right? Until new core labs are built. Our previous question, you know, it's hard to compete. But once you're in, it drives the cost down for everybody and it's more competitive for everyone and easier to participate. So that was a great question, thank you. Next slide, Ari. Infrastructure, that's my sweet spot. So when you say appropriate infrastructure, what does that mean to you, Lisa? So again, you have the adequate facilities and equipment necessary for conducting trials. So each, as we said, each trial is different. They're going to do very specific tests, have you access to the appropriate labs, have you access to, I know this sounds stupid, but even like internet, wifi, that you can send an image that is so big over the wire, you know what I mean, to the core lab efficiently without degrading. You'd be surprised how many sites don't actually have that. And it's tough. Again, the, and as I said, just the access to the imaging and the diagnostic services that you would potentially need. We're looking at, I think this is my dichotomy as well. You're looking at sites, you need to have all of that, right? But yet we still want to go to the poor socioeconomic places. We want people to be available out of the standard hours. You know, so it's like we're trying to ask or speak out of both sides of our mouth. And I think that's where, you know what I mean, you guys, you know, the sponsor, the physician, can we be creative? Can we be innovative to say, hey, here's what I can do. Here's, you know, look for the niche that you have and say, here's where I can fit, I can fulfill your, you know what I mean, diversity or just patient population, your diverse population. Does that make sense? No, it doesn't. We're all looking for that unicorn, right? That easy, kind of the easy button too, right? That site, but yet bandwidth. It's, you know, how, you know, how archaic does that sound? But I guess, you know, it makes sense that it still is an obstacle for some people, right? For smaller practices. But it's interesting to me when you say infrastructure, you're, you know, literally it comes down to bandwidth, right, of IT bandwidth, you know, the simple things that are critical to mission. Ari, if you can go forward, because from when I think of infrastructure, I think of the infrastructure in the hospital to build research, right? You need to have an organized structure in order to have credibility to the sponsors, in order to come across as an organized organization, right? You need to have, you need to understand your pathways for sign off with legal, with IRB. You need to have process. And then in order to be successful and continue to build, for the sake of the PI, you need process and operations pre-award, you need post-award, you need somebody that's reviewing your finances monthly to make sure that the appropriate charges are coming through, the appropriate invoicing is going out to the sponsor, that this sponsor is paying you. So these are all details that are critical to mission. But in order to be successful, you have to have an organized infrastructure on the backend, right? It doesn't need to be overly complicated, but do you need to have identified individuals to help you do this? Because the PI, this is not their job, right? They do not have the time to do this, nor do they have the know-how, and you know what, we don't want them to do this, right? We pay them to do something else, right? And what they do really well, we want them to continue to do. And yet it's building, finding those people, your team, to help you build the governance, organizational structure, process, operations, be able to evaluate it, the data, is this working? And then evaluate it and see, wait, what did we do wrong? What are we gonna do better next time? You know, let's tee it up for the next sponsor, right? So to me, these are some of the standard pillars that MedAxium is helping our members to build in order to be more successful and to be ready when Geneva comes for their next trial to the door, right? This is what we're gonna do. Exactly. So I'm looking at the time and it's, I can't quite believe how, you know, where the time has gone. Ari, if you don't mind forwarding, so we can kind of get through these last few slides. And this is just really quickly to say research is hard, but it's also rewarding. It's complicated, but it takes, you know, it takes a team. There's a lot of activity. And again, no one person needs to know how to do all of this, but it's knowing who you need to go to to get it done, to get the signature, to get the account set up, to figure out the code, to charge, you know, the research echo that's not going to your clinical budget, but it's going to your research budget. Who sets that up, right? These are critical details to doing it right the first time, right? Not cleaning it up six months later. So I've lived that and, you know, I have no, I would, you know, value the opportunity to help others not have to learn the hard way, right? So again, this is part of the building, the right infrastructure. Ari? Let's, you jumped right through. Ari wants us done. So really quick, geographic location. So again, it goes back to what we said, you know what I mean? We're speaking out of both sides of my mouth. We need to be, we can't have the same sites, you know what I mean? Our two sites enrolling 1000 patients, for example, you know, we need to be able to show that there's a spread that we're getting the biggest, most diverse patient population that we can possibly go to. So that's why a lot of us will limit the number of, you know, the percentage of patients that people can enroll to show FDA that, to show that there's no bias as well. So geographic location is important. And again, the catchment area that you have. So where are you situated? What access do you have? You know, both, as we said, infrastructure, patients, you know what I mean? Core labs, whatever might be needed. I think we're seeing a thread, you know what I mean? And a lot of it is saying the same thing, coming back to the same thing, you know what I mean? With sponsors are investing a lot of money. Sponsors need you to have a well-oiled machine, big or small, depending on what you want. You need to be able to access patients. You need to be able to show that, the sponsor needs to be able to show that we're not just going to the big cities. We're going everywhere. You know what I mean? We're trying to do a really, really good spread. So that's what we're looking for. Yeah, and then from my perspective, all the more reason private practice, small community health centers, small private cardiology practices need to get involved. We need to make it easier for the sponsor and we need to diversify our options, right? The patients that we're doing clinical research on. Again, we're talking about it, but I don't feel like we're doing a whole lot about it at the same time. So Ari. So financial consideration. So really quick, from your perspective, tell me what you mean by that. The site can't be exorbitant. We can't cost ourselves out of doing the study. And that goes back to the contracting and the overhead. As I said, it's tough. We sort of want everything, but it's getting that nice balance. It's really getting that. And if you're research naive, or if you're only have a couple behind you, show that, hey, you're willing to work with us. You're willing, especially for the smaller companies, that you're willing to say, hey, let's start off maybe low, let's see how it's going. And then maybe I get, if I do really well and I've cut down my price, I'm part of your ad boards or I'm part of your... I get some things another way. So just be prepared to work with us instead of saying, no, it has to be this number at all times because I'm trying to cover these costs. So don't price yourself out of the study. Absolutely. And from an institutional perspective, when I think of financial considerations, don't build infrastructure too quickly, right? I hear it all too many times where folks, they want to hire their research coordinator or research nurse, they need a new admin. I'll be honest, the surest way to fail at starting a research program is by overspending on day one, right? Building too much infrastructure. It's not sustainable. You need to be realistic. We need to start slow. Again, this is slow and steady, right? It's finding the ideal world is you find somebody that you know has a lot of potential, has done a really great job, and hopefully they're willing to grow professionally and you can grow them into a research role, right? But ideally it'd be part-time, their existing role in part-time research, right? It's a great opportunity to expand their job description, hopefully give them a little bit more money, slowly build your infrastructure cost, and that's how you succeed. But the first, again, you're going to price yourself out with the sponsors if you overbuild in the beginning, right? And that's what happens. So it's slow and steady. Be realistic about the cost. Until you have the trial signed off, delivered, and you've started recruiting, honestly, I don't even think you should be hiring, right? Because I've seen it too many times. You start hiring folks and you never even enroll, right? So credibility, it's about building credibility, right? And being successful. So from both angles, critical that you don't price yourself out. So yeah, I think that's fascinating. Ari? So I see the time. So need to have basic infrastructure in place. So this is, again, the metaxiom, the business perspective, how we help. It's help build that infrastructure so that you can do clinical research. It could also be federal NIH funding, right? It's, for me, from my perspective, it's the same infrastructure, same processes, same governance, post-award, pre-award. You still need the same system set up. You just have a little bit more flexibility with the budget when it's industry. We won't go into detail. Lisa doesn't need to hear about that. But it's understanding your real, in real time, the understanding of your cost structure. Having a handle that helps you to make quick decisions with a sponsor, right? But again, it takes a team and it takes some know-how. So that's my takeaway message to folks who want to build, build slow and steady and build realistic structure. And then again, and then it leads to hopefully success. And then lastly, the next slide, Ari, that's it. I'm incredibly grateful to you, Lisa, for your knowledge and your experience. I love seeing it through your eyes. Very educational for me. I'm hoping our members learned something. They have, you know, they walk away with something, something that has sparked their curiosity and hopefully it leads to a new research site in the future. And that benefits everybody. So with that, if you have any other questions, feel free to reach out to me. That's my personal email at medaxium. And thank you for joining this live webinar. Lisa, any closing thoughts? Yeah, I just want to say thank you, Annie. You've made this very, very easy for me. I do hope that it was helpful for people because I was very nervous. And if people want to reach out directly to me as well, I'm sure, you know what I mean, that you can find me. It's BoyleatYenneval.com. So again, thank you for the opportunity. Yeah, or through MedAxium. I'm happy to send along Lisa's contact info and thank you, you're a rockstar, Lisa. I appreciate all your experience. Thank you all. Have a wonderful, enjoy the rest of your afternoon and have a wonderful week. Thank you. Thank you, take care.

clinical research sites

infrastructure building

organized structure

processes

adequate resources

collaboration

communication

patient recruitment

compliance regulations

financial considerations