Hey, guys. Welcome to the podcast. My guest today is Gail Rosenzpahn, medical affairs leader and consultant. And we explore the role of the MSL in IITs, investigator initiated trials. I learned a lot. Great conversation. Think you guys are gonna enjoy it. Don't forget to follow me on LinkedIn. Check us out, the first Tuesday of every month at 1:30 PM EST on MSL talk live, which is a discussion that we have once a month, and it's available on LinkedIn live.
And I'm also on TikTok now, so check me out on TikTok. Thanks for joining us. Welcome to MSL talk with Tom Caravella, a podcast specifically designed for MSLs and all things field medical. Hey, Gail. Welcome to the podcast. Thanks for joining me. Thank you. It's a pleasure to be here today. I know. I am excited. So I wanna I always start by telling everybody how these things come into being. So first off, I know Gail for a 1000000 years, and I'm not that has nothing to do with my age or her age.
But we do know each other a long time. And reunited ran into each other in San Diego at a conference, got into a conversation, and here we are. So I am excited, my friend, to have you here. I think you have You came up with an awesome topic and that and more context behind the meeting is that Gail was presenting on this topic at the conference. It was Mass West last week.
So this is an awesome and very relevant topic because we have not talked about IITs on this show, so we are breaking into new ground. So, Gail, thank you for joining us. I had a good reception at Mass West. The audience was really engaged. So I think this will I think this will be a great podcast. No doubt. To it. No doubt. So but before we get into it, why don't you do an introduction and just tell everybody where you're from and a little bit about yourself? So I'm Gail Rosen Spahn.
I'm a Pharm d by training, actually a post BS Pharm d. I, have been in leadership positions in the pharmaceutical industry for over 20 years and, really passionate about medical affairs being a strategic function within the pharmaceutical industry and also about the MSL being really empowered in their role and really having meaningful activities in their day to day. And I think IITs are great discussion that will feed right into that. Yeah. No. For sure.
And, again, it's it's something that I think people hear about. Some have experience. Others have no idea. So we're gonna kinda run the gamut. So why don't we start right from the beginning? So what is an IIT? What could you tell us about what an IIT actually is? So an IIT stands for investigator initiated trial. Some people prefer the term investigator initiated study or investigator initiated research. Those terms actually are better because they're a little broader.
It doesn't necessarily have to be a clinical trial, but I always have problems with my r's, and t's are easier to say. So I say I I t instead of I I r. Well, you know, it's funny. You do hear it it is one of those things that you hear in a 1000000 different ways. So let me ask you. Are there any difference in the programs based on those acronyms, or does it all mean the same thing?
I think what you know, when you say trial, it implies that there's clinical human subjects involved where research could be, say, a retrospective chart review, or a study could be a retrospective chart review, or a linear regression analysis or something more like that. So study or research is a little broader term. I have seen people now say IITS, which is investigator initiated trials and studies. It's all good. Got you. Okay. So there are some nuances.
We're gonna put it all into one bucket, though. Yeah. Everybody does. So what so let's go back. Let's talk about the process. So how does a company develop an IIT program, let's say? Basically, you have to start with the funding. If you don't have the funding for an IIT, it's no use really talking about it.
Although, some of the HCPs, health care providers in the field, may have some ideas, it's always good if the MSLs collect those ideas and bring those insights back so that, senior management can start to understand that there are questions maybe about the clinical trial program, like gaps where certain populations weren't addressed, and then IIDs can start to fill in those gaps.
But the process is basically funding has to be secured, and then you do want a a really solid standard operating procedure SOP in place. And I particularly love when that SOP includes the role for the MSL. Got you. Okay. And we're gonna get into that. We're gonna we're gonna talk about how the MSL plays into this and what their role is. But before we do that, just to gain more of an understanding, you know, why so what's the benefit? What's the purpose? Why do companies have these IIT programs?
So I think we did, mention just a minute ago about, like, when you do your clinical trial program, you have a very prescribed patient population. You have age ranges. You have exclusion criteria. It's very drilled down. But people have questions, like, what happens when it gets into the real world? So IITs can help generate real world evidence. They can look at a specific population and see how it performs. They can answer questions about timing of doses and things like that.
They're, really informative. And what's nice is clinicians typically will have these questions as they start to use the product, and so it fills in those gaps. The other benefit of having an IIT program is it keeps noise up, if you will, about your product and your therapeutic area. So it oftentimes will fuel discussions later than either the sales reps can have depending if it's on, you know, totally on label and approved by promotional review or that the MSLs will have.
And then we saw one side benefit is that also, oftentimes, the investment community likes to see that there's engagement from the health care community. And especially, like, if, you know, really prestigious institutions get involved, sometimes they get excited about that. So I think it serves a lot of purposes. Yeah. It's funny. As you're talking, I'm thinking it it's definitely an engagement strategy.
Yeah. Yeah. We have to be careful, though, about the engagement strategy aspect because one of the things about an investigator initiated trial is that the investigator also serves as the sponsor. And what that means is he's got legal requirements in terms of adverse drug reporting and other things that are very specific to the sponsor. In order for that investigator to also be the sponsor, that IIT has to be unsolicited. He has to have the concept.
He has to conceive the, study that he wants to do. He has to write the protocol independently. It can't be where the company comes to him and says, would you like to do this study? Then you'd lose that sponsorship or that independence that's essential within the IIT process. So the sponsor is a fancy term for the person that's really responsible. Yeah. There's legal requirements from the FDA that they're responsible for.
And if the if the lines get blurred and the company is perceived to be the sponsor, then they have to know that so that they can follow those legal requirements. The biggest thing is about adverse drug reporting. So it's really important to protect the integrity of the IIT, and that is to make sure that it's independent and that the investigator, when they submit it, conceives of it, writes the protocol on their own. So the investigator and the and the sponsor can be the same individual or not.
They are the same. They are the same. In an IIT program, they are the same. Okay. So they are the same. And then the pharmaceutical company, right, is who's paying for it? Right. So they're funding it. And that's so interesting because a lot of times, the at the outside community, people think the term sponsor Means who's paying for it. Right. It's not. So they're not. Right. It's not about the money. It's about the low requirements.
So, sometimes, like, we would get, like, an introductory letter that would say, from a institution that say, we would appreciate if such and such company would sponsor our IIT, and that would cause our whole grant review committee to start twitching. Because but not the sponsor. They want funding, but they have to understand that they're a sponsor.
And that's actually a good opportunity for an MSL in their initial discussions when they hear that someone's interested in submitting an IIT to really explain what it means to be the sponsor. Right. Okay. Good stuff. Alright. So we're covering some ground here. So let's get into it. So what are what's the MSL's like, what's their role in this whole thing? How do they support this effort? So I I mean, there can a little support, there could be a lot of support.
There's some companies that feel like IITs really need to be at arm's length, and they don't want the MSLs involved at all. I think they're really losing an opportunity for that. So what I like is I like when the investigator has a way to submit their request for funding that is at arm's length. Either say through a website or even through just a dedicated mailbox. It doesn't quite have to be as fancy as a website if you don't have the time, the resources to develop that whole website.
Those websites are pretty elegant, though. But if you don't, it could be a mailbox that it goes into. The first step that I like is when the MSL is able to go in and validate the site. So they wanna go and make sure that the investigator the potential investigator, the investigator sponsor who's looking for the funding has research experience. And some people want, like, that research experience kind of recent, like maybe within the past 3 years. You know?
There's some physicians that did research when they were in their fellowship year and haven't done it for 20 years since then. That that may be a little too much history. That may be too far back. So they wanna validate the site. They wanna make sure the person has research experience. They wanna make sure they have adequate, personnel on staff to be able to help with the necessary paperwork that's needed.
They wanna make sure that they have the adequate patient population to complete the study, things like that. Because what happens is if you fund an IIT and the site isn't able to deliver on it, you have to actually go to the site and ask back ask the money back, which is never a good thing. Yeah. So you wanna make sure upfront that the person really is a good site that's gonna be able to deliver, you know, exactly what's expected in terms of the IIT. Got you.
Okay. And do MSOs, are they out there, like, soliciting KOLs for can't solicit. That's really good question. So they could not solicit. That then they have to do scientific exchange. So in other words, it has to come unsolicited or unprofited from the HCP that they're working with. Yeah. There are some companies that will put out topics of interest. That's okay. That's actually preferred.
So let's say, for example, if I'm working on a drug for insomnia and the investigator has a question about menopausal symptoms, you know, that may not be an area that the company wants to go into. So it's good that the investigator knows there's not gonna these are the areas we're funding, you know, and they're broad therapeutic areas, but they're not gonna be prescribed concepts of the study. They're not gonna be a prescribed protocol. Got you. So the MSLs do have to be cautious.
Yeah. They always you know, it's just like, when you have off label information. MSLs should be really well trained in how to handle scientific exchange and that it is unsolicited. And there may be areas in their CRM that they document that they've had the discussions. Yep. And what about, like, sales reps? Do sales rep have anything to do with IITs at all? So sales reps, you know, I love sales reps. So I understand that I do. I love them.
And they're very, customer focused, and I love that as well. So oftentimes, if a sales rep gets a question about an IIT, they'll go ahead and answer it. But they really, really should be trained that IITs are a medical affairs area. And that's because if they get too involved in the discussion, it could end up looking as a quid pro quo. It could end up looking as if you're talking about giving them money to get orders, to get prescriptions, and that's never a good look for a company. Right.
It goes back to that engagement piece. Right? You know, you're using it as an engagement strategy, but you have to be really careful at the same time. Yeah. I think, I mean, I don't know that I would like to call IITs I mean, I think you could call IITs a strategy if you have it broad enough that it's to increase our knowledge in this therapeutic area or increase our knowledge around this drug.
But if it's really so specific, in terms of the engagement strategy or maybe, like, increase with this channel of physicians, I mean, ENTs or something, you know, a group that doesn't typically have a lot of research done. But if it's so specific that you you really have, like, the protocol in mind, that's probably you're probably blurring the lines of independence. Got you. Okay. Does that make sense? That that I keep coming back to that.
Because, you know, I come from a sales background and I'm a big, you know, I'm big on the engagement piece. So Yeah. Don't listen to me. Listen to Gail. Don't listen to me. Yeah. So I really, you know, I really wanna stress that there are recent scenarios where companies have had allegations put on them and they had to pay pretty large settlements that would impact us, you know, a company, a small company, because they had their sales reps involved.
There were allegations that it looked like they were actually using it as a strategy to increase sales. So don't do that. Yeah. And I know there's risk involved in in companies doing these programs. And I know that it was a part of your talk at the conference. So how what's your advice on how to derisk these programs? I think the best thing that a company can do is have a good standing operating procedure in place before they begin to have the program at all.
And then they'll be able to kind of hit all the sensitive topics, in terms of, for example, the study has to have a real purpose. It has to answer a question, How are you gonna justify that the money that you're being funded with them is true fair market value? You know, you can't pay exorbitant fees to do something. You have to, you know, justify it against fair market value. I like when there's a grant review committee in place.
I think most companies have that, which is a cross functional committee that'll have members from regulatory, members from legal, as well as members from medical affairs. And that grant review committee getting back to the MSL engagement is a great opportunity for MSLs to be involved. So but when an IIT comes in, that the MSL is actually the champion for that m I that IIT and presents it to the grant review committee.
So what that means is they have to meet ahead of time with the HCP that submitted it. They have to feel comfortable with the HCP, comfortable with the site. We talked about that. But they also need to know, like, the background, like, why is this clinically important? Is there anything specific to know about this disease state?
And they should be pretty knowledgeable about statistics as well to make sure that the study is powered enough to really let's say, if it's a study against standard of care, is it powered enough to show a difference? Or is it just you know, you can't have 5 people in each arm and then expect to show a difference against standard of care or something like that. Right. Now are not all companies would be interested in setting up IIT programs. Correct?
Like, is this something that everybody should be doing, or is there only certain situations in certain companies? I think it's the latter for sure. Like, if you're all precommercial, most companies will not set up an IT program before they have a commercial product. Okay. For 1, IT programs are expensive, and they they consume resources. They consume money resources and also time because there's a lot of cross functional involvement.
Oftentimes, companies that are, you know, getting ready to launch their first product, they're pretty thinly staffed. Everybody's kinda already cranking at top speed. They may not have the reserve capacity to focus on it. But more importantly, if the drug doesn't get passed, what's the purpose of the IT? It doesn't make any sense. So strategically wouldn't do it.
And then lastly, sometimes, and this has happened, an adverse event can come up through an IIT study that ends up finding its way in the label. And it may be because of the selection of that patient population. So nobody does IITs if they're I shouldn't say that. Most companies do not wanna do IITs if it's pre commercialization. And then again, the company has to look, you know, IITs are expensive.
They'd cost a you know, an IIT program will cost a couple $1,000,000, not at each individual site, but, you know, the program overall. And they take time. A typical IIT from start to finish will take 4 years. So they have to see is that consistent with do they have the resources to see that? Do they have the resources to finance that? Well and is it like, do you feel like it's it's a like, is there a return on on that investment? What's what's typically right?
Well, like, what we talked I one of the first question I asked was the benefit. But, like, is there the benefit and the return on investment are 2 kinda different things. I think that there could be benefits, but is it really worth it? So when I talk about return on investment, I don't talk about sales. Okay? I talk about information. Right?
Yeah. So the return on the investment of an IIT is information that's gonna make a difference to how comfortable the HCP community feels with using your drug. Do you have information out there that addresses how the elderly are gonna respond or addresses somebody that has this comorbidity? You know? So that could be really critical. And then, it does keep I like noise. You know? It does keep people you know, it does keep the chatter up about your product.
Ultimately, an IIT should result in a presentation at a national conference and a publication. So that keeps information going out into the community. It keeps people engaged. And sometimes companies like to even talk about this with the financial community. Sometimes the, the The Street would like to hear, oh, this institution is is looking at this, and and that gets them excited as well.
Yeah. Yeah. And I don't mean to be redundant in asking these questions, but as we start to come full circle and you you it's a the couple times you mentioned how expensive it was, but I can also see all the benefits. There's there's so many reasons why, you know, it makes sense to do this, not to go into all of them. And I see that it's become every time we go to one of these conferences, I talk about IITs.
It's it's it's just one of those topics that is constantly being brought up because I think companies really wanna be good at it and incorporate these programs. Right. You have to most companies wanna do them, but most companies wanna do them right. Right. Yeah. Exactly. So yeah. And I'm glad we're talking about it because there's so much discussion and buzz around it, and we never had this conversation on the podcast yet. So, yeah. Go ahead. I I have one thought though.
You know, I wanted to talk about a little bit how to up the MSL engagement with the IEP. So we talked about upfront, you know, that MSL should visit everybody that submits, whether they're on topic or off topic. Because that person could be a key opinion leader you didn't even know about yet. It could be somebody that's so interested in your therapeutic that you they may be a rising star. You may be able to work with them. I love those new key opinion leaders that are very energetic.
But once the IIT gets approved, it's really a great opportunity for the MSL to stay close to the investigator sponsor. And, they can do inservices at the site to make sure that the study is kept top of mind and also to make sure that the staff feels comfortable with the drug. You know, if the staff doesn't feel comfortable, they won't alert doctor so and so. This patient's gonna fit into your study. They'll just kind of forget about it. So it's good to have a presence there.
Those, in services, I think sometimes people do lunch and learns, are really beneficial. And these days, staff turns over a lot. So you probably even though you maybe did one a couple months ago, you may wanna revisit and say, is there a reason to do another one? You know? So I think, that's part of the engagement. And then I like to help the communication in terms of so every IIT contract should be structured with milestones, which is you don't give the full payment upfront.
You say once you get this milestone, once you have first patient, first visit, we'll give you so much money. Once, you know, you have last page, once you submit the abstract, once you know, So there's triggers for those milestones. The MSLs can actually go in to release the milestones. They can say, you know, make sure you tell me when you get IRB approval. Make sure you send me the emails that you need. They could keep that top of mind and keep that thing going.
Because usually, the investigators that submit this are really, really busy people. And then the last thing that they can do is, like it's not the last thing, but one more thing, is they can think about, like, as it's getting towards close, like, where are you thinking about presenting this? Where is a good place for it? They can have that discussion. Where are you thinking about publishing it?
If they know they're gonna present it a s a, for example, they could keep track of where that when the abstract submission is, maybe a month ahead of time. Say, how's the abstract going? Are you able to to submit that? And then one thing I kinda like to do is if I think that there's gonna be a presentation coming up at a national conference, but I don't think the person's, like, a great presenter or I think that they're so busy. They don't pay attention to things till the last minute.
We all know them. Right? So I'll ask for, if they would like to present early findings to medical affairs. You can't present that outside the company. You have to embargo those findings, but still gives that presenter a chance to practice so you know that when he's on stage, it's not his first time up there. Oh, look at you sneaky. You Yeah. It's good for everybody. That's awesome. That's great advice.
Well, you gotta keep people on their toes and you and again, this part of goes back to the return on investment piece. Like, you wanna get the most out of this. Right? Right. Here's Right. You want that information to come through clearly. And that means that you need and so you can help you know, if you're presenting to medical affairs, medical affairs may have questions that helps the presenter anticipate questions that would come up at the congress. Yeah. So it's all good.
Yeah. No. There's and, again, it they're really the more we talk, the more the benefit and the value of doing this comes out. There's just so many ways that this benefits the company. And and, you know, and one of the things I wanna mention is that MSLs that I talk to and and that we interact with just in job searches all seem to really like being involved in IITs. So if we have, for example, we might have a job description and we might be working on a position.
Often, they'll say, does the company have any IITs? Will I be involved in that? Or will I be able to work on IITs? I think it's a real benefit from a hiring perspective to have that as part of the MSO responsibilities. Do you agree with that? Absolutely. And we've done some creative things. Like, I had a member of my team that was very involved in an IIT in a unique disease state. It was a great disease state. But he actually got to write the press release with the yeah. It's kind of fun. Right?
And he got to go to the key opinion leader and get a quote that ended up being used in the press release. So, it's a little bit of a a deep you know, it deepenings. It enriches the role of the MSL. Also got to work with marketing. So that usually, like, if we have new publications come out, whether it's not IT or another area, I would work very closely. I'll partner very closely with my marketing colleague. Maybe it'd be me, maybe it'd be somebody else on my team.
But we would digest for marketing and also for sales the background about why the, study was important, why the study was conducted, what do the results show, give the context for it. And then my marketing person would follow-up with the sales team on the field direction memo, which has been through promotional review committee and actually gives field sales the verbatims of what they can say and what they can't say. Or even the marketing strategy of what they can say what they can't say.
But the end users, like the the field people, the field sales people feel very well informed. That gives them confidence. And that's what you want from your teams. Sure. Yeah. No. It's great. This is good stuff. And getting back to the MSL, and I've just in my mind, I'm still thinking about, like, how this comes back to the role. But I would think that it gives a lot of ammunition or a lot to talk about and bring back to the company.
So, like, is this typically part of the insights that MSOs are communicating? Like, you're obviously you're involved in in these studies. You're involved with, you know, interacting with and and getting information from the investigator sponsors, and you're bringing that back to the company. Or is that being brought back in the form of insights? And is there even a place in the CRM system for this IIT? You know what I mean? Like, is it a thing in CRM?
Yeah. So, in terms of insights, it absolutely gives you opportunity for insights to bring back to the company. And then, also, as other people are talking to KOLs and they'll say, well, I'm interested in this. You can say there is an IIT on this. All these IITs should be listed on clinical trials. So, you know, it's public information that they're doing this, IIT. And you could say, doctor so and so, you may wanna call doctor so and so down the street because he's actually studying this.
And then they can have the peer to peer discussion. We're not gonna have the insights into the early, you know, data yet. They're not gonna reveal the data until it's finally, you know, ready for, submission, say, to, you know, where they're gonna do the presentation or where they're gonna do the publication. But to get to your question about the CRM, my experience has been that I've had to build the sites within the CRM Mhmm. To capture the data.
Like, I think that when the contract is signed and contract signing takes about 4 months. When the contract is signed, there's milestones that are built into that contract. I think those milestones, every MSO involved with that study should know or about with the study should know the milestones that are part of the study. Right. And it's really helpful if you could put those milestones in the CRM so that they have an idea of when it's coming up.
It really makes, like, the why you're going in for that visit very meaningful. It's not just, like, an activity. It's a purposeful activity. Sure. Yeah. No. That makes total sense. That's what made me think of it. Yeah. Okay. Last question. So what else are we missing? What other benefits to the MSL or to the company might there be? Or what are your final thoughts on this? I I think this is really great and insightful information, but I just wanted to see if there's anything else that we missed.
I don't know. What else did we miss? You wanna realize that sometimes you lose your money in your IIT funding. Mhmm. You know, if the company is wanting to fund a marketing program and they see a little pot of money out there that hasn't been spent yet, they can redistribute that money, pluck it out of your IIT budget, and give it to marketing.
So you wanna be sure that when you're talking with somebody who wants to submit an IIT, you really manage their expectations, that it's a very specific process. You can't tell them whether it's approved or not. It's gonna go through a grant review committee for approval that you never know if the money is still there because funding tends to be a little liquid or, you know, it passes through different areas. So you really wanna, you know, manage their expectations.
And I like like when the investigator sponsor or the potential investigator sponsor can submit just a concept instead of a full 16 page protocol with references and stuff like that so that they haven't invested so much time that they feel really burnt when they don't get the approval. But, it is important, I think, because you can damage relationships if they think it's go and then it doesn't happen. So it is good to manage expectations. Yeah. That was great insight. That was good.
Yeah. Well, listen, this was awesome. I learned a lot. I know everybody else did. So we'll have to think of topic 2 for you, my friend. So I would love that. Yeah. But thank you. Thank you for spending a couple minutes here. You were awesome, and, we appreciate you. Tom, I have a very interesting talk coming up on I the there's a clinical trial strategic summit coming up in San Francisco. And so this is all clinical people, and my talk is when to pull in medical affairs.
Mhmm. It's kind of interesting. So look at that. You're giving a little sneak peek at maybe what our next talk is gonna be about. I love that. Maybe. Groundbreaking. We've never done that before. Well, Gail, thank you again. Appreciate you, and I appreciate everybody for listening. You guys are awesome. Thank you for all of the comments and shares. And we are going to make an announcement this week. We're we're actually right at 200,000 listeners in over 60 countries.
So I wanna thank all of you guys for listening. You're the best. And thank you again, Gail. We'll see you soon. Thank you. Thanks for the opportunity. Thank you so much for listening to the show. And if you enjoyed it, please subscribe so that you don't miss an episode in the future and feel free to leave a rating or a review or a comment. Thanks again, and we look forward to seeing you soon.