Hey, guys. Welcome to the podcast. I am excited to bring back my dear friend, Jeff Vaughn. And with him, we have Dean McAllister. These guys are both from Inisio Engage, and I'm excited. We're gonna talk we're gonna do kind of something a little bit different. The title of this episode, is it ever too late or too early? And we're basically gonna talk about, if it's ever too early or late to bring in subject matter experts and MSLs into the product life cycle and how that timing piece works out.
I think which is I think a lot of people are gonna be interested in this. But before we get started, Inisio Engage is our sponsor today, and they are an organization that specializes in the commercialization and strategic engagement as a partner for the health care industry, delivering solutions to meet the needs of patients, providers, payers, pharmaceutical companies to improve the treatment experience and outcomes.
They create personalized impactful experiences and deliver over 5,000,000 engagements annually across all health care stakeholders. So thank you to Inisio Engage. Jeff and Dean, how are you guys doing? Good to see you again, Tom. Happy to be here, and it'll I brought Dean along because of his expertise, but, nice to be back. Thanks for having us, Tom. Always welcome to talk on this topic on the value of scientific exchange and where that fits within the health care ecosystem.
Awesome. Well, I'm excited. So let's jump into it. And, Dean, I'm gonna let you go first because Jeff's been here before. So I'll let you get started. So let's talk about timing and drug development. And how does the timing of MSLs and subject matter expert involvement impact the outcomes of drug development?
Yes. That's a great topic, and it's very apropos given that this next Monday and Tuesday as we record this, I'm gonna be at the Bio CEO event in New York where, there's a gathering of early stage companies actually talking to investors about clinical development programs and trying to get investment from those companies so that they can fund those development programs.
And often people think, well, the clinical trial has to matriculate down the field a little bit, also using a little bit of Super Bowl Hank Stram vernacular for everyone that might understand that reference. But, yeah, you think, well, what about people involved in telling the story and it help making something come to life?
And I often see people particularly at these early stage where you're maybe at the IND filing, your phase one, phase two, and and people think, well, you don't need MSLs yet for that. Mhmm. You know, that you just need to get the clinical trial companies to execute the trial. However, what's often missing in that is the reference KOLs and other HCPs that are involved that can actually understand a value proposition sooner.
And all of our data across our company shows that the value of an MSL and the storyline to helping an HCP or KOL actually see the value even if a trial is under development, even if it's under the point where you're trying to design your next phase of your trials, the better educated that that audience is as a reference, the more that it's gonna help a company as they're actually developing their clinical value proposition to ultimately become their commercial value proposition.
Yep. Interesting. And, you know, this is a common topic that comes up. This this timing topic comes up. So what are some of the common misconceptions about, you know, right time to bring in MSLs and subject matter experts? Jeff, we'll go to you for that. Yeah. I think what we've looked at historically is one size doesn't fit all when it comes to preparation of putting medical support into early phase development.
And we have to move away from what the traditional mindset has been, and the misconception is, you know, putting a team in prior to launch, and this is past phase two. This is phase three. Once the drug is approved, then you start gathering your team. But what I think a lot of companies have discovered that it it's already too late. Mhmm. A lot of the clientele that we get come to us because they've reached that point where we need bodies now. Mhmm. Actually, we need bodies yesterday.
Yeah. And the planning should have probably been taken place years ago. And so and I think you can't compartmentalize that piece of it because dealing with small biotech in terms of planning is different than what we've seen with larger pharma. Mhmm. With smaller companies, it's a really strat heavy piece, and the execution pieces tends to be a little poor.
Mhmm. And, I would say on the large farmer piece of it, you've got all the bodies in the world, and there's more of a rigid approach, for asset allocation. And and so, having dealt with both types of companies, we see that there are, different approaches that we have to use as outsource providers to help them strategize. And the message for both ends of small biotech and large pharma is pushing the message to get your teams in earlier.
And whether that's refocusing your existing team on that's already on or approved asset and pushing them back to allocate some of the team, part of the team for earlier asset resources Mhmm. For a phase two project or in the case of small biotech, making sure that you've got some initial foot on the ground, so to speak, at that phase one, phase two development piece. Yeah. So you're grooming your experts because you don't have the money to recruit 30 or 40 MSLs. Right.
So let's say, as we look at that piece, are there if if companies don't do that, are there missed opportunities? And if so, can you share some examples of what that might look like if they just wait too long? I can share an example on that with, some very real situations happening now. You see people that, are standing up in front of their investor base as the CEO or CMO, and you're talking about a phase two trial that you're trying to get accrual up to prove your value proposition.
And it's struggling with accrual because many of these are rare disease, or small market type disease incident. And you have to be able to prove your value to do that. You have to get enough clinical trial participation, and there's likely, your clinical trial provider isn't gonna necessarily have all the incentives in place to drive quick trial accrual. So the gap that we see in that and the opportunity cost is if you don't have some people involved in the story, and it may not be very many.
You know, we talk about a clinical trial MSL as part of this.
It's not just a an MSL as one might think of it today, but someone who kinda bridges the gap between the clinical trial world and the traditional MSO world who has some special skills and training, which we often recruit, allows that individual to come in and and possibly help to augment or put some giddy up in the trial accrual process because you help people in a conversation instead of just, like, sending them materials or, having the CSO have
a forum for everyone and whatever KOLs might happen to attend. This way, you deploy a couple of people that actually go and develop a relationship with the clinical trial sites, and the people involved then actually have a person to person connection. And that's one of the biggest value propositions of an MSL to begin with is someone who actually handles scientific exchange in a human format because the data is not enough.
So, therefore, the opportunity cost, Tom, is when you don't have a person or persons involved in that earlier stage setting where you're trying to prove your value prop, but you need to put a little flesh to the story and somebody who can go out and establish those relationships, get the time with them. And then it's amazing the difference in accrual in sites that have a person involved Yeah.
In that than those who just believe that somehow because your science is so good that you're going to see trial accrual follow. It's the two way communication too. Human in that. Were you gonna say something, Jeff? Yeah, Tom. I was just gonna add, just to put things into simple terms, on that early phase that Dean was talking about, just to add, putting it into three buckets, refining the clinical design, the patient recruitment strategies, and then ensuring unmet needs are addressed.
I think those three buckets can kinda summarize why it's so important to put a medical team in place at that early stage development.
And I can share with you stories of MSLs coming to me and and saying, you know, they they were put in that early development, but not early enough where they were saying, golly, you know, this this trial could we're running into problems with the FDA submission because the clinical trial itself was not designed correctly to meet the, meet the needs for that submission. And they're having to waste time and money because they're having to retrack.
So Then you're putting a person into the story then that might elicit that, well, perhaps we need to go back and do some good data analytics on where the trial should be fielded. Where's the incidence and prevalence instead of who the CMO or CSO happened to know from twenty years ago because science has marched on and it needs some good analytics.
One of our other companies in our medical division actually does that work, and they often find that they're called in when trials stall out instead of at the beginning when you're designing a trial. And then you put a person involved in that story. It makes all of the gears grind together in a much smoother fashion. So you need both the technology. You need, obviously, a good clinical trial value proposition. You need a good, target product profile established. You need all of those things.
The data and analytics should inform, but it's the human involved that helps to cause something to excel. Yep. And are there any risks, or what are the challenges, I should say, of putting a team of subject matter experts in place earlier versus later? I think for what I've seen in the field, it's knowing when to scale, because there's always that cost savings measure that you have at the very beginning. Right?
And particularly if it's a small biotech and you've got one asset, you're trying you're putting all your eggs in one basket. Yeah. It's important to realize that one is better than none. Yeah. And we've taken a conservative approach when it comes to, you know, working with our clients, realizing that, you know, they're cash strapped a lot of times.
And sometimes it's prohibitive in nature because they're like, well, I can bring that MSL on a little later down the road or, you know, there's not a need for it because it's it's an expense. It's an added expense we can't afford. But I would argue the point to say it's needed and it's scalable. So it doesn't mean that you have to bring on a team of 10 or 20 or 30 right off the get go, But the concept should be on a scalable, piece.
And I've had many leaders in field medical strategy come to me and ask me, even from big pharma, Tom Mhmm. They'll say, how about putting a working team together? Almost like an a team, a small Yeah. You know, SWAT team, if you will, to come in and discover, you know, at that early stage. So they can work the problems out. They can also further recruit down the line when you're ready to add those extra bodies Yeah. And feel more confident in your strategy.
But I think scalability is is key, and and putting a marker or a SWAT team in as early as possible is a good strategy, particularly with small biotech. You talk about the investment piece. Like, obviously, companies have to look at the bottom line, and and you can't just say, yeah. Well, you know, we're just gonna go hire a whole bunch of people and because that's, you know, human capital's big expenditure.
But what other internal value is there in bringing subject matter experts and MSLs in early as it relates to, contributing to maybe aligning clinical trial designs, helping out global regulatory and market access? I'm sure there are goals in those organizations that having MSLs or NMSL can contribute to that piece. So is there value internally, not just externally?
Yeah. I think every one of those value points, Tom, has a tie to what's the value of an individual who does go out and actually meet with and see the reference KOLs and HCPs having what our data shows to be thirty to thirty five minute conversations. Mhmm. One of our agencies within Inisio is STEM health care, and they do internal line of benchmarking.
And I checked on this to make sure it was current, but our most recent data shows that the average MSL discussion time with an HCP or KOL is running thirty three minutes. Wow. And often that's followed by a QR code survey as part of our offering that comes back. Well, what was the value you got from this discussion today to the HCP? And it always comes back nine or above on a nine to 10 Mhmm. Boundary there on a one to 10 scale.
So if you were to tell someone at the beginning of a clinical trial process that if you just give me one or two people that I can have this kind of connectivity to the audience that ultimately is gonna be the reference for how successful this product someday could be, they'll say, absolutely. Why shouldn't you do that?
And the argument can be made to your current investor base, but it can also be made up line to the private equity where the money often is held for a lot of these type of investments in the companies themselves. So you have to think if you are a start up CEO or CSO or CMO, you have to have a multivariate approach to delivering value to your investor base. Well, a big piece of that's gonna be what's the feedback loop? And your question was what's the value internally?
Well, think about having a feedback loop that includes a person who actually has the relationship equity with the people that are on the other end of who you're ultimately trying to develop this value to.
And then when the time does come to expand that team and as Jeff was saying, when they start getting into phase three and they filed their NDA and they're ready to start fully building out a team of MSLs, you already have somebody that can lead the way, that can be part of the knowledge transfer to the rest of the MSL team. And you're not coming in all of a sudden believing we have to create all this advocacy. You've already begun the path toward having the advocacy.
Mhmm. Yeah. And I think we talk about insights a lot. I mean, that's been one of those, topic areas, Tom. I know you've had them on your podcast many times. You you can slice it and dice it any way you want, but most of the conversation when it comes to insights has always been, like, post launch, post approval. You know? This is what the MSL can bring in terms of value.
But to Dean's point, those insights, we have to rethink about how the strategy goes when it comes to ROI or value and implement implementing an MSL or an MSL team in at that early stage because those insights can be valuable from the internal perspective.
And from a from a midpoint sector of looking at trial engagement, we started experimenting putting MSLs into trial, clinical trial MSLs, you know, where to Dean's point, we were able to get some valuable insights that were shared internally for to develop that strategy moving forward into that late phase when you're talking more under the payer discussion piece and the label expansion piece.
So I think the insights have to be looked at holistically in the sense that it's not always the discussion of bringing back what's said on an approved label anymore. It's Mhmm. Okay. What are what are primary PI's looking at? What are they what are the, sticking points for patient selection and and engagement? How do you get those patients to those centers? You know? Do you use a certain, code of, you know, when it comes to the analytics piece, how are we using those analytics?
Are we incorporating AI predictive analysis, which is a new another topic in itself to bring that data in? So there's ways to do that and also ways for an MSL team to provide those insights that are valuable for pushing that that product to Yeah. Approval. Let's talk about what happens when MS cells are brought in later in later phases. I've I've heard clients say things like, we needed MSLs yesterday. We we can't have them fast enough.
So in that situation, how do MSLs quickly adapt and and and create and show value when they're being brought in a little bit later in the game? Yeah. Great question, Tom. And I think that gets to a point where it comes to creative recruitment Mhmm. And finding MSLs that are very familiar with their territories and how to run the business.
So I think under those those emergency situations, you know, you want to find an MSL ideally that has that experience, knows how you know, you're not having to to up ramp them in three months or four months. They have to be a quick hit team, hit the ground running Yeah. Already have an established KOL network that they can go to and be able to take action immediately because, again, you're running behind the clock at this point.
And the assumptions should be that you want an experienced MSL, knows how to run their business, and can have those conversations. And back to the access piece, those thirty minute conversations usually happen when you've got an a relationship that's already established with a KOL. So I think the recruitment strategy has to pivot a little bit under the circumstances. Yeah. And, coincidentally, as you mentioned recruitment, I happen to be an MSL recruiter. So, you know, give me a call.
No. Shameless plug. I knew that was coming. That's where we go to, like, sidebar, commercial break. That's that's right. Caravello, the recruiter, not just That's that's right. Dean, were you gonna say something? I'm sorry. Yeah. I was just I was just gonna mention that sometimes people think, well, I've I've I've gotta have people that can go face to face to see all these people.
But what we find from that same stem health care benchmarking database is our current data shows that it's it's about 60% screen to screen. Mhmm. So there is a way to, with virtual proximity, also have a great reach, and the conversations are just as long. Mhmm. Because people are used to that format. I mean, the pandemic taught us how much can be done virtually. I mean, we're doing this virtually today. So you get the benefit of about a forty sixty split on that. So you get efficiency of labor.
It's not like they're spending all their time traveling between places. So you really don't have to have that many of these. And if you were doing a premortem at the beginning of a clinical trial, you you would you would absolutely line out the value of having a person involved in the story to bring you the insight, the feedback, to ensure that you're establishing a relationship equity.
You have someone who can tell the story of your company, not just the story of the asset that's involved with that and to the recruiting point, someone that is experienced in the space. Because as you mentioned, a recruiter is able to recruit within certain categories. So you know the ones that need to be recruited for rheumatology experience, for oncology experience, for gene therapy experience. All of those things come together, and it's that symphony of things that really bring the value.
Too many times, people approach this topic sequentially Mhmm. And only when there is a need or only when I have the money. Sometimes you have to think, well, alright. I'm gonna have to bet that in my series a, I'm gonna raise x amount of millions of dollars, and I'm gonna portion 10% of that for this. Instead of just thinking, I need to do my series a, and let's see what happens.
No. You go to your investors and say, I'm going to divide this tranche of investment across certain things, and a part of it will begin to be the value of people out in the field to help tell the story. Yep. I'll say too on the strategy piece, that it's important besides the recruitment piece of it that we spoke about. What's equally important is prioritizing the mapping in terms of your key areas that's of focus.
So going back to the scalability piece of it, Tom, I think it's important to prioritize your territories as a company. Mhmm. And and have a pretty sound, mapping system, whether you're doing it in The US or in Europe. And and in the case of Europe or outside of The US, you also have to take into consideration on and off board periods, times of notification. Those MSLs with experience, there is a longer period of time that you'll have to provide to that employee for notification periods.
Mhmm. And talking about global strategy, like, what role do MSLs play in ensuring global strategy and harmonization in the clinical development and even the commercialization process? I'll comment on that because we learned during the pandemic with, a very big one that was involved in the vaccine piece of this. We won't mention their name, but we were asked to help scale their footprint. And literally, as they were flying the plane, we helped them build it.
Well, if they hadn't gone to an outsourced provider like an IZO, they wouldn't have been able to have that kind of scale and consistency because the answer to your question ultimately is you have to establish a rubric of consistency. Well, that can only be done if you're approaching it in a one to many format.
You can't believe you can go to a European provider, an APAC provider, a US provider, all three of those separate, or do one set of them yourselves, and and believe there's gonna be any consistency around the knowledge level, the message, the execution, the feedback loops, the insights gathered. I mean, you can name a whole variety of parameters that you are risking executional errors if you don't actually have all that done in concert.
And while we were flying that plane very fast and building it at the same time, there was at least a commonality of a framework. One company was helping to do that. Sometimes companies say, well, can't we do this ourselves? Well, you can, but just think of all the effort that that's going to require, and you're also doing it likely for the first time yourself.
And you really wanna take that risk on an asset as important as you have whenever the financial variability has to be very, very narrow, your investors are gonna expect that you execute right the first time. And you go to outside consultancy because you want to capitalize on the external expertise and minimize downside risk. And And that's what we have found is a real value that we can bring in is enabling those two things for people who really cannot miss.
So let's let's try to bring this together a little bit. So how can companies create? You mentioned framework, Dean. So how do companies create a strategic framework to decide when and how to involve MSLs and at each stage of the development or product life cycle? Sure. I'll start us out on that, because it's a part and parcel of what I do across all the Inisio companies on a daily basis. My job is to listen for the dilemma that a company is trying to manage.
And I say dilemma to manage versus problem to solve because I'm not naive. I don't think we really solve many problems. I think we just really help manage dilemmas. Mhmm. And this is currently a dilemma. A clinical trial value proposition over time is a dilemma that you're managing because you cannot have everything that you want.
But you have to start at the beginning with knowing what all options are available and then where what put in points you wanna have over time because there's a piece during a clinical trial where you need to have good site selection. You need to have someone helping you to have the analytics of the disease incidence and prevalence. You need someone to help you with where you might wanna insert a person like we've talked about here.
You might wanna have someone to help you in how you're gonna gather insights, not just through the individuals who might be out as field people, but from all other sources. How can AI enable that? We have a platform to assist with that. And then you have to have someone that has a view not just of the immediate and the tyranny of the urgent, but also what does this look like two, three, four years from now? What's it look like when you actually have a commercial plan?
And beginning with that end in mind, then we can help you put a whole Gantt chart together of the key things that need to happen from today's point where you are, perhaps with the big announcement that you're making about a phase one trial is going to start. Well, that's not where you're gonna stay for very long. You have to be thinking about, alright, if we are good with this, we'll be hitting our phase two point at this section. Then we might be wanting to attract some additional investment.
And you need someone that's gone on this whole journey so that in each of those pivotal moments, you can have the counsel that you need for not just them, not just the checkers, but the chess part of it, which is over the long haul. I'll add too, Tom, that this isn't just a problem focused on small biotech, emerging biotech. Mhmm. We've had clients, big pharma clients that, you know, have people in place that focus just strictly on strategy and optimization.
And I think the key point is they're coming to us and saying, you know, where do we take our foot off the gas? Where do we break at? You know? How can we stay a step ahead of the game? Because we have a robust pipeline coming in for 2025, '20 '20 '6.
I wanna know how we can allocate our internal resources and partially pull them back for earlier development products, and where do we keep the people that are are in place without, you know, having the option of well, there's always that option to outsource, right, particularly with branded products.
But putting the internal processes in place for big organizations is all about timing and how you can stay ahead of the curve by pulling back some of your existing assets to your pipeline drugs and making that function and that merry-go-round go smoothly. Mhmm. And we've had strategic leaders come to us and go, how how do we do this effectively? Here's what our pipeline looks like. What are your recommendations? And so that diagram looks a lot different at that phase with bigger pharma.
Yeah. That makes sense. So what advice do you guys have for medical affairs teams looking to optimize their timing and impact, of their MSLs and their subject matter experts, would you say? I would say that science alone doesn't win the day. You can't just stand up in front of, a small group of investors and tell a scientific story that you as the leader are very passionate about. The translation of that from theory to practice will hit so many roadblocks, things you can't even anticipate.
And somewhere within the solve, there needs to be a person that is able to go to your KOLs and HCPs, maybe not many. It might just be one, and it can often be virtually deployed. But somebody that can be the human glue and the connective tissue between the theory of the science and the execution in practice in a clinical trial. And that's what we believe that an MSL brings.
I would say in adding to the, you know, large vast network that we have in the medical affairs space, As you do this kind of job for many years in industry, what you learn to do is network and share best practices. So if I'm, you know, a VP for a small biotech pharma company that has a launch drug for next year. And I know that you're working on, let's say, in the same venue, small biotech. What I'm gonna give you a call and say, hey, Tom. What's worked for you? You know?
What were your mistakes? So I would encourage our leaders to share their, you know, pitfalls with one another and their success stories because that's gonna drive, you know, success within your company is is learning to reach out and network with one another. Find out what works, what didn't work so well. Good stuff, guys. This was a amazing conversation. Appreciate you both coming on.
This is and it's a great I think this is one of those maybe, like, MSL leaders, MSLs, anybody that listens to this podcast, from a strategic standpoint should have an idea about this stuff. Stuff. I think it's important. So I thank you guys for bringing your wisdom. I thank you guys for being a sponsor of this program, and you guys know you're always, always welcome to come back. I appreciate you both. Thanks for having us. Alright. And, guys, thank you as always for your support.
Thanks for tuning in. Thanks for sharing the show. We'll see you next time.