Hey, guys. Welcome to the podcast. This week is something a little different. I'm actually going to air an episode of a podcast that I was on for someone else. The guy's name is John Caskey. He has a podcast called Pharma Sessions. And we talk about what it takes to build an MSL team from scratch prelaunch. So he interviews me. I thought it was a great conversation, so I decided to take the vials and post it on the MSL Talk podcast. So it's kind of a podcast swap.
So So this is one of those rare situations where Tom Carvel is getting interviewed by someone else on my own podcast, which has happened before. John Caskey happens to be the guy. He's a super good dude, and he's, works in the medical affairs space. So, hopefully, you guys get a lot of value out of this. Don't forget to follow me on LinkedIn. Check us out on MSL talk live, which is the 1st Tuesday of every month on LinkedIn live. And visit us on YouTube.
We put all of our videos on YouTube as well. So thanks for joining us. Welcome to MSL talk with Tom Caravella, a podcast specifically designed for MSL's and all things field medical. Hey, Tom. How are you today? Good, man. Good to be here, John. Thanks for, the invitation. Excellent. Excellent. So I'm here with Tom Caravella, who in addition to be to, being business owner is also a podcaster way ahead of me on MSL Talks. So it is, I'm happy and it's an honor to to be speaking with you today.
Oh, I'm glad to be here, man. For those of you that don't know, John and I, we know each other for many years through the medical affairs circuit. You know, we met by going to conferences and seeing each other. So, when, you know, when when he called and asked me if I'd join him on this podcast, I was like, yeah, man. Let's reunite. Let's do it. Absolutely.
And so the concept we came up with, with Tom's expertise, right, as as owner of the Carolyn group, that places MSLs, is if if you could build the perfect MSL team to support a drug launch, what would that look like? I I'm really excited about this because this is often the point in the development cycle that companies start reaching out to all sorts of vendors and really start putting a lot of focus on all aspects of a launch. And the MSL is a big part of that.
So I guess the first question, Tom, is when companies are looking to commercialize, how early should they plan to bring on an MSL team? Well, that's always a big question. And and I think if you asked 5 different people, 5 different medical affairs experts, you'll probably get 5 different answers. A lot of people are gonna say, oh, bring them on as early as possible, and those are people from the medical affairs camp.
And then if you talk to somebody on the commercial side, they might have a different answer. But, you know, it it's gonna vary a little bit depending on the company, the size, the magnitude of the patient population. If, you know, if it's a rare disease, it might be a little different than, you know, maybe a drug that would cater to and and serve a much larger patient population. But estimates say that companies should start considering building an MSL team as early as phase 2b.
Wow. Others might say it's more phase 3. Mhmm. And a lot of times in in my world, what happens is we will be working with a company that starts the recruiting process. They start to consider and bring MSLs on, contingent upon the data. So it all the momentum goes with really the ebbs and flows of the data. So a lot of times when you get fast track approval, for example, it's like, okay. We gotta go. We gotta you know, we need boots on the ground.
We have to start we really have to make sure we have an MSL team in place. I would imagine that that being the case, the team would probably already be in place. A lot of times Mhmm. Companies will anticipate and know that. But, again, all all companies are different, so this is going to vary a bit, but it's it's definitely usually in really those parts of the clinical development process around phase 2b to phase 3. Yeah. And I sort of skipped over this part, assuming people know you.
But just when you say in your experience, you've been doing this for a number. How long have you been working with MSLs? And roughly how many do you think you've helped place? Geez. So I've been, I've been working in the medical affairs space for over 20 years. I've we've placed 1,000 Right. Of medical science lia 1,000. Yeah. If I went back and looked it, yeah, it would be maybe tens of 1,000. It's a lot. Yeah. So significant experience is kinda what I was what I was driving at.
And I think one thing that to keep in mind is I totally get all companies do it differently. But if we're talking about building the perfect MSL team, some of those I mean, that's a lot you've seen a lot. It probably a lot of good, a lot of bad. As people are building out this team, whether it starts in phase 2 b, whether it starts in phase 3, is there, like a not cadence, but is there a sequence in which they should be doing it? Or are you starting with, management?
Are you starting with certain strategic focus? Or are you starting with people with boots on the ground experience? You have doctor relationships? How what's the kind of the sequence for hiring look like typically or in the Yeah. World? Well, that's a that's a really good question. So basically, what's the criteria of the caliber of candidate? Who do you bring on first? Who's kind of the first tranche of people you bring in and then who how quickly do you follow with the rest of the team?
Well, I'm I'm a big advocate of bring the leaders in first. It doesn't always work out that way for whatever reason. Sometimes, you might have a CMO that is at a small company that knows that they need support, and they might wind up bringing MSLs in first and then maybe promote one of those MSLs to the field director.
But, ultimately, the I think the right way to do it is that the leader of the MSL team and the leadership of the medical affairs organization should be in place first Because they should be the ones to be able to lead the recruitment process and and hire the people that they think are best for the organization. The other thing that's important is people MSLs wanna know, who am I working for? Who am I reporting to?
So if you do it the opposite way and then they meet their manager at another time, that could open up issues. Because what if I don't know. What if they it's not the what they expected? So I I would definitely recommend leadership first, then the MSLs. But in a depending on the size of the team, there should also be a medical affairs infrastructure and support staff that's going to be able to support field medical.
Mhmm. Otherwise, the, you know, what is going to be required of field medical is going to be overwhelming. Yeah, that makes a lot of sense. And it's Med Affairs, even though it's been around for a number of years, it still feels like such a tight community. Oh, yeah. That I would imagine if in MSL, even if it's their first job, right, they might be talking to others who who have experienced the the management and the styles that those people bring are probably gonna make quite a difference.
And it will probably lead to a different day to day life. How much that of everything everything that they do. From the operational and support, can you just talk a little bit more about that? What do you what do you mean? What do you think is required to have a successful team in the support? Well, yeah. So and again, depending on the size of the company, there's gonna be different levels and layers of support. So for example, there's someone has to set the strategy.
And, typically, there's a leader, maybe it's a VP of medical affairs, or even, you know, an MSL head or director depending on company size, you know, size company, what the title might be. But what happens is there's someone that has to take the strategic responsibilities of setting the plan for, and running the strategy for the organization, the field medical organization. But then you have folks that are gonna be in all of the different areas that support field medical.
So it's your you know, who's gonna be handling med info Mhmm. And pubs and communications? You know, is there a training component? Is the company large enough where they're gonna have someone handling the training component? One of the one of the things and I just got back from MAPS, and there were a ton of medical excellence people at MAPS. So medical excellence is a huge area within medical affairs.
Very important area because the medical excellence folks make sure that the field medical team has all the resources, tools, vendor relationships, and and everything that they need to be successful out in the field.
Yeah. So now if you have a biotech company with 10 people, 20, 30 people in the organization, and they need MSLs to lay the groundwork for their what's going to be their commercialization of their product, Well, a lot of that stuff that I'm talking about is probably gonna be outsourced. Yeah. They may not have that in house.
So the in house medical affairs functions can be something that sits within the organization or it could be something that's outsourced, but it encompasses everything from the communication strategy to advisory board, hand who's who's setting up and handling the advisory boards. There's so much. Yeah. Even the promotional legal review aspect. Like, who's handling that piece? Right? Who's dealing with the medical directors internally? Like, there's just so much. Who's No. Right?
There's so many any of those sub niches that you just talked about and there are industries of companies to to support each and every aspect of that. Right? So it's a super complicated, it's a super complicated thing. Right? But let's say so now we're we're still continuing on our perfect drug launch here, and we're in phase 2 b or maybe it's phase 3. We've got our leadership in place.
We've determined what, you know, med info, pubs, SICOMs, training, medical excellence, which of that is being handled internally, which are we going to outside vendors for. And then at some point, that leadership needs to come up with a plan and they need to take that up the food chain and request budget for a certain amount of MSLs. Right? And so it's some there's some territory determination that then reflects that final number of who they need.
And as you were saying, right, if it's rare, it might be one thing. If it's oncology, it might be another. And if it's, you know, Eliquis, it's it's it's a third thing. But how are you seeing companies best determine size of territory and how many MSLs they need? Yeah. Yeah. And that's another great question that will vary depending on so many different factors.
And one of the main factors when you look at the number of MSLs that need to be deployed is what are what's the patient population look like? And, and who are the targets for these MSLs? How many KOLs do these MSLs ultimately need to call on? So for example, if you have if it's a rare disease, it's a company that's in the rare diseases space Mhmm.
And it might be an ultra rare disease where there's a very limited patient population, which means there's limited amounts of specialists or key opinion leaders that would treat those patients, well, that might require, you know, 2 to 4 MSLs, let's just say. But if you have a a patient population with, the magnitude of a blockbuster where it's going to be, you know, literally thousands of KOLs across the US, Well, that might warrant an MSL team of 20 or 30 or 50. 50 is quite a bit.
That's the largest team we ever built was a 50 person MSL team. That's significant. But but it all really depends on what is the size of the market. And what I mean by market is, what's the patient population, and who are the KOLs treating those patients? And, and how would the organization want to be able to provide representation to fully educate that community? And is there typically are there typically saying all things being equal, an MSL can support up to I don't know.
I actually don't know the numbers. 50 KOLs or 500 KOLs or whatever. Is that kinda how they look at it? And they say beyond that, they're not gonna be able to actually develop relationships and provide spend enough time with people to actually provide education? Or is it something where, you know, maybe some drugs are more complex than others and you need to dive deeper with with, you know, the Uber KOLs? How is there a number that people are typically looking at?
There's a philosophy around that. So for example, some companies have a philosophy where they might be less comfortable having their MSLs call on more KOLs than less. So for example, let's just say, you might have one company and one leadership style that says each MSL is going to have 30 k o l's that they're responsible for. Right? Yep. Then you may have another organization that says your universe is going to be 60 k o l's, or maybe it's 75. So it really depends on the organization.
And the organization's philosophy on how they expect the MSLs to handle their territory. Right. What KPIs are they expecting? What are their metrics? How often do they want the MSLs to actually visit and interact with these key opinion leaders, and for what purpose? So, again, if it's a rare disease that becomes a different strategy, and it might be a really a different directive as opposed to a more broader based product. You know, there are different organizations.
There are organizations that will differentiate who their community MSLs are versus who their academic MSLs might be versus maybe their organizations have clinical trial liaisons where their function is is very different from what your therapeutic MSL might be responsible for. So the industry's really evolved. Then not to get into managed care and HEOR and folks that specialize on the payer side.
So there's so many dynamics and nuances to how organizations handle their the the, the market and what they feel is gonna be best to really be able to ultimately, it's about patient care. What's the patient need? Even in like, not to get too far into the weeds with this, but there are organizations that have, like, patient diagnosis liaisons. And what those folks do is they help identify a market that doesn't right now exist.
So if there's a rare disease where there are patients walking around, they don't even know that they have that disease. How are they gonna be educated, and how are the how are how is the community gonna be aware that this exists? So there are actually people that go out there and alert and educate on the fact that there is such a thing. It's crazy.
It's well, it also comes back to your first point of why you need the leadership first because all of that is a strategic vision, right, that you're outlined where it can go any different way and that if you're if you're an MSL, your life is gonna be really different if if you're focused on 30 kolvs versus 75 and it just not that one is good and one is bad, it's just going to be a different a different approach.
So it would seem like there needs to the the job description, it's not just an m you can't it's not just title. Right? MSL. It's not the same job everywhere. So it sounds very different, which must go in must factor into the recruiting. So that's actually the the next line. A question that I have is the the recruiting process and skill sets and things like that, but just how long does this all take to bring the right people on board?
When do companies need to start with their recruiting for MSL teams? Well and that's, you know, that's the question we always get is, like, you know, and you have to kind of begin with the end in mind. Meaning, when do you want these MSLs in territory? So let's just say for argument's sake, the answer is we want the MSLs in territory and deployed on April 15th. I'm just gonna throw that out there.
Sure. Well, you really want to have a fully executable plan probably 3 at least 3 months in advance depending on the size of the team. Now, obviously, if you're looking to build an MSL team of 50 people, you you might wanna give yourself 6 months just to really get every the all of your ducks in a row. Now we built the MSL team we built that was 50 people. The majority of that was done in 14 weeks, which is astounding. We finished the whole thing in, like, 17 weeks.
Even the 3 month number, I'm surprised at how short a time frame that is to bring in. No. We killed it. And it wasn't us. But, honestly, the organization was, like, really locked and loaded and committed and gave us the resources that we need needed. So there's a lot of factors that come into play. It's it's not an exact science. Yeah. There's a lot of moving parts, and a lot of it is based on the complexity of the search too.
If the search criteria is, like, really stringent, it's gonna take longer to fill the position. So there's a lot of nuance that goes into it. But what I would say is that people need to really give a 3 month window Mhmm. Of you know, if you set that date of April 1st, I would say start in January. Really get the ball rolling in January. Get your strategy down. Start to talk to people. You know, make sure if you're using a search partner, you wanna have that established.
If you're not using a search partner and you're doing it all in house, make sure that that internal talent acquisition team is locked and loaded, ready to go, has the process and all the tools and resources that they need. And again, let's just say they don't. Well, then you probably have to give it more time. If you really want to have the team ready to go in 3, 4 months, you just have to make sure that you have all the right things in place.
And are you saying it's 3 months to hire or 3 months to hire, train, and prepare to go see No. 3 months to hire. So for example, you start the recruitment process. You go out, and let's just say it's an 8 person MSL team. Yep. You usually, what would happen is you start the process, start screening candidates, identifying candidates, pipelining candidates, bringing them into the interview process.
And, you know, you have bunch of you know, there's like that identification phase, then there's the interview phase. And then there's the selection process where you you go about making offers and making sure that you you, you know, you're putting the right people on your team. There's a there's a 2 week notice period typically for each person if the person's employed.
Lot of times that is more than 2 weeks depending on what that person has to leave behind and and how that so on the tail end, there's time that you need to build in. So if you look at it, if it takes a few weeks to identify the candidates, if it takes a few weeks to interview the candidates, and a few weeks to onboard and get candidates started, you're you you you're easily at 2 to 4 months. Right. That all In in any given process.
And then when they start and they're deployed, that's when the training happens. I see. Okay. And then during that, and this is probably an important question, what skill sets are hire hiring managers or would you suggest hiring managers look for who should be hired? How do you balance the skills versus, you know, the role that acts for lack of a better term that somebody might be bringing to the table with their relationships?
Yeah. Well, it's interesting, John. Back in the day, when I first started recruiting MSLs, it was like, yeah, just find us a Pharm d that, you know, that knows neuroscience and, you know, we'll bring him in. Now it's like we need a a Pharm d with schizophrenia experience that lives in Sacramento that's been an MSL for 5 years. Like, it's sometimes really real the criteria is really, really specific.
Yeah. What I can tell you as a rule of thumb is when it comes to that that setting the job description and the criteria, you really you do wanna look at certain things. So for example, the first thing you wanna look at is what's the size of your organization? What's your infrastructure look like? So for example, if it's a small company that doesn't have training department, it doesn't have huge infrastructure, you don't wanna hire brand new MSLs. No offense to the aspiring MSLs out there.
But who's gonna train them? Who's gonna bring them up to speed? What's the ramp up gonna be? So there's in that situation would be a need to hire people that maybe have at least 4 to 5 years of MSL experience where they could hit the ground running, and they're not learning how to be an MSL at an organization that doesn't have a big training capacity. Maybe they're even bringing how to be an MSL to to that organization.
Yeah. So now if there's an organization that is much larger with a lot of infrastructure and they can support it, but they're looking for therapeutic experts. Maybe they're looking for somebody that has a very, very specific scientific value proposition that they're bringing to the table. Well, then they might be a little more lenient on the number of years of experience, if they have MSO experience at all.
But the sweet spot of what we're seeing is that companies seem to really want, first and foremost, the advanced scientific degree, PharmDMD, PhD, or advanced practice professionals like nurse practitioners or, physician assistants. So we're seeing a lot of Really interesting. Clinicians that are now getting hired, which is a real nice paradigm shift for folks from the clinical world. Yeah. Therapeutic focus. So oncology wants oncology. A lot of times, neuroscience wants neuroscience.
So we see that people that are more, general scientifically and and have a broader scientific skill set might wanna focus that down if they're really looking to break into industry. Mhmm. Our clients a lot of our clients are looking for MSL experience. And everybody wants soft skills. They want people that can communicate. They want people that can present Right. And and know how to present data.
So the criteria really doesn't change from a if you take a 30,000 foot view of it, you need people that are really smart scientists and have advanced degrees. You need people that can communicate that science and and have good presentation and interpersonal skills. And, you know, you you need scientific experts. So, like, though, that's really the foundation that you need to build off of. So that's that makes a ton of sense. Right?
Because what you're talking about are you want people that can go in and have scientific discussions with KOLs on at a peer level. And that's a it's a complex set of it's your educational background, it's your presentation skills, it's how quickly you can learn new information. It might be your experience or your relationships. But let's just take this kind of the scenario, the perfect MSL team supporting a drug launch full circle now. Because right now we've got our leadership.
We know the operational support that we need, we know how many MSLs we should have, we know we've we've now hired them based on on the timing and the criteria that we just discussed. And now let's say, you know, it's it's launch date. Right? What trainings have they taken, and what else needs to be considered so that we're now running a modern MSL organization post launch? What what does that look like?
Yeah. So that that deployment piece may look a little different from organization to organization. But I will tell you that typically when MSLs get hired, the very first thing they're that they have to do is they have to learn the science. Yep. So and you're an MSL or you're an organization that's deploying MSLs, you know, day 1, it's like, okay. It's time to get certified. And when I mean certified, you're getting certified, and I use that term.
Maybe that's not exactly the right term, but you you have to be, educated and trained on the science and the data that supports that organization's products. That's 1st and foremost. And a lot of times they call it a certification. We'll say, okay. Well, you know, you have to go through these training modules, and each training module has a test, and you have to pass these tests, and you have to get through it.
We we just built an MSL team for an organization, and, they have this we call it the validation. So they go through this training. And at the end of the training, they have to do a presentation and show that they know their stuff, and that's the validation. And, so there's different, I guess there's there's different ways organizations do this, but the the foundation of MSO training is scientific.
Mhmm. And then there will be training on the systems, how to use the CRM, compliance, you know, making sure that that the the right safeguards are in place so that people are not are saying the right things and and are are not putting the organization at risk. Can't just assume that everybody knows that because there's nuance to that. And then in addition to technology and and all the other stuff, it's how does the company want to transact business? What are their expectations of that MSL team?
What are the metrics? What are the KPIs? What are they going to expect the MSLs do on a day to day basis? So the training is is multi, it's multidimensional from science to operations to, even even to soft skill training, which is a piece that a lot of organizations are looking for because these folks are very scientific and they're very smart. But one of the critical pieces of the equation is to have to develop relationships with key opinion leaders.
Mhmm. That's not always easy to do for anyone. So there's the the interpersonal and soft skills training that a lot of times will be offered for organizations either, you know, before, during, or after someone gets deployed. Yeah. That sounds like it would be more likely to kinda be continuous learnings or maybe, maybe not the type of training where everybody's, you know, pulled in pulled out for a week, but just ongoing, maybe digital or smaller workshop based.
Are you seeing how are you seeing companies balance balance the approach to training? Is it still kind of that dedicated time or maybe it is for certain things like the science, versus making it a part of your your monthly schedule is is training on various soft skills or other things that are important to your job? That's a great question. And and what I've seen is that there's this real, real important, like, onboarding and initial training that MSLs have to go through.
So everybody has to go through typically, in in most organizations, everybody's gotta go through the same initial training program. And you so you can't pass go until you you pass that training. So everybody goes through that and included in that typically are all the things that I just mentioned. Then there's usually ongoing trainings.
Some organizations might do a quarterly training type of program or a, you know, maybe it's even 2 or 3 times a year where they'll bring everybody in regionally to a certain area or maybe there's a headquarters that they bring everybody into. Sometimes they'll do trainings at conferences. So there may be conferences where they'll send all their MSLs and say, alright. We're gonna all go to, you know, the MAPS conference, for example.
Like, I just got back from Nashville, and sometimes they might bring a whole team and be like, alright. You're gonna run we're gonna center our training around this conference and figure out what it is that they want to cover during that session. So it's initial training and then ongoing trainings. What they include when really depends on the organization, but that's typically what I see. Excellent.
Well, actually, that sounds like a great place to leave it because this concept of the perfect MSL team, I you heard it from the man himself. We we summarize this multi year, multimillion dollar project and do a 30 minute recap, but just to hit the high points. Again, it's it starts with leadership with that strategic vision. You're building, you're creating your operational support whether in house or outsourced prior to bringing on your MSLs.
The size of the team varying based on those strategic decisions that we talked about earlier. You're giving yourself ample time to recruit with at least 3 months, possibly more of pre hire, and then you have your training, before they get the field, their certification process as well as ongoing. So I guess it's as simple as that. Right, Tom? It's very simple. There's nothing complicated about this at all, folks. It's really, really simple. No. You know what?
It this this is and it's and, you know, John, you bring this really interesting topic to me. And and by the way, I'm not an expert on commercialization solutions. I'm an expert at recruiting MSLs. But I know how the process works. It's really complicated. There's so much nuance to this. And I hope I did this topic justice just by my experience and what I've seen. But I could tell you there's probably a lot of leaders listening to this that are like, hey, Tom. Yeah. But this.
Hey, Tom. Yeah. But that. There are so much that goes into this that I'm sure that I missed. Hopefully, I did this justice. But I could tell you, man, this is one of the most complicated parts of the drug development and preparation for launch and launch of a drug is how do you get field medical right? There's all these conferences and all these seminars and all this stuff that's out there. Everybody's trying to figure out what is the secret sauce. So it's complicated.
I hope that this was at least helpful for some folks that at least wanted to get an understanding of what it looks like. Yeah. I thought it I thought it was great. So let's let's leave it there, Tom. Thank you. Yeah, man. Hey. Thanks for having me on. This was great, John. I really appreciate it, and good luck with your show. Absolutely. Thank you so much for listening to the show.
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