Welcome back, everyone. Welcome to the podcast. My guest today is Steven Stein. He is senior director of global field medical head at Arena Pharmaceuticals. We talk about how and why MSLs bring value to an organization. Really important topic. Steven's awesome. I hope you guys really enjoy this. Don't forget to follow us on YouTube and Instagram, and, of course, reach out to me on LinkedIn. Check us out on MSL Talk live on Clubhouse, which is the first Tuesday of every month at 1:30 PM EST.
Thanks for joining me. Welcome to MSL talk with Tom Caravella, a podcast specifically designed for MSLs and all things field medical. Hey, Steven. Welcome. Thanks for joining me. Hi, Tom. Thank you for having me. Yeah. I'm excited. This was, this kinda came about on, you know, just happenstance because we met at a conference, and you had done a similar talk. It was a it was a topic that had a lot to do about MSL value.
And I just remember sitting there and being like, man, I gotta get this like, I gotta get Steven on the podcast. Yeah. So Yeah. Thanks, Tom. It's it's great to be here. Yeah. Absolutely. I know we we had scheduling issues, but I'm glad I'm here. Yeah. For sure. So why don't we start? If you could do an introduction, let everybody know who you are and what you're up to these days, that'd be great. Sure. No problem. So I'm currently, the senior director at Arena Pharmaceuticals based in San Diego.
I am the global head of the entire field medical team. I started my career in pharma in pharma in back in 2004, as an MSL at Takeda when I joined the Actos team and then kinda moved up the ranks. You know, I was an MSL director, and then I was a medical director on the Entyvio team with Takeda. And then I, came to Arena to, head up, their medical help head up their medical affairs and prepare for a launch of a product in inflammatory bowel disease.
And then we had a little restructure in 2021, and they asked me to take over the field. So here I am. I'm, the senior director heading the global field medical team. Wow. Awesome. Well, congrats on all your success, and and thanks again for for doing this. I you know, not to jump into it, but this this topic of value and the MSL is it's so relevant. It's so important. We hear about it all the time. And, you know, it makes you think. So why do we always hear that word value with MSLs?
Is it because we're proving ourselves against commercial? Is it something else? Like, I wanna hear from you because, obviously, you're an expert. You know, where where do you think this focus on the word value comes from? So I unlike commercial. Right? So there is no way to how do you measure, professional advanced degree people and what they do with external stakeholders when it's not tied to sales goals? Right? It's not tied to any kind of a revenue. Right?
We are an expensive part of an organization. We are the largest part of the organ of a medical affairs organization for the most part. Right? That's the MSL team. We are the first, foot on the ground. We are the first to engage with the external stakeholders. So there's always been a question. As long as I've been in this, profession, as long as I've been in MSL, the the the word value comes up. And how do they how do we measure value? What is the value that this team brings?
So I think that's where, this constant question comes up. And I think what you know, for me, personally, when I talk think about the value of an MSL, right, I said before, they're the largest segment of the medical affairs organization. They really are the first team deployed prelaunch for stakeholder engagement, and they really are the the source of insight and key intelligence from the scientific community. Right?
So they're they're very well respected by KOLs for their scientific acumen and everything that if you think about prelaunch, right, it's really medical affairs, in my opinion, that drives and sets the stage for commercial to be very successful. We make sure that awareness of the company is understood. Our pipeline is discussed. Our dedication to a certain therapeutic area. So that's the value. Right?
So there's no way to measure it, at least, you know, but there's definitely examples that we provide that are certainly valuable for the entire organization. Well and I think that the entire community in, you know, in in pharma, biotech has bought into this notion of we need MSLs. I'm not so sure they always know why in certain situations. Yes. Very true. Everybody's bought into it.
So when you look at the drug development process, how early would you say it's recommended that MSL should be brought in? So that's a that's a excellent question, Tom. So I and I've worked, you know, for the last 17 years in in different kind of you know, with MSLs that were hired at PDUFA, MSLs that were hired pre PDUFA, and then MSLs MSLs hired post PDUFA. Right? So we wanna make sure we have a team in place around the PDUFA time time frame. Right?
Mhmm. That 18 I think the industry standard is at 18 months out before drug approval. Right? For KOL engagement, data dissemination, inside generation. But I think the benefit and at a and one of the things that I enjoyed about coming to Arena is we don't have a product on the market. We were, when I joined Arena, over 2 years away from launching a product. I think about two and a half years that we were. And they had a full MSL team in place.
And I think one of the benefits I see starting early is that you can have MSLs involved in supporting clinical trials. And why do I say that's important? I think that gives them an appreciation and understanding of what it takes to bring a drug to market. When you start at PDUFA, the clinical operations, clinical development team is pretty much wrapping it up. Right? They're wrapping up. They're getting ready for the NDA, for the submission, for approval, whether it's in the US or ex US.
But no one understands how critical it is to run a clinical trial and what it takes to run a clinical trial. And if you have MSLs hired, I would say, even 3 years before you submit, they can be an integral part in helping not only with clinical trial deployment, but recruitment and and getting to know the PIs and HCPs, which which serves a couple of things. Right? They understand how clinical trials are done, number 1.
Number 2, they are getting those relationships with HCPs that are really seeing patients. Right? When you think about KOLs, you know, the big names like those top tier KOLs, they're not ingrained in the community, you know, in in the community's patient seeing world.
But the HCPs, and especially this becomes, I think, really important if it's a new MOA, if it's a new drug coming to market, maybe, it's not, you know, the first drug come to market, but it's maybe a new MOA that may differentiate itself. And so you wanna start educating the health care community and all HCPs, not just physicians. I'm talking about nurse practitioners, PAs on your drug, right, and on the MOA that's coming to market.
So I think it gives them a really great appreciation early and understand how how we bring a drug to market. I also think it allows for you to discuss pipeline discussions that are you know, if you're committing to a certain therapeutic area, what are the other products you have in development? Right? So that I think becomes an important part. And then you also have, you increase the awareness of your company.
If maybe you don't have anything on the market currently, you have the potential of you know, if you're bringing one drug to market in New York and people don't know your company, you can increase awareness and and show everything that you're doing to commit to a certain therapeutic space. It also allows for, obviously, early KOL engagement. Right? What is what is needed? How do we how do we maintain the life cycle management? What are some of the phase 4 studies that are we need to look at?
What are some of the unmet needs? And, also, you can start engaging payers early. You can see what what is important for payers when this drug comes to market, what are they gonna look at? What studies do they wanna see and what data do they wanna see? When they made those formulary decisions, you can start some of that work early, some of that research. So I think if you look at kinda like a timeline, I would say 2 to 3 years would be a fair assessment to bring some start an MSL team early.
Well, I mean, everything you just said, I mean, that's significant. I mean, just to be able to accomplish all those things, to be able to add I'm gonna use the word value again. To be able to add all that value, you know, in the process, that's enormous. And it's not something that can be done in with any other function. This is the medical affairs. This is what medical affairs does. This is what We own it. Yeah. Absolutely. We own it. And, again, we built those relationships.
You know, we and when we speak value, this is exactly what you just said. How do we measure that? Right? There is no metrics, right, to measure the value that this team brings, especially starting so early with with HCPs and KOLs. Yeah. And the value is that by the time you submit to the FDA, people should be aware of what's coming to market.
They should be able to if you are maybe 2nd in line or or 3rd to come to market, what is the differentiating factor of your drug versus instead of being a me too, how are you differentiated? Right? How are you how is your compound different? And you can start that a lot earlier, and that's definitely a huge value that the team brings. Yeah. No. It I I tell you, it's so critical. And, you know, when you so you bring up a good point.
So because because this isn't a tangible attached to sales, something that's that's measurable, there's gotta be, and there always is, somebody in some department that says, wow. Jeez. These MSLs are up there. This whole department costs a lot of money. These MSLs. Right. You know, they're this is this is a big number. Why do we need them again? So so you and you just spelled out so many reasons that relate to a lot of different areas, a lot of external reasons.
But how would you say that MSLs can show value internally and try to keep people on the inside satisfied and happy and and the light bulb to go off to be able to say, wow. You know what? Yeah. We these guys are this is really valuable to us. Yeah. So that's a that's another excellent question. So, yeah, you're right. So there are people that are gonna look at and say, yeah. This is a a large part of medical affairs. Expensive team, right, to keep.
And and, again, they may maybe there's, like you said, there's no way to do necessarily metrics as far as tying to any sales goals, but how do how do we convince people internally. Right? So I'll give you an example. So for this just occurred something within our company that, and I won't mention any names or anything like that, but I'll give you, like, an example as far as value.
And I presented this to the executive team, right, because this is something that, they wanted to know is how does this team bring value? So for as you know, so we are we're about a we're about a year and a half away from launching our drug. And and the, you know, everything that our team has been doing, educating KOLs, you know, building relationships, you know, discussing, the science with KOLs and HCPs, doing clinical trials.
And just recently, one one very top tier KOL was presenting to at a big medical meeting, some of the, you know, new drugs that are coming to market for our disease. And he, on his own, without, you know, ask of our of our company or ask of any MSLs, put a made a slide that differentiated our compound from our competitor.
And he basically made every single point and and in front of his colleagues and a large ACGT community, why are we should be excited for this drug coming to market and why is it this is not a me too drug, right? So this is a top tier KOL, a professor of medicine at a big medical institution doing it on his own, creating a slide on his own. And he's basically telling be excited about this class, but be more excited about this drug coming to market.
And, you know, when I show that slide to the executive team, to our entire executive team, there was this awe, right? And I can tell even though this was virtual, but I can tell there's a light bulb that went off and they got it, right? And it was really rewarding to me to be able to show just this one example. Right? There's many that I could have used.
But the fact that I used a top KOL at a top medical institution doing this on his own showed the value that the MSL that has been working with this person really brought. It wasn't you know, you're not gonna convince these KOLs, Tom, to, be on your side because your drug is, you know, better. You have to show them the science and why it's better. Right? Yeah. And then they take it because, you know, these top tier KOLs, it's their reputation on the line. Right?
They're not just gonna say something that they can't back it up. Right. But he was able to back it up with science. And this is and I knew that this is truly one of the values, and and everyone got it. Everyone in the executive team got it. Kudos to you and kudos to your MSL. I mean, that's tremendous. That that is a one of the that's a great, great example Right. Of value. Correct. And I'll give you another. And so another example to your question, I think, for internal people, Mhmm.
You know, there will be KOLs that may not believe in the MOA that you know, the drug that you're developing. Right? Maybe they are worried about a side effect, or maybe there's something that there's concerning to them, and they may speak out negatively. Right? We've had a number of KOLs that were were they're not on board yet. Right? And that that is understandable. You're not gonna win everybody over. They're not on board. They're they they have they have safety questions.
But when they start speaking with MSLs and they raise their concerns and you show them the data and you show them the science and you show them the safety, to have them be neutralized and not speak negatively, for me, is already a big win. That's a win. Maybe maybe we won't convince them to be on our side. Maybe we won't convince them that our this the drug is is good, that it's effective. Maybe but the fact that they're not speaking negatively about it, I think, is a huge win already.
And we've had that happen with a a number of KOLs as well. And think about if there is no MSL team to neutralize. And we, you know, we always talk about, well, let's talk about the victories. Let's talk about the wins. That's a win to be able to neutralize someone that may not have the most positive opinion. Because there in in any walk of life, there's there's just some people you're not gonna win over. Absolutely. And you know what?
And we're not trying to, like, we're not trying to win a popularity contest. Right? This is not who's gonna be, you know, homecoming king or queen. Right? This is really just, hey. Listen. This is the science. Here here's we're laying all the cards out on the table, and we're saying, you know, you can make an educated scientific decision. Right? And a lot of times, you can see these KOLs say, okay. You know what? Maybe I was thinking wrong about it. Right?
And there's and, you know, and they admit to it. Right? And there but they and a lot of times, what they'll do is if you can neutralize them from speaking negatively, and they and they may wanna wait until it's, you know, in its, the drug is approved and on the market to to get more safety data.
But the fact that you can neutralize them and then with real world evidence, provide data to, maybe put them at at ease regarding some of the safety concerns or efficacy of your compound is a huge win because then they may turn and say, you know what? I was wrong. And I I actually think there's a huge benefit in this compound. This is great. And and I wanna I wanna stay on this for one more second here because so many people ask me it's a it's a tough time right now.
And, obviously, you know, MSOs are having a difficult time getting FaceTime. There's this challenge between the the hybrid nature between trying to get live meetings, if possible. If not, trying to get virtual meetings. So what what are some of the ways or what are some things that maybe your team is doing to enhance medical affairs and your relationships and your messaging with some of your external stakeholders in KOLs? Yeah. So we we're living in a different time. Right?
So when I started and when when when you started, we were all obviously doing live meetings. Right? So much easier to build the relationship. Right? You're you're you you are in that physician's office and that KOL's office. And remember, relationship building, it's not just about, hey. Let's talk about the data or let's talk about competitive intelligence or let's talk about what this, you know, study said.
You can look around in an office and see pictures of their children, some of the interest that they may have. Right? So you you you it that's there's the live component to being in front of somebody that you're gonna lose virtually. Right? Because they're on camera. You don't see anything. You don't see any background. So if you're just starting out to build relationships, it's challenging. It's not easy. And and I've I've seen that at arena. Right?
Because a lot of they're newer to this therapeutic area that we are developing a drug for, and it's hard. But but, you know, but if you continue to set up you know, we we're we're we're gonna be living in a hybrid model. Right? I don't see you know, for 2022, I don't I don't know that we're gonna be all virtual or we're gonna be all live, but some kind of a hybrid, I think, will continue until we get I think until the world gets control of this pandemic.
So my my my coaching to the team is always, you know, don't just ask key insight questions, like, that that you want. You know? Relate to them as a human. You know? Like, if they say something, you know, it's almost like this art of an MSL active listening. See what they say. Start building that relationship, not just from, like, hey, data science, you know, discussion, but more like, you know, treat them as a human. Right? Yeah. Ask them just general questions. What do they do for the holidays?
What are some of their interests? Right? Try to get and that's the tough part. Right? And it's hard to coach to that, but we but you can you can persevere through this difficult time and living in a virtual world. And I think and when you do meet them live, right, you can have some maybe common interests, you know, that you can discuss as well. Right? And you've kind of paved the way and and and build that relationship through a virtual environment.
And so when you do meet them live, you have a little bit more of that human factor connected, but it's tough. It's not easy. No. It's not. But, I mean, I I love this because I really feel like there's so much training that goes into what to say, how to say it, when to say it. But there's so it's so important to have that human element, make that connection, and really develop the relationship because that's what's gonna transcend everything, including the science.
The relationship transcends everything. It always happens. Exactly. One of the things that I also tell my team is if you are having a hard time getting a KOL appointment virtually or getting, you know, them to respond to you, who in the company may have a relationship with this person? Right? Ask them to give you an introductory meeting. Right? Ask them to send an introductory email to introduce you to this KOL.
You know, we this is a you know, we work as big as pharma is, it's a very small community. Right? We we everyone knows everybody. Right? So there should be someone working in your company that probably has has had interactions with the KOL before. So don't be afraid to ask. Ask for your some of the executive team's help. Ask them if they know this person.
You know, tell me that, you know, I'm having a hard time, you know, getting an appointment or getting a FaceTime or getting a virtual meeting with this person. And then I always say, like, you know, once we are able to meet live all the time, like, go to your local meetings, go see this person speak. You know, introduce yourself at a congress. Right? If they're having a hard time, but that's easy to do when we're meeting live, but it's harder to do when it's all virtual.
So I've asked people to to let me know my team if they're having a hard time getting an appointment with a KOL that is really important that we should start building a relationship with. Let's find who in the company knows this person and see if we can do an introductory meeting because sometimes that's all it takes. Yeah. It's just one foot in the door that allows you to open the door and come in. And you need to ask. You need to put yourself out there.
The MSO role has evolved into a much more proactive role than reactive. It's not like the old days. You really have to get after it. You really have to get creative. You have to rely on relationships. Right. It's a totally different time right now. Exactly. And, you know, and it's easy to get shut down. Right? If you don't hear something, you send an email once. You don't hear anything back. You send an email again. You don't hear anything back. You don't know first of all, check the email.
I've had a number of MSLs come to me. They're like, well, they're not this payroll is not responding to me. And I always ask, well, what email are you using? Right? You know, we have companies that give you these lists, the KOLs, and their contacts. They might have moved institutions. That email may have been expired. Make sure you're emailing them. Right? Maybe it's going into their junk folder. Who knows? Right? That's why I always say, like, double check everything.
And then if you still are not getting any response from them, come and ask me, and let's find a way where we can get you in. Yeah. At least to do an introductory meeting, you know, the first introductory meeting. Because I feel after that, I'm like I always tell my team. I'm like, it's up to you now to build a relationship. Yeah. You know, I I build a relationship with a number of KOLs over the years.
I've I've been able to open some doors for our MSL team, you know, with introductory meetings, but I tell them I don't need to build a relationship with these people. I have it. It's up to you now. For sure. Yeah. So let's talk about as we'll stay obviously, staying on the value topic, let's talk about leadership.
What advice do you have to MSL leaders that are responsible for the strategic direction of their MSLs and how they should go about trying to, you know, implement, you know, value discussions and and and strategy as it relates to value? Right. So so it's really important to have the right leadership in place. And when I think of leadership, Tom, I think of, like, really 4 important points. I think of inspiring people. I think of empowering people.
I think of a shared vision, and I think how do we lead change. Right? We work in an ever changing environment in pharma, so you have to know how to lead change. So I think having the right leadership in place is really important, not to only motivate your team, but really to inspire, empower them, and share your vision for the future. I think one of the important things in leadership is really having a previous MXL MSL experience. I think you have to know the job. You have to know what they do.
You have to know the value that they bring. Because if I am presenting to the executive team on the value of my team, if I didn't have that previous experience as an MSL, I don't know that I can do the job justice. So I wanna so I think previous MSL experience is really important. You need to be able to have good trainers, and you need to lead your team with integrity. You need to empower your team.
You need to make sure everyone understands that the the leadership explains and everyone on your team understands the legal and compliance guidelines, and everybody works within that. You have to know how to advocate for your team, and you also have to you know, one of the things that leaders have to do is really provide constructive feedback. Feedback sometimes doesn't always have to be positive. Sometimes it could be negative. Right? But but you learn from the negatives.
So I think if and you have to do it in a very constructive way where it's not demeaning or demoralizing or micromanaging your team. I think if those qualities in the leadership is what I see. I think the other thing is is to really it's very important to talk to your MSLs. What are their goals, and what is their developmental plan? Because one of the things I tell my team, my job here is to lead you and lead you successfully, but my job also as a manager is to make sure you succeed beyond me.
So if there are opportunities within a company that you feel suits you better or you're interested in, let's see how we can get you there. I've had a number of MSLs that are now medical directors at other pharma companies. I've hired MSLs in my previous company where they are now leading big pharma organizations, leading medical affairs. That's my success story. My success story is not like what I've done with my career for me.
My success story is look at the person in that position that I was able to help get there. That's how I that's how I see leadership. Well, and you're building a legacy. Right. You're building a legacy. And and you gave a perfect example a couple minutes ago of how your MSL did such an awesome job with this KOL that it just became an example for everybody internally. Exactly. And, clearly, you know, you're you're doing a great job.
So let me as we were closing out this year, and, obviously, it was a very difficult year and still things are still kinda crazy. But what are you thinking 2022 is gonna look like for MSLs? I think 2022, we will continue in this hybrid model. I think we'll you know, obviously, monitoring the pandemic will be very important. Countries and, certain states reopening, closing, I think, is gonna be an important, aspect to keep be aware of.
I I, you know, I would love I would love it if we all could go back to a live world, like, 100%. Right? I'm not sure that we'll ever get there. Maybe we'll get there 80 to 90%. I think, eventually, I I'm very hopeful. But I think we've learned over the last year how to work in a hybrid model. Right? We've learned how to work in a virtual model. Right? And there's benefits, I think, to both. You know, me media like I said, meeting people live is one thing you can pick up on gestures.
You can pick up on, you know, what their interest may be if you're sitting in their office. Right? You can you there's that human factor. Virtually, it's me and you on a camera. Right? But maybe some kind of a hybrid model, I think, is what we will continue to see in 2022 until things get better. And I think this is kinda like the way of the future. One of the things, you know, with a hybrid model is you can get a greater audience. Right? And then maybe not everybody can be live somewhere.
So you need you will always, I think, have to have this virtual component to be able to continue forward, and you have to learn how to work in it and really learn how to adapt because I don't think it's going away. Yeah. Well and you we've learned how to transact business through different mediums now, and it's worked to to, you know, a good extent. I I purse I'm old school. I personally can't wait to be more in that live environment again. You know? I like to see I'm a hugger.
I wanna see people. I wanna get in there. I wanna shake your hand and, you know, give you I wanna have I wanna have, like, maybe grab lunch with someone. Yeah. I wanna be able to, like you said, shake their hand. Like, you know, the the meeting that you and I met at is the 1st live meeting that I the presentation that I did in probably a year. Yeah. Right? Everything has been virtual so far. Right? All the presentations that I've done has have been virtual.
But like you, I wanna have maybe a cup of coffee. I wanna talk to you after you did a presentation as a KOL and ask you some questions and say, hey. You presented this data. I'm really interested in learning more. And maybe, you know, a lot of times, they're like, well well, walk with me. Right? Let's talk. I walk into another session. I miss that. I'm I'm with you, and I can't get wait I can't wait till we'll get back to that. Get back to it. I really feel like we will. I agree with you.
I think so too. What's the rest of the year look like for you? If we could take you some time off or So we're wrapping up the year, you know, closing out budgets, looking at what we're gonna do next year. We're building our tactical plan right now to roll out to the field medical team. We're looking to see if we wanna increase some headcounts. So there's a lot of work we're doing.
I think right now, building getting ready 2022 for us, for me personally, for the comp for arena is gonna be really an important year. We have a lot of data dissemination coming out next year. And, really, like I said before, this is the 2022 will be the year that the MSLs really laid the foundation for launch excellence and launch readiness. So that's we're getting we're getting we're excited, and we're getting ready for it. Well, good luck to you, my friend.
I'm a big fan, and I really appreciate you coming on. This was awesome. That was great. Thank you for having me. I'm honored that you've asked me to be a part of your Yeah. Let's do it again. Enjoy this. Absolutely. Let's do it again. Anytime. I hope to see you soon live somewhere Absolutely. Some conference, something. But Absolutely. In the meantime, best of luck for the rest of the year. Thanks again. Thank you, and happy holidays to everyone. Thank you so much. Thanks, Steven. Appreciate it.
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