August 10, 2023
Episode 34: Measuring the immeasurable: Can you quantify the impact of medical affairs? With Steve Casey of Omni Healthcare Communications
More than 4.8 billion prescriptions were filled in the U.S. in 2022, and a medical affairs team had a hand in each one—even if the average patient doesn’t know they exist. Steve Casey, managing partner of Omni Healthcare Communications, joins Justin to explain the evolving role of medical affairs and why life science organizations are struggling to find KPIs that accurately measure the impact of their work from drug development through provider and payor education and beyond.
Justin and Steve look at the big questions facing medical affairs teams and the life science organizations they work for: Can developers use behavioral science to more effectively gauge MSL influence? How does the role of medical affairs change over the next decade? And how clearly defined is the line between medical affairs and marketing?
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"Definitively Speaking" is a Definitive Healthcare podcast series, recorded and produced in Framingham, Massachusetts. To learn more about healthcare commercial intelligence, please visit us at definitivehc.com. Hello and welcome to another episode of "Definitively Speaking," the podcast where we have data-driven conversations on the current state of healthcare. I'm Justin Steinman, chief marketing officer at Definitive Healthcare and your host for this podcast. There are 4.8 billion prescriptions filled in the United States in 2022 according to statista.com. That's a lot of drugs. While we somewhat take for granted the availability of everything from lifesaving drugs to prescription cream for athlete's foot, the reality is that it's somewhat of a modern medical and scientific miracle that we have so many drugs available to us. We are so fortunate to have so many drug development companies researching and testing new molecules, devices, and compounds to improve and, in some cases, save our lives. A key member of the drug development commercialization process is the medical affairs professional. These people, nearly all of whom have a PharmD, PhD, or MD, provide crucial insight throughout the development process, helping to overcome roadblocks and figure out what's working, what's not, and why. My guest today, Steve Casey, has an interesting take, however, on the current status of the medical affairs professional. Steve believes that the medical affairs role is changing and many medical affairs professionals are struggling to demonstrate their value inside companies. He has a unique perch to offer this opinion. Steve is the managing director at Omni Healthcare Communications, with more than 25 years of experience working inside and with companies to optimize the role that medical affairs can play in the development and commercialization of medical devices and drugs. So I'm personally really curious to hear what Steve has to say about this topic, and I hope you are too. Steve, welcome to "Definitively Speaking."
Hey Justin, very much looking forward to our discussion today.
Me too. So I'm excited to have you here. So before we get started, I'm pretty sure that not all of our regular "Definitively Speaking" listeners know exactly what a medical affairs professional does. So can you just briefly explain the role of a medical affairs professional?
Sure, but the first thing I'd like to do is actually take it back a step and just say, you know, life sciences companies, in general, are not just about the product. You know, everybody thinks of them as the product. So if we think about pharma companies, we're thinking, oh, they're just there to sell product. They're really dedicated to ensuring the scientific advancement of the disease understanding and also the treatments throughout the medical community. So that helps improve the healthcare outcomes as it goes on. And we'll talk, you know, you'll see how that works into what I say about medical affairs as time goes on 'cause medical affairs really plays a big part in that role of improving the disease understanding and the scientific aspects of the treatment. They really are helping healthcare providers, and they help them by, what I like to say is they engage, they educate, and that empowers the provider. So if we think about that for a second, what we're really saying is you can put a product on the market, but if the people who are gonna use the product don't know how to use it or don't know what it's good for, then the product's kind of worthless. You're not gonna sell any product. And yes, healthcare or life sciences companies are in the business of selling products to make money, that's how they monetize everything, but really, they advance the treatment and the understanding of the diseases as further treatments because of all the science that's built in. So medical affairs takes that science that's been developed and the developing side of the drug developers and brings that forward to the marketplace.
But these aren't salespeople. We all heard about drug sales reps, right? So how does a medical affairs person work with a drug rep, where's the line get drawn?
The easiest way to think about drawing the line is right at the launch. So launch being when a product can go to market. So the FDA has approved it to go to market, and the manufacturer can then start talking about it in the marketplace. Medical affairs tends to work more before that. And in those areas, they're talking generally about the science of the product or the science of the disease that's going on. So if you think about a new product, a new class of drugs that's coming out, maybe, let's take, for example, gene therapy. Worked on a gene therapy product a number of years ago. And at that point in time, a lot of folks, a lot of healthcare providers did not really have a lot of gene therapy understanding or genetic understanding. So they would spend maybe a couple hours in their medical school teaching, learning about genes, but that was about it. And they've been in the marketplace, they've been treating patients for 20 years. So coming along with a gene therapy and trying to explain that to them as far as features and benefits, they didn't understand the basic science behind it. So they were very uncomfortable in using something like that. So what a medical affairs professional would do is communicate to them prior to the launch so that they're really empowering them to be able to use products as they come to market.
So they're educating people before the product launches.
Absolutely. They're educating and informing them.
Got it. And do they also play a role in helping to figure out, you know, which molecules to develop, more kind of the science and the development, or where's their role there?
Yes, thank you. I'm talking more about the commercial side because we were talking about sales and the difference between sales and medical. But medical also extends all the way down to the development side. So they're picking up insights from all the interactions that they have within the marketplace, learning from, you know, people who are experts in their field. They're opinion leaders, experts. They know the science backwards and forwards. They may be at Yale, they may be at Children's Hospital of Philadelphia, they may be at Mayo Clinic, they may be at Scripps. But they're collecting those insights and finding new ways to treat patients and treating diseases. So they'll bring those insights all the way back to the development of the product. And development then takes those insights and incorporates them into the actual product that they're putting forth.
Okay, so then that leads into kind of why I have you here today because you just made a pretty convincing argument to me that these people are really important to their organizations, these life sciences companies. And yet you said to me when we were talking earlier, they said, medical affairs specialists are struggling to demonstrate their value. It doesn't seem like they would given me everything that you just said. What's going on?
Well, in, you know, in business, we look at things in metrics. And we look at them in terms of something that we can actually tangibly say was accomplished. And when you're looking at how medical affairs goes about things, for instance, they may be communicating out the science using scientific exchange methods like a journal article or communicating it out through medical science liaison or something along those lines, when they're doing that, it's very difficult to say that that's leading to anything, right? Except, you know, that that's building the capability to use the product later on. But using prescriptions is not a way that we can look at medical and say that medical is doing their job. The way that we can look at medical and say medical is doing their job is their ultimate goal is to improve outcomes for the patient. That's their goal. And that's really everybody's goal in whether it's a pharma, or med device, or diagnostics is get better outcomes for the patients so that healthcare improves. But when you're looking at medical and you're trying to find out where they played a part in improving the outcomes, probably the best place is in changing the clinical practice and improving the clinical practice, but that's very difficult to measure.
I really would. I mean, 'cause let's be honest, what hospital wants a medical affairs professional from their favorite drug company coming and telling them how to practice medicine?
Absolutely, and it's not about how to practice medicine, it's how these things work within, for instance, a disease state. If you're looking at a disease state, how does it actually work and how does the product work within that disease state? So that improves the practice of medicine. For headaches, we'd use aspirin, for example, but nowadays, we use acetaminophen, or ibuprofen, or a number of different products like that. So over time, you find out that aspirin has more side effects or aspirin has more power to it that you don't want. As you learn about the disease or the symptom that you're trying to treat, then you are able to take out those things, the developers are able to take out and modify so that they get something that doesn't have those side effects or doesn't have the broad base of the broad spectrum and they're targeted treatments. We see that a lot nowadays with CAR T therapies and things of that nature. They're very, very specific about where they're going and what they're doing.
So if they're struggling to prove their value, and I get it. Like I look at my world, right? So I work in marketing, right? And while I can influence sales and revenue, it often feels like the best measure of our marketing success is our lead funnel and how many marketing qualified leads my team can generate. But we do so much more than that, right? So I feel a little bit like the medical affairs professional myself, but at the end of the day, my boss still shows up and goes, "Justin, how many MQLs did you generate this month?" What are the metrics that you'd recommend a medical affairs professional use to measure their success?
Well, we're just really starting to get a handle on that and how to go about that. Up until now, it's been a lot of productivity. So if you took a look at communications, it's how many communications are you putting out? And that doesn't really lead to the best outcome in what you're trying to accomplish. As any communicator knows, you can cause more noise for your own important point that you're trying to make versus making that point. So the more communications you put out, the more noisy you cause. So in productivity, you don't want to, you know, in medical affairs, you don't want to necessarily be, you know, fixated on productivity. What you want is the outcomes. And if we can measure those outcomes and find ways to measure those, that's a much easier and much better metric for us to use. So in a lot of cases, you know, I was talking about publications or communications earlier. So in a lot of places, we're starting to look at, you know, how is that being communicated and then what kind of reaction is being seen? There are different metrics that are being designed today and being used today as well. There's metrics that look, is the publication being discussed in the social environment and a lot of social listening, looking at that type of situation? But it's ways of defining what you're trying to accomplish, but not really getting to the end goal and looking at that. I think over time, you'll see that. A lot of that is going to probably be generated from things like behavioral science and looking at behavioral activities. So if we look at the practice of medicine and how that changes using behavioral science tools, we can do that. And that's something that's kind of coming, I think.
So it's really interesting to me, it feels weird, but I feel like there's definitely a parallel to what we're doing in marketing here. I look at my product marketing team, and I could have the most productive product marketing manager, and if he sit there, he pumps out, this guy's the king of data sheets and the king of flyers. But if nobody from sales is using them, he is doing a bunch of stuff that nobody cares about, right? But he might be the number one producer of flyers and data sheets but the zero consumer. So a lot of times, I measure like the effectiveness of our product marketing team based on the feedback from our sales team, like Joe Smith over here, man, I keep using his presentations with my customers, and they're the best, right? That kind of feedback where I see how many times sales has downloaded his data sheet or how many times they've sent it to a customer. I'm almost kind of measuring my customer's adoption of the team's output, if you will.
Do you see some kind of analogy there for a medical affairs?
Yeah, I think there is an analogy there, and I think it's, you know, the output and what you're generating from, for instance, the scientific exchange. You can see that on the more of the development side, as well, it's easier to measure because it's the usefulness of the insights that are being generated. When insights were first started and being asked for, everybody was concerned about the amount of insights that was coming in. Then it became so many insights coming in that they had to find the best ones. So now we're even talking about, you know, using AI to parse through the insights because there's such a volume coming in. And I think that's part of what you're going to see and part of the challenge that lays out there for medical because all the data that is flowing towards them, there's a tremendous amount of data that we we're getting from all the digital tools that we're using and everything along those lines. They have to parse through that, figure out what's the most important data, and then be able to build what I call the scientific foundation within the, you know, the different areas that they're touching on. It's really scientific exchange, but it forms a foundation of content and educational material that's out there that the sales group and the commercial group can then use and point and refer to for as they go on and they talk about the features and benefits of a product and, you know, when to use it and where to use it. The references have to be there for the physician to be able to look and go back and say, okay, they're telling me the truth.
So if you were to give some advice, I'll put you on the spot here, to a medical affairs guy who's going in for his performance review with his boss, what are the three metrics he should be using to justify his success?
So I don't mean to be avoiding the question.
And giving any kind of roundabout answers, but it's hard to give, you know, metrics we would normally see in a human resources type of situation. You know, in a lot of cases, as I talked, productivity is being used for that, but I think it's more about, with medical affairs, because of the placement that they have in the company. and you know, we can talk about that later, that's gonna grow for them. But because of that placement in the company, it's more about how are they interacting with the team across the company and how are they filling that gap and what I call, you know, strategic commercialization. What companies are doing to be able to, you know, exist in the healthcare services or healthcare products marketplace. Even though I said we're building the scientific foundation in the medical affairs side, and even though you want to have a lot of separation between medical affairs and commercial because they're two different things, and you really don't want the medical side being seen as a commercial side because there's regulations about that, even though they have that, there's a lot of interface that has to happen on key situations. But it's not interface that says, how do I generate this prescription? It's interface is to how is this, you know, medical point that you're making fit with what I'm trying to say here in a lot of cases like that. So you find that they've got to be able to handle talking to different people, whether it's development, whether it's sales and marketing, and whether it's executives. Because all along the whole organization, people are gonna wanna know things from medical.
So you said wanna talk about placement later. We're later now. What's placement?
Well, the placement that they fall in in the commercialization, this strategic commercialization I mentioned earlier is really unique in that it's early on, as we talked about, it covers all the way down to development, and it goes all the way up into commercialization. So even though I talked about, you know, medical working up till launch, they still work past launch, they're still handling a lot of different things. So as the launch occurs and it goes out, not everything's handled by sales and marketing. If there's an inquiry, that goes back to medical, and if it's something that's very medically-oriented, it goes back to medical. So medical has to have that, they have to have some interface in the marketplace, they have to help out with situations with payers and help the payers understand where the product fits in the marketplace, especially from a scientific perspective. They have a lot of aspects on that side of the ball, but they go all the way down to pretty much product concept too. In a lot of cases, the medical could be saying, well, it's a great idea for a product, but it's not going to be used because of this, this, this, and this, you know, way of medicine is being done and then bringing in insights and having it brought. But the process of bringing a product to market and actually commercial and doing the marketing and sales of it, the key element of that, because this is, you know, healthcare is science and it's all about the science. And if you don't have the proof sources and the references clearly defined, nobody can find it, nobody can use it. And if they can't find the science and they can't use it, they're never gonna use the product because I don't know, one HCP out there, that is just gonna go on the word of another person that a product is good.
Science matters, gotcha, 100%. So where is the role of the medical affairs professional going then over the next 10 years? It sounds like it's quite a bit of evolution right now.
I mentioned payers, and as you're coming from the commercial side, the payers are incredibly important, and they become even more important. And they kind of are the first cog in the system that you've got to figure out from a commercial perspective. And you know that when you start talking, if you've ever, you know, anybody who's ever been on the entrepreneurial side and tried to build a company or along those lines, the first thing an investor is going to ask them is what's the science behind the product? And the second thing they're going to ask them is how are you gonna get paid? And that's similar to a lot of industries. It's how are you gonna monetize this, but how are you gonna get paid? And if you don't know how to do that, then you're gonna be in trouble. But getting paid is also working with the payers to get them to understand why this product is important, how it fits into the disease treatment, how the disease, our understanding of the disease is improving and where we're getting to. And that's why I think medical is going to become a huge, huge player in the biopharma, as well as medical device, as well as diagnostic area.
So I hate to keep coming back to marketing 'cause it feels very self-serving knowing my own career here, but it feels like a lot of what we've talked today is about like marketing. And so if a medical affairs professional's responsible for creating the story, scientific story, if you will, but a story nonetheless, that a life sciences company tells to the marketplace, where does the role of the medical affairs professional end and the role of a marketing manager begin? How do I think about that?
So in a lot of cases it, I would pinpoint it at branding. So a medical affairs will be talking about the science of the product, but almost invariably, they're not using a brand name in whatever they do. They're just talking about the generic name, they're talking about the product that's being developed, how it's being developed, some cases were, and what they've found from that development. So it's the scientific information along there. It has nothing to do with the branding of it. It really is building that scientific foundation. Now that scientific foundation for our industry in the healthcare industry is incredibly important and becomes part of the product, yes. But in the end of the day, that scientific information, whether it's a brand or a generic, it's the same scientific information. So essentially medical affairs sets up and educates for both types of products, a brand and a generic 'cause the generic's just going to come onto the marketplace and never have to do any education.
So almost like, if I were to think about it, the medical affairs talks about the benefits of atorvastatin, and the marketing manager talks about the benefits of Lipitor and buys the TV ads and stuff like that.
Interesting, you know, we talked earlier a little bit about omnichannel. And again, omnichannel in my world, has a very specific meaning. What does the word omnichannel mean in medical affairs?
Yeah, I think that's a great question because I think you'll get a different answer from everybody you ask in that because it is so different in medical affairs. And the reason for that is there's two things that medical affairs lives by, and there are two kind of compliance issues. So prior to launch, you can only be reactive. So you can only react to things that are being asked of you. That is to say, if a HCP wants to know some information about your product, you can, you know, talk to them about that. But if you want to go out and talk to an HCP, and they didn't ask you, then that's promotional, and you can't do that. So that's the reactive versus proactive. So in omnichannel, you know, the original way that I've always thought of omnichannel was in a retail setting. Maybe you'd be out and searching on Google and you type in that you want a new keyboard for your computer. And the next thing you know, every time you go to a site, there's a Google Ad over there, and they're showing you different keyboards that you can buy. That's omnichannel because they're feeding you the information, and you're going to a place where, and it's in a place where you can see it, but it is a place where you wanna be too. You wanna be on that site. So you see it in that nature. And omnichannel and medical affairs can't be proactive like that. It has to be in a situation where it is almost kind of an omnichannel, slash, multichannel where you're using the different scientific exchange channels to get the information out there. Once you launch the product, and you're approved by the FDA, then you can do more of a traditional omnichannel, but usually that's sales and marketing doing that anyway. So omnichannel tends to be something that's looking at trying to make it more customer-centric for the HCP or for the KOL that's going to be seeing that science. So instead of just, for example, putting, in omnichannel, what we'll do is instead of just putting a publication together and having a journal article published with the science behind it, it's also thinking in and looking at enhanced publication content, looking at things that you can use, whether it's a video enhanced publication content or things that journals are now putting out and allowing companies to, or even not just companies, individuals, authors to do, you know, where they can do visual abstracts or video abstracts of their publication. They may be invited to be on a podcast, they may be, you know, asked to do an infographic, things along those nature. And those are enhanced publication content. And that's kind of I segment that out because it's something that has to go through peer review. So it's something that is viewed and looked and made sure that it's not branding, it's not anything along those lines. It's purely the science, right? So, but you can get that science to people who want to see it in a shorter form and they want to get the CliffsNotes version, so to speak, on a video abstract. So it's more customer centric and trying to get it to a point where the customer is happier and is more prone to be engaged in the science.
Sounds like marketing. So I have to ask, is there any risk that a medical affairs professional will become too commercial and damage your scientific credibility?
I think the risk I come to on that is in an omnichannel setting, you know, you have this situation where we were talking earlier about productivity, and if you match productivity up to omnichannel and you're trying to do what we'll call more is more, and you're doing it through omnichannel, you can basically not only detract from your own message, but you can really irritate the marketplace. And that puts you in a situation where you're causing issues for yourself as well as for everybody else. So people have to be very careful about how they go about it, in my opinion.
Your opinion's why you're here. So, look, this has been great. I got to ask one last question before I let you go today, which is, how does someone even get into medical affairs? I have to admit, before I started working here at Definitive Healthcare, I'd never even heard of the role. And now I have a great appreciation for how important it is to drug development, care delivery, life sciences, our whole economy, frankly. Who goes into this field, and how do they get started? And what advice do you have for aspiring medical affairs professionals out there?
So I think that, you know, in a lot of cases, medical affairs is composed of, as you mentioned at the front end of the podcast, by scientific folks. they're mostly PhDs and MDs that are in that area. There's a lot of masters of science as well. And then you go in into affiliated fields like PharmDs and even some PAs. But all those different areas are very understanding of what the healthcare delivery is like. They all work in that, or they're all trained in that area. So that'd be the first step. You've got to have some sort of scientific understanding and understanding of, you know, how healthcare is delivered and why we approach things the way we do. And I say we, but I'm talking about healthcare providers. I shouldn't lump myself in there, but that'd be the first step. The second step is if you're in that field or in that area already, and you have that training, really, I go to, you know, different conferences, maybe Medical Affairs Professional Society, I'd join something like that. They have a lot of good educational content about medical affairs itself. Also, there's the International Society of Medical Publication Planners, and if you're interested in writing, that's a great place to learn about actual, you know, medical communications and publishing and publications because medical writers are needed all over the place, whether it's in biopharma or in healthcare itself, all around, even payers have medical writers on staff. So those are different areas. And then there's the third one, which is the Medical Science Liaison Society. And that society focuses on what is called the field force of medical, the medical science liaisons. But medical science liaisons are really folks that go out and discuss the science with key opinion leaders, people who are thought leaders in their area, whether it's, you know, from urologic cancer to, you know, heart disease, to psychiatry, they're all over and they're talking to those folks, and they're having peer-to-peer conversations about the science. So if that's something that's of interest, that's another area that you might learn about and be able to go in. And all three of those usually have some sort of mechanism by which they publish a job openings. So you can get on a list and pick those up as well.
Steve, thanks so much for your time today. I really enjoyed talking with you.
My pleasure. Really enjoyed it.
And for all our listeners out there, thank you for listening to definitively speaking.
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