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Garth Sundem 00:01
Welcome to this episode of the Medical Affairs Professional Society Podcast Series, Elevate, gathering the voices of Medical Affairs thought leaders and stakeholders to explore current trends, defined best practices and empower the Medical Affairs function. opinions are those of the presenters and do not imply endorsement by other organizations. I’m your host, Garth Sundem, communications director at MAPS. And today we have Part Two in this series of MAPS, health economics and outcomes research podcasts sponsored by the alpha group of medical communication companies. This podcast features two experts, Dr. Kent Summers, and Dr. Steve Camper. Gentlemen, hello, would you care to introduce yourselves and your backgrounds, please?
Kent Summers 00:54
Yeah, I’m Kent Summers. I’m a pharmacist by training. I went on to get a PhD in pharmaceutical sciences with a focus on economics. I’ve been working in health economics and outcomes research for about 30 years now. I’m currently the strategic lead of health economics outcomes research for AlphaQsci, a subsidiary of AlphaBioCom. Previously, I was at Lilly, I’ve also been the Vice President of HEOR for info. I’ve also in my career, been the health economist for the Indiana Medicaid program, as well as the DP pharmacoeconomics and clinical programs at Prudential Health Care.
Stephen Camper 01:39
We’ve seen why Kent is my mentor. And I have a slightly different path. I my doctoral work is in physiology, some physiologist by training, tend to tend to look at things as physiology problem, for the most part, did a fair amount of additional training in health economics and outcomes research and really tend to focus on that a little bit more, started my career in patient care in preventive medicine and rehab medicine in 20, some years ago, moved into the pharma world, and have been doing Medical Affairs and your work on and managing those functions in some capacity for the last 20 years.
Garth Sundem 02:27
Alright, well, as you know, we had a question set to start our podcast here, and it was an HEOR question, but can you tell me the story of how you met Steve 12 years ago?
Kent Summers 02:40
Well, it’s almost 12 years to the date, it may even be to the date. 12 years ago, I was a professor at Purdue University. And I was asked to come in to endo and to work with Steve Camper who represented the Medical Affairs group. And their goal was to have a program which we Steve and I worked together on to develop for the organization to talk about the principles and practices of ATR and working with the entire group. We had Medical Affairs there manage markets, we had the full spectrum of folks there. Okay, we’ve, we’ve worked together over some period of time.
Garth Sundem 03:21
Well, okay, so that’s 12 years ago, right. So why are we still talking about the integration of HEOR with Medical Affairs? When when it’s been 12 years?
Stephen Camper 03:34
Want me to start that one? Well, you know, it’s, it’s, it’s been a lot longer than 12 years, actually. But as far as looking for that integration, I think there are a number of reasons for it. I think that there are competing priorities there is, you know, in every industry silos exist. And, and, you know, everyone’s opinion that their work is first and foremost. And I think there’s always the opportunity to look at how can we do things collectively, to bring better value to the organization and that continues to be what I think most organizations are trying to do.
Garth Sundem 04:16
Okay, so can maybe get us started on how HEOR and Medical Affairs should collaborate?
Kent Summers 04:23
Well, first of all, is recognize the differences. You know, I can imagine coming from the Medical Affairs perspective, you know, where the dominance is probably going to be a lot of basic science training. physicians, pharmacist farm these, a lot of PhDs a lot of basic sciences. And as they’re viewing this whole each he or function, we’re both nebulous and nascent. By that, I mean, nebulous. What does it what’s, what does an HR person look like? Well, it’s it’s a conundrum. We have specialties in the areas of epidemiology, economics, psychometrics, public health, we have physicians, we have pharmacists, we have farm DS, we have a lot of different folks who compose what is recognized as being health economics. So it’s hard to get your handle on, it’s hard to get your hand on, if I’m looking at it from the Medical Affairs side, who is he? Or what are they in there, this nebulous group of things, and they put together studies that aren’t necessarily clinical trials. And, you know, if my job is to get registration, if my job is to get the drug over the finish line for registration, then why, you know, why do we have this he or function? And why do they try to muddle up my clinical trials with these prs, these patient reported outcomes that only add to patient burden and, you know, may even hinder may cause uncertainty regarding my metric, which is getting the drug registered?
Garth Sundem 05:58
Well, that that sets up the challenge. So what is the benefit to Medical Affairs of including the HEOR perspective, Steve?
Stephen Camper 06:07
Well, I think you have to look at it, or maybe it’s maybe it’s best to look at it by looking at the company’s customers, know that they’re, if the customer, if the customer were only the clinician, the provider, or or, or even the researcher, the clinical researcher that would lend itself to, to maybe going down one path as I just described, but from a commercialization standpoint, there are a number of customers there is the patient, there’s the provider, or the clinician, there’s the researcher, there’s the end, there is also the payer, and and I think if we start looking at the the customer universe, that that the company has, and that the ultimate goal is successful commercialization of the asset, then it would lend itself to bringing all these, these these parties to the table, and and collab and being more collaborative. Um, sometimes that’s a little bit disjointed, I think, still in our industry.
Kent Summers 07:19
Garth, if I could add on to that, think about the fundamental orientation of the study design in the statistics, the orientation is to inform clinical decisions, and that’s recognized by the FDA is requiring significant scientific evidence to inform an individual clinical decision, do I put this drug do I put this patient on this drug or not, and the FDA recognizes that and that’s the highest level of science is needed. On the other hand, the Manage markets, people in health systems don’t make clinical decisions, they make population based decisions, they make policy decisions, in which there’s such great variety in the patient presentations. clinical trial is a necessary Foundation, but it’s not sufficient to inform those policy decisions. And so that’s where health economics and outcomes research comes in. And, and I will add one thing to what he said, and he said this for years and, and I, I’m going to give him full full credit for this, in terms of bringing them together, that very data that that he just talked about, is what forms the foundation for I don’t know the number, but I’m going to the majority, I’m going to say, of, of the healer research that’s done it yeah, it might move into an economic story that’s being told, but the most of the time, it starts with what the clinical story is, and then moves into the economic story, which To my mind, says right there, let’s start let’s move these people together, let’s blend these people. Because both both sets of data, or both approaches to data are generating what the story should be. And I can even piggyback on that I continue to I’ve been on editorial advisory boards, and I continue to review papers, a lot of papers that come through that don’t get published, they don’t have a clinician on the authorship team. So I can do a database study and look at all the silly, you know, things that really don’t make any sense clinically, if I don’t have a clinician on that team guiding the questions that are being asked, you may not get published. And so that’s why I’ve made a practice that every time we have a database study, we’ve got to have a well recognized clinician, typically one of the CO ELLs in the company, would serve a great role in helping us get at what are the patients we should be looking at? What are the treatment patterns we should be following? And what makes sense? You know, does this thing have face validity this database study doesn’t have face validity. That’s the first thing I look at a reviewing paper. And if it’s just a database study that says we found that it costs X to treat y you know without Clinical Foundation, it really doesn’t make sense. nor even at the managed care at the health systems level, those folks are going to be MDs and PharmdDs, they’ve first got to be convinced that there’s a clinical need for this product, and the clinical justification for its use before you even start going into the economics component. And the patient reported outcomes component,
Garth Sundem 10:20
Oh boy, that is a gorgeous story of integration and collaboration between the clinical side and the HCP side. You know, I remember I used to do cancer communications. And I remember at one point, people were doing SEER studies and whatever and it was in JAMA or NEJM, where there was an opinion that called them data parasites. So these these researchers claimed the term; they said, Yes, we are data parasites, and we’re going to give you actionable insights into all of this SEER data that is a lot is going to allow us to use these clinical studies in the real world. Now, is that the role of HEOR is is to say, Okay, you’ve got this great new drug, can you use it? Can you not use it, here’s where you can and can’t?
Kent Summers 11:08
Well, now I’m going to I’m going to jump in here with a caveat. FDA regulations are very specific and explicit, they haven’t changed, it has to be in the approved indications. So again, we all start with the clinical indication, I can’t do a database study on hair loss if my drug is intended for, you know, treating the common cold. That’s, that’s not, that’s not good science, that’s not good practice. And that’s against FDA regulation. So it all starts with your clinical indication.
Stephen Camper 11:39
And I agree with that, I would add that it can provide and will provide insight into what is going to be an I’ll just use the the term, the most cost effective way to treat a condition. So and which are obviously more and more today, that comes into play. And that’s what’s being driven and that’s driving things. So again, it’s To me, it’s a collaboration, it’s it’s everybody, you know, it’s it’s it’s combining all of those those expertise, if you will, to speak to the different customers. And I look at that from a Medical Affairs strategy perspective. My strategy isn’t one sided, it’s it’s a blanket strategy. So everybody needs to be at the table.
Garth Sundem 12:35
Okay, so it sounds like you know, we’ve got 12 years plus you said a lot more of disintegration between your and and Medical Affairs, we do have some stories of collaboration like Kent’s story of putting clinicians on database studies, you know, on papers, but you Okay, so what is the answer, then? What is the answer? And how to bring these functions together to you know, create synergies that are that are bigger than each individually?
Kent Summers 13:06
Well, if you want, I can, I can start off, Steve, we had at the at the company, Steven I worked at, we had a monthly health economics and outcome Strategy Team. We had a monthly meeting in which we reviewed first the strategy and the tactics, and then we developed new research questions. Now, not not all of my colleagues did it the same way. Some of my colleagues would have just show up and throw up session. We’ve all been to those meetings, right? Where they show up with a big set of slides. And we’ve got 80 slides and 30 minutes, you know, that didn’t work so well. As we evolved in our working with it, we evolved into the functions. And we realized that, you know, people who are involved in the strategy are different folks that need to be involved in the research question generation. So we separate it out. So if you have a one size fits all approach, you’re probably not going to be as successful. Now, that said, we need to have you not the strategy meeting, it needs to be on track with the medical strategy, we need the ATR needs to be supporting and complimentary to the medical strategy and the messages that they’re providing to the market. It has to be on track with the managed market strategy. And it has to be fully compliant. So legal, and regulatory all need to be there, and all need to have their eyeballs on it. And if the HR person cannot justify their strategy, they need to do a little bit more work. If it’s not clear to the manager, manager, managed or to the Medical Affairs group, then they need to make it clearer, it’s up to HR to do that. And if they can make it clear, then they need to work harder. And and I will say I actually am using a version of that model today. And it’s I can’t Have a look at it a part of what Medical Affairs function is, in terms of supporting an asset or a marketing product and commercialization of those of those assets is, in a sense, you can break a lot of it down into data generation activities, data dissemination activities, that support certain positioning statements, could be a marketing positioning statement could be a medical positioning statement. But you’ve got these positioning statements that drive the commercialization of an asset. Those statements, for the most part need to be based in data. And that data may come from more more clinically based project, it may come more from a healer based project, but they all are coming together into support specific positioning statements. So to my mind, wherever anybody reports, or what the what the organizational structure looks like, there’s got to be a collaborative effort. And team, if you will, that coordinates all of that and and starts and walks through these. And to Ken’s point. It’s very, very simple. Really, we believe in this statement, do we have data to support this statement? Yes, great. If we don’t, we need to generate it. How do we generate it? There’s the discussion and that I just described, and then you move into the publication of that, and so on and so forth. So to my mind, it fits very nicely bringing everybody under, not necessarily from a reporting perspective, but from a collaboration and matrix management perspective under one umbrella to have an output. Okay, integration and education do is is that is that the summary?
Works for me.
Garth Sundem 17:03
Well, let’s leave it there then for today. Thanks, Stephen and Kent for joining us! MAPS members. Oh man, we have a lot more to talk about. So continue the conversation at our community portal. And don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series. Elevate