Garth Sundem  00:00

Welcome to this episode of the Medical Affairs Professional Society podcast series, Elevate. I’m your host, Garth Sundem, and today we’re talking about MedInfo. Specifically when to bring the MedInfo function in house. Joining us are Katie Lupke, Executive Director Scientific Communications, Drug Information and Publications at scPharmaceuticals. And Allie Reynolds, Senior Director of Veeva Medical Strategy at Veeva, and this episode is sponsored by Veeva. So, I need some understanding, some background knowledge, as we get started. Allie, doesn’t everyone have their MedInfo in house? What? What are the models now? What does it look like? What does med info look like across companies these days?

Allie Reynolds  00:51

It’s a great question. I think it really varies by the size of the organization and what their goals are. So oftentimes, what we see in small and emerging biotech is that before you are commercialized, it’s often easier, or viewed as easier, to completely outsource med info. Choose a provider that has a contact center, has services, has expertise, and they bring their own system to manage all of your medical information requests and response fulfillment, very typical for smaller on the larger end, there are always third party vendors involved. We never really get away from that in order to have global scale. But they’re often used as contact centers, and those large pharma often own their own med info system that is integrated and connected with all the upstream channels and systems and all of the downstream channels and systems. So we see a lot of variability depending on the size of the organization.

Garth Sundem  01:52

Oh, that’s cool, and at MAPS we get, we have a lot of information for mid size and large pharma. So I hear a lot about how that works. And I love that we’re talking about smaller pharma, biopharma. Now it seems like these are the organizations that are really learning how to build these systems where we can provide some concrete guidance and resources for them. So that’s great. And Katie, what does it look like at SC pharmaceuticals?

Katie Lupke  02:19

Yeah. So at SC pharmaceuticals, we our original model is we started out with a third party contact center, as Allie referred to, which they were fantastic, and that was put in place about a year prior to our product becoming FDA approved. We have one product, and it’s a drug device combination. And so that was really working well, I would say, and we had, we put together all of the content that they would send in their system. They would also triage adverse events and product quality complaints, which gets a little bit more complicated when you have that device combination. And so, like I said, that was working really beautifully for a while. And the what came down to, it really was, was the funding. And so they would charge us a flat fee every month, and we’ll get into that for a little bit. But really, as our business grew, we thought, well, we could, we could potentially do this on our own and have things more streamlined, have a quicker turnaround. We could bring in someone who could was a product, had product knowledge expertise, because originally, at the third party contact center, they would escalate questions that they could not answer. And many times those came to me and that kind of hit, hit a roadblock, and, and, and the speed in which that response was was transmitted. So, yeah, so we integrated, we we pulled everything in house about a year ago, and pulled in the Veeva system, and we’ve been live about a year, and it’s we’re not we’re not looking back.

Garth Sundem  04:00

Okay, so you hinted at some of the reasons that you transitioned from this third party call center approach, where you provided the content, but then they provided pretty much all the logistics, and would sometimes kick a question back to you that they couldn’t answer, but really they were third party, and they were fulfilling most of that net info distribution and logistics. Uh, so why did you decide to it’s not just growth. What was the tipping point in deciding to bring this med info system in house?

Katie Lupke  04:34

Well, with any small pharma company, you have to be very, very cognizant when you’re launching your first product on budgets. And so that was really kind of what initially caught our attention, and that, you know, they were, were they were doing a great job at how the cost structure was set up, is we would get billed a flat fee on a monthly rate for a certain number of medical information requests. I believe it was 45 um. Again, we’re talking small pharma and what we and then any question that went over that amount, we would get charged per question. And so you could imagine, with the business growing, we would be getting more of that, that billing from the non flat component as our questions went up. So so really, as the invoices started adding up that caught our attention. But then we said, Well, how about this? You know, we’re we’re all farm DS. We, we know the product inside and out. Could we look into potentially doing it ourselves? Because, you know, ironically, at the same time, we were getting questions that we just didn’t have the data to answer. So we were getting a lot of escalations that we would have to end up answering anyway. So we said, well, that’s the most complex part, and we’re already doing it, so why don’t we take a look to see if things could run more smoothly? And in addition, at the same time, just working with my colleague in pharmacovigilance, we were working off of the an interactive PDF form to capture all of the different potential things that could contribute to a product complaint. Again, the device component is very complicated and And originally, the call center was filling out this manual form and then emailing it to our safety support provider, as you can imagine, that process was not ideal, as you’re trying to email a form different things can be prone to error with that. So we wanted to explore a system that could be more streamlined from both a pharmacovigilance standpoint, but then obviously would serve our medical information needs.

Garth Sundem  06:40

Okay. Cool. So you had budget friction, we’ll call it. You had the excess in house. And there were some processes that might have been more streamlined if you brought them in house. Those sound like tipping points. Allie, are those the tipping points that you hear from companies more broadly? Are there more others?

Allie Reynolds  07:03

They are. I think oftentimes, it really is about getting responses to people quickly, to make decisions, to hopefully improve their patients lives, and also wanting to have the insights so that as a medical affairs teams and Katie can speak to this better than most of small and mighty teams trying to prove their impact, and I think that spans across the industry, no matter what size you are, and if you don’t have the data and the visibility at your fingertips of what questions are being asked, how are they being answered? Are there trends we can see from questions being asked in the field or content we’re creating for programs we’re creating around medical education, you can’t pull all of those pieces together and make sure that you’re communicating with one cohesive voice to be external audiences. So it is increasingly common, and I think you know, from Katie’s perspective and SC farmer’s perspective, they brought it all in house. But there also is a best of both worlds model where you can still get the scale with your contact centers if you need to do that, but own your own system, so that you have all of those insights and kind of control and visibility of the data at at your fingertips.

Katie Lupke  08:26

And Alie, I would definitely add that, you know, with when we outsource the our SOP stated a turnaround time of 72 hours. So what we found was that all, or most of our inquiries were being batched, and they fell within that 72 hours. But we said, well, we could do a lot better and get responses out quicker, because that ultimately impacts patient care. So that was another reason, and then obviously the reporting function, we didn’t have access to the system that our call center utilized, so we were limited to Excel spreadsheets, and that was really tough to navigate through where, you know, fast forward now we can customize those. She can talk a little bit more about that.

Garth Sundem  09:11

Well, it sounds like there are not only two models. There’s not only the in house model and the out of house model, but there’s a spectrum here of how much you’re doing and how much you’re outsourcing. So, Katie, as you prepared to make this transition, okay, you passed the tip, tipping point. You said we’re gonna do How did you start to prepare for that change, and what did it look like?

Katie Lupke  09:36

Yeah. So I think it’s, you know, just trying to get everybody on the same page, we justified the change from the financial point of view, and really our quality colleagues were excited to hear about, you know, having a more streamlined approach to to looking at AES and product complaints, but we wanted to get everybody around the table. So we we thought about who what? Would this change impact? Or who in the company would this impact downstream? And let’s get their buy in initially, so they have a view into what we’re doing. So to not only prepare for any problems that could occur, but you know, just taking a more proactive approach and a collegial approach. You know, some companies working or some, some divisions work in silos, and that’s really not how we wanted to do it. So we worked closely with other departments to get that buy in, and they were able to to, you know, troubleshoot and help us out along the way. So, so that was key. And so really, once we we painted out what we were going to do, then it was all a matter of executing that timeline with our Veeva colleagues and um and going from there. But I would say definitely, you know, different departments, such as quality, commercial, other folks in medical, obviously, information technology is huge, because they had to be the backbone of it, and they were fantastic. So, so yeah, that’s that’s really how we started, and then it was just execution from there. So

Garth Sundem  11:11

cross functional alignment on the fact that you are really going to do this, Alie, is that what you see more broadly from companies who are transitioning from a third party to an in house med info system.

Allie Reynolds  11:23

I do. I think, regardless of the why, replacing or making a change to your Med info model is not made on a whim. I think because of so many tentacles that it has both, you know, things like integrating a telephony system or a chat bot, or your websites, or your safety systems or quality systems on the back end, med info doesn’t live in a silo, and so a lot of times, these decisions have to be very, very cross functional, and have to get a set of of buy in. So if there is no burning platform, it requires an organization to kind of break that inertia and make a very conscious decision, and oftentimes the implementations are often long too so they have to be very thoughtful in both the why and securing the budget and also demonstrating what value they plan to get out of that shift of that model, so

Garth Sundem  12:24

internal, not only alignment, but, uh, internal buy in too. Like you have to have everyone say, this is a thing that we’re doing. Yeah. Okay, let me ask Katie how, what was your timeline from, from the realization that you had the expertise and could streamline more than the 72 hour turnaround that you were getting with a third party. What was your timeline from that realization to actual implementation?

Katie Lupke  12:52

I believe we started researching systems late in the year, so November, December, and then we went pretty quickly. We we decided to go with Veeva, you know, earlier the end of that, the end of that year. And then we kicked off the project, I believe, in February. And then we went live in it was June, I think, June of last year. So we’re coming up on a year, and it probably would have been a lot quicker if we didn’t have the device component, because the drug component was fairly simple. It was the device product quality complaint input that we had to have in the software that really took a while to customize that.

Garth Sundem  13:41

That’s amazing to me, that it was that quick, I guess. Welcome to an agile, smaller Pharma. Yes, yes, turning the barge of the large pharma that I usually hear about from Maps organizations. Well, so let me ask, did it did it work today? Yes, looking back at this transition, and do you have you wake up in the middle of the night with regrets and cold sweats over what you’ve implemented, or did it work?

Katie Lupke  14:13

It worked. It’s great, you know, it’s funny looking back, because, like I said, we hit, you know, with any project, you’re going to hit a few roadblocks that make you really think things Okay, are we doing it right? Or should we do it another way? And and we did hit a few roadblocks with our, you know, integrating that long, 10 page PDF form into our system. But I it going live, it was kind of anti climactic, because we had had, you know, we had put so much thought and effort into it proactively, and worked so closely with our Veeva partners, that by the time we went live, I remember I went to our home office, which is in Boston, and I I kept sitting there just waiting for the first medical information question to come in the system. And I kept. Looking around, like, Okay, what’s going on? And, you know, I even, I even sent myself a few test inquiries, and they went well and, and, you know, everybody was revved up about it, our it, folks, everybody. And I’m like, Okay, well, I’m just sitting here. That’s how smoothly it went. And then it just took off. So I really am proud to say that you put a lot of effort into the front end and things will go smoothly and in the back end. So we’ve been we’ve been going strong ever since.

Garth Sundem  15:30

How do you define that success? Is it in shrinking that 72 hour window is answering more med info requests, what are your metrics?

Katie Lupke  15:43

All of the above, I think initially, obviously, you know, most things revolve around money. So we came up with a cost savings formula. So we were still looking at the number of questions we got and what we would have been charged from our call center. And then we said, hey, we’ve saved this much money per month, and I do have to add that we were able to hire a full time Pharm D, and she oversees our call center. And so even with hiring her, and, you know, implementing the software, we were still, you know, close to to net neutral, just from the time we brought her in. So now it’s just we kept adding up the money that we saved. So that was the easy part, and then really just the service. I mean, I think our turnaround time has gone from about 72 hours to we answer 95% or above of cases within the same business day, which that’s huge, because that’s, you know, by the time, sometimes you wait three days, the clinician has forgotten. They even ask the question, you know, they’re, they’re on to their, you know, 20th patient from there. So we’re really proud of being able to do that. We think that the information, although it’s the same data we’re sending, it looks nicer. It’s a lot more professional from from this system. So that’s really a win. And then we’ve, you know, really ramped up our call, like, telephone call component, which has been, you know, aligned well, with having a much smoother functionality. So I could, I could keep going on all of the wins that we’ve had. The reporting function, we can get much more granular and and showing data to to the, you know, executive team. So it’s just been a huge win. I’m sure I’m missing something, Alie, but all good things.

Garth Sundem  17:35

Well, it’s funny. Katie, usually we say that medical affairs can’t be measured against financial metrics, but cost savings is one that we can actually measure against. So where, where do you go? It sounds like this is a real success story, but what are you still working on? What do you want, three, five years in the future? Where do you go next? Or

Katie Lupke  17:57

is it? Yeah, so I think, I think it’s just refining. So, so now we’ve gotten to the point where it’s working well, everything is running smoothly, but, but how can we be more innovative? So we have our process down, and that’s working very well. I mentioned briefly our telephone component. That’s more of a technical thing outside of Veeva, so I won’t elaborate on that, but I think we have some improvements to do on that end. But overall, since we have the process down, I think it’s just thinking taking a step back and thinking about how we can be more innovative. And kudos to you all. I was on your website earlier today, and you all have so many different things that that I know I need to read, like incorporating AI, you know, the different omni channel forms of communication. It’s that I think the sky’s the limit that, you know, we’re doing well, and it’s working. But where do we go, from an innovation standpoint, we’ve talked about, do we have a chat bot? Do we, you know, how can we take our existing materials and, you know, turn them into something more visual, so we could do so many things on the content side and really open those creative avenues up now that we have the process down. And obviously, who knows we may have, we may have more than one product in our company. I know that those conversations, you know, are happening. I’m not privy to those, but that would be a a growing aspect. So, so lots of different things that that make us excited.

Garth Sundem  19:27

So you’ve transitioned from what do we have to do to what could we do? Yes, that’s a neat transition. And Alie, it sounds like, I mean, obviously this is a success story. But what advice would you give to people to either replicate this success story or drive towards the individualized version of success that that companies need when they’re bringing their med info in house? What What advice do you have for folks who are doing this? I

Allie Reynolds  19:59

think Katie. We laid it out pretty well, in the sense of, if you take the time to do the business case in the beginning, to say, where are we today? From a time, from a financial from a kind of it maintenance impact, as well as some of those qualitative things in terms of manual work that’s happening with sending response documents via email and, you know, moving entering data, twice those kinds of things, if you think about them up front, make it easier to one define your requirements for kind of that first phase and measure that so that you can get the buy in to do the more advanced things you know, med inquiry as a product comes with very mature capabilities for automation and kind of reducing those manual tests. But when you’re in the first phase of a product, it’s often really hard to bite off that much. And so those come in later phases. And if you can demonstrate the success of your first phase and tie it back to the case that you made, to make the change in the beginning, it makes it easier to to kind of define that path forward.

Garth Sundem  21:14

Okay, so the planning that you put in in the beginning and the alignment and the people and the organizational buy in the business case, it sounds like front loading your experience, as opposed to launching your in house, med info next week and building the plane while you fly it, you would say that planning, planning, planning creates success. Is that right? Alie, or am I putting

Allie Reynolds  21:38

that is yes and and navigating the change and being realistic, especially, you know, in large pharma, where there are many different products and many different people involved, oftentimes in the initial kind of go live hyper care phases, it can actually be a bit slower in terms of people working, because they’re just getting used To a new way of working, and that’s okay. And so being realistic about what it means to make a fundamental change and having some grace for that initial kind of go live and hyper care phase, I think, is also really important to not have a new pressure on an area that needs to make sure that things are really

Garth Sundem  22:23

accurate. And also an interesting balance, because you’re saying to the organization, this is going to be so great. We want to do this. We’re going to get down to a 24 hour response time. We’re going to answer, you know, three times the number of inquiries that we could have previously. But you don’t want to over promise it as well, right? And you need to say there are going to be some months of of learning as we as we put this process in place. Katie, any other advice from you? Maybe for small pharma or for biotechs? Think it’s

Katie Lupke  22:56

just, you know, talking about building the plane as you fly it. I feel like that’s a lot of our small company motto, whether we pre, you know, prep for it or not. But I think that obviously the organization is key up front. But then also, you know, it’s okay if you don’t have everything figured out the first go round. You know, I, I remember when we were playing, you know, when we were deep into the software building with Veeva, sometimes you don’t know how it’s going to look on the other end, but that’s okay. You can always go back and adjust it’s getting to the point where it’s functional and it works well, and then you can go back and fine tune at a later date. So it’s, I would just say, you know, my boss always says Perfection is the enemy of good. And so I really kind of use that mantra when with this system, is that, you know, it’s a great system, but it’s, it’s easy to get caught in the details when you’re in that, that software build phase. So I would just say, Allie, use the term grace, you know, give yourself some grace as you’re as you’re building it, and knowing that you know it’s not life or death, and you can go back and and make modifications.