Peg Crowley-Nowick 0:39
Welcome to the first season of Medical Affairs Unscripted. I’m your host, Peg Crowley-Nowick, President and Founder of Zipher Medical Affairs, a full-service consulting firm. During this podcast, we’ll explore a range of topics related to the strategic role of Medical Affairs from the perspective of industry experts. Through these conversations with our guests, we will share firsthand experience to provide the listener with insights and knowledge about the evolving role of Medical Affairs. Please stay tuned at the end of the podcast to learn more about Zipher.
I’m really excited today to be joined by John Walsh, who is the Senior Vice President at Ardelyx Inc, and has been someone that I’ve worked with over a number of years. And today we’re going to spend some time talking about launch operations and what it means to really be able to not only plan for a launch, but then manage that launch as you’re going through the preparation and following the actual launch of the product. What that means from a visualization possibility from the leadership perspective, what it means from a communication standpoint, and how you really manage that on target on time, on budget aspect of the launch operations. But before we get started, I’d like to introduce John, and talk a little bit about how you became involved in Medical Affairs.
John Walsh 2:16
Great, thanks Peg. First, let me start by saying I’m really happy to be here with you today. I’m looking forward to the discussion. Yeah, I’ve been in Medical Affairs now for about thirteen and a half years and like many people in our industry stumbled into joining the pharma industry somewhat by mistake. My interaction with pharma typically had been while I was in clinical practice, with some of the sales representatives and with some of the medical science liaisons over the years, and I really thought that I would start a medical career and practice and continue and finish my career in a typical medical role. But one of the things that I really had the fortune of doing, I practiced family medicine and prehospital emergency medicine, and I had the opportunity to do some work with a number of different companies in multiple different ways. And while doing that, both on the research side, as well as on some commercial advisory work, I had the opportunity to meet some colleagues at one of the companies and really became intrigued with what the industry had to offer. So, in discussions with them, I had really expressed an interest at some point that this really sparked something that could be a passion for me. So, through those discussions over years, it became obvious that it was something I wanted to shift gears towards. And actually, one day I had gotten a call from a colleague asking if I still had interest in potentially joining the industry and hopped in as a Medical Director at a pharmaceutical company where I began my journey. But to me, it’s more than that. It’s really more about what we can do to help patients right as a physician, I took the oath to help patients above and beyond everything. And it’s great when you’re one on one with a patient. And it’s terrific to be able to help treat them and help improve their life. But it’s also really terrific when you’re able to do that on a mass scale. So, when you’re able to work in this industry, and you’re able to help physicians, payers, providers all really understand medicines, and help bring them to fruition through the development process. You realize you can help an extraordinary number of people as opposed to just a few at a time. So, for me it was great shifting gears, and I don’t think I’ll look back. I do continue to treat patients today. I love to do that. And it’s something I’ll probably not give up because it’s a passion of mine. But it keeps me grounded in what I do day to day in my Medical Affairs role.
Peg Crowley-Nowick 5:01
John, how does the fact that you’re still treating patients and the fact that you did family medicine — Does that give you a different perspective on the patients because of the type of medicine that you do? We focus a lot on oncology and see patients in the oncology space, but you’re on the boots on the ground with patients who have a broad potential of disease indications. How does that impact what you can do in Medical Affairs?
John Walsh 5:30
Sure, I think it’s very interesting in that family medicine, as you know, crosses all different genres, right? So, we see all different patients from a holistic perspective. So, when we see one patient using oncology, for instance, as an example, we may see a patient who has a particular cancer. But we’re also managing all of the other things that go along with that. So, we see how all of the medical conditions intersect and how they interplay. We see how all of their medicines work or don’t work together. We also have the opportunity to see the family as a whole — And how does their social environment impact their access to care? Or how does their social environment impact their ability to be able to deliver on their own care? So, for me, it’s really interesting. And then, as I mentioned, in the emergency medicine side, we see that in snippets, but when people are in crisis, so as I see patients in urgent care, you also see people sometimes in their worst of conditions under the most stress that they can. And you see how those dynamics impact things. So, you can have a patient, for instance, who has a particular cancer, but they’re coming in because they were just involved in a multi vehicle car accident, or they are now having a myocardial infarction or having a number of different things, but you still can’t disregard the fact that they have this cancer. So, for me, it really gives me a holistic view. So, when I sit down with any particular company that I’ve worked with, I think about the patient as the whole, right. So yeah, I get the disease state that I’m working in, I understand what we’re doing. But I’m also looking at it a little bit more broadly, to say, how does this impact the remainder of this patient’s life? And try to keep that into account? It keeps it very real for me, by being able to see patients and then bring that to the work that we do.
Peg Crowley-Nowick 7:32
I’m going to go off topic just for a minute. But from the perspective of family practice, emergency medicine, do you think enough of the physicians who practice in those areas are engaged by pharma for advice or for communications to really understand the holistic aspects?
John Walsh 7:49
Sure, I think probably not, in general. But let me speak about that for a minute. I think that in our industry in pharma, there are some areas that lend themselves to be primary care, and much of our industry has very much gone towards a specialty focus. So, I think over time, the interaction of pharma beyond just a sales representative interaction has changed somewhat with primary care. I think there is a bigger opportunity to be able to do that, and to bring that in. But I also understand the constraints that our industry has right now, in being able to use the resources that we have to be able to focus on the work that we are interested in getting done. So really focusing on that specialty market in the appropriate therapeutic area is obviously the goal of what most of us are trying to do, but where possible, I’ve always tried to introduce some thought about primary care. As an example, at a few organizations that I’ve been with, where there’s been this close intersection of primary care, I’ve really encouraged us to do programs with family medicine and internal medicine, advocacy groups and professional organizations as a way to kind of keep those folks looped in to what we’re doing because it’s really important that the primary care physician as well be aware of the therapeutic specialties and what’s happening.
Peg Crowley-Nowick 9:20
Absolutely. So great education opportunities. Also, from a safety perspective, understanding how everything mingles together and, and comorbidities plus, all of the different co-meds can make such a big difference. An exciting career that you’ve had, you’ve been involved in a number of launches, some pretty big launches. And that’s really part of the reason that we’re here today to talk but I wanted to just take that one moment and ask the question I ask of everybody on my podcast is what was the aha moment for you that led you into Medical Affairs?
John Walsh 9:53
Sure, absolutely. So, in my first role in industry, it was working in the therapeutic area that I used to see patients in on a regular basis. And I often talk about an interaction where we were trying a drug and a device that were used together. And much of the way, we were thinking about that drug device combination and how we explained the use of that to the external world was very interesting to me. And part of it was how that device worked well with the medicine. So, for me, I was able to take my clinical medical practice and sit with a roomful of people from all different disciplines within the company, and actually take that device and sit down with it and say, okay, let’s take the instructions that we’re proposing, the thoughts that we’re proposing in terms of our education. And I’d like you all to take this device and work through what we’re proposing that that people do with this, and tell me if we follow what we’re doing, are we accomplishing the end result we’re trying to get to, and something that was very much a paper and pen exercise became real life, right? They got to actually use the device, touch it, and work with it. And it dramatically changed how we thought about educating the patient. And that piece of material that we were working on, took on a new life. And for me, that’s the intersection where medicine really matters in pharma. And I’m often very blown away by, you know, it’s easy for us to talk ourselves into something in the same four walls. But when you broaden that, and you say, well, how does this actually interact with the patient? How does this work? You know, having that medical background and the interaction with a patient, being able to bring that to life for people is super, super helpful.
Peg Crowley-Nowick 11:54
That’s one of the reasons that I enjoy working with you so much is because you always ground everybody in the reality of medicine. And when we’re talking about either labels, or education, or how the patients will react to things, you always bring that real life to the story. And it does change the perspectives of your teams. And that’s, I think, something that’s so important as you’re getting ready to launch as you’re thinking about new products. Because not having that and not having a realistic view, it’s really easy to get caught up in the concept of what you want to do versus what can really be done. So, it’s great, great story, great explanation. So, I’m very happy that you moved over into Medical Affairs. But I think it’s also interesting that you continue to practice, and that’s great for the patients, and great for all the people who work for you who can take advantage of that knowledge. So, John, I want to now transition over into our topic. I have worked with you in the past in preparing for launch, and we did work a lot on the strategy. But today’s conversation isn’t so much about the strategy. It’s about what happens after the strategy is together. How do you prepare for a launch? How do you think about visualizing everything that’s getting done for a launch to make sure you understand the dependencies — that you can see what’s going to work? What isn’t going to work? And then what kind of things are expected of you from a communication standpoint, from senior management, once you’re, well, you’re still getting ready, but also on the other side once you’ve launched. So, I’d love to start talking about a couple of examples and what you’ve experienced. But what is important to you, as a leader when you’re thinking about the operations of a launch?
John Walsh 13:35
Sure, no, I think this is critically important to making sure that we get it right. I really think about launch overall as a roadmap. We have a starting position. And we have an end goal, right, we have a place that we would like to end up. And the most important thing if we were all setting out on a journey, and we were starting from different places, would be to make sure that we ended up in that right place. So, what I like to do is I like to think about how do we make sure that everyone is aligned coming into the launch, so that we don’t end up in the general vicinity of one another. But in fact, we end up at the same place that we all intend to be. A great example I like to give is, I use this often, is that if we all left different ports in the United States and said we would meet in England, for instance, we may all end up in that country, but we may all end up in different marinas. In fact, we can do that by city and still end up at different marinas. So, we need to be very specific. We need to be specific of when we’re leaving, how we’re going. How do we get there? Do we measure along the way that we’re actually headed to the destination that we’re intending? And then when we get to that destination? Are we sure we’re in the right place? And do we have what we need? And it’s not always about being spot on because I don’t think anything in life goes 100% perfectly but I think being able to keep an eye on it as we go and measure our progress is really, really important. Because it sets us up to end up in that right final destination.
Peg Crowley-Nowick 15:10
So, in Medical Affairs where you have multiple functions playing a role, sometimes siloed, sometimes all under your leadership, oftentimes in a matrix, what are some of the things that you do to bring the team together and to get them on that same roadmap?
John Walsh 15:28
Sure. So, I think like anything else, I think thorough communication is critical. So I think starting off by agreeing what port we should end up in, right, what is the strategy that we are aligning to, and I think in multiple companies, I’ve seen this done in different ways where people take verbatim word for word strategies or strategies that are resonate with one another in different buckets, I think we can all argue the pros and cons of some of those. But irrespective at the end of the day, making sure that we’re fully aligned on what the strategies are, so that we can build those tactics as a way to ultimately achieve the strategy is that critical thing, so making sure number one that we’re most aligned. And then number two, is that not just one function, or one person or one silo, unfortunately, we need to measure our progress and report off to one another, so that we know where we are along the way, as it’s appropriate. To be able to say this is how we’re progressing towards that goal. This is how we are eventually making it to the port that we choose to land.
Peg Crowley-Nowick 16:37
Within that are the dependencies. So, for instance, publications, having an actual manuscript that is published, impacts your ability to talk about the data in different ways. And if others are waiting for that to come, you need to know that things are happening on time or not happening, you need to understand all the dependencies across your function in order to be ready for what’s coming from a research perspective need to understand when those key milestones are coming, what the focus is for Congress’s Who are your thought leaders, all of those pieces have to tie together. And it’s not always easy to see that because these are pretty complex roadmaps when you have so many different functions playing into it. I know that you and I have worked together on dashboards and visualization tools. Could you talk a little bit about how you’ve used an Operations Dashboard to guide your team and, and also talk a little bit about the cadence of, of the meetings that you have. So, we can see how those tie together?
John Walsh 17:42
Sure. So, as I mentioned, having the ability to understand where you’re at on the map, right, and understand where you’re progressing is critically important. And one of the ways that I found most successful was actually a project that we worked on together, where we sat and said, okay, here are tactics that align to our strategies. Now, let’s take each one of those tactics and break them down into the very stepwise pieces of what needs to happen in order to really accomplish that tactic. And then put that into a tool that allows us to measure it against a timeline. So that any moment in time, we could just draw a line down that Gantt Chart tool, if you will, and say okay, where are we at, relative to where we think we should be at and are we ahead or behind. And I think any launch the entire organization is acutely aware of what we need to get done. But also, where are we at relative to where we need to be. So, we’re able to then take that and put it into a very tangible output so that people can see that. So then taking this tool, and ultimately creating a dashboard that we can share at a moment’s notice, to be able to say what’s on target, what’s on time, what’s on budget, and be able to present that in a very cohesive, straightforward, understandable, crisp way is super, super important. And I think it’s really made, you know, some of the launches that I’ve worked on, super, super successful, because we’re able to be accountable for each one of the tactics, it’s so easy, when you have a myriad of different things happening to focus on the one thing that’s really the issue that’s burning at the moment and lose track of the 10 other things that are happening in the background so being able to have that constant view and see where all the votes are in the water helps us all then get to that location.
Peg Crowley-Nowick 19:46
So one of the things that I enjoyed working with you as we went through the those lists of tactics, no, we have so many different groups coming up with what they’re going to do and how they intersect, but you were able to very clearly and right rapidly go through that document and decide what are the priorities if we miss on this one. So, you could, you could find the top one or two priorities across all of the functions to make sure that people were also focused on the most important things, and that those rise up to the top. So, you’re always keeping that in the front of mind, even though we know that there’s a lot of things everybody’s working on. But if we miss on these two or three things for each group, then the launch isn’t going to be as successful. And not everybody does that. They don’t always take the time to think about it. What are the absolute priorities here? And I would imagine that that makes it easier to talk about later to senior management, or also even just to lead your team, because you never take your eye off of the most critical pieces while still paying attention to all the other parts.
John Walsh 20:48
It really well, you know, understanding what our priorities are, are key. So, I was mentioned at the team, and we’ve talked about this plenty in the past is — what are those top, let’s call it three to five things that we just absolutely, positively have to get right? That if we don’t get those top three to five things right, we’re never going to be successful. So, we should be measuring those with intensity. I think one of the things that your team introduced us to, which was really helpful in our launch plans was the concept of, of signature activities. And I think often, those turned out to be some of the priority things. So yeah, some of them were kind of the cool, innovative, really different ideas. But also, we bucket it in there — what do we have to get right? And that’s what our signature was? And let’s face it, when management is asking, where are you, in relation to accomplishing your goals for launch, you can’t go through the entire laundry list of everything you’re doing. And frankly, in most cases, they don’t care. They don’t have time to understand every little gear and how it turns. So, for us to very crisply be able to say, you know, these are the top things that we have our eye on all the time, every time. Yeah, there’s a bunch of things happening in the background, we could take you through it. But if we focus on these things, we know we’re gonna get it right. And here’s where we are.
Peg Crowley-Nowick 22:13
Yeah, absolutely. And the truth is, it didn’t take that long to put it all together, it seemed I can’t actually remember. But once the strategy was in place, it seemed like it was a few weeks and a little bit of time with you. And then it’s just about managing that and keeping it and getting the rest of your team to believe that this is important that you’re using it. Because we oftentimes see companies, they put this together and put the dashboard together, but they don’t see leadership using it. So, after a while they stopped reporting into it. But you also used it in your team meetings and used it to bring forward the challenges that they were facing, rather than talk about every little project or talk about whatever project was top of mind for your functional leads, you were able to focus your meetings is what I remember. Is that, is that how you were thinking about it using it to be made and maybe be more effective in the meeting setting?
John Walsh 23:04
Absolutely, I think, you know, putting that dashboard together, the old expression of Measure twice, cut once comes to mind, right? We did take a little bit of extra time in the beginning, although it wasn’t terrible to really break those tactics down into minutiae to be able to get that dashboard together. But it’s one of those moments where if you will slow down to speed up, you invest a little bit of time, but then moving forward, it keeps us oriented. So, so you’re exactly right. So, our team meetings, we would start off with kind of a review of the dashboard. Where are we? So that we knew and at our local team meetings, meaning those within Medical Affairs, we would kind of use the expanded dashboard, if you will, that was broken up by functional area. So, we knew, for instance, where the publication’s team was, we knew where we were with our IoT program, we knew where we were with making sure that we had all the right pieces in place for KOL engagement. And I could go on in all the different areas. But at the end of the day, we use that as an overall. And we started with what are the top three to five things that are super important. And then we went to each one of the groups and they were able to use that dashboard as a way to create a framework and to keep us all prioritized to what everybody’s doing. Then we went to larger meetings. Obviously, as we went up a level in management, we would take those and make them fit for purpose for those meetings as well.
Peg Crowley-Nowick 24:35
John, I’m not sure, I can’t really remember if in yours you had a couple of top insights also that you covered at the beginning of the meeting so that you could also think about whether this changes anything that everybody’s doing. Those were brought in from many groups, but then it was agreed upon what the top three were, and then you evaluate that — is that correct?
John Walsh 24:57
Yeah, absolutely. I mean, I really see Medical Affairs as a bidirectional flow of information for our company, right? So, we’re bringing information and, and important facts and support out to the medical community. But let’s face it, we need to listen to what’s happening around us. Like I said earlier, we can talk ourselves into anything in the same four walls. But it’s really important that we focus on the patient. And when we speak to the key opinion leader community, and we speak to patient groups and advocacy, we learn. And if we don’t bring those learnings back in, we can’t fine tune to really bring the best that we can bring to patients. So, you’re exactly right. Yeah, we led insights, also, at the start of our meetings as a way to really orient people. — Are we doing what people are expecting? The need to be? Or are we meeting the needs? Or are we not necessarily paying attention? And we need to sync, right?
Peg Crowley-Nowick 25:55
Right, right. And how about as you move closer to launch, and, you know, my favorite is, “I need reporting every week,” or “I need reporting every day.” Some leadership wants to see it every day after the first day of launch. And then finally, you get to week and then month, and then eventually it slows down. But that’s the high tension point — In those weeks leading up, in the day leading up, and what you’re going to do on the day of launch. Those things are always on top of mind for senior leadership. How did this help you? Or how did you use this as the way for, for, I think, organizing your thoughts and your ability to communicate?
John Walsh 26:34
Yeah, so as an organization, we agreed on what that cadence should look like. And I think in each of the organizations I’ve been with that cadence looks somewhat different. I don’t think that’s really a revelation. But different companies want information in different ways. But for us, I think setting expectations on how we were going to deliver the information was critically important. So, we were able to let the organization know what data we had available at our fingertips that we would be able to report on the cadence that was needed. For us that became the dashboard. There were times we made a few tweaks to the dashboards that were able to meet the needs of other parts of the organization who wanted to know certain information. But frankly, because it was so straightforward, we were able to just draw the line. At that moment, as I said earlier, and pull up that dashboard, vet it, make sure it’s accurate, and be able to put that in a very rapid-fire way of presenting the information and meeting the needs of the overall launch steering committees.
Peg Crowley-Nowick 27:36
And as you’re moving forward now, and looking at other launches, are you incorporating this kind of process? Is it feasible for smaller biotech companies to incorporate this into their planning?
John Walsh 27:51
Absolutely, I think so. I think it’s critically important, I think it can be from an operational point of view, I think it can be done in multiple different ways. Frankly, I really very much liked that dashboard approach that we used in the past. And our teams are working towards making sure that we have dashboards that will be available. Because I think irrespective of what the ask is outside of the Medical Affairs organization, we need to be looking at where we are making progress within our organization. And if we’re doing that well we can satisfy the needs of the organization in terms of what their informational needs are as well. So yeah, it’s absolutely critical that we make sure that we continue to do it.
Peg Crowley-Nowick 28:36
Excellent. Any nuggets that you might have about getting ready for a launch? You’ve been through it enough times? Are there things that are your take home thoughts on launch readiness?
John Walsh 28:49
Yeah, no, I really appreciate that. I think, to me, the most important thing is really listening to the community in that pre-launch period. I will tell you that anytime that I worked on a launch, and we really truly deeply listened to what was happening in terms of feedback and insights. And we addressed whether it’s a concern, or whether it’s something that helped propel a brand forward when we had a true understanding of what that meant, and we reacted to it. And we built our actions based on what the community needed wherever we possibly could. We were as successful as possible. Anytime we didn’t go out and seek that feedback, or we thought we sought the feedback, but it wasn’t quite on the mark. We weren’t quite as successful. So, to me, it’s about meeting the needs of the ultimate customer. So, for me, it’s patient – payer – provider, right? If we understand what those three groups need, and we know it well, we can then build the things that are important to them while still accomplishing the overall strategy and goals of the company.
Peg Crowley-Nowick 29:59
Great. Great points. And also with those points, the information, the insights that you get to prepare you in that way, come from everybody on your team. I talk to a lot of people, and they think that it’s all about Field Medical. But in reality, almost everyone on your Medical Affairs team, each of the different functions are engaging with thought leaders, they’re engaging with patient organizations, they’re engaging with HCPs, who may be treating your patient population. And if you bring all of those insights together, it makes a difference, rather than just looking at it from a field medical perspective. So, it’s a great piece of advice.
John Walsh 30:37
I think that’s spot on, Peg. I think one of the other things, too, is we can even broaden that to say, it’s even beyond medical, right. So, when we go to a launch steering committee meeting, and we may hear our commercial colleagues bring in a piece of feedback that they’ve heard, or our senior management was at a meeting with, you know, whoever, and they’re bringing back feedback, I think it’s really integrating organizational wide feedback into what we do. Obviously, we integrate that in a very medically specific way. But hearing what’s happening, does two things. One is obviously, it makes sure our plans are inclusive of all the potential leads where we can, but it also is a great equalizer if you will, right. If one organization is only hearing one thing, and the other part of the organization is not hearing that same thing, what’s the disconnect? Why is it happening? Are we saying different things? We’re meeting with different people? Are there different audiences? And how should we solve for that mismatch? And what we’re hearing, right,
Peg Crowley-Nowick 31:36
The validation piece is so important.
John Walsh 31:39
Peg Crowley-Nowick 31:40
Yeah, I always think of it as we’re all scientists. So, we have a hypothesis because we’ve heard all of this information. Now let’s go validate and test that hypothesis and see if we really have the right insight, or we’re just missing it.
John Walsh 31:52
Yeah. So true.
Peg Crowley-Nowick 31:53
That is so important. Well, John, thank you so much for your time, this has been a great conversation, I think it’s so critical that we see that this is all about a program. And the tool, which is the dashboard, is just one piece of the way you can use it to help guide your team to bring leadership to Medical Affairs, and to allow you to have instant access to what’s happening in your launch preparations. I think that there’s a lot of pieces that go into a launch plan, and simplifying those so that in a leadership position, you can see it quickly and easily and have the ability to communicate on it is so critical. And you’ve really given us some great examples of how you’ve incorporated into your planning and into your team activities. And so, I really appreciate your time and your thought process on this.
John Walsh 32:44
No, thank you, Peg, I really appreciate the time as well. And look, I have to be honest, I also really credit a lot of the organization that we did on a few of these projects to your team as well, and some of the innovative ideas that your team has brought to the table. So, I wanted to thank you for that. And most importantly, thanks again for the opportunity to speak with all of you today.
Peg Crowley-Nowick 33:05
It was great to see you and to have a chance to have this conversation. Have a great day.
John Walsh 33:10
Thanks, Peg, you as well.
Peg Crowley-Nowick 33:20
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