From Chaos to Confidence: Mastering Pharma Launch as a First-Time Team with Andrew Mooney and Laurence Cooper, Launch Excellence Experts at Lumanity

[00:00:00] Hello everyone and welcome back to the Outcomes Rocket. I'm so excited to be hosting a series of episodes with the team at Lumanity. Today, I have the privilege to focus on a topic that is on the minds and agendas of a lot of small companies out there with limited commercialization launch experience. They're finding their way in this fast-changing pharma market. And while we're going to cover medium and large companies, I'm going to cover medium and large companies.

[00:00:36] in our series with Kirstie and Jeff at Lumanity. Today, we have the privilege of hosting Laurence Cooper and Andrew Mooney, both launch experts at Lumanity. Welcome to the podcast, gentlemen. Thank you. Nice to be here. We're going to be covering this very interesting space of launch in pharma for these small companies. You know, Andrew, let's get into this. What kinds of challenges are these companies facing as a

[00:01:06] as they approach launch? Before we go into individual challenges, I think we've got to just, you know, recognize the enormity of launch as a total challenge. It's, you know, it's so big, so multifactorial that I think a lot of smaller organizations who haven't done this a number of times, they look at it and there's that anxiety of, you know, how do I approach this thing? Because the stakes are so high.

[00:01:34] Everybody knows how long it takes to bring a product to market. The development costs that take, you know, maybe 2.4 billion, I think is the latest number I read. So with that, all sitting on your shoulders and the leadership attention, market expectations, you know, you can get a little paralyzed by indecision. And there's that nervousness of you don't know what you don't know. So what am I missing?

[00:02:02] And so I think that that is kind of a lot of people, you know, it's the deer in the headlights kind of thing. Their eyes get wider and wider and it's kind of what do we do here? So I think it's the enormity of the challenge that is the first thing to kind of get people through so they can start, you know, gaining some momentum.

[00:02:22] Yeah, it's a huge challenge and there's a lot at stake. And without that launch history, you know, and those established frameworks, how does a company with limited launch experience approach the challenges of launch? So, I mean, frameworks are good word to use. We have a sort of a very high level. We have a framework. We call the five fundamentals.

[00:02:46] And of course, we're talking about smaller organizations, you know, with less commercial commercialization experience here, but it's equally applicable across all sizes. And we split that up into five things. The first one of those being a robust and ambitious strategy, and that needs to be, you know, insight driven, data driven decisions that set that ambition and set the direction for the launch in the organization.

[00:03:14] The second one we look for is a launch process and governance. And this is important to keep the momentum, make sure decisions are made in a kind of timely and an efficient way so you can move forward at pace. Thirdly, organizational alignment, belief and culture. And is this kind of very stressful situation, which is launch, these things can really take a battering.

[00:03:41] So setting up that for success is going to be super important. Then there's team capabilities and engagement, making sure you have the right cross-functional mix. You've got the right size to plan. And probably we should talk about that a bit later as well, because we're talking about smaller organizations. So, you know, you can't set up like big pharma if you're not big pharma, making sure the plans are sufficient but achievable size.

[00:04:09] And then lastly is about right size and timely resourcing, making sure you have the right skills and capabilities early enough so they can have the maximum impact. So those are kind of the five things that we look for, the five fundamentals. And we can put a PDF in the description if that's useful for the listeners. Yeah, that would be fantastic. Yeah, Laurence, please.

[00:04:36] No, no, I was just going to add, because again, those are the five fundamentals. But I think when you are a first-time launcher or you're still launching your first few products, right, a couple of those are almost the bigger hurdles. And it's those last two, Andrew, that you mentioned, right, the team capability build. It's very easy to say, oh, we'll just bring someone in, right? Like it won't take long. It takes time to bring people in and get them building that and spreading that culture, right, within an organization. It takes time to get the experience as well.

[00:05:04] So you're kind of trapped either way. You can't build up the experience very quickly. You have to bring people in, but you still have to fit them to the culture. And I think that is where when you're talking about getting the right sizing and the resourcing sorted, that's where acknowledging where you need a little bit more external support is always such a valuable activity to do. It's not necessary for everything, but there are going to be certain gaps you want to have filled more so than others. And that's going to help you scale efficiently.

[00:05:31] Yeah, there's a lot of really good stuff happening here, guys, and good frameworks to think about this. You mentioned ambition and strategy as a fundamental part of the framework. What's realistic in terms of launch ambition and building a robust strategy for first-time launch companies? I mean, I can take a stab at that one, Lawrence. I think strategy is a small word, right, but it's a very big subject.

[00:05:57] And humanity, of course, is a big part of how we drive our business. I think when you're looking at smaller companies, though, I think the thing you can't compromise on, despite the size of the company and being a first-time launcher, and that's insights. Your strategy has to be driven by what we describe as decision-grade insights, whether it be the payer, the patient, or indeed the prescriber.

[00:06:23] It's about understanding how the patient moves through the journey, who they interact with, what they're searching out. All of those things we need to know about. We need to really then use that data to come up with a simple strategy that's compelling. For us, it's perhaps a cliche or perhaps a world-throden road, but the where to play and how to win is a very useful construct to think about strategy.

[00:06:51] Because then you can think about what is an ownable segment or a segment where we have a right to win with a differentiating strategy against what may be quite a lot more established or bigger players. So that would be kind of where I would start off with in terms of strategy. Lawrence, anything to add? Yeah, yeah. Just probably build on exactly that last piece you talked about, right?

[00:07:16] It's understanding and establishing that winnable segment and then being very explicit about why you're picking that segment. We know that teams are going to come in. You know you're going to have a smaller team. Be clear about why you're targeting these specific spaces and why you're not targeting others. And you can justify it, right? You can talk about how you may have a more limited team size budget. You also have to acknowledge that people are going to be wearing multiple hats, right? This is in big pharma.

[00:07:44] You can have lots of dedicated functions to do a lot of dedicated activities and deliverables. But when you're a smaller organization, you're asking the team to an individual team members to quite often wear multiple hats and deliver in multiple capacities. So mapping those roles out and then mapping them to those segments and that where to play and how to win is just really critical.

[00:08:07] So I think the word focus comes to mind when you're talking about being a very focused strategy that's focused on specific segments and takes into account the limitations of the size of the company, the budget, the people who are available, but still aims to win in the segment that you're aiming for. And being explicit, if you like, in the things that you're choosing not to do, which is what strategy is all about. Yeah, that's fantastic.

[00:08:37] You know, one quote that we love is that noise is the tactics are the noise you hear before the war is lost. And having that strategy, right? What you focus on and what you don't do, as you mentioned, is so key. So how can organizations create that belief in this ambition? And in particular, across those functions and geographies without prior launch history?

[00:09:04] Yeah, and I think this is a really nice one, one that I'm quite passionate about as well. But you've got to get the team in the right space and the right headspace, importantly, to deliver. Yeah. So when you're talking about that first launch, there's so much energy, there's so many excitement, right? And even some urgency. There's a lot of intrepidation as well, right? So you've got a lot of emotions flying around launch teams as they're moving into it, just like any team that's embarking on one of these China Office projects.

[00:09:30] You have to capitalize on the positive ones, you know, capitalize on the excitement, capitalize on the urgency, and really put the focus on that. If you can bottle that and kind of continue to sort of distribute it throughout, right? You're going to have a lot more of success. The only other thing that I guess I would call out is as you're bottling that and as you're distributing, well, it's got to be distributed by the leaders, right?

[00:09:53] So those leaders, it's on the leadership to model the decisiveness and the transparency, the momentum, the excitement, and really do whatever they can to facilitate the team's movement through. I think that's kind of what jumps out to me most of all, is how you kind of create that belief, is get the leadership, getting the right communications, and putting on all those really positive emotions that comes with the delivery.

[00:10:16] I don't disagree, but I would caution that, of course, creating belief is one thing and keeping the belief is another. Look, because, and I feel like I'm the negative guy talking about all the challenges here, but it's, you know, there will be tough times. That's great, guys. Yeah, both of you bring some good points to the table. Get that belief going. And then what kinds of challenges are these companies facing as they approach launch?

[00:10:43] Well, I suppose before we get into specific questions, we've just got to recognize the enormity that is launch, right? It's huge, and there's such a lot of pressure on everyone's shoulders. You know, leadership attention, market attention, just a million and one things that you feel that you need to get done. You always feel that you're behind. You always feel that people are sort of checking in, making sure. So, I mean, I've been in a crisis meeting.

[00:11:12] I think that's probably the right term for it, where a cross-functional team was essentially close to tears. I mean, there may have been some tears as people were sort of unloading the strain, the stress that they've been under as they've progressed through this launch. And they were talking about, you know, the impact on their personal lives, the work-life balance, missing their children, missing their wives. I mean, missing their husbands. It was full on, you know, and... It's real.

[00:11:43] Yeah, and that was actually in an organization which is a bigger pharma organization with a lot of launch infrastructure, a lot of processes established already for them to lean on. And yet, it was still that situation. And those things should really be avoidable if you do things in the right half.

[00:12:03] And I think it's, you know, frequently, purposefully kind of recontracting with your teams and sending them in, reminding them of why we're doing what we're doing is going to be important. And often overlooked. There's always going to be moments of stress. Don't get me wrong. That's part and parcel of launch. But it shouldn't be relentless like that, where it gets people to that stage of, you know, near burnout.

[00:12:31] So I think that that's the first thing to notice is that launch is a really pressured situation. And then when we talk about small organizations or first-time launches, companies with minimal commercialization experience, then you could kind of, you know, magnify that a little bit as well. Because there's still so many things to do, but less budget, less people.

[00:12:58] You're up against the big guns as well, perhaps, when you're launching. So you have to outsmart the bigger competition. The challenges are just, you know, multiplied. So I think that you have to kind of really think about how do we approach this and break it up into some constituent parts. This is hard stuff. People live this. And, you know, divorces happen. You know, people get sick.

[00:13:27] They go see a psychiatrist. Like, this is real stuff. So I love it. That was raw. What are the fundamental tools and approaches that a first-time launch company must put in place to successfully deliver on their launch ambition? Well, I'll keep moving with the positives and then Andrew can come in with the rest. He's a negative guy. We need both, right? We need both. To be honest, I'll probably filter in a couple of tripping hazards actually here so that we can maybe switch roles a bit.

[00:13:55] But I think Andrew's already talked about the governance model, right, with defined stage gates. So just knowing essentially who is making the key decisions, who you're running that path, where that sponsorship is, and making sure there's a very deliberate pathway on how those are delivered. That's step one. I would also call our critical path to launch. Now, this is one of those tripping hazards that I think we see quite regularly, right, Andrew?

[00:14:19] Which is, it's very easy to say we have got a launch timeline and we're anticipating to launch by, you know, June 2028. But when you then go and look, and we've worked with teams before, when we've then looked at the critical path, and maybe let's say they're just 12 months out from launch and we're looking through the critical activities that need to happen, not would be nice to happen, need to happen for the launch to occur.

[00:14:45] And we're spotting items that are completely out of the team's control that are just now going to be impossible and will not allow for that June 2028 delivery. And these are timelines that have been communicated to boards of directors, leadership, whatever it may be. And already, there's no way you're going to hit them. So importantly, using your critical path to launch, mapping out what that looks like early on. And I think early on is one of the really critical points.

[00:15:13] So that you can anticipate, you can set out what your base case scenario, and if you can bring it forward, fantastic. But importantly, not getting caught out at those sort of later points. It's much better to have that critical path identified at L minus 36, et cetera, or far earlier, rather than finding out L minus 12 that you're just not going to be able to make it, regardless of what you do. And then finally, what I'll add in, and it links to the critical path, is making sure that you then layer onto the critical path that integrated cross-functional plan.

[00:15:42] So the much more detail who is doing what, when, and how. And importantly, capturing that plan in a single space, a single source of truth, and not having it distributed across seven different spreadsheets in five different personal folders. I think that's some of those key tools that if you can get right, it's going to set you up for success. Yeah, I think on the integrated launch plan, I mean, that's so key when you're talking about small launch teams that are having to work together. You talked about multiple hacks earlier.

[00:16:12] If they're not coordinating and collaborating effectively, then they're really not getting as much bang for the buck as they should be out of the people resource, which will be limited. So I think that's super important. If I can just go back to the critical path one as well, I would just layer onto that, that always works your best case scenario, best case timing. Because then if there's a delay, you can use the time.

[00:16:37] Whereas if you've been conservative and things come through quicker than expected, it's very hard to catch up. So that's just a sort of a philosophical approach to critical path. Of course, you'll still need to have a base case and a worst case that you can track to as well. Other than that, I'm going to say that sticking with the idea of best case, worst case, thinking about scenarios, thinking about risk management plans, what could happen?

[00:17:06] What are the unexpected or events that might happen out in the marketplace that we need to be ready for? It's not part of the base case plan that you're tracking towards, but what are the likelihood and impact of various different events? What are the mitigating plans that we want to put in place? Thinking about that upfront means that there's going to be less fire drills, less reaction down the road.

[00:17:32] You'll be planned and sort of you can approach it in a more level-headed way, which is quite sensible. Cool. And then I think no one likes being measured right. Let's just say it. No one likes KPIs. So I think people feel judged and who puts their head up and says, yes, I like to feel judged. But it's not about being judged personally. It's about understanding where's the risks for the launch, where's the performance gaps, what do we need to do differently,

[00:18:00] or what do we need to turn up or turn down to make sure that the market is primed and ready on day zero so that when we launch, we get the trajectory that we need. Because we all know that if you don't get the right trajectory in the first year, only a very small number of launches turn that around. So, you know, it's so important that we know that we're heading into a primed marketplace. So KPIs are super important for that.

[00:18:30] And people should want to do them for themselves. So I would encourage that. Just add on to that, right? The thing with KPIs is it's always easy to go ahead and try and greenwash everything. You have to be realistic with your KPIs as well, right? You need to make sure that you're being honest. And so when you do have KPIs, if something is red, call it out as red. Do not try and just assign it in amber or green to hide something. There's a purpose for them. There's a reason.

[00:18:57] And I've seen a lot of things, a lot of teams get a nasty surprise from that because someone's been essentially saying everything's great for months down the line, only to find out there's quite the opposite. And look, I mean, this could get overwhelming, super intimidating. And so are there any key behaviors or advantages that could give a first-time launch company the competitive edge? I mean, competitive edge versus the big boys, I mean, it's a tough call.

[00:19:25] But I would say that the big pharma, there's a lot of people, and it can be quite slow-moving. It can be quite difficult to kind of corral the troops from the various different large departments who are focused on multiple different products at the same time. In these sort of situations we're talking about, it tends to be this kind of small band of brothers and sisters that are working for each other and with each other and really pulling together.

[00:19:53] And I think they can make some fast decisions. They can move with more agility. And I think that that is an advantage. And it has to be. It's sort of the David and Goliath kind of approach, right? You have to think differently. You can't outpower big pharma. You need to think more cleverly and find your way through like that. So I think that that could be seen as an advantage. Yeah. And I think tying into it, we talked about it earlier, but you've got to keep that focus. So ruthless prioritization, what's going to have an impact?

[00:20:23] And you do have the advantage that you can, as exactly as Andrew, you were saying, right? You can't think and act like big pharma. So you've got to find new and innovative ways to do that. And you've got a team that you're close to. You're a smaller organization. Instill a challenger mindset in that team. Get them to be curious. Get them to question. And that's a way that you can find those outside-of-the-box solutions which are going to give you that edge. Some great tips there.

[00:20:48] And wow, a lot to think about, but certainly a lot of promise in how we can approach launches as new companies. What are the key takeaways for those listening to this? I'm sorry. Let's go back to the beginning. What did we talk about? We talked about strategy, right? And beginning with anchoring what you're doing in a robust strategy. That robust strategy is robust because it's based on insights that can help drive your decisions.

[00:21:15] So I think that that's important and to be realistic with what you feel that you can achieve with the resources that you've got. And of course, when we talk about resources, it's in-house resources and the broader team that you put in from vendors and support partners. I'd add belief in alignment, right? And to call out, it's a cultural thing. It's a leadership job. It's not just a slide deck that sits there saying, we believe this and we're aligned to this strategy.

[00:21:44] It has to be in the behaviors, in the communications and in the various, I suppose, attitudes of the team around.

[00:21:51] And then you mentioned it, I think earlier, Lawrence, about sort of the launch discipline, having the frameworks in place, having the launch platform in place with the one integrated, consolidated, cross-functional plan, having that kind of operating system in place with governance to make sure decisions are made efficiently and robustly. So nothing's delayed and nothing's forgotten.

[00:22:19] I think having that on board, just because it's a smaller organization or its first-time launch, there's definitely ways in which you can set that operating system up and give yourself something to lean on rather than sort of finding your way sort of in an ad hoc kind of fashion. These are some really great guiding principles, Andrew and Lawrence. I want to thank you guys for sharing this, unpacking the best approach to the market.

[00:22:46] And if somebody listening is involved in a launch and this conversation is resonating, then what would you advise? So really start early and think it's necessary, and I think it's going to pay dividends. I'm going to bring up an alternative to the crisis meeting that Andrew was referring to at the beginning. A way to avoid those tiers, a way to avoid at least some of that pressure, right, is to start earlier than you think is necessary.

[00:23:13] We worked quite recently with a client who was not a first-time launcher, but launching into a new space. And because of the diligence they put in through walking through the critical path, spotting the parts which were going to be, you know, those traps necessarily or those pitfalls, then mapping out a proper plan, the cross-functional plan, and having that consistent governance in place.

[00:23:41] As they approached launch, there weren't crisis meetings. There were, in fact, standard meetings where people were feeling prepared. Yes, there were always some additional unexpected pieces, but they always had those different fundamentals to fall back on, which meant that they were coming at it from a calm pace. We were checking in and we were finding that the team were actually very self-sufficient. They were driving it themselves. So going back, I really think it's kind of a case of start earlier than you think is necessary.

[00:24:08] So this is available to everyone with what you guys have shared, this end. And that's exciting. Yeah, yeah, yeah, yeah. I mean, with the right tools in place, you know, there's always going to be some surprises, but with the right tools in place, you can manage it. That's great, guys. I love that. Well, some great call-outs there, Andrew and Lawrence. And for everybody listening, make sure you check out the show notes for the tips that we introduced.

[00:24:37] We'll have a PDF there that Andrew and Lawrence called out, as well as a link to the landing page where you could check out all the episodes in this series on Launch with Lumanity. So make sure you check that out. And just want to give a big thanks to everybody for tuning in and for, obviously, Laurence Cooper and Andrew Mooney, Launch experts at Lumanity, for joining us and sharing their insights and expertise. Thank you, gentlemen. It's been a pleasure. I love it. closer. με