Episode 3: How to Successfully Launch an Oncology Drug – In Conversation with Michelle Werner

LSVS 3 | Go-To Market

 

Launching a pharma organization is not the same as launching an item or a product. It takes a whole different approach altogether to reach and bring in the people you want to attract effectively. So how do you do it? Pharma executive Michelle Werner is back on the show to talk to us about using the go-to-market model. Sitting down with host Gaurav Kandhari, she tells us about the nuances of preparing to launch a pharma organization—from the marketing strategy, pricing and sales strategy to support functions and operational challenges. She then shares how to approach these things proactively with the go-to-market in mind. Imparting words of advice, Michelle then lets us in on her experiences where the learning curve was steep, where she had to fail to learn. Plus, she also shows us what success for her looks like and how we can track success.

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How to Successfully Launch an Oncology Drug: In Conversation with Michelle Werner

Go To Market Approach Especially Launch Readiness For A Pharma Organization

We have Michelle Werner again with us to do the three series episodes that we are doing on the topic of the evolving world of oncology. In the first two episodes, we covered what it means for the patient for the HCP and the payer. In the second episode, we covered a more inward look at how to manage an oncology business unit, if it’s big pharma, a small pharma, or even how to stand up an oncology business unit.

We heard some good stories around counselor as a US leader and as a global leader and what the capabilities are. There were some good stories that we covered. In this episode, we are going to cover the go-to-market approach. I was going to ask Michelle that it’s okay if we cover the launch aspect of the go-to-market because we may not be able to do a lot of justice to the entire go-to-market approach. Before that, welcome back, Michelle, and thanks again for taking the time and joining us.

Thanks, Gaurav. It’s great to be here. It’s great to see you again.

Likewise. Do you agree, Michelle? Do you think we can do better justice to the episode if we cover the launch aspect of the go-to-market?

Let’s do it. I love talking about oncology launches, so this should be fun.

Let’s jump in here. Why don’t I hand it over to you? How would you introduce this topic to the readers on oncology launches? What comes to your mind?

Certain things are going to be more important. Certain things are going to be more relevant.

There are a few key things that are important. For me, it’s much about speed, agility, and keeping things simple but also making sure that you’re thorough in places where it matters. Those, to me, are the key things that I would say for any launch that we’ve done in the oncology space is where I encourage my teams to think about. How do we go fast? How do we be agile and react quickly to what’s happening in the market, especially as you’re going through that launch phase? How do you make sure that you’re not overwhelming your customers but keeping things simple and focused on what value your medicine is truly bringing and making sure that you go deep on a couple of key areas that are going to make an impact on your customer?

We touched upon this topic in the oncology world. Oncology launches are not one-off brand launches. You launch a brand, you then forget about it, and it’s on autopilot. It’s a launch happening now, a month later, another indication getting launched, two months later, the third indication and before you realize there is a line change from the second line to the first line. Let’s start with that. How do you feel about that because you’ve managed a lot of those situations?

One of the key things to think about is when you’re launching a new asset like this, think about having the end in mind even when you start at the beginning. For example, you talked about perhaps having one product launch, but oftentimes, in the oncology world, one product launch means the launch of a franchise. Because one product, as you mentioned, could go for a couple of different indications. It could go for different tumor types. It might be in different lines of therapy or both in early as well as in metastatic. You have to have that big picture in mind, even when you come out of the starting gate. That’s where you set the tone for that brand that will stick with it for the duration of its entire life.

That’s an important point that you made. It takes me back to our old days when you almost set up a design and made a deliberate effort to launch the franchise when we were thinking about one brand. Everybody was thinking, “Why are we doing separate efforts to set up a franchise, a franchisee plan, a franchisee launch, and separate efforts around the upcoming brand launches?” What are the couple of learnings that are the best practices you want to share? What is the benefit of doing that? How could the oncology leaders orient themselves around that approach? It’s difficult, right? You’re almost doing two jobs where you’re taking the accountability for the franchise as a leader but then you are also helping the marketers prepare for the brand. There’s this alignment between the two as if it’s an umbrella brand and a brand-brand. Are there any thoughts there?

I would say definitely the approaches that we’ve taken before in the past is to think about the things that can and should perhaps be done in parallel but also making sure that you’re clear about the things that need to go across regardless of what indication or patient population you’re serving with each launch for any particular asset. There are some elements that extend across. The image of your brand, the brand name, the hallmark, the look and feel, and all those kinds of things are going to be the same. At the same time, you don’t want that to be a distraction from what the teams need to do in order to be able to go deep on the customer insights that are important to make sure that you can connect your product to the needs of the physicians and the needs of the patients within a particular indication.

That’s where you’re going to have the best opportunity to help provide that information that is ultimately going to be used to decide whether or not to prescribe that medicine. It’s about figuring out what you want to be able to do in parallel, things that cut across, and what can be done in channels side-by-side with each other but then making sure that you have those connection points all along the way, so there’s enough transparency, visibility, and quite frankly, some shared accountability but still having people that are focused on the key priority areas where you know you’re going to make a difference. That’s one of the key things that I’ve certainly learned along the way. It makes the difference between having a successful launch and not.

Can you exemplify a couple of things that could be common at the franchise level, so things that we could almost have a framework for all the upcoming launches, the template, or the playbook that is common and the specific areas where you say the marketers need to do their own heavy lifting on the brand?

LSVS 3 | Go-To Market
Go-To Market: The key things for any launch in the oncology space are very much about speed, agility, keeping things simple, and making sure that you’re thorough in places where it really matters.

 

There are certainly some things. For example, patient support programs which will probably be consistent across multiple indications, how you approach certain, let’s say, payers or channels, which would be consistent across different indications. All of which can be leveraged no matter what tumor type, which patient population, or line of therapy it is that you’re going for. There are certain things when it comes to thinking about how you tie the data associated with your brand and your medicine to the actual customer needs.

A lot of the insight generation wants to go deep into what I believe is the emotional behavior that ends up driving prescription behavior when treating a certain patient type. It’s different when you’re talking about breast cancer patients and you’re talking about lung cancer patients. It’s important to understand the nuances between that. You can decide how to choose which elements of your data set or which elements about your product characteristics are going to be most meaningful for that customer when you’re talking about this particular patient population. Those are the kinds of things that you have to get specific about when it comes to each individual launch and it won’t necessarily transcend as much from one launch to the next.

I may be oversimplifying here, but it’s almost like an equalizer approach when it comes to functions. For franchise, there is a setting that you set up for diagnostics. It has an appetite. Some areas have an appetite and some don’t. Do you suggest an equalizer approach where you say that the functional element is higher for this but there is this template that we have for a franchise, but it keeps on changing and marketers should be aware of that? They should not get carried away with the franchise approach and not do justice to the brand.

It’s interesting that you use that analogy. I’ve never thought of it that way but I like it. That’s absolutely true because we know for a fact that even with the same medicine, you may have one indication that includes a biomarker and one indication that doesn’t. In this one example that you shared, this is where that second category. The thing that I mentioned that drives long success is agility. Depending on the type of indication or the nuances of that indication, certain things are going to be more important and more relevant.

You may be entering into a competitive indication in one place but less competitive in another place. That might mean that you need to focus more on let’s say, share voice and differentiation and one less of that in indication number two. It’s the same thing with what you’ve said. Perhaps in one indication, you have a companion diagnostic that might not necessarily be used across all the indications. That means we need to also be investing in what it is that we need to do to do patient identification and embed testing behavior.

You bring up an important point about being 1st or 2nd to market. How much does that play or how much should that play in a commercial organization’s mind? I have seen some leaders getting too carried away with that mindset of 1st to market or 2nd to market. They are overanalyzing the numbers to see how we can be better in a horse race. Some accept it and play it accordingly. Where are you at with that mindset and what do you recommend?

First, take a step back. Sometimes, you have the ability to influence whether or not you’re 1st or 2nd. Sometimes, you don’t. Generally, pharmaceutical companies strive to be as possibly they can. Sometimes, they make it their first. Oftentimes, that’s not the case, especially not in the oncology world where we’re in these days where you have so many different classes of drugs and many different competitors within a class of jobs.

What I would say is, I do think the order of entry to the market makes a difference. There’s no question about it if you’re first. Some things are a little bit easier but also some things are a little bit more difficult because the burden is on you when you’re first to shape the market, embed certain behaviors that might be brand new, think about how do you use maybe mechanism A over a mechanism B, and that shift can be quite difficult for some customers. How you approach that type of situation is fundamentally different than if you’re 2nd to market or 3rd market where you’re shifting instead of product A, you use product B.

The order of entry to the market makes a difference.

You’re less about shifting the behavior of what class of agent or some aspects of the physician behavior. You’re trying to swap out a place in the mind of how do you be better than the agent that came before you and ultimately be able to serve patients the best possible way. I do think the way you approach those launches and those market conditions are different but what’s important, especially when you’re not necessarily first to market, I still think that you can be a market leader. I still think that there are opportunities where first in class doesn’t mean best in class. In fact, it often doesn’t mean best in class anymore or next-gen agents are oftentimes much better than the first-gen agents within the same class.

For me, it’s important to not think about the order of entry, but more stay focused on what’s your differentiation. How are you going to uniquely carve out that space for your medicine in the minds of the customer? That’s what is the most critical. What I would say is I see it oftentimes. We don’t spend enough thinking about what’s the differentiation because that’s how you’re going to win. It’s also important to keep in mind that the differentiation for medicine can come from your attributes.

Also, your data package that supports your medicine or the attributes for your particular medicine if it’s different dosing, schedule, or regimen. It’s also in terms of the entire package that you’re bringing to support that medicine, patients who are receiving that medicine, or the support that you give the customers. Those are further ways that you can differentiate, especially in crowded fields that can help you overcome the order of entry challenges that might happen if you’re later to the market.

That’s insightful and it’s a different perspective. People do not like to challenge that. They still believe the order of entry is one of the key criteria. It’s a bit of an old-school marketing concept that people are not ready to let go of. Changing gears, let’s jump into the launch itself. How do you want to talk about it? Do you want to talk about it through the pre, peri, and post-launch thought process, or do you want to do a functional view of it in marketing and market access?

I’d rather do it in phases because that’s how we think about it from an organizational perspective. Each function has roles to play in those phases but those functions have to work together based on what we talked about in our last episodes to make sure that each phase goes according to plan. That makes the most sense for all.

Let’s jump in. Let’s talk pre-launch. You may want to slide in some of the non-oncology experience because I know we are covering oncology so let’s talk oncology primarily but there is a difference between a non-oncology prep to launch versus an oncology prep to launch. Let’s talk about that as well. Let’s hear about how we prepare for a launch and how early to be prepared?

If you take it from a global perspective, we’re talking about preparing for launches easily three years out. This is where you start laying the groundwork. You make sure that your clinical trials are designed in such a way to help ensure that you’ve got an optimal data package to support the commercialization efforts. It starts pretty early on there. From a market perspective, it’s a little bit later. It’s 24 months depending on the size and the complexity of the market or the complexity of the medicine, but that’s where it all begins.

What I’d say is the most important component of that pre-launch phase and again, it’s independent of function. It’s the insight generation. It’s all about understanding the environment and being able to know what are going to be the major drivers for making certain decisions around different treatment behaviors, etc., and how things might be evolving not with the introduction of your asset, but within the entire landscape that’s around you and how you might need to plan now to adapt to those when they come.

Are you referring to the scenario planning?

It’s the scenario planning. That’s exactly right. It’s understanding the possible things that could happen and be prepared for them but it’s the insights generation because all of those insights are what’s going to help you make decisions that you’ll then be executing on when you’re in your launch phase.

LSVS 3 | Go-To Market
Go-To Market: The burden is on you when you’re first to really shape the market.

 

This is more of a fundamental question but is there a thumb rule around how much time should we have for a reasonable launch, let’s say for a country like US or one of the top five EU that we should have this much time if you want to do good justice.

You’d like to be able to give yourself a good eighteen months in order to be able to prepare. The fact of the matter is, sometimes, you don’t have eighteen months. Sometimes, you’re operating off of a much shorter time frame for a variety of different reasons either the regulatory pathway gets accelerated for some reason or maybe you’re licensing an asset, it’s already in the late stage, and you’ve got to do all the prep work based on when you license it.

You don’t always have the luxury of time. This is where I would say the most critical thing is to prioritize. Think about the things that are important. You might not necessarily be able to get everything perfect but you want to pick and choose the things that are going to matter. I’m a marketer at heart but at the same time, I also recognize that whatever image you put on your visual aid is not what’s going to make a difference to sell your drug one way or the other.

It’s interesting because marketers love doing campaign work but at the same time, it’s not necessarily the campaign that’s going to make the difference of your launch being successful or not. Sometimes, you can easily fall into the trap of spending a lot of time focusing on getting the right picture and imagery. That’s not going to be a big difference. I’d rather get the messaging right. I’d rather focus on what are the 2 or 3 things that I want physicians to know about my medicine rather than them being able to pick out what’s on the cover of my visual aid because if they know what my medicine is all about and what the key things are to understand how to use it and why, that’s what’s going to make them prescribe 9 times out of 10 when they’re not looking at your product.

That’s almost one of the key aspects of how you can operationalize the agile principle with that and if you can prioritize at that level and let go of some of those second priority items. In the first place, identifying what is 2nd priority and 3rd priority and going with the first priority items. Pre-launch, prepping the organization, market, your customer, and the brand. What is most important to you if you were to say, “This is much more important?” It’s okay if you feel that everything is important, but at different times?

I don’t think everything is important. The more and more work that you do with your customers that you can do with your customers prior to the introduction of a new medicine is probably one of the most important things. This is why, as an organization, we invest quite a lot when it comes to our medical affairs capabilities, especially in that pre-launch phase. It’s making sure that we have investigators clinicians who are enrolled in our clinical trials that they have experience using the medicine that they’re thinking about, which patients to be using it in versus others.

When they have some hands-on understanding of the clinical benefits based on their experience in a clinical trial, this is something that’s important to give them confidence at the end of the day. The medicine is when it’s introduced. At that point in time, making sure that you’re investing heavily when it comes to your medical affairs resourcing especially in that pre-launch stage. That’s something that I don’t think that we can underestimate.

The other thing that we have to be prepared for, especially when you’re introducing a new medicine or it doesn’t necessarily have to be the case when you have subsequent indications. It depends on the country. You’re preparing your payer channels at the same time and they understand that a new medicine is coming that they have to reserve budgets in order to be able to anticipate that a new treatment paradigm might be changing. There’s work that can be done there to make sure that awareness and familiarity, and they can anticipate and plan for it on their end as well.

The other thing, I would say, thirdly but also importantly is about this market shaping component which you mentioned as well. This is where I would say it’s important to make sure that you don’t underestimate the lack of clarity in the minds of a physician about what the unmet need is in a particular disease area or for a particular patient population. All of the market-shaping or market preparation work that we do oftentimes is trying to help shed a light on what those unmet needs are. It’s to make sure that there’s awareness of what we already know exists, which is dissatisfaction in the way that clinicians are treating patients. Sometimes, we all can get complacent when it comes to having our tools in our toolkit. We know exactly how to use that. We don’t think that we need a different tool in order to be able to do what it is that we do every day.

There are opportunities where first in class doesn’t mean best in class.

The fact of the matter is, if you realize that the tools that you have aren’t necessarily working as well as you think they are, you’re ready to think about, “I’ve got to tackle this problem in a different way than I’ve been tackling before. What do I need to do? How do I need to think about that?” That’s often a lot of the work that we do through our market shaping activities and it’s important because it helps prepare people to understand where the introduction of new technology and innovation might play in the treatment landscape.

That’s helpful. I may be wrong here in articulating this question but have you come across this sentiment that you’re not going to invest too much in market-shaping because let others do it. I’m going to put my money in marketing in the promotional dollar. Do you want to reflect on that a bit?

I feel like I’ve had to come across this many times in my career. I will agree that in certain circumstances, it makes sense to do market shaping and this is especially critical when you’re first to market. It might not necessarily be first in class but if you’re the first introduction in a certain patient population, you might have to be the one that shoulders that burden and does that work. You may not have to do that, though, if you come later to the market or if you’re second in class in a similar indication. If, for whatever reason, the length of the treatment landscape has moved on as such that unmet need isn’t necessarily as critical to shine a light on.

It depends on what you’re trying to achieve and what the market conditions are at that time as to whether or not that’s going to be necessary. It’s a choice that every business needs to make to see. Is it something that could pay off that we believe there’s a need to do and that we should invest in it or if you do something like that, are you preparing the market for a competitor who might be there already? It depends on what the conditions are in the market at any given time.

This is a good segue. Do you think we should talk to move to launch itself? What does that look like? What should that look like? Is there something like a great oncology launch versus a good oncology launch?

There are definitely degrees in how successful any launch would be. The most important thing that I would say that I always keep in mind when you’re launching a new medicine is you basically have about 6 or 9 months to launch. At that point in time, if you’ve done a great job, you’ll know it. If you haven’t, you might not be able to recover again. You’ve got to be thinking about the launch. It might come from your approval or it might come from reimbursement in certain countries but most of what’s going to have determined the successful launch will have already happened. That is critical.

What I say it’s so important when it comes to the launch phase, it’s to make sure that you have your customer model. You know who your key customers are, you’ve had them prioritize, you understand who the capabilities are, and the functions that are going to be most important in order to be able to address the needs of those customers at any given time. At the end of the day, it comes down to how well you execute being simple on your messaging, making sure that you get out in front of your key audience multiple times in the early phases of your launch, and to also make sure that you’re focused on getting them to try.

Sometimes, we go through launches where you’re striving to be number one in the market. You’re focused on making sure that you get every single patient. The fact of the matter is every single patient doesn’t come at the beginning of the launch. You have to start somewhere in baby steps. I like to focus on execution that is all about building a trial list. It’s getting trial to trial to trial multiple physicians that are willing to try. Instead of trying to expand your physician base to get other physicians that are willing to try, get those trials to try again.

You start having the groundswell of belief that this is an important product and that it’s changing the way that about treating my patients. When you start creating momentum that way, this is where you have the most successful launches, so it’s about focusing narrowly on how you execute what the micro milestones are in a launch, those critical key performance indicators at a launch. Yes, of course, you’ve got to look towards the big picture and what you’re trying to achieve if it’s market leadership and share of a total market but it all starts from a couple of physicians starting to try. The more and more we focus on that, the better we get at that. This is where everything else starts falling into place.

That’s powerful, Michelle. That’s almost a preference and a model. I never thought about it this way in the oncology world, so I have not heard leaders speak that and have the confidence to go with that model. There’s a lot of management pressure to go against that model to do breadth, frequency, and expand. I’m sure it’s pretty close to your heart, this entire model of going to a few triallists and creating that momentum through that epicenter, versus doing a carpet-bombing effort. While we are talking about execution, what are a couple of other things that come to mind that you feel is great execution in building towards launch. Let’s say close to the launch period. Cross-functional collaboration, does it even matter?

LSVS 3 | Go-To Market
Go-To Market: The more work you do with your customers prior to introducing a new medicine is probably one of the most important things.

 

It does, especially when you’re working on certain medicines. Let’s say, you’re introducing a new biologic. It needs to get on the formulary. If it’s not on the formulary, it’s not going to get reimbursed. There has to be a well-orchestrated machine of the various stakeholders who are important to make sure that launches go well. It’s not what your sales force is doing to get the messages out around about your business. It’s also to make sure that your field access personnel are working to make sure that the reimbursement for your medicine is well underway that your medical personnel are working to make sure that the data packages are where they need to be in order to make sure that drugs get listed on the formularies, etc.

This all has to happen in concert with each other. Let’s also keep in mind, when you’re introducing a new medicine, you also have a diagnostic, you’ve got to figure out how do you get a test, what lab do you need to use, and how do you get reimbursement for the test. There are all kinds of things that come with this. There’ll be many questions in your clinicians’ mind that will probably be like, “Hurdle.” They’re like, “It’s too overwhelming to even think about doing something different than I was doing yesterday.”

For me, the way that I see our role within a pharmaceutical company is to think about the roles of the people within our go-to-market model that are all about how do I remove that hurdle? How do I make sure this hurdle goes away? How do I make this a lot easier for the customer so the experience is positive and those barriers that would get in the way of them adopting a different technology aren’t there?

The way that this has to happen is through constant communication in an appropriate way across all the teams to know that I know that they have a patient, they prescribed, and that patient needs to go through pre-authorization to make sure that the drug can get reimbursed. I know that I need to get the field reimbursement manager to get connected to this customer so they can help. Those things have to happen. It’s in the moment that these decisions and these actions need to be taken in order to make sure that those barriers get pulled out of the way for the customer.

With that said, Michelle, I want to highlight a best practice that I learned from you. You are saying that you can do it in the moment because you may have not done that proactively earlier. That’s why we are going through a scramble model. Whereas what I’m reminded of is almost twelve months before the launch, you brought in all the leaders from medical, marketing, market access, and access services into the room for the patient journey and a customer journey up there to know where the hurdles are? Where are we engaging? Why are we engaging in a duplicate way?

I remember those very difficult four-hour-long conversations but asking those 50 questions that will make sure that we are going all aligned and as a team. One, we are not sending multiple messages out. You’re not bothering the customers with medical saying something and marketing saying something, but it’s the same customer. Also, being agile with the launch. It’s knowing exactly that we have a plan and we are delivering from versus on it becoming a siloed approach for the same brand. It was a trick question when I said, “Is it too late or not,” because I wanted to bring this up. You made sure that this is a deliberate part of the launch design that happens nine months early but if you miss that bus, you’re saying you still can scramble through it but still do a better job of the launch versus not doing it.

You’re right but it’s also why I said by the time you get to the approval or your actual launch date, the trajectory from your launch is already set even before you’re out in the market because it has everything to do with how you prepared. It’s exactly that example you shared. It’s getting all your key stakeholders on the same page to understand that they know exactly what they need to do, they’re all fired up, ready to go, and ready to respond in a coordinated fashion. They have their first patient on day one, hopefully, but it’s about going through the motions because it’s all been identified what those motions need to be in advance.

Is there anything else about the launch itself, Michelle? I would love to definitely cover the post-launch because that’s when the companies lose momentum thinking that they have done their job in order to get out of the door. Is there anything about the launch that you want to talk about?

It’s really important not to think about the order of entry, but rather on what’s your differentiation.

The only other thing that I would say is important to keep in mind is it is critical to be focused on how things are resonating once you get out there and to adapt and change if you need to. Sometimes, I’ve seen turning a blind eye on the things that aren’t working and not addressing those issues even in that launch phase, which then creates bigger problems down the road. It’s about being committed to your strategy in your go-to-market model but it’s also about having that agility, listening, learning, course-correcting if you need to, and not being afraid to make a change if that’s what’s required. I’d say that’s important in a launch as well.

Is there any example that comes to your mind where you course-corrected and you felt that this was not a part of the strategy but it’s a good continuous improvement?

Honestly, at the end of the day, there are lots of examples where you continue to iterate. Part of it comes from, let’s say, you figure out what your key messages are that you’re going to be launching with. It’s about keeping those messages simple, clear, and easy to remember but I also think a lot of the learnings come from. How exactly you tie those messages to what’s going on to individual patient types that get discussed when you’re talking to a customer.

It’s those learnings that are the gold in a launch that you can then leverage and say, “This worked because it made a lot of sense in the minds of the clinician.” It’s about saying, “Now I understand that hook and that connection, it’s about making sure that’s pulled through and how it is that you execute from one customer to the next.” Those are definitely things that you iterate and I’d say fine-tune along the way to make your launches even more successful.

That’s good. Anything about post-launch? What’s your 30,000 feet view on post-launch in the oncology world? How are people doing it? Are they doing it correctly? Is it fair? Is it good or it’s bad?

In the oncology world post-launch to me, hopefully, you’re not necessarily in a position where you’re in post-launch because if you’re doing a great job with your launch, you have continuous data generation, new indications, and different things that you can carry on re-emphasizing the importance of your medicine. Applying it to a new patient population over time. You could be in this launch phase, essentially, until you have lots of exclusivity for your medicine. The best launches in oncology are like that.

You’re aren’t necessarily falling into that zone of “You’ve been out there for 4 or 5 years. There are no new indications or new data. You’re essentially in harvesting mode where you can relax a bit more.” I don’t know. We don’t see that as often in the oncology space anymore. If we do our jobs well and we have a continuous stream of data generation over time, we can continuously be bringing new data and value for customers and patients.

With that said, besides data generation, let’s say the nomenclature’s sake, the post-launch. Once you’ve launched one product, and we know that there are three indications coming up that we may file for the first line where now is in the second line. How do you pursue that phase? Is that any different or is it the way you approach the first launch?

LSVS 3 | Go-To Market
Go-To Market: If we do our jobs really well and we have a continuous stream of data degeneration over time, you can continuously be bringing new data and value for customers and patients.

 

You have to make some choices because you have to decide where in the treatment landscape do we expect this medicine to be used, so you’ve got to be mindful about how you’re going to shift from one place to another with the introduction of new indications. That’s definitely something where you need to make those choices because they won’t make sense in the whole lifecycle of medicine to cover it all. You’ll want to be able to pick and choose what’s the priority, where is it that you’re intending for your medicine to be leveraged, and to make sure you’re focusing on those areas and getting it right. There will be some shifts in terms of your resourcing from one place to another and your efforts that you make from one place to another over the course of the lifecycle of a brand.

Do you think that the operating model could be the same besides the resource adjustments? Do you think the operating model also needs to be revisited when it comes to follow-up indication?

It might be. For example, at the beginning of a launch, it may be important, especially if we talk a lot about targeted therapies. In the beginning of a launch, it may make a lot of sense to talk about the importance of driving testing awareness, testing behavior, and patient identification but at some point, and again, if you’ve launched well, that patient identification gets incorporated into the standard of care. Hopefully, what we ideally would be striving for is that you get reflex testing upon diagnosis of a disease and you wouldn’t have to talk about that anymore because every single patient will get tested in their patient journey at the right time and that information would be used to make a treatment decision. It may not make sense to keep talking about testing if 90% of your patients are being tested upon diagnosis. Your operating model could change because some of those key criteria or key factors that were critical at one point in the lifecycle of a brand may not be as critical anymore as you move forward.

I want to keep going but I have to respect your time and readers’ time. Any final thoughts, Michelle, or anything that you felt that I did not cover when we were covering this sub-topic of non-oncology launches? Is there anything that comes to your mind?

No, it would be to reiterate the point that launches are a period of time where I call controlled chaos. Chaos because there are so many different things that have to happen, basically, in tandem with each other that it could be chaotic if it’s not well coordinated. The controlled piece is important. It’s all about how do you manage that. How do you be focused on what your priorities are? Make sure that you’re not trying to do too much and to focus on doing a few things and doing those few things well. That’s what makes a good launch.

Thank you so much, Michelle, for joining us. It was lovely talking to you. I enjoyed the conversation.

Likewise, pleasure seeing you again. Thanks so much.

Likewise. Bye now.

 

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About Michelle Werner

Industry leader and a close friend. She is a pharma executive with >20 years of experience in a variety of positions including US, ex US, and global R&D and commercial with predominant focus in Oncology.
I have had the pleasure to partner with her in helping her stand up a US Immuno Oncology org, launch brands and do interesting strategy and operational excellence work together.