Episode 2: How To Stand Up An Oncology Organization: In Conversation With Michelle Werner


With so many changes at the pharmaceutical level, the demands of people, and society’s shift into the digital age, launching an oncology medicine today has evolved a lot. Therefore, building an oncology organization also calls for brand new strategies. Continuing where they left off with their discussion, Gaurav Kandhari and Michelle Werner explain how agility, flexibility, and even creativity are required to design an operating model. This way, they can address the needs of patients despite the constant changes and regular launches. Michelle also talks from her experiences in such an environment, sharing the best practices to apply in this scenario and the importance of utilizing real-time information. She also emphasizes the power of the proper combination of marketing and medical strategies, which ultimately results in better customer engagement.

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How To Stand Up An Oncology Organization: In Conversation With Michelle Werner

How To Stand Up An Oncology Organization

We are doing this three-part series with Michelle Werner. She’s a close friend and a thorough pharmaceutical executive. Welcome, Michelle, to the show. Thanks for taking the time to do this entire series with us.

Thank you so much, Gaurav. It’s a pleasure to see you again. I hope you’ve been well.

Likewise. All good, no complaints. To give everybody a context and some background, we are doing this topic of Evolving World of Oncology and what that means to the patients, payers and clinicians. How it has impacted or evolved the pharmaceutical executives’ life and the life of pharma organizations and how they have evolved over a period of time and what could they do better. With the same theme, we covered the view from a patient’s perspective, clinician’s perspective and payer’s perspective on our last episode. If you missed that, you can view that episode and read the wonderful stories and experiences that Michelle shared.

This is the 2nd of the 3rd series where we are going to focus more inward on how executives like Michelle do and should stand up the oncology business units, how they can operate the business units. What needs to be done to make the process agile with this constant state of the launch of not only new oncology drugs but the indications that come with every drug. Michelle, I’ll let you elaborate a bit on the sub-topic and then we can jump into it.

This is an exciting area for us to explore. As a Pharmaceutical Executive, I have seen this evolve as well over the years. One of the most important things to think about when you’re in this constant state of launch and continuously bringing either new indications or new tumor types to market for any individual medicine, first and foremost, is how do we build agility and flexibility within our teams to be able to adapt to every new indication?

In the last episode, we talked about how we’re in a position where you launch in one space and you’re turning around the quarter and you’re about to do it again. That creates a lot of stress on the system and our teams. For me, as a leader, what do I need to think about to make sure that the teams are resilient and that they’re as agile as possible to be able to adapt and change to the climate in which we’re in?

Tell us more about teams being agile. I’ve seen you redesign the entire operating model of an OBU to make it a bit more agile. Tell us more about resilient teams and how to get agility out of that system when you are in Big Pharma machinery. Anything you want to share about the operating model?

If you don’t have a shared vision at the beginning, you don’t have the right approach to delivering a seamless experience on the outside.

I’ll reflect on the earlier stages of my career in the commercial space. Frequently, when we were preparing for launches, you’d start from the beginning, you’d have to think about the 101 things that you need to do to prepare for a successful launch. You do that for a year or two prior to launch, you launch, you execute through the launch, and then you’d move on to something new. Meanwhile, the next team would prepare for another launch of another asset and they would do the exact the same thing. They’ll start from the beginning, think about the 100 things that they need to do, and then go on from there. The fact of the matter is that we can’t afford that anymore. We can’t afford to reinvent the wheel each time. Now, launches are happening in a few months between one and the next, and sometimes even weeks in certain cases. You can’t start at the beginning every time.

For me, it’s been an approach to take about, “How do we make sure that we create an organization that has the ability to focus on the depth of expertise on the indication of the patient population or the tumor type that an individual launch is focused on.” At the same time, you have agility, especially in the areas that aren’t unique from one launch to the next. Let’s say, it’s a non-personal promotion or in medical education or things like that where you’re looking at specific channels that are going to be leveraged no matter what launch or what indication that you’re bringing forward. You have subject matter expertise in those arenas. At the same time, you have a depth of knowledge, expertise and insight that is focused on the patient for that specific indication and tumor type.

The best launches that we’ve done and where we’ve had the ability to pivot quickly from one launch to the next is when you bring those two pieces together. Somebody who’s coming with subject matter expertise where it’s necessary but somebody who also has the depth of knowledge about the specific medicine and tumor type that is most important. That’s helped us change dramatically the way that we think about putting together teams. Instead of having big launch teams that would do everything from the expression soup to nuts, from beginning to end, now we’re leveraging launch teams that are maybe smaller in nature. Also, tapping into teams that are focused on being excellent and delivering excellence in different channels and having that then be applied to multiple teams perhaps even simultaneously.

It’s also about not getting everything set up internally. That agility comes from lean internal teams but having the right partners to help you get through this process. The subject matter experts and people who have depth in a certain therapy area or disease area, it’s great to have accountability in them and great to have them internally but then identifying and partnering with the right external partners. You mentioned a few of those external partners in the previous episode. Has that helped you? Over a period of time, have you changed your perspective on that front? Has that given you more agility or is it been the same?

LSVS 2 | Oncology Organization
Oncology Organization: When launching a medicine, you usually try 100 different things, figure out which one worked, and then focus on it. Today, that scattergun approach is not applicable anymore.


I’m not entirely sure. We’re working with far more stakeholders than d we’ve ever worked with before. We have a lot more partners and collaborators on many of these things as well. We’ve talked about patient advocacy groups and the role that they play in terms of making sure that we’re disseminating information as best as possible through that channel to patients. We certainly do that. I would not necessarily say that makes us more agile. What it does is there are more groups in the channels in which we were.

There is truth to what you said in terms of partnering with people who do have certain expertise. For example, one of the areas, especially from a commercialization perspective we’ve seen evolve a lot over the years, is the role that medical education plays. When I started in my career, we were doing medical education where pharma was taking a lead and putting up programs. They wouldn’t be organized by members of our team whether they were field-based individuals or office-based individuals. We’d invite lots of customers, they come or not come. We put on a program that we hope would add value.

Now we do things a little bit differently. Some of those programs are the archaic way of doing things in our industry. We’re looking at how do we partner with medical education organizations that have a level of credibility in the content that they deliver. They work closely with key opinion leaders that are specialists in any individual field. They put on programs that are often in a virtual capacity, a little bit like we’re talking about, Gaurav.

Instead of us inviting a whole slew of customers that we think would like to participate in these programs, these med ed organizations that have the reputation and the expertise of delivering great content to clinicians is how we’re working these days to make sure that the education on new data and innovations is where it needs to be. That has changed. It’s changed the way that we think about how do we organize ourselves as a team? No longer do we need teams of people creating all of this content. We do need teams of people who understand what those channels are, what are the most relevant ones, and where do we want to allocate our investment. Making sure that they have all of the right information that they need to develop the content that’s going to be relevant for customers.

Bringing it back a bit more inward. It makes me nostalgic. I vividly remember those deep dives on a lot of my conversations. You almost single-handedly brought medical marketing and market access together to make these launches a bit more agile. There’s so much going on. Everybody is running in their own lanes. “How could we synergize? How could we work as a team and respecting the compliance and the regulatory requirements?” There are so many synergies that you had created. Tell us a bit more about that. I’m sure you have taken that to a new level. Anything you would want to share about medical marketing and market access integration internally?

This is an excellent point. This is where we’ve seen a big shift in not just what we do but the way we do it within our industry. You’re right. Historically, the way that we would do things is your sales and marketing teams would get together and they would do things. We’re doing things quite differently now. In the oncology world that we exist now, the golden era of innovation, having many different launches and many new indications that are coming in quick succession of each other.

What we have found is that we’ve got to be mindful of making sure that there are clear roles and responsibilities. We’re obeying the guidance and making sure that you’re giving direction from one function to the other. Align on the principle of what are we trying to achieve? What is the overall strategy for a brand? Having that for one of our medicines and making sure that we’re aligning behind that regardless of which function or which part of the organization that you’re in. Having a clear idea of, “If I’m in the commercial function, this is what I need to do with this one unified vision. What it is that we’re trying to achieve? What experience are we trying to give our customers? What opportunities are we hoping that patients have to benefit from?” Each function has its own unique way of delivering towards that vision but the vision is the same. What we found is if you don’t have that shared at the beginning, you don’t have the right approach in delivering a seamless experience on the outside.

We’ve got to keep in mind that we put up structures within our pharmaceutical companies, all of us, that makes sense for the way that our business operates. When you’re that customer on the outside, they only see you as being a representative of that company. They don’t see you as being from this function or that function and understand how they all intersect. They say, “You’re the representative from this company. Why can’t I get this information from you?” When you think about what that customer experience is and what you want to drive towards, it helps change the way that you think about internally what your setup is and how do you want to work together. Making sure that you have an appropriate communication channel between functions and that you’re delivering towards something in a unified way.

A couple of questions come to mind, Michelle. Let’s only focus on customer engagement. Any particular example or workstream that comes to mind where you said, “Marketing and medical came together to offer a substantially higher value to customer engagement?”

Communication and the connection points are what matters the most in every team building.

We’re doing it in a couple of areas. Let me first start with the headquarters. From a headquarters perspective, for the most part, all the work that we’re doing is in cross-functional teams. We’re bringing each function together at the table. We put the challenges that we’re trying to adjust on the table. We discuss it together. We then think about, “What’s my responsibility for my function to be able to address that challenge?” We then go and execute on it. That’s from an internal perspective or headquarters perspective how it is that we’re going about doing it.

From a field-based perspective, it’s similar but in a different way. “These are our key customers and our key accounts. We think about what’s the appropriate amount of information that we want to be sharing from one function to the next.” We make sure that there’s a seamless and continuous communication channel with our customer-facing teams to make sure that where one person is leaving off, another person can seamlessly pick up appropriately and carry on. It feels as that it’s one organization and one company that is interacting with that clinician. That’s generally how we try to do it. Of course, you’ve got to respect certain guidance and make sure that there are clearly defined roles and responsibilities of who is accountable for what. The communication and the connection points are what matters the most.

 Are you executing on that level of integration, be it cultural, be it more capability levels? What is that one challenge that you have faced or that comes to mind?

When we started thinking about these cross-functional teams, we’ve had to overcome some hurdles Like, “Does it make sense? Is it appropriate for us to be having one strategy, one vision for any particular medicine that we’re bringing forward?” Some of those conversations weren’t easy when we first started to have them. Over time, people feel a lot more comfortable, especially when you think about it from a patient perspective and a customer perspective and doing the right thing that makes sense for them. That has been crucial.

Getting back to the idea about, “How do we build agility? How do we build resilience?” These are what I would say are the two behaviors or values that are crucial to be able to support our teams. It is exactly that. It’s like, “What kind of support do we need to provide to make sure that teams have the ability to have the space to focus on what they need to do and can pivot when they need to when they’re going from one indication to the next?”

For us, as leaders, it means also thinking about, “What are the things that I can be doing to stop and take off the plate of my team? How do I create more whitespace, thinking space, and minimize bureaucracy for the teams to be as agile as possible?” That’s also not easy to do, especially for big organizations that have defined processes and procedures, all of which we need to get done. There’s a lot of work that we need to be thinking about. It’s not just what’s new and what’s different and what do we need to start but we also need to spend as much time thinking about, “What are the things that we need to stop doing?” That’s harder to do than it sounds.

You likely said, “Not doing some of these things leads you to some of these areas that’s a huge opportunity cost for the customer.” Taking those pauses and doing those prioritization exercises regularly helps your team focus in the right direction. The speed is fast. It’s difficult for you to not pause and consider or reconsider any new priorities when you are chasing a launch or these multiple constant states of launches.

There’s one more dimension I want to cover. I know you had spent time in the US Oncology Organization, ex-US, and then global organization. I want to cover that dimension as well. What is your experience been across these two if not three different types of roles? I don’t know if you want to answer that through the next point around capabilities. Do you want to cover it while we are covering people and teams?

Maybe I’ll touch on it a little bit from and then we can go deeper on that at a later date. First of all, there are some fundamentally different things that you think about when you’re either in a geographically different place, whether it’s the US or Europe or somewhere else, versus when you’re in a global function. From a global functional perspective, where you’re focused on is what do you need to do to be thinking about driving value, not today but years from now? A far more longer-term picture strategic focus. You still think about launching a lot but you’re thinking more about, like, “What’s the right sequence of indications to make sure that physicians can understand the role of the medicine and the treatment paradigm?” You can also think about, “What are the payer challenges that you might have in certain geographies by bringing one indication first instead of another?” It thinks like a big macro lens.

When you’re in a market like the US or one of our European markets, you think about it more from a micro perspective. “What are the things that I need to do to drive a successful launch at that moment, with that customer, with this indication that I haven’t in hand?” There are some big differences, of course, in the US because of some of the regulations. You clearly have more freedom to operate when it comes to what you can do with and for patients directly. That is fantastic because I do think that we are in a day and age where patients are more empowered and more educated and want to be more involved in their treatment journey. That’s something that we spend a lot more time thinking about and focused on in the US.

LSVS 2 | Oncology Organization
Oncology Organization: If we’re not taking responsibility to make sure that patients can be appropriately assessed and identified, nobody is going to do it.


In our European markets or other markets, we spend far more time thinking about, “What do we need to do to make sure that our medicines get reimbursed, that governments are going to want to list them on their formularies, and that patients will be able to get access to it?” When you’re in a government, a payer market, which are most countries outside of the US, this is at the crux of any successful launch. You don’t launch until you get reimbursement. Reimbursement becomes the number one priority. It’s a different way of thinking about what your priorities are and how you need to focus.

Thinking more generally, one of the things that I would say has changed dramatically in terms of the launches over the years, we used to take an approach where you launched a medicine, you tried 100 different things, you figured out which one worked, and then you focus on it. We’re not doing that anymore. We don’t take that scattergun approach like we used to. We think differently about how you prepare, what were the 2 or 3 most important must-win critical moments for us to address? You did 2 or 3 things well. Instead of 100 things, it’s fewer. It’s about that prioritization. It’s about going deep to understand what those 2 or 3 things are, and then doing it better than anybody else does them.

Let’s pivot a bit to capabilities. You spoke well about people and teams and how we can make them agile. Let’s talk about how capabilities have evolved. What are the must-have capabilities in the world nowadays without which an oncology business unit would not be able to operate the way it should for this customer experience?

There are a few things that are critical. Especially in this day and age, data and digital capabilities are absolutely important. We’ve talked a little bit in this series already about the role of digital channels and social media. A lot of that is based on an understanding of, “Where customers are, what are the analytics that we need to understand in terms of how they want to access information and content but then creating an experience.” We often call it an omnichannel experience where we can bring together digital channels face-to-face or person-to-person types channels in a seamless way where the story can flow. You need data analytics and digital capabilities to do that. That’s one of the most important capabilities that we’re looking for in this day and age.

There are a few others that I would say are much more important now than perhaps ever has been. We talked a little bit about some of the challenges that come being in the golden age of innovation in oncology and the added stress that might put on the healthcare systems and the payers as well. We’re thinking differently about, “What do we need to do? What are the teams that we need to put in place to be able to support that, pay that end from a field-based payer capability or a headquarters-based capability to prepare, execute, deliver, and make sure that there’s support both on the patient side and the practitioner side where it’s necessary?” That’s something that we’re doing much more robustly in the last few years than we’ve ever done in the past.

There are more specialized capabilities too. We talked a little bit about now being a world where there are precision medicine and targeted therapies. When you have a targeted therapy or you’re working in a disease area where patients are bifurcating by different, let’s say, genomic classifications, there’s a different approach that you need to take to make sure that patients are adequately and appropriately getting identified. They can be treated more optimally than perhaps being lumped together as one group of patients and getting the same thing that everybody else is getting. It’s getting much more personalized and much more specialized. There are different capabilities that we’re putting in place to focus on what’s the optimal support you need to give for precision medicines. Making sure that the institutions are prepared to be able to identify patients in the right way and test them for certain biomarkers and to make sure that they’re getting treatment based on those tests. That’s another thing.

We can talk about a lot of different capabilities that are important. Another one that I would say is about what are the patient support systems and services that we also need to be thinking about. That could be in the form of people like nurse educators who might be there in the field and helping patients who are being prescribed one of our medicines. They may need some additional support, information, and education to have a good experience. It could also be other support programs that we put in place to make sure that they have the information that they are adhering to and complying with their regimen. They have access to the facilities and the support that they need to be able to have the most positive experience. There are lots of things that we’re doing there, which is different than we’ve done in the past. These are all emerging capabilities that, if you’re going to be a leader in oncology, are critical for institutions to adopt.

A couple of follow-up questions come to mind, one each for these two capabilities that you spoke about. The big data organization, the data capability, has evolved drastically within a pharma organization. Any best practices or learning you want to share when it comes to that capability?

I’ll speak about our sales teams. We would get general information about our customer universe. We would come up with a segmentation. We would come up with a deployment plan. Our salesforce would go out and speak to those customers based on that deployment plan that was determined. Now It’s different. We’re using a lot of different data and data sets to help drive in-the-moment decisions about when somebody from our organization needs to be speaking to a customer to be able to have the best return on investment.

We’re using real-time information about what’s happening in an individual practice, what’s happening with patients that are being seen within that practice, and using that as the real fuel for the deployment model. We’re not using this generic customer data anymore. We’re talking about looking at nearly real-time data to be able to determine, “Do you see Dr. A or do you see Dr. B now?” It’ll make all the difference about whether or not you’re more likely to have the impact that you intend to have.

Data analytics and digital capabilities are among the most important things to look for in this day and age.

That space is evolving by the day. You see a lot of trigger programs. You’re almost helping the clinicians and the patients to even identify where is the journey going in. Can they help them diagnose some of these ailments earlier based on some of these records and some of their history and trends? From a pharma perspective, putting that in perspective and creating programs that involve a lot of machine learning and artificial intelligence to help with the entire customer journey over a period of time. “Where exactly the interventions need to be? What type of intervention would help?” You’re continuously learning from patient to patient.

We’re seeing these cottage industries pop up to support this type of capability. We talked a little bit about, “What do you need to do in-house versus what is it that you need to outsource?” This is another thing as well. We’re are great at manufacturing innovative medicines and distributing them amongst the world. Data, digital, and analytics capabilities, we can be okay but we’re never going to be as good as some of the real experts in this space. This is another area as well that we can debate about. Sometimes when you’re partnering in these areas, you can get the best of that expertise and marry it with the two different parties, and then you can deliver a much more optimal experience.

It’s best to play to your competency. Why would you create that competency that’s already available? Why would you spend ten years building that competency when that’s not your core competency? The pharma company, why try to become a data company? The second element I wanted to ask a question around was at the precision medicine and the nurse educator organization. We have spent some time working together on these programs where we have stood up that entire capability. We have seen a lot of challenges in the reception of that entire capability, both internally as well as externally.

“What exactly do these guys do? What exactly do the nurse educators do? What is the role of diagnostic liaisons? Are they medical affairs people? Are they MSLs? Are they reps?” I don’t understand. That’s been a dilemma, internally. When a rep looks at these customer-facing roles within the precision medicine organization, they say, “What exactly are you doing here? How are you supporting me? How are you supporting my customer?” The customer is a bit unsure. “How are these roles different from what an MSL does for me or what a rep does for me?” Any thoughts there?

Internally, what I would say is this is where identifying what the roles and responsibilities are is crucial. You talked about precision medicine. Let’s say, field-based diagnostic liaisons, these are individuals who are seeing oftentimes different customers. Instead of focusing on oncologists, they’re focused on a pathologist, they’re focused on the laboratories, making sure that there’s quality testing in place, making sure that they understand what they need to do. They can start the behavior of reflex testing for a specific, let’s say, biomarker upon diagnosis. It’s different from what a sales rep does. It’s different than what a medical affairs liaison would do. It’s a specialized nuanced skill, it’s focused on a specific customer. It gets back to the point that we talked about in the last episode about the real role of the multidisciplinary teams and thinking about all the different stakeholders that are important to make sure the patient can get the best care that they possibly can get.

Of course, that might create some dynamic tension at times. When you think about it in that perspective and you think about, like, “What are the clear roles and responsibilities?” Diagnostically, they’re not talking about the medicine at all. They’re talking about the biomarker, the test, the testing practice, or whatever it is, the quality of the test. How to interpret the results? What do they need to do with those results? Those things, which are different. It also provides a huge amount of value. Especially when you’re talking about innovation that is fundamentally changing the way patients are going to be segmented and identified, it’s quite different than how it was in the past.

You would agree, it’s a coefficient of time. That role is not readily available. We do not have these experts who are trained diagnostic liaisons. You can hire them like you hire the reps and MSL. There is a lot of training and development that is required to do the role, to play the role that you said. Playing that role, helping with the assessment and the diagnostics, how to engage with those customers, how to provide value, and get the continuum going is not easy. It’s not a role that has been there for decades. There are thousands of diagnostic liaison experts out there. Would you agree to that?

LSVS 2 | Oncology Organization
Oncology Organization: Launching an oncology medicine is a lot more complex these days than it was years ago. Now, it takes more investment and preparation.


Absolutely. There’s no question about it. We’ve certainly had that same experience where you have to start with, “What’s the problem you’re trying to solve? What’s the customer problem that you’re trying to solve? What’s the patient problem that you’re trying to solve?” On this particular topic, the patient’s problem is, “I get diagnosed with lung cancer. I have no idea if I am an EGFR type or if I’m not. I’m the patient. I don’t know that even those two things are important.” You start with a place of, “How do we help make sure that we can figure this out and we can identify it? Are they in Category A? Are they in Category B?” This is where we had to create a whole new function to be able to prepare for that.

We’re talking about precision medicine. I’ve had the privilege of working on several targeted therapies in my career. We also have to think about, like, “What’s the role of a pharmaceutical manufacturer to be able to drive precision medicine versus what’s the role of the diagnostic partner that we might be working with to bring a new test or new biomarker assay to the market?” It’s different. A lot of companies think, “Maybe it’s the responsibility of our biomarker partners or diagnostics partners to do this or maybe it’s not.”

This was a big learning for me over the course of my career. A pharmaceutical manufacturer needs to take accountability for this. The business models of a diagnostic company and a pharmaceutical company are, quite frankly, fundamentally different. If we’re not taking responsibility for making sure that patients can be appropriately assessed and identified, nobody is going to do it. That’s where this role came about.

We have seen pharma manufacturers taking accountability, having a good rub-off effect on the diagnostics industry. I don’t want to put it that way. The diagnostic industry has evolved suddenly. There’s been explosive growth in the diagnostic industry, not because they organically planned for it but because pharma took accountability and said, “This landscape is changing. We need to deliver this value.” This is an important and pivotal part of that entire patient journey, the assessment. The targeted therapies and gene therapies are coming to play.

Patient outcomes are on the line. We know patients will do better. If they have a specific type of cancer, they should have a specific type of medicine to address it. We’ve learned that in time. We also have a responsibility from a patient perspective to make sure that happens as well as it can.

We used to live in a world in the oncology space where the data sold the medicine. That is not true anymore.

We spoke about people, teams, agility, and how can we bring agilities. We spoke about important key capabilities that an oncology business unit needs to bring in or keep evolving and do continuous improvement on. Anything else that comes to mind from an inward-looking perspective? You’ve gone to different oncology business units and you’re like, “This is the part that is missing. This is something that needs to be refined.” Anything else from a process perspective or cultural perspective?

I would say a couple of things. I don’t know about missing but I would say it’s quite different. It’s more complex these days. Launching an oncology medicine is a lot more complex these days than it was years ago when I even started. It takes more investment and preparation. What it comes down to is truly having a depth of knowledge and insight into what’s happening in the external world and being able to leverage that appropriately. The diseases are more complex. The treatment paradigms are more complex. The competitive field is a lot more complex than it used to be. All of these things factor into,
“What it is that we need to do to prepare, the investment that it takes for us to get ready.” That’s something that we need to be mindful of as companies as well to make sure that we’re set up for success and putting our best foot forward.

Any final thoughts? We want to cover the go-to-market approaches on the next one. It’s going to be a right segue now that we have discussed the people teams, the capabilities, and the investment point. Anything else you want to highlight? Any fallacy that you’ve heard about or you’ve come across? Any myths that you want to talk about from building an oncology organization perspective?

Maybe we’ll talk about this when we go to the go-to market. We used to live in a world in the oncology space where the data sold the medicine. That is not true anymore. That’s something that we’ll be able to have a good chat about.

That’s a great closure. I don’t want to speak anything beyond this. That’s a great way to close this one. Thank you, Michelle, for joining. Thank you, readers, for joining me with Michelle.

It’s my pleasure. It’s good seeing you again, Gaurav.


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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.