Transcript

This episode of our podcast is sponsored by Cantina Consulting. Cantina crafts innovative experiences, products, and services for a connected world. They help organizations solve complex and transformational initiatives, making them indispensable to customers. Learn more at cantina.co.

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Kaitlin Milliken: Hey, you’re listening to Innovation Answered, the podcast for corporate innovators. And this is a very special season where we take you inside the C-suite of big organizations. In each episode, we’ll interview a different C-level leader to talk about how they work to foster innovation. I’m your host, Kaitlin Milliken from Innovation Leader.

This is our last episode of this season, so we’re going all the way to the metaphorical top floor — the corner officer with the view. Deborah Dunsire has been the chief executive of four public and private companies, and since 2018, she has been CEO of Lundbeck.

Folks outside of the pharma space may not know Lundbeck by name. But the Copenhagen-based company manufactures many well-known medications that treat psychological and neurological disorders. That includes the antidepressants Celexa and Lexapro — as well as treatments for Parkinson’s, Alzheimers, and epilepsy. In 2020, the company generated $2.75 billion dollars in revenue. Lundbeck operates in over 56 countries, and its medications are distributed in over 100 countries. 

The drug development process is usually lengthy, and can consume hundreds of millions of R&D dollars. It entails carefully planned clinical trials and, if you’re lucky, eventual regulatory approvals before a treatment can hit pharmacies. During our conversation, Deborah shared how the company makes funding decisions and navigates a highly regulated environment. We’ll be back with more from Deborah after this break.

[AD JINGLE]

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Kaitlin Milliken: And we’re back, with Deborah Dunsire, CEO of Lundbeck. In her role, Deborah leads the company in its mission to improve the lives of patients living with mental illness and brain disorders. That includes overseeing teams that discover new medicines in Copenhagen and California, as well as others who market and sell the company’s products around the world.

So to get us started, can you talk a little bit about your background and your journey to this role as CEO of Lundbeck?

Deborah Dunsire: I was born in Zimbabwe and then in high school and medical school, I went to South Africa, and I was a practicing physician. For some years, I joined industry in South Africa in clinical research, and then have moved with the industry to Switzerland, where I worked in global commercialization, to the US in New Jersey, working in building an oncology unit for Novartis, became the CEO of Millennium Pharmaceuticals in Boston. Ultimately worked for Takeda, the acquiring company that bought Millennium for five years, working with a Japanese company building their oncology business from the US. And now since two-and-a-half years, I have been in Denmark as the CEO of Lundbeck.

Kaitlin Milliken: And can you talk a little bit about how Lundbeck approaches research and development and innovation? What’s the mandate that guides that mission?

Deborah Dunsire: Lundbeck has been the only global company that’s been singularly focused on brain disease and neuroscience over the last 70 years. And so that’s our passion. It’s the reason we exist. So we do our own internal research. Even though our group is substantial, we can’t have all the good ideas in neuroscience so we seek ideas and innovation externally as well. We collaborate with academic institutions. We’ve recently formed a partnership with the major teaching institution in Denmark for brain shuttle work. We partner with academic institutions in the US, we partner with small companies. We license molecules in from outside. So it’s a real blend of both internal innovation and external innovation,

Kaitlin Milliken: Breakthroughs in pharmaceuticals, especially. There’s a longer timeframe there. How do you approach that type of R&D when there’s such a long timeline for certain developments?

Deborah Dunsire: It’s a great question. And I think we try and balance our portfolio looking for areas of transformative outcomes, where we can get information from biomarkers either to select patient populations, or to get biomarkers of efficacy readouts that can allow us to shorten clinical development timelines, that’s more difficult in psychiatry than it is in in neurology. So in other areas where there is a longer timeline, we try to bring in different molecules at different stages of development, sometimes licensing a later stage molecule in that can help us accelerate. But one of the things that’s fabulous for Lundbeck is that in Denmark, there exists a model of industrial foundations that can own parts or all of companies. And we are partly owned by the Lundbeck Foundation. And that gives us a stable investor ownership that has a long term perspective, and whose desire is to build the long-term sustainability of the company. So it allows us to pursue important advances over a longer period of time.

Kaitlin Milliken: It’s very interesting that you mentioned the foundation element and how that can impact funding. When it comes to researching new areas or innovating in different spaces, how do you set priorities for where research dollars should go?

Deborah Dunsire: I think we look to where are the advances coming from in understanding the biology of disease? Where are we getting insights into biomarkers, and that’s really critical for us. Because with that, we know that, first of all, we believe we can create transformative medicine. Then second of all, we can do it in a quicker cadence of time. There are huge areas of unmet need. But it’s important for us to focus on where the biology is tractable. So for instance, in Alzheimer’s disease — huge unmet medical need — but right now, the biology is understood at a basic level, but not exactly how to select the patient population so that you can get the best signals. So we might not go into that area until the biology is a little bit more advanced. Whereas in some of the inflammatory diseases in neurology, there are better biomarkers, and so you can get more traction and faster. Multiple sclerosis would probably be the archetype, ALS, Lou Gehrig’s syndrome. So it’s a question of when to invest in which area.

Kaitlin Milliken: Very interesting to hear how you select focus areas and focusing on looking for things where there’s already research into the biology that you can work with. Does that affect metrics at all? I’m sure that when it comes to certain conditions, especially psychiatric ones, measuring how well a certain drug is improving those symptoms may be challenging. What are some metrics that your team is looking for when you’re testing these new solutions and scientific processes?

Deborah Dunsire: That’s a great, great question. In psychiatry, that really is a challenge because there are not as many hard biomarkers. So we are measuring scales, which give you a much greater challenge with placebo, elevating the scales, as well as an active medicine. And so what we’re doing is we’re trying to combine that with looking at different populations in psychiatry for common biomarkers, for instance, the hallmarks of stress, elevated cortisol. There are certain people with anxiety disorders, certain people with depression, certain people with PTSD, who all share an elevation of the hormones of the stress axis, and those people may be treatable by a specific type of antidepressant medication that will do better for them than people who don’t have biomarkers of an increased stress response alongside those diseases. So even in psychiatry, we’re starting to try and unpack what else can go along with these scales to select patient groups that are more likely to respond to a medicine.

Kaitlin Milliken: If you could walk us through the development process for a new treatment or drug that your team is working on. And if there’s an example that you can use, that would be really wonderful.

Deborah Dunsire: Well, let’s think of a drug we actually have on the market, but was discovered in our labs, and that’s Trintellix — an antidepressant molecule that is the only one that has the improvement of cognition, the abilities speed of processing, included in it in its label. So it’s particularly great for people who need to be alert, but also manage their depression. So it was discovered by people in our labs, looking at how they could make a chemical to modulate certain neurotransmitters in the brain, and they formulate the chemistry. And then that’s tested in animal models. And looks like it does the right thing. They look at the safety, they may tweak the chemical based on what they learn. And eventually, after we have sufficient safety data for animals, then we can test in the first humans, and we have to get regulatory approval to do that.

Then we test in human volunteers to make sure that there’s no untoward effects on blood pressure, or the brain, or kidneys. Once we know a bit about the safety, we start to test it in patients to see if we get a readout on depression, because that’s what we’re trying to solve for. And if we’ve got a positive there, then we broaden out the trials in phase three, with Trintellix. We did I think over seven, phase three trials that were about 300 people each, to look at the comparison versus a sugar pill or placebo, and demonstrate the ability of of this agent to improve mood in a sustainable way. Once we have all that data together from those trials, it’s put together in what’s called a new drug application and sent to the regulators and various different countries, they review the totality of the data, right? From the chemistry through the animals to the people all the way to the end of the clinical trials, and then they decide whether it’s both safe and effective. If it’s decided to be safe and effective, then we get what’s called an approval. And then we can commercialize.

Kaitlin Milliken: In terms of actually doing the measuring, how much of it is getting a patient’s personal experience in an anecdotal manner, how much of it is bringing them into a lab setting and tracking these certain measurable responses?

Deborah Dunsire: You are right at the forefront of psychiatry. The need for change, because whenever we bring someone into a lab setting or a hospital setting for follow up, we’re introducing a difference to their normal life. So we’re looking at how many scales can be administered digitally or with a patient in their home setting, even if it’s on Zoom. Does that leave the system a little less perturbed than bringing somebody into a hospital?

So we’re looking at utilizing technologies, the other technologies that are coming into bear are, can you use cell phone data, GPS tracking, that allows you to see is a person moving away from their home in a normal way. For instance, a person about to have a schizophrenic breakdown tends to stay more at home. And as you see their circle of movement drop, you can potentially intervene before a psychotic break.

For depressed patients, the same types of things applied the change in their ability to move broadly in their environment, outside of COVID time I need to say, can be a symptom of their disease changing and we’re evaluating how can that data be used. And again, still in its infancy, but hopefully those could add additional digital tools to these scales that are more subjective.

Kaitlin Milliken: We’ve all heard so much about the different phases for clinical trials in the last year. What are you measuring early on, and is it different from later in the process?

Deborah Dunsire: So the very early stages, the first in humans, in psychiatry and neurology, you’re actually working with healthy volunteers first, and you’re seeing, what does your drug do to healthy person? Checking mainly for safety. And then you move in the later phase to development into proof of concept where you’re looking at some parameters of efficacy, usually biomarkers to see, in a patient does your drug have the opportunity to do what you think it does? And then of course, in phase three, you have to test both efficacy and safety in a much larger population. The metrics we use in phase one are mainly focused on blood biomarkers or cardiovascular or measurement. In phase two and phase three, we start to introduce the efficacy scales into psychiatry. So you do shift.

I think one of the other things that we’re doing is building in more of these digital metrics. For instance, for Parkinson’s disease, one big issue for Parkinson’s patients is that they can fall. Sometimes the rigidity makes them fall a lot. And we have partnered with a small company that has an insoles for shoes, that will give us a digital readout. If their gait is unsteady, we can monitor we can capture change over time, digitally, in certain instances.

Kaitlin Milliken: To pivot, I’m sure that everyone knows pharma is a very regulated space. How do you navigate trying to make new things happen, in addition to that legal and compliance element?

Deborah Dunsire: Often it’s in collaboration with regulators. So if ever we’re going to implement something, for instance, those digital insoles in a Parkinson’s trial, we will talk to the regulators about it, we’ll show them what are we planning? We’ll get their insights. We’ll try and understand from the regulator’s how would they view it? What data would they need to see? What validation would they need to see? There’s ways forward when we come up with a new idea to engage the regulators early and to do it in multiple continents so that we can see how to go forward? The other thing is, if there’s a new way of reaching out commercially. How are we going to use virtual promotion? Again, one has to deal with the regulations on that. Once again, it’s working with internal and external legal, internal and external regulatory consultants, putting together something we propose to use and then testing it with regulators.

Kaitlin Milliken: I do have a few questions here that just have to do with failure. What happens when a project that you’re working on is unsuccessful? And what’s the attitude towards failure in the pharma space?

Deborah Dunsire: You want always to be learning from everything you do. And in our space, where you’re testing new biology, and you’re moving from testing it and animals to testing it in humans, you can’t know everything before you start. So you are going to find out things along the way that may be very surprising to you, and could constitute failure. Sometimes we’ve had to scrap a molecule.

We’ve always learned from that. And sometimes that enables you to go back and create that second generation very much more quickly, because you know precisely how to tune it. The second thing is to do a diagnostic to say, “Is there something that should have warned us? If there’s something that we should have known that somehow our process allowed us to overlook, that needs to be addressed and corrected.” But I think the most important thing is to be able to openly acknowledge and honestly say, “What has been learned and how it can benefit us going forward?”

Kaitlin Milliken: And is there a formal way of tracking that? I know that recording it may be a big part of that process.

Deborah Dunsire: First of all, we thank the team, we thank them for all the work that they have done. And we acknowledge that yes, it failed, but it was worth doing. Then we asked them to come several, up to a couple of months later, and tell us what were the key learnings and were there any things that they would have done differently if they had to do again. And then, we’ll call that a deep dive and round off the project with one of those.

Kaitlin Milliken: Failing and learning is important. The timing of that is arguably more important in terms of finding things that aren’t working, ending them early, and pivoting quickly. Are there checkpoints that you’re looking for when it comes to trying to catch those things that may not be working in the early stages?

Deborah Dunsire: Our Head of R&D, Johan Luthman always talks about make sure you experiment in the early stages. So during a broader set of early clinical trials right at the beginning in phase one, adding some patient data, even in phase one can give you so much more information to adequately inform your decision going forward. And when you fail in phase one, you’ve spent probably a tenth or less of what you would spend if you failed in phase three.

We do more experimentation, we drive harder to uncover the right biomarkers that are going to inform us in the latest stages of development, and we ask a lot of questions. We test with regulators, we try out digital solutions. And we have a group called experimental medicine whose job it is to really focus on those biomarkers and how they bridge from the earliest stages of development into the latest stages. And we’ve invested more in that group to increase the sophistication, the skills, the scale, so that we can do that early experimentation and kill things faster.

Kaitlin Milliken: A lot of our listeners, they’re working in innovation, they’re working in R&D. And one of the things that they want to know is how they can get support from top leadership as CEO, when it comes to a new field of research or a new project. What are things that can help people get your support?

Deborah Dunsire: Connecting it, first of all, to the mission of the business, right? How is this particular idea or project going to help the mission? So even if it’s not a drug discovery project in our business, but maybe an IT project, to tell me how does this fit into either speeding up, or increasing the accuracy of our decision making. Connect it to how it impacts the mission of the business first, first and foremost. Then, outline the steps. What can we invest to learn something early, so that we can get more security about whether we should continue this investment. So give me a plan that has mileposts along the way that says, we’re going to get a pilot, we’re going to try this, we’re going to invest this much to phase one. And that will bring us to a decision point about the rest of the investment. So stage the investment based on success criteria, and then point out how we’re going to come back and learn from it.

Kaitlin Milliken: A lot of times, people we have spoken to say that creating the culture is top-down. So senior leadership sort of sets innovation as a priority, and then teams are encouraged to work toward that. How is culture created at Lundbeck specifically? And if it is top-down, how are you creating a place that allows for innovation?

Deborah Dunsire: Unless culture is driven, it will form itself. So in some ways, there is a top-down. Does it come directly from the CEO? I think it comes from the leadership team. So you do set priorities, and then the action has to support it. The words are good, but they are nowhere, and they can go nowhere, unless there’s action behind it. And if innovation is a priority, one has to allow — first of all — a safe place to fail, one has to allow debate and encourage debate. So the organization needs to understand how to manage conflict of ideas. So the people who raise questions or who raise off the wall ideas or who disagree with a particular path forward, need to know that there is a safe space for them to disagree. And ultimately, it can be driven through a focus on the mission. Patients are waiting. There is a passionate desire to be able to perform better for patients. When the debate is done in that spirit, and when the challenge comes in, “Is this really the best we can do for patients?” Then I think it’s much easier to have the dialogue.

Kaitlin Milliken: Great. And this is my final question for you: What can innovators at large organizations do to stay in communication with their CEO and just maintain that positive relationship outside of new projects?

Deborah Dunsire: Find ways to showcase that innovation. In Lundbeck, we have — again, organized by our head of R&D — idea fairs. And a couple of times a year people are able to bring forward their ideas, we create posters. We create time and space for people to be able to present an idea. They’re given five minutes — five minutes only — to present an idea. And we select some of those ideas to be funded and go forward. So I think creating those kinds of spaces where new ideas can be put forward in a structured way is one way to do that. Not the only way for sure, but it’s at least one way.

Kaitlin Milliken: Great. Thank you so much, Deborah, for taking the time out.

Deborah Dunsire: Thank you. Appreciate the time.

[ACKNOWLEDGMENTS]

Kaitlin Milliken: You’ve been listening to Innovation Answered. This episode was written and edited by me, Kaitlin Milliken, special thanks to Deborah Dunsire for sharing her insights. This was the final episode of our inside the C-suite series, but our team will be releasing special bonus content over the summer. To get updates from our show, subscribe to Innovation Answered wherever you get your podcasts or check out our website, innovationleader.com/podcast. If you’ve enjoyed this season of Innovation Answered, give us a rating or review on your podcast app of choice. Thanks so much for listening, and we’ll see you soon.

Special thanks to our sponsor, Cantina Consulting. Cantina crafts innovative experiences, products, and services for a connected world. They help organizations solve complex and transformational initiatives, making them indispensable to customers. Cantina is made up of a community of strategists, designers, and engineers who rise to the needs of their clients. No challenge is too small or too large — whether it be building a digital business for one of the country’s largest retirement services companies, or making a connected dog collar which became one of Oprah’s Favorite Things. Their team has also helped a major movie studio reopen after COVID-19 shut it down, and designed a new approach with AR/VR to train fighter pilots. Learn more at cantina.co.