Christi Shaw is the chief executive of Kite, a Gilead Company, a position she has held since 2019. Kite is the global leader in cell therapy with two FDA-approved CAR T-cell therapies in multiple blood cancer indications that have treated more than 11,000 patients worldwide. Kite products are approved in more than 20 countries and represent a new frontier in cancer treatment that has only been approved since 2017. McKinsey senior partner Laura Furstenthal sat down with Shaw for an in-depth conversation about Kite’s therapies, what it means to put the patient first, and how she leads while science and circumstances rapidly change. What follows is an edited version of their conversation.
Laura Furstenthal: Before we get into questions about your work as Kite’s CEO, I think it would be helpful to start with a layperson’s description of CAR T-cell therapy. Most people are familiar with the idea of treating cancers with radiation and chemotherapy. Why is cell therapy considered so innovative and different?
Christi Shaw: What we’re doing here is taking a patient’s own immune system that is used to fight diseases every single day and reengineering their white blood cells so their immune system can fight a specific disease—in this case, blood cancer.
Our patients go to an authorized treatment center and have their blood drawn via a process called “apheresis” so that the T cells, the fighter cells, get taken out. Those T cells are shipped to our cell therapy research labs. We have three cell therapy manufacturing facilities now. Then our research engineers, our cell therapy specialists, take that patient’s T cells, engineer them with a chimeric antigen receptor (CAR) gene, and help grow and expand them to fight the cancer. That bag of engineered cells gets shipped back to the patient in the hope of a cure for that patient.
Laura Furstenthal: CAR T-cell therapy is new—it was only introduced as an FDA-approved treatment for adults in 2017. You joined Kite as CEO two years later. As a leader, how do you create strategies and set goals in an area that is growing and changing so rapidly?
Christi Shaw: Things have changed so rapidly, not only year to year, but month to month. What I described to you about harnessing a patient’s own cells is called “autologous cell therapy.” When I first came to Kite in 2019, the thinking at the time was that autologous cell therapy would be quickly disrupted by donor cell therapy, and that within two years we would no longer need autologous cell therapy. But that’s not what’s happened. The durability of responses hasn’t been as good as we would have liked with donor cell therapy; the side effect profile still requires hospitalization or staying close to a hospital. We’ve had to be adaptable and pivot.
We also thought we’d be going into solid tumors next because we’re working in blood cancers now. What we’re actually seeing through the science is that maybe other diseases beyond cancer may come first. We’ve seen some great data on patients in immunology, for example, and in virology.
We can’t predict where that science is going to evolve, unfortunately. But if we stay nimble, we can evolve things very quickly. Some things might go faster than we thought. And new frontiers are appearing in front of us that we never even dreamed of three years ago.
Laura Furstenthal: What are you most proud of, so far, about being Kite’s CEO? And what are you most excited about going forward for patients, for advancements in science, and for your employees?
Christi Shaw: The last three years have been some of the most meaningful work in my 30-year career. To be able to bring something that is so life changing, that literally changes the way cancer is being treated, is fulfilling personally and professionally.
We have five indications now in all different kinds of blood cancers. And we went from treating hundreds of patients to over 11,000 patients. With the hope of a cure for some cancers, it’s incredibly meaningful work.
Our “true north” at Kite is first, to focus on patients and to be able to reach as many patients as possible. We are now in over 20 countries, with patient access and reimbursement across five major continents. We’re really trying to reach every patient who’s eligible for CAR T-cell therapy.
Second is thinking about our future. Today, we have about a 50 percent cure rate for patients living with certain blood cancers. These patients have typically been told they have only months of life left. But we’re not reaching every single patient. So, as we look at trying to reach more patients, it’s about reaching them through increasing the number of authorized treatment centers, bringing centers closer to where the patients are, and continuing to expand even beyond the 20 countries we’re in currently.
It’s also about earlier lines of therapy and trying to get more patients eligible within the same indications that we have today. And then as we look at the science and where we’re going in the future—because only about half of patients respond to the therapy—our number-one goal is to try to figure out: How do we evolve our therapy so that more patients have a great response?
Laura Furstenthal: Let’s talk about patient access. This is a novel and expensive therapy and something that is manufactured in batches of one. How can patients afford it, and how can you ensure access to it?
Christi Shaw: Patient access has so many dimensions to it, starting from when the patient is diagnosed. Are they or is their doctor even aware of or educated about the therapy? Then, how do they get to the place where they would undergo cell therapy? How far away do they live from an authorized treatment center?
In response, we’re going direct to patients through digital education and through healthcare professionals. And we’re strengthening that referral route so that a community oncologist can refer their patient to a blood cancer specialist and an authorized treatment center.
Once the patient is at the treatment center, they need to stay for four to six weeks, or sometimes longer if they have any side effect management that extends their stay. They need travel, lodging, and support for that piece of the journey as well. We now have over 315 authorized treatment centers worldwide, with 120 in the United States, where we started out with only 60.
One of the things that I get asked a lot about Kite is, “This is an expensive product. How do you justify the cost?”
We’ve actually seen that when you use this one-time therapy—there’s no need for additional therapies after this—that the healthcare system actually saves a lot of money. [In the US] Medicare is fully reimbursing. In Europe, we’ve signed outcomes-based agreements in which we guarantee certain outcomes for a certain price. Taking a patient-outcome approach is something I’d love to see happen in the United States.
During the pandemic, we all came together in the healthcare system to focus on patients. I think focusing on patient outcomes and reimbursing for patient outcomes is how we can put the best interests of the patient in mind again.
I think focusing on patient outcomes and reimbursing for patient outcomes is how we can put the best interests of the patient in mind again.
Laura Furstenthal: You came into this role in 2019 and then COVID-19 hit. What can you tell us about leading through that experience, and how has the pandemic catalyzed change within Kite?
Christi Shaw: We ship the cells in what we call a “dewar,” which looks like a little Star Wars R2-D2 machine robot. It keeps the cells frozen. That dewar gets shipped on a plane, and our team tracks that plane and those cells. Right at the outset of the pandemic, a dewar left on a plane from LAX [Los Angeles International Airport] to Chicago to be shipped to Europe, and once that dewar got to Chicago O’Hare Airport, it sat there. The team was getting the alerts: one flight canceled, then another canceled, then nine flights canceled. We were all involved in this, being alerted, calling the airlines, calling everyone we could.
We didn’t think that those cells were going to make it, because you only have a 72-hour window. But they did make it. The team, through sheer willpower, through solutions, collaboration, not taking no for an answer, finding a different avenue, they did it. Once that happened, we developed plans A, B, C, D, and E [for this scenario]. It was week-to-week, day-to-day, hand-to-hand holding to find new routes. In some cases in the US, it was faster for us to use trucks than to fly. We literally had some employees who used to work getting medical supplies into war-torn countries helping us navigate getting our cells to patients.
The hope is that we never go back to prepandemic thinking, that we can continue to keep that patient at the center of everything that we do and say, “That is what’s most important.” We actually now map out the entire patient journey and say, “How do you get the cells faster to a patient?” We’re now down to only seven days to manufacture, seven days for sterility. We’re getting them back to patients on average within 16 days in the US.
However, it’s months before they actually get to the point where they do the apheresis in the hospital to get their cells. So we’re saying, “If we’re a leader, and we want to take the learnings of the pandemic, how do we harness and help and collaborate with the whole healthcare system to cut these months down for the patient to weeks and days just like we’re doing during the manufacturing process?”
Laura Furstenthal: How have advancements in digital and technology that happened during COVID-19 affected Kite?
Christi Shaw: We have something we call “Kite Konnect,” which was first established just to make sure that we could track patients’ cells from the authorized treatment center to the manufacturing site and back. That digital system has evolved to include servicing patients, having their data, being able to resolve questions, and understanding why there are cancellation rates.
We hope to be able to scale that to lead to better science. To use it not just for treating patients as it was originally designed but to possibly learn, based on all of the data that we’re capturing, why some patients respond and others don’t. Could some of the signals that we’re getting from this data feed back into our R&D pipeline to better improve the therapies that we’re delivering? How do we also use it for gathering patient information in an appropriate, compliant manner?
Laura Furstenthal: Last, regarding the pandemic, did it change your ways of working?
Christi Shaw: Our employees who work with the patient cells were so committed that they kept coming in during the pandemic. In fact, in March of this year in China, there were actually over one hundred manufacturing employees living in the research lab so that they could continue to deliver for patients. We had just launched in China in January. This is our joint venture, Fosun Kite, with Fosun, a pharmaceutical company. Huge demand. At this point in the pandemic in China, if the employees went home, they couldn’t come back. So we have pictures of them sleeping on the floor, showering, and living in the lab.
So that part hasn’t changed, the commitment to the patients and going to the cell therapy factories every day. What has changed, though, is that many of us outside the labs now work from wherever we are. We’ve learned to be more efficient. We’re trying to have core days where if people are coming to the office, they know other people will be here.
Laura Furstenthal: Switching tracks a bit, how do you think about globalization in a world where geopolitical complexity is amplifying?
Christi Shaw: Our goal is that every patient who needs our therapy receives the therapy. So over time, we’ve been able to reach new patients, new geographies. On five continents, in 20 countries, we have reimbursement. In fact, most recently we filed regulatory filings for approvals in Brazil, Singapore, and Saudi Arabia. We have already launched in Japan and China. We have commercial partners there, a joint venture in China, and we recently announced that Daiichi Sankyo is transferring the Yescarta marketing authorization in Japan to us.
I can’t emphasize enough that there’s the geographic expansion, but there’s also the expansion needed in the countries we’re already in. After five years postapproval for diffuse large B-cell lymphoma, even today only two out of ten patients who are eligible are actually receiving the therapy. Forty-three percent of patients are alive five years after receiving this therapy, so that’s a big chance at life that every patient deserves. So geographic is one kind of expansion but also just expanding within the geographies we have is very important. And then the last piece is really expanding the number of indications and the different types of diseases that we treat.
Forty-three percent of patients are alive five years after receiving this therapy, so that’s a big chance at life that every patient deserves.
Laura Furstenthal: Kite is an innovative organization within a pharmaceutical giant, Gilead. What are the benefits and the challenges of that larger relationship?
Christi Shaw: Cell therapy is a complex area where investment is required before you see any kind of profitability. That’s what Gilead has provided: the investment and support needed to really take such innovation to the masses. That’s been a tremendous benefit for us.
A big decision that was made before I got here by the then-new Gilead CEO Dan O’Day was to keep Kite as an independent company—not isolated from Gilead—but independent. I think that’s one of our biggest advantages. Kite is vertically integrated and exclusively focused on cell therapy and the only company that’s structured this way. Cell therapy requires incredible integration between the various parts of the company. We operate in a team sport environment where our manufacturing, research, clinical development, commercial, medical affairs, and our G&A [general and administrative] functions like legal, HR, finance are all highly integrated to operate as one.
That cross-functional approach—having that independence—has allowed us to really run fast and scale fast in the last three years. At the same time, we have the luxury of some of the things that we don’t need to replicate or duplicate, such as IT infrastructure. The support that we get from Gilead is tremendous.
Laura Furstenthal: You brought up this analogy of team sports, which makes me think about teams, talent, and diversity in the life sciences. You are somewhat unusual, not only as a woman CEO but also because you grew up on an Iowa farm, and you’re the first in your family to go to college. Can you share a bit of your story and also talk about how you’re pursuing diversity company-wide?
Christi Shaw: I grew up on the farm in Iowa. In the summers, I got up at the crack of dawn. I always had chores and really learned hard work. My dad was in corporate America. He traveled during the week, came home on the weekends. On the other side, my mom was extremely philanthropic, always helping with the neighbors and at church. She also started her own restaurant once my siblings and I were grown.
I was a junior in high school when I learned about this industry. My science teacher had a brother who worked in the industry, and I thought, “What a great way to use some of the skills I’ve learned—probably received from my father on the business side—while also doing good, learning from what my mom had taught me.”
Now fast-forward to where I am today. We need diversity within Kite so that we can ensure that we don’t have blind spots in how we approach the patient journey. Our cell therapy specialists, who are in our labs reengineering patients’ cells, make up the majority of our employees. They actually are trained by us; it takes six months. So we’ve asked, what kind of background do they need to come to Kite? It used to always be a four-year college degree, but we have now actually entered into some community college associate degree programs to help teach cell therapy along the way. We want to help these students become aware of it through training programs while they’re in school and internships. It’s been so successful, and it also helps us reach a more diverse population. We’re actually looking at carrying that into high schools.
We’re also trying to bring the patient journey every week into the organization. Diverse patients that we treat come and talk to our employees in the cell therapy labs and our offices, and give us their insights.
The third area we look at is our clinical-trial diversity. Our goal is to work with the organizations, academic centers, and treatment centers that are great at making sure that they recruit diverse populations so that we can ensure that we know the results of how our therapy works on different ethnicities.
Laura Furstenthal: In 2016, you put your career on hold and spent a year as a caregiver to your sister, who had multiple myeloma, a cancer that ultimately took her life. How did this experience change you and change the way you lead, if at all, as a CEO?
Christi Shaw: After caring for my sister in 2016, I had a whole new outlook on what it means to be patient focused. That includes simple things, like the amount of paperwork that’s placed upon a patient when they’re at their sickest. And the little things, like when they’re on so many medications and the color of their pill changes because the pharmacy is buying the medication from a different place.
And then there’s the point where the doctor walks in the room and gives you the information that he or she thinks you need, and then leaves the room. At that point, my sister said, “I have no idea what he said.” That’s an example of a patient not understanding scientific jargon. It’s very, very difficult.
So, for me, coming back to the industry after that experience has meant a huge focus on patients. In our meetings, we say, “How does this affect patients?” “How is this going to help patients?” Or, “I’m glad we fixed our problem. But we didn’t fix the patient’s problem.”
It has to be all about that patient journey, not just our sliver of it, not just the pharmaceutical industry’s point of view. My experience has made me understand it has to be about bringing that patient journey lens into focus from end to end.