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Throughout her more than 20 years as a noted oncologist and drug developer, Dr. Vicki Goodman has been involved with some of the biggest cancer blockbusters in history, including Bristol Myers Squibb’s Opdivo and Merck & Co.’s Keytruda, and influenced treatment decisions while at the FDA.

Goodman joined Exelixis at a critical juncture, and she has her sights set on elevating the oncology biotech to become a global company with a productive and innovative pipeline. Exelixis’ flagship molecule, cabozantinib, has been successfully commercialized in multiple cancer indications and is in ongoing pivotal phase 3 trials, despite recent disappointing results associated with its CONTACT-01 late-stage trial evaluating the agent in combination with Genentech’s Tecentriq versus the chemotherapy docetaxel in patients with metastatic non-small cell lung cancer (NSCLC). Also in the pipes are XL092, which is a next-generation tyrosine kinase inhibitor; XB002, an antibody-drug conjugate; and XL102, a CDK7 inhibitor.

“It has been a challenge in shifting focus from having a single successful drug to growing a diverse pipeline across multiple stages of development, and then building a team to ensure we can capitalize on the promise of that pipeline,” Goodman said. “In the development of oncology products, we are seeing a lot more diversification of pipelines beyond the immuno-oncology checkpoints … and I think that the pipeline we’re building, including novel biotherapeutics such as antibody-drug conjugates, which can be directly targeted to cancer cells, as well as bispecific antibody molecules, holds a lot of potential in the field.”

Goodman’s journey has been influenced by personal tragedy — her mother succumbed to breast cancer just before she graduated medical school.

“I always think of the patients who have sons, daughters, wives, mothers, fathers — it just comes back to tying everything we’re doing is ultimately for the patients,” she said.

As executive vice president of product development and medical affairs and chief medical officer, Goodman revels in the diverse role, which traverses non-clinical development, clinical regulatory pharmacovigilance and medical affairs.

“There’s never a dull moment, and I like the breadth of challenges that I deal with on a daily basis; I’m somebody who really likes to have an opportunity to grow and learn,” she said. “I think all of the experiences I’ve had over the years — whether at FDA, GSK, BMS, and Merck — has positioned me very well to do this.”

In this episode of our Woman of the Week podcast, Goodman discusses her evolving journey bringing much-needed cancer therapies to market, how she learned to lead by example and how her father influenced her love of science at a young age.

Welcome to WoW, the Woman of the Week podcast by PharmaVoice, powered by Industry Dive.

In this episode, Taren Grom, editor-in-chief emeritus at PharmaVoice meets with Vicki Goodman, MD, executive vice president, product development & medical affairs and chief medical officer, Exelixis.

Taren: Dr. Goodman, welcome to the WoW podcast program.

Vicki: Thank you, Taren. It’s great to be here.

Taren: You have been in your current role for just about a year. Can you share what that journey has been like so far, and then talk about what has surprised you, delighted you, and challenged you.

Vicki: I have been in Exelixis just shy of a year now. I would say I really joined the company at an inflection point. It has been a challenge of shifting a focus from having a single successful drug to really growing a diverse pipeline across multiple stages of development, and then growing a team, building a team really to ensure that we can capitalize on the promise of that pipeline.

And I think that you can see some of that in terms of the change. That change is being reflected in the data releases that we’ve had this year. So for example, for cabozantinib, we had the positive top-line readout earlier this year for the first primary endpoint of COSMIC-313, which is a first line study in renal cell carcinoma and the first trial in RCC to compare a triplet combination with new standard of care doublet.

But we’ve also shared this year our first data for several of our pipeline molecules, so clinical data for XL092, which is our next generation tyrosine kinase inhibitor we shared at ESMO this year, which is the European Society for Medical Oncology, XB002 which is our first antibody drug conjugate. We shared promising data from dose escalation at the triple meeting ENA. And actually, this month, we’re sharing data for XL102 which is our CDK7 inhibitor, and that will be shared at the upcoming San Antonio Breast Cancer conference.

So in addition to that, with the pipeline shift, really, I’ve been very focused on expanding and building out my team and their capabilities. And I think a key part of that also has been the opening of a site here in King of Prussia, in the Greater Philadelphia area. So this has been a tremendous opportunity for us to build out and expand our talent base. Philadelphia has a tremendous amount of talent from the pharmaceutical industry with lots of people coming from a variety of different companies with some great experience. So really a great opportunity, again, to expand and to ultimately pivot to becoming a global company.

Taren: I would say that is very exciting. And you talked earlier about it being an inflection point. I remember when Exelixis had one product. And so this has to be a tremendously exciting time at the company. How do you harness all that excitement, yet knowing how dicey drug development can be?

Vicki: Right. So obviously, we’re coming out of this tremendous era of the tremendous success of PD-1 inhibitors within oncology. And I think the oncology field now, while of course, those continue to play a major role in the treatment and in the development of oncology products, you’re seeing a lot more sort of diversification of pipelines beyond the immuno-oncology checkpoints or building on those, and I think that our pipeline that we’re building, including novel biotherapeutics, such as antibody drug conjugates, which can be directly targeted to cancer cells, as well as bispecific antibody molecules. There’s a lot of potential remaining in the field.

So while the PD-1s have certainly changed the treatment of many cancers, there are still big areas of unmet need, and still patients who don’t respond. So I still see tremendous opportunity in the oncology field. And we’re excited about the pipeline that we’re building both within our own discovery efforts and through business development opportunities.

Taren: Fantastic. And congratulations. So tell me, you talked about you’ve been in the job for just less than a year. What’s the one thing that has really surprised you about your role there?

Vicki: So my role is quite diverse across all of development, so including non-clinical development, clinical regulatory pharmacovigilance medical affairs. So what I’m doing day to day can be quite varied. And so of course, there’s never a dull moment, but I just think that the breadth of the types of challenges that I deal with on a daily basis, I’m somebody who really likes to have an opportunity to grow and learn. So for me, that’s a key part of really, the attraction of this role is that I’m looking at it a number of different angles on any particular issue on any given day.

Taren: I would say, yes, you’re never bored. Every day is a new challenge, across a number of different fronts, I would imagine. With all that pipeline growth, you’re also having to manage talent growth too, as you said, looking into that Philadelphia area to recruiting new folks to come into the organization, which is a full-time job in and of itself.

So you have been very successful working in the field of oncology at some of the biggest names in the industry now, including Exelixis. What are some highlights for you? I know you’ve been involved in the blockbusters as well.

Vicki: So when I reflect back on my career, when I first entered oncology, when I was in training, the treatment for most cancers was pretty dismal. In fact, there were still faculty members when I trained who felt that the best thing that you could do for a patient with cancer that had spread outside of the primary site was really palliative care, no active treatment. And so that has changed entirely over the course of the last 20 years.

And I would say I feel honored to have been a part of that. I joined GSK as tyrosine kinase inhibitors, which targeted angiogenesis, so new blood vessel formation within tumors, were really just becoming prominent. So I had been involved in reviewing some of those agents when I was at the Food and Drug Administration, and then moved to working on pazopanib, which ultimately became Votrient.

And at the time, those agents were mostly being approved in renal cell carcinoma because of the known role that angiogenesis plays in that tumor and were being explored for a number of other diseases. And then I had a great opportunity to work on dabrafenib in melanoma which targets a particular mutation that’s present in approximately half of all melanomas, but again, radically altering the landscape of a tumor for which there had really been no treatment.

When I moved to BMS, it was right at the height of really the IO revolution, and in particular, as PD-1s were taking off with first approvals in melanoma. And I was fortunate enough to lead a team that was focused on developing nivolumab both by itself and in combination with ipilimumab in melanoma and genitourinary tumors, again, right at the time that that was really starting to take off, so seeing approvals in melanoma for both single agent and the combination, and then in renal cell carcinoma and in bladder cancer.

And in fact, I had a role actually, in collaboration with Exelixis at that time when I was at BMS where the study that became CheckMate 9ER and led to the approval of cabozantinib in combination with nivolumab in first line renal cell carcinoma, I designed that trial while I was at BMS in collaboration with Exelixis and the CMO at that time, Gisela Schwab. So that study led to global approvals of cabozantinib in first line RCC. So in a sense, I’ve kind of come full circle.

Subsequently, went to Merck, again, really building out, thinking about combination approaches for PD-1 inhibitor. So I feel that all of the work that I’ve done across these multiple companies has really set me up well for this role that I’m doing now, and again, come full circle back to working on tyrosine kinase inhibitors and immuno-oncology combinations, looking at novel combinations. So I’ve been really fortunate to be part of that revolution in cancer treatment over the last 20 years.

Taren: I was going to say you have been part of some of the biggest innovations in the industry. How does that feel to you? I can’t even imagine.

Vicki: Well, it’s tremendous. And I have to say that having had an opportunity to meet with multiple patients over the years whose lives have been changed by some of the medicines that I’ve helped to develop really has been one of the most touching parts of my career, just to see on a personal level the difference that these treatments can make.

Taren: Absolutely. And I do feel like we need to take a moment to talk about Gisela because we did lose her not that long ago. And I had spoken to her a couple of times, and she had been a PharmaVOICE 100. And so tell me about your interactions with her in those early days when you were collaborators.

Vicki: Yeah, Gisela was a wonderful person. Her loss is still felt at Exelixis. Loved by the team, loved by everyone at the company. Just such a genuine person, very kind person. And as a collaborator, I would say, really, a very collaborative person, easy to work with. We understood each other well, and each other’s points of view. And we could always work through any issues that came up, also just a tremendously dedicated person, always available, and very passionate about the work that she did, which really was something that shone through as I had my interactions with her.

Taren: Nice. Thank you so much. Appreciate that. As you said, you had made the leap to Exelixis from Merck. What gave you the courage to jump from Merck over to this still sort of fledgling global company?

Vicki: Yeah, so my time at Merck was wonderful. I was there for a relatively short time. It was about 18 months and it was during the heart of the pandemic so most of it was remote. But I did have the opportunity to lead a great team, to work on building that team, building the capabilities within that team, and obviously, with the Merck portfolio, balancing quite a bit, also looking at new pipeline assets, again, business development.

And as I said before, I think all of the experiences I’ve had over the years, whether at FDA, at GSK, at BMS, and then subsequently at Merck, I feel like positioned me very well to do this. And this was really about taking on a new challenge, moving beyond the clinical development space to a role, yes, at a smaller company, but with a broader scope. And again, knowing that the company was really at an inflection point, and the way that we work was going to need to change and we were going to need to build on leadership capabilities. All of it felt like the right role at the right time for me. And so I was really thrilled to have this opportunity to join Exelixis in particular, at this point in the journey, and really, again, build a great team and a great pipeline.

Taren: Exciting, so kudos to you. You touched on it a bit earlier, I want to expand on about, some of the time that you spent at the FDA. How does that give you an edge? Is it because you know what the regulators even before?

Vicki: Well, I mean, what regulators are looking for evolves over time. I will say that my experience at FDA, I often somewhat jokingly refer to as a second fellowship. It’s all of the things that you don’t learn in a clinical fellowship about how to develop drugs. So in clinical fellowship, yes, of course, we do research, we learn how to take care of patients but understanding the multidisciplinary aspects of drug development. And as a good drug developer, you need to know not only your area of expertise, but enough about the other areas of expertise in order to really work with other functions because this is a team sport.

So FDA taught me that, taught me how to work in a cross-functional group, taught me how to lead and influence in a cross-functional team, and really, I think made me aware of their particular challenges and how they think about things that are coming in. Of course, things change over time, initiatives change. You have to keep up with that. But I think in terms of putting on a regulator’s hat occasionally has benefited me certainly in terms of thinking about what their expectations might be and how we might meet them.

Taren: You started to say how you lead, but then you changed it to influence. That was an interesting nuance because there’s two parts to that, right? There is being a great leader, and then there’s having that ability to influence. How did you build up that influence piece of your portfolio?

Vicki: Yeah, so oftentimes in industry, you lead without authority. And so influencing becomes really your main tool. And so what I mean by that is, as you’re leading these cross-functional teams, the people that you need to influence, often the people on your team are not people who report directly to you. So you don’t have the managerial influence that you would otherwise.

And so you have to rely on influencing skills and you have to understand where the other person is coming from, what’s important to them, and think about the different tools in your toolbox in terms of okay, I hear where this person is coming from, and how can I address that and help influence them in the right direction, again, without the authority of being a manager?

Taren: Sure. Absolutely. And I just wanted to point that out because I do think that there’s a subtle difference there. So thank you for that. I appreciate it. If you don’t mind, I’d like to dig in a little bit to your personal story. I understand that you had an affinity for science at a very early age, and then your medical career was really influenced by a personal tragedy, the loss of your mother. Can you share a little bit about your childhood and what sparked your interest in science? And then how your mom’s tragic death led you to oncology?

Vicki: Sure. So yes, my passion for science started at an early age. Actually, I was very curious as a kid. My father was a science teacher in the public schools in New York City. And I asked a lot of why and how questions. I think I drove my mother crazy, and she always told me, go ask your father. I think at the age of eight, I asked him, how does the eye see color? And being a biology teacher, he started talking about rod cells and cone cells, and it got me very excited and I felt very grown up that I was able to understand what he was telling me.

And then his school had decommissioned some microscopes, and he brought one home, and it became kind of a treasured possession for me at a very early age. And so I did start to gravitate toward a career in the biological sciences but really wanted to marry that with helping people. And that’s how I gravitated toward medicine. And that was really cemented, I think, by my mom’s illness. She was diagnosed with breast cancer when I was a medical student, and ultimately, succumbed to breast cancer just a few months before I graduated, which was, as you might imagine, really challenging for me. I think that between my mom’s illness and seeing what she went through and how hard the treatment was, and how, in the end, it didn’t extend her life, and then my own clinical experience in medical school and then in residency and the dismal prognosis for so many cancers with so few treatment options.

But at the same time, knowing as a scientist and having worked in different laboratories, the understanding of cancer biology, leaps and bounds were being made, and it really kind of connected in my head is this can change, that we could have better treatments, we could develop better treatments for patients with cancer. And so that really steered me into oncology, and I think ultimately pushed me toward drug development as a career.

Taren: When you look back at those times and you think about how much progress has been made, it’s such a shame because your mom’s life could probably have been saved if she was diagnosed today.

Vicki: Yeah, I think we never know. And so when I’m thinking about my career and keeping myself motivated, I always think patients have sons, daughters, wives, mothers, fathers, and again, it just comes back to tying it back to the patient, and then everything that we’re doing is ultimately for the patients.

Taren: Absolutely. Just out of curiosity, that microscope, you still have it from your childhood?

Vicki: I wish I did. I moved so many times that I don’t know what happened to it. I was thinking about that not too long ago and wondering if it’s something that I haven’t unpacked, despite the fact that I’ve lived in my current house for 15 years.

Taren: I think we all have boxes that we just have attached to that log, so no judgment. Thank you so much for sharing that very personal story with us. And there’s so many words in there that are so poignant to everybody who’s listening. And let’s face it today, nobody’s life has been untouched by cancer at this point. So all those things that you say and about the patients and, and making a difference is so important.

And it’s why so many people go into medicine or oncology or the healthcare industry overall. So many smart people doing so many good things and working towards better cures, and I think this is a point in time to them. Twenty, twenty-five years ago, we used to say cancer and say current care at the same time, they were contradictory. But now, we are starting to talk about cures. Do you find that meaningful to you?

Vicki: I’m astounded by the progress that we’ve made over the last 20 years, and at the same time, just how far we still have to go, there are so many patients who– and people reach out to me all the time, people I know well, people I don’t know well, for help with a family member or a friend and someone who’s run out of options and is looking for a clinical trial. So I think what keeps me motivated in the end is knowing that there are still patients who are not being served by the current treatments and that we need to do better.

Taren: Understood. And I also think we’ve seen cancer move from this big holistic oncology space to it being really a personalized, almost like a rare disease because it’s so dependent upon the individual. And we’ve made such progress there as well.

Vicki: Well, cancer, it’s so many diseases and it’s been understood historically in terms of the histology, right? What’s the primary site of the cancer? So it’s lung cancer, it’s liver cancer, it’s kidney cancer. But even there, there are so many different varieties, only some of which we now understand. A lot of it is genetically defined, and understanding those underlying mutations or alterations in the tumor can help guide treatments, and certainly, treatments are being developed that are targeted at many of those, dabrafenib coming back to that and the BRAF inhibitor, which just made a dramatic difference in that particular tumor type.

And now, there are so many more, but it’s still ongoing. And so I think you’re starting to see, for example, lung cancer is a very common cancer, non-small cell lung cancer which is the most common variety. But in reality, there are many, many different subtypes with different mutations which already are helping guide treatment, and perhaps, in the future will help guide treatment for additional patients. But I think, again, it is so many different diseases. And as we better understand the underlying biology, I think we’ll be able to offer good medicines for more patients.

Taren: Absolutely, and I think you were seeing such strides being made towards those goals every day. In your current role, you are now in the C-suite, and just as a natural extension that you become a role model to other women. How does that mantle of responsibility feel to you?

Vicki: I embrace it.

Taren: Good for you.

Vicki: One of the things that was a little bit of a surprise to me, maybe as a somewhat introverted scientist, was the degree to which I really– well, I’ve always enjoyed teaching, but the degree to which I enjoy mentoring and mentoring other women in particular, and so that’s both within the company but also outside of the company. I’ve been involved in efforts to expand the role of women, even in the academic setting, into study leadership roles, creating ties between women in industry and women in academia so that we can help develop women in their career. So it’s something I’m very passionate about.

And if people look at me and feel if she can do it, maybe I can do it. I think that’s great. I’m at a point in my career where I really do want to give back to others and help others learn to become great drug developers, great oncologists. And so I embrace that, and it’s one of the things that gives me tremendous satisfaction.

Taren: Good for you. I’d love to hear that because we do see that so many of the best scientists have been coming out of academia. They don’t have that kind of clear vision and path to how they can get to that next level. So I love that you’re reaching back down and bringing some folks back up with you. You mentioned at first, did you have to return your career?

Vicki: So I’ve had multiple mentors in my career, several former bosses, who I maintain friendships with, I will say, in terms of one particular person who made a big influence on me. I think, as I moved from GSK into BMS, I was kind of at a moment where I was building some team leadership skills, but I saw myself first and foremost, really, as a technical expert, and he really helped me understand figure out maybe who I was as a leader and taking that leadership to the next level and that I had something important to share with others beyond the scientific aspect of the expertise. And so, I think that really opened my eyes a lot to the importance of great leadership and I’m very grateful for that.

Taren: Nice. What is some of the best leadership advice you’ve ever received?

Vicki: Be authentic. Coming back to that, so early days at BMS, and I was a vice president and development lead for Opdivo and Yervoy, I was one of three. My two colleagues were both male and very different personalities, but I think very outgoing personalities in terms of how they presented themselves and just thinking, gosh, what do I add to this when I get up on stage to talk about something? I’m maybe a little bit more of the dry scientist. And again, I mean, being pushed and said, no, you’re different. But people want to hear from you, from the authentic Vicki.

And so I embrace that and recognize that I did have something different to contribute. And it may not be that I’m the extrovert, but that I could really make a difference, not only in drug development, but in terms of people’s careers. And so I think that authenticity is really important for building trust and building relationships. And so I would say, that’s the most important piece of advice I’ve gotten in my career.

Taren: Absolutely. And the fact that as an introvert is you know that as you self-described yourself to be. That’s a tough transition to move outside of that internal kind of space and become an external conveyor of information. So kudos to you for making that leap and doing it comfortably. I don’t know if I did it comfortably, but you did, so. You also joined the group called Chief. What does this organization bring to your world?

Vicki: A great network of women. I’ve only been for a few months, but it is kind of an instant network. And I think that it’s women across different industries, but who nevertheless are facing similar challenges in terms of leadership, in terms of just things going on in the world, like post-pandemic, returning back to the office, just an opportunity to connect with other senior women in their fields, bounce ideas off. I’ve connected with several of them on a number of different topics. I’ve attended some of the chief programming. I hope to attend more in the new year, but I think that networking and building relationships with women and other industries has been really helpful to me. Although not specific for my role, I think, again, just building a group of people you can bounce ideas off of has been very helpful.

Taren: Fantastic. Thank you. When you’re speaking with other leaders, what are some of the top concerns they have or you have, as you look ahead to 2023, 2024? Is it still coming out of the pandemic? Like, what’s top of mind for you in terms of some of your leadership and strategic goals?

Vicki: Yeah, I mean, I think, for me, it’s still all about talent, and you can have a great pipeline. But at the end of the day, if you don’t have the right people to develop it, you’re never going to realize the potential of that pipeline. And I’m sure that’s true across all industries. So thinking about how to build the best team, how to develop that team, we’re growing fast, so bringing people together for the first time, you’re bringing people from diverse backgrounds, diverse companies, places, and for them to become a team, I think is a really important part of it.

So it’s still pretty tight in terms of attracting talent. There’s much more of a sense out there that people want to, for some reason, continue to work remotely. And so I think that bringing people back into the office because I really do think that’s an important part of building a company culture, and especially for a company that’s growing and developing like ours, and building that great team because we’ve got a lot ahead of us, I think, a lot of great work ahead of us. But we really need to grow and maintain the talent that we have in order to be able to develop those pipeline assets.

Taren: Gotcha. It is a delicate balance because you’re right, there are some folks who still– they figured it out during the pandemic, how to be able to be great at their job and be home instead of being in the office. And they figured that out that work-life balance, but certainly, building that company culture. And the flip side is you know that it’s also so important. So it’s not an easy task that you all have ahead of you as leaders. You’ve touched a couple of times upon team building. What are one or two of your best tips on building a highly effective team, a high performing team?

Vicki: Yeah, so one, I think it is really important to bring people together and develop a common understanding of where we’re going. I’ve thus far and plan to continue to do this, brought my leadership team together so all of my executives twice this year, and I plan to do that twice yearly going forward. It’s to think about where we’re going, identify things that we continue to need to work on, build leadership skills and capabilities. I think all of that’s important.

But also aligning on a mission, I mean, when you think about the mission that we have, really to help patients live longer and better lives, right? And so that is so fundamental to building a great team. When you think about, when you’re tying the work that you’re doing on a given day to that higher mission, I think that is really critical for building up a high performing team.

Taren: Fantastic. Thanks for sharing that with us. Your 20-plus career, which has been extremely successful, you’ve had a number of significant demarcation points, the loss of your mom, the launch of a couple of blockbuster oncology drugs, but is there a wow moment in your career that either changed the trajectory of your career or has left a lasting impression on you? Can you narrow down to one?

Vicki: Well, if I’m going to narrow it down to one, I’m actually going to go really far back. And I’ll go back to my clinical training. And it’s coming back, Taren, to what I talked about a little bit earlier about that sort of aha moment, that treatment for cancer was dismal, but there was a brighter future ahead. And it was really after the approval of what’s now Gleevec (imatinib) in CML, a rare type of chronic leukemia.

And starting to see patients who, I mean, there were no treatments for this disease. A couple of things that you could do that were palliative, none that extended lives, and then you come in with this treatment that was targeted directly for the particular molecular aberration and that particular leukemia. And the responses were so dramatic and long lasting.

And to the point you made earlier, we were whispering about the potential for cure. I mean, we didn’t know at the time, but there were whispers. Could these patients be cured? How long do we have to continue treatment? Can we stop at some point?

And it just kind of set off a light bulb for me, I mean, all this talk about personalized treatment and targeted treatment. And it certainly stood out in terms of the efficacy, the tremendous efficacy in that small population of patients, but again, it was the way that cancer treatment was so dismal. But on the other hand, how understanding the biology of cancers could really dramatically change the treatment. That was really the aha moment that steered me toward drug development. And so yeah, I think in terms of pivotal career moving changes, I think that’s the one that sent me from thinking I was going to do clinical medicine, ultimately, into drug development.

Taren: I think that is an excellent wow moment. Wow. I’ve talked to a couple of folks who have noted that as well. That was like the turning point for oncology. And it just started to unlock, as you said, so many possibilities. I got chills when you’re talking about that. I find it to be fascinating that there is a single moment that can change your perspective, to then change hundreds of thousands of lives. So thank you so much for sharing that story with us.

Vicki: Thank you, Taren.

Taren: Vicki, thank you so much for being part of our WoW podcast program. It has been such a delight to meet you. And I wish you great success in continuing to lead Exelixis into really a global company focused on treatments for underserved patient population. So thank you so much.

Vicki: Thank you, Taren. It’s been great having an opportunity to speak with you today.

Thanks for listening to this episode of WoW, the Woman of the Week podcast. For more WoW episodes, visit PharmaVoice.com.