As part of our ongoing series of interviews with healthcare pioneers, we’re delighted to present Kimberly Popovits, Chairman of the Board, CEO, and President of Genomic Health. Ms. Popovits currently sits on the boards of the California Life Sciences Association (CLSA), the Personalized Medicine Coalition (PMC), the American Clinical Laboratory Association (ACLA), and MyoKardia, a precision medicine firm focusing on cardiovascular disease. In this interview, we discover how audacious thinking, risk-taking, and the quest for once-impossible scientific breakthroughs are positively reshaping the lives of cancer patients.

SLONE PARTNERS: Genomic Health is recognized as a trailblazer in molecular diagnostics. When you first started in 2000, what challenges did you face?

KIMBERLY POPOVITS: It was almost serendipitous. I often think if we had launched our vision with a traditional diagnostics mindset, we would have been discouraged to believe what we were trying to accomplish was possible. The business model for high-value, high-complexity molecular diagnostics wasn’t yet proven. When I queried folks at Genentech and in the industry and laid out what we were attempting to do – from a technical, clinical, and business perspective – most responded with, “It sounds great, but that’s about 20 years from now.” Looking back, they were probably more right than wrong. Disruption that is truly transformational often takes decades to reach a tipping point.

I was interested in joining the Genomic Health founding team because we had the experience in both drug development and commercialization to drive a new industry forward. At Genentech, we were looking at a pipeline of incredibly targeted therapeutics, yet the reality was that they would never reach patients unless we found a way to determine who would benefit from them. I sat on the product development committee when Herceptin was being developed and knew the drug would not have made it to market without finding a diagnostic solution to identify those patients who overexpressed HER2.

By the time Genomic Health was forming, this experience was fresh in my mind and I believed that if we could be successful in developing a genomic solution, we would have a much better shot at getting the potential targeted therapeutics in biotech pipelines to market. I recall our mantra from the beginning was; “How can we call a drug “targeted” if it only works on 20% of patients that get it and we have to treat 100% to find the 20%?”

This was the problem we were trying to solve.

SLONE PARTNERS: That’s a small number of patients who actually benefit. Can you expand on that?

KIMBERLY POPOVITS: Looking back at 2000 when we started, we knew we had a completely new and unproven business model. We knew that we were going to be faced with the challenge of changing a standard of care that was well embedded into medical practice. For example, in early-stage breast cancer, most patients at that time received chemotherapy even though the clinical data showed very few actually benefited. In fact, the data supports that only 4 in 100 patients benefit from chemotherapy in early-stage breast cancer. As a practice, chemotherapy was offered to every patient because, short of knowing who the 4 in 100 were, a physician did not want to tell a breast cancer patient that there was nothing they could do if there was even a small chance chemotherapy could prevent their disease from recurring. When we launched the Oncotype DX® breast cancer test, more than 70% of women with early-stage breast cancer were receiving chemotherapy.  Our goal was to determine an approach where only those who would benefit most would receive chemotherapy. That was the premise around the founding of Genomic Health.

When we built our first test, our second test, and our third test we started with a very specific clinical question that was of the utmost importance to physicians and the patients that they were treating. With breast cancer, it was “Do I need chemotherapy?” With colon cancer it was, “Do I need aggressive treatment beyond surgery like chemotherapy?” With prostate cancer it was, “Do I need aggressive treatment like a radical prostatectomy or radiation therapy?”  You must ask important clinical questions. If you do that successfully you will have an actionable result and an actionable product.

What has really plagued this industry, since 2004 when we launched the breast test, is reimbursement. What we know from payers is that they do not want to reimburse for information that isn’t actionable. An example of that would be if you were to sequence your entire genome and hand it to your physician, it could create a lot of fear and confusion that potentially could lead to a diagnostic odyssey. You would likely find out that you have mutations that are not linked to anything actionable, so what do you do next? Lose sleep, worry, and eat differently? The lack of actionable information is what payers are worried about and we as an industry must address that.

I also think recognizing that we were attempting to change a standard of care that was cemented in clinical practice was important.  In 2000, the human genome had been sequenced, we knew that cancer was a molecular disease, and the question that our founder Randy Scott was asking is, “How can we understand all of this and not be doing something different in terms of how we’re diagnosing patients with cancer?” We treat them all the same and yet we know that we could be looking at their individual tumors as a signature to guide them to more effective treatment. Our goal was to end the “one size fits all” treatment of cancer.

SLONE PARTNERS: What specific changes have you had to make in recent years to be able to bring your new products to market?

KIMBERLY POPOVITS: Reimbursement is the number one thing that companies need to think about. Once the breast cancer test was successfully reimbursed by all major payers, it was expected that other tests, such as colon and prostate cancer, would be easier to get reimbursed.  Unfortunately, this is not the case which continues to make reimbursement a top priority.

Another thing that we have had to successfully navigate is global scaling. The diagnostics business has not historically been a global business. In order for us to be able to serve patients around the world from a lab in California, we had to figure out a global approach and how to scale toward that end. Although we are not yet where we want to be, we have made great progress. Scaling the company, in general, and then scaling to serve patients around the globe is a big challenge. It is something we continue to focus on.

We also continue to face the challenge of getting new technology integrated into oncology practice guidelines. When dealing with various third-party groups that evaluate new technology, we need to work with them to determine what they are looking for in their assessments. A lot of focus is around actionability and education that needs to occur with both the payers and physicians in order to move to a new standard of care.

SLONE PARTNERS: What else are you thinking about, not just regarding Genomic Health, but about other companies in the precision medicine space? Do you think that the new administration is going to impact this thinking in terms of regulatory bodies like the FDA, and do you see that as a supporting process or a hindrance? What is your general philosophy towards policymakers?

KIMBERLY POPOVITS: I think this is one where we, as an industry, must come forward with solutions and resources to help move the field forward. I am really pleased to see the change in just the last 3-5 years around the conversation of precision medicine.  It’s center stage and global, as evidenced by initiatives like the Moon Shot and national sequencing programs.

The barrier we’re going to face is that it cannot be done in a siloed manner. All of the data that is generated has to be shared in some way or we won’t ever achieve the full potential of precision medicine. I think that people are aware of this issue and are trying to figure out the best way to make this happen. How do we incentivize the sharing of this data and information for the greater good of patients around the world? I also think that we have to put policies in place. There is a lot of work being done by a lot of different companies and academic institutions. We need to know what the truth is in sequencing and we need standards to evaluate the impact. This work is ongoing and supported by many stakeholders.

Everybody recognizes that our healthcare system is broken. One of the key elements to fix it would be better initial diagnosis of disease, better allocation of resources, and recognition of value across our healthcare system. This is what we have been pushing for in the last decade. It is not just diagnostics; it should be everywhere. If we are going to charge thousands of dollars for a diagnostic test, we should be accountable for demonstrating that the test delivers enough value to justify paying for it. The same standard should apply for every aspect of healthcare. Genomic Health committed to this early on. We spend a lot of our time and resources on demonstrating economic value, cost-savings to the healthcare system, and benefit to patients. Historically, our healthcare system has not rewarded accurately diagnosing disease up front, this needs to change.

SLONE PARTNERS: What are some of the most promising areas of genomic testing?

KIMBERLY POPOVITS: This is when it gets promising and where I get really excited. I feel at Genomic Health, we have forever changed the way early-stage cancer is being treated. I’m extremely proud of this and I am really happy for the patients and their families that we’ve been able to serve and help over the last decade. I feel like this is just the beginning.

Until now, Genomic Health has been focused on patients who have already been diagnosed with early-stage cancer. Our next phase is about helping those patients who recur or get diagnosed with later-stage disease. Looking at how we can do a better job of guiding these patients to the next best treatment without wasting a lot of time and money experimenting with drugs that potentially aren’t going to work is a critical need. This is the emerging field of companion diagnostics, it’s one where there is a lot of interest and a lot of promise. If we’re going to put a patient on a therapeutic that costs $100,000 a year, imagine being able to figure out within weeks if they are actually responding to that drug based on their blood versus waiting months to do a pet scan.

Another promising area of genomics is screening. Imagine if we could take the “it’s broken, let’s fix it” mentality and get to a place where we shift to predicting what is likely to happen and then prevent it or alter the course of what could be coming.  I use heart disease as an example.  We did not cure heart attacks, but what we did do is develop a way to anticipate heart disease. We have made progress in managing heart disease by understanding who is most likely to develop heart disease.  I think that is what we are now doing with cancer, and the way to do it is through genetics and genomics. This is where we need to go and it is exciting that the technology is here to make it happen.

SLONE PARTNERS: Looking back in time, how did you get to Genomic Health, and what inspired you to go on this journey?

KIMBERLY POPOVITS: I have had two major components to my career – a Genentech/Genomic Health story. Before going to Genentech, I was in small molecule commercialization with a big pharmaceutical company. When Genentech contacted me back in the 80s to join them, I distinctly remember speaking with them and thinking about how amazing the potential of biotech was.  If it were to happen it could be game-changing and I had this feeling of ‘I want to be a part of something that big.’ I remember when I talked to my advisors –I call them my internal Board of Directors – their voices were unsure. I had a two-week-old baby and a growing career with a great company, yet I remember thinking that it was going to be predictable – not the baby, the career. I felt I knew what my next move was and didn’t know if it was really that exciting. The reason I bring this up is because it was the same feeling I had when Genomic Health contacted me 15 years later.

When I met Randy Scott and asked about what he was thinking of doing at Genomic Health, I had that exact same feeling again. I was thinking this would be transformative. I have personal experience with family and cancer, we all do. I had just gone through the Herceptin experience at Genentech and I thought ‘This sounds like Star Wars again,’ but if it could work we would forever change the way cancer is treated. I knew it was risky, but what was the worst thing that could happen? If it failed, was that a bad thing? I would have learned a ton; we would have made some discovery somewhere. Randy is an extraordinary entrepreneur and visionary and being able to connect with that vision and mission and wanting to be a part of executing on it was just really exciting to me. I remember saying to him one day that I never thought of myself as an entrepreneur or visionary. I was surrounded by people like Randy and Art Levinson at Genentech, and thinking, ‘Wow, these people see things few others can see as possibilities.’ Randy said to me, “You are more than you think you are, but beyond being a visionary, no one executes like you do.” You can have great ideas but you have to build a team that shares the mission and vision and you’ve got to pull together players that can execute on it. One of the things that Randy always said was, “Knowing what role you’re playing and what you do well is so important when you’re trying to change the world.” I have always said that to my team – know when to get out of the way, know when you are at a critical juncture, when you don’t have the expertise, and set your ego aside to discover the path forward.  We have done that all along at Genomic Health.

SLONE PARTNERS: Is there anything that you would like to add?

KIMBERLY POPOVITS: It’s still a tough business model. The path to reimbursement is not as predictable as we want it to be and how we ultimately are regulated as an industry is still an unanswered question. One that we as the stakeholder community, need to continue working on. I really feel our industry is going to be the solution to the healthcare issues we face, while also being the solution to how we develop better medicines for patients in all therapeutic areas.  We are going to start treating individuals as individuals and not by the name of their disease. If you’re signing up for molecular diagnostics, you’re signing up for everything I mentioned here, or you’re not going to be successful. Clinical evidence and demonstrated value matters; we owe that to patients.

About Kimberly Popovits

Committed to changing the paradigm of cancer care, Kim Popovits has led Genomic Health in revolutionizing the treatment of cancer through genomic-based diagnostic tests for breast, colon and prostate cancers that personalize and optimize treatment decisions. Kim has served as Genomic Health’s Chairman of the Board since 2012, and Chief Executive Officer and President since 2009. She was President and Chief Operating Officer since joining the company in 2002. Prior to joining Genomic Health, Kim served as Senior Vice President, Marketing and Sales at the biotechnology company, Genentech, Inc. During her 15 years at Genentech, Kim led the successful commercialization of 14 new therapies, including Herceptin®, the revolutionary targeted treatment that changed the way doctors treat a particularly aggressive form of breast cancer. Kim currently serves on the boards of the California Life Sciences Association (CLSA), the Personalized Medicine Coalition (PMC), the American Clinical Laboratory Association (ACLA), and MyoKardia. Kim is also the President of The Coalition for 21st Century Medicine. Kim’s contributions to the science and commercialization of the biotechnology industry have been acknowledged by multiple organizations including being named Most Admired CEO in 2014 and one of the Forever Influential Women in the Bay Area by the San Francisco Business Times. She was also named Woman of the Year by Women Health Care Executives in 2008, received the Ferolyn Powell Leadership Award from MedTechWomen in 2016, and received the Salute to Excellence Award from the American Liver Foundation in 2017. Kim holds a Bachelor of Arts degree in Business from Michigan State University.

About Slone Partners

Slone Partners delivers the leaders who build amazing organizations – People Are Our Science™. Since 2000, Slone Partners specializes in delivering world-class C-suite leadership, executive, and upper management talent to the most promising and established life sciences, research, diagnostics, precision medicine and laboratory services companies. With coast-to-coast presence in the most active healthcare industry hubs of Boston, San Francisco, Los Angeles, San Diego, Dallas, Research Triangle Park NC, and Washington DC, Slone Partners uniquely and precisely provides an array of executive search and advisory services to exceptional clients. Our full suite of services includes identifying, negotiating with, onboarding, and relocating talent, in addition to post-placement mentoring, success monitoring, and culture fit services.

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Edited on 7/2/2023