The vision of precision oncology is to be able to look at a genomic or other test and know in advance whether or not a patient’s tumor will respond to treatment. In doing so, patients are spared from having to take treatments that may have little shot of working for their particular cancer. 

Caris Life Sciences is one of a handful of companies on the vanguard of developing such tests. These sensitive assays, known as molecular diagnostics, sequence a tumor’s DNA, RNA and proteins for a host of biomarkers. Results are then compiled into a report that clinical oncologists use to decide which treatments are best for their patients.

Many hospitals and regional labs can run next-generation sequencing tests in-house but choose not to due to the complexity and cost involved. “We went through a lot of trial and error…to get to the place where we are now,” said Michael Sullivan, SVP and chief commercial officer for the Irving, Texas, company. 

He spoke with me about the complexity of tumor profiling and its inherent marketing challenges in the greater context of the march toward precision oncology. Below is an edited transcript of our conversation.

Give us a quick summary of your background.

I’ve been in the diagnostic space for more than 25 years and have had virtually every commercial leadership type role there is, including sales and marketing, key accounts and corporate accounts, as well as global. The large majority of my career has been in clinical diagnostics, working with laboratories, diagnostic technologies and biomarkers. 

Which role(s) would you say have helped you the most in terms of preparing you for your current position?

I’ve worked for three major healthcare companies: Abbott, Johnson & Johnson and Roche Diagnostics. It was during my time at Roche Diagnostics that I was introduced to the concept of precision medicine and personalized healthcare in oncology. 

At Roche virtually all of my time was spent on oncology, but I had two roles which were specifically focused on companion diagnostics and collaborating with pharma companies to develop them. I had full P&L responsibility for a $1 billion business unit that encompassed sales and marketing for all of the on-market products and for the products in development. That was a great learning lesson for me in preparation for assuming the CCO role at Caris. 

I started my career in sales, and it wasn’t until perhaps midway through that I converted to marketing. Sales experiences are always very important to any commercial leader, dealing firsthand with customers and real customer issues. I’ve also been fortunate enough to have had both U.S.-specific and global marketing roles, in which I’ve been able to learn the differences in how the same products are messaged and marketed in different countries and different regions around the world, which is critical when a company has aspirations of global success and global expansion.

What’s your typical day like?

We’ve been in significant growth and expansion mode. So, with a large and growing sales organization, quite a bit of my time is spent focusing on sales-related activities, ensuring we’re doing what we need to do to meet and exceed objectives. I have been spending a lot of time with our marketing team, as well, on communication initiatives and strategies, to ensure that we’re getting the right messaging out to our customer base and to potential customers. I’m also involved in many corporate initiatives, working with our other senior leaders, be it in operations, R&D, regulatory or quality.

In what ways are you building Caris’ marketing function?

Caris was always very strong in social media and with social media channels. But we have spent a lot of time over the last year or so, focusing on that in an effort to increase our awareness across key audiences. And we really see the value and are investing in marketing resources. We’re building out our marketing teams, both in Dallas and in Phoenix, where our R&D and operations hubs are. And right now we’re focused on strategy, really understanding our marketplace to a greater degree, which includes better understanding our target audiences. 

Following our launch of a Whole Transcriptome Sequencing (WTS) offering, which looks at the entire RNA sequence of 22,000 genes, the first in the market, we’re also on the verge of several big launches in the next three to nine months: modifications to our current DNA panel, a germ-line hereditary panel, a next-generation profiling tool that applies our DEAN artificial intelligence to our library of cancer cells and—perhaps most significantly—a blood-based assay. 

Who is your customer and what are the particular challenges in engaging them?

Our core business is comprehensive molecular profiling, so the clinical oncologist is our primary customer in that they are the patient-facing clinician that will order a molecular profile from us or from someone else. But we have many other critical customers that are influencers in our business: the molecular pathologist, surgical oncologist, hospital administrators, members of ancillary affairs, billing, private and government payers, the FDA, etc. 

Some companies focus just on the therapeutics and the drug and, “Here it is. Good luck with it.” We put all of the pieces of the puzzle together and say, “Here are all of the available tests with those results and all of the therapies that those results point to that a doctor can then use to best treat their patients.”

The challenge of the last 10 years was developing a [genetic] sequencer that a regional hospital could purchase, install and produce a result. [Now,] the real challenge is actually interpreting the results, [and] ensuring that, number one, the instrument is processing with the sensitivity and specificity levels required to ensure that you’re getting the best result possible and that you’re covering the entire span of diagnostic results important to each patient. Then, you need a team of physicians and scientists to review and interpret those results and direct them to therapies. 

That is still a very challenging situation, one which many major academic medical centers are facing around the country. They have the ability to sequence in-house and produce results, but for one reason or another they’re not always able to produce the level of results in the way that their oncologist would like. And that’s because it’s hard. We’ve spent more than a decade building this specialty and refining it (not that we didn’t have our own trials, tribulations and learnings along the way) to the point that we now see 4,000 patient cases a month, a volume which enables us to do this in a cost-effective manner.

Currently just a small percentage of cancer patients undergo genetic testing. What’s being done to help bring it to the masses?

There’s still a big need for education and awareness in the market, and that applies to treating-physicians, researchers, payers and certainly to patients. A decade ago, there were no immunotherapies and the number of personalized therapies was almost nonexistent.

We’re still just barely scratching the surface in terms of what we will be able to do over the next 20, 30, 50 years in this space. As a result, the overall awareness among all of those key stakeholders is still very small about what molecular diagnostics is, what it can do and how it applies to some of these immuno- and targeted therapies. 

The number of [marketed] treatments that fit that descriptor are in the 10 to 15 range. But if you look at the pipeline of therapies in development, it is significantly more than that. Now the majority [of treatments] in oncology, at least, are going to be these targeted and/or immunotherapies. 

Some of the senior oncology executives we’ve spoken with are the first to admit that the large majority of their own practicing physicians don’t have a complete understanding of molecular profiling, molecular diagnostics, how it works, when to use it and what the results mean. Some of them have specifically asked Caris for help in educating their physicians about how our report can help them create a patient treatment plan, one which can last patients years if not decades.

We’re doing that through direct interactions in the field with our sales organizations and with our medical and scientific affairs group and our medical scientific liaisons. We’re very active in the community in terms of meetings, both domestic and international, so we’re trying to get the message out. 

We’re also broaching the idea of direct-to-patient communications. Because we know that at the end of the day, all patients want to know how they can get the best care, where they can go, [whether] all the questions have been asked and answered. You’re starting to see some messaging in our space about molecular science, molecular profiling and genetic testing. And we will get there. The other big bucket is around payers and trying to increase coverage.

Speaking of that, what does managed-care access look like for Caris? 

Working with CMS for Medicare coverage has been a focus of ours, and we currently have more than 45 different contracts—some of them with large, national private payers like Aetna and Humana—covering more than 182 million lives for Caris molecular profiling. 

That’s the positive news. The challenge is that there still are many payers who do not cover molecular profiling mostly because they don’t understand what it is. There’s still a lot of education that needs to be done [to distinguish what we do from what some of the reference labs do]. Coming from the traditional diagnostic industry, which has been in place for more than a hundred years, when you talk about precision medicine [developing] over the course of the last 10 years, we’re just getting started here and we’re just barely scratching the surface.

Marketing is moving toward expressing “value” vs. solely brand awareness. How do you express value to the clinical oncologist?

Since I’ve been here, I have continued to try to build on our strong value proposition. We utilize the most sensitive and the most specific technology that we can for patients, offer the broadest range of available results with the best quality, and also focus on the finest service and support that we can provide to physicians in terms of getting the results to them as quickly as we can. Those priorities help us provide the patient with the best possible result. 

Then, it’s a matter of being able to use facts and data (healthcare economics and outcomes data as part of market access) to communicate those differentiators and those value messages to our customers, whether it be through direct sales resources, traditional and conventional marketing, social media or public relations.

The vision of precision oncology seems far off, in that very few patients are benefiting right now. How else is the company preparing for that direction?

In the big scheme, it’s still in its infancy. That being said, when you think of the number of large pharma companies investing in this on the diagnostic or therapeutic side, a lot of effort is being deployed. For our part, this year we will run profiles on 50,000 patients, and that’s not insignificant. And when you expand that out to the market segment, it’s obviously more. We all know there’s more to do, but I’m encouraged by the growth and how fast it’s happening. We’re reaching tens of thousands of patients every year, but I also think about everything that we can and should do to try to reach more oncologists, alliances, organizations and, ultimately, patients. That’s why we get up every day and come to work. 

Caris is applying its AI technology, DEAN, to its library of cancer cells, an effort which ultimately could help to ensure more patients are eligible for precision medicine. Where do you see this evolving next?

We’ve developed next-generation profiling (NGP), which uses a deliberation analytics tool (referred to as DEAN) in an AI-powered platform to power analysis of outcomes and biomarker data. We use all of this to generate potential results that will help diversify our offering and improve the overall amount of information we’re able to provide to physicians and clinics. 

Our WTS assay encompasses about 22,000 different genes, the large majority of which are still research-oriented biomarkers. We’re constantly doing research, along with the assistance of our precision oncology alliance and key opinion leaders, to continue forging the new frontier of molecular science, DNA and RNA testing in particular. We have actually profiled almost 180,000 patients and have one of the most robust repositories in the world. 

What’s your most pressing task and what new commercial initiatives are you planning to roll out in the next six months?

I joined about a year ago, but over the last six to nine months we have tripled the size of our U.S. sales organization to approximately 150 people. Many of those people have come onboard within the last 60 to 90 days. And so one of the top priorities for us is implementing sales training, getting all of these new sales associates up to speed on our offerings and technologies.

We have also made the decision to implement as a customer relationship management tool, so that we can support our sales organization and approach our U.S. customer base from an organized and disciplined manner. We use the saying, “We’re building the plane while we’re flying it,” because our sales force is out there interacting with customers every day, but we’re also implementing new sales tools and training everybody to get them up to speed as quickly as we can.

We’re also focusing our marketing strategy by building out our lifecycle marketing team in Phoenix, adding more resources and working more closely with our R&D organization and our project teams there to develop new precision-medicine technologies.

Our marketing team has been working very closely with our Phoenix R&D team to launch the WTS product, and to create new materials for customers and for sales presentations. Development of our blood-based liquid biopsy assay is also picking up steam. We’re committed to bringing it to market and are building out a state-of-the-art laboratory that will serve as our R&D headquarters.

Why did you take the job, and what’s surprised you most? Is it what you thought it would be? 

No, it’s not what I thought it would be. It’s more than I ever could have imagined it would be.

I spent the majority of my career at large healthcare companies, international corporations that are developers of products, instruments and assays. And although I was not looking to leave Roche, I saw Caris as a great opportunity that was right in the space I’m passionate about, which is precision medicine, oncology and companion diagnostics. 

When I came here, I wanted to come to work for a rapidly growing company with a strong executive leadership team. My experience here over the last year has frankly surpassed all of my expectations. 

I don’t know anyone in my professional network that has been able to join a company in a senior commercial role and who’s been given the ability, authority and resources to basically triple the size of a sales organization, completely build out a commercial infrastructure and hire a specific leadership team to support a world-class commercial operation.

Every day is different. Every day is a challenge. And we’re just getting started.

This column will appear every Thursday. Got an issue or story tip related to healthcare marketing? Contact me at [email protected]