February 2021

Answering the ‘why, when, what and who’ when launching a Companion Diagnostic

Ken Ruppel, VP of Precision Medicine and Companion Diagnostics, Amplity Health

The immerging segment of immunotherapy

I recently saw a statistic that stated it can take up to 4.5 years for a biomarker to reach an 80% testing rate among patients. Looking back over my experience working in Precision Medicine in the last decade, this seems about right. HER2, KRAS, BRAF, EGFR, to name some of the big ones, took several years before they achieved what may be considered peak testing rates for those tests in their respective areas of focus. Don’t let me stop there – what about one of the largest companion diagnostics to come out in the last five years – PD-L1? Peak testing rates for this biomarker accelerated beyond anything we have seen: testing rates began accelerating in 2016 and within a year, year and a half, was reaching testing rates consistent with proven biomarkers in the space; 70-80% of all patients in this disease state where tested with PD-L1.

You might be thinking, “Yes, this biomarker was and is associated with a blockbuster therapy, a class of therapies that have ushered in a new era of precision medicine.” What’s interesting is it also should have ushered in a new way of thinking for pharmaceutical companies launching a therapy with an aligned companion diagnostic. Why hasn’t the latter occurred?

The drug in the example above was a ‘once-in-a-generation’ therapy. Sure, but was it when it was first launched? Was the industry fawning over the therapy and the biomarker that went along with it? Was the parent company known for several successful, large oncology therapeutic launches? Not exactly.

In 2016 there was a struggle for which therapy would accelerate and capture the immerging segment of immunotherapy. It was an epic battle of all-comer strategy vs. precision medicine: large, historical oncology-focused pharmaceutical companies vs. a bit of a newcomer to the world of oncology. Launch strategies developed and implemented – market was flooded with messaging around why one approach was better than the other. Confusion was the name of the game back in 2016: do I test, what test, what instrument, is it required, is it helpful, companion vs. complimentary? It was a very muddy landscape of marketing messaging and maybe for the first time in our industry, tweets favoring one approach vs. the other. Truly a fascinating time in our industry. In some ways, this therapy’s overwhelming success overshadows the precision medicine approach required to allow a drug to emerge, accelerate, and meet premarket expectations.

The four simple areas that must be considered when launching a precision medicine therapy: why, when, what, and who

Developing strategies and personnel around these four keys should be front and center for every brand team, marketing team, and commercial team within pharma. Thinking about these in the context of precision medicine is new. It requires a deep understanding of the entire timing, process, and players needed to capitalize on a precision medicine approach.

“Why”

. The why behind precision medicine starts the process. It comes before the timing aspect because we need to understand its advantages to a precision medicine approach. Understanding “Why we are doing this” is a cultural shift that needs embedded throughout the organization. It needs to be anchored to the core tenant for all healthcare companies, the patient. Precision Medicine provides a tremendous opportunity to patients. Every ask we generate for our internal teams and our customers has to be centered on the why. For a diagnostic, the why behind the testing needs to be vividly clear to those doing the test. The why behind reimbursement needs to be vividly clear to the payers. The why behind everything we do needs to focus on the patient.

“When”

. Historically, this is the question Pharma has most often gotten wrong. The process of a precision medicine launch should start much earlier in the product life cycle than currently occurs today. We don’t want that “oh no” moment when the FDA informs us we now have a companion. We want to plan for this early on and develop our strategy as soon as possible. The timing allows thoughtful consideration to the “what” and “who”.

“What”

. It needs to be understood that Precision Medicine is a key or a process to unlock a therapy’s potential. Precision medicine is a process, not a product. The therapy will always be king. The Precision Medicine process must be embraced throughout the product life cycle. We need to think about the right patient, the right therapy at the right time, but we also need to think about the right message, to the right stakeholder, at the right time. Developing your “what” takes time and understanding of the therapy’s journey, the diagnostic, the specimen, the decision-makers, and the influencers.

“Who”

. This one is often overlooked. We understand this at various levels. We tend to target treaters, and rightfully so. But in precision medicine, it is much more complicated. Understanding the entire landscape is key, and each “who” needs to understand the “what” and the “why” associated with the patient, not their role. Remember the therapy is king. Not because it’s what we are promoting but because that is what impacts a patient. The what message closely aligns to the why and is different for every who. One last part in the “who” category. Who should deliver the what and why messaging? This is where we need to evaluate the messaging and impact on the overall landscape continually. This is a critical consideration and one that is often overlooked. It is imperative that we address who is delivering our message and the best characteristics for that person to interact with our target audience.

Now what?

Amplity has spent the last 5 years evaluating the process, understanding the triggers that have repercussions on precision medicine launch performance. The four “W’s” create opportunities to accelerate awareness and accelerate performance. We have developed workshops to focus our pharmaceutical partners on understanding in in-depth detail these fundamental principles. When you’re ready to partner on bringing a Companion Diagnostic to market alongside your therapeutic, we’re here to help. Start the conversation by emailing our Precision Medicine business analyst, Taylor Horsfield.

Meet the Author

Kenneth Ruppel

VP, Precision Medicine and Companion Diagnostics

Through his work in the laboratory setting as well as partnering with pharmaceutical companies to launch their products, Ken has had a hand in the commercialization of nearly all of the companion diagnostics on the market today.

Ken first began his diagnostics career in the clinical laboratory over two decades ago, supporting the launch of many commonly used diagnostics for cardiology, women's health and urology. Growing in his role, he began supporting the launch of expanded lipid panels, Thin Prep, HPV and Urovysion, quickly becoming a leader within his organization.

Ken then accepted an opportunity in a small, upstart oncology reference laboratory. He participated in the launch of many new assays and began his work with the companion diagnostics Her2, KRAS, EGFR, ALK among others, growing the lab to ultimately become the United State’s largest single-center breast cancer testing faculty.

Ready for a new challenge, Ken began leading a new business venture working alongside the pharmaceutical industry to provide oncology testing for clinical trials. With his network of stakeholders and Key Opinion Leaders and his Commercial experience, Ken began developing the strategy the industry now recognizes as being critical: aligning commercial therapeutic launches with a diagnostic.

To help pharma execute on this strategy, Ken joined Amplity in 2016 and has since supported the launch of over 15 indications with a companion diagnostic across multiple methodologies. Throughout Ken’s experience in both the commercial and laboratory setting, Ken has developed deep, collaborative relationships with Key Opinion Leaders (KOL) throughout the industry, providing Amplity’s clients with a rich opportunity to gain the attention and support of many KOL’s.