In this new era of personalized medicine, matching the right patient with the right targeted therapy requires pharmaceutical and diagnostic companies to reach across industry lines and collaborate long before launch. Together, they need to create a strategy that enables the companion diagnostic to differentiate and accelerate the therapy rather than impede its growth. I’ve witnessed a few ways that these entities can create a go-to-market strategy in unison and carry that tight-knit collaboration all the way to market. To illustrate the inherent challenges, let’s consider the case of two fictional oncology companies that have entered into a research and commercialization agreement: Pharma Depot Co. and Diagnostics “R” Us Inc.
While successful and experienced in their own worlds, Pharma Depot and Diagnostics “R” Us lack experience in co-launching their products. Given the small number of such tandem launches, both companies rely on their trusty launch playbooks, failing to align their efforts. With a rich arsenal of resources, Pharma Depot overlooks the wealth of customer knowledge that Diagnostics “R” Us brings to the table. As a result, Pharma Depot misses out on an opportunity to differentiate its product and help providers, patients and payers gain clarity in an increasingly complex market.
As this example points out, separate “divide and conquer” strategies can produce suboptimal outcomes and thereby slow the evolution of diagnosis and treatment paradigms critical to personalized medicine. Some pharmaceutical and diagnostic companies have recognized the value in proactively acknowledging and addressing their key differences in peak sales and margins, exclusivity periods, launch resources and objectives, and development and regulatory timing, to name a few. Here are four key strategies for coordinating therapeutic and companion diagnostic launches, and what it would look like if our two fictional companies had leveraged them:
- Put plans in motion earlier with integrated custom launch playbooks. Pharma Depot and Diagnostics “R” Us start the planning process during phase II of the clinical trial to be better prepared for the complexities of co-launching two products. The companies create one custom playbook that accounts for the nuances of each launch, including additional work streams, a more cohesive strategy and unique strategic imperatives. They establish a plan to proactively address potential tensions stemming from their differences.
- Expand the patient journey to create value propositions that resonate. To ensure the rapid uptake of its therapeutic—and get ahead of competitors—Pharma Depot focuses on accelerating the adoption of Diagnostics “R” Us’s new companion diagnostic. To do so, Pharma Depot expands the patient journey to include a “sample journey,” or a detailed account of what happens once the patient has given a sample. This approach helps the company identify all of the nonclinical barriers that impede diagnostic adoption and to determine key messaging for new diagnostic customers. With a better understanding of the role that tumor boards, medical oncologists, surgical oncologists, laboratory directors and pathologists play in purchasing discussions, Pharma Depot and Diagnostics “R” Us create value propositions that resonate with each of these stakeholders to drive better adoption rather than using a “one size fits all” approach.
- Cross-pollinate expertise and boost team empathy. The two companies build capabilities and empathy in each other’s industries. While this can happen through many mechanisms, such as buying a company, hiring industry experts or creating a separate and dedicated business unit, the result is the same: Each company creates a launch team with personnel that has expertise in diagnostics and therapeutics. Pharma Depot and Diagnostics “R” Us now have people who understand the differences between a 510k and PMA, CLIA certification and FDA approval, complementary and companion and CPT and miscellaneous coding, and who recognize trends in oncology treatment, relationship dynamics between labs and providers, and a host of other issues specific to personalized medicine. When expertise and empathy increases, friction between the two entities decreases.
- Focus resources on the patient, not the product. In preparing for and resourcing a successful tandem launch, both companies consider how value-based pricing and market access might affect the diagnosis and treatment continuum. Amid an increasingly complex testing environment, Pharma Depot invests more heavily in educating the market on the diagnostic and establishing partnerships with centers of excellence to help shape standards for diagnosis and treatment. Diagnostics “R” Us ensures that the launch of its companion assay benefits its platform technology and collaborates with Pharma Depot to create diagnostic liaisons to assist with its commercialization efforts. The two companies work together to match the right patient with the right diagnostic that leads to the right treatment option.
As personalized medicine continues to gain traction, therapeutic interventions are becoming more specific and tailored to individual patients and increasingly reliant on diagnostic tests to help physicians select the right drug for the right patient. Successfully launching drugs and diagnostics in tandem is still a work in progress, and companies are at different points in their maturity. By collaborating from the outset, pharmaceutical manufacturers and diagnostic companies can combine strengths and establish a true partnership that will lead to a successful dual launch and better patient outcomes.