Don’t Wait for Data

As biotech goes through one of its cyclical downturns, a trend that had started about a decade ago is intensifying: the commercial team is waiting until after their registration enabling trial reads out to begin launch planning. (Or, in extreme cases, the company is waiting for data to hire a commercial team!) This is an understandable temptation, but one that ought to be avoided, for a number of reasons.

First, there are many critical activities that are not dependent on data. Fully understanding the current competitive landscape, prescribing habits, the payer environment and the patient journey are all time-consuming activities that are critical to successful launch planning. If the team has strong insights in these areas when the data becomes available, they won't find they have unanswered questions when it comes time to settle on the brand's positioning and go-to-market strategy.

Second, even decisions that will depend on data to be finalized can be prepared for in the absence of final data. Many in the industry seem to have soured on scenario planning, because it is often too complex and specific. There is no reason to develop highly specific scenarios in most cases: we usually find three suffice. Plan for a "base case" approval with the level of efficacy that you would need to justify approval, a "best case" that represents the realistic hope for what the data looks like if most things go right, and a "challenging path" scenario that combines your base case efficacy with a more difficult side effect profile. Don't worry about secondary endpoints, and don't create scenarios for different competitive activities unless there is something a competitor could do that would completely change how you approach launch in your base case scenario. Remember, you aren't doing scenario planning so you know exactly what you'll do when you get data: you're doing it to have thought through what the future might look like so you can make faster decisions when you know your actual data.

Third, an increasingly large share of medical brands do not "sell themselves", even if their data is strong. Physicians are so busy that if they aren't thinking about your disease state and the problem you solve before your launch, your launch might not really break through. I recently worked with an oncology brand that had launched a few years before with good data in a tough-to-treat indication, but their customers weren't thinking about the mutation the drug targeted and neglected both testing and talking to their patients about the possibility of targeted treatment. If they had prepared the market more effectively for their innovation, they might have created a testing habit and changed their launch trajectory.

Finally, people talk. The opinion leaders that will greatly influence the uptake of your brand are talking to colleagues, researchers and your competitors about how they see the field evolving, what future approaches seem most promising, and what the key problems are that they're concerned with fixing. Showing up strong at conferences in the years leading up to launch builds key relationships and helps create momentum around your innovation. It is also advisable to do KOL and relationship mapping before launch to understand how ideas spread through the physician community.

Marketers who try to address all of the above hectic months between data availability and brand launch are inevitably spread too thin, and have to make painful tradeoffs between different pre-launch activities. Maybe that's why McKinsey found two-thirds of launches underperformed pre-launch sales predictions.

We know that it can seem prudent to hold off on investing in launch preparations until it is clear that your trial has been successful. With investors pulling back and the regulatory environment looking less favorable, a lean launch can be necessary. But lean doesn't have to mean late: Ratio had approaches to make launch planning more streamlined without cutting corners. If you're deciding when to jump into launch planning, we'd love to talk and see if we can help you chart a better course.