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In the white heat of a major brand launch, we can be consumed by the day to day challenges and make mistakes. But some of the worst mistakes can be avoided with a little foresight, writes Ken Begasse.
Anyone who has spent any significant time in pharmaceutical marketing has experienced the sheer terror of a brand launch. Years of research and planning culminate in a single moment; personal and corporate reputations and vast sums of money are at stake; dozens if not hundreds of people are working around the clock trying to coordinate that perfect message that will maximize results. A poorly executed launch can mean ongoing suffering or even death for needy patients, and careers can be made or lost from a single off-hand decision or miscommunication. Any adventurer who thinks bungee jumping or skydiving or wrestling alligators is too tame ought to try working on a pharmaceutical brand launch sometime; it’s the business risk-taker’s greatest and most frightening thrill.
In the white heat of a major brand launch, we can easily become so consumed by the day to day challenges, by just surviving from one minute to the next, that ideas of long-term strategy are sometimes lost. And that’s when mistakes get made. Some of those mistakes are minor, and can be easily corrected later; some are unavoidable due to the inherent uncertainties of the marketplace. But some of the worst mistakes, those that can doom a brand before it is even born, can be avoided with the help of a little foresight. In our many years of observing and working on pharmaceutical brand launches, these are the mistakes we’ve seen over and over again that never had to be.
Be quick but don’t hurry
Perhaps the most common launch mistake is the deadly combination of waiting and rushing.
Any good launch requires many flavors of market preparation – educating the marketplace about your disease target, building a communications infrastructure with important constituencies, using what you learn from those constituencies to tweak your messaging and value proposition, and plenty more. All this should be going on well before any civilian lays a hand on your brand, so that once the actual launch happens, interest has been brought to a rolling boil already.
Unfortunately, that’s not the way things usually happen. For a number of reasons, but mostly due to the risk associated with regulatory uncertainty, many brands don’t get around to these sorts of critical activities until after their product has already launched. Which means they spend the first six months of their brand’s commercial life, sometimes longer, scrambling to educate customers and respond to their concerns rather than activating those customers.
We get why this happens. Brand managers don’t want to bet their limited resources on the vagaries of CDER; they don’t want to get caught conditioning a marketplace for the benefit of their competitors if their product gets hit with a regulatory delay.
But executives who allow that worry to dominate their thinking are making the commonplace mistake of allowing the small risk that’s nearby to blot out the much bigger risk that’s a little further off. Under optimal conditions we believe that a pharmaceutical brand should be reaching its peak sales number in two to three years. But if a brand waits until after launch to do its market prep, if it spends those critical first six to twelve months desperately trying to educate and learn and tweak and sell all at once rather than focusing on prep beforehand and selling after, it could be pushing that peak sales moment off substantially, to five years out or more. Given the limited amount of time we have to sell any branded drug, the opportunity cost lurking behind that could be much more expensive than the cost of premature market preparation.
Have a Plan B
Approval delays are not the only pre-launch regulatory risk the new brand manager faces. Many times now we’ve seen products actually approved by FDA but with a different, more limited label than the company had hoped for or expected – and the company is completely unprepared for the new scenario. This lack of preparation translates into marketing materials that have to be entirely reworked, revenue goals that are no longer realistic, and – at worst – a perception of failure and a cutting-off of resources if the folks in the C-suite are still basing their decision making on that best-case Plan A. In fact, we’ve found that a large percentage of launches that are seen internally as failures fall into that particular black hole not because they are truly performing poorly but because the company’s leadership never realigned its perceptions of opportunity or potential when the labeling came out differently than they’d expected.
This sort of situation happens primarily due to a lack of scenario planning. Very early in the brand development process, long before any communications materials are developed, all the folks with the brand’s fate in their hands, from marketing to med/reg, should hash out a roadmap of potential scenarios based on the various decisions that FDA might make regarding labeling. When complete, each scenario in this roadmap should have its own unique marketing guidelines, its own scope of opportunity and potential, and its own revenue projections. Without such a roadmap, and human nature being what it is, expectations inevitably default to the best-case scenario no matter what FDA does – but with it, everyone inside the company has been preprogrammed to shift gears – and expectations – as necessary. Given the stakes of a new brand launch, it is an ongoing marvel to us that so few companies do this sort of scenario planning as a default part of the launch process.
Don’t take the first offer
The first rule of job-hunting, car-buying, and virtually any other business transaction is not to take the first offer. And yet when it comes to negotiating with FDA over labeling, many companies, especially those trying to bring their first product to market, suddenly turn into teenagers begging their parents for the car, or the kid out of college hoping for his first job offer, willing to accept virtually any limitation or restriction or salary as long as the word “yes” comes before it.
Folks, FDA is not your parents, and approval is not a binary equation. With all that scenario planning that a brand’s stewards have hopefully done beforehand – see above – they should walk into discussions with regulators with a clear idea of what they want, the best case scenario, what they are willing to accept, what is high or low priority, what the fallback positions are. That might mean pushing for a looser interpretation of non-optimal Label B if Label A isn’t going to be approved; it might mean bringing post-market studies into the conversation. What it should never mean is accepting that first offer, unless the first offer is everything you were hoping for.
The corollary to all this is that the people doing the scenario planning and the people doing the negotiating with FDA, if they aren’t the same people, must at least be working from the same script. In our notoriously siloed industry, it is quite common for the folks in the marketing department to happily draw up their scenario plans without saying a word about it to the R&D and regulatory people who actually have to deal with FDA, which leaves those R&D and regulatory people without any realistic sense of what their negotiating positions might mean in the real world. The solution is simple: make sure those negotiators are in the room when the scenarios are being planned, so that everyone involved understands quite clearly what the various potential outcomes with FDA will mean to the brand.
Don’t just have a Plan B for now; have one for later too
Scenario planning should never just be for launch; the day and month and year after that are just as important. In pharma we have the good fortune of being given previews of the future in the form of our competitors’ clinical trials, and so we have the capability of looking into that future more accurately than our counterparts in most other industries. And so we need to be scenario planning today for what might happen at launch plus six months, launch plus twelve months, launch plus 24 months, and so on. Far too frequently we see molecules enter the marketplace to great fanfare, roll up impressive sales for a while … and then collapse when the ground shifts and the brand’s stewards continue to stick to the Day One plan. For further reading, see the HCV market.
So we as brand planners need constantly to be thinking like chess players, two and three and four moves ahead. If that competing compound is approved next year with a broader indication and better general efficacy than mine, are there more targeted areas on which I can focus my efforts? Can my compound become part of a dual therapy protocol? Are there other potential label extensions that I can explore? And the time for asking and answering such questions is now, not a year from now when that new competitor has already done its own market priming and is prepared to take your lunch money. Adjusting your brand’s approach to deal with a major marketplace shift is just as critical as launch itself, and deserves just as much advance planning and preparation. When preparing for initial launch, you should also be preparing for all those other adjustment “launches” that might come in six or twelve or 24 months.
These are not, of course, the only mistakes that brands make when launching. But they are the big ones, the errors that can cause the most long-term damage to a brand and are the most difficult to undo. With a little forethought, though, they are all avoidable. We can never eliminate the inherent risks and challenges of bringing new compounds to market. But we can minimize them, if we play smart.
Ken Begasse is Founder and CEO, Concentric Health Experience. He can be contacted by email at firstname.lastname@example.org and Twitter: @kbegasse