The numbers are dramatic: 50% of pharma launches fail to meet forecasts, with 25% widely missing the mark. If you’re in a pre-launch phase, with the odds stacked against launch excellence, what can you do?
To achieve excellence, or even approach it, we first have to define it. Experts on the topic have a range of perspectives, with some saying internal/external communication is key to launch success, and others insisting rigorous strategic alignment or aggressive department-by-department functional planning will get you there. Still others say you need a laser-like focus on the financial bottom line.
Each viewpoint has merit, but do any of them get to the crux of the issue?
At CMK Select, we’ve seen launch excellence first hand—because we’ve helped make it happen. In our experience, while strategy, planning, communication and financial focus are all vital, true excellence at launch comes down to one thing: getting the right drug to the right patient at the right time.
Get that done, and you’ll find a lot of other things falling in line.
The right drug?
Is your drug the right drug? It may be—if it fills a clear and genuine need. That means:
- Physicians will prescribe it consistently
- Patients will take it, compliantly
- Payers will pay for it, dependably
While the clinical/R&D team is charged with creating a molecule that meets the identified need, it’s up to the commercial group to assess if the final, developed product will fully capitalize on the molecule’s attributes. They must determine whether a differentiated space in the marketplace can be effectively owned.
Ideally, these two arms of the enterprise will be working closely together from the outset, meeting regularly, sharing information and planning strategy. We’ve seen early, consistent and cooperative coordination pay big dividends at launch.
The right patient?
Supplying the right drug to the right patient is a foundational mission for every pharma company. Making sure your product fulfills that goal means asking key questions early in the planning process, such as:
• Which patient population will benefit the most from the product’s medical value?
• What are the specific characteristics of those target patients?
• How will we position the product vis-à-vis those patients while differentiating from competitors in a meaningful way?
• How will we communicate so physicians, patients and payers respond?
It’s not easy to verifiably answer those questions, but doing so is well worth the effort. Today, marketers at companies large and small strive to pinpoint patient targets, identify key physicians and access points, and position products strategically. Instead of an older, broad brush approach, pharma is micro-targeting patients, micro-segmenting prescribers and payers, and micro-messaging them all.
This approach puts the idea of the “right patient” in a new light. It opens possibilities like accessing searchable patient databases for patients fitting very specific profiles; or dispatching trained professionals to personally connect with patients and caregivers where they live.
The right time?
Brand teams evaluate countless internal and external factors throughout each pre-launch phase, appraising the marketplace and adjusting timing of their plans in response. They consider everything from clinical trial schedules, length of regulatory reviews, managed care access and marketing implementation timelines to competitors’ moves and countermoves.
The team also has to assess the duration of manufacturing processes and supply chain requirements to ensure product readiness at FDA approval—or before approval, in cases where early access is granted.
Here are some launch timing-related facts to consider:
- Many innovator drugs now have four years before competitors launch—down from a previous eight years
- Breakthrough therapy approval from the FDA can occur in less than six months
- The average time from FDA approval to U.S. reimbursement is six weeks
Given these factors, new product planning teams might ask, “How will our market change between now and launch?” and, “Will we have supply to meet the demand at the time of approval?” If the product is a follow-on medication in a crowded category, they might ask, “Will our product still meet the patient need at that time?” or, “Shouldn’t we launch before the category leader’s patent expires and we face generic competition?”
A myriad of such questions can make launch management more art than science. But, in the end, launch excellence may really boil down to this question:
“Are we delivering the right drug for the right patient, when they need it?”
Optimizing your next launch
Experience shows that brand teams focused on delivering the right drug to the right patient at the right time can be on a path to great success. CMK Select has been walking the path to excellence with leading organizations for more than a decade, working on more than 65 pharma launches. We offer a proven methodology to optimize your product’s trajectory.