No Time to Delay

Getting your drug approved is only half the battle. It's how and when you launch that makes all the difference to the bottom line.
Mar 01, 2007

The early bird gets the worm. It's an adage that means whoever arrives first has the best chance of success. But for pharma companies, launching a new drug is about more than just a taste of victory—it also means the loss or gain of billions of dollars, and avoiding harm to patients awaiting the arrival of a potential cure.

All in a Days Work
Some causes of delay are unanticipated—for example, receiving a regulatory approval letter later than expected—but other roadblocks are a result of poor planning. There is so much focus and energy on the regulatory submission that preparation for launch takes a backseat in the process. And given the high stakes and competitive landscape of the pharma industry today, a delay in launch can cost a company an average of $15 million per drug, per day (see "All in a Day's Work"). But regardless of a drug's revenue potential, delaying launch reduces a firm's ability to recoup its investment in R&D, wastes precious time in a product's patent life, and can leave the door open for competitors to usurp market share—or even a first-to-market position.

Why, then, do delays occur? Higher-priority products may divert a company's focus and take precedence, or financial constraints may limit a company's ability to launch. However, many delays are unintentional and can be prevented with foresight and proper planning. What do product managers need to know in order to successfully react to challenges that may arise when launching a drug in time? Here's a look at how three different companies used dynamic project management to get their products to market quickly, despite less-than-stellar conditions.

Expect the Unexpected

The time a company takes from receiving an approval letter to making its commercial debut can range anywhere from a few short days to many long months (see "Across the Spectrum"). So what enables a company to hit the ground running right after approval? It takes detailed planning and disciplined execution, but more than anything, it takes the ability to act effectively when things go wrong.

Across the Spectrum
The most crucial step is to develop a robust launch plan. An obvious first move, but launch planners often act before vital questions have been answered. To ensure success from the first step, the company should ask questions like: "What are the critical tasks?" "What problems might we encounter?" and "How will we deal with these challenges, should they occur?"

Here are some general principles to help guide a product team through effective launch planning:

  • Start early and work backwards Launch planning should start as soon as the company knows it has a clinically viable product. For a drug, that could be at the beginning of Phase III. It's also crucial to construct the launch plan working backwards—from the earliest conceivable approval date—to ensure the company is in a position to act if the agency moves quicker than expected.
  • Document it Each team needs to provide input on the time and effort they anticipate will be required for launch. Use that data to develop a project plan that identifies roles, responsibilities, and timelines.
  • Stay focused and bucket activities Identify the 20 or so critical tasks that are truly essential to the success of your launch, and keep them front and center. Gather activities into two groups: those required to prepare for the launch date, and those that are triggered by approval.
  • Don't over-or under-do, but prepare for the worst Construct detailed plans and schedules for each team and each person—but be careful: Getting mired in the minutiae can be just as confusing as insufficient instruction. Brainstorm anything and everything that might go wrong: Review lessons learned from your company's previous launches and research the challenges other companies have faced under similar circumstances. Create "what if" flowcharts. Assess the likelihood and magnitude of each risk to fully grasp the impact of various scenarios.
  • Develop Plan B...and C and D Using the information you've collected, determine and document the actions you would take to manage each potential problem. What's most important is to anticipate what's ahead and know how to handle it so that the launch stays on track.
  • Make someone "it" Designate one manager to be responsible for the entire launch effort. He or she is not obliged to any one functional department, but provides a bridge across functional silos, facilitates problem-solving, and ensures everything gets done. Not only must this person excel in leadership and organizational skills, but be a consummate diplomat as well.

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