Breakthrough Designation = Breakneck Pace « Return On Focus --- http://returnonfocus.com --- Return On Focus

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    Breakthrough Designation = Breakneck Pace

    February 10, 2014

    SpeedEveryone wants to be the commercial point person for a Brand with ‘Breakthrough’ designation, right? Not so fast… because maybe it’s just too fast. Securing ‘Breakthrough’ designation often puts a big red target on a Marketing Director’s back. You barely (or don’t) have time to do things the right way, but you definitely don’t have time to get anything wrong.

    What is clear is that you need to throw out the traditional launch playbook and quickly garner some focus before the usual questions from senior management come raining down from on high.

    Consider these five action items in order to maximize your chance for success under the extremely tight deadlines:

    1. Work Backwards – Start with the launch readiness date and work backwards so you can budget accordingly; too often time is wasted upfront deliberating on non-essential tasks
    2. Pick the Right Finish Line – Approval is usually based on an initial indication for which the unmet need is high already; keep the portfolio of indications in mind when making key strategic decisions, particularly when thinking about launch positioning and targeting
    3. Plan Incubation Time – Good strategic thinking and good creative development requires incubation time, if the answer was obvious you wouldn’t need to spend time addressing it; look for points in the project plan where development time is crucial and plan around it
    4. Convert Demand First – Normally product launches are focused on demand generation, but most of the time this is less of an issue for products with ‘breakthrough designation,’ the real focus has to be on demand conversion particularly in ramping up manufacturing and ensuring access and reimbursement services are ready at approval
    5. Get Out Into the Community – Prioritize getting outside of the KOL community and into the trenches to better understand the potential issues for your Brand in the real prescribing world; instead of conducting market research in NYC, Chicago, and LA try Baltimore, St. Louis, and Seattle instead

    Executing the action items above helps put you in the position to ensure that you’re doing the right things for your Brand, while also being able to withstand the intense scrutiny of Senior Management and the dreaded Launch Readiness Review.

    A clear focus on the elements necessary to plan a successful launch is the best route to engender confidence in the commercial plan when time is precious.

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