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  • Advice You - The Most Important Stories You Tell

    Stories can inspire or deceive; motivate or manipulate; challenge or deflate; persuade or console; unite or divide; ignite or resolve; anger or connect. But, none of this is new n
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    ews. Stories are everywhere, all the time. In the papers we read, in the content we watch or listen to, and in the places we frequent. That includes our workplaces. And we're all
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    storytellers.

    The stories we choose to tell about ourselves and others impact how we're perceived at work: team player or not team player; victim or problem-solver; resilient or
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    discouraged; approachable or distant. They impact what work culture we help create: trusting or distrusting; silos or teams; soul-enhancing or soul-depleting. And most importantly
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    they impact how we see ourselves. Our choice of stories matter, increasing or decreasing our potential to be winning at working.

    But the most important stories you tell at work a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    re the ones you tell about yourself, to yourself. For me, one of those is that I'm technically challenged. Okay, I know what you're probably thinking and you're right. The more I
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    tell myself the story of my technical incompetence, the more likely it is that my behavior lives up to my expectations. That's true on the reverse side, too. Another self-story fo
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    my life is that I can invent the future that I want to face. In both cases, as T. Harv Eker puts it, "You will live into your story."

    Kyle Maynard is a good example. Before he w
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    as nineteen he was a Wrestling Hall of Famer with the impressive title of the "World's Strongest Teen." He's been living into his story, summarized by the title of his book, "No E
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    xcuses." You see, Kyle has a congenital condition called quadramenbral phocomelia. He has no limbs below the elbows and knees. His becoming a wrestling champion goes beyond normal
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    y impressive feats. But Kyle lives his "no excuses" story not only in the wrestling arena, but in all parts of his life, learning to type fifty words a minute and drive a car.

    Wh
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    at stories are you building your life around? Are they enhancing your potential or minimizing it? If your story is a victim story then you'll find problems. If it's about winning
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    at working and achieving your life's potential, you'll see challenges to meet. It's not about the words, it's about your self-vision behind them. How you see your life is how you
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    live it.

    Sometimes we're not even aware of the stories we've adopted as our own. We've grown up hearing about who we are, what we're like, what abilities we have or don't have an
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    we overlay those stories onto our life as our own. But here's the wonderful thing about stories. We can write new ones.

    For much of my life, a story I lived into was being quiet
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    and shy. It was true I was a very shy child, but I kept the story alive as I grew older. At times, it kept me on the sidelines as a spectator to my life. But now I find that stor
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    y confining, limiting and detrimental to the work I want to do. So, I've let go of it and replaced it with one that better fits this stage of who I am and what I'm about. I've cho
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    en a different story to live into.

    You see, you have the power over your life story. Winning at working is a choice. What I learned in twenty years in management is this: people
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    who are winning at working realize they're the ones with the pen. They know they're the author of their own work story and they act accordingly. So, if they don't like how their s
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    tory is evolving, they create a better one and start living it. They write their story as they go, building the outcome they desire.

    (c) 2006 Nan S. Russell. All rights reserved


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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