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  • Your Space - The Seasons Of Life, Part 4 of 5

    This week is Part Four of our five part series on The Season's of Life.

    In Part One of the series we discussed:

    a) That life is about
    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
    constant, predictable patterns of change.

    b) For all of us, the only constant factor is our feelings and attitudes toward life.

    c) We
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    as human beings have the power of attitude and that attitude determines choice, and choice determines results.

    In Part Two of our series
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    we discussed:

    a) Life and business are like the changing seasons.

    b) You cannot change the seasons, but you can change yourself.

    c)
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    A major lesson in life to learn is how to handle the winters.

    d) Winter time allows you to get stronger, wiser, better. The winters w
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    on't change, but you can.

    In Part Three of our series we discussed:

    a) Spring is the season for entering the fertile fields of life wi
    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
    h seed, knowledge, commitment, and a determined effort.

    b) It is the promise of spring that as we sow, so shall we also reap, that for
    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
    every disciplined human effort we will receive a multiple reward.

    c) There are just a handful of springs that have been handed to each
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    f us. Don't just let the seasons pass by.

    This week we will talk about the third major lesson in life to learn; how to nourish and prot
    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
    ect your crops all summer. Sure enough, as soon as you've planted, the busy bugs and noxious weeds are out to take things over. Here is
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the next bit of truth: they will take it, unless you prevent it.

    There are two key phrases to consider with the third major lesson. Th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e first is "all good will be attacked." Don't press me for a reason. I was not in on some of the early decisions, so I don't know why.
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    just know that it's true. Let reality be your best beginning. Every garden will be invaded.

    The second phrase is "all values must be d
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    efended." Social values, political values, friendship values, business values - all must be defended. Every garden must be tended all s
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    mmer. If you don't develop this skill, you'll never wind up with anything of value.

    But for those who make diligent efforts to plant, p
    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
    rotect, and preserve there are not enough birds, bugs, or other obstacles to destroy all the efforts of last spring.

    (Next week we will
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    alk about fall, the time of harvesting the fruits from our springtime labor.)

    To Your Success,

    Jim Rohn

    ******************************
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    **************************
    To read previous articles, quotes, and Q and A from the Jim Rohn Weekly E-zine Archives, or to get a comp
    .

    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
    ete listing of Jim Rohn's books, audios, videos and seminar schedule, or to place an order; please go to: elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ww.jimrohn.com">www.jimrohn.com or call 800-929-0434 M-F 8:30-5:30 CST.
    *******************************************************


    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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