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    L’Etat? c’est Moi!

    This example -– "The State? I’m the State," uttered by Louis XIV –- could be used w
    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
    hen discussing the IQ of organizations. And the IQ of the state (organization) is not what I mean. What I do m
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ean is that the state or -- let’s focus on a company -- behaves (like) a human (organism), until proven otherw
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ise. An organism functions in a way where all the different parts should cooperate in some way or the other. Y
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ou wouldn’t like to work for a company in which the left arm fights against the right arm instead where both a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    re used to please the same customer (but in different moments in time). “Can we help you?”

    The IQ of an organ
    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
    ization could represent the way in which an organization is successful in processing information and taking (t
    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
    he right) decisions. An organization should learn … up to a certain level. Like a normal human being with an I
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    Q, there is a ceiling for everything. But learning is key and knowledge management is the process in which thi
    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
    s is done.

    One example of The Fifth Discipline from Peter Senge that is often quoted is the anomaly in
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    which a team of intelligent managers with individual IQ’s of about 120 constitute a team with a collective IQ
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    of half this figure.

    We all know that ten economists are able to deliver a dozen or what visions on the same
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    economy. One business team may consist of various specialists that will –- if you would ask them -– know more
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    than a dozen visions and solutions on a apparent single matter. Maybe the first step is to recognize that an
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    organization should be more than a team of individuals with their own goals and their own directions.

    What wo
    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
    uld prevent that all those different expert opinions interfere with each other rather than that they amplify e
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ach other? This is very unlikely to do with individual IQ’s. To raise the overall Q of your organization, you
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    don’t have to be afraid of those IQ’s. Attention is required however for the EQ part.

    Or if you don’t want to
    .

    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
    think about this one, just use the following directive;

    "I don’t know (and don’t care) how you are going to
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    solve this one, but when this meeting is over, you present me the solution accepted by all."

    © 2006 Hans Bool


    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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