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    “Character, in the long run, is the decisive factor in the life of an individual and of nations alike.” Theodore Roosevelt

    I
    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
    don’t mean to alarm you. But—we are going to discuss a very painful subject to many people. My discussion involves an organizational taboo. Ma
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    y institutions refuse to conduct leadership succession planning because they don’t want to offend anyone (that charismatic founder or his pote
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    tial replacement). Can any great organization exist after the death of its visionary founder? At the death of a distinguished leader, most org
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    nizations are left in confusion. Why does a leader feel that the world must stop if he’s not leading? Therefore, seasoned leaders must adequat
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ly prepare for their replacements. Everyone knows that a leader can’t live forever; however, many organizations avoid this topic. This is a f
    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
    tal organizational mistake. Below are some positive planning suggestions before organizational transition:

    1. Recognize the need. Leaders nee
    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
    replacements.
    2. Conduct a candid discussion with the incumbent leader.
    3. Develop an organizational succession plan.
    4. Imple
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ent the plan.
    5. Develop a list of possible candidates.
    6. Conduct any additional leadership training.
    7. Provide mentoring ses
    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
    ions with potential candidates.
    8. Keep communications open about potential changes.
    9. Measure and track results of plan.
    10.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ontinue to make organizational improvements.

    Let’s explore this matter further. To every thing, there is a season. A wise leader knows when h
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    leaves. On the contrary, a foolish leader will prolong his reign. Good leaders deal with the realities of living (you live—you die). I’ve se
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    n some leaders delay leadership development because of fear; however, these leaders have no foresight. Followers often know better but lack
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    he power for organizational changes. This is a fatal mistake for most organizations. Who is going to replace this beloved leader? Will the re
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    laced leader have problems from the incumbent’s loyalists? There is bound to be trouble. If these veteran leaders are truly concerned about
    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
    heir organizations, they should prepare future leaders by implementing a succession planning process.

    Succession planning involves mentoring
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    or the future. Chip Bell, a mentoring expert, defines mentoring as the “act of helping another learn.” Throughout history, leaders have been r
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    placed. A great leader who has vision is difficult to replace. Why would you wait until he/she is dead to consider a replacement? Don’t be un
    .

    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
    repared for future leadership changes. Start today!

    References:

    Bell (2002). Managers as Mentors. San Francisco: Berrett-Koehler’s Publisher
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    , Inc.

    Sugarman, K (2000). Leadership Characteristics. [Online]. Available: http://www.psywww.com/sports/leader.htm.

    © 2006 by Daryl D. Gree


    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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