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    Once you've set a goal for yourself as a leader - whether it is to create your own enterprise, energize your organization, build a church, or excel in sports - t
    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
    he challenge is to find good people to help you accomplish that goal. Gathering a successful team of people is not only helpful, it's necessary.

    So to guide you
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    in this daunting task of picking the right people, I'm going to share with you a four-part checklist.

    Number One: Check each candidate's history. Seek out avai
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    lable information regarding the individual's qualifications to do the job. That's the most obvious step.

    Number Two: Check the person's interest level. If they
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    re interested, they are probably a good prospect. Sometimes people can fake their interest, but if you've been a leader for a while, you will be a capable judge
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    of whether somebody is merely pretending. Arrange face-to-face conversation, and try to gauge his or her sincerity to the best of your ability. You won't hit the
    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
    bull's-eye every time, but you can get pretty good at spotting what I call true interest.

    Number Three: Check the prospect's responses. A response tells you a
    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
    lot about someone's integrity, character, and skills. Listen for responses like these: "You want me to get there that early?" "You want me to stay that late?" "T
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e break is only ten minutes?" "I'll have to work two evenings a week and Saturdays?" You can't ignore these clues. A person's responses are a good indication of
    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
    his or her character and of how hard he or she will work. Our attitudes reflect our inner selves, so even if we can fool others for a while, eventually, our true
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    selves will emerge.

    And Number Four: Check results. The name of the game is results. How else can we effectively judge an individual's performance? The final j
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    udge must be results.

    There are two types of results to look for. The first is activity results. Specific results are a reflection of an individual's productiv
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ty. Sometimes we don't ask for this type of result right away, but it's pretty easy to check activity. If you work for a sales organization and you've asked your
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    new salesman, John, to make ten calls in the first week, it's simple to check his results on Friday. You say, "John, how many calls did you make?" John says, "W
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ell..." and starts telling a story, making an excuse. You respond, "John, I just need a number from one to ten." If his results that first week are not good, it
    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
    is a definite sign. You might try another week, but if that lack of precise activity continues, you'll soon realize that John isn't capable of becoming a member
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    f your team.

    The second area you need to monitor is productivity. The ultimate test of a quality team is measurable progress in a reasonable amount of time. And
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    here's one of the skills of leadership: be up front with your team as to what you expect them to produce. Don't let the surprises come later.

    When you're follo
    .

    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
    wing this four-part checklist, your instincts obviously play a major role. And your instincts will improve every time you go through the process. Remember, build
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ing a good team will be one of your most challenging tasks as a leader. It will reap you multiple rewards for a long time to come.

    To Your Success,
    Jim Roh


    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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