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    At the beginning of the year good intentions run rampant. We are all setting objectives, putting together resolutions, creating goals, and determining that we are, for sure, going
    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
    to do something better or bigger this year. Well, how’s it going? Have you taken stock of where you are at against those goals?

    I’ve noticed a trend when it comes to goal setti
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    g. This is what it looks like:

    *

    Beginning of the year starts out strong. Goals are set and pacts are made to reach those goals.

    *

    Over the course of the next month or two th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    business shifts focus and you are off and running in a completely different direction.

    *

    A few more months go by and you settle into the same routine you’ve been in for the past
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    few years.

    *

    Two more months go by so fast you don’t even notice they’ve past.

    *

    The end of the year rolls around and you realize you are in the same spot you were this time la
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t year, but…

    ...this year is going to be different. You know why? You’re starting to read this article. If you continue reading you’re guaranteed to grow your awareness of how
    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
    mportant it is to review your goals and objectives on a regular basis.

    There’s a Harvard study that brings the point home:

    Harvard did a study of their own graduates’ goal settin
    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
    . Over a period of thirty years they found that only three percent (3%) of the population surveyed actually wrote down their goals. Those who had set goals and had written the goa
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s down made 2-3 times more money than those without goals. Those who took it one step further and carried their goals with them at all times made 10 times more money than everyone
    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
    lse.

    Imagine the success you can have if you write down your goals and focus on them regularly! Powerful!

    From personal experience I can attest to the power of writing and revie
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ing goals. I have accomplished every career goal I’ve set out to achieve, some sooner than I thought possible. The goals are written down and reviewed regularly. All of my busin
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ss goals are written down. They are reviewed regularly, not just by me, but with an advisory board as well. Huge!

    Take stock. Examine and Re-examine. On-going awareness give
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    you a greater chance of reaching the goals than if you articulate them once and never come back to them.

    Sometimes the problem isn’t in the action of taking stock, but just in re
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    embering to actually do it. Putting a mechanism in place to take stock on a regular basis could be the essential ingredient to support your success. Here are some methods you can
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    use to remember to take stock on a regular basis:

    *

    Put your goals where you can review them regularly (office wall, refrigerator, in your wallet or purse, taped to the back of y
    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
    ur ipod or pda).

    Set up a regular meeting with yourself monthly to review your goals.

    *

    Email yourself reminders.

    *

    Pre-create tasks for the whole year that remind you to revi
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    w your goals.

    *

    If you want the support and accountability, ask a manager or colleague to meet with you regularly to review goals.

    When you do take stock what do you review? An
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    wering some of these questions may help you:

    *

    Where did I start?

    *

    Where am I now?

    *

    Am I still working toward the same goals I originally established?

    *

    What are the barr
    .

    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
    ers to success?

    *

    What’s gone well?

    *

    What could be better?

    *

    What should I keep doing?

    *

    What should I stop doing?

    *

    What should I start doing?

    *

    What needs to happen
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    or me to achieve this goal?

    Have you started yet? No time like the present. If you don’t stay focused on where you want to go then wherever you get to should be okay. Take stock


    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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