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    Articles Under Author Name: Charles Vaughn

    If I Knew Where I Was Going All Along, How In The World Did I Get Here

    Don't Know What Motivates You? Think Back to When You Were a Kid

    Hello Again!

    IN my
    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
    past articles I have written about what motivates (the innate gifts he has) a person and how the roots of that motivation can be traced back to your childhood. I pray that this article injected a bit
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    of excitement in some of you in searching for what you want to do when you grow up; whether you are 18, 23, 25, 30 or+.

    The second article followed up with learning how to search for that perfect care
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    er for you by examining that career and verifying that you will be utilizing the major gifts that motivate you. If you do not see them in the future career you are looking at don't make a mistake of be
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    coming the square peg in the round hole. Move on in your search.

    At this time, I want to continue on in writing about your gifts. Each of us has those God-given (yes, I said God again) gifts or talent
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    s since we were in our mommy's womb. They developed after birth and continue growing as we age. I am not certain that they ever stop growing. I tend to believe that they lie dormant until something tha
    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
    t draws the gift or talent out of us and we then have an AHA moment.

    I am certain that you have heard the phrase "it fits him/her (being fair to the ladies) to a tee". When you can apply that phrase 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
    a person in a career, doing a job, playing a sport, or even performing well in an academic class, it means that he is utilizing his talents to the fullest and he is most satisfied. Now that doesn't ne
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    cessarily mean that he is the best among his peers or competitors but it does mean that he has a much better chance at being successful in what he is doing. Only hard work and God's providence will ma
    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
    ke him the best. "When we function according to our giftedness, the work (whatever it is) almost doesn't seem like work-it's more like fun. Incredible revenues of energy are released."

    Gifts or gifted
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ness used here is not used in the sense of school smarts although he/she may be using them in their schools successes. In schools gifted frequently means that the student(s) have more abilities and apt
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    itude that his/her peers and, therefore he/she is placed in a gifted program. But that is NOT what we are speaking of here. Secondly, giftedness, gifts, or talents are not traits that many assessment m
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    odels claim to identify. Lastly, these gifts that you have are your and cannot be acquired by another unless they have them innately like you. These gifts were given to you. You did not have to work to
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    obtain them and very little work to develop them.

    To conclude, I would like to give you a personal family example. My son Michael, now 29 years of age had a difficult four years of high school. Not b
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    cause he was not bright nor because he was disinterested. Asthma caused him to miss many days of school and when he was in school, it was difficult for him to concentrate. However, he played lead trump
    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
    et in the school's award winning marching and concert band. He loved art and could draw a picture of his girlfriend , at that time, that looked like a photograph. Music and art are two of his gifts. BU
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    T what is he doing today, much to my surprise.........he is the MIS department manager of a well-known Company that deals in software for merchants. He was just asked to open up a new site in another l
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ocation to the tune of $150,000/year.

    Pretty good for a fellow who never went to College. Dad still hopes that he will go someday. I asked Michael one day, "what is the connection with art and music
    .

    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
    in what you do?" and he said "everything dad, everything". I just don't get it but I believe it.

    I hope that I have been able to clarify, even further, what these gifts and talents are and what they a
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    re not. Continue to look for your and you will make the correct decisions about career choice, college major and any work endeavor you pursue. Do what you love and the money will follow.

    Charles Vaugh


    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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