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  • E-Articles - Already There - Just Didn't Realise

    We've all heard the saying: "You don't know what you've got until it's gone."

    A couple of short stories:

    Story one. A few years ago I travelled to South Africa to do some work with one of my best friends who is the he
    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
    ad of a charity which works internationally with children who suffer as a result of living in poverty. We travelled in and around the poorest parts of Johannesburg conducting a needs analysis to ascertain where the chari
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ty would focus it's energy, money, resources and time. Most of the trip was spent working with organisations (hospitals, orphanages, homes) who care for children who have the AIDS virus. Over the course of a couple of we
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    eks, I saw hundreds of children, who through no fault of their own, had been given a death sentence. I hugged them, fed them and cried over them.

    It was a life-changing and attitude-changing experience for me.

    I saw a
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    child who weighed two kilos (4.4lbs) at the age of two (who died the next day) and I met four year-olds who weren't going to make their fifth birthday. To say it was confronting and uncomfortable for me would be the un
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    derstatement of the decade. So the white boy from his comfortable middle-class, privileged existence in Melbourne, Australia who had a periodic tendency to complain about how tough his life was, and who thought he had i
    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 all figured out realised that:

    1. he didn't really know much at all
    2. he had no (real) problems
    3. he made his life harder than it needed to be and
    4. he had absolutely no idea how great his
    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
    ife was or how ignorant he was.


    Spend some time with kids with AIDS (or any terminal illness) and your perspective will change. I returned home and had a completely new appreciation for, and awareness of e
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    verything in my life; I realised I was genuinely privileged. I learned that my (few) challenges and hurdles were relatively inconsequential.

    Nothing had changed, yet everything had changed.

    Story two. I have a friend
    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
    who is a Personal Development junkie. Books, seminars, CD's, DVD's, newsletters, affirmations on the mirror... and a life-coach (of course). He doesn't want to do well; he wants to be obscenely rich (his words). His l
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ife is pretty cool; great wife, loving family, good health, good career and lots of reasons to be happy. I'm not saying his life is without problems or challenges but in the overall scheme of things, there ain't a whole
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    lot of hardship going on.

    He's rarely happy.
    Rarely satisfied.
    Never enjoys where he is.
    So busy striving and pushing towards his incredible future that he fails to see what he already has which
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    is incredible.


    One of the problems with some Personal Development students is that they are so pre-occupied with creating their amazing future that they don't really appreciate, or let themselves enjoy, t
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    heir pretty-darn-good 'right now.' Considering that we live in the present and never in the future, it's a good idea to be able to enjoy the here and now (while still having goals and dreams for the future).

    The truth i
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    most of us have many reasons to be happy (now) yet we seem to have an amazing ability to find reasons not to be.

    Story three.
    Years ago I worked with a guy who has without doubt, one of the best wives in the world
    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
    . She is one of the most loving, caring, generous, thoughtful people I've ever met. I always teased him about how she was too good for him and how one day, she would dump him for me. I was always surprised by how litt
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    le he seemed to appreciate or acknowledge his wife's efforts. In fact I was astounded at how much he complained about so many things and how critical he was of her.
    He was the 'big man' with the doting wife.
    Ki
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ng of the Castle.
    Master of his domain.

    Idiot.

    So one day the doting wife got up and left (not for me). And the King of the Castle turned into a blithering wreck. He begged, pleaded, cried an
    .

    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
    d moped. For a long time.

    She didn't come back for nearly a year. Needless to say, his attitude and behaviour had changed somewhat.

    Five years down the track they're still happily together and he knows (and shows) ho
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    w great his life is. Smart.

    It's great to be driven to achieve our best life but it's also crucial that we learn to enjoy what we already have.

    The time to appreciate things is when we have them, not when we lose them


    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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