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  • Digg It - The Hare And The Tortoise

    Once upon a time a tortoise and a hare had an argument about who was faster. They decided to settle the argument with a race. They agreed on a route and started off the race.

    The hare shot ahead and ran briskly for some time. Then seeing that he was f
    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
    ar ahead of the tortoise, he thought he'd sit under a tree for some time and relax before continuing the race.

    He sat under the tree and soon fell asleep. The tortoise plodding on overtook him and soon finished the race, emerging as the undisputed c
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    hamp.

    The hare woke up and realised that he'd lost the race.

    The moral of the story is that slow and steady wins the race.

    This is the version of the story that we've all grown up with.

    But then recently, someone told me a more interesting version
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    of this story. It continues.

    The hare was disappointed at losing the race and he did some Defect Prevention (Root Cause Analysis).

    He realised that he'd lost the race only because he had been overconfident, careless and lax.If he had not taken things
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    for granted, there's no way the tortoise could have beaten him.

    So he challenged the tortoise to another race. The tortoise agreed.

    This time, the hare went all out and ran without stopping from start to finish. He won by several miles.

    The moral of
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    the story? Fast and consistent will always beat the slow and steady.

    If you have two people in your organisation, one slow, methodical and reliable, and the other fast and still reliable at what he does, the fast and reliable chap will consis
    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
    tently climb the organisational ladder faster than the slow, methodical chap.

    It's good to be slow and steady; but it's better to be fast and reliable.

    But the story doesn't end here.

    The tortoise did some thinking this time, and realised that there
    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
    s no way he can beat the hare in a race the way it was currently formatted.

    He thought for a while, and then challenged the hare to another race, but on a slightly different route. The hare agreed. They started off. In keeping with his self-made comm
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    itment to be consistently fast, the hare took off and ran at top speed until he came to a broad river.

    The finishing line was a couple of kilometers on the other side of the river.

    The hare sat there wondering what to do. In the meantime the tortoise
    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
    trundled along, got into the river, swam to the opposite bank, continued walking and finished the race.

    The moral of the story?

    First identify your core competency and then change the playing field to suit your core competency.

    In an organisation,
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    f you are a good speaker, make sure you create opportunities to give presentations that enable the senior management to notice you. If your strength is analysis, make sure you do some sort of research, make a report and send it upstairs. Working to yo
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ur strengths will not only get you noticed but will also create opportunities for growth and advancement.

    The story still hasn't ended.

    The hare and the tortoise, by this time, had become pretty good friends and they did some thinking together. Both
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    realised that the last race could have been run much better.

    So they decided to do the last race again, but to run as a team this time.

    They started off, and this time the hare carried the tortoise till the riverbank. There, the tortoise took over an
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    d swam across with the hare on his back. On the opposite bank, the hare again carried the tortoise and they reached the finishing line together. They both felt a greater sense of satisfaction than they'd felt earlier.

    The moral of the story?

    It's go
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    d to be individually brilliant and to have strong core competencies; but unless you're able to work in a team and harness each other's core competencies, you'll always perform below par because there will always be situations at which you'll do poorly
    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
    and someone else does well.

    Teamwork is mainly about situational leadership, letting the person with the relevant core competency for a situation take leadership.

    There are more lessons to be learnt from this story.

    Note that neither the hare nor th
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e tortoise gave up after failures. The hare decided to work harder and put in more effort after his failure.

    The tortoise changed his strategy because he was already working as hard as he could. In life, when faced with failure, sometimes it is approp
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    iate to work harder and put in more effort

    Sometimes it is appropriate to change strategy and try something different. And sometimes it is appropriate to do both.

    The hare and the tortoise also learnt another vital lesson. When we stop competing agai
    .

    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
    nst a rival and instead start competing against the situation, we perform far better.

    To sum up, the story of the hare and tortoise teaches us many things.

    Important lessons are:

    •that fast and consistent will always beat slow and steady;
    •wor
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    k to your competencies;
    •pooling resources and working as a team will always beat individual performers;
    •never give up when faced with failure;
    •and finally, compete against the situation. Not against a rival.

    In Short, BE STRATEGIC


    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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