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  • Your Space - Why You May Want To Rejoice When Others Mock You!

    It does not matter how successful, respected, authoritative, wealthy or famous they are. For as long as they do not have the passion for, insight into and knowedege about an issue that YOU do, they are unlikely to see wha
    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
    t you see - at first. The problem is that because such people tend to feel they already "know"(and many others tend to believe that these people actually do know!), they will not be aware that "they do not know" as much a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s you do.

    Robert Goddard today has America's Space Center named after him. But during his lifetime, he enjoyed little in the way of recognition for the work that would win him the honor of immortality. In 1920, The New Y
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ork Times (and reporters who followed him around, taunting him after each failed test-launch of his first "Nell" rockets) in a stinging editorial played a leading role in mocking Goddard's scientific publication.

    He cons
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    equently, developed an aversion for publicity/the press, continuing his work in "near" secrecy, often refusing to supply details of breakthroughs recorded even when asked. Among other things, he wondered why they would no
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    "mind their business".

    Ironically, while his countrymen ridiculed him, the Germans periodically contacted him about his work. Evidence that he knew what he was talking about later emerged when Germany launched over 1,10
    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
    0 V-2 rockets at London, badly damaging the city. The missiles later examined(and a captured German scientist interviewed) revealed they were modelled after those developed by Goddard - only his were not meant for use as
    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
    war instruments.

    Forty-Nine(49) years later, in 1969, after the US' Apollo 11 rocket(built based on Goddard's work) took off for the moon, a retrospective New York Times editorial admitted that further research evidence
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    and experimentation had confirmed Goddard's theories(that rockets can fly in a vacuum - such as space - as well as in an atmosphere) to be correct. The editorial ended thus : "The Times regrets the error." A great lesson,
    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
    taught by a great man.

    The scientist (who had died of throat cancer 24 years earlier) did not get to see the rocket launch or read the apology, but the FACT that both happened (see Time Magazine March 29, 1999, Vol. 153
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    No. 12 ) confirms that sometimes people who mock another for his/her ideas do so out of a lack of insight or knowledge that the latter has. The originator of a new or untested idea must therefore follow his/her conviction
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    s unflinchingly, till s/he is proved right.

    James Cook in his book "The Startup Entrepreneur", expressed a similar sentiment when he wrote that an entrepreneur should consider him/herself in "good company" whenever his/h
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    er ideas attract "doubt or scorn" from others.

    To give anyone who faces this kind of challenge further reason to stay resolved towards achieving his/her set goal, the insight offered by Napoleon Hill in the book "Think a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    nd Grow Rich" is also quite instructive. In explaining the fact that defeat is a "temporary condition", Hill pointed out that we all daily see people who encounter obstacles in their pursuit of a set goal and readily give
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    up, just as we see others who trudge on, again an again, remaining undaunted by repeated setbacks they encounter.

    One thing, according to Hill, that most of us do not however notice, is what he called the "silent but ir
    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
    esistible power" that inevitably "rescues" those who refuse to give up in their pursuit of success in a chosen endeavour - adding that if we acknowledge it at all, we call it "persistence". He then ends by saying that one
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    fact we all do acknowledge, is that anyone who lacks the quality of persistence CANNOT achieve significant success in any thing s/he does.

    Moral: When people mock you, rejoice(!), because it is most likely a good
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    sign that you are on the right path. Keep going, and you'll succeed!

    "Life is either a daring adventure, or nothing. Security does not exist in nature, nor do the children of men as a whole experience it. Avoiding da
    .

    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
    nger is no safer in the long run than exposure." - Helen Adams Keller (1880-1968)

    "Some people make the mistake of equating consensus with truth. That you, and others who think like you, agree among yourselves tha
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t a centipede is a millipede wearing a metal coat, will not make the centipede become a millipede." - Tayo Solagbade

    "Even if 50 million people say a foolish thing, it is still a foolish thing" - Anatole Franc


    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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