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    I have a sign on my office door. It pretty much summarizes my philosophy of life.

    The sign simply says…..”Whatever it takes.”

    Short. Simple. To the Point.

    “Whatever it takes,” means exactly that. That I will do “whatever it takes” to get what I really want. It is the best description that I have e
    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
    ver been able to come up with to summarize the entrepreneurial experience.

    Decision. Commitment. Result.
    Something I pretty much had ingrained into my subconscious, playing sports as a kid.

    Make the Decision.
    Commit to that outcome. Visualize.
    Experience that Result.

    With my friends 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
    d colleagues I abbreviate and say…W.I.T. I’ll often refer to individuals as either having W.I.T or not. Y’know it’s like in the Rocky movies…”the eye of the tiger.” You can tell when someone has W.I.T and when someone is faking W.I.T.. Or, worse yet when someone doesn’t even know about it!

    Walt Disne
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    suffered through a bankruptcy and breakdown. Milton Hershey experienced bankruptcy in his pursuit as the “chocolate king.”

    H.J. Heinz saw his newborn company forced into liquidation. All these individuals understood W.I.T.

    It often confounds me though how many people will never understand what “wha
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tever it takes” really means?

    It seems that I developed my understanding of this philosophy through hardship. A tough teacher but an effective one nonetheless.

    Maybe you can relate.

    When I first started my life as an entrepreneur I thought I was pretty focused on what I wanted. Instead I got the exac
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    opposite. Working long hours for little or no pay, dealing with creditors, angry customers, unresponsive vendors, indifferent intermediaries, idiotic bankers, erratic sales, loaning money to the company, etc. Quite frustrating until I discovered that all of that had been a training ground of sorts that
    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
    taught me the alchemy of turning problems into opportunities. The one characteristic that every great businessperson must possess.

    Whatever it takes. Problems into Opportunities.

    W.I.T made me understand that it is not what happens to you. W.I.T makes you look at what are you going to do about it?

    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
    Before I had discovered W.I.T I had never realized that I had a “BLAME” list that was responsible for my circumstances. There were so many problems standing in the way of my success. I was convinced that I needed less problems. “If Only’s” so to speak….

    I rationalized that successful people had less
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    roblems than I did which allowed them to be successful. LOL! I hate to admit it, but it is true.

    “Well you know the economy…”
    “But the Government….”
    “If I only had more money…”
    “Its all in who you know….”


    All of these are huge lies which will prevent you from understanding “W.I.T.”
    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

    Everybody has problems. But problems begin to dissolve when you acquire skills. I was guilty of wishing and hoping for less problems. What I needed though was better skills. Without skills your focus gravitates to the problem. A very poor focus indeed.

    How often do you complain? Most of us are n
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t conscious of how regularly we demonstrate that our “FOCUS” is on the problem and not the solution. I was thinking about this the other day when I overheard a group of employees whining about their circumstances. It reminded me of my “BLAME LIST.” No W.I.T.

    One of the benefits of being an employee
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is not having to take TOTAL responsibility for your life. Its made me realize that rarely have I observed successful individuals complain about their circumstances. It is a major distinction between people who exhibit entrepreneurial flair and those who will always remain employees. W.I.T.

    The bigges
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    issue that I have found with success is actually defining “the word” SUCCESS on my own terms. Over the years I have developed a love affair with dictionaries. You might remember those books our ancestors used in the pre-search engine days. Anyway, I use dictionaries regularly to see how they define
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    word. What has become fascinating about this is that dictionaries often disagree with one another….kind of like the search engines do today.

    If you look up the word success in most dictionaries it will normally come up with some variations of the following ideas:

    accomplishment, achievement, attainme
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    nt; triumph, victory

    And my experience has been that these synonyms promote the following viewpoints:

    When you get what you want then you can be happy.

    Life begins when you get X.

    What you don’t have is better that what you do have.

    More is better.

    I find these perspectives woefully inadequate for t
    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
    uly defining the elements of a successful life. Until you decide what success means to you, inadvertently you will fall for one of these perspectives. The key is defining SUCCESS based upon what is ultimately significant to your life, on your own terms, by your own design.

    For me, W.I.T. is a wonderful
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    definition of SUCCESS. Football coach and legend Vince Lombardi said, “The pride of success is hard work, dedication to the job at hand, and determination that whether we win or lose, we have applied the best of ourselves to the task at hand.” If anybody understood W.I.T, it was Vince Lombardi.

    I, a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    lso however am reminded of the French prisoner Papillon who was unjustly condemned to life imprisonment on Devils Island. He was disturbed by a recurring nightmare. His dream was that he stood before a harsh tribunal.

    “You are charged,” they would shout, “with a wasted life. How do you plead?”

    “Gui
    .

    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
    ty.” He would mutter. “I plead guilty.” Papillon, the prisoner knew that to waste his life under the control of others was WASTE.

    He also consistently pursued his freedom. W.I.T.

    Life is essentially composed of energy, time and space. To ultimately live a successful life would mean that we intense
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    y understand these basic elements and invest them wisely without waste in pursuit of our goal.. The rich have money. The successful individual has a rich entrepreneurial life and lives it intensely.

    Success is a passionate love affair with life. W.I.T. On your own terms, by your own design.

    So be it


    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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