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    “Prince Rabadash’s army lay close behind them, Anvard ahead. If they did not reach Anvard before Rabadash and his horde, their journey, their entire lives, would have been wasted. The horses, Bree and Hwin (both of whom could, of course, talk) galloped. Certainly both horses were doing, if not all they co
    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
    uld, all they thought they could do; which is not quite the same thing. But a lion appeared out of nowhere and with the spur of terror; Bree now discovered that he had not really been going as fast, not quite as fast, as he could”.

    This extract is of course taken from The Chronicles of Narnia, th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    at fount of a million, simple and usually overlooked truths and it illustrates perfectly what it takes for some of us to be steered out of our comfort zone.

    Perhaps of all the temptations we meet in life, money, power, sex, alcohol, drugs and fame, the subtlest of all is the comfort zone, that invitation to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    settle for less, to go for content when the stresses of over achievement beckon. The way that takes you out of the comfort zone is the route less travelled by. Most of us when we come to that place where the two paths divide prefer the one that leads to safety, to warmth and to comfort.

    Both in sport and in
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    business, I have witnessed countless companies, friends, colleagues and team-mates that underachieved, despite having far superior skills and talents when compared to others who have made it to the top. The reasons have always been the same, fear of leaving the comfort zone and entering into the unknown, th
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    land potentially of failure and rejection. But I believe there is another way to motivate individuals and coax them out and it relies on one simple fact, most people do not know what they want from life. Certainly, the majority working in a commercial field will say they crave success but without understand
    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
    ing what success means for them. Of course, describing success is difficult, because it will be different for all of us. The definition I prefer is “The achievement of a worthwhile goal

    I believe that I can speak with authority about the comfort zone, but in my case, I was lucky enough to discover E
    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
    rl Nightingale, probably the greatest motivational speaker and personal development guru of our time,and yes, I include Anthony Robbins, Brian Tracy Tom Peters et al in that assessment. It was towards the end of 1990 when I felt the first pangs of professional unfulfilment and began to contemplate the harsh
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    reality that with my fortieth year fast approaching if I was really going to leave my mark on the world and achieve something for me, then I really needed to get cracking.

    Oh that it were that simple! Moving out of a comfort zone, which included a six-figure salary, sizeable bonus, stock options, luxury co
    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
    pany car, pension and relative security would take guts for sure, but it would also require huge commitment and tremendous self-belief. Armed with a newly acquired MBA and almost twenty years commercial experience gained working for some of the biggest players around the globe at the highest levels, I though
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t I knew a thing or two about business, but translating that knowledge and experience into a saleable commodity would be the real challenge.

    Over the next four years I remained in my cocoon of security very much like the man invited to join those masochists who, once a year, usually on Christmas Day, insist
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    on plunging through the ice into the Serpentine in London. I would nervously approach the water’s edge, shiver, convince myself it would be too cold, and then retreat to the warmth of my towel and robe. I did this several times but the thought process and learning process accompanied me on my travels from N
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    w York to Johannesburg and from Paris to Kuwait, whilst I continued to enjoy the comforts afforded to me from my corporate existence. Those four years were certainly not wasted because I took the opportunity to attend as many lectures, seminars and courses as I could reasonably fit in and I read voraciously,
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    looking for the spark of inspiration – some divine intervention that would lead me to my true vocation. Then in 1994 I attended my first Earl Nightingale seminar.

    On that day in September, as I listened to him illustrate the fact that most people are like rudderless boats bobbing up and down on the ocean,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    eing taken wherever the currents should wish to lead them, then reminiscing in old age and saying to themselves ‘If only I had’ or ‘I wish I had’ and essentially blaming everybody else for their unfulfilment and lack of achievement. Whereas, he said, that the small percentage that took control of their vesse
    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
    l and steered into ‘harbours of opportunity’ would look back with satisfaction and say ‘I have’ and ‘I did’.

    I remember he quoted Albert Einstein,” The definition of insanity is to continue to do the same things in the hope that those things will miraculously achieve a different result.” In other wor
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    s, “Keep doing what you are doing and you will keep getting what you have been getting” and in my case that was unacceptable.

    He also said that all successful people had at least two things in common: The first was their attitude and the second was that they all expected to be successful and because
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    they wanted it badly enough, they brought about its happening i.e. fulfilled expectation.

    As I drove home that evening, I felt inspired… I had experienced my epiphany and my mind was made up, I was ready to leave the comfort zone.

    Finally in 1995 I dropped my towel for the last time and plunged in; jfa was
    .

    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
    born and that journey of a thousand miles had begun with a first tentative step.

    In Summary:

    Success should be something you do not just ‘Kinda Sorta’ want to achieve but something you must achieve. Generally, successful people expect to be successful and as a consequence, they usually are. They are
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    driven by a have to attitude not a want to attitude. If you are going to climb out of your comfort zone, you must deep down feel that you have to.

    My experience is that you cannot have everything you want but you can anything you really want.

    Copyright © 2006 Jonathan Farrington. All rights reserve


    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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