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Useful Advices - Are You Selling Out Your Integrity?
Integrity in business is a quality that is highly under-rated by executives these days. Many executives are so "pushed and pulled" by a not so hidden force
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
called the "profit motive" that they often find themselves compromising something that without which they could lose all credibility and trust from those
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
they are trying to retain business from.
Isn't it ironic that something (i.e. the profit motive) that is supposed to help guide businesses into the black
Isn't it ironic that something (i.e. the profit motive) that is supposed to help guide businesses into the black
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
often drives them blindly into the red? Why is this? Well it's because often executives who run such businesses put profits above their own personal and bu
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
siness integrity. This treacherous mistake can easily lead one to ruin as has been witnessed in some recent scandals i.e. Enron, World Com, Arthur Anderson
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
and others less publicly known.
As an Executive Coach, Psychiatrist and Specialist trained in the underlying emotional issues that lead to ethical dilemm
As an Executive Coach, Psychiatrist and Specialist trained in the underlying emotional issues that lead to ethical dilemm
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
as, I have witnessed that the main causes of such ethical tragedies stem from an executive's low self esteem. Yes, you heard it correctly, "low self esteem
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
". Seems ironic doesn't it as many of us may consider some of the stalwarts of the business world who run these huge companies as the heros of our age. In
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
fact, when one scratches the surface of these CEO's one finds a very different kettle of fish.
A key sign of this low self esteem is as follows. Just ref
A key sign of this low self esteem is as follows. Just ref
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
lect on the gruelling pace that these executives keep, some working almost constantly and neglecting health, relational needs, family commitments and other
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
personal needs and desires. Only someone with low self esteem, or a low self regard would do something like this to themselves.
Those among us who think
Those among us who think
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
that such a pace is normal, acceptable and necessary are likely to question my judgement on this. That's fine. All I ask of those individuals is to notice
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
how they feel about themselves. I might suggest that if they are sacrificing "life and limb" just to survive then that probably doesn't make for a very hap
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
py existence. Does it? So how happy are you really? How happy are these executives.
Such a grueling pace and out right disregard for personal needs and de
Such a grueling pace and out right disregard for personal needs and de
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
sires is a clear sign of low self esteem. Often executives are so unaware of how badly they feel or how empty they feel emotionally because they are too af
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
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
raid to feel such feelings. The fear is that feeling such feelings might cause them to collapse or to seriously start doubting themselves. Of course this f
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ear is quite terrifying as it portends, at least in their minds, possible decompensation at every level.
Yet it is this same fear that is forcing such exe
Yet it is this same fear that is forcing such exe
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
cutives to drive themselves harder, to take chances that are riskier to themselves and to their organizations and thereby causing them to come closer to th
.
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
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
e brink of collapse anyway. Sounds like a "no-win situation" doesn't it?
Well the truth is that there is a way out of this vortex. If any of this is reson
Well the truth is that there is a way out of this vortex. If any of this is reson
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ating with you and you are sufficiently concerned about how trapped you feel in all of this then feel free to visit the web site below. Before its too late
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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