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Most politically correct folks cringe when we talk about Machiavellian

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

Management as in the Western World we are more into a win/win situati

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

on than any sort of dog-eat-dog attack style business negotiation or m

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

anagement. Nevertheless, cheating, lying, deceit and positioning for y

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ur advantage is consider Business a Usual in many nations and the Amer

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

Combination pro

ican Entrepreneur who thinks it is not has got some hard lessons to be

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

learned if he does business over seas.

You see, Machiavellian Style

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

Management Very Popular Over Seas and that is the way it is in politic

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

, business, war and sports. Business is all of those put together beli

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

eve the Sun Tzu followers of Asia, so perhaps you might indeed simply

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

forget your MBA and consider getting a reality check on the subject.

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

Do I personally approve of all this? Totally irrelevant to the subject

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

in fact I have no comments only stories of businesses deals and hard

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

lessons along the way. Yes, indeed I came out victorious as I recogniz

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ed what was going on.

Thus I believe every good Corporate Manager and

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

executive ought to read; The Prince and consider some of the Machiave

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

lian Tactics we see every day in normal primate human politics from ki

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ds in the sand box to those who are wonder what color their parachute

.

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

would have been if someone climbing the corporate ladder had not throw

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

n them out of the plane with only a backpack on? Think on this in 2006

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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