Cases - Business

Many folks believe that all business people and CEOs are greedy Machiavellian types and should be arres

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

ted. It is amazing how few people take everything for granted without realizing that it was the busines

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

Examples of combination products may in

ses and entrepreneurs who have brought in everything you see, everywhere you go. It is Over Regulation

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

in the US that is truly hurting consumers.

What is interesting is that with over lawyering and over re

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

ulation we are defeating ourselves. The Rule Breaker, Rule Maker Syndrome is certainly coming true for

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

Combination pro

start-ups, which get a foothold and grow into corporate giants, take Google for instance and just as pr

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

edicted by the Motley Fools, now they are making the rules. Why? Well it is all about survival and batt

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

ing bureaucracy.

You must fight the bureaucracy builders and yet you need to be focused like a laser b

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

eam to win in business. You need economies of scale to get top billing. Henry Kissinger was right and s

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

o was Colonel Boyd in discussing the guerilla warfare of labeling your opponent unfit to lead only so t

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

ey can indeed take their place. And yet so few understand how business works or why their negative comm

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

Following aspects would a

ents about business is exactly the problem, which causes the over regulation and bureaucracy in the fir

dd to the challenges in developing combination products:

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

st place.

Personally, I am an advocate of the "Red Magic Marker" committee and Ronald Regan got it rig

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

ht in his quote about "if it moves tax it, stops subsidize it" and even Google, as it grows into a huge

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

multi-national conglomerate corporation will have to deal with its own growth and size. But just like 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

he US government Google must stay agile with fluidity of motion to win.

As an entrepreneur I only care

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

Professional from academic institutions, pharmaceutical industries, health care indust

about winning and if you define that correctly as in Western "Win-Win" style its all good. We should a

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

l understand that businesses are not evil, large companies are not bad, CEOs are doing their job, entre

.

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

preneurs are the life blood of America and if we want more integrity, honesty and cooperation, we need

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

Companies that provide selfless information through particip

to limit the bureaucracy and support our own team here. I hope this article will propel thought in 2007

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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