Advice You - Business

There are more and more top executives in Corporations calling it quit

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

s. Indeed this gives rise to the next generations to move up the ladde

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

Examples of combination products may in

, unfortunately when we look at the cause of all these departures we s

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

ee some huge problems. Namely all this change management is being caus

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

d by over regulation such as Sarbanes Oxley and CEOs realize that they

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

Combination pro

will be hung out to dry if a mistake is made and find themselves in l

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

tigation or worse in Prison.

So, instead they are leaving the compani

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

es, with their golden parachutes, pensions and departing years earlier

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

This often leaves a leadership vacuum that the corporation must fill.

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

Easier said than Dunn, who just got sacked at HP. The new CEOs coming

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

into power are worried that they too will end up the next fall gal or

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

Following aspects would a

all guy and they just may. In fact the risks are often so great that e

dd to the challenges in developing combination products:

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

ven if the new CEO makes it thru a couple of years, they realize that

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

t is not worth pushing their luck and they too retire early.

Change M

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

anagement and over regulation is causing huge leadership and experienc

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

gaps in our American Corporations and makes them easy targets in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

market place to foreign competition. Unfortunately Senator Sarbanes an

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

Senator Oxley were not quite bright enough to see this through, altho

.

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

ugh they certainly should have, as any HS Future Business Leaders of A

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

Companies that provide selfless information through particip

erica Club Member could have told them that? Consider all 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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Advice You - Change Management and Over Regulations Causing Chaos

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