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Most people I meet have been raised to give their best efforts when they work. Somewhere they got the message that if

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

they work hard and give their best efforts, they will be rewarded fir their loyalty.

And sometimes they are . . . and

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

Examples of combination products may in

generally, they aren’t.

For most people, work involves travel to and from a place away from home, dressing a certain

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

way and following direction to them according to company rules. You are expected to deliver a certain amount of outpu

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

t for which you receive a salary and, perhaps, benefits and periodic raises.

For many people, raises do not keep them

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

Combination pro

ahead of inflation. Through October 2005, the consumer price index was up 4.3% and the core inflation index (the one

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

that excludes food and energy prices) was up 2.1% (could you do without food and fuel?).

This means just to keep up w

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

th inflation, a worker who was paying taxes of 25% on the federal, state and local level would have to receive a raise

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

of at least 5.4% just to stay even with their income txes. Add in property tax and school tax increases that occurat

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

different times and that raise you’ve gotten won’t go very far.

What should you do?

Walking in to your boss’ office,

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

pounding their desk and demanding a raise is not a good idea, expecially if you don’t know the value of your experien

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

Following aspects would a

ce in the job market.

Instead, update your resume and get yourself another job. Why allow yourself to get paid less t

dd to the challenges in developing combination products:

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

han your market value. Are you that rich that you can forgo the additional income?

For example, if you earned $50000

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

and received a 10% salary increase, you would be earning $55000. You would be ahead of inflation (inflation is5.4% inc

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

uding the tax bite; you would be getting an actual raise ahead of inflation).

But let’s look at the multiplier—5 year

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

s from now, if you only received a 5% raise each year, here’s what would happen:

Year		Raise to:	Money you are a

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

Professional from academic institutions, pharmaceutical industries, health care indust

head

$50000	        $55000	        $5000
 $55000		$57500		$12250
 $57500		$60300		$22550
 $60300		$63315

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

$35815 $63315 $66480 $52295

Can you really afford to ignore over $50000 in earnings? And what if you joined

.

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

a company where raises were even higher?

Most people I meet work to take care of their family, to save for their futu

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

Companies that provide selfless information through particip

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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