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Do you ever notice a particular idea or concept popping up in your life? It is as if a new movement in life

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 symphony has begun and it has a reoccurring theme? It keeps showing up in unexpected places. It was neve

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

Examples of combination products may in

r there before, but keeps presenting itself in one form or another. So it has been for me lately with the

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

idea of the adjective. Once we get beyond grammar school, we don’t spend much time contemplating parts of s

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

peech. We tend to let our words be what they are and fall where they may. Contemplating the adjective, how

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

Combination pro

ever, has proven to be instructive.

My adjective awareness started when I read about Leo Burnett, one of t

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

he great Chicago advertising agencies. We can thank Burnett for such cultural icons as Tony the Tiger, the

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

arlboro Man, Pillsbury Doughboy and The Jolly Green Giant. Burnett wrote that the “excess use of adjective

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

s makes for dull, exaggerated and ineffective advertising copy.” That reminded me of a sermon by a hero of

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

mine, Carlyle Marney. Marney was one of the great theological minds of the twentieth century. A Georgia bo

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

rn Baptist preacher he was an activist in his words and a gentleman in his spirit. He instructed to never

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

Following aspects would a

elevate an adjective to the level of a noun.

Adjectives do tend to muddy the water. Straight forward nouns

dd to the challenges in developing combination products:

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

bring clarity. Adjectives qualify, confuse and confound, especially when applied to people. Adjectives “m

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

ale,” “female,” “black,” “white,” “gay,” “straight” “Jew,” “Christian,” “Muslim,” “homeless,” “wealthy,” “R

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

publican,” or “Democrat,” are partial descriptions of whole and the far more important nouns -- “human bein

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

g,” “person,” or “friend.” When adjectives are given the power of nouns, people and nations inevitably get

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

Professional from academic institutions, pharmaceutical industries, health care indust

in trouble. Sometimes fights and even wars can breakout, just because the adjectives are given too much au

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

thority. Most of us have nouns in common. It is the adjectives that divide us.

Mark Twain said, “A man's

.

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

character may be learned from the adjectives which he habitually uses in conversation.” Today is probably

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

Companies that provide selfless information through particip

a good day to listen for adjectives and to do as Mark Twain also suggested, “…when in doubt, strike it out.

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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