Advice You - Business

By: Donald J. Eversdyk February 18, 2007

The latest fashion trend that seems to be

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

becoming the norm is the way people dress. Whether it is for work, daily activities

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

Examples of combination products may in

or a special event, people are lowering their standards. Seems everywhere I go lat

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

ly either people don’t care what they look like, are just plain lazy, or a combinati

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

n of both. I’d like to give you three examples that happened to me in the past month

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

Combination pro

A company was holding an open interview session for invited candidates for a numbe

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

of open positions. They took a group of people in at a time and gave a brief overvi

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

w of the company. All of the candidates were professionally dressed, but the intervi

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

wer told them they were all overdressed. Khakis and polo shirts are fine and we even

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

have a blue jean Friday policy. Strike One.

My next adventure led me to the shoppin

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

mall. Men, women, teenagers, and younger kids all dressed in baggy jeans, extra lar

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

Following aspects would a

ge shirts, or sweat pants. Shirts not tucked in, pants hanging down, basic general h

dd to the challenges in developing combination products:

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

giene obsolete. Strike Two.

The third and final example led me and my wife to a Win

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

Tasting at the Milwaukee County Zoo. As we entered, it was obvious we were in the m

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

nority of formal dressers. Blue jeans and tee shirts were once again the standard at

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

ire, even for a special event. Strike Three, I’m Out!

While I don’t want everyone t

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

Professional from academic institutions, pharmaceutical industries, health care indust

wear Armani Suits or designer Italian shoes when they go to work or to the grocery

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

tore, it would be nice is if they took a look at themselves before leaving the house

.

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

and say to them selves “Do I look good in this, or am I just being lazy?”

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

Companies that provide selfless information through particip

"_new" href="http://www.donaldeversdyk.blogspot.com/">donaldeversdyk.blogspot.com

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 - Dressing Casual Should Not Be the Norm

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