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While watching Face the Nation one Sunday earlier this year, Bob Schiffer discussed the airline industry, his mother and ethics in business. Like Bob, I th

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

ink it is a sad commentary today, that we have to police businesses. Whatever happened to going into business to provide a needed service, being loyal to e

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

Examples of combination products may in

mployees, and keeping promises.

It seems like no one today is concerned about doing good business or being ethical in the process. Our forefathers woul

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

be ashamed at what this society has come to. I know I am.

Chuck and I teach our students how to run a good business, by being ethical, and making sure

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

that everyone is happy. We run our business using the adage, “The customer is always right”. We know, however, from looking at others in business both on

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

Combination pro

and offline, that we are in the minority. For most it is all about making money. They don’t care who they have to step on, how many lies they tell, just “s

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

ow them the money”. As I pointed out in my article regarding “The Almighty Buck”, this should not be your only incentive for going into business, and if it

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

is, you won’t be in business long.

We see sites every day that you can’t find a telephone number on, an address for, they just want you to take it on f

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

aith that they are on the up and up. Years ago, a business would never even think of operating this way. Their name, address, phone number, slogan etc. was

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

very prominent on everything they did. Unfortunately today, you can’t take people on faith anymore. It’s very sad, but it seems if you do so, most of the

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

time, you will get burned.

Years ago, companies were known for their honesty, their integrity, and their good products. They had to be to stay in busin

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

Following aspects would a

ess and keep the good image they wanted to project. This gave their company a good name. As many of you know, we come from New York. Kodak, Grumman, and IB

dd to the challenges in developing combination products:

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

were major companies in down and upstate NY. If you got a job with them you had a job for life, and once you retired you didn’t have to worry. Today, peop

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

le are losing their medical benefits, their pensions, their life savings; due to businesses thinking of only the bottom line.

Every time you open a news

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

paper or watch the news today you hear about another business’ unethical business practices. They cook the books, take bonuses they don’t disclose, while 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

ey expect employees to work for less. There is something very wrong with this picture. It also says to our future entrepreneurs, that this behavior is alri

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

Professional from academic institutions, pharmaceutical industries, health care indust

ght, just don’t get caught.

Like Bob Schiffer, I’d much rather go back to the time when businesses dealt with us in an ethical manner and didn’t only c

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

oncentrate on lining their pockets, like today. Also, like Bob, I think what we need are different teachings in our business schools. The philosophy of tod

.

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

y’s teachers, needs to re-vamped to reflect the philosophies of old. What we need is to “throw out the new, and bring back the old”. As Bob said, if his mo

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

Companies that provide selfless information through particip

m was teaching today, students would get a completely different view…an old fashioned one. Kudos to Bob’s mom!

Copyright 2003 DeFiore Enterprises

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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There are things you should know if you want to establish a vending machine company. Going online you will be able to find reputable vending distributors with which you can do business.

If you need to partially conceal your cameras from view, wireless security cameras are the way to go. Locations such as banks use a combination of wireless and wired, visible and hidden cameras to intimidate potential robbers, but continue photographing them even if they disable the wired cameras.

As a volunteer, individuals offer their services without receiving a salary or wage in return. It is an act that is performed of his or her choosing and desire.

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