Main Subject - Business

It's true.

Ducks hold meetings in the park. And these quacky meetings have remarkable similarities to business meeti

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

ngs (held in conference rooms, for example).

Here's what they do.

1) No one pays attention to anyone.

Every duck i

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

Examples of combination products may in

s looking in a different direction. Most don't even appear to be part of the meeting. And none of them are watching t

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

e duck who is quacking. But they are all there because ducks have to know about everything that is happening in the p

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

ark.

2) Ducks deliver lengthy monologues.

Expect to hear: "Quack. Quack. Quack. Quack. Quack. Quack. Quack. Quack.

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

Combination pro

uack."

Sure, this may last only half a minute but that's a long time for a duck with an attention span of five secon

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

ds. It's useful, however, because during this monologue the other ducks forget what they were going to say. So they b

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

gin quacking about something else.

It sounds like:

"Quack. Quack. Quack. Quack. Quack. Quack. Quack. Quack. Quack."

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

"Quack. Quack. Quack. Quack. Quack. Quack. Quack."

"Quack. Quack. Quack. Quack. Quack. Quack. Quack. Quack. Quack.

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

Quack. Quack."

Certainly, this is a pointless discussion.

3) More than one duck quacks at the same time.

Research

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

on duck social dynamics has shown that this occurs because a) none of the ducks pay attention to the quacker, b) none

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

Following aspects would a

of the ducks care about what the quacker is quacking, and c) none of the ducks have manners.

4) The meeting seems t

dd to the challenges in developing combination products:

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

lack organization.

This may take some careful study because of the similarities to meetings held by people. Neverth

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

eless, it's true. The ducks started this meeting without a goal or an an agenda. As a result, ducks never know when a

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

meeting has ended.

5) Ducks come and go throughout the meeting.

Since nothing is being accomplished, it doesn't mat

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

ter when you arrive or leave. Some ducks simply walk through a meeting while offering a few thoughtful quacks.

6) No

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

Professional from academic institutions, pharmaceutical industries, health care indust

one seems to be in control.

Without a goal or an agenda, any duck can run the meeting. And they do. Sometimes the du

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

ck who started the meeting has left to attend another meeting. But the rest of the ducks remain, quacking away.

7) T

.

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

ere are no minutes.

Here the ducks show unexpected wisdom. Since they accomplish nothing, there is no reason to writ

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

Companies that provide selfless information through particip

e about it.

Second News Flash. People can hold more effective meetings than ducks. Visit my web site to find out how

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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Using the paper is considered gospel by many people in business. Use it wisely and it can be a good tool.

Accounting is known to be the study of how businesses keep track of their income and assets over a period of time. There are a lot of things one can learn from a career in accounting.

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