Main Subject - Business

Negotiation made simple indeed, no this was not an actual book

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

I bought this week, although there is no doubt someone has writ

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

Examples of combination products may in

ten such a book. The fact is that negotiation is not so simple

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

and until you have done lots of negotiation, you really are not

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 good at it and it is not so simple. You see, there are so

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

Combination pro

many little tricks that are used in negotiation. Simple psycho

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

logical tricks of the trade and when it is all over if you are

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

not so good at it, you think to yourself, what just happened.

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

Obviously in a negotiation you much perform well for your team

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

or your own interests and if you do not have that mindset well

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

you should not be there. The other team certainly does and they

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

Following aspects would a

may do whatever it takes to serve their will using every trick

dd to the challenges in developing combination products:

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

in the book really. So, best to be prepared, but how do you pr

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

epare for negotiation?

Indeed you need to find out all the tru

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

e desires of the other party. Perhaps they want fame, credibili

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

ty, awards and it is not all about money? Perhaps they have oth

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

Professional from academic institutions, pharmaceutical industries, health care indust

er motivations that you have not considered. If you know what t

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

hese other things are you can appeal to their psyche and get wh

.

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

at you want insuring that they come out looking good and get th

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

Companies that provide selfless information through particip

at recognition they are looking for. Consider all this in 2006.

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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