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Periodically, I interview car dealers, Realtors and various business people to get t

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

heir input for my negotiation seminars and corporate training programs.

A young Rea

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

Examples of combination products may in

ltor, whose dad has also been in the field for decades with a prominent firm, recent

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 mentioned it is paramount for buyers to have a talk with themselves before negoti

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

ating for properties.

“They need to get their priorities straight,” she said with e

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

Combination pro

arnestness.

If they get caught up in bargaining fever, she asks them point blank: “

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

Do you want a good deal or do you want a great house?”

People can plunge themselves

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

so deeply in dickering and trying to beat the other party that they forget negotiat

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

ing is about optimizing as well as maximizing.

Sure, we want to save as much as we

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

can, but what we really need is VALUE.

Ask yourself the same question before house

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

unting.

What is my primary purpose, to find a livable, comfortable home that I’ll b

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

Following aspects would a

e happy in for years? Or, am I looking to “flip houses,” which speculators do when t

dd to the challenges in developing combination products:

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

hey try to find bargains, fix them up a little, and then place them back onto the ma

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

rket at a profit?

Ideally, you want to get a great bargain on your dream house, but

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

this is very unlikely. If it’s that cool of an abode, and the seller isn’t desperat

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

e or dumb, you won’t be alone in bidding for it.

I came across a professional home

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

Professional from academic institutions, pharmaceutical industries, health care indust

speculator, who specializes in repairing and restoring 1920’s and 1930’s Spanish sty

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

le homes in Southern California, and then he re-markets them.

But when it came to h

.

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

is own house, his wife insisted they purchase a top-notch place, and he admits “I pa

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

Companies that provide selfless information through particip

id full price for it.”

Why?

“Making your wife happy is worth a lot!” he points 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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