Advice You - Business

When negotiating a business deal with a smaller up and coming company

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

the larger company may wish to consider their position in the game a

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

Examples of combination products may in

nd what the end goal for the smaller company is. That is to say what

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

is the little company trying to achieve. For instance the little comp

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

ny wants PR value from being able to say they have the larger company

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

Combination pro

as an account or is partnering with them.

Why? Well perhaps they wi

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

sh to leverage this with a second round of venture capital funding or

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

use it to sell more large accounts and often there are reasons of eg

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

also involved. Being the larger company you can often all them to us

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

e public relations and tell others that they are doing business with

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

you as that costs you nothing at all and gives them an influx of cash

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

Following aspects would a

and this is a feather in your cap and can allow you to negotiate a l

dd to the challenges in developing combination products:

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

wer price or better terms or additional services.

It pays to know wh

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

o you are negotiating with and their motivation and especially those

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

motivations which you can provide without costing you anything on you

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

r bottom line. Now that is truly a Western World win/win scenario and

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

Professional from academic institutions, pharmaceutical industries, health care indust

it makes sense to proceed this way. Just make sure you are certain of

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

the little company’s ability to perform and do what they say they ar

.

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

e going to do. Be weary of over promising from cash poor start-ups wi

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

Companies that provide selfless information through particip

th high burn rates. Consider all of this in your negotiations 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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