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Many entrepreneurs see themselves someday as becoming venture capitalists bec

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

ause they think the venture capitalists are the people with all the money. 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

deed, over time many of them have made a huge killing and many have lost a sm

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

all fortune. It is amazing that so many people look up to the venture capita

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

ists and of those in the know often referred to them as vulture capitalists,

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

Combination pro

because really that's what they are.

But he with the gold makes the rules an

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

that is the game. If you want their venture capital money that you have to

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

sell your soul and go along with their game plan, which is probably a return

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

n investment of 10 times their initial first round of funding within three ye

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

ars.

If not the company will be salt and all its assets and they're cashing

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

ut, whether or not they made any money. Why do they play the game so tight,

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

Following aspects would a

because it is a disciplined game and that's the only way they have found it w

dd to the challenges in developing combination products:

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

rks. If you have fallen in love with your business plan and your entrepreneu

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

rial dream did venture capital is not the way to go.

If however you just wan

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

to make money and you really don't care and you have a really good idea at 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

he right time in the marketplace that you might find excellent company with a

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

Professional from academic institutions, pharmaceutical industries, health care indust

venture capitalist.

Once you do two or three deals this way and become what

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

they call a serial entrepreneur then perhaps you are ready to play on their s

.

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

de of the fence and become a cheesy venture capitalist. And I mean that in t

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

Companies that provide selfless information through particip

he most sincere way. Truly I do, I just love them. 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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