Useful Advices - Business

So often we find that entrepreneurs are looking for venture capitalists to fund the

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

ir next adventure. Unfortunately many entrepreneurs do not understand that venture

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

Examples of combination products may in

capitalists are pretty industry-specific at least the very good ones are. Why is

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

this you ask?

Well, because even venture capitalists have limited amounts of resou

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

ces and hundreds and hundreds of deals that people want them to do. They cannot us

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

Combination pro

e them all and they want to make sure they get the most bang for their buck; that i

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

ncludes the quickest return on investment for the least amount of capital outlay in

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

the shortest amount of time.

You can see why a venture capitalist’s job is not ea

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

y and why it is so important to find the right one that is industry-specific to you

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 entrepreneurial business plan. There's really no need to contact venture capit

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

alists, which do not specialize in your industry other than perhaps to ask them for

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

Following aspects would a

a referral to call, because they are busy and not interested. They truly aren't a

dd to the challenges in developing combination products:

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

d it is nothing personal is simply business.

There's just not enough time in the d

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

ay to read all these great business plans by all these entrepreneurs. In fact in my

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

day I have read a number of business plans too many to list over several years and

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

I imagine a venture capital is probably reads that many business plans in a single

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

Professional from academic institutions, pharmaceutical industries, health care indust

week. Don't waste their time and do not waste your time.

You need to make sure th

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

ey're industry-specific to your industry ask them if they are interested by phone a

.

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

nd if so send them an executive summary, not the entire business plan as it will ju

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

Companies that provide selfless information through particip

st become scratch paper or end up at around file. Please 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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