Advice You - Business

Everyone has a good idea. The hard part is turning that dream in the head or on paper into a reality. One of 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

biggest stumbling blocks is money because without the much-needed capital, it is impossible to make it happen.

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

Examples of combination products may in

The entrepreneur can get a loan from the bank to help with this endeavor. But if the interest rates are to high

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

or the person does not have collateral, then this is not such a good idea after all.

The best thing to do will

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

be seek out a venture capitalist. The money this person will infuse into the business will go a long way in star

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

Combination pro

ting it or keep it going.

The first thing the entrepreneur needs to do is to write a business proposal. Researc

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

h has shown that more than 80% of those who decided to start something fail in the end because no studies were c

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

onducted.

The document must have a clear idea as to direction of the business, how much will be needed as well

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

s how long before the return of investment starts coming in.

It is not that difficult to find a venture capital

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

ist. The hard part is selling the idea because there are also others who will be sending a proposal, which has s

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

imilar contents in the texts.

Apart from reading the proposal, the entrepreneur will also have to explain this

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

Following aspects would a

in person why this should be accepted over the others. An ocular inspection of the place will also need to be si

dd to the challenges in developing combination products:

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

ce such as decision will not be made overnight.

Once hooked and the money is approved, both the entrepreneur an

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

d the capitalist investor have made a partnership which will hopefully last for the long term.

The capitalist i

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

nvestor does not only give money. There may be times that the entrepreneur is stuck in a crossroad and this may

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

also offer good advice. After all, the money of the person is in here and will surely do everything possible to

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

Professional from academic institutions, pharmaceutical industries, health care indust

et it back with a profit.

In the end, the venture capital investment is similar to a loan but does not have hig

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

h interest rates compared to a bank. It is also like launching an IPO but without the need to release a certain

.

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

number of shares to the people.

Will it be beneficial to talk with a venture capitalist? The answer is definite

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

Companies that provide selfless information through particip

ly yes because it becomes a win-win situation for everyone without one side ever getting the better of the other

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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A Business with no prior experience on the use of CLV should start with a simple approach: a limited complexity Customer value model. An RFM (recency – frequency – monetary) score can be used as a proxy for the CLV. This score can be a cost-effective initial Customer value ranking. In certain cases even a recency score may be a complex start. Frequency and/or monetary scores may be more suitable as a starting point. The use of a Customer value ranking is only a means to the efficient use of business resources (value-based management). The accurate estimation of the Customer Lifetime value may be not only very difficult but also of limited business value.

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