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Looking To The Future. If you are in business there is a good chance that sometime in the near future you will need to approach your bank for a loan. You may want to expand

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

or branch out into an additional line. You may have the opportunity to take on a major project that requires up front funding. Can you be sure that your bank manager will

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

Examples of combination products may in

ook kindly upon your request?

Bank managers are people, just like you and I. They have a job to do and if you take the time to understand what makes them tick, you are hal

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

way there. The banks make their profits by lending money that doesn’t belong to them to people who are prepared to pay a premium for the use of it for a set length of time

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

In simple words: People put money into a deposit account with the expectation of earning interest at a set rate. For example, 3% per annum. That money does not languish i

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

Combination pro

the bank vaults, it needs to earn it’s keep. The bank lends this money to other people who need a short term loan, at a higher rate, perhaps 6.5%, but only to those who th

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

manager trusts to repay on time.

That is the whole point. The bank manager must trust you before you qualify for a loan of any size. On the other hand he needs to have as

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

much of his clients money earning money for the bank, as is prudent.

How do you earn the banks trust? When you open your business account, if it is a large branch, you wi

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

l be assigned a business adviser, who will be the person who will advise you on the running of your account. He/She will give you advice on insurance and accounting amongst

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

other things. He/She will also be the one you will see regarding taking out a business loan.

Keep in regular touch with your adviser. Make sure that you are someone he/she

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

knows. Not just a number on an account. Your business adviser should be on top of your list of business friends. In a very short space of time, you will be offered overdraf

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

Following aspects would a

facilities. Use them, but stay well within your limit and be sure you are not in the red at the end of the month when your bank statement arrives.

Now is the time to ask

dd to the challenges in developing combination products:

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

or a small loan. You don’t need it but get it just the same. Pay it back in plenty of time. (You have just earned your first brownie point.) Wait a couple of months and req

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

est another loan. A slightly bigger one this time. Be sure to pay it back within the time limit. (More brownie points.) All this time you are building your business and the

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

money passing through your account is increasing month by month. Do this a couple of times a year to increase your standing and keep your name in front of those that matte

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

..

The day will come, as it almost always does with an expanding business when an opportunity presents its-self that requires a serious capital input. What are your chance

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

Professional from academic institutions, pharmaceutical industries, health care indust

of getting a bank loan to cover it? You have a very good record at your bank. You have used your overdraft facilities sensibly. They make a small profit from this. You hav

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

had several loans in the past and always repaid them on time. They made a profit from the interest on the loans. The money passing through your account is steadily increas

.

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

ng.

You are what is known as ‘In good standing’ with the bank. You are just the type of person that the bank likes to deal with. Your loan is assured. Just make sure that

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

Companies that provide selfless information through particip

ou repay this one on time and the manager will be inviting you to a round or two of golf. You can’t have too many friends in high places.

Homer.

Copyright 2006 Homer Fare

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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Business plan outlines help you structure your answers to the most important business planning questions: who what, when, where, and why. The answers to these 5 W's must be included in your business plan outline.

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