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How I hate budgets!

Every time an accountant told me to put together a budget for my company, my response w

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

as - “When I get the time I will!” I just never seem to get the time.

For several years when I first start

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

Examples of combination products may in

d my company I never paid attention to a budget. I knew if I made money by looking at my financial statemen

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

ts and that was good enough for me. Also, every time I tried to put something together I never compared my

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

ctual financials to the budget numbers I created.

Two years ago, I decided to take a different approach. I

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

Combination pro

developed a forecast for a quarter of what I expected income and expenses to be. I came up with the figure

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

based on the previous year's actual numbers. It was easy to look at last year and just add a percentage 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

crease to the numbers. Then I took the time to review once a month the forecast with where we were at that

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

oint.

By using this system of creating a forecast and comparing that to actual financials on a monthly basi

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

s I was able to focus on income areas that were falling behind and stop expenses that I didn't need to make.

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

I am an avid fan of informational products. I buy thousands of dollars every month. With the forecast in

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

Following aspects would a

lace I caught myself spending more then I allocated and was able to just cut back the next month. The great

dd to the challenges in developing combination products:

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

thing about this system is that you are not locked into a specific figure each month but yet you stay withi

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

guidelines of where you want to be before the year or quarter finishes.

The best way to set this up is to

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

use a financial program such as Quickbooks or Peachtree. Track all income and expenses using the software.

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 next step is to print financial statements that track what you have done. Then take the numbers of your

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

Professional from academic institutions, pharmaceutical industries, health care indust

financial statements and increase your income by the percentage you want to raise revenue by. Then look at

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

expenses and determine what categories will increase based on the sales increase. This will become your fi

.

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

nancial projections.

The last step is to review your actual financial statement (Income Statement or Profit

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

Companies that provide selfless information through particip

and Loss) to your projections. Have systems in place to increase revenue and decrease expenses as necessary

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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