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According to my handy, dandy Illustrated Oxford Dictionary, an entrepreneur is: "a person who undertakes an enterprise or business, with the chance of profit or loss."

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

Well now that's a big yawn.

But, let's take a look at the word "spirit", which actually has several different senses to the same word. Setting aside the ghostly stuf

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

Examples of combination products may in

f and the distilled liquor, I am tickled to share these definitions: "the vital animating essence of a person" and "a person possessing these: courage; energy; vivacity

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

." Now we're talking.

Have you always had a burning desire to own and operate your own business based on what you are most passionate about? Possibly, you are lucky

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

enough to already be doing so. Maybe, you started young with a lemonade stand, or other youthful enterprise, and got a taste of being your own boss that has followed y

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

Combination pro

u through your life nipping at your heels like a playful puppy while you worked for someone else.

Could it be that you are a part-time entrepreneur as part of a "portf

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

olio career" that includes working a day job for someone else? Are you an accidental entrepreneur who is starting your own business because you got downsized? Or are

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

you a stay-at-home mompreneur who wants to be with the kids, and add to the family income? Possibly you are a creative multipreneur who has developed multiple streams

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

of income from various self-employment ventures. For example: A writer who is also a speaker and a seminar leader and a snowboarding instructor and…? You get the idea

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

.

Wherever you fall in this spectrum, I say congratulations all you brave, enterprising souls. It is not an easy road, but it is a rewarding one. There are some grea

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

tools to help you along the way. I recommend the following three books to help you in your growth as an entrepreneur.

1. "The E-Myth Revisited" by Michael Gerber

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

Following aspects would a

I would be remiss if I did not give high praise to one of the best-selling small business books in the world. It is an absolute must-read for anyone starting a busines

dd to the challenges in developing combination products:

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

s or wishing to turn around a floundering business. His distinction between working on your business and working in your business is worth the price of the book alone.

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

2. "The One Page Business Plan: For the Creative Entrepreneur" by Jim Horan

I am shocked at how many solopreneurs and small businesses are working without a written

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

business plan. How can you know where you are going if you don't have a map of some sort? This is an easy-to-use and empowering process that creates a clear road map

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

for your business - plus it includes an Entrepreneur's Toolkit CD.

3. "The Enlightened Entrepreneur" by Grace Bulger On the first page she writes: "If your dream is

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

Professional from academic institutions, pharmaceutical industries, health care indust

to start your own company, then let's be clear about it: you're doing more than incorporating a business related to what you do or physicalizing an outgrowth of your pe

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

rsonality. You are giving birth to a living entity, with a spirit and soul and personality. This is a sacred creative act that demands respect. This book takes you t

.

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

hrough a process to help you create and market your own company as clearly and consciously as possible." I couldn't have said it better.

There are different levels an

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

Companies that provide selfless information through particip

d ways to let your own entrepreneurial spirit out to play. So all you people of "courage, energy, and vivacity" get out there. The world is awaiting your unique gifts

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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Discussing with Erik Lie the experiences with Stock Options Backdating (SOBD) and the economic impact of his work. According to Erik, at least 15% of the stock options grants between 1996 to August, 2002,were backdated. Some were within 30 days of the grant date, others more egregious. The number of companies though he said that were going to come clean would be far less than 15%. Here is what we came up with.

The venture capital industry competes in a volatile marketplace typified by high risk and high reward. Venture firms invest millions of dollars on seasoned executives and entrepreneurs who present great promise of creating significant shareholder value with the identification of the next big idea or innovation that will revolutionize an industry.

Do you remember your parents asking you what you want to be when you grow up? By the time I was in the 9th grade, my mother started asking me that same question until I graduated from high school. A...

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