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Entrepreneurs are an interesting breed. They'll eat Ramen noodles and cancel the cable to have t

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

he funds they need to start their own businesses that may or may not succeed. Entrepreneurs are

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

Examples of combination products may in

willing to take a pay cut just to be their own bosses. What makes us so strange?

Born o

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

Made?

Entrepreneurs are born, not made. How else can you explain that constant twitch

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

to be creating something new that we feel?

Thinking back through my life, it makes sense that I

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

Combination pro

was always destined to be an entrepreneur. I never saw limits for my capabilities. As a child an

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

d teenager, I was a bit stubborn, but managed to find a way to do whatever it was I was set on d

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

ing.

In the workplace, I never could settle. Whether it was a micromanaging boss, bumping my he

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

d against the glass ceiling, or just tolerating the daily commute in angry traffic, I knew I was

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

destined for more than a life of corporate work. It's only in the last few years that I've real

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

zed I'm not wrong for not fitting in to the corporate world. I'm an entrepreneur, and I forge my

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

Following aspects would a

own path.

Entrepreneurs for Life

The term "serial entrepreneur" has gained p

dd to the challenges in developing combination products:

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

pularity recently. But I know very few entrepreneurs who are happy just creating one business an

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

never moving on to the next thing. So in a sense, the very definition of entrepreneurship inclu

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

es the "serial" factor.

When I meet other entrepreneurs, I love seeing that passion about what

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

hey do. I can relate, because I love my company. There is nothing more satisfying than having co

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

Professional from academic institutions, pharmaceutical industries, health care indust

mplete creative control over my business' activities, despite the problems that it encounters fr

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

m time to time, like all businesses.

This is a tribute to all of you entrepreneurs (and those o

.

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

you who have yet to realize that deep down, you have an entrepreneurial spirit waiting to be se

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

Companies that provide selfless information through particip

free from your cubicle)! Congratulations for taking the leap into the unknown world of business

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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In any business entity, the type of business determines the income tax return form to be filed. In other words, the business structure determines the legal and tax considerations. S Corporation is one of the most common forms of business structure with a limited number of shareholders that is treated as a partnership for tax purposes.

Many corporations are spending a lot of money to come up with a statement about their Corporate Culture, which then of course is valid for and must be lived up by each and every employee! This approach contains already failure and I'll tell you why!

Dr. gary S. Goodman, President of Customersatisfaction.com, expert customer service trainer, and best-selling author, recalls a memorable scene in the film, “In The Heat of The Night,” when Sidney Poitier’s character is tired of the guff and disrespect he’s getting from his colleague, the Sheriff, portrayed by Rod Steiger. To end the condescension, Poitier says: “Call me MISTER Tibbs!” Goodman, a popular keynote speaker and radio and TV expert commentator, feels the same way when he's speaking to a CSR who has taken the liberty of using his first name, without permission.

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