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Planes, Trains, And Automobiles

When most of us think of global businesses we typically get an image of highly paid, well dressed executives glancing at expensive watches as they move from th

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

e airport to the boardroom. It is a common scenario. As corporations grow they push into more distant markets ultimately hoping to increase the bottom line.

But it is not the only scenario. Global m

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

Examples of combination products may in

rketing has increasingly taken on a quieter form. The executives are not so well dressed. They sometimes do business in their pajamas. They may have expensive watches but they don’t have to look at t

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

em so often. And instead of rushing from airports to boardrooms they stroll from the living room to the kitchen.

The World At Your Door Step

There is an old saying I have used myself quiet o

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

ten. It goes like this: "It’s a small world but I wouldn’t want to paint it." The geographic world has not shrunk. But the world of communication has… and with it the world of business.

In days of o

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

Combination pro

d a king would not know whether he won or lost a battle until a runner arrived with the news. Today we watch the battle unfold on television. We no longer wait for the Pony Express to bring word from

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

the folks back east. We shoot off an email to a distant country. Electronic communication has brought the world to your doorstep.

Why Not Go Global?

Why has the nature of communication chang

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

ed the world of business? The answer is obvious. Business depends on the transfer of information to thrive. The world of information touches every area of our lives.

This leads me to another questio

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

. Don’t answer this one too quickly. Think about it… ponder it. Here it is…

Why not take advantage of the information revolution and build a global business?

Here are a few answers:

I lo

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

e my job and I don’t want to think of anything else.

I make too much money already.

I don’t know what I would do with a flexible schedule.

I would miss rush hour traffic.

I am

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

ure you have a few more answers.

The fact is an increasing number of people are building successful global businesses with none of the trappings of corporate life. These are intelligent, resourceful

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

Following aspects would a

passionate… ordinary people.

That’s right. They are ordinary people. That is what excites me. I am pretty ordinary. But these ordinary people have something the world wants.

Give The World What

dd to the challenges in developing combination products:

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

It Wants

What is the world after? Peace and the end of global warming. But after these the world wants information. In fact it is ravenous for it. Everybody wants it. I want it. You want it. Per

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

aps that is why you are reading this article. You want to know something.

Here is the great news for you. You have information that the world wants. Yes… you do. Not everyone in the world wants it.

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

Maybe no one in your neighborhood wants it. But there is a significant population that does want it. Where are these information starved people? They are scattered across this great globe of ours.

Y

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

ur knowledge, your experiences, your loves and passions can be turned into information a significant number of people would love to have. In fact with some work you could carve out an information nic

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

Professional from academic institutions, pharmaceutical industries, health care indust

e that you own.

I did say work. You will have to work at it. But it is fun work. It is work that flows from your loves, your knowledge, and your passions.

Where Do I Put It?

With some work

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

ou can identify an information niche that would be beneficial to many thousands of people all over the world. What do you with it? Put it where everybody already is. Put it where you spend your time.

.

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

Put it on the internet.

How do you do that? You build a niche focused website full of the information people are seeking. Give people what they want in an environment we are all used to. The interne

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

Companies that provide selfless information through particip

is where we go for information. Be there.

Think about it. You can create a global market from your kitchen table. All you need is the right plan and some determination.

Fuzzy slippers are optional

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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