Advice You - Business

My son slipped a penny in the slot, cranked the machine, and turned his (or was it mine?) penny flat. He can't spend it now, but who uses pennies these days? We have drawer

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

s full of them. Watching him made me think of Thomas Friedman's book, The World Is Flat: A Brief History Of The Twenty-First Century (an easy recollection since I was

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

Examples of combination products may in

reading the book).

Friedman writes for the New York Times editorial department. He has written Longitudes and

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

Attitudes and The Lexus and the Olive Tree. The World is Flat completes a trilogy that validates

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

Marshall McLuan's maxim, "We now live in a global village...a simultaneous happening."

Friedman makes global observations with wise criticism and keen understanding. Fo

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

Combination pro

r example, listen here to Friedman talk about the Iraq

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

War, "If you don't visit a bad neighborhood in a flat world, it will visit you, " and it did.

11/9 and 9/11 I won't give away the entire content of Frie

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

man's book. I couldn't do it justice, and it is too long (471 pages). I will tell you that two events hinge the world for Friedman. The fall of the Berlin Wall, the rise o

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

f Windows95, and the fall of Windows on the World. Oddly, the first happened 11/9/1989 and the last 9/11/2001.

Finding Flat Pennies The world is flat bec

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

ause nothing is proprietary. What can be made, learned, constructed, and used in America can be made, learned, constructed, and used almost anywhere. Information and innova

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

tion are not constrained; the Internet, the cell-phone, and imagination have global instincts. Almost anyone can flatten a penny.

What a flat world means to your in

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

Following aspects would a

vestment choices Friedman does not address foreign investing. He emphasizes collaboration between scientist, analysts, researchers, academics, and corporations.

dd to the challenges in developing combination products:

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

I encourage you to read the many examples of outsourcing, insourcing, and infosourcing articulated by Thomas Friedman. If we are to maintain a viable international presence,

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

we must involve ourselves with other nations, their betterment, and our mutual benefits.

We can make one keen observation. Investments are not ethnocentric. Intelligence

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

s not either. Every investor must accept a future that involves opportunities in China, India, and Singapore (oriental not occidental). American companies scramble for this

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

opportunity; the Congress and the President should avoid quasi-protectionist acts.

My Son Must Do More Than Flatten Pennies Fortunately, he does! While

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

Professional from academic institutions, pharmaceutical industries, health care indust

doing homework, he types messages to his classmates (discovered girls recently). I told him, "When you spend time sending messages, a young man your age in China or India is

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

working on his next math problem. He is your competition." Americans are not entitled. Encourage and warn your children and grandchildren.

"The flattening of the world i

.

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

s moving ahead...nothing is going to stop it. But what can happen is a decline in our standard of living, if more Americans are not empowered and educated to participate....

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

Companies that provide selfless information through particip

This is not a test. This is a crisis, and as Paul Romer has so perceptively warned, 'A crisis is a terrible thing to waste'" (The World Is Flat, page 305f)

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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