References - Recreation and Sports

It is a simple question from a seven year old that starts me on a life review. ”Why do you run?” she asks when I stop for lemonade at her make-shift stand, the one sporting a sign that war

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

ms my heart: ” lemonaid 10 cents.”

But I can’t answer her. For several seconds, I sip at the cup and smile at her sun-freckled nose.

“Why?” she asks again.

“It makes me feel good,” I re

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

Examples of combination products may in

ply, tossing the paper cup into the garbage pail, glad that I can slip away without saying more. Her question unsettles me though. The answer I have so glibly thrown at her does not seem 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.

ring true.

Why DO I run?

I have been a runner for 27 years, yet I am hard pressed to say exactly what makes me run. My first turn around the local high school track was motivated by she

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

er vanity. Having gained over 40 pounds with the birth of my first child, I was determined to make running the means to an end. I shed the pounds, but found in the process of doing so a ne

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

Combination pro

enthusiasm. Those were heady late twentysomething days when running seemed more like a cult than a sport—part of the Brave New World of Fitness that made me feel like a colt. It made me f

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

eel sleek, toned and fit, filling me with a kind of coltish momentum, as though I were riding the crest of a fast, furious wave.

Ten years later, I was still running, but the momentum had

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

slowed to a trot. With a second child and a full-time job, I found a different reason for running: it was now my way of slowing down the pace, my refuge from the frenetic rush of schedule

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

and deadlines. Feeling more like a cow than a horse, I ran to be still, allowing the rhythm of a body in motion to be a kind of stabilizing grace. During those years of music lessons, day

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

care and baseball practices, running became my still point in a turning world.

Twelve years later, when my husband fell terminally ill, I ran to stop the pain from swallowing me whole. I

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

an against the pain and through the pain, sometimes weeping, sometimes cursing as my legs carried me numbly over stones and rubble. When my husband passed away after an eleven month battle

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

Following aspects would a

against an illness that had the upper hand from the very beginning, I ran to make peace with the pain. Somehow in the echoes of my falling steps, I found a rhythm that seemed at one with

dd to the challenges in developing combination products:

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

the sky—stars suspended in darkness that made brilliant their light. And I realized that there was not much difference between this world down here and the one up there: we leave the way w

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

live because nothing shines brighter than a dying star.

Now in my fifties, I am running more than ever. I can’t help but sense that the question ”Why do you run?” seems beside the point.

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

I cannot live without running; it has become as much a part of me as breathing is. I run because running has been the only constant in my life, the only thing that hasn’t changed or has s

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

rvived despite the change. My children are now grown, my eldest son the father of two. We have new additions to the family, even as my husband has moved to a different peace. I have change

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

Professional from academic institutions, pharmaceutical industries, health care indust

d; my hair has greyed and my body has shifted to a more matronly cast. I forget recent events, but my memories of the good old days are etched forever in stone. No longer the colt nor the

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

cow, I have the permanence of time. Change seems no longer a menacing beast because I know I have been blessed—blessed with life in whatever form it takes. And I know I will survive in wha

.

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

ever form I take. I know because there is nothing in this world—nothing-- that can beat the beauty of a cool, steady run.

Come to think of it, my answer to the little girl is not quite so

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

Companies that provide selfless information through particip

glib after all.

Why do I run?

Because running has made me feel good. It does so still and God willing, it will make me feel even better in years to come.

Copyright 2005 Mary Desaulnier

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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Six Sigma is a management methodology for accuracy in manufacturing, etc. to make sure things are done right the first time and with that comes increases of economies of scale-fewer returns, etc. Such processes are especially important in Military, Health Care, manufacturing, transportation and computer industries.

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References - Why Do You Run?

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