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If we are unlucky enough to be at the wrong place at the wrong time, we experience a personal tsunami - a misfortune of devastating proportions that sweeps away our routine lifestyle and forever changes the world we know.

Yet despite the

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

frequency of such events - the tidal waves of Asia, the hurricanes of the Gulf Coast, the loss of life in the Middle East, the wildfires and mudslides of California - most of us are only indirectly affected. We bleed for those who have los

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

Examples of combination products may in

t everything, give what we can out of our pocketbooks and our hearts, but our world is essentially unchanged and we move along in our personal life journey relatively unscathed.

The vast majority of us will never undergo the wrenching jol

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

t of a major disaster, natural or man-made. The sheer size of the human race insulates millions of us from the floods, the bombs, and the mayhem. For us, the life-changing events we experience never hit the front page. Personal, quiet disa

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

sters - divorce, death, bankruptcy, or unemployment - change our lives forever but remain unnoticed by all but our closest friends and family. We pick up the pieces and try to get it together without government or private succor and suppor

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

Combination pro

t.

It is the isolation of personal loss that is so emotional destructive. We struggle alone to try to make sense of what went wrong and how we can recover our equilibrium.

Others are sympathetic and wish us well but there is an abyss bet

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

ween those who have a job and those who cannot find one. The longer we are out of work, the more alienated we become. Even those who love us start to worry that there's something wrong with us. They start to suspect that we're not as motiv

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

ted as we say we are. Everyone has plenty of glib advice: "Have you tried . . . ?" Of course we have -many times and always without success. We become more disheartened as we analyze everything we've done and realize we have tried every tr

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

ick in the book and still cannot find anything suitable.

Some of us get stuck in depression, anger, or paralyzing anxiety. Our energy drains away and even the smallest action becomes more and more difficult. As frustration and financial p

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

ressures mount, we wallow in the unfairness of it all and reminisce about how perfect everything was when we had a job and a future and hope, wondering why all this had to happen.

As with hurricanes and tsunamis and terrorism, the victims

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

are not responsible for the catastrophe they face. Life-changing events do just that - change our lives, sometimes forever. Change can be negative, fear-provoking, and desperately uncomfortable. But, if we look closer, we'll see it also h

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

Following aspects would a

as a positive face. Without change, our modern world wouldn't exist. We would be living the way our ancestors did. And while olden times may sound attractive in their pristine simplicity, such times were filled with disease, inequality and

dd to the challenges in developing combination products:

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

a raw brutality we could not stomach today. We need to embrace change and, despite the turmoil it brings, look for the silver lining hidden within the storm clouds.

Although you now remember your job with nostalgic affection, there were

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

undoubtedly times that you wished you could quit. Even if you loved what you were doing, any single job position only taps into a small part of your potential. Being forced to make a change allows you to develop other domains of your perso

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

al character.

Try to analyze your interests and preferences and identify things you would like to do which have not been utilized by your prior jobs. Can you think of an industry or a particular job title that might allow you to move in a

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

new direction? Think about, and complete some preliminary research on, jobs in new industries that you might be able to do. You may not have directly related experience but there are common themes that permeate every kind of work: the abi

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

Professional from academic institutions, pharmaceutical industries, health care indust

lity to communicate, to work as part of a team, to learn rapidly, to be aware of details, to organize and prioritize. If you pick an area of genuine personal interest, you enthusiasm will clearly and naturally emerge and that is something

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

all employers seek.

The job hunting you have been doing may, without your realizing it, have become routine and uninspired. The experience of failure and the frustration of never receiving positive feedback may have led to your merely "go

.

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

ing through the motions," already convinced, in your own mind, of the futility of your efforts.

Taking a new direction can open up your job search tunnel. Instead of beating your head against the wall and revisiting every technique and le

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

Companies that provide selfless information through particip

ad you've tried before, moving into a different environment may give you a new sense of purpose and appreciation of your own potential. That is when the positive effects of forced change can become a new source of pleasure and satisfaction

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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