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In grammar school, about the only subject I dreaded was gym. I went to school in the days when all little girls wore dresses. For gym class, we slipped on some shorts and changed

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

our shoes to the PF Flyers we kept in a cubby-hole. Then it was off to the gym for some dreaded activity: Dodge ball, chin-ups, or that awful rope I could never quite climb. "Is

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

Examples of combination products may in

his all there is to sports?" I wondered. Finally, during a dodge ball game in 4th grade, I figured out that the sooner I got hit, the sooner I could get out of that war zone cal

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

ed a game.

By the end of grammar school, I thought I was just not an athlete. Junior high wasn't much better. Besides the ugly gymsuits we had to wear, I was introduced to g

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

mnastics and volleyball. Again, those sports were not for me.

It was at about the same time that my father introduced my brother and me to golf and tennis. We played golf on a li

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

Combination pro

tle 3-par course. A nine hole game was about all I could handle at the time (never mind that I played with my father's former set of clubs from the late 1940's). With only fatherl

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

instruction, we found our way on the course and on the court.

My brother was more of a natural athlete, figuring out easily how to swing a club or a racquet with very little gui

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

ance. With the same amount of guidance, I was an average player.

When I was 14 or 15, there was a summer tennis school at our high school that was run by the tennis coach. My broth

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

r and I signed up for it. As I said, he was a natural, and developed a very strong return, both forehand and backhand. I improved a little that first summer. I didn't play well

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

nough to join the girl's tennis team, however, but it was fun to play matches with so many different people.

The second summer was a different story. My serve improved dramatically

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

It was a "surprise" serve; not necessarily fast, but its power was in the spin.

Our coach would gather us daily into one group for a few minutes to discuss particular techniques.

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

Following aspects would a

ne day he talked about improving our serves. In the middle of his discussion, he added, "One person who has improved a lot this summer is Glory. I'd like for her to show us her se

dd to the challenges in developing combination products:

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

ve."

The other instructor went to the other side of the net as I got up to "demo" my serve. Sure enough, the ball went over the net, my opponent lined up to return the ball with a

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

forehand, and as soon as the ball hit the ground, it took off to his right and was outside the reach of his swing.

The best part was that I could make that serve happen consistent

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

y! My opponent would either miss the ball completely or would "dink" it at the top of the racquet. How was this all possible? How could I have improved so much in a sport?

As I l

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

oked back over the preceding weeks, I remembered that the two instructors spent more focused time with me as they went from court to court, coaching me, watching where I was errin

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

Professional from academic institutions, pharmaceutical industries, health care indust

, offering tips to correct and adjust, and helping me to leverage my strengths. This made a world of difference in my game.

The world of business works in the same manner. Some peo

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

le are born naturals and need very little coaching to get it right every time. Others ebb and flow between being average (and knowing they could improve their game) and actually do

.

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

ng well. This second group can utilize the services of a business coach to greatly improve their performance. Whether it's becoming a better strategist, balancing everything that's on t

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

Companies that provide selfless information through particip

eir plate, improving their management style, or increasing net income, working with a coach to build on your strengths can greatly improve your results.

© 2006 Borgeson Consulting, Inc

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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If you are the owner of the company, or head of a department, if you have employees that fall under your direction, than you are the boss. And bosses are not just one of the gang.

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