References - Recreation and Sports

Tiger woods has a wonderful golfer’s brain wouldn’t you agree?

There is a story of ho

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

w he won his first major tournament. He played on a very difficult course and he knew

; 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 would be very difficult to win. So, he did some home work.

He studied the course an

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

realized that most if not all of the holes were on greens that sloped from the back t

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

o the front. In other words, if he shaped his golf swing to hit his ball past the ho

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

Combination pro

e, he would have a difficult down hill put to finish with.

So, what did he do?

When

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

e hit his ball onto a green, he made sure the ball finished below the hole. This mea

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

nt he had an up hill put and so was able to attack the hole.

Putting down hill from t

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

e other side of the hole was a slow dribble of a put with no authority, and the ball w

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

s at the mercy of any inconsistency on the way to the hole that would put it off line.

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

He won his tournament, and displayed a wonderful example of how professionals think d

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

Following aspects would a

uring a round of golf or even before one.

They put the ball where they have the best

dd to the challenges in developing combination products:

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

pproach to their next destination, and finally their best approach to the flag.

There

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

by hangs a tail. When you play a round of golf, you have to determine where you want t

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

he ball to be so that you can have a clear shot for your next attack on the green in f

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

ont of you. You make your golf swing accordingly.

You tee up on the side of trouble

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

Professional from academic institutions, pharmaceutical industries, health care indust

and hit away from it.

You place your ball in the best strategic position before each

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

green to enable you to hit the ball as near to the pin as possible.

You have to thi

.

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

k your way around the course, and also, take a leaf out of Tiger’s book and leave your

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

Companies that provide selfless information through particip

ball below the hole if the hole is on a slope.

Do it now. Start your new golfing life

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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References - Golf Swing Series: Thinking Your Way Around the Golf Course

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