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I want to share my answer to a frustrated golfer. Skip has been a friend for many years. He knows about Concept Golf but has had little time to absorb the principles.

What Skip is saying here is that

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

he keeps hitting behind the ball, and by his assessment, it is because he is getting ahead of the ball during the backswing. He transfers all his weight to his back foot but then leans over to his fron

; 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 foot before his through-swing begins. At the top of his backswing his weight is on his front foot instead of his back foot. This forces his arms to make up for the lack of power that is available fro

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

m his legs. Fat, short, crooked shots are the result.

My response follows his letter.

Dear John,

Once again I am compelled to challenge our friendship by pleading for some help with my golf game.

Y

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

esterday I was coupled with the only other "walk-on” at a great golf course (Musket Ridge, Myersville, MD) who turned out to be a professional golfer playing on the Nation Wide Tour. This alone added

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

Combination pro

some pressure as I preferred not to make a total fool of myself. As bad luck would have it (bad luck and bad game seemed to show-up immediately after being told my playing partner was a pro) I hit 70%

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

of my shots FAT and not just a little fat but sometime 6 inches behind the ball. I tried keeping by head very still (knowing full well that this goes against everything Concept Golf teaches) staying

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

behind the ball, slowing down, speeding up, and even said a few prayers. Nothing worked to correct my dilemma.

My own analysis is that I, in spite of my best efforts, naturally transfer my weight fro

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

m my right leg to my left leg far too early. From this position I am forced to flip at the ball with my arms. My question is: why in hell am I seemingly unable or incapable of staying on my right sid

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

e. I know the five principles and have often been able to apply all 5 with spectacular results. I am tired of hitting the big ball first and scoring far above my potential.

Help,

Skip

P.S. I was

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

putting and chipping superbly and shot 92.

Dear Skip:

Thanks for the good news letter!!!!! Let me answer your question.

The solution to your fat shots is quite simple. It is Concept Golf swing prin

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

Following aspects would a

ciple five that you are dealing with. Once your weight has transferred to your back leg during the backswing, make sure your back leg is flexed, quite flexed, and stays flexed. The scientist would say

dd to the challenges in developing combination products:

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

that your power leg should be flexed about 64 degrees during the backswing. I’m not sure you will sense exactly how much that is but in your case you will be quite sure your knee will touch the ground

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

during your backswing. You won’t touch the ground or even get close, but your stupid senses will yell that to you. Ignore them. Flex your leg. Your senses will also tell you that flexing your leg that

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

much will insure that you will hit behind the ball. Not true.

By keeping your power leg flexed during the backswing, your weight will be on your power leg as your swing reverses. You will not be able

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

to get your weight on your front leg before your through swing. By being flexed, your power leg is in position to push against the ground to create your through swing. Your arms have little (really not

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

Professional from academic institutions, pharmaceutical industries, health care indust

hing) to do during the through swing.

Your senses will say to you that the swing is a “squat, thrust” motion. Squat during the backswing and allow the automatic thrust during the through swing.

The s

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

wing will become automatic, thoughtless. This is a very good thing. You will start to realize that the exact distance you want with short wedge shots comes from the thrusting of your power leg. It may

.

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

seem that the power leg would be too strong for a delicate shot. The truth is that it requires real strength to be delicate and your power leg is the right thing to create the right distance for short

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

Companies that provide selfless information through particip

shots. You use your power leg to throw a dart, pitch a penny or toss a ball underhand. It seems quite natural with those activities.

Get two grass stains on your right knee and call me in the morning.

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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