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It seems the accepted approach to working on a “mental game” is to learn how to “cope” more effectively. Most clients enter into our work together with this mindset because it is the one most often written about

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

and used. The way most people go about “fixing” their performance issues is to find more “coping” mechanisms. The following is an excerpt from an upcoming book. The dialogue below takes place through “Dan’s” eyes

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

Examples of combination products may in

(the client). I begin this portion with a question and “Dan’s” responses are in italics. He has just spoken about a number of his performance complaints:

“Are you more interested in adopting more coping strateg

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

es to deal with all these performance issues you just told me about OR do you want to create a new approach that reduces the number of times they show up?”

Dead silence. “I thought the whole idea was to learn be

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

tter coping strategies”. I said.

“Well, that would be the idea most people have but I don’t believe it’s the optimal way to go about things. This is why I’ve asked you the question. So, I’m awaiting your answer”

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

Combination pro

Well, if I had a choice I guess I’d like to create something new and reduce the number of times these things happen…if I had a choice”.

“You do have a choice.” David said.

“Can you tell me why you asked that

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

question?”

“Sure. Here’s one of the first insights I’d like you to consider. There is a difference between coping and creating and many people, out of habit or training, think coping is the way to go. When you l

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

ook at what the word really means you’ll understand why I don’t focus on it. For example, the synonyms for the word “cope” are: “to manage, to get by, to struggle with and muddle through”. Is that what you’re str

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

ving for?”

“No, definitely not!”

“Well, that’s what coping is!”

“When you explain it like that it sounds pretty average.”

“Learning to “cope” means you are keeping your chin above water and it reflects the mi

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

ndset of “just trying to get by”. It’s subtle and I want you to know you are capable of so much more than that.” David said. End of excerpt.

I just received the following email from a client who read my earlier

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

book “Wired To Win” and then took action to make an appointment. The original email is longer than what is presented here and I’ve edited portions for the sake of space. He writes: Dear David,

“Everybody has ho

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

Following aspects would a

pes that with just one more key, they'll be playing like pros. On top of that almost nothing in the golf world really works for more than a few days.

I don't know if you realize this but your material is the onl

dd to the challenges in developing combination products:

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

y thing that has made a lasting improvement that I can "count" on. More importantly look at the nature of the improvement. Numerically speaking, this process reduced my scores by about 15% from an average of 81

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

to an average of 70!!! Years of practicing hitting drives, years of practicing putting, years of measuring how far each swing would throw the ball what particular distance but nothing was there to tie it togethe

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

r until I read your material and spoke with you and most importantly; it sticks, it continues to work and there is simply nothing else in golf to compare it to. So admire their (golfer’s in general) ability to h

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

pe because they have no way to understand the good you are out to do them, until they have it in their hands.”

Jim Fenney

This was quite a remarkable and unexpected letter to receive. Will everyone drop 11 stro

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

Professional from academic institutions, pharmaceutical industries, health care indust

kes? No. We didn’t set out to drop 11 strokes from Jim’s game, it happened as a result of his expanded awareness and application of the principles I write about so often.

I invite you to take a look at your appr

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

oach to the game of golf or of life. Are you busy “coping” with things like poor focus, lack of confidence, reactions to unfair bounces, stress, pressure and generally performing below your capabilities? Is your

.

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

utomatic approach to find more “coping” skills? Take a look and see if you’re spending time coping or creating something new for yourself.

THANK YOU! Thanks to the hundreds of folks who requested the free PDF o

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

Companies that provide selfless information through particip

n “7 Keys To Play Your Best Golf”. This free offer will be made for the final time this week. To receive it; please go to: www.theflowzone.net and click on “contact us” and type “free pdf” in the comments section

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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