Summary - Relationships

Boy last night was a lulu. I got home from work and my wife and I started talking a

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

bout a touchy subject. We started talking and almost instantly had a misunderstandi

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

Examples of combination products may in

g. The misunderstanding would have turned into a fight a year ago. I mean a knockd

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

wn drag out. I mean we would have had a yelling match and hard feelings for days.

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 you understand the kind of fight I am talking about? So what is different now? W

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

Combination pro

y did we have a calm discussion and agree to revisit it later, when we're not feelin

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

g so emotional?

Well, today I recognize how to have a disagreement without arguing

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

bout it. We will sometimes revisit it later. Sometimes we will agree to disagree.

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

What you find is when you start feeling more secure in yourself, it becomes less imp

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

rtant be right. If you can avoid connecting your confidence to being right, then you

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

find it doesn't matter most of the time.

What is amazing is how much better my marr

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

Following aspects would a

iage is now that I have a better self image. There are several ways to help improve

dd to the challenges in developing combination products:

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

your self image. I outline some in my book "The Barbarian's Guide to Success"

Here

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

is a secret, if you don't try to "win" all the time, then when it is important, your

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

spouse will listen closer. That is because arguing is not par for the course. If i

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

is important enough to argue about, unconsciously he/she will listen to you closer.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Boy life is better now than it was a year ago, two years ago, two and one half yea

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

s ago. It is getting better everyday.

If mama ain't happy ain't nobody happy. Wel

.

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

I have a happy house. I hope yours is the same.

Get the Barbarian Mind Set and ke

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

Companies that provide selfless information through particip

p it. Stay tr? to yourself and to your family everything else will work itself out

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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