Cases - Business

I Never Noticed

My father was the glue that held my connection to a hundred or more rela

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

tives together and since he passed away, my family has become smaller and smaller for me.

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

Examples of combination products may in

Pictures have disappeared, replaced occasionally by emails and new names. And I never n

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

oticed. The branches of my relationship tree prune themselves. And I am diminished.

Sa

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

ly, that is normal and usual, part of the constantly shifting patterns of life. It seem

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

Combination pro

s we only pay attention to our relationships when they are very close and breaking or bro

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

en. The rest we take for granted and we let them drift.

But they, too, are subject to t

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

he laws of thermodynamics. They, like everything else in the universe, drift inexorably

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

rom order to disorder. Some relationships get more and more tenuous and then, like very

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

remote points of light, they blink out. And we don’t notice that our life gets somehow d

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

mmer.

Some relationships get increasingly more difficult. It’s always ‘their fault’ and

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

Following aspects would a

we wish they would disappear. But the quality of our life is measured by the quality of

dd to the challenges in developing combination products:

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

our relationships and there doesn’t seem to be anything we can do about it.

You know tha

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

t all business is relationships and so are all organizations and communities - but what c

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

n we do about them? How do we build them, how do we strengthen them? Even if we knew ho

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

w, doing it never occurs as something urgent. After all, life changes; so do relationshi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s. These, too, shall pass.

This is why I’m a coach. Yes, I help fix what’s broken, but

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

I also build and nurture what we take for granted. It makes a real difference in the qu

.

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

lity of your commitments – and in the productivity of your life. I am not a wall full of

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

Companies that provide selfless information through particip

self-help books. I say, “There is no You, there’s only You And. I make the And better.

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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