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There was a time that one could assume that the phrase ‘show me the green' was interchangeable with ‘show me the money' (and in some respects it still is), but tod

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

ay it's really taking on a whole new meaning – it's a phrase with a movement behind it.

We, the people, are changing our view of green as fast as the kaleidoscope

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

Examples of combination products may in

will turn. And the color is vivid. We are thinking green in our lifestyles, our products, the food we eat, the homes we live in and the world we inhabit. And if

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

we're thinking and living green in all of those areas it stands to reason that this green-way of thinking will spill over into being green in our careers.

But wh

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

t does ‘being' green in your career mean? Well, it is different for different people – some say it means working for a company that is producing environmentally s

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

Combination pro

fe products, or clean technology. Others say it is working for a company who is giving back to the community, some say it's about recycling and others say ‘hey, i

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

t's just a place I go to from 9a – 5p and it pays the bills' (ouch…)!

But, one of the insightful things about all this green way of thinking is what it is creatin

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

inside of us - our own internal environment. We are really all eventually drawn to ‘service', to a way to give back to the greater good. And that brings up the

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

uestion; Who are y-o-u, from the inside out? What is going on within your own internal environment and how is your internal ecosystem? Where do you want to make

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

your mark, and what impact do you want to have in the world. Of course, we can't all be Gandhi, but we can all make a difference – in his beautiful quote "be the

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

hange you want to see", Gandhi knew the richness of green from the deepest level of his being. He knew where he lived inside.

Living your life in a green-way and

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

Following aspects would a

contributing to life through the makeup of your own internal environment means reaching in and really deciding who you are, what you want, and how you can make a d

dd to the challenges in developing combination products:

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

ifference; and then bringing YOU into all aspects of your life, including your career.

Once you make this shift it stands to reason that you will seek out and ali

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

n yourself with a company that is stepping up to the ‘green-way' from the inside out too. That means more than just writing some fancy language about it in the co

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

pany's annual report. It means more than just sharing an internal eco-vision (internal harmony, diversity, etc.). It means a call to action, accountability and a

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

nswers to who, what, when, where, and why. In other words, companies need to step up and show us what they stand for and how they are committed to contributing to

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

Professional from academic institutions, pharmaceutical industries, health care indust

the greater good.

Companies expect us to show up with more knowledge, better information, fresh creativity and vast energy. To show up in those ways we have begu

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

to look deeper and deeper inside our being to come up with our best. And the by-product of all that inner searching is a new expectation about what we want and e

.

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

xpect from the companies we work for.

Today companies need to pay attention because ‘we the people' are blossoming in a big way – big buds, big sprouts, big roots

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

Companies that provide selfless information through particip

of all kinds. We're achieving new internal clarity, setting new expectations and aligning with new goals; one of the strongest is all about "green" – inside & 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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