Main Subject - Business

Our position is this: Profits and growth are about performance and performance is 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

people. Therefore, invest in people. Invest in people because this is potentially a h

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

Examples of combination products may in

ighly leveraged investment.

In our work as development experts, we work with lots of in

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

dividuals who are winners. But a winner, like any champion, is bound to have one or two

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

vulnerabilities that could hold them back or even knock them out of the game. Any profe

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

Combination pro

ssional, whether athlete or businessperson, can have just one small thing wrong with the

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

ir game but, without fixing it, they won’t perform at a championship level. In fact, ch

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

mpions require expert and intensive coaching.

On the flip-side of this issue of high-pe

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

rformance behavior, either culture or management can screw up a player’s game if they do

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

n’t know how to handle the person psychologically. Fast-trackers and potential champion

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

are often like thoroughbreds — lots of determination and flash and speed — but they can

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

Following aspects would a

also be sensitive, reactive, and quirky. So, they’re frequently more demanding and dif

dd to the challenges in developing combination products:

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

ficult to handle than the more ordinary performer. And, quite typically, you won’t get

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

championship performance out of them if you’re not managing them with finesse; and each

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

ne’s different!

Consequently, we advise our clients to beware that with even the best o

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

f their players, slumps will happen.

As a result, we suggest that you:

Be prepare

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

Professional from academic institutions, pharmaceutical industries, health care indust

d for slumps — be vigilant

Catch problems early on — early identification and ea

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

ly intervention are the watch words

Call a spade a spade — don’t be overly pati

.

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

ent and tolerant and then blow a gasket

Don’t throw in the towel and don’t make

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

Companies that provide selfless information through particip

it worse — the problem is fixable, so

Fix it

And, forget quick fixes.

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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Over the years I have worked with numerous people on career development, from the high flyers in the city to mothers that wanted to start a home based business. Some of the people that I worked with said that they had their dream job, or it would be if only they could get a pay rise and be adequately paid for the great job that they do.

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