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Is your current management team operating like a Swiss Watch? Wo

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

uld you say that you have significant Organization Capital in yo

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

Examples of combination products may in

ur management team? Does your team work well under deadlines and

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

crisis? Can your management team handle just about anything wit

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

hout breaking the law or causing conflict with your mission stat

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

Combination pro

ement?

Do you have a mission statement? Is it a good one? Do yo

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

u follow it? When was the last time your team sat down to review

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

it and or revise it if necessary? You need to obviously have a m

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

ission statement and one, which is well defined? Do you believe

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

if your lower level managers and employees read that mission sta

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

tement they would grade you low or high on it?

You management t

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

Following aspects would a

eam and every employee for that matter in your small business, c

dd to the challenges in developing combination products:

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

orporation, political action committee, non-profit, sports team

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

or even military unit must have a mission statement that is larg

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

r than self and one which you all agree upon and commit too.

Ju

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

st as you are committed in everyway to your family; you must be

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

Professional from academic institutions, pharmaceutical industries, health care indust

committed also to your mission statement. All of you, everyone o

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

n the team needs to be in it to win it and you must constantly r

.

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

eview it and think about it. It should be posted, discussed and

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

Companies that provide selfless information through particip

decision should be based on it. Please consider all this in 2006

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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