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Today the stress of work, home and school can spoil most anyone’s optimism and enthusiasm. Teamwork within a gro

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

up of people needs to be handled so that any stressors are handled. We had a recent episode of teambuilding, or

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

Examples of combination products may in

is that team dividing, the other day.

Where I work, and many others, there are mixed crowds of engineers, law en

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

forcement types, contractors and sub contractors. In my workplace, the contractors do a certain job, which is to

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

maintain network connectivity. A certain person named “Bob” didn’t like the work of the contractors. He actuall

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

Combination pro

y thought it was so bad, it was worth joking about. The author of this didn’t think the entire line of jokes was

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

all that funny, but continued to deal with it and not cause a fuss, thinking it would stop someday. Well, it ne

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

ver stopped, and one day the author had sent an email, carefully crafted and worded regarding a project he had wo

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

rked on for some time. The person replied to the contractors email with a single line. A single email, a single

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

line of apathy stating that he thought it would work just as bad as some other projects.

What was the result of

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

that single email? Hurt feelings, team disruption, and a reason for the person to discuss the issue with others

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

Following aspects would a

to put an end to it.

The take away lesson from this:

Teamwork is a combination of good friends, serious profes

dd to the challenges in developing combination products:

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

sionalism, fun and respect. People enjoy spreading rumors, talking garbage, and listening to peoples mistakes.

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

Admit it, it’s FUN! But we need to keep in mind that these things can also degrade a teams ability to perform.

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

Technology in todays workplace is not going away and we will continue to have skill sets very diverse from one pe

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

rson to the next. Abilities come from training and experience. Some people are better at one thing that others

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

Professional from academic institutions, pharmaceutical industries, health care indust

are not. The key to keeping your team fighting and strong is with good leadership and professionalism when neede

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

d. Let your people laugh and joke, but not at the expense of others. And of course don’t spread opinion and t

.

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

rivialities through email. Email is permanent and can easily be taken out of context.

Copyright 2006, Rod Deluh

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

Companies that provide selfless information through particip

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Is your family in synch as to where the family business is going? A family divided risks failure to succeed over the long term.

Can’t bear the thought of writing a business plan? Try this simple alternative that works!

Not everyone can become a good salesperson. In fact, research conducted by Caliper Corporation says that 55% of the individuals in the sales profession should be doing something else! Since I first joined the “professional ranks” over 17 years ago, the business world has exponentially increased in complexity and it will continue to do so throughout my (and your) professional life – as a result, the world’s most sought after profession is probably the world’s most dynamic profession – it’s constantly evolving. But, I am surprised that there are so many myths about the sales profession.

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