Advice You - Business

Do you ever walk with your head faced down? You might have been just absorbed by a profound thought. Or there might have

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

been another reason why you have missed the opportunity to observe the person that had just passed. Remarkably dressed. W

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

Examples of combination products may in

hat a style!

But you were just preparing for that interview. A company has invited you to explain about the method you h

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

ave just implemented. You need to get back soon, because you have more meetings and at three o’clock you have this import

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

ant presentation.

You have reached the company. You present yourself at the reception. They are waiting for you and you

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

Combination pro

join someone to the third floor.

In the mean time you observe this new building. The people (talking), coffee cups sprea

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

d over tables. You also observe the bulletin board. A poster with formal training announced on the left. A post-it with “

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

room needed in the center of town.” And there is a magazine communicating the company “behind the screens.”

The session

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

is very fruitful. They appreciated your presentation and there was a lot of dialogue afterwards. It was not only about th

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

is new method but also about the background of both companies. “How do you handle this kind of issues?” After the inter

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

iew you go back and you compare the situation at your organization. You think about the style. “What is the way in which

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

Following aspects would a

we do things over here,” you figure.

You attend a meeting. It is very well organized. It ends exactly at eleven. “I’m go

dd to the challenges in developing combination products:

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

ing to my next meeting,” you hear.

In the afternoon there is a decision to be taken. It is a crucial one and open for a

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

few weeks. “Today is the big day. All the preparations are set. The information is there.”

After lunch, which you have s

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

pent with your colleagues in the canteen, you go back to work. You remember to prepare for your presentation at three.

I

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

n the end people enter your office so you get completely hooked up before three and in the mean time, you think, “well, w

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

Professional from academic institutions, pharmaceutical industries, health care indust

hatever, I know the story.”

At three the meeting room is filled with visitors. They are interested in buying the applica

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

tion. The project with the last enhancements had previously finished. “A work of art,” you agree.

And then, on your way

.

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

back home you think again about the presentation. About your team having presented the new product. “Indeed there are fam

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

Companies that provide selfless information through particip

iliar products like this one,” you know, “but this one has our style in it; unique.”

Just come to life!

© 2006 Hans Boo

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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When doing medical billing, you'd think that it's impossible to bill the wrong carrier. This true story tells us that anything is possible. Enjoy a good laugh at a serious problem.

Have you ever left your business card at home - office while you're attending some occasion which you knew you would meet some people that have good prospect for your business? Or even worst, you left it while you’re about to see a new client?

The article illustrates all you need to know about placing ads in a magazine. There are several factors to consider, but once some thought has been put into the idea, your business should attract more customers.

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