Main Subject - Business

What do you think of when you hear the word “model?” And what do you see? I’ll leave my own answe

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

r for myself.

Overture supplies a lot of different (key word combination) usages, of which busin

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

Examples of combination products may in

ss model is not one of them. That strikes me.

But this is not about a business model. A model ca

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

n be something like an example. Or it could be a sort of image, portrait or even a metaphor to co

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

vey a message. It can be concrete, but not seldom it is abstract.

If you want to explain and dis

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

Combination pro

uss a complex (business) topic, an abstract model could help you in doing so. More complex than w

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

hat we currently experience in Europe is hardly imaginable. In a situation that is so divers and

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

omplex to manage a model can express essentials without words.

Andr? Sapir has “designed” a mode

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

to explain some main issues in the European community (Globalisation and the Reform of European

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

Social Models). If you want to have a look at this you can explore the link below:

http://www.br

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

egel.org/Repositories/Documents/publications/working_papers/Sapir_Summary_080905b.pdf

The model

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

Following aspects would a

tself called – The Four European Models -- shows a simplified typology of countries about the dis

dd to the challenges in developing combination products:

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

tribution of Equity (Low and High) and (labour) Efficiency. It is used in the paper to stress a c

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

rtain policy recommendations.

The strength of such a model is that you can enter the discussion

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

sing only your eyes, “at a glance.”

But that is only the beginning of that presentation. One of

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

the disadvantages of a model is that a lot of people do not like abstract thinking. In the same w

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

Professional from academic institutions, pharmaceutical industries, health care indust

y that you have students who are more at ease with microeconomics than with macroeconomics. Micro

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

(I understand that there is now also something called “pico-economics”) is more dedicated to the

.

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

man in the street. Macro is more about nations, people in general, culture and other abstractions

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

Companies that provide selfless information through particip

The clue is that you need both. Like real teamwork. Also in your presentation.

To be continued

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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Foreign investors need to familiarize themselves with the Chinese business culture before entering into the China market. As China is a relatively new market compared to the others, not many are familiar with the way the Chinese carry out their businesses.

Are you getting your name, photo and the name of your business in the newspapers and professional publications? Or are you reading stories about your competition all the time? Do you have a dismal record of getting articles published? How healthy is your media visibility? It is critical to understand that the media is not in business to promote you or your business. The media’s role is to produce articles of interest to their readers. That means you need to provide interesting and relevant information to the journalists so they will want to publish your article. Here is a prescription from your PR Doctor on how to gain healthy media visibility.

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Main Subject - Models That Color Your Presentation

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