Advice Pool - Reference and Education

As the coordinator of the Online Think Tank it is essential that one has a good grasp on what a creative

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

person is, what a genius is and what the difference and similarities are between those and the eminent

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

Examples of combination products may in

achiever. Not long ago, I decided to look into these concepts of psychology to determine what exactly it

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

was all about. Reason being that people from all over the world contact us to join our organization.

S

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

, I purchased several books on the subject and started reading one on creativity first. Mostly due to th

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

Combination pro

e fact that there are probably 8-10 times as many creative people as geniuses. So, I got to page 125 on

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

the "Creativity Flow" book and decided that I think I agree with much of what "Mihaly Csikszentmihalyi"

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

as saying.

I also noticed that Mihaly credits Professor Dean Simonton in the introduction with specific

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

thoughts that went into the book and cited DK Simonton as an expert on the psychology of geniuses and t

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

he definition.

That is to say "what is a genius?" Professor Simonton uses the term "eminent achiever" a

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

the best single attribute to describe genius. Indeed, I myself agree with this. It therefore made sense

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

Following aspects would a

that Geniuses were creative, but not all creative folks were in fact geniuses. This of course means it

dd to the challenges in developing combination products:

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

is hard to say what Genius is or where one sits on an imaginary scale of such.

In studying the Creative

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

Flow book which is quite good, it seems that Mihaly absolutely pegged the Creativity Personality Profil

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

and Typical Traits. Indeed, I would receive a 100% score on that one. I had not considered all this the

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

prior and so I am in fact extremely appreciative that we started this project and this entire subject w

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

Professional from academic institutions, pharmaceutical industries, health care indust

as brought to my attention.

On this basis it seems that now the online think tank knows what to expect

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

hen confronted by these creative geniuses, create types and/or eminent achievers. I certainly hope this

.

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

article is of interest and that is has propelled thought. The goal is simple; to help you in your quest

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

Companies that provide selfless information through particip

to be the best in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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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Advice Pool - Creativity - Genius and the Eminent Achiever Considered

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