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The starting point for any story is the apotheosis – the seminal insight, enlightenmen

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

t or illumination that the hero has.

Once you have that, then you know what the obstacle to

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

Examples of combination products may in

the illumination is (atonement with the father).

With the above two in hand, you can

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

work backwards and forwards along the path of the Hero’s Journey.

e.g.

In The Sha

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

shank Redemption, Andy Dufresne's apotheosis is that you either get busy living or you ge

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

Combination pro

t busy dying. He reaches that insight in the scene by the prison wall with Red (Morgan Freema

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

n). His illumination is that he will never get out of prison (Warden Norton will never let hi

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

m go).

With this information, you have the hero and a number of resistances that prevent him

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

attaining his illumination, which he has to conquer – you have the basis of a story.

e.g.

I

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

n Al Pacino Scarface, Tony Montana's insight is that the rewards of the path he's chos

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

en are not worth the spiritual price he is paying, expressed with the words (in the restauran

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

Following aspects would a

t scene): "is this it? Is that what it's all about Manny? Eating, drinking, f*cking, sucking,

dd to the challenges in developing combination products:

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

"no free rides in this world kid," "I lost my appetite," "is that what I worked for? With th

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

ese hands? Is that what I killed for? For this?"

Again, with this information, you already k

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

now what the illumination (apotheosis) is. All you have to do is figure out what the temptati

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

on was and you have the basis of a story.

The Complete 188 stage Hero’s Journey and FREE

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

Professional from academic institutions, pharmaceutical industries, health care indust

7 stage sample and other story structure templates can be found at http://www.managing-cr

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

eativity.com/

You can also receive a regular, free newsletter by entering your email address

.

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

at this site.

Kal Bishop, MBA

**********************************

You are free to reproduc

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

Companies that provide selfless information through particip

e this article as long as no changes are made and the author's name and site URL are retained

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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