Actual - Writing and Speaking

The Hero's Journey is the template upon which the vast majority of successful stories and Hollywood blockbusters are based upon – understanding this template is a priori

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

ty for story or screenwriters.

The Hero's Journey:

· Attempts to tap into unconscious expectations the audience has regarding what a story is and how it should be told

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

Examples of combination products may in

· Gives the writer more structural elements than simply three or four acts, plot points, mid point and so on.

· Interpreted metaphorically, laterally and symbolically

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

allows an infinite number of varied stories to be created.

The Hero's Journey is also a study of repeating patterns in successful stories and screenplays. It is compel

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

ing that screenwriters have a higher probability of producing quality work when they mirror the recurring patterns found in successful screenplays.

Master of the Two

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

Combination pro

Worlds

The Master of the Two Worlds is in fact the Final Conflict between the hero and the antagonism. Here, the hero has developed sufficiently to be master of bot

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

his Old and his New World. There are a number of elements that are common in this stage of the Hero's Journey:

a) The Master of the Two Worlds may be separate or a con

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

inuation of the Crossing of the Return Threshold. If a continuation, it is likely that the hero will undergo an impossible dilemma before moving forward to tackle the an

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

agonist. In Spiderman (2002), Peter Parker has to save the people in the falling lift or Mary Jane – he cannot do both. Once this challenge is overcome, he is free to co

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

bat the Green Goblin.

b) The hero faces the antagonist one-on-one / a hand-to-hand battle. In Star Wars (1977), Vader has to come out to face Luke.

c) The Master of th

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

Two Worlds / Final Confrontation often takes place in a dangerous environment. It is not unusual for the battle to occur in the antagonist's lair. In Lord of War (2005

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

Following aspects would a

), Yuri faces off Valentine in prison – somewhere where he will likely spend the rest of his days if not careful.

d) The Hero will often view the Final Confrontation fr

dd to the challenges in developing combination products:

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

m a distance and judge it. The hero will be strangely confident. Similarly, the anticipated event will (often) be welcomed by the antagonist, who will also be confident.

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

e) There will be intense Time Pressure to resolve the conflict. This is most apparent in the Bond franchise, where a nuclear bomb or similar is usually set to explode.

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

f) Multiple catharses. The hero may defeat the antagonist over a series of stages or alternatively, catharses are built up by the defeat of multiple antagonisms (the ant

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

gonist, his lieutenants and the manifestation of their dastardly deeds etc). In Spiderman (2002), the Green Goblin is defeated, he begs for mercy, enacts a deception and

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

Professional from academic institutions, pharmaceutical industries, health care indust

is only then finally destroyed. In Die Hard (1988), John McClane defeats Hans – but Karl suddenly appears from under the paramedic's blanket.

Learn more...

The detaile

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

, complete deconstruction and the Complete 188 stage Hero’s Journey and FREE 17 stage sample and other story structure templates can be found at

.

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

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

Companies that provide selfless information through particip

al Bishop, MBA

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

You are free to reproduce 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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