Top Adding - Writing and Speaking

[From our deconstruction of hundreds of Hollywood blockbusters and sitcoms at www.clickok.co.uk and our isolation and identificat

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

ion of more than 188 stages of the Hero's Journey that you need to know about...]

The Hero's Journey is the template upon which

; 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 vast majority of successful stories and Hollywood blockbusters are based upon. In fact, ALL of the Hollywood movies we have d

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

econstructed are based on this template.

Understanding this template is a priority for story or screenwriters.

The He

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

ro's Journey:

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

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

Combination pro

be told.

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

c) Inte

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

rpreted metaphorically, laterally and symbolically, allows an infinite number of varied stories to be created.

and more...

T

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

he Final Conflict

The Final Conflict is the stage of the journey between the Crossing of the Return Threshold and the Master

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

of Two Worlds. It is where significant challenges are conquered and, amazingly, often completely overlooked.

This stage of the

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

journey includes many important elements, including:

a) Punishment / Interdiction. Often there is a punishment / interdiction /

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

isk of Crossing the Return Threshold or engaging with the Challenge / Enemy.

b) Allies. Often the hero will meet with allies bef

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

Following aspects would a

orehand and their relationships will be developed / the relationship challenges resolved.

c) Magical Gifts. The magical gifts /

dd to the challenges in developing combination products:

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

weapons that may be used against challenges / enemies will be made explicit.

d) Consequences. The consequences of not engaging w

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

ill be made explicit.

e) Dissonance. A cathartic, dissonance releasing, often humorous moment will precede the battle.

f) Reite

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

ration. Mentors will reiterate the challenges and methodology of the Final COnflict.

g) Engagement. The battle will be engaged 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.

h) Celebration. A celebration will confirm the hero's victory.

i) Challenge Resolution. One of the other challenges will be

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

Professional from academic institutions, pharmaceutical industries, health care indust

resolved postthe battle.

Learn more…

The Complete 188 stage Hero’s Journey and other story structure templates ca

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

n be found at http://www.clickok.co.uk/

You can also receive a regular, fr

.

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

ee newsletter by entering your email address at this site.

Kal Bishop, MBA

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

You are free to

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

Companies that provide selfless information through particip

reproduce this article as long as no changes are made, the author's name is retained and the link to our site URL remains active

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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