Just Answers - Writing and Speaking

When an author decides to write fiction one of the primary methods of storytelling is through a first person perspect

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

ive. For many writers this is the most comfortable manner of storytelling.

In a first person narrative the reader is

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

Examples of combination products may in

allowed to relate to the story one dimensionally. The story is presented to the reader from the viewpoint of a charac

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

ter in the story. The narrator might be the main character attempting to relate their own story. The story might also

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

be told from the perspective of a bystander who may not be overtly involved in the storyline.

In the movie, “Charlie

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

Combination pro

and the Chocolate Factory”, the story is narrated by a deeper male voice. It is only at the end that we discover the

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

story was related by one of Willie Wonka’s Oompa Loompas. This is an example of first person storytelling.

This type

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

of story telling is well used in cinema. Many early filmmakers used first person narrative to present their stories.

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

The reason this type of format was used is primarily due to early filmmaking technology that required some help in th

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

transition between scenes. Narration provided that transition. Film noir and other detective dramas relied heavily o

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

first personal narratives to further their storylines.

Today’s authors are more adept at relating a story from othe

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

Following aspects would a

r perspectives such as second or third person which will be dealt with in other articles.

A first person narrative a

dd to the challenges in developing combination products:

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

lows you to understand the specific character of the narrator. You are likely to find yourself identifying with the s

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

toryteller in a variety of ways. You will either love or despise their mannerisms, but it is their character that pro

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

ides the strongest connection to the storytelling process.

Because your narrator is finite they will never have all

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

he details of the story they are unfolding for you. Sometimes this creates a unique perspective because the story can

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

Professional from academic institutions, pharmaceutical industries, health care indust

sometimes become more about the narrator (at least for awhile) then about the actual storyline. This can occasionall

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

provide a comedic touch to the novel or at the very least some rabbit trails to follow just for the fun of it.

Inte

.

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

restingly some first person narratives are actually related from the perspective of a consortium. The premise is that

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

Companies that provide selfless information through particip

a group of individuals are relating the story. This is identified by the use of ‘we’ or ‘us’ as part of the narration

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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