Actual - Writing and Speaking

Write your book backwards!

As a writer I will be the first to tell you that one of my most difficult jobs is writing a bo

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

ok. Short stories, poems and articles, no big deal, I can knock those out in a day. The book though is another story. Ther

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

Examples of combination products may in

are recommended techniques that we are to use, we were taught them in school, brainstorming, outlining and gathering and

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

rganizing our resources. What about when those techniques just aren’t helping you. You’re stuck, the dreaded writers block

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

There are other ways; different techniques to use that will help you get the job done. Here are other ways to write your

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

Combination pro

ook.

You don’t have a story idea; brainstorm, seems to be drought season. Here are some suggestions to help you find a st

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

ry idea. Look around, pay attention to people and the world outside the window. Your neighbors are constantly watering the

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

r yard, moving sprinklers, their lawn is beautiful and the landscapers have just come to plant trees. The creative mind th

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

t you are, why are the so meticulous about watering the grass, and why more trees they already have ten. You slowly realiz

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

that there have been missing children in the neighborhood… or maybe you haven’t seen the wife in a few days. Hello! Story

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

idea! If you don’t want to use the neighbors, in case they find out, look at the pictures in your home, or in a magazine a

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

Following aspects would a

d make a story about that picture

My big problem is usually that I know what I want the ending to be, or the catalyst and

dd to the challenges in developing combination products:

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

I start writing and I jump to the end. I haven’t built up the story or developed the characters for my readers. I know who

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

they are and what they are about and why what is happening is happening, but the reader is clueless. What helps me, writin

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

the story backwards. I write the ending and work to the beginning. Why I am sure you are asking. Because I know what I wa

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

t the end to be, and then you have to ask yourself all the questions of why is this where the story ended, how they got he

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

Professional from academic institutions, pharmaceutical industries, health care indust

e, who are these people. I know, you’re thinking that is the problem to begin with. Well, get the ending out, read it and

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

ow explain it, all the way to the beginning.

There are ways to get the book done and not use the school taught techniques

.

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

Sometimes they just don’t work. If you need a story idea look around, use life as your source of inspiration. Try writing

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

Companies that provide selfless information through particip

your book backwards, it gives it a whole new perspective and will help you build the character and story to fit the ending

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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