Actual - Writing and Speaking

Ask anyone that you meet if they’ve ever had an idea to write a book and I bet that 99% of th

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

e time their eyes light up and they say ‘Yes.’

Everyone has numerous wonderful book ideas.

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

Examples of combination products may in

My experience and conversations with thousands of people tell me that this is true. The diff

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

erence between those that actually write a book and those that don’t is simple. Those that d

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

on’t write a book don’t believe that they can.

That’s simply not true. Anyone can write a b

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

Combination pro

ook.

If you can talk, you can write.

Take a look at 5 of your favorite books, fictio

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 or Non-fiction it doesn’t matter. In fact, grab a few of each. Now, open each book and re

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

ad a few paragraphs. What do you see? What you’ll likely notice is that there is a common t

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

heme running in all of them.

They’re written conversationally. They’re written like you

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

talk. Conversational style is the best style because it is easy to read, easy to understand

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

nd easy to write.

Take a look at some of the most prolific authors, both fiction and Non

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

Following aspects would a

-fiction. Stephen King comes to mind as a very prolific fiction writer. Non-fiction writers

dd to the challenges in developing combination products:

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

might include the Chicken Soup series and co writers Jack Canfield and Mark Victor Hansen.

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

All of those books are written conversationally. They’re accessible to readers of all ages,

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

income levels, and IQ's.

Conversational style eliminates jargon. It eliminates large words

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

that people have to rely on a dictionary to understand. Conversational style also uses the wo

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

Professional from academic institutions, pharmaceutical industries, health care indust

rd ‘you’ often. It’s written as if you were writing a letter or telling a story to a friend.

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

Basically, if you can write a letter to a friend, then you can write a book—I promise. Of

.

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

course you need to be able to plan a book too but all that requires is a plan or an outline.

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

Companies that provide selfless information through particip

Once your outline is established, writing the book can take as little as a month to complete

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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Actual - Why Anyone Can Write A Book

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