Others - Writing and Speaking

You have a non-fiction book in mind. You know it's going to be great and it'll help a lot of people. But you also have mountains and mountains of material--so much good information! So much excellent research! How do you organize it all to create a

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

powerful book? Here are the basic building blocks of a non-fiction book. Keep these in mind and you won't get overwhelmed by your material.

1.) Think About Your Reader

When you think about your reader you're thinking two things: "What does the r

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

Examples of combination products may in

eader get out of my book?" and "What kind of relationship do I want to establish with the reader?" One of your duties as an author is to offer your reader something of value which could even change their life for the better. Ideally you'll make it

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

lear what this value is when you title the book. It's pretty clear, for instance, what you'll get when you pick up Stephen Covey's "The 7 Habits of Highly Effective People". This could also provide the structure for your chapters. If you're teachin

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

g how to improve your golf stroke in 10 steps, you could include a chapter on each step. You don't have to make it more complicated than that.

As for your relationship with your reader, what do you want it to be? Will it be a teacher/student relat

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

Combination pro

ionship? Peer-to-peer? A storytelling relationship? If you're writing a biography, you may want to be a storyteller and have your reader be a listener. Will your voice be friendly and homely? Or authoritative and formal? The point is that you're al

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

ays asking yourself "To whom and I speaking and how do I want to be heard?" What choices will best suit your audience?

2.) What's Your Theory?

Theory is how the writer is proposing to make his ideas play themselves out. It's how it all works. In

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

Anthony Robbins' book, "Awaken the Giant Within", he's making the point that you are in control of your decisions and you can really tap into your human potential. Well, how do you do that? His theory of how you do that is to become aware that you

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

are in control of everything that happens within you. You are in control of your emotions, of making choices, of creating what he calls "neuro associations" that will draw you towards a positive behavior or help you move away from a negative behavi

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

r. That's his theory.

I'm assuming if you have already decided to write a non-fiction book that you have a plan that you're presenting to the world. Non-fiction books are often the result of what you do in your everyday life; you may notice that t

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

hings could work better if people did things in a different way. Maybe your how-to just makes more sense, or it fits your readers better than someone else's theory. That's why it's important for you to have your own ideas. It truly is about what yo

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

Following aspects would a

u're bringing to the book, how much you're putting yourself into it, because that's what brings energy and vitality to the work and makes a lasting impression on the world.

3.) What Stories Will You Tell?

Stories are a crucial ingredient in non-f

dd to the challenges in developing combination products:

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

ction books. They are what will help bring your points home to the reader and make them real. Most writers use anecdotes from their professional lives. Life coaches use stories from clients, real estate brokers use stories from people they've worke

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

d with. Stories help the reader see that 1) other people have dealt with the same problems and 2) the writer has direct experience and knows how to bring about a successful solution.

When you use stories you're also using an ages-old technique--it

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

's even used in the Bible, where stories (or parables) are told to educate the reader on complex concepts. I think our brains still respond positively to this technique. Stories can be a softer way of taking medicine--that spoonful of sugar that he

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

ps the medicine go down!

4.) What's Your Call to Action?

When you craft a call to action for your reader, you are designing a way of telling them, "Here's what you do now that you have this information, here's how you make it work." Let's use a w

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

Professional from academic institutions, pharmaceutical industries, health care indust

eight loss book as an example. Maybe the theory is about overeating. If you were writing this book, you might want to include calls to action throughout the book giving the reader different strategies about how to avoid overeating. You'll include h

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

ow not to overeat in restaurants, how to avoid overeating at bedtime, how to avoid overeating while traveling or at buffets, whatever.

In some books the author will present questions and exercises. That's part of a call to action because it makes

.

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

he reader stop and absorb what they've just learned and even to design their own action plans based on their own unique circumstances. In our example above, you might challenge the reader to choose two alternative things they could do instead of ov

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

Companies that provide selfless information through particip

ereating.

What's Next?

Now you have to write the book! Keep this structure in mind and you'll be well on your way to creating a powerful book that will inform, educate and--in the best of all possible worlds--change the way we live for the better

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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