Top Adding - Writing and Speaking

David Keck, author of In the Eye of Heaven, has graciously answered my questions on writing and publishing. I enjoyed his responses very much. David is a Canadian, currently residing in New York,

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

where he teaches at a Junior High. In the Eye of Heaven was published by Tor Books on April 4, 2006, and is available in paperback as of March 6, 2007.

About "In The Eye of Heaven"

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

Examples of combination products may in

ary: What is the target audience for your book?

David: Like most writers, I can only write what I like. I’m a reader who has a terrible sweet tooth for traditional fantasy, but whose patience

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

or paint-by-numbers characters and settings is just plain worn out. I want stories that feel real to me. I want to be surprised. I want to be challenged. I want the language to have a little life in it

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

. If I succeed, I’m giving the readers what I want.

Mary: What makes your story unique?

David: A lot of reviewers have talked about the grittiness of the setting. (And it is faintly odd t

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

Combination pro

think of realism in a land of fiends and sorcerers). But that’s what I want to do. The world needs fleas and omens if it’s to feel real. Maybe we’re not in the real world, but we might be in world as p

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

ople imagined it to be.

Mary: What was the hardest part of world creation?

David: World creation is a pure joy. I’ve spent years and thousands on it. I’ve spent vacations climbing castles

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

and hunting for henges. When I was poorer, I spent days in libraries. Now that I’ve got a day job, I keep the booksellers in business. In my work, the only difficult area is making sure not to lose the

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

reader. I often mention Patrick O’Brian’s nautical fiction when I talk about world building. The man filled his pages with impenetrable jargon, but, somehow, managed to haul his readers in. As a reader,

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

I never doubted his world for an instant.

Now, fantasy readers would likely be less patient with a real barrage of historical accurate terminology. Still, I want the readers to know that the world around

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

the characters isn’t full of borrowed backdrops and worn props. It needs to feel real.

Mary: Does the protagonist, Durand, share any characteristics with you?

David: I suppose Durand does

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

Following aspects would a

share a thing or two with me. When I first began the book, we were both at the beginnings of our careers and very uncertain about whether we’d ever be able to find our feet. It might also be said that my

dd to the challenges in developing combination products:

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

Durand is a person very concerned about ethics, and such issues must be in my thoughts as well (or I would hardly have built a novel on a character like Durand). Sadly, however, I don’t think I would have

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

gone very far in the world of professional thugs and honorable killers.

Mary: Is there a message in your novel?

David: I haven’t thought much about whether there might be a message in my wr

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

iting. I think that novel-length work can deal with various themes and issues, but that it’s hard for a satisfying work of that scale to send a single message. A reader could probably see evidence of my

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

hinking about a great many of life’s issues if that reader cared to look.

Mary: I notice you have sketches of your main characters on your website. Do you draw the picture and then use it to create

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

Professional from academic institutions, pharmaceutical industries, health care indust

a character, or is the sketch done after a character is developed?

David: Drawing is something I’ve been doing since before I can remember, and it’s a big part of my thinking process. I often begi

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

n with an image and try to capture it on paper (just as I’ll later try to wrestle the image onto paper). You will have no idea how long I will have obsessed over some detail of a character’s appearance.

.

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 trouble with writing, of course, is that you can only gesture toward such details. I think that a writer has to be careful to choose only the most telling details rather than stopping the narrative to

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

Companies that provide selfless information through particip

rovide an exhaustive portrait.

Check out what others have had to say about David's book at http://www.keckbooks.com/KindWords.html

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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Top Adding - Interview with Author David Keck, Part Two

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