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I was exchanging correspondence with a fellow writer when he mentioned his interest in morphing from being an

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

article contributor into becoming an e-book author and publisher.

I want to share my take on this with you,

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

Examples of combination products may in

as well as what I told him regarding conventional book publishing.

What I'd like to know is:

(1) Who is ma

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

ing real money in e-books?

(2) What are their topics?

(3) What is their pricing?

(4) How are they promotin

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 them?

(5) Are there commercial lists available for rent or purchase of recent e-book buyers?

Conventional

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

Combination pro

book publishing seems to get harder all the time with industry mergers offering fewer buyers to the author, b

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

ut more significant is the fundamental flaw in how books are acquired by book retailers:

It's by consignment

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

.

So, let's say Barnes & Noble orders 10,000 copies of my latest book, but sells only 5,000.

The unsold cop

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

es are either discounted-in-place by publishers, meaning B & N gets to cut the invoice price, or they are sen

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

t back to the publisher. And there is no time limit for returning them. A book could be out of print for year

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

and returns trickle in and credits are paid out.

Anyway, retailing of books has become a "fashion" business

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

Following aspects would a

, driven by fad, celebrity titles, and the like, so it's too bad for most authors.

Plus, and this is wild, m

dd to the challenges in developing combination products:

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

ost books being retailed are bought by women, so I was informed by a woman senior editor at a medium sized pu

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

lishing house. This mirrors the fact that most book editors are women, as are book agents.

Last night at a f

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

aculty dinner at UCLA, I met a publisher of about 1,000 books, mostly geared to the real estate market.

As i

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 were reciting a script, he said most of his authors don't make any money through book sales but by collat

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

Professional from academic institutions, pharmaceutical industries, health care indust

eral business that book sales bring to them. I call it after-market, and I count on it, too, however, I said

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

to this guy, "Every deal must stand on its own so I expect hefty advances."

He laughed, knowing I know his g

.

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

me, and he knows mine.

His take on it is to offer NOTHING to the author but the illusion of fame and importa

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

Companies that provide selfless information through particip

nce, so back we are, giving away our information.

At some point these efforts MUST be cashed in, as I see it

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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