Just Answers - Writing and Speaking

It will probably come as no surprise to you that these days it is very hard to publish a book. For those of you, new authors, who haven’t learned the reasons for this, consider the following facts

•

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

Under incessant attack from TV, film, CD, video, and of course the Internet, the market for serious printed books has shrunk a good deal from what it was in prior decades. While all of these, especial

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

Examples of combination products may in

ly the last, may not seem like direct competitors in kind, they are all direct competitors for the potential reader’s time.

• One might be tempted to place significant blame on the declining qual

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

ity of education as well. Insofar as this is true, it also operates synergistically with a decline in the quality of popular culture, particularly of the young who would otherwise be consumers of futu

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

re literature.

• As a result, conventional print book publishers have had to concern themselves more and more with the bottom line, tending away from the effort and concern they previously expend

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

Combination pro

ed in consciously supporting the quality of literary output. They no longer can maintain armies of in-house editors whose job it is to screen manuscripts sent to the publishing house by authors. The r

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

ecognized freelance literary agent is now typically used to pre-screen such manuscripts.

• For newly written fiction, well over 95% of manuscripts by unknown / first time authors are rejected by

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

agents. Of those manuscripts which are accepted by agents, over 95% are rejected by conventional publishing houses, believing they represent a serious risk to their bottom line. There is thus currentl

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

y almost no market in conventional book publishing for fiction by new authors in the U.S.

• Authors of authoritative or otherwise interesting non-fiction generally have an easier (but not always

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

easy) time with conventional book publishing. This may be particularly true of scholarly works written by recognized experts (of course, new fiction by well-known authors in general also gets an easy

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

path to conventional publication.)

How can we authors publish a book in the face of this current unsatisfactory condition? Fortunately, there are three relatively recent developments in book pub

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

Following aspects would a

lishing, book printing, book marketing and promotion that, if used wisely, can be used to overcome the publishing brick wall and get our books out to the public:

• Web-based publishing and simil

dd to the challenges in developing combination products:

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

ar state-of-the-art printing technology allows us to print relatively few high-quality books at a time at remarkably low cost. Though that cost is typically borne by the author, the process allows him

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

to retain all rights to his literary creation — something that conventional book publishers never permit.

• Internet-published books, or e-books, are a very good way for small manuscripts to be

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

created with virtually no printing costs, since the e-book exists only in electronic form.

• The Internet is an excellent way for the author or his allies to promote and even to sell his book dir

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

ectly to the reading public. It is not usually recommended that it be the only way to promote your book, but it provides an excellent start.

This route to publish a book has a number of advantage

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

Professional from academic institutions, pharmaceutical industries, health care indust

s for you, the author. You may not have even thought of some of them, or if you did, gave them much merit. Still, consider, if you will, some of these:

• Your publication plans do not have to dep

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

end on a publisher’s opinion of your work, which is at least as likely to be based on his estimate of the likelihood of making money from it as of its literary worth.

• The fact that you do not h

.

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

ave to wait for anyone’s opinions or views, nor do you have to surrender any of your rights to the publication, can act as a powerful energizer to you while you actually carry out your planned publica

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

Companies that provide selfless information through particip

tion.

• You can save a great deal of time to publish a book — typically the many months that it takes to find an agent; and if you finally do, for the agent to find a conventional book publisher.

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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