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Writing a book is the easy part. The hard part begins when you attempt to publish the book. I’ll share the five options I found as I considered publishing my book, MORE THAN MEETS THE EYE: True Stories about Death, Dying and Afterlife. I’ll also tell you about a new trend-setting publisher 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

at is changing the way books get to market.

Option One: You may find a mainstream publisher who is willing to take a look at your book, but if you’ve ever tried to pitch a book you will realize that the rejections are extremely high and the possibility of having a publisher pick up the

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

Examples of combination products may in

ab is not very likely. You must be able to market yourself and have a tough skin when it comes to rejection. Even if you do get lucky, you will still have to do a major portion of the marketing, so it helps to have some extra money to use for publicity. While mainstream commercial publishers an

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

university presses have budgets for advertising and promotion, they tend to only use their resources to promote highly visible personalities whose books are easily sold by the power of that person's notoriety. These publishers will rarely risk a dime on the unknown author, and if they do, the

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

indow of time for the book to be deemed successful is roughly six weeks. If your book doesn't justify its costs in that time, it is back-listed and disappears from print. The author has little recourse, and can only wait out the time period until he can purchase back the rights to his book.

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

Combination pro

Option Two: is to use a “print/publish on demand” (POD) or vanity publisher. Most of these companies will accept ANY work from ANYONE, but you can expect to spend upwards of $1,000 and that will not get any copies in your hand for that price! That will cost you about $5-6 per book. You ma

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

do all the design work yourself or you may choose a la carte services or packages that include editing, designing the cover, formatting the page layout to their specifications, fulfilling orders and marketing the book. The POD will help you obtain an ISBN and list the book on Amazon.com, Barne

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 Noble and other major chain bookstores, but remember whoever owns the ISBN, owns the copyright. You may think you are self-publishing, but unless you purchased the ISBN under your name, you may very well have given your publication rights to the vanity publisher. One good thing about POD

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

s they do handle distribution and order fulfillment. When someone wants to purchase your book, they will print a copy, ship it, and pay you about 30% of the purchase price as a royalty. I checked into three companies: iuniverse.com, 1stbooks.com, lulu.com and booksurge.com. They each offered

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

bout the same thing for nearly the same price.

Option Three: I checked into printing the book by using a local commercial printing company. The best price I found was three cents per black & white page. A 195-page book would cost about $6.50 including the cover (which you have designe

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

) and perfect binding. If you want the book in color, the price could easily make the book cost more than you can sell it for. The printer I used allowed me to print as many or as few as I wanted since they offer digital printing—the same technology PODs use.

It is most important to have some

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

Following aspects would a

ne proofread your text before submitting your file because the printer will print exactly what you send without making an edits or doing any revisions. If you print the book in this manner, you will still have to market the book, fill and ship orders.

Option Four: Publish it as an eBook

dd to the challenges in developing combination products:

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

This is the least expensive way to publish, and people do actually buy eBooks. I had a graphic designer create my cover image to use for promotion of the book on my Web site. I set up a business account with PayPal and added my ISBN to my product list. They created an html code that I copied

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

to my Web site. When someone makes a purchase, I receive an email notification. I respond to the email by attaching the pdf of my book and sending it to the customer. It would be better to have an auto responder email the eBook to the customer upon purchase but Godaddy, the company who sends m

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

permission-based newsletter, does not offer an auto responder.

Option Five: Since publishing my book in 2005 through Booksurge, I have found an independent press called Nightengale Press that combines the best of both worlds. A contractual fee covers the costs of artwork design fees, g

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

aphic design of the book, an author's website and affiliate program, uploading of files to a print-on-demand and off-set mass production through Lightning Source, the first press release about the title, and all the associated costs of registering the book in the proper agencies for cataloging

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

Professional from academic institutions, pharmaceutical industries, health care indust

the title and tracking sales.

What makes this company so different from the old world view of publishing is clear. Not only do they take care of order fulfillment and distribution, offer industry connectivity to all online and bricks and mortar bookstores reporting sales back to Ingram and Bak

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

r & Taylor, they also pay 70% net royalties to the author and even repay the author’s contractual fees through the sales of the author's books whether in bookstores, on the internet, or directly through back of the room sales, or through any other marketing means. Furthermore, the authors reta

.

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

n the rights to their books, and can at anytime request release from the contract with a simple letter and thirty days notice.

Nightengale has criteria the book must meet before it is accepted into production. Therefore a short query letter is needed. You will still need to set aside some mone

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

Companies that provide selfless information through particip

for publicity, but this company offers some group rates to its authors who want to chip in and take a full-page ad in a major publication.

I have weighed all my options and decided to go with Nightengale Press for the book I am currently writing. Good luck to you in whatever method you choose

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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