Actual - Writing and Speaking

Previously – in Part One.

The First Level of Publishing is to print one copy. The Second Level of Publishing is when you receive five copies. The Third Level of Publishi

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

ng is when you want 50 copies.

Now - Part Two.

The Fourth Level of publishing is next. For the Self-Publisher or Internet Publisher, this is when they aim for sales of

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

Examples of combination products may in

00 copies. This means they have exhausted friends and family, all of them, including long-lost aunts, uncles, and people you used to work with years ago. It also means pe

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

ple you meet in Libraries and cafes, at Book signings and at Writers' Workshops. As one Literary Festival organiser told me a few years ago, it probably means you're a 'r

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

gional writer', quite well known in your own particular area, your neck of the woods.

You will have been featured in your local newspaper and on local radio, maybe even

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

Combination pro

V. It's quite a high target and a place that some Internet Publishers never reach. Strangely, this is a level not even noticed by Traditional Publishers. If one of their

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

igned authors stops at this level, Level Four, they would be viewed as a complete disaster, a huge loss of finanical investment and someone not worth bothering about in t

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

e future.

Similary for Level Five. This is where a single book's sale amount to five thousand copies. This would be laughable for a Traditional Publisher. Sure, some har

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

backs launched in the UK never sell more than a few thousand copies, but this is mainly to get the critics interested and establish some kind of presence.

The hardback t

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

at gets noticed through this initial launch would be followed by a paperback edition that would be expected to sell in the tens of thousands. Anything less, and the autho

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

would be quietly dropped, (even if a long-term contract had been agreed) and swiftly replaced by a new hopeful. For the Internet Publisher, this is a far more significan

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

Following aspects would a

t level. It means that the Self-Publisher will start to see an important contribution to their income. It starts to look as though they can really think about planning to

dd to the challenges in developing combination products:

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

give up the day job. It seems that they might finally make it into the realms of the 'full-time, professional author'. Why the big difference? Because an Internet Author

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

oesn't have to make a huge profit for the publisher who signed them up.

Those publishers need big sales to pay for all their glossy offices and expense account lunches,

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

ll the Conventions and Festivals they have to attend, plus the hangers-on, the Literary Agents, the publicity people, the photographers and layout artists, the book jacke

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

designers. An author who has followed through on publishing their own book (with the help of an online publisher like Lulu) will be pleased to reach Level Five and will

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

Professional from academic institutions, pharmaceutical industries, health care indust

tart to feel their careers are finally taking off. For a Traditional Publisher, looking at one of their authors at Level Five, means that if the person has peaked at this

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

level, then they have completely failed.

Traditional Publishers want Level Six, at least, that is, sales of fifty thousand. Even then, the author isn't a 'success'. They

.

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

won't be on the Bestsellers list, (they need the next level for that) and will be on the cusp of being 'profitable'. Still, with an author at this level, the Publisher wo

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

Companies that provide selfless information through particip

ld probably be willing to risk the next book and may even put some effort into it, perhaps even providing an Advertising Budget, at least.

(To be continued in Part Three

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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