Top Adding - Writing and Speaking

The First Level of Publishing is to receive a single copy of a book. The Second Level of Publishing is when you receive five copies. The Third Level of Publishing is when you want 50 copies. The Fourth Level of publishing is when you aim for sales of 500 copies. Level Five is where a single book's

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

sales amount to five thousand copies.

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

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

Examples of combination products may in

an author at this level, the Publisher would probably be willing to risk the next book and may even put some effort into it, perhaps even providing an Advertising Budget, at last.

The irony is that we are now at the level of the 'Midlist'. A generation ago, Traditional Publishers were happy to ha

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

e a range of authors, perhaps with many at this level. They were balanced, and ultimately paid for, by a clutch of Bestsellers, but the Midlist made a publisher respectable, admired in literary circles, showing that they had a stable of professional writers, skilled and able to produce a regular s

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

tream of novels that might produce steady sales, be well received by critics, (even if ignored by the vast mass of the population, who weren't enthused enough to make any of these people a runaway success). But some of them did. The investment in the Midlist meant that publishers had a string of p

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

Combination pro

eople producing solid work, and who knows, each next book might be the one, the 'breakthrough' novel that would take them up to the level of 'household name', fame and, ultimately, fortune. If there is one thing that characterises the collapse of the confidence in Traditional Publishers in recent

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

ears it is that they have given up on the Midlist. Now, all they want is Bestsellers. They will tolerate a few near misses, but if the author is stuck at Level 6, they won't last long. They might survive for a novel or two, but then it's goodbye. (Sadly, this means there are a new clutch of 'might

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

-have-beens' out there, writers who achieved the Holy Grail, the Publishing Contract, only to lose it in a few short years. Their fate? To be reviled and shunned by other Publishers. 'You didn't make it then? We don't want to know you now'.)

What of the Internet Publisher? If you've put a book to

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

gether, loaded it up on the web and seen it sell this kind of numbers, then you are swimming in money. Unfortunately, this is the time to be most wary. It's when Traditional Publishers will come swarming over the horizon, clutching their chequebooks. They will offer all kinds of silly money, hopin

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

to woo you. Beware! Their enthusiasm, as we've seen, can be short lived. You're at Level 6, great, but if your next book doesn't hit the next level up, you will die, as surely as all their other signings. There is no sentiment in the world of Traditional Publishing.

Level Seven is the top. It in

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

dicates sales of five hundred thousand, which makes you an international bestseller. In fact, anything over one hundred thousand will probably get you into the top sales charts, at least for a short time, which means publicity, interviews on TV, and journalists willing to hear your life story. It'

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

Following aspects would a

s all gravy, as they say, or more accurately, champagne, for a while. Beware, again. You have to be interesting! The mistake most authors make is that they spend so much time sitting at a desk, staring at sheets of paper, they don't have time to go out and do silly things. They don't put enough en

dd to the challenges in developing combination products:

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

rgy into affairs, or divorces, or scandals. They don't go out enough, to Opening Nights, to art galleries, to nightclubs and swanky restaurants. In fact, some writers see the public life as something of a distraction, and avoid it. Big mistake! Is it any wonder that one of the all-time and current

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

bestselling authors in England is an ex-politician called Jeffrey Archer. He's spent the last few years assiduously building his career. He's been in prison. Now that is interesting! Sadly, most authors don't have his flair for publicity, (and don't last as long as he will).

Where are Internet A

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

uthors? They're probably nowhere near this level. If they could achieve it, they would have been signed up, tempted by pieces of silver and seduced away from the internet years before. That's fine, because Internet Authors know one thing. The best reward for an author is not glory, but to be given

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

the time and money to sit at home and write books, which is something you can achieve at Level Five (on the internet). You don't need anything else. Levels 6 and 7 lead to a life in the spotlight, dragging you away from writing and taking up your precious time with fripperies. It's sometimes seen

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

Professional from academic institutions, pharmaceutical industries, health care indust

as a necessary evil by successful writers, but you can live without it. More important, you can exist as an author without it, which is more important.

Let's learn the lessons of the Seven Levels. Authors, people who want to see their work in print, can achieve most of their ends through the inte

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

rnet, at minimum cost in terms of both time and effort, (and money). Traditional Publishing only comes into its own for the top 2 levels, and then, it comes at a price, (in terms of mind-boggling banality and triviality). Why bother? If you write and want to share your work, find out about the opp

.

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

rtunities on the internet. Don't be tricked by online Vanity Publishers of course, but see what print-on-demand can give you and work with the kind of Internet Publishers that other authors will recommend, (through chat rooms and discussion forums).

The bottom line is this. 99% of people who have

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

Companies that provide selfless information through particip

written a book will never see it in print, especially if they pursue the fruitless and time-consuming task of trying to interest a Traditional Publisher in their work. If you take up Internet Publishing, you get the most important part of what you want at Level One! Anything after that is a bonus

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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