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Traditional Publishers are strange people. They have a habit of wanting everything - even if it's completely contradictory. For instance, I've just read an article where an established publisher was complaining that the standard of books published on t

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

he internet was 'very low'. He said that he'd checked out various author's web sites and was moved to 'get his editing pen out'. He wanted to correct all the grammatical errors, tighten up the plotting and improve the characters. He also said: 'All my

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

Examples of combination products may in

ublishing instincts said Reject, Reject, Reject'. That's odd. He wanted to improve the writing, but also turn the work down! That's contradictory, surely. If he could improve the novel looked at, then he could publish it, right? If he wanted to reject

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

t, he didn't have to suggest corrections. Why on earth did he think he needed to do both?

Unfortunately, this is common. Any writer who's had cause to send submissions to Traditional Publishers will know that they can get letters back detailing all th

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

e things wrong with the manuscript, while rejecting it out of hand. If the woeful author makes the mistake of trying to 'correct' the defects, s/he will be wasting their time. The second submission will be just as quickly returned. Does it make sense?

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

Combination pro

nly if you appreciate that the only reason a publisher lists your mistakes is in order to justify them turning you down. They don't seriously expect you can do better.

That's one case of contradiction. The latest one to add to the list is the bleating

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

of Traditional Publishers when they hear people like me recommend authors to put their books up on the internet - first. They don't want that. They want first crack at your writing, (even if they do turn it down, which they inevitably will). They also

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

worry that, increasingly, authors are seeing their books on the web, getting a few copies printed (by Print-on-Demand) and stopping there. Those writers could still choose to submit their work, but many decide not to. Why should they? They've got their

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

work in print. They've seen their manuscript turned into a real book which they can hold in their hands. They've also got a few copies to give to friends and relatives. By my measurements, they've reached Level Two of the Seven Levels of Publishing (se

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

previous article) and they're happy. Publishers aren't. They're sanguine about authors having web sites, but they still expect to see a mass of manuscripts rolling in to their offices. If authors get satisfied with internet publishing, the submissions

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

will dry up (they think).

Possibly. The fact is there is a long way to go, but publishers have never been good with reality. In the real world, 99 per cent of all submissions to Traditional Publishers simply bounce back. Publishers aren't being honest

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

Following aspects would a

if they say anything different. Also, most of the books that are published don't actually come out of the postman's sack. They get sent round by courier from agents, or friends, or established authors, or other publishers. No, the bulk of brown envelo

dd to the challenges in developing combination products:

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

es that a publisher receives simply ends up piled on a desk. It's called the Slush Pile. That means it's layers of manuscripts from authors the publisher doesn't know personally and hasn't been recommended to try. The Pile languishes, only sometimes be

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

ng stirred at all. More usually a lowly member of staff or clerical temp will be delegated to put the submitted manuscripts back in their enclosed Stamped Addressed Envelopes and send them off with a pre-printed Rejection Slip. Reality? It sucks.

Publ

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

ishers shouldn't worry. What happens now? Occasionally, if a publisher, an editor or other member of staff, has a spare hour, they might delve into the Slush Pile. If they have the time, (which they mostly don't), or if there is an unexpected gap in th

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

publishing schedule that month and for some rare reason they are looking for a new book, yes, it may happen. The good news for publishers is that even if the tide of submissions decreases - because authors realise they can actually get what they want

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

Professional from academic institutions, pharmaceutical industries, health care indust

rom the internet (without the humilation of flogging their hard-fought creations off to an ungrateful range of Traditional Publishers) - then the books are still out there. No, they aren't sitting in the Slush Pile, but they're on the internet. You're

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

a publisher with a spare hour? Get on the computer. Who knows, you might find something to your taste.

The future is likely to be that more and more authors will turn to the internet first. They'll put their books up on a site like Lulu, print off cop

.

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

es and pause. Some will plow on, sending samples of that work and others off to publishers and accumulating Rejection Slips, while some will not bother. Either way, it's likely that some established publishers - and many agents - will become Internet P

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

Companies that provide selfless information through particip

ospectors, surfing hither and thither to check out the new releases. Looking for gold. It won't be like it is today, but that's the lesson, isn't it? The future of publishing - if it exists at all - is not going to be recognisable. It's going to change

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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