Top Adding - Writing and Speaking

There are some wonderful artists that have created lovely and breathtaking paintings.

They have produced numerous works; obj

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

ects of true beauty, and many people with and without a trained eye would say they are gifted.

But if they haven’t sold any

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

Examples of combination products may in

of their pieces, these artists aren’t professionals.

Don’t get me wrong, they’re making themselves happy, and perhaps their

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

friends and family, and all of us would agree that they’re individuals of rare achievement.

Still, they aren’t pro’s.

The a

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

ge old distinction applies, whether you’re a writer, a speaker, a bowler, a consultant, or a painter.

You’re an amateur if y

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

Combination pro

ou do it without payment.

And what do I mean by being paid?

EXAMPLE: I have published 12 books with major companies, and in

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

every case I was paid an advance against royalties. That fact makes me a professional author.

Not long ago, I was shopping

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

title, and as is my habit, I put my proposal into many hands. One publisher said he’d love to publish it but his small firm

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

can’t afford to pay advances; only royalties based on sales.

Is that a payment? It’s speculative, and if he doesn’t act in g

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

ood faith and print, distribute, and promote the work, my end of the bargain could be nothing. So, it isn’t an offer befittin

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

g a true professional.

Another publisher was willing to pay a moderate advance against royalties, yet her firm insisted that

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

Following aspects would a

its authors be available nearly around the clock to do interviews far and wide to promote their works.

There is no compensa

dd to the challenges in developing combination products:

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

tion for doing unceasing interviews. Therefore, the advance is illusory. You could easily “lose” more money by giving over yo

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

ur calendar than you could gain from the advance, and even the royalties.

Is that a professional offer?

Not in my book, par

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

on the pun.

So, I passed on it, electing to publish it elsewhere for a larger advance, zero commitment to interviews, and be

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

fore the first year elapsed after publication, my work was spinning off royalties having earned back its significant advance.

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

Professional from academic institutions, pharmaceutical industries, health care indust

That is a real deal.

Given these examples, you might wonder what I think of when someone approaches me to do an unpaid spe

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

ech, yet he claims that the audience will consist of my kind of clients.

He’s saying there’s a marketing “payment” that he’s

.

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

giving me by exposing me to these people, by hosting my presentation, and by positioning me as an expert.

There’s no money,

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

Companies that provide selfless information through particip

but there’s a benefit, he contends.

Generally, I regard this as an offer that is not appropriate for a professional speaker

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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Top Adding - Top Author, Speaker & Consultant Says: Real Professionals Get Paid!

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