Main Subject - Business

“What are you doing up?”

That was at 5:00 a.m. and the speaker was my wife. I said, “I woke up at 4:00, didn’t go back to sleep so I got up.”

She disappeared as silently as she appeared

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

. I guess she crawled back in bed.

Of course I woke up because I had grandiose plans. Every once in a while I have a brainstorm that results in a grandiose plan.

Back when

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

Examples of combination products may in

I was working for a living, rather than spending the day goofing off, I would go to one of our manufacturing plants that made fine crystal. The Director of R & D there had a strange-looki

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

ng cookie-jar-like container of very ancient, quaint, and foreign origin and on it were engraved in gold the words Grandiose Plans.

I always peeked into that jar-thing when I visi

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

ed the plant. It was always empty. NO grandiose plans for that day!

I don’t have a jar for my grandiose plans but I always have a few tucked away in my mind that just need pruning. My wi

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

Combination pro

e always asks, “What are you up to now?”

Well for sure it is another of my grandiose plans that will surely make me healthy, rich and famous or all of the above at the very same time. Ho

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

wever, for some reason, they seem to make me poorer.

I think surely if I send out this offer to 1000 opportunity seekers I will get a 1-2 percent return and if they each mail out 1000 of

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

ers I will make a zillion bucks.

I send out my 1000 offers and I get zero response. Let’s see: Postage $370 (which will soon be $400), 1000 names $85, Printing $100, my time FREE, TOTAL

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

$555.00.

In accounting there are credits and debuts. The above IS NOT a credit.

You know that 1-2% is the average yield for a mail order offer. I usually use 0.5 % to predict my minimum

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

income. But, you can get a nice return of ZERO instead of the 10-40% that the guy that sent you the offer said he was making. Liar, Liar, Pants on Fire!

Sometimes it's best to place a sm

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

ll classified ad saying that you have a grandiose idea and would the reader like to learn more about it. It's a lot cheaper! You are after inquiries to which you will send your offer. You

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

Following aspects would a

will do better!

I notice quite a lot of you have been reading my article Empty Mail Box: The Truth About Mail Order and Direct Mail.

Hmmnnnn!

I think I’ll go to that reference

dd to the challenges in developing combination products:

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

gain before I blow anymore of my hard earned dough.

I don’t know of any business puddle in which you can make a bigger belly flopper in the shortest time than mail order. However, it wou

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

ld be against my business religion to not give it a Good Ol’ College Try when I have Grandiose Plans.

I have a new mail order plan and I’m going to cautiously give it a try but I

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

m only going to send it to other suckers like me, the ones that send me offers. Teh, heh as George W. says it!

I went to my main business website this morning and added two free items to

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

those who order during my Christmas Special. My sales have drooped lately partly because I changed by offline magazine advertising. I get the same number of hits but fewer buyers. I moved

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

Professional from academic institutions, pharmaceutical industries, health care indust

to a less affluent audience because the magazine editor said I would do much better than I was doing with the National slick magazines I was using.

Well, it is still early. Magazine res

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

onse can be sloooooow.

I also have been losing sales to my competitor. I see that he has been hogging the search engine ratings. That’s why I have to go back and change my strategies the

.

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

re too.

If you don’t watch the competition on the Internet, in mail order, and direct mail, you can get clobbered with a capital “C.”

Well, it looks like the sun is up, although it’s ra

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

Companies that provide selfless information through particip

ning and I can’t see it. It’s still too early for breakfast. (I like to have breakfast about 11:00.)

I hope my competition is still sleeping!

The End

copyright©John T. Jones, Ph.D. 200

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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Recently, I read a generally helpful article about using seminars as a means of attracting new clients, and I wholeheartedly agree with that premise. I’ve been doing just that for years, and it has helped my consulting practice, tremendously. But there was a trap in that article for the unwary. The author said: “If the purpose of your seminar is primarily to get clients, you shouldn't be expecting to make money on the seminar itself.” If you can make money on the seminar, I say you should, for five reasons, says Dr. Gary S. Goodman, top keynote seaker, seminar produce, best-selling author, and Fortune 1000 consultant.

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