Useful Advices - Business

"May I help you?"
"Just looking, thanks."
"Okay, if you do need anything I'll be right here."
"Uh, okay. Thanks."

Does any of the

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

above sound familiar? I'll bet it does. It's the usual scenario when you walk into some type of shop and most of us will probably recognise it, or

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

Examples of combination products may in

have been victim to it, at one time or another.

I did some retail work, once upon a time a long, long time ago. Where, or why, it doesn't matter.

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

Misspent youth, I suppose.

In the process, I've had quite a lot, and I mean a LOT, of sales training. One particular course always sticks to my min

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

d as I am convinced that it was probably the best sales training course I have ever encountered, bar none. I won't go into the nitty gritty, the mea

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

Combination pro

t of the course, as such.

I will say that, if I remembered the instructor's name he would definitely get a mention here. I do remember he was Welsh

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

. It was a long time ago, after all.

After this particular course, being new to the industry and rather naive, I figured I had to do exactly what I

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

was taught when I got back to work. No-one else got duped so easily.

As a result, within a couple of weeks I had phone calls from people from far

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

away lands wanting to speak to me. Yes, I mean the kind of place where no-one wants to go: like Birmingham. You see, these people had heard of me.

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

I had become somewhat of a legend without realising it.

Apparently, I was setting some sort of sales record within this particular company. Wow!

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

I was surprised to say the least. The guys would call up, ask to speak to the manager, and then ask who I was. As soon as I told them, they would

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

Following aspects would a

say something along the lines of, "aahhhaaa, so YOU’RE him," leaving me a little bemused. And then they would explain what was going on.

I must adm

dd to the challenges in developing combination products:

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

it, it was flattering. Especially when the area manager refused to let me leave the store on a transfer, and literally chucked money at me to stay t

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

here. Money I hadn't worked for.

What exactly was the secret recipe for this, you may wonder? Would you believe it was all in the introduction?

W

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

hile everyone else stuck to the same old routine, as above, I just went up to the person, stuck my hand out and said, "Hi, I'm Rezbi. What's your na

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

me?" Ninety percent of the time, they would shake my hand and just tell me.

Then I would just invite them over to have a seat and start chatting.

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

Professional from academic institutions, pharmaceutical industries, health care indust

During this chat I would ask probing questions to find out exactly what they wanted.

You see, once the introduction was over and we knew each other'

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

s name, it was like we were friends and it was much easier to just talk, as opposed to sell.

Who was it who said, "A stranger is a friend I haven't

.

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

yet met?" I forget. But how true it is.

I know it’s difficult on paper, but maybe you’ll get this practical training. Or maybe you’ve already had

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

Companies that provide selfless information through particip

it. If so, I highly recommend you use it.

Try it. Be comfortable with each other first. Be familiar. Be naive.

Copyright 2006 Ghulam Nabi Rezb

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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