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I spend a lot of my time reading books and listening to tapes about b

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

usiness and marketing. I guess that's understandable.

Many of the a

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

Examples of combination products may in

uthors of these materials are known as experts, gurus or marketing ge

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

niuses. However, a few weeks ago I was listening to a discussion abo

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

ut marketing and one of the participants made a point that struck me

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

Combination pro

like a ton of bricks.

He said: "The only true marketing genius is th

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

e customer".

What a succinct and powerful statement!

The truth of t

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

he matter is that no matter how much good advice or information or tr

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

aining we get in marketing, the only person's opinion that really mat

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

ters is the customers. No matter how good the idea seems to be, if t

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

he customer doesn't respond then nothing else matters.

What's the mo

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

Following aspects would a

ral?

Simple. You need to constantly stay in tune with your customer

dd to the challenges in developing combination products:

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

s interests and desires and give them what they want, how they want i

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

t, when they want it. If they don't respond to a particular offer, y

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

ou need to do your best to find out why (through follow-up surveys or

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

any other method at your disposal).

If they do respond to an offer

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

Professional from academic institutions, pharmaceutical industries, health care indust

it's still a good idea to find out why. It may be for a different re

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

ason than you think.

We should all certainly continue to study marke

.

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

ting and listen to what the "experts" say, but we need to give just a

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

Companies that provide selfless information through particip

s much (or more) attention to what our customers are saying as well.

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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