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Two days before St. Patrick's Day I was telling a friend that I had to rus

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

h to the mall and buy a green shirt to go to a St.Patrick's Day party. (Ca

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

Examples of combination products may in

you believe it? A genuine Irish lady who doesn't possess a green shirt!)

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

She replied that the scarf I wore the day before had a green pattern on i

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

and I could wear that. But I knew she was wrong so I said: "No, it doesn'

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

Combination pro

. That scarf is purple and pink."

The next day I was driving to a meeting

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

wearing the same scarf. I looked down as I drove and what did I see - a g

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

een pattern woven through the purple and pink. I began to wonder if I was

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

going crazy! What happened was that I had originally bought that scarf t

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

match a purple suit and I only ever wore it with that suit so to me the s

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

arf was purple and pink. My mind had never registered the color green unti

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

Following aspects would a

l someone pointed it out to me.

What has this to do with marketing and wr

dd to the challenges in developing combination products:

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

ting? Lots!

It shows how we perceive selectively through our own filters,

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

whatever they may be. We see what we want to see because it’s relevant to

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

us. We hear what we want to hear because it has some meaning to what’s goi

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

g on with us right now.

People don’t always hear what you think you said

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

Professional from academic institutions, pharmaceutical industries, health care indust

or see what you think you presented to them. That’s why it’s so important

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

o be able to put yourself into the minds and shoes of your potential clien

.

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

ts and figure out what’s most likely to catch their attention because they

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

Companies that provide selfless information through particip

relate to it in some way.

If you can do that, you'll be ahead of the game

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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