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Many years ago I had phoned a General Manager of a major hotel chain. In response to one of my questions he told me that he was blind

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

and requested that I send him information in braille. I politely explained to him that I did not have any information that was written

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

Examples of combination products may in

exclusively for the blind. Our conversation abruptly ended, but I felt like something was not right here?

In response to my curiosity

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

I then decided to find out if this GM was really blind so I made a call to the Front Desk Manager. According to this manager, the GM

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

as not blind. I knew that he was pulling my leg, but I wanted to be 100% sure that the GM was not blind. I then asked the FDM if he c

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

Combination pro

uld transfer me to another employee to confirm his statement. Again, I was told the very same fact--he was not blind! Once I heard the

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

truth I felt insulted and then became disgusted by what I had learned!

I was feeling this way because he had lied to me and I took it

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

personally--I had an aunt who was blind. I decided to call the GM to let him know what I had learned and what I thought of him. We ex

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

hanged a few words back and forth and he was very apologetic. He said that he was just joking and made a mistake. After accepting his

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

apology, I then explained to him why I was calling and he responded with genuine interest in what our company had to offer and what we

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

could do for him.

A few minutes passed by and he said to me," I'd like to go ahead and do this, but on one condition." I responded,

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

Following aspects would a

What condition might this be?" He said, "I will do the deal if you buy me a 1 year subscription to a 'not so nice' magazine?" How co

dd to the challenges in developing combination products:

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

ld he say such a thing after what he told me at the beginning of our conversation? While I was surprised at his request, my curiosity

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

got the best of me so I decided to play along and continue our conversation.

I then asked him, "Why is this so necessary?" He explain

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

d to me that he wanted this magazine because next month a model who did a camera shoot at his hotel will be featured in this publicati

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

n. The GM told me that once he receives his first issue he will accept my offer and the deal will be closed.

Since I have a good sens

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

Professional from academic institutions, pharmaceutical industries, health care indust

of humor I took him up on his unusual request. Did he follow through with his side of the bargain? Yes, he did follow through with

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

is word and the deal was closed. Perhaps you would have handled this conversation in a completely different way? I'm sure that many

.

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

f you would have hung up on him, right? What's the point of this story besides a good laugh? The point of this story is to demonstra

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

Companies that provide selfless information through particip

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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