Advice You - Business

I was out for a quick afternoon snack and stopped by a local Jack In The Box. I looked over the items and pulled up to the microphone to p

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

lace my order. I was greeted, “Welcome to the world’s best Jack In The Box. How may I help you?”

I laughed at the greeting. Had I somehow

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

Examples of combination products may in

stumbled on what was indeed the best Jack In The Box restaurant in the world? Or had I stopped in at a fast-food restaurant, which though

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

of itself as the embodiment of the world’s best Jack In The Box? Or, had I (which was most likely) simply chanced upon a very sarcastic e

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

mployee? Over the microphone and speaker communications system, you would think that sarcasm would be easy to detect, and yet I was coming

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

Combination pro

up with zero indicators. I would have to wait for a face-to-face meeting to decide on the intent of the greeting.

I pulled up to the serv

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

ice window. A friendly face took my money, gave out my order, and wished me a good day. There was no sarcasm. There was only efficiency an

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

a genuine friendliness. He name was Carmen.

As I drove away I promised myself to send an email to corporate headquarters of Jack In The

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

Box. I did, and received a standard reply thanking me for my comments, which they promised to pass along to the restaurant. I never heard

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

ny more. I’ve gone to other Jack In The Box restaurants, and they’ve presented no claim of being the best in the world, so I’m left with 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 feeling that perhaps this was the best in the world.

It’s not often that I visit this particular restaurant, but I have several times

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

Following aspects would a

since the initial incident. One time I got the same clerk and was charmed again by her delivery. At other times I was greeted by friendly

dd to the challenges in developing combination products:

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

eople, but without the belief that this was indeed the World’s Best Jack In The Box. I stopped by recently and was charmed by another cler

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

k. He didn’t use the same phrasing, but from his voice there was an element of belief.

I think what I experienced was a moment in time wh

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

n this was indeed the World’s Best Jack In The Box . . . and perhaps it still is each time Carmen is present. I don’t know that my accolad

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

es were ever passed along, but in a world of customer service complaints I hope that she received my complimentary comments. Encouragement

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

Professional from academic institutions, pharmaceutical industries, health care indust

is sometimes everything for front-line service workers.

There is a glimmer of hope that Carmen had a hand in training and passed along he

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

r enthusiasm and her passion to her fellow workers that she somehow worked for The World’s Best Jack In The Box, and they do, too.

I thin

.

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

we should all have the belief that we work with the best people and provide the best service and best products in the best organization f

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

Companies that provide selfless information through particip

or the best industry in the world, and we should share those beliefs and feelings with our fellow employees . . . as well as our customers

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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