Main Subject - Business

I was very good friends with Edmund Ezel. He worked at the Falstaff Brewery in New Orleans for 40 y

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

ears. He told me a story about a cousin of his that was worth a lot of money.

Every time he saw hi

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

Examples of combination products may in

cousin, he would make it his business to be kind to him. Years passed by and he saw in the paper t

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

at his cousin had passed away. Edmund told me that he went to his cousin funeral. He knew that his

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

cousin did not have any living relatives. To my knowledge I was the only cousin he had living. Ed

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

Combination pro

und said that he was curious to find out to whom his cousin left all of his fortune.

There were ver

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

few people at the funeral. Edmund introduced himself to a gentleman standing near the casket.

The

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

man introduced himself as his cousin’s attorney. The attorney told him that his cousin left all o

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

his five million dollars to the Salvation Army. Edmund told me that he was shocked.

The Salvation

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

Army Edmund said out loud in the funeral parlor. I am the only living cousin that he had left. I w

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

s always very nice to him. Why the Salvation Army?

The attorney said, your cousin told me that the

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

Following aspects would a

Salvation Army was the only people that remembered him and his family during the 1947 hurricane. Th

dd to the challenges in developing combination products:

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

y lived out in the country. Everything was under water.

No one came out to check on them, except th

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

Salvation Army. They rowed out in a small boat and offered him and his family a hot cup of coffee.

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

He said that coffee tasted so good. The attorney said he never forgot that cup of hot coffee.

Edmu

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

d Ezel passed away a few years ago. One of his daughters called to tell me that her Father wanted me

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

Professional from academic institutions, pharmaceutical industries, health care indust

to do the eulogy at his funeral. I had never done a eulogy before. Right before I was to go up to

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

the front of the chapel to give the eulogy, his daughter came up to me and handed me a cup of hot co

.

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

fee. I asked what this for? She said my Father told me to give this to you right before you gave h

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

Companies that provide selfless information through particip

s eulogy. One good turns deserves another. How may I serve humanity with humility? What can I do

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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