Useful Advices - Business

During long sticky days at sea, one of the many exciting activities offered to passengers (we called them cones for some reason) on a cruise ship is skeet shooting.

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

We used lead free pellets and biodegradable skeet discs to make certain that no creatures of the sea were harmed in any way. Never mind that we were handing a shotg

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

Examples of combination products may in

un over to an inebriated, over heated, somewhat older and usually male cone. Happily full from the generous late afternoon lunch buffet and rum-runners, these cones

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

would pay about thirty dollars just to pop off a few rounds and hopefully hitting enough targets to brag about it at the dinner table that night. Our older cones usu

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

ally traveled in threes, husband, wife and his heart condition. This heart condition would make itself known at the most interesting times.

As part of the emergency

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

Combination pro

response team (yes, they put a twenty year old cruise staff member in charge of saving lives!), my job was respond to a “code alpha” announcement with basic paramedi

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

c supplies while the ship’s doctor squirmed his way out of whatever cone’s cabin he might have been lounging in for that particular cruise. In this case, a code alph

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 was called to the aft section of the ship, the skeet shooting area. As I sped along the deck with supplies in hand my mind was going crazy. Had a deranged old man

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

killed his wife in a drunken fit of rage? I was expecting to arrive to gruesome scene all blood and guts, only to find a peaceful looking man laying on his side, a

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

heart attack victim. His ticker shut down with the explosive sound of the shotgun. As I began my unfortunately

Chapter Eight-Bang-Bang, Make Room in the Walk-In Co

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

tinued… unsuccessful revival routine his wife of obviously many years was by my side telling me how she “expected this to happen” and that “his doctor warned us not

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

Following aspects would a

to go on this cruise”. As he vomited all over me as I attempted to inabate him, I wanted to smack her. I knew she was just trying to make herself, and me feel bet

dd to the challenges in developing combination products:

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

ter. It was nice, but I had heard it all before. It happened at least two times per cruise. We called it “the cruise to death” plan. Someone condemned by their do

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

ctor to a life of pain and misery usually from congenital heart disease would quite literally go on a cruise as their “last hurrah”, a final happy chapter in their

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

life. I really could not blame them, why not go in paradise? It just bothered me a bit that I always ended up with my fingers down their throat trying to find the t

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

ongue that they had just swallowed.

What was even better was the fact that our older cruise ships did not have a morgue. Not able to just leave poor John Doe at th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e next foreign port of call, it was necessary to find a way to keep him cold until we got back to Miami so his wife could make the sad arrangements. So what do you d

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

o with the recently deceased when you are at sea and the temperature is in the upper eighties? You call the chef. The huge walk in refrigerators on this older ship

.

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

often doubled as make shift morgues. So we made room next to that nights dinner for the body bag.

As I sat that night at the Captain’s table with the wife of the ju

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

Companies that provide selfless information through particip

st departed, I could not bring myself to eat. I bought the new widow a drink and wondered to myself as she busily gnawed away on a leg of lamb…did she have any idea

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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