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E-Folder - Dead Fish - A Strategic Lesson
Malcolm Muggeridge is quoted as saying that only dead fish swim with the stream. I was reminded of this truth
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
yesterday as we enjoy the beautiful summer day by taking a walk for the neighborhood. A small stream flows
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nder our street a few yards down from our house. The afternoon sun illuminated a small portion of the stream
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
where between the surface and the bottom a school of small fish provided some intellectual entertainment. Do
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ens of these fish no more than 2 inches long were swimming aggressively against the current as if their life
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
epended on it. One might think their ultimate destination was upstream. The truth is their journey was goin
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
to take them down stream where they eventually would join the Great Lakes.
It seems logical that they could
It seems logical that they could
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
get to the Great Lakes quicker if they would turn around and use the same energy to swim downstream. However
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
as I watched them it became apparent that by swimming upstream the current was slowly taking them to their de
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
tination, and in the process their actions were making them much stronger. Undoubtedly by the time these sma
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
l fish reach Lake Erie they will have built the stamina and strength to deal with the adversities that await
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
hem, particularly from the large fish we could not even fit in this small stream.
Such is life in the busine
Such is life in the busine
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s world. Some go with the flow, doing what others do, doing it the way others do it, and become surprised wh
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
n their results are less than stellar.
Others go against the flow. They take chances that no one else will
Others go against the flow. They take chances that no one else will
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ake, giving them results that others will not achieve.
Such is the case with Sam Walton. When there was a c
Such is the case with Sam Walton. When there was a c
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
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
y that discounters needed to upscale their product lines and store presentations, Sam bucked the trend. He n
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
t only stuck with what he was currently doing, he looked for ways to cut the glitz and glamour of his already
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
modest stores. The result speaks for itself. The fish that went with the stream died, without realizing that
.
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
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
once the flow started to carry them they were already dead.
As you look at the results of your current effor
As you look at the results of your current effor
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
s, and feel you want to improve them, look at the way the stream is flowing -- and go the other way.
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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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