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Main Subject - Consultants - If We Can't Laugh At Ourselves?
There are hundreds of varieties of Consultants these days. We can find Consultants to take care of our d
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
iets, our physical well being, our mental well being, and pretty much anything you can imagine when it c
; 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
mes to business.
The story below might just indicate that we take ourselves a little too seriously some
The story below might just indicate that we take ourselves a little too seriously some
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
imes.
A shepherd was herding his flock in a remote pasture when suddenly a brand new Beemer advanced ou
A shepherd was herding his flock in a remote pasture when suddenly a brand new Beemer advanced ou
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
of the dust clouds towards him. The driver, a young man in a Brioni suit, Gucci shoes, Ray Ban sunglass
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s, and a Zegna tie, leaned out his window and asked the shepherd, “If I can tell you exactly how many sh
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
eep you have in your flock, will you give me one?”
The shepherd looked at the man, then looked at his p
The shepherd looked at the man, then looked at his p
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
acefully grazing flock, and calmly answered, “Sure.”
The yuppie parked his car, whipped out his IBM Thi
The yuppie parked his car, whipped out his IBM Thi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
kPad, connected it to a cell phone, and surfed to a NASA page on the Internet. He called up a GPS satell
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
te navigation system, scanned the area, and then opened both a database, and an Excel spreadsheet with c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
mplex macro formulas. He then sent an email on his Blackberry, and after a few minutes he received a res
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
ponse. Finally, he prints out a 150-page report on his hi-tech miniaturized printer in the car, then tur
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 to the shepherd and says, “You have exactly 1623 sheep.”
“That is correct, take one of the sheep” sai
“That is correct, take one of the sheep” sai
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
the shepherd. He then watches the young man select one of the animals and bundle it into his car. Then
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
he shepherd says, “ If I can tell you exactly what you do for a living, will you give me back my beast?”
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
“O.K., why not?” answered the man.
“Clearly you’re a consultant” sad the shepherd. “That’s correct,” s
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
ays the yuppie, “but how did you guess that?”
“No guessing required,” answered the shepherd. “You turne
“No guessing required,” answered the shepherd. “You turne
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
up here, although nobody called you. You want to get paid for an answer I already knew, to a question I
.
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
never asked, and you don’t know a thing about my business. Now give me back my dog.”
The lesson seems t
The lesson seems t
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
be to keep my Consulting assignment to the things I know about. I think I’m safe because sheep scare me
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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