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E-Folder - Solo Professionals and Consulting
So many very smart folks are retiring early these days and then the
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
y get bored and well industry keeps calling them back to help out.
; 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
Why? Well these top professionals have made many friends and people
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
in the industry know of their expertise. I have met people who have
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tried to retire 5-times or more over the year only to keep taking
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n new jobs.
Many have gotten wealthy doing this and yet part of th
Many have gotten wealthy doing this and yet part of th
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
em wants to stay in the game and part of them is saying; I want to
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
enjoy life and do all those things I have always wanted to do. Perh
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ps travel or learn to fly or something of that nature.
Indeed it i
Indeed it i
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
s possible to have it all, but that will take some strategic planni
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
g if you are one of these folks in this ever-growing category of se
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
mi-retired professionals. The trick is to outsource and coordinate
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
and try to duplicate yourself; sure you can run redline and do it a
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
l yourself, but if you do you will not be able to straddle both wor
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
lds.
That is to say being in the game and out of it to enjoy your
That is to say being in the game and out of it to enjoy your
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
ree time; because you will not have any to enjoy. So, for these sol
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
o-professionals they must outsource and coordinate. They must help
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
companies help themselves and learn to delegate carefully and educa
.
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
e properly. It is amazing how much you can do and still maintain yo
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
ur sanity and free time, if you will just consider all this in 2006
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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