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Advice You - Life Begins at 55
When I sold my business, at the age of 55, I felt liberated. Now I could do all those things that seemed so interesting, but were
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
denied me by the "ball and chain" of small-business ownership.
Sure, in those twenty years, I had some concurrent professional
Sure, in those twenty years, I had some concurrent professional
; 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
ctivities going on. For much of the last fifteen I was a roving adjunct professor, and an occasional consultant. There were even
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
couple of full-time jobs in there, where frequent phone calls to, and most Saturdays at my business had to be enough to impart m
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
unique brand of management.
So, I am available world! Or at least the greater New Orleans area.
Several months of clearing up
So, I am available world! Or at least the greater New Orleans area.
Several months of clearing up
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
my backlog of miscellany were rather pleasant, and then the call came. President of a local economic development agency? That sou
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
ds good to me. But I soon found out what a come-down it was from business owner/executive to political whipping-boy. Thanks for t
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
e opportunity, but I would just as soon stay home.
After another pleasant interlude of a few months, another call came. Scholar-
After another pleasant interlude of a few months, another call came. Scholar-
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n-Residence at a local university sounds great! And it was a pleasant two years, including one semester as a visiting scholar in
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
New York. But financial exigency did me in. Last hired becomes first fired. Well, I did mouth-off a little too much about the adm
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nistration’s shortcomings, but I am pretty sure it was the cash crunch that cost me the job.
It was the summer of my discontent.
It was the summer of my discontent.
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
My backlog was so cleared up that I was killing time with a blunt instrument. The local economy had softened a bit, and there wer
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
no jobs to be found that came even close to the level of income and importance to which I had become accustomed.
So, how is thi
So, how is thi
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
s for an idea? Study for an MBA! I was only 60 years old then, so it should be worth the investment. I had been teaching entrepre
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
eurship at several local business schools, so it was time that I should get my first business degree. My 35-year-old Ph.D. in eng
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
neering had pretty much expired by then.
At 62, in August 2005, I received the MBA and checked out the job market for a week or
At 62, in August 2005, I received the MBA and checked out the job market for a week or
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 until Katrina arrived. We evacuated in time, spent about three weeks on the road, and settled in Columbus Ohio for about three
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
months.
In Columbus, Ohio State was very welcoming toward Katrina refugees and we were given professor offices, Susan in Politic
In Columbus, Ohio State was very welcoming toward Katrina refugees and we were given professor offices, Susan in Politic
.
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
l Science, mine in business. Other courtesies were extended to us through the end of the fall quarter.
The temporary nature of t
The temporary nature of 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
e Columbus stay eased the pressure to find gainful employment there. On our return, though, it would be time to peddle my new MBA
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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