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Main Subject - Never Hire Anyone Dumber Than You Are!
In a previous life I was a Navy Pilot. Great life, great people to be around. People who were all doing great things around the world flying off great big aircraft carriers. In an environment that complex an
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
d dangerous, you need to have teams of people working as one, or bad things begin to happen in large quantities.
The people onboard aircraft carriers are divided into two groups, those that make the ship fl
The people onboard aircraft carriers are divided into two groups, those that make the ship fl
; 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
at and those that make the planes fly. Those that make the ship float are known as "ship's company", and those that make the planes fly are with "the airwing". During one tour of duty, I was assigned to the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
"airwing staff". The airwing staff coordinated the activities of the ten aircraft squadrons deployed aboard the aircraft carrier. It was while working for our Airwing Commander, Captain Jerry Norris, that I
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ould unknowingly learn what has to become my most valued rule as an entrepreneur.
Captain Norris was quite the character. A fighter pilot with all the fixings! Tall, handsome, and with enough confident char
Captain Norris was quite the character. A fighter pilot with all the fixings! Tall, handsome, and with enough confident char
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sma to handle any situation, be that in the air, on land, or at sea. But the truth of it is, none of the eight officers on the staff considered Captain Norris to be the sharpest knife in the drawer.
It wasn
It wasn
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
't that things were not going well for he or the airwing. It just seemed strange that so simple and relaxed an individual could lead so effectively. You must understand that Captain Norris was in charge of 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 operations of nearly 3000 men and almost 100 of the most complex flying machines on the planet. But fly we did, and did it well. Our airwing was often singled out for acts of excellence.
It was during a s
It was during a s
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hort visit in Cannes, France that Captain Norris was to give me my lesson. Like so many of life's lessons, the lesson was unintended.
If there is one thing that flying fellows enjoy more than flying, it is
If there is one thing that flying fellows enjoy more than flying, it is
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
he telling of tales while ashore! And it seems nothing gets the mind flowing like the flow of beer. Our cups runneth over, as did our mouths!
The topic of the evening turned to how smart each of us was comp
The topic of the evening turned to how smart each of us was comp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
red to our fearless leader. We were even so bold as to believe that he was fearless because he simply did not understand what was going on around him. In fact, it was we who did not understand what was going
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
on around us!
The good Captain was sitting quietly within the sound of our voices. He had heard every one of our comments on his lack of intellect.
As the Commander with the confident charisma approached,
The good Captain was sitting quietly within the sound of our voices. He had heard every one of our comments on his lack of intellect.
As the Commander with the confident charisma approached,
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
we were certain that if we were shown mercy we would be court martialed, and we feared that if the Captain choose not to be merciful, we would just be shot right on sight!
Speaking got us into this predicam
Speaking got us into this predicam
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
ent, so silence seemed the best choice. Captain Norris spoke. He acknowledged our belief that each of us had among the finest minds in the entire Navy in our specific specialty. He flattered those things tha
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
each had done since beginning our assignment with the airwing. Captain Norris offered that he had hand selected each one of us from the entire fleet, having had to call in favors, make threats, and impose d
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
mands, just to have each of us work with him. We were there because he believed us to be the best, and he wanted only the best. Seems he held us in the same regard that we held ourselves.
Then Captain Norri
Then Captain Norri
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
s spoke to the issue of intellect, specifically our perception of his lack thereof. Captain Norris said, "The mark of the true leader is not one who gives orders, or feigns knowledge, but rather the leader w
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o plants the needed seed in a fertile mind so gently, that the subordinate believes the idea emerged from within."
Continued silence. He was in complete control of our actions and had always been. He chose
Continued silence. He was in complete control of our actions and had always been. He chose
.
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
each of us knowing full well that in our specific areas of expertise, we were well beyond him. And knowing full well that in his area, that of building teams of the best and brilliant, then allowing them to
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
ake ownership of ideas, he was the expert.
Captain Norris asked what I had learned. My response, "I should never hire anyone dumber than I am." "You've got it," he said. "Must have just emerged from within.
Captain Norris asked what I had learned. My response, "I should never hire anyone dumber than I am." "You've got it," he said. "Must have just emerged from within.
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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