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Main Subject - Talking to Teddy (Bears)
So there you are, working along on a project with a deadline (don't they all have deadlines?), feeling pretty good about the progress you're making, in that nice place of "flow" where
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
the ideas and next steps just float into your mind almost effortlessly.
And the phone rings, or someone taps on your door or your cubicle wall.
Whoops.
Even if their question or pro
And the phone rings, or someone taps on your door or your cubicle wall.
Whoops.
Even if their question or pro
; 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
lem is quick, they've broken your concentration. You not only don't have that lovely feeling of flow any more, but you can't even remember what you were about to do next.
Not much fu
Not much fu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
. And it's also not much fun to think about how many times you've done that to someone else! Even with the best of intentions, it's really hard not to interrupt people, especi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
lly when you're totally stuck with a problem that has to be solved somehow. You probably know the polite way of doing it ("'Scuse me, do you have a minute, or should I come back later
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
"), but that doesn't always prevent the interruption-damage from being done.
A long time ago, back in my corporate "geekdom" days (I was a software engineer for many years, and a proj
A long time ago, back in my corporate "geekdom" days (I was a software engineer for many years, and a proj
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
ct manager/program manager/technical department manager for a lot of years after that), I read a number of wonderful geeky technical books. My favorite technique for keeping these typ
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
es of interruptions to a minimum comes from one of those books. The book itself is long gone from my shelves and my memory, but the story remains.
It seems that a successful software
It seems that a successful software
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
organization had a rule in its technical support area. (You know tech support. That's those people we love to hate when we have to call them to resolve problems with something on our
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
computers. Of course, in reality most of them are hard-working people who truly want to help, hard as that may be to remember when your computer has gremlins.)
None of their support
None of their support
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nalysts were allowed to interrupt anyone else, no matter how hard the problem was they were working on, and no matter how stuck they felt, UNTIL ...
Until they went to the cubicle of
Until they went to the cubicle of
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
he Tech Support Teddy Bear, and explained the problem in detail to Teddy.
How many times have you explained a problem to someone, and suddenly the light bulb went on - BLINK - and you
How many times have you explained a problem to someone, and suddenly the light bulb went on - BLINK - and you
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
knew the answer?
So next time you think you need help with something, even if you're sure you're completely stuck, try explaining it to Teddy first. Or your cat, or dog, or even the
So next time you think you need help with something, even if you're sure you're completely stuck, try explaining it to Teddy first. Or your cat, or dog, or even the
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
frican violet on your desk - though it helps if whatever it is has eyes (even plastic ones!) that you can look into while you're talking.
There are three keys to making this work.
There are three keys to making this work.
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
l>
It has to be a true problem, not a lack of resources. If you're missing a piece of equipment, for instance, or there's some skill or information you don't have, this won't wor
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
. In the case of missing information, though, you might want to give it a try. You may find you know more than you think.
You must explain the problem in detail, just as yo
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
would explain it to a real person. If you don't go into the details, your brain can't hear them, and your thoughts will just spin around in the same rut they're already in.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Finally, you have to take the process seriously. If you treat it as a joke, you won't be paying attention, and your brain won't engage.
The next time someone interrupts y
The next time someone interrupts y
.
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
u, give them a copy of this article and ask them to come back after they've told Teddy their problem. In fact, you could even put your very own Teddy Bear in the entrance to your offi
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 or cubicle, holding a copy of this article.
"Exit, pursued by a bear." Stage direction from "The Winter's Tale," William Shakespeare, English playwright and poet, 1564 - 1616
"Exit, pursued by a bear." Stage direction from "The Winter's Tale," William Shakespeare, English playwright and poet, 1564 - 1616
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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