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E-Folder - Planning and Execution - Lessons from Prisoners
If you haven't seen it, Shawshank Redemption is a 1994 film adaptation of a Stephen King short story that receiv
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
ed seven Oscar nominations. Tim Robbins plays Andy Dufresne, a city banker, wrongfully convicted of murdering h
; 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
is wife and her lover. He is sent to Maine's Shawshank Prison in 1947 and receives a double life sentence for th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
crime. Andy forms an unlikely friendship with "Red" (Morgan Freeman), the man who "knows how to get things."
A
A
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s their 20 year incarceration unfolds, Andy Dusfesne succeeds in not only orchestrating his successful escape bu
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t accumulating enough wealth to allow him to comfortably retire to a secluded beach community in Mexico where Re
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
joins him upon his parole.
"Fear can hold you prisoner. Hope can set you free." - Shawshank Redemption tagli
"Fear can hold you prisoner. Hope can set you free." - Shawshank Redemption tagli
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
ne
What can we borrow from this tale? For some, a double life sentence would would deflate all hope. Instead A
What can we borrow from this tale? For some, a double life sentence would would deflate all hope. Instead A
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ndy patiently and meticulously planned his future and then worked his plan. The first "thing" that Red procured
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
or Andy was a rock-hammer supposedly for his hobby of sculpting small pieces of stone. But over decades, it serv
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ed to carve a gateway for his eventual escape route. Andy gained the trust of the warden, secured an accounting
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
position, helped the warden to skim proceeds from prison labor projects and channel them to special bank accoun
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. Those bank accounts eventually funded Andy's retirement while he framed the warden for fraud. Andy shared hi
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 vision with Red. It provided them with the hope necessary to mentally set them free. It was compelling enough
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
to motivate Andy to trudge through a half mile of raw sewerage during his escape. Through brilliant planning an
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
methodical, unyielding execution, Andy's vision was achieved and he shared the achievement with his closest fri
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
end.
How can we apply this to our business? Take The Shawshank Quiz
Considering the planning and execution st
How can we apply this to our business? Take The Shawshank Quiz
Considering the planning and execution st
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
andards set by Andy Dusfesne, ask yourself...
* What is the vision of our organization?
* Is it compelling e
* What is the vision of our organization?
* Is it compelling e
.
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
ough raise the hope of our stakeholders?
* Is our written plan sufficient to get us there?
* Do we have the
* Is our written plan sufficient to get us there?
* Do we have the
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
necessary engagement and commitment to achieve it?
* Have we moved significantly closer to it in the past year
* Have we moved significantly closer to it in the past year
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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