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E-Folder - A Look Inside the Strategic Mind
The strategic mind is an unrolling canvas of ideas and thoughts—shapes and forms, maps and pathways. Constantly churning the mind is sensitive to movements around it, interpreting the factors and elements swirling a
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
bout but not controlled by them. Seeing, planning, rehearsing, revising, they can incorporate new ideas easily and fluidly instead of rejecting or discarding them. They question not for questioning sake but to add a
; 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
d grow the depths of their knowing.
Because they zero in on their goals so clearly and have a focused determination, they think themselves well into the future planning many steps ahead. They don't wait for the uni
Because they zero in on their goals so clearly and have a focused determination, they think themselves well into the future planning many steps ahead. They don't wait for the uni
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
verse to support them or supply them with answers. They go forth into the world collecting information, searching, processing, and asking more than what can ever be asked of them.
Always thinking, where am I? Where
Always thinking, where am I? Where
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
am I going? How will I get there? Questions marks float about and they grab them tightly, but only for a little while before letting go. The only limits in view are self imposed and usually temporary for they are on
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a journey without end.
A tape runs continually…
A tape runs continually…
- No matter how good things are, success is a moving target.
- No matter how bad things are, failure is not an option.
- Anything worth any amount of t
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
ime requires a plan.
If the world didn't change we'd only need one plan for a lifetime.
The pursuits of the strategic mind challenge all notions of defeat and welcome the opportunity to risk for the sake
The pursuits of the strategic mind challenge all notions of defeat and welcome the opportunity to risk for the sake
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
f curiosity and a passion for learning. The stories from the strategic mind unfold from beginning to end in full complete images not in small pieces or parts. At the first site of a block or wall they see the light
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
above it and the path around it. Because most things are possible they keep seeking a way. For every action a counter action is considered. They keep reviewing the tape until it reveals a clear path to the end. This
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
mind does not measure failure by how often it is right or wrong, but by whether or not it is left behind.
Since failure is not on option, the only thoughts left are how to succeed in spite of change, obstacles, and
Since failure is not on option, the only thoughts left are how to succeed in spite of change, obstacles, and
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
disappointments that are sure to come. Time is spent pondering only those things that they can control and they have the ability to control more things than most. They find hidden keys to unlock closed doors and bui
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
ld bridges of curiosity over doubt. If it has ever been done they are certain that they can do it. If it's never been tried, there must be a way. In a quest for relevance the mind is turned toward what has to be don
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
differently to beat change at its own game.
The visions are deliberate and focused without being fixed or limited. They see long range, but don't get too lost in thoughts of the future. Their task is how to create
The visions are deliberate and focused without being fixed or limited. They see long range, but don't get too lost in thoughts of the future. Their task is how to create
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
many possible futures in spite of circumstances and constraints. They see long range, wide angled pictures painted in vivid color. They think big and far, and high and wide—no limits.
They have the ability to reas
They have the ability to reas
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
n through the multiple choices and develop primary responses. They can easily navigate several paths all leading to their ultimate goal. Energy is never wasted but is all spent on discovery. There is an end in site
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
ut this is not the time to rest.
They are miles ahead of change. They consider options, trends and predictions—before making one move. It is often difficult to tell exactly what they are thinking but they are alway
They are miles ahead of change. They consider options, trends and predictions—before making one move. It is often difficult to tell exactly what they are thinking but they are alway
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 deep in thought. Quiet and still they are not easily thrown off balance by small challenges of the day. When everything around them is in chaos they simply make slight adjustments and changes in their position but
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
they never leave the course.
And all of this happens in the strategic mind… before one word is ever spoken.
When they open their mouths to speak, they do so with an unsettling conviction and a sense of authority t
And all of this happens in the strategic mind… before one word is ever spoken.
When they open their mouths to speak, they do so with an unsettling conviction and a sense of authority t
.
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
hat is so descriptive everyone catches the vision. They can support their positions with sound reasoning and are still open and flexible enough to add to or take away as they share information with others.
The goal
The goal
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
of the strategic thinker is to raise the stakes of possibility and participate fully in making the future happen—not only for themselves but all those around them.
Wouldn't you like to meet a few strategic thinkers
Wouldn't you like to meet a few strategic thinkers
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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