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Useful Advices - The Stress of Secret Keeping
We business-minded Americans put a high value on secret-keeping. There are good reasons:
competition: If a competitor gets the right information about a competitor's product or plan
it could literally be the end of that co
competition: If a competitor gets the right information about a competitor's product or plan
it could literally be the end of that co
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
mpetitor's company.
premature death: If a budding proposal leaks out inside the company or organization
before it is properly prepared and presented it could get killed. This is a
big danger when seeking informal advice f
premature death: If a budding proposal leaks out inside the company or organization
before it is properly prepared and presented it could get killed. This is a
big danger when seeking informal advice f
; 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
om associates.
feeling important: Secret-keeping makes the keepers feel important. Given the high degree
of job insecurity that goes with the territory of high productivity in return for
high wages, feeling important is a
feeling important: Secret-keeping makes the keepers feel important. Given the high degree
of job insecurity that goes with the territory of high productivity in return for
high wages, feeling important is a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
powerful need and motivator. Just think
about this for a moment: how do you feel when the memo you receive is stamped
"Confidential, destroy after reading"? What if you were invited to a high level
company meeting at a g
about this for a moment: how do you feel when the memo you receive is stamped
"Confidential, destroy after reading"? What if you were invited to a high level
company meeting at a g
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
taway location, no calls in or out and not to be
discussed with anyone? Secret-keeping is a form of validation.
You could probably add more reasons why keeping secrets is important to your company. Important as secrets may
discussed with anyone? Secret-keeping is a form of validation.
You could probably add more reasons why keeping secrets is important to your company. Important as secrets may
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
be, however, there is a downside to consider.
The Downside of Secret Keeping First, having to keep secrets is a stress producer. Secondly, keeping secrets is unproductive and obviously diminishes communication in the work
The Downside of Secret Keeping First, having to keep secrets is a stress producer. Secondly, keeping secrets is unproductive and obviously diminishes communication in the work
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
place.
Why stressful, you might ask. The answer is subtle. When we are entrusted with a secret we are not free to talk about it. But that does not mean we never think about it. The natural human process is to talk with one
Why stressful, you might ask. The answer is subtle. When we are entrusted with a secret we are not free to talk about it. But that does not mean we never think about it. The natural human process is to talk with one
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
nother about our work and about what is running through our minds. The secret keeper, therefore, must constantly be on guard not to do this with the secret. Constantly. That makes thinking about the secret more difficult to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
turn off and more likely to take center stage in the theater of our mind. No one else know this is happening and therein lies another source of stress: isolation.
The human need and instinct is to find comfort and relief by
The human need and instinct is to find comfort and relief by
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
connecting with one another over matters important. This is all the more true with the people who share work or personal life. Keeping a secret runs against this grain, creating an invisible barrier with the people who matte
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
most.
Unless the secret happens to be of monumental proportions the stress will likely be minimal. The Board tells you in confidence that they are considering end of the year bonuses: not too terribly stressful to keep thi
Unless the secret happens to be of monumental proportions the stress will likely be minimal. The Board tells you in confidence that they are considering end of the year bonuses: not too terribly stressful to keep thi
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
s secret. Monumental would be if the Pentagon called you to describe a lethal virus being developed which could kill the entire world but you may not tell a single soul. The real stress about secret keeping is that it is alw
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
ys there and, if secret gets piled upon secret, all those little stresses start to add up like snow flurries that won't quit. To paraphrase the late Senator Dirksen about money, "a little stress here and a little stress ther
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
e and pretty soon it is a lot of stress".
Why unproductive? Secrets are information which cannot be shared. That's the rub: we cannot compare notes, be inspired, work together or contribute additional information and ideas
Why unproductive? Secrets are information which cannot be shared. That's the rub: we cannot compare notes, be inspired, work together or contribute additional information and ideas
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
o something we haven't heard about. The secret keeper cannot use the secret in any shared, productive process. If the secret has to do with a problem the secret keeper cannot engage the normal methods of problem solving by i
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
volving others for a solution. If the secret has to do with product or market development the important process of brainstorming and bouncing ideas off of others for reality-testing and creative suggestions must be suspended
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
.
In a nutshell: keeping secrets prevents the secret keeper from developing perspective based on interactive information.
Without perspective any further action or decision is likely to be flawed. You will almost always lo
In a nutshell: keeping secrets prevents the secret keeper from developing perspective based on interactive information.
Without perspective any further action or decision is likely to be flawed. You will almost always lo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
k back and say it could have been better, why didn't we notice this or think of that?
Bottom line: secret keeping may be flattering and may give rise to a sense of importance. Sometimes it is necessary. But it is a necessar
Bottom line: secret keeping may be flattering and may give rise to a sense of importance. Sometimes it is necessary. But it is a necessar
.
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
y evil, something that should be done very sparingly when there are absolutely no other options. It will produce stress and hurt communication. It is essentially a non productive mode of operating and should be followed by f
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
cused efforts to restore communication and shared problem solving. If secret keeping happens to be a prominent part of your management style it is time to review the management style and search for more productive approaches
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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