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Digg It - Three Foundation Stones for Building Organizational Integrity
When the stock market crashed in 1929, there were a lot of people who lost everything they had. You would think that the result of that event would be complete and utter despair. And, in fact, there were those who reacted that way. There were numerous cases of people who committed suicide because they lost their life savings on that fateful day. They simpl
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
y went into a depression and just couldn’t bring themselves to go on with life.
But there was another group of people who reacted differently. These, too, lost everything and there is no doubt that they were just as devastated at their loss as were the others. It is just that they seemed to have better coping mechanisms. These folks were, somehow, able to t
But there was another group of people who reacted differently. These, too, lost everything and there is no doubt that they were just as devastated at their loss as were the others. It is just that they seemed to have better coping mechanisms. These folks were, somehow, able to t
; 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
ke it in stride. Many of those went on to create another fortune.
What was the difference? Both lost everything. Why did they react so differently? The answer is that they placed their values in different places. As a result, the path they chose was also entirely different. The ones who committed suicide saw money as an end in itself. When it was gone
What was the difference? Both lost everything. Why did they react so differently? The answer is that they placed their values in different places. As a result, the path they chose was also entirely different. The ones who committed suicide saw money as an end in itself. When it was gone
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
here was nothing left to live for so they ended their lives. Those who started over placed their values more in the process of living life. They valued relationships and personal growth over money. They realized that money comes and goes, but life goes on. They chose to value things that give life meaning whether there is money or not.
This is but one exa
This is but one exa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ple of the many ways this plays out in our lives. We all constantly deal with trials and disappointments. Whether it is with finances, business opportunities, relationships, sports competition, academics or whatever, we all face those times when we don’t have the outcome we want.
The choices we make at those moments do not just happen. While we may, sometimes
The choices we make at those moments do not just happen. While we may, sometimes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
feel limited in our possibilities, the fact is quite different. At any moment we have way more possibilities than we imagine. One of the major choices we make is our value system, and the decisions we make in life are based on those values.
While all too many people simply fall into their value system without due consideration, it should not, and need not, b
While all too many people simply fall into their value system without due consideration, it should not, and need not, b
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
that way. In the "era of Enron" and “MCI” with it's focus on the bottom line above all else, it is time to refocus on where true value lies in the enterprise of business.
Let's face it, money is everywhere. It is in good places and in bad places. It is used for good things and for bad things. The question is not, "Will we have money at our disposal?" It
Let's face it, money is everywhere. It is in good places and in bad places. It is used for good things and for bad things. The question is not, "Will we have money at our disposal?" It
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
is, "What will we do with what we earn?" We have to assume that our business will be making money - no profit no business. Money, in and of itself, is a neutral commodity. Rather, it is the values we establish about the business and its resources that define the outcome.
We are not born with values - either as individuals or as a business entity. We absor
We are not born with values - either as individuals or as a business entity. We absor
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
them from our environment (family, teachers, colleagues, etc.) and we craft them from our life experiences (what we read, who we listen to, desires and dreams).
But values have to be based on something. American culture emerged out of a way of thinking that was based on an objective value system which emphasized personal responsibility. The thinking was, “I
But values have to be based on something. American culture emerged out of a way of thinking that was based on an objective value system which emphasized personal responsibility. The thinking was, “I
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
something was bad or wrong with my business, it was my responsibility to make it right.” It included a very strong objective sense of what was right and wrong. The result of that value system is the powerful economic engine that the United States has become in the world today.
In recent years, though, there has been a significant shift in thinking. Rather
In recent years, though, there has been a significant shift in thinking. Rather
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
than a system which emphasizes personal responsibility, it is now very much one which places responsibility on everything else but self, with right and wrong being a matter of personal preference. This system cannot help but develop an Enron mentality.
There are a lot of different ways that we can get at right and wrong in business dealings. Every business
There are a lot of different ways that we can get at right and wrong in business dealings. Every business
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
as to structure its efforts according to its own line of business, the personalities of its people and the corporate culture. But there are three basic principals that must be the underlying foundation for all of them if that business wishes to progress to higher and higher levels of value.
The Three Foundational Principles of Business Values
1. There is an
The Three Foundational Principles of Business Values
1. There is an
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
objective right and wrong
There are two possible ways of looking at ethics. One is that there is a set of values which are right and the right values must be followed no matter the short term consequences. The second possibility is that particular values shift according to the situation.
The reason an objective set of values is so important is that it create
There are two possible ways of looking at ethics. One is that there is a set of values which are right and the right values must be followed no matter the short term consequences. The second possibility is that particular values shift according to the situation.
The reason an objective set of values is so important is that it 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
stability for the organization. Sure there must be flexibility to change with the times, but the flexibility needs to be in procedures, not in underlying values. If a company does not have a solid set of principles it is founded on and guided by, then every time a new leader comes along, the whole focus of the company might change. In the long run, this will
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
end up creating a disaster in company morale, stability and in the integrity of the organization.
2. The business maintains personal responsibility for it’s actions.
Responsibility for ultimate outcomes has to reside somewhere. Ultimately it resides with the person who is in charge. But for there to be a smooth and efficient operation of the organization, pi
2. The business maintains personal responsibility for it’s actions.
Responsibility for ultimate outcomes has to reside somewhere. Ultimately it resides with the person who is in charge. But for there to be a smooth and efficient operation of the organization, pi
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
ces of it have to reside with the individuals who carry out the various actions. To the degree everyone involved accepts responsibility for their piece of the operation, the company will move forward with great strength. The moment anyone begins trying to shift responsibility away from themselves, productivity and efficiency begin to go down.
3. Personal inte
3. Personal inte
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
rity is the rule. There is a commitment to do what is right.
We live in an era where many people look at integrity as an option, rather than a bedrock foundation stone. This means that you treat your customers and make business deals according to what seems useful at the moment.
This, though, creates two huge problems. The first is that you won’t have any c
We live in an era where many people look at integrity as an option, rather than a bedrock foundation stone. This means that you treat your customers and make business deals according to what seems useful at the moment.
This, though, creates two huge problems. The first is that you won’t have any c
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nsistency across the various parts of your business and over time. The second problem is that your customers and clients will not be sure how to deal with your organization. Both of these together will ultimately wreak havoc on your organization.
You Will Sink or Swim by Your Foundation
You do have a set of values that your organization operates by. The ques
You Will Sink or Swim by Your Foundation
You do have a set of values that your organization operates by. The ques
.
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
ion is not, “do they exist.” Rather, it relates to “what kind of control do you have over them?” If you do not consciously know what your organizations guiding principles are, you can not use them to build a strong identity, and your business relationships will flounder.
If you do not consciously know what they are, everyone will be creating their own and the
If you do not consciously know what they are, everyone will be creating their own and 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
e will be massive inconsistencies and confusion. It is worth whatever time and effort it takes to get a grip on the underlying principles that guide your organization’s operation, and to begin to create a conscious one that you can communicate to everyone. At that point, you will gain control of your operation in ways that allow your to move forward with power
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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