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Main Subject - A Leadership Truth: It's OK Not to Know It All
Executives and other business leaders who “make it to the top” typically have invested many years in education, hard work, and self-sacrifice. Th
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
ey are seasoned veterans who have the potential to lead their organizations to new heights of competitiveness, profitability, and success.
But tr
But tr
; 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
thfully, most business leaders don’t know everything they need to know. It’s not their fault -- it’s simply a fact that’s helpful to admit. Runni
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
g an organization of any size is a complicated undertaking. Organizations are living, breathing entities in a constantly changing environment and
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the folks at the top have one of the toughest jobs around. How could they possibly know everything?
Successfully getting everyone on the same pa
Successfully getting everyone on the same pa
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e, developing vision, planning, and then executing to maximize profits and attain other objectives requires a delicate balance of cooperation, coo
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
rdination, and communication. In the present business climate, executives are expected to accomplish increasingly ambitious goals with a decreasi
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
g pool of resources.
To compound this problem, many capable executives heap added pressure on themselves by thinking and expecting that they shou
To compound this problem, many capable executives heap added pressure on themselves by thinking and expecting that they shou
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d know everything. Some may even feel embarrassed if they don’t have all the answers all the time.
In fact, people don’t expect those who are le
In fact, people don’t expect those who are le
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
ding them to be self-sufficient. They simply want them to be willing to ask for help when it’s needed, and to know where to go to get the answers
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
In other words, there’s no place for superheroes or “know-it-alls” in organizational leadership.
An interesting story about Henry Ford will illu
An interesting story about Henry Ford will illu
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
minate this point. After World War I, Mr. Ford – relatively uneducated, but one of the most economically powerful men on the planet - filed a law
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
uit against the Chicago Tribune for calling him “ignorant.” During the trial, the newspaper’s lawyer repeatedly tried to embarrass Mr. Ford with
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
rivial, needling questions designed to prove how much he didn't know.
Finally, when his patience was fully exhausted, Ford told the court that he
Finally, when his patience was fully exhausted, Ford told the court that he
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
had a series of buttons on his desk. He said that whenever he desired information or needed help to accomplish a task, he could immediately summon
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
the right person to fulfill his need. Henry Ford had deliberately surrounded himself with experts.
There was silence in the courtroom. The Chicag
There was silence in the courtroom. The Chicag
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
o Tribune’s attorney dropped his jaw in surprise. Up until that moment the lawyer had been enjoying considerable fun at what he believed to be Fo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d’s expense. But Ford’s remark spoiled the lawyer’s fun and changed the course of the trial.
When Henry Ford needed help, he knew exactly where
When Henry Ford needed help, he knew exactly where
.
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
o turn. In fact, he planned for it. Business leaders don’t need to be experts in everything. But they do need to be willing and able to ask for
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
help in the areas where they lack knowledge and experience.
So where is it that you may need some help? And what are you planning to do about it
So where is it that you may need some help? And what are you planning to do about it
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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