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Digg It - How to Help Your Company Become a World Class Company
Most people think real change in an organization occurs as a result of top-level leadership. This isn't always the case.
Oftentimes, it's someone within the rank and f
Oftentimes, it's someone within the rank and f
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
ile who stands up and challenges the status quo. Remember the old adage, "If the people will lead, the leaders will follow."
Years ago I was the s?les manager for comp
Years ago I was the s?les manager for comp
; 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
ny with about 30 employees. The business was struggling, and a management consultant had been called in to try and get things back on track.
In one of my meetings with
In one of my meetings with
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the consultant, I told him about some of the things that were going on that I didn't agree with. I explained that even though we were all encouraged to be open and hon
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
st, I feared that what I had to say might cost me my job.
His response was something I won't forget. He asked me if I really wanted to work for a company that said one
His response was something I won't forget. He asked me if I really wanted to work for a company that said one
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
thing and did another. He showed me that I really didn't have anything to l?se.
It was time to walk my talk. I could no longer hide behind the fear of losing my job.
It was time to walk my talk. I could no longer hide behind the fear of losing my job.
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
had to speak my truth. I did, and I didn't get fired. And even if I had been, it would have been worth it.
Anyone can be the catalyst for change. Sometimes all it tak
Anyone can be the catalyst for change. Sometimes all it tak
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
es is a question. Sometimes it requires a brave person pointing to the dusty mission statement hanging on the wall and saying, "Does this reflect our purpose?" or "Is t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
is consistent with our core values?"
Those responsible for the Enron and WorldCom scandals did not do their greedy deeds in a vacuum. Others knew something wasn't righ
Those responsible for the Enron and WorldCom scandals did not do their greedy deeds in a vacuum. Others knew something wasn't righ
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
t and yet they remained silent. At the very least we all have a responsibility to report illegal activity. We also should work toward making our company a world class c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
mpany.
Yes, it's true that it's risky. It does take courage. But like that consultant said to me, what do you really have to l?se? Better to shake things up a bit than
Yes, it's true that it's risky. It does take courage. But like that consultant said to me, what do you really have to l?se? Better to shake things up a bit than
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
remain silent. It's easier to find another job with a company more in tune with your values than to treat an ulcer or high blood pressure. Besides, it's the right thin
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
to do.
You can challenge with respect. You can question without being insubordinate. In so many instances, I've found that when just one person stands up for what's r
You can challenge with respect. You can question without being insubordinate. In so many instances, I've found that when just one person stands up for what's r
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
ight, others step forward as well. A leader doesn't have to be elected or appointed. A leader is often just someone who cares enough to speak what's in the hearts and m
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
nds of others.
Sometimes leadership becomes enlightened by blinding flashes of the obvious illuminated by those in the trenches. And if management can't handle the tru
Sometimes leadership becomes enlightened by blinding flashes of the obvious illuminated by those in the trenches. And if management can't handle the tru
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
th, it's time to seek out new management.
My personal belief is whether you work for--or own a company--you want it to be something you're proud of. You want the time
My personal belief is whether you work for--or own a company--you want it to be something you're proud of. You want the time
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
nd energy you invest in your career to be worthy of the best that's within you. You want it to make a difference.
Average isn't good enough. You want to look back on y
Average isn't good enough. You want to look back on y
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
our contribution with pride. Just putting in your time and collecting a paycheck may work for some people, but it shouldn't be sufficient for you. Stand up for excellen
.
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
e. Help your company become a world class company.
To get our fr?? report 'The Ten Pillars of a World Class Business' send an email to wcb@successnet.org For full deta
To get our fr?? report 'The Ten Pillars of a World Class Business' send an email to wcb@successnet.org For full deta
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
ils on the next World Class Business Conference, go to http://WorldClassBusiness.com
Copyright Michael Angier
Copyright Michael Angier
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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