Useful Advices - Business

There seems to be two types of leaders in the corporate world these days; on the one extreme is the micromanager who supervises everyone's work,

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

and on the other end of the spectrum is the person who wants everyone to love him. Interestingly, neither approach is effective for true leadersh

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

p. Whereas the micromanager tends to turn people off simply because he doesn't respect the workers ability to do their jobs properly, the "lover"

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

commands no respect either as he tends to avoid taking a stand on any issue; he just wants to keep everyone happy and hopes they will somehow wor

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

together towards some common goals. Inevitably they do not and chaos ensues. I am reminded of what former UK Prime Minister Margaret Thatcher sa

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

d, "Standing in the middle of the road is very dangerous; you get knocked down by the traffic from both sides."

Frankly, to be an effecti

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

ve leader, I think you have to find a medium between the two extremes. As many of you know, I am an advocate of worker empowerment where you mana

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

e from the bottom-up, not just from the top-down. I think it is important to treat workers as professionals, such as giving them responsibility a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

d holding them accountable for their actions. If they believe their voice is heard, they are more inclined to accept responsibility and direction

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

I think this is an important part of leading a worthy life, both personally and professionally.

I'm also smart enough to know that a manager is

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

not in a popularity contest and is responsible for delivering results. This means the leader has to know the right direction to be heading, be ab

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

le to articulate it to the staff, and motivate them to get the job done. As such, it is more important for a manager to be respected as opposed t

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

loved. People will simply not produce the deliverables you want if they do not respect you.

One classic example of how you cannot lead through

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ove is exemplified in NBC's hit comedy, "The Office." In the sho

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

, Michael Scott (as played by actor Steve Carell) is a regional branch manager of an office that sells paper. Here, the manager desperately wants

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

to be loved by his staff, and the more he tries, the less the staff respects him and the office just stumbles along.

When it comes to leadership

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

, there can only be one captain, you cannot lead by democracy. You have to be able to give an order, and you have to have confidence the workers

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ill respond accordingly. This doesn't mean you have to sit over people with a whip and a chair as exemplified by micromanagement. It is about emp

.

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

werment and respect. If you haven't got respect, you won't be leading anybody anywhere anytime.

Perhaps the best interpretation of leadership I'

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e come across is from President Harry Truman who said, "Leadership is the ability to get men to do what they don't want to do and like 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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Useful Advices - Leadership - Two Extremes

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