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'Management and leadership', frequently these terms are heard together.

Are they interconnected?

Are there any differences between them?

This is a conversation that has been going on for so

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

me time and will be around for some time to approach. It is a general topic for debate in all places. The fact is that you cannot escape this topic if you are working.

A leader is a person wh

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

Examples of combination products may in

o leads whereas a manager is one who manages. This is not funny, but we have to start somewhere and what better than the basic definitions. The biggest difference as supposed by others is the

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

way in which they motivate people. In life nothing is black or white, everything is a different shade of grey. In the same way a manager can be a leader and vice versa. So, we can have a mixtu

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

e of both.

Management will tell you that managers have subordinates. Managers are given some powers by the company and the subordinates have to do as they are told. The incentive for a subord

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

Combination pro

inate to do what the manager says is the reward that is given. So, if the subordinate does as he/she is told they are going to get their pay. They are not blind robots but the incentive makes

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

them behave like that. In contrast leaders have followers. And following is a voluntary activity. Leaders do not tell people what has to be done, instead they show them the way by taking initi

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

ative and doing things first. Leaders show them that if they follow the leader they are going to fulfill their heart's desire.

What is the chief focus for a manager?

Management will tell you

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

that the chief focus for a manager should be a manager. They are paid to get things done. After all they are themselves subordinate to some other manager. They often have deadlines looming ahe

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

ad so they cannot afford focusing on anything else. Leaders on the other hand focus on people. They have a way with people; they give recognition to others and take blame themselves. This crea

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

tes a loyal base of followers around them. This doesn't mean that they are very friendly with their followers.

On the contrary most of them maintain a sort of unfriendliness to maintain their

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

Following aspects would a

charisma. Managers seem to seek comfortable lives. They are planners and so avoid taking risks. They avoid situations which will lead to conflict and prefer to have cordial relationship wit

dd to the challenges in developing combination products:

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

others. Leaders on the other hand, seem to seek risk. It is not that they are looking for thrills. The thing is that leaders have a vision and so, are ready to face any problems that they enc

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

ounter in order to make that vision a reality.

There is a difference in the perspective of both. At the same time as managers think incrementally, leaders think radically. You have all heard

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

of the phrase "Managers do things right whereas leaders do the right thing." So, while managers tend to do think by the book, leaders tend to go more by their instinct. A manager is practical

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

whereas a leader is more emotional. That is why we tend to follow leaders because they reach us at an emotional level. Management usually consists of people who are experienced in their field.

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

Professional from academic institutions, pharmaceutical industries, health care indust

They are people who know how the whole system works. A leader on the other hand can be a new employee with new ideas and vision, but without the necessary experience and wisdom to make it work

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

.

So, will the twain never meet? They will and they do. As any management will declare a great manager is one who is also a good leader. But, for a manager to be effective he cannot just be a

.

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

leader. He needs the formal authority of management to be really effective. Similarly a leader needs to have some managerial skills if he has to realize his vision. We can go on about the dif

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

Companies that provide selfless information through particip

ferences between management and leadership.

Understanding the differences is necessary so as to make the workplace more productive.

And this all I want to say about a “MANAGER” & a “LEADER “

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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