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According to a recent government report the business world is currently in a leadership crisis. Up and coming managers, those w

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

ho will be our business leaders of the future do not see examples of “inspirational leadership” in their work places. Employee

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

Examples of combination products may in

long to see a genuine shared vision, real confidence and trust in teams and respect for colleagues, customers and employees. Le

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

s than 40% of managers actually see these traits on display in the workplace.

Where did all our leaders go? Perhaps we have pla

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

ed too much emphasis on management of our businesses instead of leadership. I would hazard a guess that more people are comforta

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

Combination pro

le with the thought of becoming a manager then they are with being asked to take the position of leader. Therefore, naturally w

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

have more aspiring managers than leaders but a much bigger percentage of managers are capable of becoming leaders in their fiel

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

s that are actually stepping up to this role. Why?

What is leadership? Perhaps we don’t have as many leaders as we need because

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

not enough of us understand what leadership is really all about and who can become a leader. Can you take someone who isn't a na

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

ural leader and turn them into one? Are we all leaders in our own unique way? What do Leaders do and what skills do they need?

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

Leadership is about behaviour first, skills second. Good leaders are followed chiefly because people trust and respect them, ra

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

Following aspects would a

her than the skills they possess. Leadership is different to management. Management relies more on planning, organisational and

dd to the challenges in developing combination products:

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

ommunications skills. Leadership relies on management skills too, but more so on qualities such as integrity, honesty, humility,

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

courage, commitment, sincerity, passion, confidence, positivity, wisdom, determination, compassion and sensitivity. Some people

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

re born more naturally to leadership than others. Most people don't seek to be a leader. Those who want to be a leader can devel

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

p leadership ability. Leadership can be performed with different styles. Some leaders have one style, which is right for certai

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

Professional from academic institutions, pharmaceutical industries, health care indust

situations and wrong for others. Some leaders can adapt and use different leadership styles for given situations. Some leaders

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

re big, bold and brash characters, others are quiet, unassuming but determined and visionary. As a leader you must know yoursel

.

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

and know your own strengths and weaknesses, so that you can build the best team around you. Leadership is about finding the bes

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

Companies that provide selfless information through particip

in yourself and giving the best of yourself. Leaders always go first, setting the example, walking the talk, doing not dabbling

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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