Advice You - Business

Take a moment to paint a mental image of someone you hold in esteem as a leader. Focus on appearance, actions, habits, and life-style. When your picture appears sharp and clear, ask yourself these question

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

s:

o What specific personality characteristics does this person possess?

o How does this person relate to others, professionally and socially?

When you’ve examined thoroughly the qualities that you feel m

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

Examples of combination products may in

ake this person a leader, ask yourself one more questions: Was this person born with such well developed leadership traits? The answer, though it may be startling to some, is that they are all learned, whe

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

ther in childhood or later in life. Erase from your mind now, any traces of the myth that “leaders are born, not made.”

For some this may take away the last vestiges of hope, as one may think that his or h

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

er only hope for achieving effective leadership are the qualities with which they were born. For others, this may be the first bright rays of the dawn. Let me say to those in both categories, do not be dis

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

Combination pro

couraged. There is hope. Possibilities begin here because the development of your leadership abilities lies in your hands. This is where you have the opportunity to blossom and flourish as you learn to co

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

nstruct the abilities that you need and desire as a leader at any level.

As you set your foot on the path to great leadership, it is important to look inwardly and evaluate where you are in different facets

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

of your life. Ask yourself “How am I doing mentally, socially, and physically? Are my finances and career where I want them to be or at least on track to get where I want them to be? Am I putting enough

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

thought into my personal beliefs and my family life?” These are basic life areas that everyone puts time into, to some degree, depending on what stage in life in which they are. Evaluating these areas is a

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

n important first step to effective leadership, for as you learn to balance these areas well in your own life, you will lead by example those under you. Furthermore, you will be able to understand and addre

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

ss the problems of a subordinate who is having trouble balancing these areas.

Gaining a firm grasp on the different areas of your personal life will enable to then look at where you are with skills, job kno

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

Following aspects would a

wledge, and productivity. You will be able to focus on whether or not you and/or your subordinates are bringing your organization the profit of which you and they are capable. You will be able to improve y

dd to the challenges in developing combination products:

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

our time management and develop more effective ways to improve your people and your products.

In articles to follow I will be discussing effective ways to evaluate and set goals for personal, family, and or

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

ganizational life areas. As we focus on these areas, we need to remember this epitaph of an Anglican bishop.

“When I was young and free and my imagination had no limits, I dreamed of changing the world. A

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

s I grew older and wiser, I discovered that the world would not change, so I shortened my sights somewhat and decided to change only my country.

But, it too, seemed immovable.

As I grew into my twilight ye

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

ars, in one last desperate attempt, I settled for only changing my family, those closest to me. But alas, they would have none of it.

And now as I lie on my death bed, I suddenly realize if I had only chan

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

Professional from academic institutions, pharmaceutical industries, health care indust

ged myself first, then by example, I would have changed my family. From their inspiration and encouragement, I would then have been able to better my country, and who knows, I may have changed the world.”

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

Ambitions are both good and necessary. But if we try to change what is around us before changing ourselves, our sphere of influence will shrink to molecular levels. As we are all that we can actually full

.

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

y and completely control.

It stands to reason that we ought to start here and work our way out. If we do not, it is much like trying to extinguish a fire from the top down. We spray and spray and yet, bec

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

Companies that provide selfless information through particip

ause we are not spraying at the base of the fire, the flames may be contained but are never extinguished until we run out of foam and realize that we have accomplished nothing and the flames will consume us.

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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Failure has a devastating effect on people who are easily discouraged. This is not something that you should be ashamed about. You are a failure only when you quit trying. Those with big successes usually had a few a failures along the way. Failing doesn't mean failure; it just indicates that you need to keep trying.

There is a single fundamental truth in branding that is true regardless of industry, company, or product: IN ORDER TO BE SUCCESSFUL, YOU MUST BE WILLING TO WIN. The great Vince Lombardi once said, “Winning isn’t everything, but the will to win is everything.” Meaning, if a company, team, or individual does not have the will to win, they will never be able to win.

If we are unlucky enough to be at the wrong place at the wrong time, we experience a personal tsunami - a misfortune of devastating proportions that sweeps away our routine lifestyle and forever changes the world we know.

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