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Nearly all leaders I've encountered are underachievers. They're getting a fraction of the results they are capable of. And in most cases, it

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 their fault. Their failures are the result of the choices they make. For the opportunities to consistently get more results are all aroun

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

Examples of combination products may in

them all the time, theirs for the taking.

For instance, to start getting more results than you are accustomed to getting, you simply have to

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

change your mind-set. You should aim to make your leadership your life and your life your leadership. If you don't, you diminish both your l

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

adership and your life.

To have the change in mind-set really sink in so it changes you in a deep, fundamental way, you must cultivate two dy

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

Combination pro

amics: a vision of the purpose of your leadership, and the dedication to realize that purpose.

The word "vision" has been used and misused ad

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

nauseam. The trouble is that most leaders misunderstand it. When they think "vision", they look at themselves, at what they can do for thems

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

lves. To do well for yourself, an inward focus is the wrong place to look.

Here's a vision that you can carry with you for the rest of your

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

areer, for the rest of your life. I call it the Leadership Imperative.

I WILL LEAD PEOPLE IN SUCH A WAY THAT THEY NOT ONLY ACHIEVE THE RESUL

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

S WE NEED BUT THEY ALSO BECOME BETTER AS PEOPLE AND AS LEADERS.

This vision has two parts: one is result-accomplishments and the other is the

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

betterment of the people.

You are never more powerful as a leader as when, in getting results, you are helping others be better than they are

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

Following aspects would a

-- even better than thought they could be. Guided by the Leadership Imperative, you'll find that the jobs you take on, the career(s) you hav

dd to the challenges in developing combination products:

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

, will, in terms of your doing well by them, take care of themselves.

However, vision alone is not enough. You must be dedicated to realizin

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

it. Realizing this vision means living not an easy life for ourselves but a hard life for others.

There are many ways to make such realizat

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

on happen, and it should be our life's journey to find them and put them into action. The point is that when you turn the focus of your ambit

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

ons away from yourself and toward other people, when you become truly ambitious for their success, your success will take care of itself.

How

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

Professional from academic institutions, pharmaceutical industries, health care indust

do we really let our leadership sink deeply into our life and change it and shape it throughout our lives? By dedicating ourselves to passion

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

.

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

le may be republished in newsletters and on web sites provided attribution is provided to the author, and it appears with the included copyrig

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

Companies that provide selfless information through particip

t, resource box and live web site link. Email notice of intent to publish is appreciated but not required: mail to: brent@actionleadership.co

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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