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One of the best lessons I have learned is the impact and importance of leadership. It is so easy to identify dysfunct

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

ional leadership in a company (or of a governmental entity!). Many times, the common misconception is that the execut

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

Examples of combination products may in

ves in the “ivory tower” sit around and relax, while the “workers” do all the work. Of course, happy and motivated em

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

loyees are essential to a company (I still teach that in seminars that I conduct). But I have observed and learned t

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

at it is the leadership in an enterprise that makes the difference ... and that is not exclusive to commerce.

I am a

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

Combination pro

avid devotee of Right Action, and I believe it is the umbrella for everything worthwhile in life, in our endeavors

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

nd, in my opinion, a solemn responsibility of every human being. Power comes not from dictatorship but from respect,

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

ogic and compassion ... all given by and returned to a quality leader. The substance of any situation is, of course

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

important ... but what makes any enterprise function well, easily, profitably and with verve and passion is people

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

working together. That is when Spirit is at its best, when respect and honor are not just words and when a truly gr

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

at company shines in daylight and in darkness. For many years, I counseled and taught this very principle. I gav

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

Following aspects would a

e a seminar called “The Magic of People” in which I taught the value and wisdom of “people first.” It is the essence

dd to the challenges in developing combination products:

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

f leadership.

Vision is extending ideas, sometimes simple ideas, “outside the box” and creating a new, really new,

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

hought. The person who conceived of eBay is a good example of this ... they thought that the internet had in it, as

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

part of its intrinsic nature, some characteristic that would fit some human need that was not yet conceived. They t

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

ought about many commonplace human endeavors and matched them up with internet capabilities ... and, yes, they came u

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

Professional from academic institutions, pharmaceutical industries, health care indust

with the activity “auction” and realized that the net was an ideal vehicle to carry that concept. This venture capit

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

list took the idea and translated it into action. It was a billion dollar idea!

Not to veer from the point here, it

.

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

is essential for the leader to constantly be projecting, envisioning, visualizing ... that is the root of entrepreneu

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

Companies that provide selfless information through particip

ial genius. Of course an action plan is required ... but only after the leader has set the stage for the performance

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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I recently received a phone call from a very enthusiastic, if not perky, flight attendant who has been working in the commercial sector for several years. I could tell that the airliner end of flying was no longer for her; I also heard a certain excitement in her voice as she imagined herself flying within business aviation. Truthfully, it is this type of conversation that inspires me to promote our industry as I believe it is one of the best industries around.

Everyone, at some time in their life, is overwhelmed and frightened. What do you do to change this situation.

It's critical, especially in this profession, that you have a never-ending plan that keeps your outlook (and correspondingly, your performance) at sky-high levels. And there's one proven way to do that consistently.

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