Main Subject - Business

In Part One, I described the Leadership Talk and how it is a much more effective leadership tool than presentations or speeches.

I also described two fundamental premises

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

that the Leadership Talk is based on.

In Part Two, I will show you the purpose of the Leadership Talk. You won't be able to give a Leadership Talk effectively on a cons

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

Examples of combination products may in

istent basis if you misunderstand its purpose.

The Leadership Talk doesn't drive purpose. Purpose drives the Leadership Talk. There is one and only one purpose of the L

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

adership Talk: that's to motivate people to be your cause leaders in meeting the challenges you face.

This is important in understanding the difference between Leadership

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

Talks and presentations/speeches.

You're a leader. You have a task to complete. Do you want the people you lead to simply do the task? Or do you want those people to

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

Combination pro

ctually take leadership of accomplishing the task? For the difference between doing and leading in terms of accomplishment is stock car and a formula 1 racer.

Clearly, y

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

ou can order them to accomplish the task; and if you're in a position of authority, they will most likely carry out the order. But they might not do it with full commitme

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

t. Or they may resent being ordered. Or they may be inclined to do nothing unless ordered, and so after accomplishing the task, they do little else but wait for the next

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

order.

However, their committing to take leadership involves your establishing a special relationship with them.

For instance, going back to the example I used in Part

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

ne, if one is a floor sweeper, one does the best floor sweeping, not simply by doing it but by taking leadership of floor sweeping.

Such leadership might entail: taking t

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

he initiative to order and manage supplies; evaluating the job results and raising those results to ever higher levels; having floor sweeping be an integral part of the ge

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

Following aspects would a

neral cleaning policy; hiring, training, developing other floor sweepers; instilling a "floor sweeping esprit"that can be manifested in training; special uniforms and insi

dd to the challenges in developing combination products:

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

nias; behavior, etc.; setting floor sweeping strategy and goals.

Otherwise, in a "doing" mode, one simply pushes a broom.

You may say, "Listen, Brent, a job is a job is

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

a job. This leadership thing is making too much of not much!"

Could be. But my point is that applying leadership to a task changes the expectations of the task. It even c

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

anges the task itself. Think of it, when we ourselves are challenged to lead and not simply do, our world is, I submit, changed.

Furthermore, though you may order people

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

to do a job, you can't order anybody to take leadership of it. It's their choice whether they take it or not.

This is where the Leadership Talk comes in. Using it, you

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

Professional from academic institutions, pharmaceutical industries, health care indust

et up the environment in which they make that choice.

The Leadership Talk is not only the most important way to get cause leaders; it is the only way to get them on a con

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

sistent basis.

In the final part of this three part series, I'll show you how to develop and deliver a great Leadership Talks.

2005 © The Filson Leadership Group, Inc.

.

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

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

Companies that provide selfless information through particip

rs with the included copyright, 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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Main Subject - Turbo Charge Your Career With The Most Powerful Leadership Tool Of All: The Leadership Talk: Part 2

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