Main Subject - Business

Have you ever worked with someone who always seemed to have the answers; who always seemed to know what should be done; who could always quote the experts vie

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

w on a certain situation, but for some reason, just couldn't perform as expected?

Working with a client last month I was struck by the fact that my client wa

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

Examples of combination products may in

s already very knowledgeable about the issue that we were discussing. As we talked through the situation it was clear to me that my client was well read on th

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

is subject. He also recounted for me several situations where his peers had similar issues and exactly how they were handled.

While many of my clients are ei

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

ther new in management, or have recently been promoted to a new, more challenging position, that was not the case with this individual. This was a seasoned le

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

Combination pro

der; an experienced executive who had been in his current role for several years.

He knew what to do.

He knew why he had to do it.

He knew what would happe

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

n if he did not act.

Yet here we were discussing a fairly routine issue that he should have handled without a second thought. He was not struggling with what

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

he needed to do. Rather he was struggling with actually doing it.

He had a fear of the results of his actions.

He had a fear of confrontation.

He had a fe

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

ar of action and struggled to do what he knew he needed to do.

Even more surprising was that he did not immediately recognize the struggle.

During our first

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

discussion of this issue, we talked about what the situation was and how it should best be handled. We agreed on the action steps and the timeframes for acti

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

n. Several weeks later the same topic came up again and I was surprised to find that he had not taken the actions agreed upon. In fact, he was very interested

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

Following aspects would a

in discussing the theories around what should be done and the expected results. You could see and hear that the discussion energized him and that he was prou

dd to the challenges in developing combination products:

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

d of his knowledge and his ability to understand and articulate the concepts.

But he could not, or would not act.

A leader who does not take action is like

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

a guard dog that growls but won't bite. The growl may fool the burglar for a while, but eventually he will just ignore the dog.

It should come as no surprise

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

that there is a big difference between understanding what to do and actually doing it. Whether it be in life, sports, or business we often know the right thi

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

g to do and how it must be done. But actually doing it can be a different thing altogether.

Especially when what has to be done is unpleasant.

Good managers

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

Professional from academic institutions, pharmaceutical industries, health care indust

and leaders know that doing unpleasant things, and making unpopular decisions are a part of their responsibility. The difference between successful and unsuc

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

cessful leaders lies not in knowing what to do, but in doing the right thing at the right time.

If you find that you know what needs to be done, but struggle

.

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

with actually doing it, then it may be time for a good hard look in the mirror. It's not enough to know what must be done if you don't take action.

Knowledg

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

Companies that provide selfless information through particip

e without action is empty leadership. You may be able to fool yourself, but you won't be able to fool the people who are looking to you for hope and direction

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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...In many situations we act without even knowing why we act the way we do...This is no longer desirable when your organization is changing too often...Knowledge Management is (amongst other aspects) about making the “private” knowledge “publicly” available...So that you can bridge the Knowledge Gap...But your organization was not used to this. Different teams applied different principles...And now what? How to address this new set of principles so that knowledge management is adopted in the primary process?

You probably already have a business plan in place, or you are in the process of writing your business plan. But, what about your life plan? Having a life plan is just as important to the success of your business as your business plan is. Learn more about why a life plan is important to the success of your business. Learn about the important elements to consider in developing your life plan.

College entrepreneurs and business owners are often hindered by remaining in college. This article will tell you why it might be a good idea to drop out of college.

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