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I just learned of another NBA player who has been accused of domestic violence. This is the third or fourth time that this player has had off-court pr

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

oblems which are in addition to numerous on-court issues. I am waiting to hear the lame excuse his team officials are going to use to defend this guy.

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

Examples of combination products may in

Oh, did I mention he is an all star?

This guy is a cancer on his team and is going to negatively affect it. It never fails…there will be an inevita

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

ble implosion sometime down the road and the team owners and coaches will bang their heads and think “we should have kicked him off the team a long tim

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

e ago”.

I am amazed at how many business leaders have these same kinds of characters working for them, being protected because they are “all stars” (i

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

Combination pro

e. leading producers) whom they protect because of their production, turning their back on their negative behavior.

They are holding the company hosta

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

ge. And it happens every day.

The best companies attract good people. They don’t want people who are characters, they want people of character.

The

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

people in companies who are the characters are the ones who are slowly corroding the company from the inside. As if outside forces such as competition

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

, strategic decisions, hiring and recruiting decisions, and our friends at the government(s) weren’t enough, these characters eat at the guts of the co

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

mpany by actions such as not enthusiastically participating in team meetings, constantly questioning management decisions, and calling other employees

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

nd complaining about everything that they can’t control. The creep moves slowly but it can be a powerful negative force. Exposure to new employees ca

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

Following aspects would a

n be disastrous.

Does this sound like one of your employees? If so, what can you do?

Here are a couple of things that should be done and soon.

Firs

dd to the challenges in developing combination products:

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

t of all, senior management needs to confront the situation head on. The character in question must be made aware of how the negative consequences of

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

his or her actions can impact the culture of the company and ask if they would be willing to watch their actions. It is possible that the person in qu

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

estion is simply not aware of how they are affecting the company and they will be glad to cooperate.

If the actions continue in spite of the request o

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

management, the character must be removed. This can be done with compassion and kindness, but it must be done.

Otherwise, the culture of the company

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

Professional from academic institutions, pharmaceutical industries, health care indust

will continue to be one of ambivalence as other employees observe the behavior in question and rationalize that either that behavior is acceptable or

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

that it is only acceptable behavior for the company top producers. Either way, this is bad.

Additionally, and predictably, the negative behavior whic

.

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

h is quietly being approved by management reaches the point of intolerance and action has to be taken swiftly. This usually becomes uncomfortable, str

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

Companies that provide selfless information through particip

essful, and internal company headline news.

Early positive action is the better choice. Remember…great teams are built with character, not characters

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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When a disaster happens, failing to prepare is preparing to fail. Those that are prepared in advance with the correct supplies and action plan will inevitably be in a better position than those that do not. You should develop a unique action plan for each place that you and members of your family visit; this includes work, school, the gym and the homes of other members of your family.

You are certain to have conflicts with your boss if you are a pro-active type. But you can manage these dust-ups to your advantage.

What you learn now should not only grow your business but should set the stage for how your business will run in the future.

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