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Sun Tzu in the Art of War talks about the perils of a leader who lacks the ability to be decisive. When battling in business today, you are watched very cl

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

osely as a leader. One thing that teammates of a leader will not forgive is lack of certainty. By your words, voice qualities and body language - you either

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

Examples of combination products may in

transfer certainty or you transfer doubt. People want to follow a leader who can clearly paint a compelling picture of the future. The events of the past se

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

eral years have shaken that trust in corporate America with a sting of disappointments.

Maybe your company saw it stock price chopped by 80% or more, had r

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

peated downsizings or even went out of business. There still are many companies and individuals in the survival mode today. They are concerned with survivin

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

Combination pro

and not thinking how they can out innovate, out think and out hustle the competition.

What difficult leadership situations have you found yourself in the

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

ast few years? One simple concept to remember when facing adversity is that there is a difference between difficult and impossible. A couple years ago when

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

playing for the Arizona Cardinals, Jake Plummer and his team found themselves down my 21 with twelve minutes left against the Eagles in Philadelphia. Most t

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

ams would fold in that situation, but the Cardinals had Jake. According to an article in Sports Illustrated, this was not a new situation for him. In six se

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

sons there he directed 21 game-winning drives in the forth quarter or overtime.

The story in the newspaper by the AP quoted Jake as saying, “With 12 minute

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

I don’t think I had to say it, but I did anyway.” I said, “We’re down, but we’re still in it!” Then he went down the benches yelling, “You gotta’ believe!”

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

Following aspects would a

They came all the way back and won the game 25-24 on a last second field goal by Chris Jacke.

I’ll bet he didn’t go to just anybody on the bench. He went h

dd to the challenges in developing combination products:

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

s “go to” guys that he knew he could ignite a spark of conviction in first. He did it with enthusiasm, conviction and planted the seed of possibility in the

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

r minds. Sometimes to turn around momentum, all it takes is one person who makes a decision. A key belief to adopt as a leader is:

I can rally others to be

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

lieve in what has not happened yet.

What can you do to test yourself? Set up a video camera to record your performance speaking to your team. It takes guts

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 record and even more to watch it. You get more feedback on what you are doing well and how to improve quickly than you can imagine.

When faced with adve

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

Professional from academic institutions, pharmaceutical industries, health care indust

sity on the job or at home, how do you handle it? Does you attitude quickly become negative and resort to the “this is going to be impossible to turn around

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

mode? Or do you think, “I love a challenge. This is not going to be easy, but it is absolutely possible!” Once you can get yourself, a teammate or one of y

.

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

ur children to acknowledge that the challenge ahead is difficult but not impossible, then the brain kicks in and says: Then there is a way to overcome this?

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

Companies that provide selfless information through particip

What is my first step?” Companies today are starving for leaders to step up and take a stand. Victory in the next battle your company faces may hinge on you

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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If you plan on graduating in May, you should start planning now. Entering the real world may come at you like a ton of bricks if you do last minute preparations. This article will help 4th year college students start post-grad preparations now without denting free time. What you should do-

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