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When Patrick Lencioni wrote ‘The Five Temptations of a CEO’ he gave a pretty clear picture of the level of mastery required for high performance leadership. These are tricky times make no mistake. CEO’s have a 90 day or less window to show results which makes sense given the speed of time but not when pl

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

aced in corporate culture and working environments distracted by superficial symptoms of a deeper dynamic.

Global change activates a subtle, typically undetected dynamic, putting pressure on the cultural context. It is imperative to see what is at work beneath the surface otherwise it is easy to do what

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

Examples of combination products may in

has always been done while expecting different results. Upgrading existing skills assists in two ways:

1) widening of the perceptual lens to see how the global dynamic creates what is on the surface and

2) accessing insight to know what changes will create the desired result no matter how complex the s

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

ituation is.

There are three groups of skills that can heighten the effectiveness of corporate leadership. Samples are provided in case you want to try this out:

Sensing skills to gather information:

We typically rely on the mind and ideas. Since the origins of performance are not visible i

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

takes a strong sensing skill to avoid the temptation to do what has always been done, when the situation calls for a radically different approach.

Skill #1: Develop your Personal Self-Witness: You can’t change what you can’t see. Your witness is your trained observer, the one who can step o

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

Combination pro

tside your day to day actions and see things as a movie camera does—WITHOUT JUDGING what is going on. Your witness is your conscious ally, your friend who assists you in seeing yourself. Seeing what you are unknowingly doing creates the clarity required to see things differently.

Skill #2: Ask Questi

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

ons the Logical Mind Cannot Answer: Questions enable you to reveal assumptions, follow your hunches, and assess situations before jumping to conclusions. Curiosity allows you to suspend judgment, the latter being totally completely useless when there is a need to improve performance or engage the dis

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

ngaged. Inevitably organizational problems are addressed with the same solutions: cut expenses, increase revenues, train people. Digging deeper allows you to see the root problem enabling clearer insight into the actions that leverage results.

Skill #3: Whole Body Listening: Next time you

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

re listening to someone, notice what your mind is doing. Since only 7% of communication is in the word then the rest is in your sensory capacity to detect what image is being conveyed.

Gaining clarity – Expanding perspective:

Organizational patterns and habits can drive even the most astute

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

individual into a narrow lane giving the appearance of limited options. As organizational patterns come into clear view you have the chance to widen the range of alternatives and forge direction anew. These tools reveal the heart of the matter – a powerful ally to create lasting solutions rather than mo

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

e the furniture around.

Skill #4: Actively Reflect on Experience: We do not learn from experience, we learn from reflecting on it. Reflection is the ground where experience becomes knowledge and wisdom, where understanding and alternatives surface. Once a week whether you need it or not. Ot

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

Following aspects would a

erwise, your habits are doing all the driving and misunderstandings accelerate into deeper divisions. You can’t connect the dots unless you stop, stand back to see what they are.

Skill #5: Increase your emotional awareness at the source of your expression: The force of emotion is clearly conveyed

dd to the challenges in developing combination products:

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

through word and is absorbed by the listener. The human emotional processor operates at about 80,000 times faster than the mental one. Whatever you are feeling emotionally, unless you have mastered the unhealthy habit of emotional repression, it is felt by the listener.

Selecting the best course

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

of action given a series of complex and contradictory factors.

Making sense out of contradictory information operating within an even more complex dynamic demands use of all of the above skills plus consistently exercising pulse checks using the skills below.

Skill #6: Shifting Perspective<

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

b>: Perspective is defined as a visible scene, the state of ones ideas. Wouldn’t it be helpful to be able to shift the scenery and view before committing to costly and irreversible action? This is very useful portable skills but for executives it is helpful before making big moves to explore the range of

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

possibilities before taking the step. This is not to be confused with exploring or exercising options. Step out of one perspective and viewing the situation from a totally different place can change the effectiveness and level of leadership engaged. The ability to shift perspective is the key to gain

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng enlightened insight.

Skill #7: Discernment: Judgment, guided by your mind, sorts information (or people) into right or wrong, weak or strong with convenient labels. The file drawer is sorted out and who knows what insights and hidden potential were also filed and dismissed in the process.

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

Discernment is the delicate ability to distinguish what is not evident, what is true or appropriate.

Finally developing or upgrading yourself in any way requires self-discipline.

This is what horses have that keeps them from betting on people. Steve Pavlina on his blog defined “Self-di

.

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

scipline (as) is the ability to get yourself to take action regardless of your emotional state.”

Self-discipline helps us stay on the path when it would be easier to stray or submit to other temptations like distraction, procrastination or avoiding something appearing scary or unfamiliar.

Notice ho

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

Companies that provide selfless information through particip

you practice these skills in your own life and at work. You must be willing to see the current situation for what it really is rather than the way you want it to be and be open to making changes.

This is not about ‘fixing’ yourself. It is about improving your relationship with you. The rest will follow

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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Just Other Articles - Executive Skills - 7 Critical Upgrades for Personal and Professional Use

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