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I recently read about a 66-year-old Romanian woman who gave birth to a baby girl. Sixty-six! She is the world’s oldest mother ever recorded, and it reminded me, as many things do, of the incredible uncertainties we face in life. (I’m uncertain whether the mother or

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

daughter will need the most naps ... or diapers.)

We hear stuff like this in the news every day, things that catch us completely off guard: Ken and Barbie (the dolls) break up after 40 years of dating, Martha Stewart goes to prison, SBC buys AT&T, K-Mart buys Sears .

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

Examples of combination products may in

. People say, "These are uncertain times we live in," and they’re right. But people have always said that. There are cave paintings in France that have been translated to read: "These are uncertain times we live in."

There’s no escaping the subtle and profound unce

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

rtainties in our lives. And although it’s tempting to try, we really shouldn’t want to escape. Think how boring complete certainty would be, how stagnating: certain what each day would bring at work, certain what we would do every night and every weekend, certain wh

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

t our path through life would be. Still, leading through uncertainty can be tough and stressful and scary, whether we are leading ourselves or other people.

You’ve probably all seen Deepak Chopra on TV — famous philosopher, self-help guru, and holistic healer. He w

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

Combination pro

sely points out that, ‘The search for security and certainty is actually an attachment to the known. There’s no evolution in that.’

In other words, uncertainty is essential for our personal growth. Hang on to what you know, and you’re not moving forward. The inevitab

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

le challenges in our lives often create beneficial paths and opportunities, if we’re prepared to take them.

How about this: "Let Go of What You Know To Grow!" That's a little like: "Use the Force, Luke." Or, "Be the ball, Danny."

Again, I make the argument that noth

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

ng is certain. Except for the usual suspect — death, taxes, and the sun rising and setting — certainty is an illusion that you might think you can get your hands around, but more times than not, you are fooled into a false sense of security.

Our path through life i

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

s never straight and smooth; we will sometimes need to backtrack, take new paths, and find our way out of the woods (usually when we least expect it). Like it or not, we have little choice but to embrace the unknown to survive and thrive.

What do leaders need to le

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

d themselves and others through uncertain times? Five key needs come to mind:

Clarity - People want their leaders to have a level of certainty in uncertain times. To do this, leaders need a strong core, and they need to help other people have a strong core. This me

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

ns having self-respect and dignity, solid principles and values, and a clear vision and mission. It allows us to maintain some stability through the uncertainties we encounter as we learn, grow, and progress.

Resiliency - We must be able to bounce back from setbacks

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

Following aspects would a

and obstacles in our path. Leaders must be willing and prepared to embrace the unknown, which means acting thoughtfully, and with courage, in situations that are new or uncomfortable. To be resilient, effective leaders learn from their mistakes, they don’t wallow to

dd to the challenges in developing combination products:

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

long in self-pity, they don’t walk away from a worthwhile fight or challenge, and they are willing to take risks or even change paths when opportunities arise. (As the turtle knows, we don’t progress without sticking our neck out.)

Perspective - Each of us, obviou

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

sly, sees the world through a relatively narrow set of experiences, biases, and perspectives. We tend to choose routines we are comfortable with, friends who are of a like mind, points of view that revolve around our circle of interest and influence … and that’s oka

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

. But to deal with an uncertain world, and lead others through uncertainty, we need to be open to new perspectives from a widely diverse group of people.

Continuous Learning - In his 1970 book, Future Shock, Alvin Toffler predicted: "The illiterate of the year 2000

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

will not be the individual who cannot read and write, but the one who cannot learn, unlearn, and relearn." Toffler was not far off the mark. Our ability to accept and adapt to rapid change dominates our lives. Continuous learning throughout adulthood used to be a lu

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

Professional from academic institutions, pharmaceutical industries, health care indust

xury, now it is a survival tactic. What we consider high performance today may likely be average or even low performance tomorrow. To continuously learn, we need to get in the habit of breaking old habits and routines that stifle our growth. Breaking and forming hab

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

ts is not easy, and it takes clarity, resiliency, and diverse perspectives to motivate us to make it happen.

Creativity - In past organizations, leadership tended to flow from the top down; decisions were made by a very few, and everybody else followed along in quiet

.

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

obedience. In these organizations, changes were slow to evolve, and managers were mostly concerned with maintaining the status quo. Improvement was primarily defined as eliminating performance gaps. Today’s organizations need to be more dynamic, nimble, and creat

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

Companies that provide selfless information through particip

ve to survive. They need to share leadership to allow people at all levels to challenge the status quo, make decisions, make suggestions, and make profound changes.

What additional personal ways do you lead yourself and others through the uncertainties in your life

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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A few keyboard shortcuts will pay off huge dividends in streamlining your workflow and enhancing the sheer enjoyment of working with Photoshop!

Quality logos are the foundation of marketing and promotional techniques for business. Among the characteristics associated with high quality logo design are uncluttered images and text, and minimal colors. The McDonald’s logo, “Golden Arches”, is a great example of an uncluttered logo that is simple, effective and widely recognized. Size is another characteristic which underlines the quality of a logo. Big or small, a quality logo has a matching background and distinct texture. The logo is included on all promotional material including business letterhead, presentation boxes, billboards and brochures.

Many factors such as globalization, technological advances, deregulation, privatization, mergers or acquisitions coupled with a movement of labor-intensive projects to less expensive locations and changing customer demands are forcing organizations to constantly review their purpose, vision and future strategy.

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