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Remember playing in your childhood sandbox? If you enjoyed being outside for most of the day, you could play in the sandbox for hours on end—shaping and pouring the sand or mixing it with a little water t

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

o form a castle or hill. Children enjoy playing with sand or dirt and learn at an early age how to make the most of this play time activity.

Playing in a sandbox usually starts out as a solitary exercis

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

Examples of combination products may in

e; however, smart parents know that in order to develop their child’s ability to relate to others, another child or two must be introduced into that same sandbox. This is when the fun truly begins.

When

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

children play together in the same sandbox:

They learn to trust each other.

Their ability to be gentle, kind and considerate is developed.

Friendships are initiated and nur

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

ured.

Positive interaction increases and selfishness decreases.

They find creative ways to work together, satisfying their curiosity and increasing their enjoyment and fun.

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

Combination pro

You’re Never Too Old for the Sandbox

There’s a tremendous amount of pressure as we grow older to learn to act our age (whatever that means). In fact, most people consider age a number not an indi

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

cation of vitality, health or maturity.

Nevertheless, too many of us leave the things of childhood behind us. This is both good and bad. It is good to leave childish behavior behind, but bad whe

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

we discard many childlike behaviors that can make us successful adults.

One such childlike behavior is learning how to develop reliable relationships with others through experiences in the same s

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

andbox that teach us how to cooperate, exchange ideas, and communicate.

When we play together in the same sandbox at work:

It is important to know and understand the rules and limitations of p

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

lay; but when we take the time to do so, we find that it is fun to mix with others, develop positive peer relationships naturally, and to encourage a spirit of lighthearted camaraderie.

We learn

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

to practice balanced self-control—the right combination of expressing our opinions and feelings when facing difficult or unexpected events. Our sensitivity to and concern for others is demonstrated as we

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

Following aspects would a

attempt to understand their perspectives.

We willingly let down our guards and shift our mindsets to try new and fresh ways of doing old tasks. We bask in the energy boost that results from expe

dd to the challenges in developing combination products:

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

rimentation, creativity, innovation, and learning new skills.

Our communication skills are stimulated and enhanced. Bridges are built between people who were once estranged. Conflict surfaces

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

and is resolved.

How to Have More FUN in Your Workplace Sandbox

Think of yourself playing with your co-workers in the same sandbox (Don’t turn into a skeptic on me now).
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

Share your creative ideas for improving your team’s effectiveness with the entire team; then together select one on which to experiment.

Make sure to include every member of your team in s

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

ome part of the experiment. Develop receptiveness and tolerance of others.

Solicit their feedback on a regular basis and bring any challenges or obstacles to the entire team for resolution. Do

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

Professional from academic institutions, pharmaceutical industries, health care indust

n’t be afraid to proactively exchange differences in opinion. These are healthy if allowed to surface early. They can be destructive if allowed to fester.

Celebrate every accomplishment—no mat

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

er how small. Little wins recognized as they occur communicate a sense of satisfaction and accomplishment, build confidence and turn an average team into a highly motivated one.

Play dynamicall

.

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

y and interact enthusiastically with each other. It has been said that a burden shared is a burden halved. So, have some fun in your work together.

Select another experiment and begin the proce

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

Companies that provide selfless information through particip

ss all over again.

If you’re not having fun at work while playing in the same sandbox with co-workers, you’re not doing it right. Give it another try. I think you’ll be pleased that you did

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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Digg It - Building Successful Work Relationships--Playing In The Same Sandbox

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